GOVERNMENT OF INDIA 

MINISTRY OF HEALTH AND FAMILY 
WELFARE 

(Department of Health) 

THE DRUGS AND COSMETICS ACT 
AND RULES 

THE DRUGS AND COSMETICS ACT, 1940 

(23 OF 1940) 

(As amended  up to the 31st  December, 2016) 

and 

THE DRUGS AND COSMETICS RULES, 1945 

(As amended  up to the 31st  December, 2016) 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LIST OF ABBREVIATIONS USED 

A.O. 1950  ……………………………… 
Cl.  …………………………………. . … 
Ins.  …………………………………….. 
P.    ……………………………………… 
Pt.  ……………………………………… 
Reg.  ………………………………........ 
Rep.  …………………………………… 
S.  ……………………………………… 
Sch. ……………………………………. 
Sec.  ………………………………......... 
Subs.  …………………………………… 
w.e.f.  …………………………………… 

For  Adaptation of Laws Order, 1950 
Clause 
‖ 
Inserted 
‖ 
Page 
‖ 
Part 
‖ 
Regulation 
‖ 
Repealed 
‖ 
Section 
‖ 
Schedule 
‖ 
Section 
‖ 
‖ 
Substituted 
‖  With effect from 

CONTENTS 

Pages

The Drugs and Cosmetics Act, 1940   (23 of 1940)  ………….     1−30 

The Drugs and Cosmetics Rules, 1945  ……. . . ……………...   31−546 

2 

 
 
 
 
 
 
 
 
 
 
 
 
THE DRUGS AND COSMETICE ACT, 1940 

iii 

CHAPTER I 

INTRODUCTORY 

Sections 

1.        Short title, extent and commencement. 

2.        Application of other laws not barred. 

3.        Definitions. 

3A.  Construction of references to any law not in force or any 

functionary not in existence in the State of Jammu and Kashmir. 

4.        Presumption as to poisonous substances. 

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY 
AND THE DRUGS CONSULTATIVE COMMITTEE 

5.        The Drugs Technical Advisory Board. 

6.        The Central Drugs Laboratory. 

7.        The Drugs Consultative Committee. 

7A. 

Sections  5 and 7 not to apply to Ayurvedic, Siddha or Unani 
drugs. 

CHAPTER III 

IMPORT OF DRUGS AND COSMETICS 

8.        Standards of quality. 

9.        Misbranded drugs. 

9A.      Adulterated drugs. 

9B.       Spurious drugs. 

9C.       Misbranded cosmetics. 

9D.      Spurious cosmetics. 

10.       Prohibition of import of certain drugs or cosmetics. 

10A.  Power of Central Government to prohibit import of drugs and 

cosmetics in public interest. 

11.       Application of law relating to sea customs and powers of 

Customs officers. 

12.       Power of Central Government to make rules. 

13.       Offences. 
14.       Confiscation. 
15.       Jurisdiction.

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

CHAPTER IV 

MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND 
COSMETICS 

Sections 

16.       Standards of quality. 
17.       Misbranded drugs. 
17A.     Adulterated drugs. 
17B.      Spurious drugs. 
17C.      Misbranded cosmetics. 
17D.     Spurious cosmetics. 
18. 

Prohibition of manufacture and sale of certain drugs 
and cosmetics. 

18A.     Disclosure of the name of the manufacturer, etc. 
18B.      Maintenance of records and furnishing of information. 
19.       Pleas. 
20.       Government Analysts. 
21.       Inspectors. 
22.       Powers of Inspectors. 
23.       Procedure of Inspectors. 
24. 

Persons bound to disclose place where drugs or cosmetics 
are manufactured or kept. 
25.       Reports of Government Analysts. 
26.       Purchaser of drug or cosmetic enabled to obtain test or analysis. 
26A.  Power of Central Government to prohibit manufacture, etc., 

27. 

of drug and cosmetic in public interest. 
Penalty for manufacture, sale, etc., of drugs in contravention 
of this Chapter. 

27A.  Penalty for manufacture, sale, etc., of cosmetics in 

contravention of this Chapter. 

28.       Penalty for non-disclosure of the name of the manufacturer, etc. 
28A.  Penalty for not keeping documents, etc., and for non-disclosure 

of information. 

28B.  Penalty for manufacture, etc. of drugs or cosmetics 

in contravention of section 26A. 

29.       Penalty for use of Government Analyst‘s report for advertising. 
30.       Penalty for subsequent offences. 
31.       Confiscation. 
31A.     Application of provisions to Government departments. 
32.       Cognizance of offences. 
32A.     Power of Court to implead the manufacturer, etc. 
33.       Power of Central Government to make rules. 
33A.     Chapter not to apply to Ayurvedic, Siddha or Unani drugs. 

CHAPTER IV A 

PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS 

33B.     Application of Chapter IV A. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Sections 

33C.         Ayurvedic, Siddha and Unani Drugs Technical 

Advisory Board. 

33D.        The Ayurvedic, Siddha and Unani Drugs Consultative 

Committee. 

33E.         Misbranded drugs. 
33EE.       Adulterated drugs. 
33EEA.      Spurious drugs. 
33EEB.  Regulation of manufacture for sale of Ayurvedic, 

Siddha and Unani drugs. 

33EEC.      Prohibition of manufacture and sale of certain 
Ayurvedic, Siddha and Unani drugs. 
Power of Central Government to prohibit manufacture, 
etc., of Ayurvedic, Siddha or Unani drugs in public 
interest. 

33EED. 

33F.         Government Analysts. 
33G.        Inspectors. 
33H.        Application of provisions of sections 22, 23, 24 and 

33-I. 

25. 
Penalty for manufacture, sale, etc., of Ayurvedic, 
Siddha or Unani drugs in contravention of this 
Chapter. 

33J.         Penalty for subsequent offences. 
33K.        Confiscation. 
33L.         Application of provisions to Government departments. 
33M.        Cognizance of offences. 
33N.        Power of Central Government to make rules. 
33O.        Power to amend First Schedule. 

CHAPTER V 
MISCELLANEOUS 

33P.      Power to give directions. 
34.       Offences by companies. 
34A.     Offences by Government departments. 
34AA.    Penalty vexatious search or seizure. 

35.       Publication of sentences passed under this Act. 
36.       Magistrate‘s power to impose enhanced penalties. 
36A.     Certain offences to be tried summarily. 
37.       Protection of action taken in good faith. 
38.       Rules to be laid before Parliament. 

THE FIRST SCHEDULE. 

THE SECOND SCHEDULE.

5 

 
 
 
 
 
 
 
 
 
1                                                        Drugs and Cosmetics  Act, 1940 

THE DRUGS AND COSMETICS ACT, 1940 

(23 OF 1940)1

[10th   April, 1940.]

An Act to regulate the import, manufacture, distribution and sale of drugs 

[and cosmetics]; 

2

3

2

WHEREAS  it  is  expedient  to  regulate  the 
cosmetics];  
AND WHEREAS  the  Legislature  of  all  the  Provinces  have  passed  resolutions  in  terms  of  section  103 
of  the  Government  of  India  Act,  1935  (26  Geo.  5,  c.2),  in  relation  to  such  of  the  above-mentioned 
matters  and  matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act; 

[import,  manufacture,  distribution  and  sale]  of  drugs 

[and 

It is hereby enacted as follows:- 

CHAPTER I 

INTRODUCTORY

1. Short title, extent and commencement.⎯ (1) This Act may be called the Drugs 

2

[and Cosmetics] 

Act, 1940.

(2)  It extends to the whole of India 4[ * * *]. 
5 as  the 
(3)   It  shall  come  into  force  at  once;  but  Chapter  III  shall  take  effect  only  from  such  date
Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall 
5  as  the  State  Government  may,  by  like  notification, 

take  effect  in  a  particular  State  only  from  such  date
appoint in this behalf: 

[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from 
such date10 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as 
the Central Government may, by notification in the Official Gazette, appoint in this behalf.] 

6

2. Application of other laws not barred.- The provisions of this Act shall be in addition to and not in 

derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force. 

3.  Definitions.—In this Act, unless there is anything repugnant in the subject or context, 
7
[(a) ―8[Ayurvedic, Siddha or Unani] drug‖ includes all medicines intended for internal or external use 
8
for  or  in  the  diagnosis,  treatment,  mitigation  or  prevention  of 
[disease  or  disorder  in  human  beings  or 
animals,  and  manufactured]  exclusively  in  accordance  with  the  formulae  described  in,  the  authoritative 

9

books of 

[Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;] 
9
[(aa) ―the Board‖ means— 

9

9

[Ayurvedic,  Siddha  or  Unani]  drug,  the 

(i)  in  relation  to 
Drugs Technical Advisory Board] constituted under section 33C; and 
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board 
constituted under section 5;] 

[Ayurvedic,  Siddha  and  Unani 

1. For Statement of Object and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see ibid., p. 143. 

The Act has been applied to all the partially excluded areas in the State of  Orissa, see Orissa Government Notification No. 3358-LSG., dated the 25th
August, 1941. 

2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964). 
3. Subs. by the A.O. 1950, for certain words. 
4. The words ―except the State of Jammu and Kashmir‖ omitted by Act 19 of 1972, s .2. (w.e.f. 31-5-1972). 
5   1st   April, 1947; see  Notifn. No. F. 28 (10) (3) 45-H (1), dated the 2nd September 1946, Gazette  of India, 1946, Pt. I, p.1349. 

Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1st  April, 1947, see ibid., Chapters III and IV came into force in the 
States of Himachal  Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1st   April, 1953, vide Notification No. S.R.O. 
663, dated the 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451. 
Chapter IV came into force in the Union territory of Dadra and Nagar Haveli   w.e.f. 1st  August, 1968, see Notification No. ADM/Law/117(74), 
dated the 20th July, 1968, Gazette of India, Pt. III, Sec. 3,  p.128. The Act is extended to Dadra and Nagar Haveli  by Reg. 6 of 1963, s. 2 and Sch. 
I; to Pondicherry by Reg. 7 of 1963. s. 3   and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and Sch. and to Laccadive, Minicoy and 
Amindivi Islands by Reg. 8 of 1965. s.3 and Sch. 

6.   Added by Act 19 of 1972, s. 2. 
7    Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
8.   Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
9.   Clause. (a) was relettered as cl. (aa) by Act 13 of 1964 s.  2, (w.e.f. 15-9-1964). 
10. 24th August, 1974, vide notifin no. S.O. 2185, dt. 9th August, 1974.

6 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[

2
[(aaa)]  ―cosmetic‖  means  any  article  intended  to  be  rubbed,  poured,  sprinkled  or    sprayed  on,  or 
introduced  into, or  otherwise  applied  to,  the  human  body  or  any  part  thereof  for  cleansing,  beautifying, 
promoting  attractiveness,  or altering the appearance, and includes any article intended for use as a component 

of cosmetic 

4

3
[* * *] ;] 

[(b) ―drug‖ includes— 

5
[(i)  all  medicines  for  internal  or  external  use  of  human  beings  or  animals  and  all  substances 
intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder 
in human beings or animals, including preparations applied on human body for the purpose of repelling 
insects like mosquitoes;] 

(ii) such substances (other than food) intended to affect the structure or any function of the human 

6

body  or intended to  be  used  for  the  destruction  of 
[vermin]  or  insects  which  cause  disease  in  human 
beings or animals, as may be specified from time to time by the Central Government by notification in 
the Official Gazette;] 

7
[(iii) all substances intended for use as components of a drug including empty gelatin capsules; and 
(iv)  such  devices*  intended  for  internal  or  external  use  in  the  diagnosis,  treatment,  mitigation  or 
prevention of disease or disorder in human beings or animals, as may be specified from time to time by 
the Central Government by notification in the Official Gazette, after consultation with the Board;] 

8

[(c) ―Government Analyst‖ means— 

9

(i)  in  relation to 
Central Government or a State Government under section 33F; and 
(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central 

[Ayurvedic,  Siddha  or  Unani]  drug,  a  Government  Analyst  appointed  by  the 

Government or a State Government under section 20;] 

10

[*  *  *  *   *] 

11

[(e) ―Inspector‖ means— 

9

(i) in relation to 

[Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central 

Government or a State Government under section 33G; and 

(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government 
or a State Government under section 21;] 

13

12
[

14

[(f)]  ―manufacture‖  in  relation  to  any  drug 
[or  cosmetic]  includes  any  process  or  part  of  a 
process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise 

14

15

treating or adopting any drug 
include the compounding or dispensing  
the ordinary course of retail business; and ―to manufacture‖ shall be construed accordingly;] 

[sale or distribution] but does not 
[of any drug, or the packing of any drug or cosmetic,] in 

[or cosmetic] with a view to its 

16

17[(g)]  ―to  import‖,  with  its  grammatical  variations  and  cognate  expressions  means  to  bring  into 

18[India]; 

1.      Ins.  by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964). 
2.     Clause. (aa) relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964). 
3.    omitted by Act 68 of 1982, s.3, certain words. 
4.    Subs. by Act 11 of 1955, s. 2, for cl. (b). 
5.    Subs. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983). 
6.    Subs. by  Act 13 of 1964, s. 2,  for  ―vermins‖ (w.e.f. 15-9-1964). 
7.    Ins. by Act 68 of 1982, s.3  (w.e.f. 1-2-1983). 
      The Central Government has specified (vide S.O. 1468 (E), dated 6-10-2005) the following devices intended for external or internal use in human 

beings or drugs with immediate effect, namely:- 

      (i) Cardiac Stents           (ii) Drug Eluding Stents       (iii) Catheters       (iv) Intra Ocular Lenses          (v) I.V. Cannulac              (vi) Bone Cements 
      (vii) Heart Valves          (viii) Scalp Vein Set              (ix) Orthopaedic Implants      (x) Internal Prosthetic Replacements 
8.    Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f.15-9-1964). 
9.    Subs. by Act 68 of 1982 s.2, for ―Ayurvedic (including sidda) or Unani‖ (w.e.f. 1-2-1983). 
10.  Cl. (d) omitted by Act 19 of 1972, s. 3.                                             15.  Subs. by  Act 68 of 1982, s.3, for  ―sale and distribution‖(w.e.f. 1-2-1983). 
11.  Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).             16.  Subs. by Act 21 of 1962 s. 4,  for ―or  the packing of any drug‖. 
12.  Ins. by Act 11 of 1955,  s. 2.                 17.  Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961). 
13.  Clause. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).   
14.  Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).                                 18.  Subs. by Act 3 of 1951, s. 3 and Sch., for  ―the States‖. 

7 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

2
[(h)] ―patent or proprietary medicine‖ means,— 

[

(i)  in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all    formulations containing only 
such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani 
Tibb  systems  of  medicine  specified  in  the  First  Schedule,  but  does  not  include  a  medicine  which  is 
administered  by  parenteral  route  and  also  a  formulation  included  in  the  authoritative  books  as  specified  in 
clause (a); 

(ii) in relation to any other systems  of  medicine,  a  drug which is  a remedy or prescription  presented in 
a form ready for internal or external administration of human beings or animals and which is not included in 
the  edition  of  the  Indian  Pharmacopoeia  for  the  time  being  or  any  other  Pharmacopoeia  authorised  in  this 
behalf by the  Central  Government  after  consultation  with  the  Drugs  Technical  Advisory  Board  constituted 
under section 5;] 

2

3
[

[(i)] ―prescribed‖ means prescribed by rules made under this Act.] 

4

[*   *     *   *    *] 

5

[3A. Construction of references to any law not in force or any functionary  not in existence in the 
State  of  Jammu  and  Kashmir.—Any  reference  in  this  Act  to  any  law  which  is  not  in  force,  or  any 
functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed 
as  a  reference  to  the  corresponding  law  in  force,  or  to  the  corresponding  functionary  in  existence,  in  that 
State.] 

4. Presumption as to poisonous substances.—Any substance specified as poisonous by rule made under 
6
[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of 
[or Chapter IVA], as the case may be. 

Chapter III or Chapter IV 
6
Chapter III or Chapter IV 

CHAPTER II 

THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABOURATORY 

AND THE DRUGS CONSULTATIVE COMMITTEE 

5.  The  Drugs  Technical  Advisory  Board.—(1)  The  Central  Government  shall,  as  soon  as  may  be, 
constitute  a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and 
the  State  Governments on technical matters arising out of the administration of this Act and to carry out the 
other functions assigned to it by this Act. 

7

[(2) The Board shall consist of the following members, namely:— 

(i) the Director General of Health Services, ex officio, who shall be Chairman; (ii) the Drugs 
Controller, India, ex officio; 
(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;  
(iv) the Director  of the Central Research Institute, Kasauli, ex officio; 
(v) the Director of Indian Veterinary Research Institute, Izatnagar, ex officio; 
(vi) the President of Medical Council of India, ex officio; 
(vii) the President of the Pharmacy Council of India, ex officio; 
(viii) the Director of Central Drug Research Institute, Lucknow,  ex officio; 
(ix) two persons to be nominated by the Central Government from among persons who are in 

charge of drugs control in the States; 

1. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983). 
2. Cls. (c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2  (w.e.f. 16-3-1961). 
3. Subs. by Act 11 of 1955, s. 2, for  cl. (e). 
4.  Clause. (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, s. 3 and Sch. 
5.  Ins. by Act 19 of 1972, s. 4 (w.e.f. 31-5-1972). 
6.  Ins. by Act 13 of 1964, s. 3 (w.e.f. 15-9-1964). 
7.  Subs. by Act 13 of 1964, s. 4,  for sub-section (2) (w.e.f. 15-9-1964).

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(x)  one person, to be elected by the Executive Committee of the Pharmacy Council of India, from 
among  teachers  in  pharmacy  or  pharmaceutical  chemistry  or  pharmacognosy    on  the  staff  of  an 
Indian university or a college affiliated thereto; 

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from 
among teachers in medicine or therapeutics on the staff of  an Indian university or a college affiliated 
thereto; 

(xii) one person to be nominated by the Central Government from the  pharmaceutical industry; 

(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of  Medical 
Research;  

(xiv) one person to be elected by the Central Council of the Indian Medical Association; 

(xv) one person to be elected by the Council of the Indian Pharmaceutical Association; 

(xvi) two persons holding the appointment of Government Analyst under this Act, to be 
nominated by the Central Government.] 

(3)  The  nominated  and  elected  members  of  the  Board  shall  hold  office  for  three  years,  but  shall  be 

eligible for re- nomination and re-election: 

1

[Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or 
clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the 
office by virtue of which he was nominated or elected to the Board.] 

(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a 

quorum and regulating its own procedure and the conduct of all business to be transacted by it. 

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, 
not  exceeding  three  years,  as  it  may  decide,  or  temporarily  for  the  consideration  of  particular  matters, 
persons who are not members of the Board. 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein. 

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the 

Board with such clerical and other staff as the Central Government considers necessary. 

6. The Central Drugs Laboratory.—(1) The Central Government shall, as soon as may be, established 
a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to 
carry out the functions entrusted to it by this Act or any rules made under this Chapter: 

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in 
[or cosmetic or class of cosmetics] shall be carried out at the Central 
respect of any drug or class of drugs 
Research  Institute, Kasauli,  or  at any  other  prescribed  Laboratory  and the functions of  the  Director  of the 
Central  Drugs  Laboratory  in  respect  of  such  drug  or  class  of  drugs 
[or  such  cosmetic  or  class  of 
cosmetics]  shall  be  exercised  by  the  Director  of that Institute or of that other Laboratory, as the case may 
be. 

2

2

(2) the Central Government may, after consultation with the Board, make rules prescribing— 

3

(a)   the functions of the  Central Drugs Laboratory; 

[*   *  *    *   *] 

(d)  the  procedure  for  the  submission  to  the  said  Laboratory 

4
[under  Chapter  IV  or  Chapter  IVA]  of 

[or cosmetics] for analysis or test, the forms of Laboratory‘s reports thereon and the 

2

samples of drugs 
fees payable in respect of such reports; 

1.  Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964). 
2.  Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964). 
3.  Cls. (b) and (c) omitted by Act 11 of 1955, s. 4. 
4.  Subs. by Act 13 of 1964, s. 5, for ―under Chapter IV‖ (w.e.f. 15-9-1964).

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(e) such  other  matters  as may  be  necessary  or  expedient  to  enable  the said  Laboratory  to 

carry  out  its functions; 

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1). 

7.  The  Drugs  Consultative  Committee.—(1)  The  Central  Government  may  constitute  an  advisory 
committee  to  be  called  ―the    Drugs  Consultative  Committee‖  to  advise  the  Central  Government,  the  State 
Governments  and  the  Drugs  Technical  Advisory  Board  on  any  other  matter  tending  to  secure  uniformity 
throughout 

1
[India] in the administration of this Act. 

(2)  The    Drugs    Consultative    Committee    shall    consist    of  two    representatives    of    the    Central  
Government  to  be nominated  by  that  Government  and  one  representative  of  each  State  Government  to  
be  nominated  by  the  State Government concerned. 

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and 

shall have power to regulate its own procedure. 

2[7A.  Sections  5  and  7  not  to  apply  to  Ayurvedic,  Siddha  or  Unani  drugs.—Nothing  contained  in 

sections 5 and 7 shall apply to 3[Ayurvedic, Siddha or Unani] drugs.] 

4

CHAPTER III 

[IMPORT OF DRUGS AND COSMETICS] 

5
8. Standards of quality.—
[(1) For the purposes of this Chapter, the expression ―standard quality‖ 
means— 

(a)  in relation to a  drug, that the drug complies with the standard  set out in 
and 
(b)  in relation to a cosmetic, that the cosmetic compiles with such standard as may be 
prescribed]. 

6
[the Second Schedule], 

(2)  The  Central  Government,  after  consultation  with  the  Board  and  after  giving  by  notification  in  the 
Official Gazette not less than three months‘ notice of its intention so to do, may by a like notification add to or 
otherwise amend 
[the  Second 
Schedule]  shall  be  deemed  to  be amended accordingly. 

[the Second  Schedule],  for  the  purposes  of  this  Chapter,  and  thereupon 

6

6

7

[9. Misbranded drugs.—For the purposes of this Chapter a drug shall be deemed to be misbranded— 

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to 

appear of better or greater therapeutic value than it really is; or 

(b) if it is not labelled in the prescribed manner; or 

(c) if its label or container or anything accompanying the drug bears any statement, design or 

device which makes any false claim for the drug or which is false or misleading in any particular.] 

8

[9A. Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be adulterated.— 

(a)   if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 
(b)    if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may  

have  been contaminated with filth or whereby it may have been rendered injurious to health; or 

1.  Subs. by Act 3 of 1951, s. 3 and Sch., for  ―the States‖. 

2.  Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964). 
3.  Subs. by Act 68 of 1982, s. 2  for certain words (w.e.f. 1-2-1983). 
4.  Subs. by Act 68 of 1982, s. 4,  for ―IMPORT OF DRUGS‖ (w.e.f. 1-2-1983). 
5.  Subs. by Act 21 of 1962, s. 6, for sub-section (1) (w.e.f. 27-7-1964). 
6.  Subs. by Act 13 of 1964, s. 7, for  ―the Schedule‖ (w..e.f. 15-9-1964). 
7.  Subs. by Act 68 of 1982, s. 5, for s.  9 (w.e.f. 1-2-1983). 
8.  Subs. by Act 68 of 1982, s. 6, (w.e.f. 1-2-1983).

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(c)      if  its  container  is  composed  in  whole  or  in  part,  of  any  poisonous  or  deleterious  substance 

which may render the contents injurious to health; or 

(d)   if it bears or contains, for purposes of colouring only, a colour other than one which is 

prescribed; or 

(e)    if it contains any harmful or toxic substance which may render it injurious to health; or 
(f)    if any substance has been mixed therewith so as to reduce its quality or strength. 

9B. Spurious drugs.— For the purposes of this Chapter, a drug shall be deemed to be spurious— 

(a)   if it is imported under a name which belongs to another drug; or 
(b)   if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner 
likely to deceive  or  bears  upon  it  or  upon  its  label    or  container  the  name  of  another  
drug  unless  it  is  plainly  and conspicuously marked so as to reveal its true character and its 
lack of identity with such other drug; or 

(c)   if the label or the container bears the name of an individual or company purporting to be the 

manufacturer of the drug, which individual or company is fictitious or does not exist; or 

(d)   if it has been substituted wholly or in part by another drug or substance; or 
(e)   if it purports to be the product of a manufacturer of whom it is not truly a product. 

9C. Misbranded cosmetics.—For the purposes of this chapter, a cosmetic shall be deemed to be 
misbranded— 

(a) if it contains a colour which is not prescribed; or 

(b) if it is not labelled in a prescribed manner; or 

(c)  if  the  label  or  container  or  anything  accompanying  the  cosmetic  bears  any  statement  which  is 

false or misleading in any particular. 

9D. Spurious cosmetics.—For the purposes of this Chapter, a drug shall be deemed to be spurious,— 

(a) if it is imported under the name which belongs to another cosmetic; or 

(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a 
manner  likely  to  deceive  or  bears  upon  it  or  upon  its  label  or  container  the  name  of  another  cosmetic, 
unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with 
such other cosmetic; or 

(c)  if  the  label  or  the  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or 

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.] 

10.  Prohibition  of  import  of  certain  drugs  or  cosmetics.— From  such  date
Central Government by notification in the Official Gazette in this behalf, no person shall import— 

1 as  may  be  fixed  by  the 

(a)   any drug 

2

[or cosmetic] which is not of standard quality; 

  3[(b) any misbranded drug 4[or misbranded or spurious cosmetic;] 

1.  1st April, 1947 for cls. (a), (b), (c), (e) and (f) and 1st April 1949 for cl. (d) see Notifn. No.18- 12/46-D (I), dated the 11th February 1947, Gazette of 

India, 1947, Pt. 1, P. 189 as amended by Notifn. No.F.1-2/48-D (1), dated  the 29th  September,1948. 
1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal,Tripura, Vindhya Pradesh and Manipur; vide Notifn. No. S.R.O. 666, 
dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p.451. 

2.  Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964). 
3.  Subs. by Act 21 of 1962, s. 8,  for cl. (b) (w.e.f. 27-7-1964). 
4.  Subs. by Act 68 of 1982, s.7, for ―or misbranded cosmetic‖ (w.e.f. 1-2-1983).

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

2

[(bb) any 

3

[adulterated or spurious] drug;] 

(c) any drug 

[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and 

in accordance with, such licence; 

4[(d)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed  manner  on  the 
label or container thereof  5[the true formula or list of active ingredients contained in it, together with the 
quantities thereof;] 

(e)  any  drug  which  by  means  of  any  statement,  design  or  device  accompanying  it  or  by  any 
other  means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other 
effect, as may be prescribed; 

3[(ee)  any  cosmetic  containing  any  ingredient  which  may  render  it  unsafe  or  harmful  for  use 

under  the directions indicated or recommended;] 

(f) any drug 3[or cosmetic] the import of which is prohibited by rule made under this Chapter: 

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small 

quantities of any drug for the purpose of examination, test or analysis or for personal use: 

Provided further that the Central Government may, after consultation with the Board, by notification in the 
Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class 
of drugs not being of standard quality. 

6

[*  * *  *  *] 
7

[10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.—
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that 
the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does 
not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no 
therapeutic  justification  and  that  in  the  public  interest  it  is  necessary  or  expedient  so  to  do  then,  that 
Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.] 

11. Application of law relating to sea customs and powers of Customs Officers.— (1) The law for the 
time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of 

the  Sea  Customs  Act,  1878  (8  of  1878)

  shall,  subject  to  the  provisions  of  section  13  of this  Act,  apply  in 

9

8

respect of drugs 

[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs 

and  officers  empowered  under  that  Act  to  perform  the  duties  imposed  thereby  on  a 

[Commissioners  of 

Customs]  and  other  officers  of  Customs,  shall  have  the  same  powers  in  respect  of  such  drugs 
cosmetics]  as  they  have  for  the  time  being  in  respect  of  such  goods  as aforesaid. 

11

10

[(2)  Without  prejudice  to  the  provisions  of  sub-sections  (1),  the 

[Commissioners  of  Customs]  any 
officer  of  the  Government  authorized  by  the  Central  Government  in  this  behalf,  may  detain  any  imported 
[or  cosmetic]  the  import  of  which  is  prohibited  under  this 
package  which  he  suspects  to  contain  any  drug 
Chapter and shall forthwith report such detention to the Drugs Controller, India, and, if necessary, forward the 
package or sample of any suspected drug 

[or cosmetic] found therein to the Central Drugs Laboratory.] 

9

9

9

[and 

10

12.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may, 

[after 
consultation with or on  the  recommendation  of  the  Board]  and  after  previous  publication  by  notification  in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

12

1.    Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964). 
2.    Subs. by Act 68 of 1982, s.7, for ―adulterated‖ (w.e.f. 1-2-1983). 
3.    Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964). 
4.    Subs. by Act 11 of 1955, s. 5, for cl. (d). 
5.    Subs. by Act 68 of 1982, s.7, for certain words (w.e.f. 1-2-1983). 
6.    Explanation omitted by s.7, ibid. (w.e.f. 1-2-1983). 
7.    Ins. by s. 8, Act 68 of 1982. (w.e.f. 1-2-1983). 
8.    Now see the Customs Act, 1962. 
9.    Ins. by Act 21of 1962, s. 9 (w.e.f. 27-7-1964). 
10.  Subs. by Act 22 of 1995, s. 83, for ―Customs Collector‖. 
11.  Subs. by Act 11 of 1955, s. 6, for sub-section (2). 
12.  Subs. by Act 68 of 1982, s.9, for certain words (w.e.f. 1-2-1983).

12 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central  Government  is  of 
opinion that circumstances  have  arisen  which  render  it  necessary  to  make  rules  without  such  consultation, 
but  in  such  a  case  the Board shall be consulted within six months of the making of the rules and the Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules.] 

(2) Without prejudice to the generality of the forgoing power, such rules may— 

2

3

(a)   specify the drugs or classes of drugs 

[or cosmetics or classes of cosmetics] for the import of 

which  a  licence  is  required, 
[and  prescribe  the  form  and  conditions  of  such  licences,  the  authority 
empowered to issue the same, the fees payable therefor and provide for the cancellation, or suspension of 
such licence in any case where any provision of this Chapter or the rules made thereunder is contravened 
or any of the conditions subject to which the licence is issued is not complied with]; 

(b)   prescribe  the  methods  of  test  or  analysis  to  be  employed  in  determining  whether  a  drug 

cosmetic] is of standard quality; 

(c)   prescribe,   in   respect   of   biological   and   organometallic   compounds,   the   units   or   

2

[or 

methods   of standardization; 

4
[(cc)  prescribe  under  clause  (d)  of 

contain for purposes or colouring;] 

5
[section  9A]  the  colour  or  colours  which  a  drug  may  bear  or 

(d)  specify the diseases or ailments which an imported drug may not purport or claim 

cure or mitigate] and such other effects which such drug may not purport or claim to have; 

(e)    prescribe  the  conditions  subject  to  which  small  quantities  of  drugs,  the  import  of  which  is 
otherwise  prohibited  under  this  Chapter,  may  be  imported  for  the  purpose  of  examination,  test  or 
analysis or for personal use; 

6
[to prevent, 

2
[or  cosmetics]  may  be  imported,  and  prohibit  their 

(f)      prescribe  the  places  at  which  drugs 

import  at  any other place; 

(g)    require  the  date  of  manufacture  and  the  date  of  expiry  of  potency  to  be  clearly  and  truly 
stated  on  the label or container of any specified imported drug or class of such drug, and prohibit the 
import  of  the  said  drug  or  class  of  drug  after  the  expiry  of  a  specified  period  from  the  date  of 
manufacture; 

2

[or  
(h)    regulate    the    submission    by    importers,    and    the    securing,    of    samples    of    drugs   
cosmetics]  for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if 
any, payable for such examination, test or analysis; 

(i)    prescribe  the  evidence  to  be  supplied,  whether  by  accompanying  documents  or  otherwise,  of 
the  quality of  drugs  2[or  cosmetics]  sought  to  be  imported,  the  procedure  of  officers  of  Customs 
in  dealing  with  such evidence, and the manner of storage at places of import of drugs  2[or cosmetics] 
detained pending admission; 

(j)    provide  for  the  exemption,  conditionally  or  otherwise,  from  all  or  any  of  the  provisions  of 
2
[or cosmetics] imported for the  purpose only  of 

this  Chapter and  the rules made  thereunder  of  drugs 
transport through, an export from, 

[India]; 

7

(k)    prescribe the conditions to be observed in the packing in bottles, packages or other containers, 
of  imported  drugs  2[or  cosmetics]  8[including  the  use  of  packing  material  which  comes  into  direct 
contact with the drugs]; 

2

(l)      regulate  the  mode  of  labeling  drugs 

[or  cosmetics]  imported  for  sale  in  packages,  and 

prescribe  the matters which shall or shall not be included in such labels; 

(m)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added  to  or 
contained  in any imported drug, prohibit the import of any drug in which that proportion is exceeded, 
and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the 
rules made thereunder; 

1.  Ins. by Act 11 of 1955, s. 7. 
2.  Ins. by Act 21of 1962, s. 10 (w.e.f. 27-7-1964). 
3.  Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983). 
4.  Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964). 
5.  Subs. by Act 68 of 1982, s. 9, for ―section 9B‖ (w.e.f. 1-2-1983). 
6.  Subs. by Act 11 of 1955, s. 7, for  ―to cure or mitigate‖. 
7.  Subs. by Act  3 of 1951, s. 3 and Sch., for ―the States‖. 
8.  Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).

13 

 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(n)    require  that  the  accepted  scientific  name  of  any  specified  drug  shall  be  displayed  in  the 
prescribed manner on the  label or wrapper of any imported, patent or proprietary  medicine  containing 
such drug;  

(o)   provide for the exemption, conditionally or otherwise, from all or any of the provisions of this 
Chapter or the rules made thereunder, of any specified drug or class of drugs  1[or cosmetic or class of 
cosmetics]. 

2[13. Offences.—(1) Whoever himself or by any other person on his behalf imports, — 

(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 
9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) 
of  section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine 
which may extend to five thousand rupees; 

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is 
prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a 
term which may extend to six months, or with fine which may extend to five hundred rupees,  or with both; 

(c) any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, 
shall be punishable with imprisonment for a term which may extend to three years, or with fine which may 
extend to five thousand rupees, or with both; 

(2) Whoever having been convicted of an offence— 
(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, 
shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  five  years,  or  with  fine  which  may 
extend to ten thousand rupees, or with both; 

(b)  under  clause  (b)  of  sub-section  (1),  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with  imprisonment  for  a term  which  may  extend to one year,  or  with fine  which  may  extend  to 
one thousand rupees, or with both. 

(3) The punishment provided by this section shall be in addition to any penalty to which the offender 

may be liable under the provisions of section 11.] 

14.  Confiscation.—Where any offence punishable under section 13 has been committed, the consignment 
of the drugs 3[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation. 

15. Jurisdiction.—No Court inferior to  that 

4
[of a Metropolitan Magistrate or of a Judicial Magistrate 

of the first class] shall try an offence punishable under section 13. 

CHAPTER IV 

MANUFACTURE, SALE AND DISTRIBUTION OF 

5

[DRUGS AND COSMETICS] 

16. Standards of quality.—

6
[(1) For the purposes of this Chapter, the expression ―standard quality‖ 

means—  

(a)    in  relation  to  a  drug,  that  the  drug  complies  with  the  standard  set  out  in 

Schedule], and  

7
[the  Second 

(b)    in  relation  to  a  cosmetic,  that  the  cosmetic  complies  with  such  standard  as  may  be 

prescribed.] 
8

[Central  Government],  after  consultation  with  the  Board  and  after  giving  by  notification  in 
(2)  The 
the  Official Gazette not less than three months‘ notice of its intention so to do, may by a like notification 
[the  Second  Schedule]  for  the  purposes  of  this  Chapter,  and  thereupon  7[the 

add to or otherwise amend 
Second Schedule] shall be deemed to be amended accordingly. 

7

1.  Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964). 
2.  Subs. by Act 68 of 1982, s.10, for  s.13 (w.e.f. 1-2-1983). 
3.  Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964). 
4.  Subs. by Act 68 of 1982, s. 11, for certain words  (w.e.f. 1-2-1983). 
5.  Subs. by Act 68 of 1982 for ―DRUGS‖ (w.e.f. 1-2-1983). 
6.  Subs. by Act 21 of 1962, s. 12, for sub-section (1)  (w.e.f. 27-7-1964). 
7.  Subs. by Act  13 of 1964, s. 11, for ―the Schedule‖ (w.e.f 15-9-1964). 
8.  Subs. by Act 11 of 1955, s. 8, for ―State Government‖.

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1

[17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,— 
(a)      if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to 

appear of betapeutic value than it really is; or 

(b)      if it is not labelled in the prescribed manner; or 
(c) if its label or container or anything accompanying the drug bears any statement, design or 
device which makes any false claim for the drug or which is false or misleading in any particular. 

17A.  Adulterated drugs.—For the purposes of this Chapter, a drug shall be deemed to be adulterated,— 

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or 
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been 

contaminated with filth or whereby it may have been rendered injurious to health; or 

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which 

may render the contents injurious to health; or 

(d) if it bears or contains, for the purposes of colouring only, a colour other than one which is 
prescribed; or 
(e) if it contains any harmful or toxic substance which may render it injurious to health; or 
(f) if any substance has been mixed therewith so as to reduce its quality or strength. 

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—  

(a) if it is manufactured under a name which belongs to another drug; or 
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner 
likely to deceive  or  bears  upon  it  or  upon  its  label  or  container  the  name  of    another  drug  unless  
it  is  plainly  and conspicuously marked so as to reveal its true character and its lack of  identity with such 
other drug; or 

(c)  if  the  label  or  container  bears  the  name  of  an  individual  or  company  purporting  to  be  the 

manufacturer of the drug , which individual or company is fictitious or does not exist; or 
(d) if it has been substituted wholly or in part by another drug or substance; or 
(e) if it purports to be the product of a manufacturer of whom it is not truly a product. 

17C.  Misbranded  cosmetics.—  For  the  purposes  of  this  Chapter,  a  cosmetic  shall  be  deemed  to  be 
misbranded, -- 

(a) if it contains a colour which is not prescribed; or 
(b) if it is not labelled in the prescribed manner; or 
(c)  if  the  label  or  container  or  anything  accompanying  the  cosmetic  bears  any  statement  which  is 

false or misleading in any particular. 

17D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-- 
(a) if it is manufactured under a name which belongs to another cosmetic; or 

(b)  if  it  is  an  imitation  of,  or  a  substitute  for,  another  cosmetic  or  resembles  another  cosmetic  in 
a  manner likely to deceive or bears upon it or upon its label or container the name  of another cosmetic 
unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with 
such other cosmetic; or 

(c) if the label or container bears the name of an individual or a company purporting to be the 

manufacturer of the cosmetic which individual or company is fictitious or does not exist; or 
(d) if it purports to be the product of a manufacturer of whom it is not truly a product.] 

2[17E  Adulterated  cosmetics.-  For  the  purposes  of  this  Chapter,  a  cosmetic  shall  be  deemed  to  be 
adulterated,-  
(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or  
(b)  if  it  has  been  prepared,  packed  or  stored  under  insanitary  conditions  whereby  it  may  have  been 
contaminated with filth or whereby it may have been rendered injurious to health; or  
(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may 
render the contents injurious to health; or  
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or  
(e) if it contains any harmful or toxic substance which may render it injurious to health; or  
(f) if any substance has been mixed therewith so as to reduce its quality or strength.] 

1.  Subs. by Act 68 of 1982, s.13, for s.17, 17A and 17B (w.e.f. 1-2-1983). 
2. Ins. by Act 26 of 2008, s 2 (w.e.f 10-8-2009)

15 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

18.  Prohibition  of  manufacture  and  sale  of  certain  drugs  and  cosmetics.—From  such   date  1as  may 
be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself 
or by any other person on his behalf— 

2
[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale] or 

(a)  
distribute— 

2
[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; 

12[(ii) any cosmetic which is not of a standard quality or is misbranded or  spurious;] 
3
[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the 

[the true formula or list of active ingredients contained in it together with 

label or container thereof 
the quantities thereof];] 

2

(iv) any drug which by means of any statement, design or device accompanying it or by any other 
means, purports or claims  4[to prevent, cure or mitigate] any such disease or ailment, or to have any 
such other effect as may be prescribed; 

5[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under 

the directions indicated or recommended; 

(vi)  any  drug  or  cosmetic  in  contravention  of  any  of  the  provisions  of  this  Chapter  or  any 

rule  made thereunder;] 

(b) 6[sell, or stock or exhibit or offer for sale,] or distribute any drug 7[or cosmetic] which has been 

imported or manufactured in contravention of any  of the provisions of this Act or any rule made 
thereunder; 

6

(c) 

[manufacture  for  sale  or  for  distribution,  or  sell,  or  stock  or  exhibit  or  offer  for  sale,]  or 

[or cosmetic], except under, and in accordance with the conditions of, a licence 

distribute  any  drug 
issued for such purpose under this Chapter: 

7

                     Provided  that  nothing  in  this  section  shall  apply  to  the  manufacture,  subject  to  prescribed 
conditions, of small quantities of any drug for the purpose of examination, test or analysis: 

8

Provided further that the 

[Central Government] may, after consultation with the Board, by notification in 
6
the Official Gazette, permit, subject to any conditions specified in the notification, the 
[manufacture for sale, 
or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs 
not being of standard quality. 

9

[*  *  *   * *] 
10

[18A.  Disclosure  of  the  name  of  the  manufacturer,  etc.—Every  person,  not  being  the  manufacturer 
of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the 
name, address and other particulars of the person from whom he acquired the drug or cosmetic.] 

11

[18B. Maintenance of records and furnishing of information.—Every person holding a licence under 
clause  (c)  of  section  18  shall  keep  and  maintain  such  records,  registers  and  other  documents  as  may  be 
prescribed  and  shall  furnish  to  any  officer  or  authority  exercising  any  power  or  discharging  any  function 
under  this  Act  such  information  as  is  required  by  such  officer  or  authority  for carrying out the purposes of 
this Act.] 

1.  1st April,1947 for sub-clauses (i), (ii), (iv) and (v) of clause (a) and clauses (b) and (c) ; 1st April, 1949 for sub-clause (iii) of clause (a) in so far as it 
takes  effect  in  Delhi,  Ajmer  and  Coorg,  see  Notifn.  No.  18-12/46-D.  II,  dated  the  11th  February,  1947.  Gazette  of  India,  1947,  Pt.  I,  p.189;  as 
amended  by  Notifn.  No.  F.  1-2/48-D(II),  dated  the  29th  September,  1948;  1st  April,  1953  for  the  States  of  Himachal  Pradesh,  Bilaspur,  Kutch, 
Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Notifn. No. S.R.O. 664, dated the 30th March,1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 
451. 

2.  Subs. by Act 68 of 1982, s.14, for certain words (w.e.f. 1-2-1983). 
3.  Subs. by Act 11 of 1955, s. 9, for sub-clause (iii). 
4.  Subs. by Act 11 of 1955, s. 9,  for ―to cure or mitigate‖. 
5.  Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964). 
6.  Subs. by Act 68 of 1982, s. 14, for certain words (w.e.f.1-2-1983). 
7.  Ins. by Act. 21 of 1962, s. 14 (w.e.f. 27-7-1964). 
8.  Subs. by Act 11 of 1955, s. 9, for ―State Government‖. 
9.  Explanation omitted by Act 68 of 1982, s.14 (w.e.f. 1-2-1983). 
10.  Ins. by Act 13 of  1964, s. 14 (w.e.f. 15-9-1964). 
11.  Ins. by Act 68 of 1982, s. 15  (w.e.f. 1-2-1983). 
12. Sub. by Act 26 of 2008, s 3, for sub-clause (ii) (w.e.f 10-8-2009), before substitution, stood as under : 
          ―any cosmetic which is not of a standard quality or is misbranded or spurious‖ 

16 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

19. Pleas.—(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under 
this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 
1

[or  cosmetic]  in  respect  of  which  the  offence  has  been  committed  or  of  the  circumstances  of  its 
manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not 
been prejudiced by the sale. 

[For  the  purposes  of  section  18  a  drug  shall  not  be  deemed  to  be  misbranded  or 

2
[adulterated  or 
(2) 
spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below 
standard quality] only by reason of the fact that— 

2

4

(a) there has been added thereto some innocuous substance or ingredient because the same is required 
[or  cosmetic]  as  an  article  of  commerce  in  a  state  fit  for 
[or cosmetic] or to 

for  manufacture  or  preparation  of  the  drug 
carriage or consumption, and not to increase the bulk, weight or measure of the drug 
conceal its inferior quality or other defects; or 

1

1

[*  * *  *  *] 
(b)  in  the  process  of  manufacture,  preparation  or  conveyance  some  extraneous  substance  has 
unavoidably become intermixed with it: Provided that this clause shall not apply in relation to any sale or 
distribution  of  the  drug  1[or  cosmetic]  occurring  after  the  vendor  or  distributor  became  aware  of  such 
intermixture. 
5[(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, 

shall not be liable for a contravention of section 18 if he proves— 

(a)    that  he  acquired  the  drug  or  cosmetic  from  a  duly  licensed  manufacturer,  distributor  or 
dealer thereof; 
(b)    that he did not know and could not, with reasonable diligence, have ascertained that the drug 

or cosmetic in any way contravened the provisions of that section; and 

(c)    that  the  drug  or  cosmetic,  while  in  his  possession,  was  properly  stored  and  remained  in  the 

same state as when he acquired it.] 

6

[20.Government  Analysts.—  (1)  The  State  Government  may,  by  notification  in  the  Official  Gazette, 
appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such 

areas in the state and in respect of such drugs or 
as may be specified in the notification. 

7

[classes of drugs or such cosmetics or classes of cosmetics] 

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it 

thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 
of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification. 

7

[classes 

(3)  Notwithstanding  anything  contained  in  sub-section  (1)  or  sub-section  (2),  neither  the  Central 
Government nor a State Government shall appoint as a Government Analyst any official not serving under it 
without the previous consent of the Government under which he is serving. 

8

[(4) No  person  who  has  any  financial interest in  the  import,  manufacture  or sale  of  drugs  or  cosmetics 

shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.] 

21. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official 
Gazette, appoint such persons  as  it thinks fit,  having  the  prescribed  qualifications,  to  be Inspectors for such 
areas as may be assigned to them by the Central Government or State Government, as the case may be. 

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, 
the  drugs  or  9[classes  of  drugs  or  cosmetics  or  classes  of  cosmetics]  in  relation  to  which  and  the 
conditions,  limitations  or  restrictions  subject  to  which,  such  powers  and  duties  may  be  exercised  or 
performed shall be such as may be prescribed. 

1.  Ins. by Act 21 of 1962, s.15 (w.e.f. 27-7-1964). 
2.  Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964). 
3.  Subs. by Act 68 of 1982, s.16, for ―adulterated‖ (w.e.f. 1-2-1983). 
4.  Cl.(aa) ins. by Act 11 of 1955, s. 10 and omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964). 
5.  Subs.by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964). 
6.  Subs. by Act 35 of 1960, s. 4, for ss. 20 and 21 (w.e.f. 16-3-1961). 
7. Subs. by Act 21 of 1962,  s. 16,  for ―class of drugs‖ (w.e.f. 27-7-1964). 
8.  Ins. by Act 68 of 1982, s.17 (w.e.f.1-2-1983). 
9.  Subs. by Act 21 of 1962, s.17, for ―class of drugs‖ (w.e.f. 27-7-1964).

17 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(3) No person who has any financial interest 
shall be appointed to be an Inspector under this section. 

1

[in the import, manufacture or sale of drugs or cosmetics] 

(4) Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian 

Penal  Code  (45  of  1860),  and  shall  be  officially  subordinate  to  such  authority 
qualifications,] as the Government appointing him may specify in this behalf.] 

2
[having  the  prescribed 

3

[22.  Powers  of  Inspectors.—(1)  Subject  to  the  provisions  of  section  23  and  of  any  rules  made  by 
the  Central Government in this behalf, an Inspector may, within the local limits of the area for which he is 
appointed,— 

4

[(a) inspect,— 

(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for 

standardising and testing the drug or cosmetic; 

(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for 

sale, or distributed; 

(b)   take samples of any drug or cosmetic,— 

(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is 

being distributed; 

(ii)  from  any  person  who  is  in  the  course  of  conveying,  delivering  or  preparing  to  deliver  such 

drug or cosmetic to a purchaser or a consignee; 

(c) at all reasonable times, with such assistance, if any, as he considers necessary,-- 

(i) search any person, who, he has reason to believe, has secreted about his  person, any drug  or 

cosmetic in respect of which an offence under this  Chapter has been, or is being, committed; or 

(ii) enter and search any place in which he has reason to believe that an offence under this Chapter 

has been, or is being, committed; or 

(iii) stop  and search any vehicle,  vessel or  other conveyance  which, he  has  reason to  believe, is 
being  used for  carrying  any  drug  or cosmetic in respect  of  which an  offence under this  Chapter  has 
been, or is being, committed, 

and order in writing the person in possession of the drug or cosmetic in respect of which the offence has 
been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period 
not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the 
possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by 
means  of  which  the  offence  has  been,  or  is  being,  committed  or  which  may  be  employed  for  the 
commission of such offence;] 

5

4

[(cc) examine any record, register, document or any other material object found 

[with any person, or 
in any place,  vehicle,  vessel  or  other  conveyance  referred  to in  clause  (c)],  and seize the  same  if  he  has 
reason  to  believe that  it  may  furnish  evidence  of  the  commission  of  an  offence  punishable  under  
this  Act  or  the  rules  made thereunder;] 

4

[(cca)  require  any  person  to  produce  any  record,  register,  or  other  document  relating  to  the 
manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any 
drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been, 
or is being, committed;] 

(d) exercise such other powers as may be necessary for carrying out the purposes of this Chapter or 

any rules made thereunder. 

1.  Subs. by  Act 21 of 1962, s.17, for ―in the manufacture, import or sale of drugs‖ (w.e.f 27-7-1964). 
2.  Ins. by Act 68 of 1982, s.18 (w.e.f. 1-2-1983). 
3.  Subs. by Act 11of 1955, s. 11, for s. 22. 
4.  Subs. by Act 68 of 1982, s.19, for certain words (w.e.f. 1-2-1983). 
5.  Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961).

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
[the  Code  of  Criminal  Procedure,  1973  (2  of  1974)]  shall,  so  far  as  may  be, 
apply  to  any  search  or  seizure  under  this  Chapter  as  they  apply  to  any  search  or  seizure  made  under  the 

(2)  The  provisions  of 

Drugs and Cosmetics Act, 1940 

authority of a warrant issued under 

[section 94] of the said Code. 

1

2

[(2A) Every record, register or other document seized under clause (cc) or produced under clause (cca) 
shall  be  returned  to  the  person,  from  whom  they  were  seized  or  who  produce  the  same,  within  a  period  of 
twenty  days  of  the  date  of  such  seizure  or  production,  as  the  case  may  be,  after  copies  thereof  or  extracts 
therefrom certified by that person, in such manner as may be prescribed, have been taken.] 

(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred upon him by or 

2

under this Chapter, 
[or  refuses  to  produce  any  record,  register  or  other  document  when  so  required  under 
clause  (cca)  of  sub- section (1),] he shall be punishable with imprisonment which may extend to three years, 
or with fine, or with both.] 

23. Procedure of Inspectors.—(1) Where an Inspector takes any sample of a drug 

3

[or cosmetic] under 

this Chapter, he shall tender the fair price thereof and may require a written acknowledgment therefor. 

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of 

any drug 

3
[or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form. 

(3) Where an Inspector takes a sample of a drug 

3
[or cosmetic] for the purpose of test or analysis, he shall 
intimate  such  purpose  in  writing  in  the  prescribed  form  to  the  person  from  whom  he  takes  it  and,  in  the 
presence  of  such  person  unless  he  wilfully  absents  himself,  shall  divide  the  sample  into  four  portions  and 
effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any 
of the portions so sealed and marked: 

Provided  that  where  the  sample  is  taken  from  premises  whereon  the  drug 

manufactured, it shall be necessary to divide the sample into three portions only: 

3
[or  cosmetic]  is  being 

Provided further that where the drug 

3

[or cosmetic] is made up in containers of small volume, instead of  

3

dividing a sample  as  aforesaid,  the  Inspector  may,  and  if  the  drug 
[or  cosmetic]  be  such  that  it  is  likely 
to  deteriorate  or  be otherwise damaged by exposure shall, take three or four, as the case may be, of the said 
containers after suitably marking the same and, where necessary, sealing them. 

(4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to 

the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:— 

(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; 

(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in 

respect of the drug 3[or cosmetic]; 

4[(iii) the third, where taken, he shall send to the person, if any, whose name, address and other 

particulars have been disclosed under section 18A.] 

(5) Where an Inspector takes any action under clause (c) of section 22,— 
3

(a) he shall use all despatch in ascertaining whether or not the drug 

[or cosmetic] contravenes any of 

3
[or cosmetic] does not so contravene, 
the provisions of the section 18 and, if it is ascertained that the drug 
forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be 
necessary for the return of the stock seized; 
3
[or  cosmetic],  he  shall  as  soon  as  may  be  inform 

(b)  if  he  seizes  the  stock  of  the  drug 
Magistrate] and take his orders as to the custody thereof; 
(c)  without  prejudice  to  the  institution  of  any  prosecution,  if  the  alleged  contravention  be  such  that 

[a  Judicial 

5

the  defect may be remedied by the possessor of the drug 
the defect has been so remedied, forthwith revoke his order under the said clause. 

3
[or cosmetic], he shall, on being satisfied that 

1.  Subs. by Act 68 of 1982, s.19, for ―the Code of Criminal Procedure, 1898‖ (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 19. (w.e.f. 1-2-1983). 
3.  Ins.by Act 21 of 1962, s.15 (w.e.f. 27-7-1964). 
4.  Subs. by Act 13 of 1964, s.16, for cl. (iii) (w.e.f.15-9-1964). 
5.   Subs. by Act 68 of 1982, s. 20, for ―a Magistrate‖  (w.e.f. 1-2-1983).

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
3

1

[(6) Where  an  Inspector seizes any record, register, document  or any  other  material object  under clause 
(cc) of sub- section (1) of section 22, he shall, as soon as may be, inform  2[a Judicial Magistrate] and take his 
orders as to the custody thereof.] 

Drugs and Cosmetics Act, 1940 

24.  Persons  bound  to  disclose  place  where  drugs  or  cosmetics  are  manufactured  or  kept.  —Every 
person for the time being in charge of any premises whereon any drug 3[or cosmetic] is being manufactured or 
is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to 
the Inspector the place where the drug 3[or cosmetic] is being manufactured or is kept, as the case may be. 

[or 
25. Reports of Government Analysts.—(1) The Government Analyst to whom a sample of any drug  
cosmetic]  has  been  submitted  for  test  or  analysis  under  sub-section  (4)  of  section  23,  shall  deliver  to  the 
Inspector submitting it a signed report in triplicate in the prescribed form. 

(2)  The  Inspector  on  receipt  thereof  shall  deliver  one  copy  of  the  report  to  the  person  from  whom  the 
sample  was taken  4[and  another  copy  to  the  person,  if  any,  whose  name,  address  and  other  particulars  have 
been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the 
sample. 

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be 
evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the 

5
sample  was  taken 
[or  the  person  whose  name,  address  and  other  particulars  have  been  disclosed  under 
section  18A]  has,  within  twenty-eight  days of  the  receipt  of  a  copy  of  the  report,  notified  in  writing  the 
Inspector  or  the  Court  before  which  any  proceedings  in respect of the sample are pending that he intends to 
adduce evidence in controversion of the report. 

(4)  Unless  the  sample  has  already  been  tested  or  analysed  in  the  Central  Drugs  Laboratory,  where  a 
person  has under sub-section (3) notified his intention of adducing evidence in controversion of a Government 
Analyst‘s report, the Court may, of its own motion or in its discretion at the request either of the complainant 

3
[or  cosmetic]  produced  before  the  Magistrate  under  sub-
or  the  accused,  cause  the  sample  of  the  drug 
section  (4)  of  section  23  to  be  sent  for  test  or analysis to the said Laboratory, which shall make the test or 
analysis  and  report  in  writing  signed  by,  or  under  the  authority  of,  the  Director  of  the  Central  Drugs 
Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein. 

(5)  The  cost  of  a  test  or  analysis  made  by  the  Central  Drugs  Laboratory  under  sub-section  (4)  shall  be 

paid by the complainant or accused as the Court shall direct. 

26.  Purchaser  of  drug  3[or  cosmetic]  enabled  to  obtain  test  or  analysis.—Any  person 

[or  any 
recognised  consumer  association,  whether  such  person  is  a  member  of  that  association  or  not,]  shall,  on 
application  in  the  prescribed  manner and on payment of the prescribed fee, be entitled to submit for test or 

6

3

7
[purchased by him or it] and to receive a report of 

analysis to a Government Analyst any drug 
such test or analysis signed by the Government Analyst. 

[or cosmetic] 

8

9

10

[Explanation.—For  the  purposes  of  this  section  and  section  32,  ―recognised  consumer  association‖  
means  a voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any other 
law for the time being in force.] 

[26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public 
interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is 
satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that 
any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients 
and  in  such  quantity  for  which  there  is  no  therapeutic  justification  and  that  in  the  public  interest  it  is 
necessary  or  expedient  so  to  do,  then,  that  Government  may,  by  notification  in  the  Official  Gazette, 
11[regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.] 

12[26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in public 
interest. – Without prejudice to any other provision contained in this Chapter, if the Central Government is 
satisfied that a drug is essential to meet the requirements of an emergency arising due to epidemic or natural 
calamities and that in the public interest it is necessary or expedient so to do, then, that Government may, by 
notification in the Official Gazette, regulate or restrict the manufacture, sale or distribution of such drug.] 

[27.  Penalty  for  manufacture,  sale,  etc.,  of  drugs  in  contravention  of  this  Chapter.—Whoever, 
himself  or by any other person on his  behalf,  manufactures  for  sale or for distribution, or  sells,  or  stocks or 
exhibits or offers for sale or distributes, — 
1.  Ins. by Act 35 of 1960, s. 6 (w.e.f. 16-3-1961).                                                              9.  Ins. by Act 68 of 1982, s. 21  (w.e.f. 1-2-1983). 
2.  Subs. by Act 68 of 1982, s. 20, for ―a Magistrate‖  (w.e.f. 1-2-1983).                            10. Subs. by Act 68 of 1982 s. 22, for s.  27 (w.e.f. 1-2-1983). 
3.  Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).                                                            11. Sub. by Act 26 of 2008, s 4, for ―prohibit‖ (w.e.f 10-8-2009). 
4.  Subs. by Act 13 of 1964, s. 17, for certain words (w.e.f. 15-9-1964).                            12. Ins. by Act 26 of 2008, sec 5(w.e.f. 10-8-2009). 
5.  Subs. by Act 13 of 1964 s.17, for ―or the said warrantor‖(w.e.f. 15-9-1964). 
6.  Ins. by Act 71 of 1986, s. 2  (w.e.f. 15-9-1987). 
7.  Subs. by Act 71 of 1986 s. 2, for  ―purchased by him‖  (w.e.f. 15-9-1987). 
8.  Added by Act 71 of 1986 s. 2, (w.e.f. 15-9-1987). 

20 

 
 
Drugs and Cosmetics Act, 1940 

(a)  any  drug  deemed  to  be  adulterated  under  section  17A  or  spurious  under  section  1[17B  and 
which]  when  used  by  any  person  for  or  in  the  diagnosis,  treatment,  mitigation,  or  prevention  of  any 
disease  or  disorder  is  likely  to  cause  his  death  or  is  likely  to  cause  such  harm  on  his  body  as  would 
amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely 
on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall 
be 2[punishable with imprisonment for a term which shall not be less than ten years but which may extend 
to a term of life and with fine which shall not be less than ten lakh rupees or three times value of the drugs 
confiscated, whichever is more;] 

3[Provided that the fine imposed on and released from, the person convicted under this clause shall be 
paid, by way of compensation, to the person who had used the adulterated or spurious drugs referred to in 
this clause. 

Provided further that where the use of the adulterated or spurious drugs referred to in this clause has 
caused  the  death  of  a  person  who  used  such  drugs,  the  fine  imposed  on  and  realised  from,  the  person 
convicted under this clause, shall be paid to the relative of the person who had died due to the use of the 
adulterated or spurious drugs referred to in this clause. 
Explanation.—For the purposes of the second proviso, the expression "relative" means— 
(i) spouse of the deceased person; or 
(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or 
(iii) parent of the minor victim; or 
(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a son or a daughter 
who has attained the age of eighteen years; or 
(v) any person, if wholly or in part, dependent on the earnings of the deceased person at the time of this 
death,— 
       (a) the parent; or 
       (b) a minor brother or an unmarried sister; or 
       (c) a widowed daughter-in-law; or 
       (d) a widowed sister; or 
       (e) a minor child of a pre-deceased son; or 
       (f) a minor child of a pre-deceased daughter where no parent of the child is alive; or 
       (g) the paternal grandparent if no parent of the member is alive.] 

           (b) any drug— 

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or 
(ii) without a valid licence as required under clause (c) of section 18, 

shall be punishable with imprisonment for a term  which shall 4[not be less than three year but which may 
extend to five years and with fine which shall not be less than one lakh rupees or three times the value of 
the drugs confiscated, whichever is more]: 

Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, 
impose a sentence of imprisonment for a term of 5[less than three years and of fine of less than one lakh 
rupees]; 

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) 
shall be punishable with  imprisonment  for  a  term which shall  6[not be less  than  seven years  but  which 
may  extend  to  imprisonment  for  life  and  with  fine  which shall not be less than three lakh rupees or 
three times the value of the drugs confiscated, whichever is more]: 

Provided  that  the  Court  may,  for  any  adequate  and  special  reasons,  to  be  recorded  in  the 
judgment,  impose  a  sentence  of imprisonment for a term of 7[less than seven years but not less than three 
years and of fine of less than one lakh rupees]; 

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention 
of  any  other  provision  of  this  Chapter  or  any  rule  made  thereunder,  shall  be  punishable  with 
imprisonment for  a term  which  shall  not be  less than  one year but which may extend to two years 8[and 
with fine which shall not be less than twenty thousand rupees]: 

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment 

impose a sentence of imprisonment for a term of less than one year. 

1. Sub. by Act 26 of 2008, s 6(i)(A), for ―17B or which‖ (w.e.f 10-8-2009). 
2. Sub. by Act 26 of 2008, s 6(i)(B), for ―punishable with imprisonment for a term which shall not be less than five years but which may extend to a term 
of life and with fine which shall not be less than ten thousand rupees;‖ (w.e.f 10-8-2009). 
3. Ins. by Act 26 of 2008, s. 6(i)(C) (w.e.f.10-8-2009). 
4. Sub. by Act 26 of 2008, s 6(ii)(A), for ―not be less than one year but which may extend to three years and with fine which shall not be less than five 
thousand rupees;‖ (w.e.f 10-8-2009). 
5. Sub. by Act 26 of 2008, s 6(ii)(B),for ―less than one year and of fine of less than five thousand rupees;‖ (w.e.f 10-8-2009). 
6. Sub. by Act 26 of 2008, s 6(iii)(A),(w.e.f 10-8-2009). 
7. Sub. by Act 26 of 2008, s 6(iii)(B),(w.e.f 10-8-2009). 8. Sub. by Act 26 of 2008, s 6(iv), for ―and with fine‖ (w.e.f 10-8-2009).

21 

 
 
 
 
Drugs and Cosmetics Act, 1940 

8[27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.—Whoever 
himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or 
exhibits or offers for sale— 

9[(i) any cosmetic deemed to be spurious under section 17D or adulterated under section 17E shall be 
punishable with imprisonment for a term which may extend to three years and with fine which shall not be 
less than fifty thousand rupees or three times to value of the cosmetics confiscated, whichever is more; 

(ii) any cosmetic other than a cosmetic referred to in clause (i) in contravention of any provisions of this 
Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend 
to one year or with fine which may extend to twenty thousand rupees, or with both.] 

1[28.    Penalty  for  non-disclosure  of  the  name  of  the  manufacturer,  etc.—Whoever  contravenes  the 
provisions of section 18A 2[or section 24] shall be  punishable with imprisonment for a term which may 
extend to one year, or  3[with fine which shall not be less than twenty thousand rupees or with both.] 

4[28A.  Penalty  for  not  keeping  documents,  etc.,  and  for  non-disclosure  of  information.—Whoever 
without  reasonable  cause  or  excuse,  contravenes  the  provisions  of  section  18B  shall  be  punishable  with 
imprisonment  for  a  term  which  may  extend  to  one  year  or  12[with fine  which shall  not be less than  twenty 
thousand rupees or with both]. 

28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.—Whoever 
himself  or  by  any  other  person  on  his  behalf  manufactures  or  sells  or  distributes  any  drug  or  cosmetic  in 
contravention  of  the  provisions  of  any  notification  issued  under  section  26A,  shall  be  punishable  with 
imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to 
five thousand rupees.] 

29.  Penalty  for  use  of  Government  Analyst‘s  report for  advertising.—Whoever  uses  any  report  of a 
test  or  analysis  made  by  the  Central  Drugs  Laboratory  or  by  a  Government  Analyst,  or  any  extract  from 
such report, for the purpose of advertising any drug 5[or cosmetic], shall be punishable with fine, which may 
extend to five hundred rupees. 

6[30.  Penalty for subsequent offences.— 7[(1) Whoever having been convicted of an offence— 

(a)  Under  clause  (b)  of  section  27,  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with imprisonment  for  a  term  which  shall  not  be  1 0[less  than  seven  years  but  which  may 
extend to  ten years and with fine which shall not be less than two lakh rupees]; 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, 
impose a sentence of imprisonment for a term of 11[less than seven years and of fine of less than one lakh 
rupees]; 

1.  Subs. by Act 13 of 1964, s.19, for s. 28 (w.e.f.15-9-1964). 
2.  Ins. by Act 68 of 1982, s. 23 (w.e.f. 1-2-1983). 
3.  Subs. by Act 26 of 2008 s. 7. Earlier Subs. by Act 68 of 1982, s.23. 
4.  Ins. by Act 68 of 1982, s. 24,  (w.e.f. 1-2-1983). 
5.  Ins. by Act 21 of 1962, s. 15 (w.e.f.27-7-1964). 
6.  Subs. by Act 11 of 1955, s. 14, for s. 30. 
7.  Subs. by Act 68 of 1982, s. 25, for sub-section (1) (w.e.f. 1-2-1983). 
8. Subs. by Act 68 of 1982 s. 22, for s.  27A (w.e.f. 1-2-1983), Earlier s. 27A was inserted by Act 21 of 1962, s 19 (w.e.f. 27-7-1964). 
9. Subs. by Act 26 of 2008 s. 7, for clause (i) and (ii) (w.e.f. 10-8-2009). 

10.  Subs. by Act 26 of 2008 sec. 11(a)(i)(A), for ―less than two years but which may extend to six years and with fine which shall not be less than ten 

thousand rupees‖;( w.e.f. 10-8-2009)  

11. Subs. by Act 26 of 2008 sec. 11(a)(i)(B), for ―less than two years and of fine of less than ten thousand rupees‖; (w.e.f. 10-8-2009). 
12. Subs. by Act 26 of 2008 s. 7, for ―with fine which may extend to one thousand rupees or with both‖ (w.e.f. 10-8-2009).

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(b)  under  clause  (c)  of  section  27  is  again  convicted  of  an  offence  under  that  clause,  shall  be 
punishable with imprisonment  for  a  term  which  shall  1 2 [ less  than  ten  years  but  which  may  extend  to 
imprisonment for life and with fine which shall not be less than three lakh rupees]; 

(c)  under  clause  (d)  of  section  27,  is  again  convicted  of  an  offence  under  that  clause  shall  be 
punishable with imprisonment  for  a  term  which  shall  not  be  less  than  two  years  but  which  may  extend 
to  four years or with  fine which shall not be less than 13[fifty thousand rupees], or with both.] 

1[(1A)  Whoever,  having  been  convicted  of  an  offence  under  section  27A  is  again  convicted  under  that 
section, shall be punishable with imprisonment for a term which may extend to two years, or with fine which 
may extend to 2[two thousand rupees], or with both.] 

(2)  Whoever,  having  been  convicted  of  an  offence  under  3[*  *  *]  section  29  is  again  convicted  of  an 
offence  under  the  same  section  shall  be  punishable  with  imprisonment  which  may  extend  to  4[two  tears,  or 
with fine which shall not be less than ten thousand rupees], or with both.] 

5
[(1)] Where any person has been convicted under this Chapter for contravening any 
such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the 

31. Confiscation.—

stock  of  the  drug 

[or  cosmetic]  in  respect  of  which  the  contravention  has  been  made  shall  be  liable  to 

6

confiscation 

7
[and if such contravention is in respect of— 

8

[(i)  manufacture  of  any  drug  deemed  to  be  misbranded  under  section  17,  adulterated  under  section 

17A or spurious under section 17B; or 

9
[manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or 

(ii) 

distribution of any drug without a valid licence as required under clause (c) of section 18; 

any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or 
coverings  in  which  such  drug  is  contained  and  the  animals,  vehicles,  vessels  or  other  conveyances  used  in 
carrying such drug shall also be liable to confiscation.] 

10

[(2) Without prejudice to the provisions contained in sub-section (1) where the Court is satisfied, on the 
application  of  an  Inspector  or  otherwise  and  after  such  inquiry  as  may  be  necessary  that  the  drug  or 

cosmetic  is  not  of  standard  quality  or  is  a 
spurious cosmetic,] such drug or, as the case may be, such cosmetic shall be liable to confiscation.] 

[misbranded,  adulterated  or  spurious  drug  or  misbranded  or 

9

11

[31A. Application of provisions to Government departments.—The provisions of this Chapter except 
those contained in  section 31 shall apply in relation  to  the  manufacture, sale or distribution  of drugs of any 
department  of Government as they apply in relation to the manufacture, sale or distribution of drugs by any 
other person.] 

32. Cognizance of offence.—14[(1) No prosecution under this Chapter shall be instituted except by- 

1.    Ins. by Act 21 of 1962, s. 20 (w.e.f. 27-7-1964). 
2.    Subs. by Act 68 of 1982, s. 25, for ―one thousand rupees‖ (w.e.f. 1-2-1983). 
3.    The words and figures ―section 28 or‖ omitted by Act 13 of 1964, s. 26 (w.e.f. 15-9-1964). 
4.    Subs. by Act 26 of 2008 sec. 11(b), for ―ten years, or with fine, or with both‖. 
5.    S. 31 re-numbered as sub-section (1) by Act 35 of 1960, s. 9  (w.e.f. 16-3-1961). 
6.    Ins. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964). 
7.    Ins. by Act 13 of 1964, s. 21 (w.e.f. 15-9-1964). 
8.    Subs. by Act 68 of 1982, s. 26, for cl. (i) (w.e.f. 1-2-1983). 
9.    Subs. by s. 26, ibid., for certain words (w.e.f. 1-2-1983). 
10.  Sub-section  (2) ins. by Act 35 of 1960, s. 9 and subs. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964). 
11.  Ins. by Act 13 of 1964, s. 22 (w.e.f.15-9-1964). 
12. Subs. by Act 26 of 2008 sec. 11(a)(ii), for ―less than six years but which may extend to ten years and with fine which shall not be less than ten 

thousand rupees ‖;( w.e.f. 10-8-2009)  

13. Subs. by Act 26 of 2008 sec. 11(a)(iii), for ―five thousand rupees ‖; (w.e.f. 10-8-2009) 
14. Subs. by Act 26 of 2008, sec 12, for sub-section (1) and (2) (w.e.f. 10-8-2009)

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(a)  an Inspector, or  
(b)  any gazetted Officer of the Central Government or a State Government authorized in writing in this 
behalf by the Central Government or a State Government by a general or special order made in this 
behalf by that Government; or  

(c)  the person aggrieved; or  
(d)  a recognised consumer association whether such person is a member of that association or not. 

(2) Save as otherwise provided in this Act, no court inferior to that of a Court of Sessions shall try an 
offence punishable under this Chapter.] 

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under 

any other law for any act or omission which constitutes an offence against this Chapter. 

1

[32A.   Power of Court to implead the manufacturer, etc.—Where, at any time during the trial of any 
offence under  this  Chapter  alleged  to  have  been  committed  by  any  person,  not being  the  manufacturer  of  a 
drug  or  cosmetic  or  his  agent  for  the  distribution  thereof,  the  Court  is  satisfied,  on  the  evidence  adduced 
before  it,  that  such  manufacturer  or  agent  is  also  concerned  in  that  offence,  then,  the  Court  may, 

notwithstanding anything contained 
[in sub-sections (1), (2) and (3) of section 319  of the Code of Criminal 
Procedure,1973  (2  of  1974)]  proceed  against  him  as  though  a  prosecution  had  been  instituted  against  him 
under section 32.] 

2

3[32B.  Compounding  of  certain  offences.-  (1)  Notwithstanding  anything  contained  in  the  Code  of 
Criminal Procedure, 1973 (2 of 1974), any offence punishable under clause (b) of sub-section (1) of Section 
13, Section 28 and Section 28A of this Act(whether committed by a company or any officer thereof), not being 
an offence punishable with imprisonment only, or with imprisonment and also with fine, may, either before or 
after  the  instructions  of  any  prosecution,  be  compounded  by  the  Central  Government  or  by  any  State 
Government or any officer authorized in this behalf Central Government or a State Government, on payment 
for credit to that Government of such sum as that Government may, by rules made in this behalf, specify:  

Provided  that  such  sum  shall  not,  in  any  case,  exceed  the  maximum  amount  of  the  fine  which  may  be 

imposed under this Act for the offences so compounded:  

Provided further that in cases of subsequent offences, the same shall not be compoundable.  

(2)  When  the  accused  has  been  committed  for  trial  or  when  he  has  been  convicted  and  an  appeal  is 
pending,  no  composition  for  the  offences  shall  be  allowed  without  the  leave  of  the  court  to  which  he  is 
committed or, as the case may be, before which the appeal is to be heard.  

(3)  Where  an  offence  is  compounded  under  sub-section  (1),  no  proccding  or  further  proceeding,  as  the 
case may be , shall be taken against the offender in respect of the offences so compounded and the offender, if 
in custody, shall be released forthwith.] 

33.    Power  of  Central  Government  to  make  rules.—

5
[after 
consultation  with, or on the recommendation of, the Board] and after previous publication by notification in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

[(1)  The  Central  Government  may 

4

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion 
that circumstances  have  arisen  which  render  it  necessary  to  make  rules  without  such  consultation,  but  in 
such  a  case  the  Board  shall  be  consulted  within  six  months  of  the  making  of  the  rules  and  the  Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules.] 

1.  Ins. by Act 13 of 1964, s. 23  (w.e.f.15-9-1964). 
2.  Subs. by Act 68 of 1982, s. 28, for certain words (w.e.f. 1-2-1983). 
3.  Ins. by Act 26 of 2008, s. 13; (w.e.f. 10-8-2009) 
4.  Subs. by Act 11 of 1955, s. 15, for sub-section (1). 
5.  Subs. by Act 68 of 1982, s. 29, for certain words (w.e.f. 1-2-1983). 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

 (2) Without prejudice to the generality of the foregoing power, such rules may— 

(a) provide for the establishment of laboratories for testing and analysing drugs 

1
[or cosmetics]; 

(b) prescribed the qualifications and duties of Government Analysts and the qualifications of  
Inspectors; 

(c) prescribe the methods of test or analysis to be employed in determining whether a drug 

1

[or 

cosmetic] is of standard quality; 

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of 
standardisation; 

2
[(dd) prescribe under clause (d) of 

3

contain for purposes of colouring;] 

[section 17A] the colour or colours which a drug may bear or 

4[(dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may bear or 

contain for purposes of colouring]; 

(e) prescribe the forms of licences 

6
[for the manufacture for sale or for distribution], for the sale 
[or  of  cosmetics  or  any 
and  for  the  distribution  of  drugs  or  any  specified  drug  or  class  of  drugs 
specified  cosmetic  or  class  of  cosmetics],  the  form  of  application  for  such  licences,  the  conditions 
[,  the 
subject  to  which  such  licences  may  be  issued,  the  authority  empowered  to  issue  the  same 

1

3

qualification  of  such  authority]  and  the  fees  payable  therefor 
[and  provide  for  the  cancellation  or 
suspension  of  such  licences  in  any  case  where  any  provision  of  this  Chapter  or  the  rules  made 
thereunder  is contravened  or  any  of  the  conditions subject to  which  they  are  issued  is  not  complied 
with;] 

3

3

[(ee)  prescribe  the  records,  registers  or  other  documents  to  be  kept  and  maintained  under 
section 18B; 

(eea)  prescribe  the  fees  for  the  inspection  (for  the  purposes  of  grant  or  renewal  of  licence)  of 

premises, wherein any drug or cosmetic is being or is proposed to be manufactured; 

(eeb)    prescribe  the  manner  in  which  copies  are  to  be  certified  under  sub-section  (2A)  of 
section 22;] 

(f) specify the diseases or ailments which a drug may not purport or claim 
mitigate] 

and such other effects which a drug may not purport or claim to have; 

5

[to prevent, cure or 

(g)  prescribe  the  conditions  subject  to  which  small  quantities  of  drugs  may  be 

manufactured  for  the purpose of examination, test or analysis; 

1.  Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
2.  Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
3.  Ins. by Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983). 
4.  Ins. by Act 26 of 2008, s. 14(i) (w.e.f. 10-8-2009) 
5.  Subs. by Act 11 of 1955, s. 15, for ―to cure or mitigate‖. 
6. Subs. By Act 68 of 1982, s. 29 ( w.e.f. 1-2-1983).

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(h) require the date of manufacture and the date of expiry of potency to be clearly or truly stated 
on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or 
exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified 
period from the date of manufacture or after the expiry of the date of potency; 

(i)  prescribe  the  conditions  to  be  observed  in  the  packing  in  bottles,  packages,  and  other 
2
1
containers of drugs 
[including the use of packing material which comes into direct 
contact with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs 
1
[or cosmetics] packed in contravention of such conditions; 

[or cosmetics], 

(j) regulate the mode of labelling packed drugs 1[or cosmetics], and prescribe the matter which 

shall or shall not be included in such labels; 

(k)  prescribe  the  maximum  proportion  of  any  poisonous  substance  which  may  be  added  or 
contained  in  any  drug,  prohibit  the  manufacture,  sale  or  stocking  or  exhibition  for  sale,  or 
distribution of any drug in which that proportion is exceeded, and specify substances which shall be 
deemed to be poisonous for the purposes of this Chapter and the rules made thereunder; 

(l)  require  that  the  accepted  scientific  name  of  any  specified  drug  shall  be  displayed  in  the 
prescribed  manner  on  the  label  or  wrapper  of  any  patent  or  proprietary  medicine  containing  such 
drug; 
3

[****] 
4
[(n)  prescribe  the  powers  and  duties  of  Inspectors 

5
[and  the  qualifications  of  the  authority  to 
6
which such Inspectors shall be subordinate] and 
[specify the drugs or classes of drugs or cosmetics 
or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to 
which, such powers and duties may be exercised or performed;] 

(o)  prescribe  the  forms  of  report  to  be  given  by  Government  Analysts,  and   the  manner  of 

application for test  or analysis under section 26 and the fees payable therefor; 

[(p)  specify  the  offences  against  this  Chapter  or  any  rule  made  thereunder  in  relation  to 

which  an  order  of confiscation may be made under section 31; 8[****]] 
(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of 
this  Chapter  or  the rules made thereunder, of any specified drug or class of drugs 1[or cosmetic or 
class of cosmetics]; 9[and] 

10[(r) sum which may be specified by the Central Government under section 32-B.] 
11[****] 

7

12[33A.  Chapter  not  to  apply  to      13[Ayurvedic,  Siddha  or  Unani]  drugs.—Save  as  otherwise 

provided in this Act, nothing contained in this Chapter shall apply to 13[Ayurvedic, Siddha or Unani] drugs.] 

PROVISIONS RELATING TO 

13

[AYURVEDIC, SIDDHA AND UNANI] DRUGS 

14

[CHAPTER IVA 

33B. Application of Chapter IVA.—This Chapter shall apply only to 

13

[Ayurvedic, Siddha and Unani] 

drugs. 

15

33C. 

[Ayurvedic,  Siddha  and  Unani    Drugs  Technical  Advisory  Board].—(1)  The  Central 
Government shall, by notification in the Official Gazette and with effect from such date as may be specified 
therein,  constitute  a  Board  (to  be  called  the 
[Ayurvedic,  Siddha  and  Unani  Drugs  Technical  Advisory 
Board])  to  advise  the  Central  Government  and  the  State  Governments  on  technical matters arising out of 
this Chapter and to carry out the other functions assigned to it by this Chapter. 

15

(2) The Board shall consist of the following members, namely:— 

1.    Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964). 
2.    Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983). 
3.    Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1965). 
4.    Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961). 
5.    Ins. by Act 68 of 1982, s. 29 (w.e.f. 15-9-1965). 
6.    Subs. by Act 21 of 1962, s. 22, for ―the drugs or class of drugs‖ (w.e.f. 27-7-1964). 
7.    Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964). 
8.   The word ―and‖omitted by Act 26 of 2008, sec. 14(ii) (w.e.f. 10-8-2009) 
9.   Ins. by Act 26 of 2008, Sec. 14 (iii) (w.e.f. 10-8-2009) 
10. Ins. by Act 26 of 2008, Sec. 14 (iv) (w.e.f. 10-8-2009) 
11.    Sub-section (3) ins. by Act 35 of 1960 and omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964). 
12.   Ins. by Act 13 of 1964, s. 25 (w.e.f. 1-2-1969). 
13.   Subs. by Act 68 of 1982, s. 2, for ―AYURVEDIC (INCLUDING SIDDHA) OR UNANI‖  (w.e.f. 1-2-1983). 
14.   Ins. by Act 13 of 1964, s. 26  (w.e.f. 1-2-1969). 
15.   Subs. by Act 68 of 1982, s. 30, for certain words (w.e.f. 1-2-1983).

26 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(i) the Director General of Health Services, ex officio; 

(ii) the Drugs Controller, India, ex officio; 

1[(iii)  the principal officer dealing with Indian systems of medicine in the Ministry of  Health, ex officio;] 

(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio; 

(v)  one  person  holding  the  appointment  of  Government  Analyst  under  section  33F,  to  be  nominated  by  the 

Central Government; 

(vi)  one Pharmacognocist to be nominated by the Central Government; 

(vii) one Phyto-chemist to be nominated by the Central Government; 

2[(viii)    four  persons  to  be  nominated  by  the  Central  Government,  two  from  amongst  the  members  of  the 
Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and 
one from amongst the members of the Siddha Pharmacopoeia Committee;] 

(ix) one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government; 

(x)   one   teacher   in   ILM-UL-ADVIA   and   TAKLIS-WA-DAWA-SAZI,   to   be   nominated   by   the   Central 

Government; 

3[(xi) one teacher in Gunapadam, to be nominated by the Central Government; 

(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the 

Central Government; 

(xiii)  three  persons,  one  each  from  among  the  practitioners  of  Ayurvedic,  Siddha  and  Unani  Tibb  system  of 

medicine, to be nominated by the Central Government.] 

(3) The Central Government shall appoint a member of the Board as its Chairman. 

(4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination. 

(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and 

regulating its own procedure and conduct of all business to be transacted by it. 

(6) The functions of the Board may be exercised notwithstanding any vacancy therein. 

(7) The  Central Government  shall appoint a person  to be  Secretary of  the Board and shall provide the Board  with 

such clerical and other staff as the Central Government considers necessary. 

4[33D.  The  Ayurvedic,  Siddha  and  Unani  Drugs  Consultative  Committee.—(1)  The  Central  Government  may 
constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise 
the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board 
on  any  matter  for  the  purpose  of  securing  uniformity  throughout  India  in  the  administration  of  this  Act  in  so  far  as  it 
relates to Ayurvedic, Siddha or Unani drugs. 

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated 
by the Central Government as representatives of that Government and not more than one representative of each State to 
be nominated by the State Government concerned. 

(3)  The  Ayurvedic,  Siddha  and  Unani  Drugs  Consultative  Committee  shall  meet  when  required  to  do  so  by  the 

Central Government and shall regulate its own procedure. 

33E. Misbranded drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drugs shall be deemed 

to be misbranded— 

1. Subs. by Act 68 of 1982, s. 30, for cl. (iii)  (w.e.f. 1-2-1983). 
2. Subs. by Act 68 of 1982, s. 30, for cl. (viii)  (w.e.f. 1-2-1983). 
3. Subs. by Act 68 of 1982, s. 30, for cls.  (xi) and (xii) (w.e.f. 1-2-1983). 
4. Subs. by Act 68 of 1982, s. 31, for ss. 33D and 33E (w.e.f. 1-2-1983).

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(a) if it is so coloured, coated, powered or polished that damage is concealed, or if it is made to appear of better 

or greater therapeutic value than it really is; or 

(b) if it is not labelled in the prescribed manner; or 

(c)  if  its  label  or  container  or  anything  accompanying  the  drug  bears  any  statement,  design  or  device  which 

makes any false claim for the drug or which is false or misleading in any particular. 

33EE. Adulterated drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed 

to be adulterated,— 

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated 

with filth or whereby it may have been rendered injurious to health; or 

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render 

the contents injurious to health; or 

(d) if it bears or contains, for purposes of coloring only, a colour other than one   which is prescribed; or 

(e) if it contains any harmful or toxic substance which may render it injurious to  health; or 

(f) if any substance has been mixed therewith so as to reduce its quality or strength. 

Explanation.—For  the  purpose  of  clause  (a),  a  drug  shall  not  be  deemed  to  consist,  in  whole  or  in  part,  of  any 
decomposed  substance  only  by  reason  of  the  fact  that  such  decomposed  substance  is  the  result  of  any  natural 
decomposition of the drug: 

Provided  that  such  decomposition  is  not  due  to  any  negligence  on  the  part  of  the  manufacturer  of  the  drug  or  the 

dealer thereof and that it does not render the drug injurious to health. 

33EEA. Spurious drugs.—For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed 

to be spurious— 

(a) if it is sold, or offered or exhibited for sale, under a name which belongs to another drug; or 

(b) if it is an  imitation  of, or is a substitute for, another drug  or resembles another  drug  in  a  manner likely to 
deceive,  or  bears  upon  it  or  upon  its  label  or  container  the  name  of  another  drug,  unless  it  is  plainly  and 
conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or 

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the 

drug, which individual or company is fictitious or does not exist; or 

(d) if it has been substituted wholly or in part by any other drug or substance; or 

(e) if it purports to be the product of  a manufacturer of whom it is not truly a  product. 

33EEB.  Regulation  of  manufacture  for  sale  of  Ayurvedic,  Siddha  and  Unani  drugs.—No  person  shall 
manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, 
if any, as may be prescribed in relation to that drug. 

33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drug.—From such date 
as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself 
or by any other person on his behalf, shall— 

(a) manufacture for sale or for distribution— 

(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs; 

(ii)  any  patent  or  proprietary  medicine,  unless  there  is  displayed  in  the  prescribed  manner  on  the  label  or 

container thereof the true list of all the ingredients contained in it; and

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any 

rule made thereunder; 

(b)  sell,  stock  or  exhibit or offer  for  sale  or  distribute,  any  Ayurvedic,  Siddha or  Unani  drug  which  has  been 

manufactured in contravention of any of the provisions of this Act, or any rule made thereunder; 

(c)  manufacture  for  sale  or  for  distribution,  any  Ayurvedic,  Siddha  or  Unani  drug,  except  under,  and  in 

accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority: 

Provided  that  nothing  in  this  section  apply  to  Vaidyas  and  Hakims  who  manufacture  Ayurvedic,  Siddha  or  Unani 

drug for the use of their own patients: 

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of 

small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. 

33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in 
public  interest.—Without  prejudice  to  any  other  provision  contained  in  this  Chapter,  if  the  Central  Government  is 
satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani 
drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value 
claimed or purported to be claimed for it and   that in the public interest it is   necessary or expedient so to do then, that 
Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.] 

33F.  Government  Analysts.—(1)  The  Central  Government  or  a  State  Government  may,  by  notification  in  the 
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for 
such areas as may be assigned to them by the Central Government or the State Government, as the case may be. 

(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government 
shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government 
under which he is serving. 

1[(3)  No  person  who  has  any  financial  interest  in  the  manufacture  or  sale  of  any  drug  shall  be  appointed  to  be  a 

Government Analyst under this section.] 

33G. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official Gazette, 
appoint  such  persons  as  it  thinks  fit,  having  the  prescribed  qualifications,  to  be  Inspectors  for  such  areas  as  may  be 
assigned to them by the Central Government or the State Government, as the case may be. 

(2)  The  powers  which  may  be  exercised  by  an  Inspector  and  the  duties  which  may  be  performed  by  him  and  the 
conditions, limitations  or restrictions  subject to  which such  powers and  duties  may be  exercised  or performed  shall  be 
such as may be prescribed. 

(3)  No  person  who  has  any  financial  interest  in  the  manufacture  or  sale  of  any  drug  shall  be  appointed  to  be  an 

Inspector under this section. 

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code 
(45 of 1860) and shall be officially subordinate to such authority as the Government appointing him may specify in this 
behalf. 

33H. Application of provisions of sections 22, 23, 24 and 25.—The provisions of sections 22, 23, 24 and 25 and 
the rules, if any,  made thereunder shall,  so  far as  may  be,  apply  in  relation  to  an  Inspector  and  a  Government  Analyst 
appointed  under  this  Chapter  as  they  apply  in  relation  to  an  Inspector  and  a  Government  Analyst  appointed  under 
Chapter IV, subject to the modification that the references to ―drug‖ in the said section, shall be construed as references 
to 2[―Ayurvedic, Siddha or Unani] drugs‖. 

3[33-I.  Penalty  for  manufacture,  sale,  etc.,  of  Ayurvedic,  Siddha  or  Unani  drug  in  contravention  of  this 

Chapter —Whoever himself or by any other person on his behalf— 

(1) manufactures for sale or for distribution,— 

1.  Ins. by Act 68 of 1982, s. 32 (w.e.f.1-2-1983). 
2.  Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 33, for ss. 33-I and 33J  (w.e.f.1-2-1983).

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

1[(a) Any Ayurvedic, Siddha or Unani drug –  

(i)  deemed to be misbranded under section 33E, 
(ii) deemed to be adulterated under section 33EE, or  
(ii) without a valid licence as required under clause (c) of section 33EEC,  

shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less 
than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more;] 

(b)  any  Ayurvedic,  Siddha  or  Unani  drug  deemed  to  be  spurious  under  section  33EEA,  shall  be  punishable 
with imprisonment for a term which shall not be less than one  year but which  may extend to three  years  and  with 
fine which shall not be less than 2[fifty thousand rupees or three times the value of the drugs confiscated, whichever 
is more]: 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a 
sentence of  imprisonment for a  term of  less  than one  year  and of fine  of  less  than  2[fifty thousand rupees or three 
times the value of the drugs confiscated, whichever is more]; or 

3[(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of any notifications issuedunder 
Section  33-EED  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  three  years  and  with  fine 
which may extend to fifty thousand rupees or three times the value of the drugs confiscated, whichever is more.] 

(2) contravenes any other provisions of this Chapter or of section 24 as applied by section 33H or any rule made 
under  this  Chapter,  shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  4[ six months and with 
fine which shall not be less than ten thousand rupees.] 

5[33J. Penalty for subsequent offences.—Whoever  having being convicted of an offence,— 

(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall 
be punishable  with imprisonment  for a term  which  may extend to  two  years and  with  fine  which  shall  not be less 
than 6[fifty thousand rupees or three times the value of the drugs confiscated, whichever is more]; 

(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall 
be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years 
and  with  fine  which  shall  not  be  less  than  7[one  lakh  rupees  or  three  times  the  value  of  the  drugs  confiscated, 
whichever is more:] 

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a 
sentence of imprisonment for a term of less than two years and of fine of less than 7[one lakh rupees or three times 
the value of the drugs confiscated, whichever is more;] 

1. Sub. by s. 15(a)(i), for clause (a) (w.e.f. 10.08.2008). Clause (a), before substitution, stood as:―(a) Any Ayurvedic, Siddha or Unani drug –  (i) deemed 
to be adulterated under section 33EE, or (ii) without a valid licence as required under clause (c) of section 33EEC, shall be punishable with imprisonment 
for a term which may extend to one year and with fine which shall not be less than two thousand rupees;‖ 
2. Sub. by Act 26 of 2008, s. 15(a)(ii), for ―five thousand rupees‖ (w.e.f. 10.08.2008) 
3. Ins. by Act 26 of 2008, s. 15(a)(iii)  (w.e.f. 10.08.2008)  
4. Sub. by Act 26 of 2008, s. 15(b) for ―three months and with fine which shall not be less than five hundred rupees.‖ (w.e.f. 10.08.2008) 
5. Sub by Act 68 of 1982,s.33 for section 33J(w.e.f. 01.02.1983) 
6. Sub. by Act 26 of 2008, s. 16(a), for ―two thousand rupees‖ (w.e.f. 10.08.2008) 
7. Sub. by Act 26 of 2008, s. 16(b), for ―five thousand rupees‖ (w.e.f. 10.08.2008) 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(c)  under  sub-section  (2)  of  section  33-I  is  again  convicted  of  an  offence  under  that  sub-section, 
shall  be  punishable  with  imprisonment  for  a  term  which  may  extend  to  5[one year  and  with  fine  which 
shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever 
is more;] 

33K.  Confiscation.—Where  any  person  has  been  convicted  under  this  Chapter,  the  stock  of  the 
1[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to 
confiscation. 

6[33-KA.  Disclosure of  name  of  manufacturer  etc.,  –Every  person,  not  being  the  manufacturer  of  any 
Ayurvedic, Siddha or Unani drug or his agent for the distribution thereof, shall, if so required, disclose to the 
Inspector the name, address and other particulars of the person from whom he acquired the Ayurvedic, Siddha 
or Unani drug.] 

6[33-KB. Maintenance of records and furnishing of information.— Every person holding a licence under 
clause (c) of section 33-EEC shall keep and maintain such records, registers and other documents as may be 
prescribed and shall furnish to any officer or authority exercising any power or discharging any function under 
this Act such information as is required by such officer or authority for carrying out the purposes of this Act. ] 

33L. Application of provisions to Government departments.—The provisions of this Chapter except 
those contained  in  section  33K  shall  apply  in  relation  to  the  manufacture  for  sale,  sale  or  distribution  of 

1
[Ayurvedic,  Siddha  or  Unani]  drug  by  any  department  of  Government  as  they  apply  in  relation  to  the 

any 
manufacture for sale, sale or distribution of such drug by any other person. 

33M. Cognizance of offences.—(1) No prosecution under this Chapter shall be instituted except by an 

Inspector 2[with the previous sanction of the authority specified under sub-section (4) of section 33G]. 

(2) No Court inferior to that 

3

[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] 

shall try an offence punishable under this Chapter. 

[after 
33N.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may, 
consultation with, or on the recommendation of, the Board] and after previous publication by notification in 
the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter: 

4

Provided  that  consultation  with  the  Board  may  be  dispensed  with  if  the  Central  Government  is  of 
opinion  that  circumstances have arisen which render it necessary to make rules without such consultation, but 
in  such  a  case,  the  Board  shall  be  consulted  within  six  months  of  the  making  of  the  rules  and  the  Central 
Government  shall  take  into  consideration  any  suggestions  which  the  Board  may  make  in  relation  to  the 
amendment of the said rules. 

(2) Without prejudice to the generality of the foregoing power, such rules may— 

(a) provide for the establishment of laboratories for testing and analysing 1[Ayurvedic, Siddha or 

Unani] drugs; 

1.  Subs. by Act 68 of 1982, s. 2, for ―Ayurvedic (including Siddha) and Unani‖  (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 34,  (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 34, for certain words (w.e.f. 1-2-1983). 
4.  Subs. by Act 68 of 1982 , s. 35, for certain words (w.e.f. 1-2-1983). 
5.  Sub. by Act 26 of 2008, s. 16(c), for ―six months and with fine which shall not be less than one thousand rupees.‖ (w.e.f. 10.08.2008) 
6.  Ins. by Act 26 of 2008, s. 17, (w.e.f. 10.08.2008).

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

(b) prescribe the qualification and duties of Government Analysts and the qualifications of Inspectors; 

(c) prescribe the methods of test or analysis to be employed in determining whether any 1[Ayurvedic, Siddha or 

Unani] drug is labelled with the true list of the ingredients which it is purported to contain; 

(d) specify any substance as a poisonous substance; 

(e) prescribe the forms of licences for the manufacture for sale of  1[Ayurvedic, Siddha or Unani] drugs,2[and for 
sale  of  processed  Ayurvedic,  Siddha  or  Unani  drugs,]  the  form  of  application  for  such  licences,  the  conditions 
subject  to  which  such  licences  may  be  issued,  the  authority  empowered  to  issue  the  same  and  the  fees  payable 
therefor;  2[and provide  for  the  cancellation or suspension  of such  licences in  any case  where any provision  of this 
Chapter  or  rules  made  thereunder  is  contravened  or  any  of  the  conditions  subject  to  which  they  are  issued  is  not 
complied with]; 

3[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the 
use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs 
and prescribe the matters which shall or shall not be included in such labels;] 

(g) prescribe  the  conditions  subject  to  which  small  quantities  of  1[Ayurvedic,  Siddha  or  Unani]  drugs  may  be 

manufactured for the purpose of examination, test or analysis; 

2[(gg) prescribe  under  clause  (d)  of  section  33EE  the  colour  or  colours  which  an  Ayurvedic,  Siddha  or  Unani 

drug may bear or contain for purposes of colouring; 

(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under    section 33EEB 7[***];] 

8[(ggb) prescribe the records, registers or other documents to be kept and maintained under section 33 KB; and] 

(h) any other matter which is to be or may be prescribed under this Chapter. 

33-O.  Power  to  amend  First  Schedule.—The  Central  Government,  after  consultation  with  the  Board  and  after 
giving, by notification in the Official Gazette, not less than three months‘ notice of its intention so to do, may, by a like 
notification,  add  to  or  otherwise  amend  the  First  Schedule  for  the  purposes  of  this  Chapter  and  thereupon  the  said 
Schedule shall be deemed to be amended accordingly.] 

4[CHAPTER V 

MISCELLANEOUS 

5[6[33P.] Power to give directions.—The Central Government may give such directions to any State Government 
as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of 
this Act or of any rule or order made thereunder.] 

34.  Offences  by  companies.—(1)  Where  an  offence  under  this  Act  has  been  committed  by  a  company,  every 
person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct 
of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to 
be proceeded against and punished accordingly: 

Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided 
in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to 
prevent the commission of such offence. 

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by 
a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to 
any  neglect  on  the  part  of,  any  director,  manager,  secretary  or  other  officer  of  the  company,  such  director,  manager, 
secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and 
punished accordingly: 

1.  Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983). 
2.  Ins. by Act 68 of 1982, s. 35, (w.e.f. 1-2-1968). 
3.  Subs. by Act 68 of 1982, s. 35, for cl. (f) (w.e.f. 1-2-1968). 
4.  Subs. by Act 11 of 1955, s. 16, for Chapter V. 
5..  Ins. by Act 35 of 1960, s. 11 (w.e.f. 16-3-1961). 
6.  S. 33A re-numbered as s. 33P by Act 13 of 1964, s. 27 (w.e.f. 15-9-1964). 
7. The word ―and‖ omitted by Act 26 of 2008, sec.18(i) (w.e.f. 10.08.2009) 
8. Sub. by Act 26 of 2008, s. 18(ii) (w.e.f. 10.08.2009)

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Explanation.—For the purposes of this section— 

(a) ―company‖ means a body corporate, and includes a firm or other association of individuals; and 

(b) ―director‖ in relation to a firm means a partner in the firm. 

1[34A. Offences by Government Departments.—Where an offence under Chapter 1V or Chapter 1VA has been committed 
by any department of Government, such authority as is specified by the Central Government to be in charge of manufacture, sale or 
distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and 
shall be liable to be proceeded against and punished accordingly: 

Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in 
Chapter 1V or Chapter 1VA, as the case may be, if such authority or person proves that the offence was committed without its or his 
knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.] 

2[34AA. Penalty for vexatious search or seizure.—Any Inspector exercising powers  under this Act or the rules 

made thereunder, who,— 

(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or 

(b) vexatiously and unnecessarily searches any person; or 

(c)  vexatiously  and  unnecessarily  seizes  any  drug  or  cosmetic,  or  any  substance  or  article,  or  any  record, 

register, document or other material object; or 

(d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that 

such act is required for the execution of his duty, 

shall be punishable with fine which may extend to one thousand rupees.] 

35. Publication of sentences passed under this Act.— (1) If any person is convicted of an offence under this Act, 3[the Court 
before  which  the  conviction  takes  place  shall,  on  application  made  to  it  by  the  Inspector,  cause]  the  offender‘s  name,  place  of 
residence,  the  offence  of  which  he  has  been  convicted  and  the  penalty  which  has  been  inflicted  upon  him,  to  be  published  at  the 
expense of such person in such newspapers or in such other manner as the Court may direct. 

(2) The expenses of such publication shall be deemed to form part of the cost relating to the conviction and shall be recoverable 

in the same manner as those costs are recoverable. 

36.  Magistrate‘s  power  to  impose  enhanced  penalties.—Notwithstanding  anything  contained  in  4[***]    5[the  Code  of 
Criminal Procedure, 1973 (2 of 1974)] it shall be lawful for 6[any Metropolitan Magistrate or any Judicial Magistrate of the first class] 
to pass any sentence authorised by this Act in excess of his powers under 4[*    *    *] the said Code. 

7[36A. Certain  offences  to  be  tried  summarily.—Notwithstanding  anything  contained  in  the  Code  of  Criminal 
Procedure, 1973 (2 of 1974), 8[all offences except the offences triable by the Special Court under Section 36-AB or Court 
of Sessions  under this  Act,]  punishable  with  imprisonment  for  a  term not  exceeding  three  years,  other  than  an offence 
under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first 
class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of 
sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial: 

Provided  that,  in  the  case  of  any  conviction  in  a  summary  trial  under  this  section,  it  shall  be  lawful  for  the 

Magistrate to pass a sentence of imprisonment for a term not exceeding one year: 

Provided  further  that  when  at  the  commencement  of,  or  in  the  course  of,  a  summary  trial  under  this  section  it 
appears to the Magistrate  that the nature of the case is  such  that a  sentence of  imprisonment  for a term exceeding one 
year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, 
after  hearing  the  parties,  record  an  order  to  that  effect  and  thereafter  recall  any  witness  who  has  been  examined  and 
proceed to hear or rehear the case in the manner provided by the said Code.] 

1.  Ins. by Act 13 of 1964, s. 28  (w.e.f. 15-9-1964). 
2.  Ins. by Act 68 of 1982, s. 36 (w.e.f. 1-2-1983). 
3.  Subs. by Act 68 of 1982, s. 37, for certain words  (w.e.f. 1-2-1983). 
4.  The words and figures ―section 32 of‖ omitted by Act 13 of 1964, s. 29 (w.e.f.15-9-1964). 
5.  Subs. by Act 68 of 1982, s. 38, for ―the Code of Criminal Procedure, 1898‖  (w.e.f. 1-2-1983). 
6.  Subs. by Act 68 of 1982, s. 38, for certain words (w.e.f. 1-2-1983). 
7.  Ins. by Act 68 of 1982,  s. 38, (w.e.f. 1-2-1983). 
8.  Sub. by Act 26 of 2008, s. 19 for all offences (w.e.f. 10.08.2009)

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

3[36-AB. Special Courts. – (1) The Central Government, or the State Government, in consultation with the Chief 
Justice  of  the  High  Court,  shall,  for  trial  of  offences  relating  to  adulterated  drugs  or  spurious  drugs  punishable  under 
clause (a) and (b) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28-A, 
Section 28-B and clause (b) of sub-section (1) of Section 30 and other offences relating to adulterated drugs or spurious 
drugs, by notification, designate one or more Courts of Sessions as a Special Court or Special Courts for such area or for 
such case or class or group of cases as may be specified in the notification.  

Explanation.- In this sub-section, ―High Court‖  means the  High Court of the State in  which a Court of Sessions 

designated as Special Court was functioning immediately before such designation.  

(2) While trying an offence under this Act, a Special Court shall also try an offence, other than an offence referred 
to in sub-section (1), with which the accused may, under the Code of Criminal Procedure, 1973 (2 of 1974), be charged at 
the same trial.] 

3[36-AC. Offences to be cognizable and non-bailable in certain cases. –  
(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974)-  

(a)  every  offence,  relating  to  adulterated  or  spurious  drug  and  punishable  under  clause  (a)  and  (c)  of  sub-
section (1) Section 13, clause (a) of sub-section (2) of Section 13, subsection (3) of Section 22, clause (a) and 
(c) of Section 27, Section 28, Section 28A, 40 Section 28B and sub-section (1) and (2) of Section 30 and 
other offences relating to adulterated drugs or spurious drugs, shall be cognizable. 
(b)  no person  accused,  of  an  offence  punishable  under  clause  (a)  and  (c) of  sub-section  (1)  of  Section  13, 
clause (a) of sub-section (2) of Section 13, sub-section (3) of Section 22, clause (a) and (c) of Section 27, 
Section 28, Section 28A, Section 28B and subsection (1) and (2) of Section 30 and other offences relating to 
adulterated drugs or spurious drugs, shall be released on bail or on his own bond unless-  
(i)   the Public Prosecutor has been given an opportunity to oppose the application for such release; and 
(ii)  where  the  Public  Prosecutor  opposes  the  application,  the  court  is  satisfied  that  there  are  reasonable 
grounds  for  believing  that  he  is  not  guilty  of  such  offence  and  that  he  is  not  likely  to  commit  any 
offence while on bail:  

Provided that a person, who, is under the age of sixteen years,or is a woman or is sick or infirm, may be released 

on bail, if the Special Court so directs.  

(2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in addition to the limitations under 

the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in force on granting bail.  

(3) Nothing contained in this section shall be deemed to affect the Special powers of the High Court regarding bail 
under Section 439 of the Code of Criminal Procedure, 1973 (2 of 1974) and the High Court may exercise such powers 
including the power under clause (b) of sub-section (1) of that section as if the reference to ―Magistrate‖ in that section 
includes also a reference to ―Special Court‖ designated under Section 36AB.]  

3[36-AD. Application Code of Criminal Procedure, 1973 to proceedings before Special Courts. – (1) Save as 
otherwise  provided  in  this  Act,  the  provisions  of  the  Code  of  Criminal  Procedure,  1973  (2  of  1974)  (including  the 
provisions  as  to  bails  and  bonds),  shall  apply  to  the  proceedings  before  a  Special  Courts  and  for  the  purpose  of  said 
provisions, the Special Court shall be deemed to be a Court of Sessions and the person conducting the prosecution before 
the Special Court, shall be deemed to be a Public Prosecutor:  

Provided that the Central Government or the State Government may also appoint, for any case or cases or group of 

cases, a Special Public Prosecutor.  

(2) A person shall not be qualified to be appointed as Public Prosecutor or a Special Public Prosecutor under this 
section unless he has been in practice as an advocate for not less than seven years, under the Union or a State, requiring 
special knowledge of law.  

(3)  Every  person  appointed  as  a  Public  Prosecutor  or  a  Special  Public  Prosecutor  under  this  section  shall  be 
deemed to be a Public Prosecutor within the meaning of clause (u) of 41 Section 2 of the Code of Criminal Procedure, 
1973 (2 of 1974) and the provisions of that Code shall have effect accordingly.] 

3[36AE.  Appeal  and  revision.-  The  High  Court  may  exercise,  so  far  as  may  be  applicable,  all  the  powers 
conferred by Chapter XXIX or Chapter XXX of the Code of Criminal Procedure, 1973(2 of 1974), on a High Court, as if 
a Special Court within the local limits of  the jurisdiction of the High Court were a Court of Session trying cases within 
the local limits of the jurisdiction of the High Court.] 

37. Protection of action taken in good faith.—No suit, prosecution or other legal proceeding shall lie against any 

person for anything which is in good faith done or intended to be done under this Act. 

1[38. Rules to be laid before Parliament.— Every rule made under this Act shall be laid as soon as may be after 
it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised 
in one session or in two or more successive sessions, 2[and if, before the expiry of the session immediately following the 
session or the successive sessions aforesaid], both Houses agree in making any modification in the rule or both Houses 
agree that the rule should not be made, the rule shall thereafter have effect only in such modified from or be of no effect, 
as  the  case  may  be;  so  however  that  any  such  modification  or  annulment  shall  be  without  prejudice  to  the  validity  of 
anything previously done under that rule.] 

1.  Ins. by Act 13 of 1964, s. 30  (w.e.f. 15-9-1964). 
2.  Subs. by Act 68 of 1982, s. 40, for certain words  (w.e.f. 1-2-1983). 
3. Ins. by Act 26 of 2008, s. 20 (w.e.f. 10.08.2009)

34 

 
 
 
 
Drugs and Cosmetics Act, 1940 

1[THE FIRST SCHEDULE 

[See section 3(a)] 

2[A.—AYURVEDIC AND SIDDHA SYSTEMS] 

Serial No.                               Name of book 

Ayurveda 

1.                                        Arogya Kalpadruma 
2.                                        Arka Prakasha 
3.                                        Arya Bhishak 
4.                                        Ashtanga Hridaya 
5.                                        Ashtanga Samgraha 
6.                                        Ayurveda Kalpadruma 
7.                                        Ayurveda Prakasha 
8.                                        Ayurveda Samgraha 
9.                                        Bhaishajya Ratnavali 
10.                                      Brihat Bhaishajya Ratnakara 
11.                                      Bhava Prakasha 
12.                                      Brihat Nighantu Ratnakara 
13.                                      Charaka Samihita 
14.                                      Chakra Datta 
15.                                      Gada Nigraha 
16.                                      Kupi Pakva Rasayana 
17.                                      Nighantu Ratnakara 
18.                                      Rasa Chandanshu 
19.                                      Rasa Raja Sundara 
20.                                      Rasaratna Samuchaya 
21.                                      3[Rasatantra Sara Va Siddha Prayoga Sangraha—Part 1] 
4[21 (a)                                Rasatantra Sara Va Siddha Prayoga Sangraha—Part II (Edition 2006)] 
22.                                      Rasa Tarangini 
23.                                      Rasa Yoga Sagara 
24.                                      Rasa Yoga Ratnakara 
25.                                      Rasa Yoga Samgraha 
26.                                      Rasendra Sara Samgraha 
27.                                      Rasa Pradipika 
28.                                      Sahasrayoga 
29.                                      Sarvaroga Chikitsa Ratnam 
30.                                       Sarvayoga Chikitsa Ratnam 
31.                                      Sharangadhara Samhita 
32.                                      Siddha Bhaishajya Manimala 
33.                                      Siddha Yoga Samgraha 
34.                                      Sushruta Samhita 
35.                                      Vaidya Chintamani 
36.                                      Vaidyaka Shabda Sindu 
37.                                      Vaidyaka Chikitsa Sara 
38.                                      Vidya Jiwan 
39.                                      Vasava Rajeeyam 
40.                                      Yoga Ratnakara 
41.                                      Yoga Tarangini 
42.                                      Yoga Chintamani 
43.                                      Kashyapasamhita 
44.                                      Bhelasamhita 
45.                                      Vishwanathachikitsa 
46.                                      Vrindachikitsa 

1.  Subs. by Act 13 of 1964, s. 31, for the Sch. The First Schedule came into force with effect from 1-2-1969 and the Second Schedule came into force 

with effect  from the 15th September, 1964. 

2.  Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983). 
3.  Subs. by Notification No. G.S R. 658 (E), dated 31-08-1994. 
4. Added by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).

35 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Serial  No.                              Name of book 

47.                                           Ayurvedachintamani 
48.                                           Abhinavachintamani 
49.                                           Ayurveda-Ratnakara 
50.                                           Yogaratnasangraha 
51.                                           Rasamrita 
52.                                           Dravyagunanighantu 
53.                                           Rasamanjari 
54.                                           Bangasena 
1[54A                                         6 [ Ayurvedic Formulary of India and its Parts) 
54B                                         Ayurveda Sara Samgraha] 
2[54C                                         Ayurvedic Pharmacopoeia of India.] 
5[54D. 

  Ayurvedic Pharmacopoeia of India and its Parts.] 

Siddha 

55                                            Siddha Vaidya Thirattu 
56                                            Therayar Maha Karisal 
57                                            Brahma Muni Karukkadai (300) 
58                                            Bhogar (700) 
59                                            Pulippani (500) 
60                                            Agasthiyar Paripuranam (400) 
61                                            Therayar Yamagam 
62                                            Agasthiyar Chenduram (300) 
63                                            Agasthiyar (1500) 
64                                            Athmarakshamrutham 
65                                            Agasthiyar Pin (80) 
66                                            Agasthiyar Rathna Churukkam 
67                                            Therayar Karisal (300) 
68                                            Veeramamuni Nasa Kandam 
69                                            Agasthiyar (600) 
70                                            Agasthiyar Kanma Soothiram 
71                                            18 Siddar‘s Chillarai Kovai 
72                                            Yog Vatha Kaviyam 
73                                            Therayar Tharu 
74                                            Agasthiyar Vaidya Kaviyam (1500) 
75                                            Bala Vagadam 
76                                            Chimittu Rathna (Rathna) Churukkam 
77                                            Nagamuni (200) 
78                                            Agasthiyar Chillarai Kovai 
79                                            Chikicha Rathna Deepam 
80                                            Agasthiyar Nayana Vidhi 
81                                            Yugi Karisal (151) 
82                                            Agasthiyar Vallathi (600) 
83                                            Therayar Thaila Varkam 

31[84                                            Siddha Formulary of India (Part I)] 

5[85                                            Siddha Formulary of India and its Parts] 

4[B.—UNANI  TIBB SYSTEM] 

Serial No.                                    Name of book 
1                                                  Karabadin Qadri 
2                                                  Karabadin Kabir 
3                                                  Karabadin Azam 
4                                                  Ilaj-ul-Amraz 
5                                                  Al Karabadin 
6                                                  Biaz Kabir Vol. II 
7                                                  Karabadin Jadid 
8                                             Kitab-ul-Taklis 
9                                             Sanat-ul-Taklis 
10                                           Mifta-ul-Khazain 
11                                           Madan-ul-Aksir 
12                                           Makhzan-ul-murabhat 
1[13                                         National Formulary of Unani Medicine 7[****]] 
8[14                                         Unani Pharmacopoeia of India] 

1.  Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.         6. Subs. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010). 
2.  Ins. by Notifn. No. G.S.R. 423 (E), dated the 11th June, 2002.             7.  Omitted by GSR 780(E), dt 25-11-2004. 
3.  Ins. by Notifn. No. G.S.R. 735 (E), dated the 28th August, 1987.         8. Ins by GSR 780 (E), dt. 25.11.20114. 
4.  Subs. by Act 68 of 1982, s. 41 (w.e.f. 1-2-1983). 
5. Ins. by G.S R. 337 (E), dated 15-04-2010 (w.e.f. 20.4.2010).  

36 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

4[THE SECOND SCHEDULE  

(See sections  8 and 16) 

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS  MANUFACTURED FOR SALE, SOLD, 
STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED 

Class of drug                                                       Standard to be complied with 

1                                                                                        2

1.   Patent   or   proprietary   medicines   1[other   than 
Homoeopathic medicines] 

2.  2[Substances  commonly  known  as  vaccines,  sera 
toxins,    toxoids,    antitoxins    and    antigens    and 
biological  products  of  like  nature,  for  human  use  or 
for veterinary use. 

3[*  *    *   *] 

4. Substances (other than food) intended to affect the 
structure  or  any  function  of  the  human  body  or 
intended  to be used  for  the destruction of  vermin  or 
insects  which  cause  disease  in  human  beings  or 
animals. 

5[1[4-A. Homoeopathic Medicines. 

(a)  Drugs  included  in  the  Homoeopathic 

Pharmacopoeia of India. 

(b)  Drugs not included in the Homoeopathic 
Pharmacopoeia  of  India  but  which  are 
included 
Homoeopathic 
the 
Pharmacopoeia  of  United  States  of 
America  or  the  United  kingdom  or  the 
German Homoeopathic Pharmacopoeia. 

in 

(c)  Drugs not included in the Homoeopathic 
Pharmacopoeia  of  India  or  the  United 
States  of  America,  or 
the  United 
Kingdom  or  the  German  Homoeopathic 
Pharmacopoeia. 

The  formula  of  list  of  ingredients  displayed  in  the 
prescribed  manner  on  the  label  of  the  container  and 
such other standards as may be prescribed. 

The  standards  maintained  at 
the  International 
Laboratory for Biological Standards, Stantans Serum 
Institute,  Copenhagen  and  at  the  Central  Veterinary 
Laboratory, Weybridge Surrey, U.K., and such other 
the  World  Health 
laboratories 
Organization  from  time  to  time,  and  such  further 
standards  of  strength,  quality  and  purity,  as  may  be 
prescribed.] 

recognized  by 

Such standards as may be prescribed. 

Standards of identity, purity and strength specified in 
the  edition  of  the  Homoeopathic  Pharmacopoeia  of 
India  for  the  time  being  and  such  other  standards  as 
may be prescribed. 

Standards  of  identity,  purity  and  strength  prescribed 
for  the  drugs  in  the  edition  of  such  Pharmacopoeia 
for the time being in  which they are given and such 
other standards as may be prescribed. 

The  formula  or  list  of  ingredients  displayed  in  the 
prescribed manner on the label of the containder and 
such  other  standards  as  may  be  prescribed  by  the 
Central Government].] 

1.  Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt.   II, Sec. 3 (ii), p. 819. 
2.  Subs. by Notifn. No. G.S.R. 299(E), dated  the 23rd April 1984. 
3.  Entry 3 omitted  by Notifn. No. G.S.R. 299(E), dated the 23rd April, 1984. 
4. Subs. by Act 13 of 1964, S. 31, for the Schedule. 
5. Subs. by G.S.R. 820 (E), dt. 6-6-1978, for item 4A, earlier Ins. by Notifn. No. S.O. 887, dated the 19th March 1966, Gazette of India , Pt.   
II, Sec. 3 (ii), p. 819.

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Act, 1940 

Class of drug                                                   Standard to be complied with 

1                                                                                   2 

1[5. Other drugs: 

(a) Drugs included in the Indian Pharmacopoeia 

Standards  of  identity,  purity  and  strength  specified 
in  the  edition  of  the  Indian  Pharmacopoeia  for  the 
time being in force and such other standards as may 
be prescribed. 

In case the standards of identity, purity and strength 
for  drugs  are  not  specified  in  the  edition  of  the 
Indian  Pharmacopoeia  for  the  time  being  in  force 
but  are  specified  in  the  edition  of  the      Indian 
pharmacopoeia 
the 
standards  of  identity,  purity  and  strength  shall  be 
those  occurring  in  such  immediately  preceding 
edition of the Indian Pharmacopoeia  and such other 
standards as may be prescribed. 

  immediately 

  preceding, 

in 

Standards  of  identity,  purity  and  strength  specified 
for  drugs 
such  official 
the  edition  of 
Pharmacopoeia  of  any  other  country  for  the  time 
being  in  force  and  such  other  standards  as  may  be 
prescribed. 

not 

Indian 
included 
(b)  Drugs 
Pharmacopoeia  but  which  are  included  in  the 
official Pharmacopoeia of any other country. 

the 

in 

In case the standards of identity, purity and strength 
for  drugs  are  not  specified  in  the  edition  of  such 
official  Pharmacopoeia  for  the  time  being  in  force, 
but  are  specified 
immediately 
preceding,  the  standards  of  identity,  purity  and 
strength    shall    be    those    occurring    in    such 
immediately 
official 
Pharmacopoeia  and such other standards as may be 
prescribed.]]

the  edition 

preceding 

such 

of 

in 

1. Subs. by Notifn. No. G.S.R. 885, dated  the 4th August, 1973, Gazette of India, Pt. II, s. 3(i), p. 1643, for item 5.

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules, 1945 

[21st  December 1945] 

Notificaiton: No. F. 28-10/45-H (1). _In exercise of the powers conferred by 1[sections 6(2), 
12, 33 and 33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central 
Government is pleased to make the following Rules:-  

PART I 
PRELIMINARY

1.  Short  title,  extent  and  commencement. 

Drugs 9[and Cosmetics] Rules, 1945. 

 (2) They extend to the whole of India. 2[***] 

10[***] 

(1)  These  Rules  may  be  called  the

2. Definitions. 

In these Rules, unless there is anything repugnant in the subject or

context 

(a) ―the Act‖ means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as 

amended from time to time; 

3[(b)  ―Central  Licence  Approving  Authority‖  means  the  Drugs  Controller, 

India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) 
appointed by the Central Government;] 

(c) ―Director‖ means the Director of the Central Drugs Laboratory; 

(d)  ―Form‖ means a form set forth in Schedule A; 

4[(dd)  Homoeopathic  medicines  include  any  drug  which  is  recorded  in 
Homoeopathic provings  or  therapeutic efficacy  of  which  has  been  established 
through  long  clinical  experience  as  recorded  in  authoritative  Homoeopathic 
literature of India and abroad and which is prepared according to the techniques 
of  Homoeopathic  pharmacy  and  covers  combination  of  ingredients  of  such 
Homoeopathic   medicines   but   does   not   include   a   medicine   which   is 
administered by parenteral route;] 

(e) ―Laboratory‖ means the Central Drugs Laboratory; 
5[(ea) ―registered Homoeopathic medical practitioner‖ means a person who 
is registered in the Central Register or State Register of Homoeopathy;] 
8
[(eb)―Phytopharmaceutical drug‖ includes purified and standardised fraction 
with  defined  minimum  four  bio-active  or  phyto-chemical  compounds 
(qualitatively and quantitatively  assessed) of an extract of a medicinal plant or 
its part, for internal or external use of human beings or animals for diagnosis, 
treatment,  mitigation  or  prevention  of  any  disease  or  disorder  but  does  not 
include administration by parenteral route.] 

6[(ee) ―Registered medical practitioner‖ means a person 

(i)  holding a  qualification granted by  an  authority specified or  notified 
under  section  3  of  the Indian Medical Degrees  Act, 1916 (7 of 1916), or 
specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 
1956); or 

(ii)  registered  or  eligible  for  registration  in  a  medical  register  of  a 
State meant for the registration of persons practising the modern scientific 
system of medicine  7[excluding the Homoeopathic system of medicine]; or 

1.  Subs. by G.S.R. 370(E), dt. 7-4-1994.             2.  Omitted by G.S.R. 358, dt. 15-3-1975. 
3.  Sub. by GSR. 579(E), dt. 20-9-2006, earlier Ins. by  G.S.R. 923(E), dt. 14-12-1992.         
4.  Ins. by Notfn. No. F. 1-59 / 68-D, dt. 19-11-1969. 
5.  Ins. by G.S.R 680 (E), dt. 5-12-1980.              6.  Ins. by Notfn.  F. 1-22 / 59-D, dt. 9-4-1960. 
7.  Ins. by S.O. 2139, dt. 15-6-1972.                     8.  Ins. By G.S.R 918(E), dt. 30-11-2015.  
9. Ins. by GSR 1183(E), dt 17-8-1964.                 10. Sub-rule  (3) omitted by GSR 19, dt. 15-12-1977. 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

 (iii)  registered  in  a  medical  register,  1[other  than  a  register  for  the 
registration of Homoeopathic practitioner], of a State, who although not falling 
within sub-clause (i) or sub-clause (ii) is declared by a general or special order 
made by the State Government in this behalf as a person practising  the  modern 
scientific  system  of  medicine  for  the  purposes of this Act; or 

(iv) registered or eligible for registration in the register of dentists for a 

State under the Dentists Act, 1948 (16 of 1948); or 

(v)  who  is  engaged  in  the  practice  of  veterinary  medicine  and  who 

possesses qualifications approved by the State Government;] 

2[(f)  ―retail  sale‖  means  a  sale  3[whether  to  a  hospital,  or  dispensary,  or  a 
medical, educational or  research institute  or  to  any  other  person]  other  than  a 
sale by way of wholesale dealing]; 

4[(g)  ―sale  by  way  of  wholesale  dealing‖  means  sale  to  a  person  for  the 
purpose  of  selling  again  and  includes  sale  to  a  hospital,  dispensary,  medical, 
educational or research institution;] 

5[(h) ―Schedule‖ means a Schedule to these Rules;] 
6[(i)   State   Government   in   relation   to   a   Union   Territory   means   the 

Administrator thereof; 

9[***] 

PART II 

THE CENTRAL DRUGS LABORATORY 

3. Functions. 

It shall be the function of the Laboratory

(i)  to  analyse  or  test  such  samples  of  drugs  as  may  be  sent  to  it  under  sub- 

section (2) of section 11, or under sub-section (4) of section 25 of the Act; 

7[*   *    *    *  *] 

(iii)  to  carry  out  such  other  duties      as  may  be  entrusted  to  it  by  the  Central 
Government  or,  with  the  permission  of  the  Central  Government,  by  a  State 
Government after consultation with the Drugs Technical Advisory Board. 
8[3A.    (1)The  functions  of  the  Laboratory  in  respect  of  the  following  drugs    or 
classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the 
functions  of  the  Director  in  respect  of  the  said  drugs  or  classes  of   drugs  shall  be 
exercised by the Director of the said Institute : 

(1)      Sera. 

(2)      Solution of serum proteins intended for injection. 

(3)      Vaccines. 

(4)      Toxins.    

(5) Antigens. 

1.  Ins. by S.O. 2139, dt. 5-6-1972. 
2  Subs. by Notfn. No. F. 1-3/51-DS., dt. 15-11-1954. 
3.  Ins. by  G.S.R 681 (E), dt. 6-6-1988. 
4. Subs. by Notfn. F-1-16/57, dt. 15.6.1957. 
5.  Subs. by Notfn. No. F. 28-10/45-H (1), dt. 31-3-1957. 
6.  Subs. by  Notfn. No. F-1-16/57-D, dt. 15-6-1957. 
7.  Cl. (ii) omitted, by  Notfn. No. F-1-16/57-D, dt. 15-6-1957. 
8  Ins. by  Notfn. No. F. 4-1 / 60-D, dt. 15-5-1961. 
9. Cl. (j) omitted by GSR 592(E), dt. 13-08-2008 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

 (6) Anti-toxins. 

(7)      Sterilized surgical ligature and sterilised surgical suture. 

(8)    Bacteriophages: 

1[Provided that the functions of the Director in respect of Oral Polio Vaccine shall 
be  exercised  by  the  Deputy  Director  and  Head  of  the  Polio  Vaccine  Testing 
Laboratory in case of  Central Research Institute, Kasauli only.] 

2[(1A) The functions of the Laboratory in respect of   Oral Polio Vaccine shall be 
carried out by the following Institutes and the functions of the Director in respect of 
the said drugs shall be exercised by the Director of the respective Institutes :- 

(a)  Pasteur Institute of India, Coonoor. 

(b)  Enterovirus  Research  Centre  (Indian  Council  of  Medical  Research), 

Haffkin Institute Compound, Parel, Bombay-400012.] 

3[(c) The National Institute of Biologicals, NOIDA.] 

4[(2) The functions of the Laboratory in respect of the following drugs or classes of 
drugs  shall  be  carried  out  at  the  Indian  Veterinary  Research  Institute,  Izatnagar  or 
Mukteshwar and the functions of the Director in respect of the said drugs or classes of 
drugs shall be exercised by the Director of either of the said institutes. 

(1)    Anti-sera for veterinary use. 

(2)    Vaccines for veterinary use. 

(3)    Toxoids for veterinary use. 

(4)    Diagnostic Antigens for veterinary use.] 

5[(3)  The  functions  of  the  laboratory  in  respect  of  testing  of  condoms  shall  be 
carried  out  at  the  Central  Drugs  Testing  Laboratory,  Chennai,  and  the  functions  of 
the Director in  respect of the  said products shall be  exercised by  the  Director of  the 
said Laboratory.] 

6[(4)]  The  functions  of  the  Laboratory  in  respect  of  the  following  drug  shall  be 
carried  out  at  the  Laboratory  of  the  Serologist  and  Chemical  Examiner  to  the 
Government of India, Calcutta and the functions of the Director in respect of the said 
drug  shall  be  performed  by  the  Serologist  and  Chemical  Examiner  of  the  said 
Laboratory : 

         VDRL Antigen. 

     7[(5) The function of the Laboratory in respect of Intra-Utrine Devices and Falope 
Rings  shall  be  carried  out  at  the  Central  Drugs  Testing  Laboratory,  Thane, 
Maharashtra and  the functions of  the  Director in  respect of  the  said devices shall be 
exercised by the Director of the said Laboratory.] 

1.  Subs. by G.S.R.445(E), dt. 30-4-1992. Earlier Ins. by G.S.R.62(E), dt. 15-2-1982. 
2.  Ins. by G.S.R. 445(E), dt. 30-4-1992. 
3.  Ins. by G.S.R.249(E), dt. 4-4-2002. 
4.  Ins. by Notfn. No. F.-1-6/62-D, dt. 2-7-1969. 
5.  Sub. By G.S.R. 651(E), dt. 9-9-2009, earlier Ins. by S. O. No. 2139, dt. 12-8-1972. 
6.  Sub-rule (4) omitted and sub-rule (5) renumbered as sub-rule (4) by  Notfn. No. G.S.R. 62(E), 

dt. 15-2-1982. 

7. Subs. by  G.S.R 242(E), dt. 18-3-1998. Earlier Ins. by G.S.R. No. 865 (E), dt. 25-10-1990. 

41 

 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(6) The functions of the Laboratory in respect of human blood and human blood 
products  including  components,  to  test  for  freedom  of  HIV  antibodies,  shall  be 
carried out  by  the  following Institutes/Hospitals and  the  functions of  the  Director in 
respect  of  the  above  mentioned  products  shall  be  exercised  by  the  head  of  the 
respective Institute, namely:- 

(a)    National    Institute    for    Communicable    Disease,    Department    of 

Microbiology, Delhi. 

(b) National Institute of Virology, Pune 

(c)  Centre  of  Advanced  Research  in  Virology,  Christian  Medical  College, 

Vellore.] 

2[(7) The functions of the Laboratory in respect of  Homoeopathic medicines shall 
be  carried  out  at  the  Homoeopathy  Pharmacopoeia  Laboratory,  Ghaziabad  and  the 
functions of the Director in respect of the Homoeopathic medicines shall be exercised 
by the Director of the laboratory.] 

3[(8) (a) The functions of the Laboratory in respect of the following kits or class of 
drugs  shall  be  carried  out  at  the  National  Institute  of  Biologicals,  Noida  and  the 
functions  of  the  Director  in  respect  of  the  said  drugs  or  class  of  drugs  shall  be 
exercised by the Director of the said institute.  

(b) The kits or class of drugs referred to in clause (a) are-  
(1) Blood grouping reagents.  
(2) Diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen 

and Hepatitis C Virus. 
(3) Blood products-  

(a) Human Albumin;  
(b) Human Normal Immunoglobulin (intramuscular and intravenous);  
(c) Human Coagulation Factor VIII;  
(d) Human Coagulation Factor IX;  
(e) Plasma Protein Fractionation;  
(f) Fibrin Sealant Kit; 
(g) Anti Inhibitor Coagulation complex. 

(4) Recombinant products such as- 

(a) Recombinant insulin and insulin analogue; 
(b) r-erythropoietin (EPO); 
(c) r-Granulocyte Colony stimulating Factor (G-CSF). 

(5) Biochemical kits- 

(a) Glucose Test Strips; 

(b) Fully Automated analyzer based glucose reagents.] 

4.  Despatch  of  samples  for  test  or  analysis.-  (1)  Samples  for  test  or  analysis under 
sub-section (4)  of  section  25  of  the  Act  shall  be  sent  by  registered post  in  a  sealed 
packet,  enclosed,  together  with  a  memorandum  in  Form  1,  in  an  outer  cover 
addressed to the Director. 

(2)  The  packet  as  well as  the  outer  cover, shall  be  marked with  a  distinguishing 

number. 

(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used 
to seal the packet shall be sent separately by registered post to the Director. 

5. Recording of condition of seals. 
On receipt of the packet, it shall be opened by an  officer authorised in  writing  in  that 
behalf  by  the  Director who  shall  record  the condition of the seal on the packet. 

          1.  Ins. by G.S.R 16(E), dt. 10-1-1990.                   2.  Ins. by  G.S.R 246(E), dt. 1-5-1991. 

3.  Sub. by G.S.R. No. 908(E), dt. 4-4-2014. Earlier Ins. by G.S.R. No. 249 (E), dt. 4-4-2002.

42 

 
 
 
 
 Drugs and Cosmetics Rules 1945 

6. Report of result of test or analysis.  After test or analysis the result of the test or
analysis, together with  full protocols of the tests applied, shall be supplied forthwith 
to the sender in Form 2. 

7. Fees.  The fees for test and analysis shall be those specified in Schedule B.

8.   Signature  of   certificates. 

Certificates  issued   under   these   Rules   by   the
Laboratory shall be signed by the Director or by an officer authorised by the Central 
Government by Notification in the Official Gazette to sign such certificates. 

1[PART  III 

[RULES 9 to 20- omitted by SRO. 2136 dated 15-06-1957] 

PART IV 
2[IMPORT AND REGISTRATION] 

21. In this Part.– 

3[(a) ―import licence‖ means either a licence in Form 10 to import drugs  4[* * 
*];  excluding  those  specified  in  Schedule  X,  or  a  licence  in  Form  10-A  to 
import drugs specified in Schedule X;] 

(b)  ―licensing  authority‖  means  the  authority  appointed  by  the  Central 
Government to perform the duties of the licensing authority under these Rules and 
includes  any  person  to  whom  the  powers  of  a  licensing  authority  may  be 
delegated under Rule 22; 

(c) ―licence for examination, test or analysis‖ means a licence in Form 11 to 
import small  quantities of drugs the  import of  which is  otherwise prohibited, for 
the purpose of examination, test or analysis; 

5[(d)  ―manufacturer‖  includes  a  manufacturer  of  drugs,  who  may  be  a 
Company  or  a  unit  or  a  body  corporate  or  any  other  establishment in  a  country 
other  than  India,  having  its  drugs  manufacturing facilities  duly  approved  by  the 
National  Regulatory  Authority  of  that  country,  and  who  also  has  a  free  sale 
approval of the drugs approved by the said authority in the concerned country, and 
/or in other major countries; 

(e)  ―Registration  Certificate‖  means  a  certificate  issued  under  Rule  27A  by 
the  licensing authority in  Form 41  for  registration of  the  premises and  the  drugs 
manufactured by the manufacturer meant for import into and use in India.] 

22. The licensing authority may with the approval of the Central Government by an 
order in writing delegate the 2[power to sign licences and Registration Certificate and] 
such  other  powers  as  may  be  specified  in  the  order  to  any  other  person  under  his 
control. 

1.  Part III (Rules 9 to 20) omitted by Notfn. No. F. 1-16/57-D (SRO 2136), dt. 15-6-1957. 
2.  Sub. by G.S.R 604 (E), dt. 24-8-2001. 
3.  Subs. by  G.S.R  462 (E),dt. 22-6-1982. 
4.  Omitted  by G.S.R 604 (E), dt. 24-8-2001. 
5. Ins. by G.S.R 604 (E), dt. 24-8-2001.

43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[23. Import licences.–An import licence in Form 10 shall be required for 2 [import 
of drugs], excluding those specified in Schedule X, and an import licence in Form 10- 
A shall be required for the import of drugs specified in Schedule X.] 

2[24.  Form  and  manner of  application for  import licence.– (1)  An  application for 
an  import  licence  shall  be  made  to  the  licensing  authority  in  Form  8  for  drugs 
excluding  those  specified  in  Schedule  X,  and  in  Form  8A  for  drugs  specified  in 
Schedule X, either by  the manufacturer himself having a  valid wholesale licence for 
sale  or  distribution  of  drugs  under  these  Rules,  or  by  the  manufacturer‘s  agent  in 
India either having a valid licence under the Rules to manufacture for sale of a drug 
or having a valid wholesale licence for sale or distribution of drugs under these Rules, 
and  shall be accompanied by  a  licence fee  of  one thousand rupees for a  single drug 
and an additional fee at the rate of one hundred rupees for each additional drug and by 
an undertaking in Form 9 duly signed by or on  behalf of the manufacturer: 

Provided that in the case of any subsequent application made by the same importer 
for  import  licence  for  drugs  manufactured  by  the  same  manufacturer,  the  fee  to 
accompany each such application shall be one hundred rupees for each drug: 

(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, 
shall be accompanied by  a  copy of  Registration Certificate  issued in  Form 41  under 
Rule 27A: 

Provided  that  in  case  of  emergencies  the  licensing  authority  may,  with  the 
approval of the  Central Government, issue an  import licence in  Form 10  or  10A, as 
the case may be, without the issuance of Registration Certificate under Rule 27A, for 
reasons to be recorded in writing. 

3[Provided  further  that  Registration  certificate  shall  not  be  required  to  be 
accompanied with an application for an import licence under the Rules for the import 
of  in-vitro  diagnostic  kits  and  regents,  except  for  the  diagnostic  kits  notified  from 
time to time under sub-clause (iv) of clause (b) of section 3.] 

(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the 

licence issued under this Rule, if the original is defaced, damaged or lost.] 

4[24A.  Form  and  manner  of  application  for  Registration  Certificate.—(1)  An 
application  for  issue  of  a  Registration  Certificate  shall  be  made  to  the  licensing 
authority  in  Form  40,  either  by  the  manufacturer  himself,  having  a  valid  wholesale 
licence  for  sale  or  distribution  of  drugs  under  these  rules,  or by his authorised agent 
in India, either having a valid licence under the rules to manufacture for sale of a drug 
or having a valid wholesale licence for sale or distribution of drugs under these rules, 
and shall be accompanied by the fee specified in sub-rule (3) and the informations and 
undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the 
manufacturer. 

1.  Subs. by  G.S.R. 462 (E), dt. 22-6-1982. 
2.  Subs. by  G.S.R 604 (E), dt. 24-8-2001. 
3. Ins. by  G.S.R. 35(E), dt. 20.1.2005. 
4. Ins. by G.S.R 604 (E), dt. 24-08-2001.

44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(2) The authorisation by a manufacturer to his agent in India shall be documented 
by a power of attorney executed and authenticated either in India before a First Class 
Magistrate,  or  in the country  of  origin    before   such    an    equivalent  authority,  the 
certificate  of  which  is  attested  by  the  Indian  Embassy  of  the  said  country,  and  the 
original  of  the  same  shall  be  furnished  along  with  the  application  for  Registration 
Certificate. 

(3)  (i)  A  fee  of  one  thousand  and  five  hundred  US  dollars  1[or  its  equivalent  in 
Indian rupees] shall be paid along with the application in Form 40 as registration fee 
for his premises meant for manufacturing of drugs intended for import into and use in 
India 

(ii) A fee of one thousand US dollars 1[or its equivalent in Indian rupees] shall be 
paid along with the application in Form 40 for the registration of a single drug meant 
for import into and use in India and an additional fee at the rate of one thousand US 
dollars for each additional drug: 

Provided  that  in  the  case  of  any  subsequent  application  for  registration  of 
additional  drugs  by  the  same  manufacturer,  the  fee  to  accompany  shall  be  one 
thousand US dollars 1[or its equivalent in Indian rupees] for each drug. 

(4)  The  fees  shall  be  paid  through  a  Challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or  any  other bank, as  notified, from time  to  time,  by  the  Central Government, to  be 
credited  under  the  Head  of  Account  ―0210-Medical  and  Public  Health,  04-Public 
Health, 104-Fees and Fines‖: 

Provided that in  the  case  of  any  direct payment of  fees by  a  manufacturer in the 
country of origin, the fees shall be  paid through Electronic Clearance System (ECS) 
from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, 
New Delhi, through the Electronic Code of the bank in the Head of Account ―0210- 
Medical and  Public  Health, 04-  Public  Health, 104-Fee and  Fines‖, and  the  original 
receipt  of  the  said  transfer  shall  be  treated  as  an  equivalent  to  the  bank  challan, 
subject to the approval by the Bank of Baroda that they have received the payment. 

(5)  The  applicant  shall  be  liable  for  the  payment  of  a  fee  of  five  thousand  US 
dollars  1[or  its  equivalent  in  Indian  rupees]  for  expenditure  as  may  be  required  for 
inspection or visit of the manufacturing premises or drugs, by the licensing authority 
or  by  any  other  persons  to  whom  powers  have  been  delegated in  this  behalf  by  the 
licensing authority under Rule 22. 

(6) The applicant shall be liable for the payment of testing fees directly to a testing 
laboratory  approved  by the Central Government  in India  or   abroad,  as   may   be 
required for examination, tests and analysis of drug. 

(7) A fee of three hundred US dollars 1[or its equivalent in Indian rupees] shall be 
paid  for  a  duplicate  copy  of  the  Registration  Certificate,  if  the  original  is  defaced, 
damaged or lost. 

(8) No Registration Certificate shall be required under these Rules in respect of an 
inactive  bulk  substance  to  be  used  for  a  drug  formulation,  with  or  without 
pharmacopoeial conformity.] 

1. Ins. by G.S.R. 35(E), dt. 20.1.2005.

45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

25. Licences for import of drugs manufactured by one manufacturer.– (1) A single 
application may be made, and a single licence may be issued, in respect of the import 
of more than one drug or class of drugs manufactured by the same manufacturer: 

1[Provided that  the  drugs or  classes of  drugs  are  manufactured at  one  factory  or 

more than one factory functioning conjointly as a single manufacturing unit: 

Provided further that if a single manufacturer has two or more factories situated in 
different places manufacturing the same or different drugs a separate licence shall be 
required in respect of the drugs manufactured by each such factory.] 

2[*  *   *  * *] 

3[25A.  Condition to  be  satisfied  before  a  licence  in  Form  10  or  Form  10-A  is
(1) A licence in Form 10 or in Form 10-A shall be granted by the licensing

granted. 
authority having regard to– 

(i)  the  premises,  where  the  imported  substances  will  be  stocked,  are 
equipped with proper storage accommodation for preserving the properties of the 
drugs to which the licence applies; and 

(ii)  the  occupation,  trade  or  business  ordinarily  carried  out  by  the 

applicant: 

Provided that the licensing authority may refuse to grant a licence in Form 10-A 

in respect of any applicant where he is satisfied,-- 

(a) that the applicant has not complied with the provisions of the Act or 

these rules; or 

(b) that by reasons of— 

4[(i) his conviction under the Act or these Rules or the Narcotic Drugs 
and  Psychotropic  Substances  Act,  1985  (61  of  1985)  or  the  rules  made 
thereunder;] 

(ii) previous suspension or cancellation of the licence granted to him; 

he is not a fit person to whom licence shall be granted. 

(2) Any person who is aggrieved by the order passed by the licensing authority 
under  this  Rule  may,  within  thirty  days  of  the  receipt  of  the  order,  appeal  to  the 
Central  Government  and  the  Central  Government  may  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
making a representation in the matter, make such orders in relation thereto as it thinks 
fit.] 

1.  Ins. by Notfn. No. F. 1-19/48-D, dt. 27-10-1949. 
2.  Omitted Notfn. No.F. 1-16/57-D, dt. 15-6-1957. 
3.  Subs. by G.S.R 462(E), dt. 22-6-1982. Earlier Ins. by Notfn. No. F. 1-9/52-D. dt. 3-11-1958. 
4.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 

46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[25B.    Registration    Certificate    for    import    of   drugs    manufactured    by   one 
manufacturer.--(1)  A  single  application  may  be  made,  and  a  single  Registration 
Certificate in Form 41 may be issued in respect of the import of more than one drug 
or class of drugs, manufactured by the same manufacturer: 

Provided  that  the  drug  or  classes  of  drugs,  are  manufactured  at  one  factory  or 

more than one factory functioning conjointly as a single manufacturing unit: 

Provided further that if a single manufacturer has two or more factories situated in 
different  places  manufacturing  the  same  or  different  drugs,  separate  Registration 
Certificates  shall  be  required  in  respect  of  the  drugs  manufactured  by  each  such 
factory.] 

26.  Conditions  of  import  licence. 

An  import  licence  shall  be  subject  to  the

following conditions: 

(i) the manufacturer shall at all times observe the undertaking given by him 

or on his behalf in Form 9; 

(ii)  the  licensee   shall  allow   any   Inspector   authorised  by  the  licensing 
authority in that behalf to enter with or without notice any premises where the 
imported  substance  is  stocked,  to  inspect  the  means,  if  any,  employed  for 
testing the substance and to take samples; 

(iii)  the  licensee  shall  on  request  furnish  to  the  licensing  authority  from 
every  batch  of  each  substance  or  from  such  batch  or  batches  as  the  licensing 
authority  may  from  time  to  time  specify  a  sample  of  such  amount  as  the 
licensing authority  may  consider  adequate for  any  examination required to  be 
made, and the licensee shall, if so required, furnish full protocols of the tests, if 
any, which have been applied; 

(iv) if the licensing authority so directs the licensee shall not sell or offer 
for  sale  any  batch  in  respect  of  which  a  sample  is  or  protocols  are  furnished 
under the  last  preceding sub-rule until  a  certificate  authorising the  sale  of  the 
batch has been issued to him by or on behalf of the licensing authority; 

(v) the licensee shall, on being informed by the licensing authority that any 
part of any batch of the substance has been found by the licensing authority not 
to  conform  with  the  standards  of  strength,  quality  and  purity  prescribed  by 
Chapter III  of the Act, or the rules thereunder and on being directed so to do, 
withdraw  the  remainder  of  that  batch  from  sale  and,  so  far  as  may  in  the 
particular  circumstances  of  the  case  be  practicable,  recall  the  issues  already 
made from that batch; 

(vi) the licensee shall maintain a  record of all sales by  him of substances for 
the  import  of  which  a  licence  is  required,  showing  particulars  of  the  substance 
and  of  the  person  to  whom  sold  and  such  further  particulars,  if  any,  as  the 
licensing authority may specify and such record shall be open to the inspection of 
any Inspector authorised in that behalf by the licensing authority: 

1.  Ins. by G.S.R. No. 604(E), dt. 24-8-2001.

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Provided that in respect of the sale or distribution of drugs specified in    Schedule 
X,  the  licensee  shall  maintain  a  separate  record  or  register  showing  the  following 
particulars, namely:  

1. Name of the Drug, 

2. Batch number, 

3. Name and address of the manufacturer, 

4. Date of transaction, 

5. Opening stock on the business day, 

6. Quantity of drug received, if any, and the source from which received, 

7. Name of the purchaser, his address and licence number, 

8. Balance quantity of drug at the end of the business day, 

9. Signature of the person under whose supervision the drugs have been 

supplied.] 

(vii)   the   licensee   shall   comply   with   such   further  requirements,  if   any, 
applicable  to  the  holders  of  import  licenses,  as  may  be  specified  in  any  rules, 
subsequently  made  under  Chapter  III  of  the  Act  and  of  which  the  licensing 
authority has given to him not less than four months‘ notice. 

27. Grant of import licence.  On receipt of an application for an import licence
in the form and manner prescribed in Rule 24, the licensing authority shall, on being 
satisfied  that,  if  granted,  the  conditions  of  the  licence  will  be  observed,  issue  an 
import licence in Form 10 1[or From 10A, as the case may be]. 

2[27A  Grant  of  Registration  Certificate. 

(1)  On  receipt  of  an  application  for

Registration Certificate in the Form and manner specified in Rule 24A, the licensing 
authority shall, on  being satisfied, that, if  granted, the  conditions of  the  Registration 
Certificate will be observed, issue a Registration Certificate in Form 41: 

Provided    further    that   if    the    application    is    complete    in    all    respects    and 
informations specified in Schedules D-I and D-II are in order, the licensing authority 
shall,  within  nine  months  from  the  date  of  receipt  of  an  application,  issue  such 
Registration  Certificate,  and  in  exceptional  circumstances  and  for  reasons  to  be 
recorded in writing, the Registration Certificate may  be  issued within such extended 
period, not exceeding three months, as the licensing authority may deem fit. 

(2) If the applicant does not receive the Registration Certificate within the period 
as specified in the proviso to sub-rule (1), he may appeal to the Central Government 
and  the  Central  Government may  after  such  enquiry  into  the  matter,  as  it  considers 
necessary, may pass such orders in relation thereto as it thinks fit.] 

1.  Ins. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Ins. by G.S.R 604 (E), dt. 24-8-2001.

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[28.  Duration  of  import  licence.  A  licence  unless,  it  is  sooner  suspended  or

cancelled, shall be 2[valid for a period of three years from the date of its issue:] 

Provided  that  if  application  for  a  fresh  licence  is  made  three  months  before  the 
expiry of the existing licence the current licence shall be deemed to continue in force 
until orders are passed on the application.] 

3[28A. Duration of Registration Certificate.—- A Registration Certificate, unless, 
it is sooner suspended or cancelled, shall be valid for a period of three years from the 
date of its issue: 

Provided that  if  the  application for  a  fresh  Registration Certificate  is  made  nine 
months  before   the   expiry   of   the   existing  certificate,  the   current  Registration 
Certificate  shall  be  deemed  to  continue  in  force  until  orders  are  passed  on  the 
application.] 

4[29.  Suspension  and cancellation  of import  licence. 

 If  the  manufacturer  or
licensee fails to comply with any of the conditions of an import licence, the licensing 
authority may after giving the manufacturer or licensee an opportunity to show cause 
why  such  an  order  should  not  be  passed,  by  an  order  in  writing  stating  the  reasons 
therefor,  suspend  or  cancel  it  for  such  period  as  it  thinks  fit,  either  wholly  or  in 
respect of some of the substances to which it relates: 

Provided  that  a  person,  who  is  aggrieved  by  the  order  passed  by  the  licensing 
authority under this rule may, within thirty days of the receipt of the order, appeal to 
the Central Government, and the Central Government may, after such enquiry into the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in  the  matter, pass such orders in relation thereto as it  thinks 
fit.] 

3[29A.  Suspension  and  cancellation  of  Registration  Certificate.  —If 
the 
manufacturer  fails  to   comply  with   any   of   the  conditions  of   the   Registration 
Certificate, the licensing authority may after giving him an opportunity to show cause 
why  such  an  order  should  not  be  passed,  by  an  order  in  writing  stating  the  reasons 
therefor, suspend or cancel the Registration Certificate for such period as it thinks fit 
either wholly or in respect of some of the substances to which it relates: 

Provided  that  a  person,  who  is  aggrieved  by  the  order  passed  by  the  licensing 
authority under this rule may, within thirty days of the receipt of the order, appeal to 
the Central Government, and the Central Government may, after such enquiry into the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in  the  matter, pass such orders in relation thereto as it  thinks 
fit.] 

1.  Amended by Notfn. No. F. 1-10/62-D, dt. 19-4-1964. 
2.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 
3.  Ins. by G.S.R 604 (E), dt. 24-8-2001. 
4.  Subs. by G.S.R 604 (E), dt. 24-8-2001.

49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

30. Prohibition of import after expiry of potency. —No biological or other special 
product specified in Schedule C or C (I) shall be imported after the date shown on the 
label,  wrapper  or  container  of  the  drug  as  the  date  up  to  which  the  drug  may  be 
expected to  retain  a  potency  not  less  than,  or  not  to  acquire  a  toxicity  greater  than, 
that required, or as the case may be, permitted by the prescribed test. 

1[* * *   *  *] 
2[30AA.  Import  of  new  Homoeopathic  medicine.—(1)  No  new  Homoeopathic 
medicine  shall  be  imported  except  under  and  in  accordance  with  the  permission  in 
writing of the Licensing Authority. 

(2) The importer of a New Homoeopathic medicine when applying for permission 
shall produce before the Licensing Authority such documentary and other evidence as 
may be required by  the Licensing Authority for assessing the therapeutic efficacy of 
the medicine including the minimum provings carried out with it.] 

3[Explanation.  —For  the  purpose  of  this  rule,  ‗New  Homoeopathic  Medicine‘ 

means— 

(i) a Homoeopathic medicine which is not specified in the Homoeopathic 
Pharmacopoeia of India or United States of America or of the United Kingdom 
or the German Homoeopathic Pharmacopoeia; or 

(ii)  which  is  not  recognized  in  authoritative  Homoeopathic  literature  as 

efficacious under the conditions recommended; or 

(iii)  a  combination  of  Homoeopathic  medicines  containing  one  or  more 
medicines which are not specified in any of the Pharmacopoeias referred to in 
clause (i) as Homoeopathic medicines and also not recognized in authoritative 
Homoeopathic  literature  as  efficacious  under  the  conditions  recommended.]

4[30B. Prohibition of import of certain drugs. 

No drug, the manufacture, sale

or distribution of which is prohibited in the country of origin, shall be imported under 
the same name or under any other name except for the purpose of examination, test or 
analysis.] 

5[31.  Standard for  certain imported drugs.—No drug shall be  imported unless it 
complies  with  the  standard  of  strength,  quality  and  purity,  if  any,  and  the  test 
prescribed in the Rules shall be applicable for determining whether any such imported 
drug complies with the said standard: 

Provided  that  the  drugs  intended  for  veterinary  use,  the  standards  of  strength, 
quality  and  purity,  if  any,  shall  be  those that  are  specified in  Schedule F(1)  and  the 
test prescribed in that Schedule shall be applicable for determining whether any such 
imported drug complies with the said standards and where no standards are specified 
in  Schedule F(1)  for  any  veterinary drug, the  standards for  such  drug  shall  be  those 
specified  in  the  current  edition,  for  the  time  being  in  force,  of  the  British 
Pharmacopoeia Veterinary: 

1. Rule  30A  omitted  by  G.S.R.944  (E),  dt. 21-9-1988. Earlier rules  30A    and  30AA  ins.  by  Notfn.  F.  1-
30/48-G,  Dt.  14.4.1952. 
 2.  Ins. by notification No. F 1-30/48, dt. 14-01-1952. 
3.  Subs. G.S.R. 680 (E) ,dt. 5-12-1980. 
4.  Ins. by Notfn. No. F. 1-45 4-1-1951. 
5.  Subs. G.S.R. 604 (E), dt. 24-8-2001.

50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided further that the licensing authority shall not allow the import of any drug 

having less than sixty per cent residual shelf-life period as on the date of import: 

Provided also that in exceptional cases the licensing authority may, for reasons to 
be  recorded  in  writing,  may  allow,  the  import  of  any  drug  having  lesser  shelf-life 
period, but before the date of expiry as declared on the container of the drug.] 

1[32. Packing and labelling of imported drugs.  No drug shall be imported unless
it   is packed and labelled in conformity with the Rules in Parts IX and X 2[* * *] and 
further  conform to  the  standards  laid  down  in  Part  XII  provided  that  in  the  case  of 
drugs intended for veterinary use, the packing and labelling shall conform to the rules 
in Parts IX and X and Schedule F(1)]. 

3[32A  Packing  and  Labelling  of  Homoeopathic  medicine.  No  Homoeopathic
medicine  shall  be  imported unless it  is  packed  and  labelled in  conformity  with  the 
rules in Part IX-A.] 

33. Import of drugs for examination, test or analysis  Small quantities of drugs
the  import  of  which  is  otherwise  prohibited  under  section  10  of  the  Act  may  be 
imported  for  the  purpose  of  examination,  test  or  analysis  subject  to  the  following 
conditions: 

(a)   No  drug  shall  be imported for  such  purpose except under a  licence in 

Form 11; 

(b)      the  licensee  shall  use  the  substances  imported  under  the  licence 
exclusively for purposes of examination, test or analysis and shall carry on such 
examination, test or analysis in the place specified in the licence, or in such other 
places as the licensing authority may from time to time authorise; 

(c)  the licensee shall allow any Inspector authorized by the licensing authority 
in this behalf to enter, with or without prior notice, the premises where the substances 
are  kept,  and  to  inspect  the  premises,  and  investigate  the  manner  in  which  the 
substances are being used and to take samples thereof; 

(d)    the  licensee  shall  keep  a  record  of,  and  shall  report  to  the  licensing 
authority,  the  substances  imported  under  the  licence,  together  with  the  quantities 
imported, the date of importation and the name of the manufacturer; 

(e)  the licensee shall comply with such further requirements, if any, applicable 
to  the  holders  of  licences  for  examination, test  or  analysis as  may  be  specified in 
any  rules  subsequently  made  under  Chapter  III  of  the  Act  and  of  which  the 
licensing authority has given to him not less than one month‘s notice. 

1.  Subs. by Notfn. No. F. 1-6/62-D (SO 2889), dt. 2-7-1969. 
2.  Certain words omitted  by G.S.R. 661(E), dt. 3-7-1992. 
3.  Ins. by S. O. No. 2139, dt. 5-6-1972.

51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[33A  Import  of  drugs  by  a  Government  Hospital  or  Autonomous  Medical 
Institution for the treatment of patients.—Small quantities of new drug, as defined in 
Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, 
may be imported for treatment of patients suffering from life threatening diseases, or 
diseases causing serious permanent disability, or  such disease requiring therapies for 
unmet  medical  needs,  by  a  Medical  Officer  of  a  Government  Hospital  or  an 
Autonomous Medical Institution providing tertiary care, duly certified by the Medical 
Superintendent  of  the  Government  Hospital,  or  Head  of  the  Autonomous  Medical 
Institution, subject to the following conditions, namely:- 

(a) no new drug shall be imported for the said purpose except under a licence 
in Form 11-A, and the said drug has been approved for marketing in the country 
of origin; 

(b) the licensee shall use the substances or drugs imported under the licence 
exclusively for the purpose of treatment of patients suffering from life threatening 
diseases,  or  diseases  causing  serious  permanent  disability,  or  such  diseases 
requiring  therapies  for  unmet  medical  needs,  under  the  supervision  of  its  own 
Medical Officers at the place, specified in the licence or at such other places, as 
the licensing authority, may  from time to time authorise; 

(c) the licensee shall allow an Inspector authorised by the licensing authority 
in  this  behalf  to  enter,  with  or  without  prior  notice,  the  premises  where  the 
substances or drugs are stocked, and to inspect the premises and relevant records 
and investigate the manner   in which the substances or drugs are being used and 
to take, if necessary, samples   thereof ; 

(d) the licensee shall  keep a  record of,  and shall  submit the  said  report half 
yearly  to  the      licensing  authority,  the  substances  or  drugs  imported  under  the 
licence, together with the quantities imported and issued to the patients, the date 
of importation, the name of the manufacturer, the name and address of the patient 
for whom the drug is prescribed and the name of disease; 

(e) the licensee shall comply with such other requirements, if any, applicable 
to the holders of import licences for import of new drugs for treatment of patients 
by  Government  Hospitals,  as  may  be  specified  from  time  to  time  in  any  rule 
subsequently  made  under      Chapter  III  of  the  Act  and  of  which  the  licensing 
authority has given to him not less than one month‘s notice; 

(f)  the  drug  shall  be  stocked  under  proper  storage  conditions  and  shall  be 

dispensed under the supervision of a registered pharmacist; 

(g) the quantity of any single drug so imported shall not exceed 100 average 

dosages per patient: 

Provided that  the licensing authority may, in exceptional circumstances, sanction 

the import of drug of a larger quantity.] 

34.  Application for licence for examination, test or analysis. 

(1) An application
for a licence for examination, test or analysis shall be made in Form 12 and shall be 
made or  countersigned by  the  head of  the  institution in  which, or  by  a  proprietor or 
director  of  the  company  or  firm  by  which  the  examination, test  or  analysis  will  be 
conducted. 

1.  Ins. by  G.S.R 604 (E), dt. 24-8-2001.

52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(2) The licensing authority may require such further particulars to be supplied as 

he may consider necessary. 

1[(3) Every application in Form 12 shall be accompanied by a fee of one hundred 

rupees for a single drug and an additional fee of fifty rupees for each additional drug. 

(4)  The  fees  shall  be  paid  through  a  challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or any other Bank, as notified, from time  to  time,  by the Central Government, to be 
credited  under  the  Head  of  Account  0210-Medical  and  Public  Health,  04-  Public 
Health, 104- Fees and Fines.] 

2[34A.  Application  for  licence  to  import  small  quantities  of  new  drugs  by  a 
Government  Hospital   or   Autonomous  Medical   Institution  for   the   treatment   of
patients.  (1) An application  for an import licence for small quantities of a new drug,
as defined in Rule 122-E for the purpose of treatment of patients suffering from life 
threatening  diseases,  or  diseases  causing  serious  permanent  disability,  or  such 
diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, 
by a Medical Officer of the Government Hospital or Autonomous Medical Institution, 
which shall be certified by the Medical Superintendent of the Government Hospital or 
Head of the Autonomous Medical Institution, as the case may be. 

(2) The licensing authority may require such further particulars to be supplied, as 

he may consider necessary. 

(3)  Every  application  in  Form  12-AA  shall  be  accompanied  by  a  fee  of  one 
hundred  rupees  for  a  single  drug  and  an  additional  fee  of  fifty  rupees  for  each 
additional drug. 

(4)  The  fees  shall  be  paid  through  a  challan  in  the  Bank  of  Baroda,  Kasturba 
Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, 
or any other Bank, as notified, from time  to  time,  by the Central Government, to be 
credited  under  the  Head  of  Account  0210-  Medical  and  Public  Health,  04-  Public 
Health, 104- Fees and Fine.] 

35. Cancellation of licence  for examination, test  or analysis.  (1)   A  licence for
examination, test or analysis may be cancelled by the licensing authority for breach of 
any of the conditions subject to which the licence was issued. 

(2)  A  licensee  whose  licence  has  been  cancelled  may  appeal  to  the  Central 

Government within three months of the date of the order. 

1.  Subs. by G.S.R 604 (E), dt. 24-8-2001. 
2.  Ins. by  G.S.R 604 (E), dt. 24-8-2001.

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 Drugs and Cosmetics Rules 1945 

1[35A.  Cancellation  of  licence  for  import  of  small  quantities  of  new  drugs.  (1)  A
licence  for  import  of  small  quantities  of  a  new  drug,  defined  in  Rule122E,  for  the 
purpose  of  the  treatment  of  patients  suffering  from  life  threatening  diseases,  or  diseases 
causing  serious  permanent  disability,  or  such  diseases  requiring  therapies  for  unmet 
medical needs, by a Government Hospital or an Autonomous Medical Institution may be 
cancelled by the licensing authority  for breach of any of the conditions subject to which 
the licence was issued or   for contravention of any of the provisions of the Act and rules 
made thereunder. 

(2)  A  licensee  whose  licence  has  been  cancelled  may  appeal  to  the  Central 
Government within three months from the date of the receipt of the order, and the Central 
Government  may  after  such  enquiry  into  the  matter,  as  it  considers  necessary  and  after 
giving  the  appellant  an  opportunity  for  representing  his  views,  may  pass  such  orders  in 
relation thereto, as it thinks fit.] 

36. Import of drugs for personal use.  Small quantities of drugs, the import of which
is  otherwise  prohibited  under  section  10  of  the  Act,  may  be  imported  for  personal  use 
subject to the following conditions: 

(i) the drugs shall form part of a passenger‘s bona fide baggage and shall be the 

property of, and be intended for, the exclusive personal use of the passenger; 

(ii) the drugs shall be declared to the Customs authorities if they so direct; 

(iii)  the  quantity  of  any  single drug  so  imported  shall  not  exceed one hundred 

average doses : 

Provided  that  the  licensing  authority  may  in  an  exceptional  case  in  any  individual 

case sanction the import of a larger quantity: 

2[Provided  further  that  any  drug,  imported  for  personal  use  but  not  forming  part  of 
bona  fide  personal  baggage,  may  be  allowed  to  be  imported  subject  to  the  following 
conditions, namely: 

(i)    the  licensing  authority,  on  an  application  made  to  it  in  Form  12A  is 

satisfied that the drug is for bona fide personal use; 

(ii)    the  quantity  to  be  imported  is  reasonable  in  the  opinion  of  the  licensing 
authority  and  is  covered  by  prescription  from  a  registered  medical  practitioner  ; 
and 

(iii)   the licensing authority grants a permit in respect of the said drug in Form 

12B.] 

3[37.  Packing  of  patent  or  proprietary  medicine.  —Patent  or  proprietary 

medicines shall be imported in containers intended for retail sale: 

4[Provided  that  such  medicines  may  be  imported  in  bulk  containers  by  any 
person  who  holds  a  licence  to  manufacture,  if  such  person  has  obtained  permission  in 
writing to import such medicines from the licensing authority at least three  months prior 
to the date of  import  and  the  imports  are  made  within  a  period  of  twelve  months  from 
the  date  of issue of such permission].] 

38. Statement to accompany imported drugs.  All consignments of drugs sought to be
imported  shall  be  accompanied  by  an  invoice  or  other statement  showing  the  name and 
address of the manufacturer and the name and quantities of the drugs.

39. Documents to be supplied to the Customs Collector.  Before drugs for the import
of which a licence is not required are imported a declaration signed by or on behalf of the 
manufacturer or by or on behalf of the importer that the drugs comply with the provisions 
of  Chapter  III  of  the  Drugs  and  Cosmetics  Act,  1940  and  the  Rules  thereunder  shall  be 
supplied to the Customs Collector. 

1.  Ins. by  G.S.R 604 (E), dt. 24-8-2001. 
2.  Ins. by Notfn. No.F-1-36/54-D.S., (SRO 560), dt. 3-3-1955. 
3.  Ins. by Notfn. No.F-1-3/51-D.S., (SRO 3262), dt. 15-10-1954. 
4.  Ins. by Notfn. No.F-1-45/58-D, (SO 115), dt. 4-1-1961.

54 

 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[40. Procedure for the import of drugs.   (1)  If the Customs Collector has reason
to doubt whether any drugs comply with the provisions of Chapter III of the Act and 
Rules thereunder he may, and if requested by an officer appointed for this purpose by 
the  Central  Government  shall,  take  samples  of  any  drugs  in  the  consignment  and 
forward  them  to  the  Director  of  the  laboratory  appointed  for  this  purpose  by  the 
Central Government and may detain the drugs in  the consignment of which samples 
have  been  taken  until  the  report  of  the  Director  of  the  said  laboratory  or  any  other 
officer  empowered  by  him  on  this  behalf,  subject  to  the  approval  of  the  Central 
Government, on such samples is received: 

Provided that if the importer gives an undertaking in writing not to dispose of the 
drugs without the consent of the Customs Collector and to return the consignment or 
such  portion thereof as  may  be  required, the  Customs Collector shall  make  over  the 
consignment to the importer. 

(2) If an importer who has given an undertaking under the proviso to sub-rule (1) 
is required by the Customs Collector to return the consignment or any portion thereof 
he  shall  return  the  consignment or  portion  thereof  within  ten  days  of  receipt  of  the 
notice.] 

2[41. (1) If the Director of the laboratory appointed for the purpose by the Central 
Government  or  any  other  officer  empowered  by  him  on  this  behalf,  subject  to  the 
approval  of  the  Central  Government,  reports  to  the  Customs  Collector  that  the 
samples  of  any  drug  in  a  consignment  are  not  of  standard  quality,  or  that  the  drug 
contravenes in any other respect the provisions of Chapter III of the Act or the Rules 
thereunder  and  that  the  contravention  is  such  that  it  cannot  be  remedied  by  the 
importer,  the  Customs  Collector  shall  communicate  the  report  forthwith  to  the 
importer  who  shall,  within  two  months  of  his  receiving  the  communication  either 
export  all  the  drugs  of  that  description in  the  consignment, to  the  country  in  which 
they were manufactured or forfeit them to the Central Government which shall cause 
them to be destroyed : 

Provided that the importer may within fifteen days of receipt of the report make a 
representation against the report to the Customs Collector, and the Customs Collector 
shall forward the representation with a further sample to the licensing authority, who 
after  obtaining,  if  necessary,  the  report  of  the  Director  of  the  Central  Drugs 
Laboratory, shall pass orders thereon which shall be final. 

3[(2)  If  the  Director  of  the  laboratory  appointed  for  the  purpose  by  the  Central 
Government  or  any  other  officer  empowered  by  him  on  this  behalf,  subject  to  the 
approval of the Central Government reports to the Customs Collector that the samples 
of any drug contravene in any respect the provisions of Chapter III of the Act or the 
Rules  thereunder  and  that  the  contravention  is  such  that  it  can  be  remedied  by  the 
importer,  the  Customs  Collector  shall  communicate  the  report  forthwith  to  the 
importer and  permit  him  to  import the  drug  on  his  giving  an  undertaking in  writing 
not  to  dispose  of  the  drug  without  the  permission  of  the  officer  authorised  in  this 
behalf by the Central Government.]] 

4[*  *    *    *   *] 

1. Subs. by Notifn. 1-99/52-D.S., dated 3-11-1953. 
2.  Subs. by Notfn. No. F. 7-7/47-D, dt. 5-1-1954. 
3.  Ins. by Notfn. No. 7-11/47-D, dt. 5-10-1951. 
4.  Rule 42 omitted  by Notfn. No. F. 1-9/52-DS., dt. 3-11-1953.

55 

 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

43.  The  drugs  specified  in  Schedule  D  shall  be  exempt  from  the  provisions  of 
Chapter III of the Act and of the Rules made thereunder to the extent, and subject to 
the conditions specified in that Schedule. 

1[43A. No drug shall be imported into India except through one of the following 

places, namely: 

Freozepore Cantonment and Amritsar Railway Stations: 

In respect of drugs imported by rail across the frontier with Pakistan. 

Ranaghat, Bongaon and Mohiassan Railways Stations: 

In respect of drugs imported by rail across the frontier with Bangladesh. 

5[Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in 
Tripura :  

In respect of drugs imported by Road from Bangladesh;] 

2[Raxaul:  
In respect of drugs imported by road and railway lines connecting Raxaul in India 
and Birganj in Nepal;] 

4[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla and Inland Container 
Depots at Tuglakabad and Patparganj in Delhi and Tuticorin  in Tamil Nadu and 
Marmugao port in Goa and Visakhapatnam in Andhra Pradesh:  
In respect of drugs imported by sea into India; 

Chennai, Kolkata, Mumbai, Delhi,Ahmedabad, Hyderabad, Goa, Bengaluru and 
Visakhapatnam:  
in respect of drugs imported by air into India.] 

4[43-B.  Drugs,  consignments  of  which  are  in  transit  through  India  to  foreign 
countries and which shall not be sold or distributed in  India shall be exempted from 
the requirements of  Chapter III  of  the  Drugs and  Cosmetics Act, 1940 (23 of  1940) 
and the Rules made thereunder: 

Provided that if the Government of the countries to which the drugs are consigned 
regulate their import by the grant of import licences, the importer shall at the time of 
import into India, produce such import licences.] 

1.  Subs. by G.S.R 478 (E), dt. 6-8-1981. Earlier Ins. by Notfn No. F.7/7/47-D. dt. 5-1-1954. 
2.  Ins. by G.S.R 120 (E), dt. 5-3-1998. 
3.  Sub. by G.S.R 532 (E), dt. 18-05-2016. Earlier sub. by G.S.R 575 (E), dt. 17-11-2012, G.S.R 101 (E), dt. 
18-2-2011, G.S.R 45 (E), dt. 21-1-2010,  G.S.R 504 (E), dt. 18-7-2002, G.S.R 647 (E), dt. 28-10-1998.  

          4.  Added by Notfn. No.  E. 1-60/D, (SO 1056) dt. 19-3-1964. 

5. Ins. by G.S.R. 116 (E), 24-01-2009.

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 Drugs and Cosmetics Rules 1945 

PART V 

1[GOVERNMENT ANALYSTS, INSPECTORS, LICENSING 
AUTHORITIES AND CONTROLLING AUTHORITIES] 

2[44.   Qualifications   of   Government   Analyst. 
Government Analyst under the Act shall be a person who 

A   person   appointed   as   a

(a)   is  a  graduate  in  medicine  or  science  or  pharmacy  or  Pharmaceutical 
Chemistry  of  a  3[University  established  in  India  by  law  or  has  an  equivalent 
qualification  recognized  and  notified      by  the  Central  Government  for  such 
purpose] and  has had not less than five years‘ post-graduate experience in the 
testing  of  drugs  in  a  laboratory  under  control  of  (i)  a  Government  Analyst 
appointed under the Act, or (ii) the head of an Institution or testing laboratory 
approved for  the  purpose by  the  appointing authority,  4[or  has  completed two 
years‘  training  on  testing  of  drugs,  including  items  stated  in  Schedule  C,  in 
Central Drugs Laboratory], or 

(b)   possesses  a  post-graduate degree  in  medicine  or  science  or  pharmacy 
or  Pharmaceutical   chemistry  of  a  3[University established in  India by  law  or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government for  such  purpose] or  possesses the  Associateship Diploma of  the 
Institution of Chemists (India) obtained by passing the said examination with 
‗Analysis  of  Drugs  and  Pharmaceuticals‘  as  one  of  the  subjects  and  has  had 
after  obtaining  the  said  post-graduate  degree  or  diploma  not  less  than  three 
years‘ experience in the testing of drugs in a laboratory under the control of (i) 
a  Government  Analyst  appointed  under  the  Act,  or  (ii)  the  head  of  an 
Institution  or  testing  laboratory  approved  for  the  purpose  by  the  appointing 
authority 4[or has completed training on testing of drugs, including items stated 
in Schedule C, in Central Drugs Laboratory]: 

Provided that- 

4[(i) for purpose of examination of items in Schedule C,- 

(ia)  the  persons  appointed  under  clause  (a)  or  (b)  and  having  degree  in 
Medicine,   Physiology,   Pharmacology,  Microbiology,  Pharmacy    should 
have  experience  or  training  in  testing  of  said  items  in  an  institution  or 
laboratory approved by the appointing authority for a period of not less than 
six months; 

(ib)  the  person  appointed under  clause(a)  or  (b)  but  not  having  degree  in  the 
above  subjects  should  have  experience  or  training  in  testing  of  said 
Schedule C drugs for a period of not less than three years in an institution or 
laboratory  approved  by  the  appointing  authority  or  have  completed  two 
years  training  on  testing  of  drugs  including  items  stated  in  Schedule  C  in 
Central Drugs Laboratory;] 

1.  Subs. by G.S.R 443 (E), dt. 12-4-1989. 
2.  Subs. by G.S.R. No. 1427, dt. 22-10-1977. 
3. Subs. by G.S.R. 71(E), dt 30.1.1987. 
4.  Ins.  by G.S.R 697(E) dt. 26-10-1995.

57 

 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(ii)  for a period of four years from the date on which Chapter IV of the Act 
takes effect in  the  States, persons whose training and  experience are  regarded 
by the appointing authority as affording, subject to such further training, if any, 
as may be considered necessary, a reasonable guarantee of adequate knowledge 
and competence,   may be appointed as Government Analysts.   The persons so 
appointed may, if the appointing authority so desires, continue in service after 
the expiry of the said period of four years; 

(iii) no person who is engaged directly or indirectly in any trade or business 
connected with the  manufacture of  drugs shall  be  appointed as  a  Government 
Analyst for any area: 

Provided  further  that  for  the  purpose  of  examination  of  Anti-sera,  Toxoid  and 
Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a 
person  who  is  a  graduate  in  Veterinary  Science,  or  general  science,  or  medicine  or 
pharmacy and  has  had  not  less  than  five  years‘  experience in  the  standardization of 
biological  products  or  person  holding  a  post-graduate degree  in  Veterinary  Science, 
or  general  science,  or  medicine  or  pharmacy  or  pharmaceutical  chemistry  with  an 
experience of not less than three years in the standardization of biological products : 

Provided  also  that  persons,  already  appointed  as  Government  Analysts  may 
continue to remain in  service, if  the  appointing authority so desires, notwithstanding 
the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) 
or the preceding proviso. 

45. Duties of Government Analysts.−(1) The Government Analyst shall cause to  
be  analysed  or  tested  such  samples  or  drugs  1[and  cosmetics]  as  may  be  sent  to 
him by Inspectors or other persons under the provisions of Chapter IV of the Act and 
shall furnish reports of the results of test or analysis in accordance with these Rules. 

(2)  A  Government  Analyst  shall  from  time  to  time  forward  to  the  Government 
reports  giving  the  result  of  analytical  work  and  research  with  a  view  to  their 
publication at the discretion of Government. 

46.  Procedure  on  receipt  of  sample.−On  receipt  of a  package  from  an  Inspector 

containing a sample for test or analysis, the Government Analyst shall compare the 
seals  on  the  packet  2[or  on  portion  of  sample  or  container] with  the  specimen 
impression received  separately  and  shall  note  the  condition  of  the  seals  on  the 
3[packet  or  on  portion  of  sample  or  container].   After  the  test  or  analysis has  been 
completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 
of the result of the test or analysis, together with full protocols of the tests or analysis 
applied: 

1.  Ins. by S.O. 2139 dt. 5-6-1972. 
2.  Ins. by G.S.R. 59(E), dt. 7-2-1995. 
3.  Subs.by G.S.R. 59(E),dt. 7-2-1995.

58 

 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Explanation.  It  shall be  deemed to  be full  and  sufficient compliance with the
requirement of the rule in respect of the supply of ―protocols of the tests or analysis 
applied‖, if 

(1)  for  pharmacopoeial  drug,  where  the  tests  or  methods  of  analysis 
prescribed in the official pharmacopoeia are followed, references to the specific 
tests or analysis in the pharmacopoeias are given in the report; 

(2)  for  patent  or  proprietary  medicines  for  which  the  tests  and  methods 
prescribed  in  any  of  the  official  pharmacopoeias  are  applicable  and  are 
followed, references to the specific tests or analysis in the pharmacopoeias are 
given in the report; 

(3 )for patent or proprietary medicines containing pharmacopoeial drugs for 
which  the  official  tests  or  analysis  or  methods  of  assays  are  modified  and 
applied,  a  description  of  the  actual  tests  or,  as  the  case  may  be,  analysis  or 
methods of assays so applied is given in the report; 

(4) for patent or proprietary medicines for which no pharmacopoeial tests or 
methods  of  analysis  are  available  or  can  be  applied  but  for  which      tests  or 
methods  of  analysis  given  in  standard  books  or  journals  are  followed,  a 
description  of  such  tests  or  methods  of  analysis  applied  together  with  the 
reference to  the  relevant books or journals from which the tests or  methods of 
analysis have been adopted, is given in the report; 

(5)  for  those  drugs  for  which  methods  of  test  are  not  available  and  have 
been  evolved  by  the  Government  Analyst,  a  description  of  tests  applied  is 
given in the report.] 

47. Report of result of test or analysis.  An application from a purchaser for test
or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the 
report of test or analysis of the drug made on such application shall be supplied to the 
applicant in Form 14B. 

48.  Fees. 

The  fees  to  be  paid  by  a  person  submitting  to  the  Government
Analyst  under  section  26  of  the  Act  for  test  or  analysis  of  a  drug  3[or  cosmetic] 
purchased by him shall be those specified in Schedule B. 

2[49.  Qualifications  of  Inspectors.  —A  person  who  is  appointed  an  Inspector 
under  the  Act  shall  be  a  person  who  has  a  degree  in  Pharmacy  or  Pharmaceutical 
Sciences  or  Medicine with  specialisation in  Clinical  Pharmacology or  Microbiology 
from a University established in India by law: 

Provided that only those Inspectors: ⎯ 

1.  Ins. by No. F. 1-60/61-D, dt. 12-7-1962 (G.S.R 984 (E), dt. 12-7-1962). 
2.  Subs. by No. G.S.R 658 (E), dt. 19-10-1993. 
3. Ins. by No. G.S.R 1140 (E), dt. 26-8-1978.

59 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(i) Who have not less than 18 months‘ experience in the manufacture of 

at least one of the substances specified in Schedule C, or 

(ii)  Who  have  not  less  than  18  months‘  experience in  testing  of  at  least 
one of the substances in Schedule C in  a laboratory approved for this purpose 
by the licensing authority, or 

(iii)  Who  have  gained  experiences  of  not  less  than  three  years  in  the 
inspection of firms manufacturing any of the substances specified in Schedule 
C during the tenure of their services as Drugs Inspectors;  

shall be authorised to inspect the manufacture of the substances mentioned in Schedule 
C:] 

1[Provided further that the requirement as to the academic qualification shall not 
apply to persons appointed as Inspectors on or before the 18th day of October, 1993.] 

2[ 49A. Qualification of a Licensing Authority.—No person shall be qualified to be a 
Licensing Authority under the Act unless:- 

(i) he is a  graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine 
with  specialization in  clinical  pharmacology  or  microbiology  from  a  University 
established in India by law; and 

(ii) he has experience in the manufacture or testing of drugs or enforcement of 

the provisions of the Act for a minimum period of five years: 

3[ Provided that the requirements as to the academic qualification shall not apply 
to  those  inspectors  and  the  Government  Analysts  who  were  holding  those  positions 
on the 12th day of April,1989.]] 

4[50.  Controlling  authority.  (1)  All  Inspectors  appointed  by  the  Central
Government shall be under the control of an officer appointed in this behalf by the 
Central Government. 

(2) All Inspectors appointed by the State Government shall be under the control 

of an officer appointed in this behalf by the State Government. 

(3) For the purposes of these rules an officer appointed by the Central Government 
under  sub-rule  (1),  or  as  the  case  may  be,  an  officer  appointed  by  the  State 
Government under sub-rule (2), shall be a controlling authority.] 

1.  Ins. by  G.S.R 552 (E), dt. 4-12-1996. 
2.  Ins. by G.S.R 443 (E), dt. 12-4-1989. 
3.  Subs. by G.S.R. 532 (E), dt. 14.8.1991. 
4.  Subs. by  S.O. 2139, dt. 5-6-1972.

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 Drugs and Cosmetics Rules 1945 

1[50A. Qualification of a Controlling Authority. 

(1) No person shall be qualified

to be a Controlling Authority under the Act unless 

(i)  he  is  a  graduate  in  Pharmacy  or  Pharmaceutical  Chemistry  or  in 
Medicine  with  specialization  in  Clinical  Pharmacology  or  Microbiology  from  a 
University established in India by law; and 

(ii) he has experience in the manufacture or testing of drugs or enforcement of 

the provisions of the Act for a minimum period of five years: 

2[Provided that the requirements as to the academic qualifications shall not apply 
to those Inspectors and the Government Analysts who were holding those positions 
on the 12th day of April, 1989.] 

51.   Duties   of   Inspectors   of   premises   licensed   for   sale. 

Subject   to   the
instructions of the controlling authority, it shall be duty of an Inspector authorized to 
inspect premises licensed for the sale of drugs 

(1) to inspect  3[not less than once a year] all establishments licensed for the 

sale of drugs within the area assigned to him; 

(2) to satisfy himself that the conditions of the licences are being observed; 

(3)  to  procure  and  send  for  test  or  analysis, if  necessary, imported packages 
which  he  has  reason  to  suspect  contain  drugs  being  sold  or  stocked  or  exhibited 
for sale in contravention of the provisions of the Act or Rules thereunder; 

(4) to investigate any complaint in writing which may be made to him; 

(5)  to  institute  prosecutions  in  respect  of  breaches  of  the  Act  and  Rules 

thereunder; 

(6) to maintain a record of all inspections made and action taken by him in the 
performance  of  his  duties,  including  the  taking  of  samples  and  the  seizure  of 
stocks, and to submit copies of such record to the controlling authority; 

(7) to make such enquiries and inspections as may be necessary to detect the 

sale of drugs in contravention of the Act; 

1.  Ins. by  G.S.R 443 (E), dt. 12-04-1989. 
2.  Subs. by G.S.R 532 (E), dt. 14-8-1991. 
3.  Subs. by G.S.R. 700 (E), dt. 28-9-2001.

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 Drugs and Cosmetics Rules 1945 

(8)  when  so  authorized by  the  State  Government, to  detain  imported packages 
which he has reason to suspect contain drugs, the import of which is prohibited. 

52.  Duties  of  Inspectors  specially  authorized  to  inspect  the  manufacture  of
1[drugs or cosmetics].  Subject to the instructions of the controlling authority it shall
be the duty of an Inspector authorized to inspect the manufacture of drugs 

(1)  to  inspect  2[not  less  than  once  a  year],  all  premises  licensed  for 
manufacture of  1[drugs  or  cosmetics]  within  the  area  allotted  to  him  to  satisfy 
himself that  the  conditions of  the  licence  and  provisions of  the  Act  and  Rules 
thereunder are being observed; 

(2)  in the case of establishments licensed to manufacture products specified 
in Schedules C and C(1) to inspect the plant and the process of manufacture, the 
means  employed  for  standardizing  and  testing  the  2[drugs  or  cosmetics],  the 
methods and place of storage, the  technical qualifications of the staff employed 
and all  details of location, construction and administration of the establishment 
likely to affect the potency or purity of the product; 

(3)  to  send  forthwith  to     the  controlling  authority  after  each  inspection  a 
detailed report indicating the conditions of the licence and provisions of the Act 
and   rules   thereunder  which   are   being   observed  and   the   conditions  and 
provisions, if any, which are not being observed; 

(4)  to  take  samples  of  the   1[drugs  or  cosmetics]  manufactured  on  the 

premises and send them for test or analysis in accordance with these Rules; 

(5)  to  institute  prosecutions  in  respect  of  breaches  of  the  Act  and  Rules 

thereunder. 

53. Prohibition of disclosure of information.  Except for the purposes of official
business  or  when  required  by  a  Court  of  Law,  an  Inspector  shall  not,  without  the 
sanction  in  writing  of  his  official  superior,  disclose  to  any  person  any  information 
acquired by him in the course of his official duties. 

54. Form of order not to dispose of stock.  An order in writing by an Inspector
under clause  (c)  of  section 22  of  the  Act requiring   a  person not  to  dispose of  any 
stock in his possession shall be in Form 15. 

1.  Subs. by G.S.R 504 (E), dt. 18-7-2002. 
2.  Subs. by G.S.R 700 (E), dt. 28-9-2001.

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1[54A. Prohibition of sale.  No person in possession of a drug 2[or cosmetic] in
respect of which an Inspector has made an order under clause (c) of sub-section (1) of 
section 22 of the Act shall in contravention of that order sell or otherwise dispose of 
any stock of such drug 2[or cosmetic]. 

3[55.  Forms  of  receipts  for  seized  drug,  cosmetic,  record  register,  document  or 
any  other  material  object.--  A  receipt  by  an  Inspector  for  the  stock  of  any  drug  or 
cosmetic or for any record, register, document or any other material object seized by 
him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be 
in Form 16.] 

4[55A.  Manner  of  certifying  copies  of  seized  documents.—The  Drugs  Inspector 
shall return the documents , seized by him under clause (cc) or produced before him 
under  clause  (cca),  of  sub-section  (1)  of  section  22  of  the  Act,  within  a  period  of 
twenty days of the date of such seizure or production, to the person from whom they 
have  seized  or,  as  the  case  may  be,  the  person  who  produced  them,  after  copies 
thereof of extracts therefrom have been signed by the concerned Drug Inspector and 
the person from whom they have seized , or, as the case may be , who produced such 
records.] 

56. Form of intimation of purpose of taking samples.  When an Inspector takes a
sample of a drug for the purpose of test or analysis, he shall intimate such purpose in 
writing in Form 17 to the person from whom he takes it. 

5[56A.  Form  or  receipt  for  samples  of  drugs  where  fair  price  tendered  is 
refused.—Where the fair price, for the samples of drugs taken for the purpose of test 
or  analysis,  tendered  under  sub-section  (1)  of  section  23  has  been  refused,  the 
Inspector  shall  tender  a  receipt  therefor  to  the  person  from  whom  the  said  samples 
have been taken as specified in Form 17A.] 

57. Procedure for despatch of sample to Government Analyst.  (1) The portion of
sample  or  the  container  sent  by  an  Inspector to  the  Government Analyst  for  test  or 
analysis under sub-section (4) of section 23 of the Act shall be sent by registered post 
or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in 
an outer cover addressed to the Government Analyst. 

(2)  A  copy  of  the  memorandum and  a  specimen  impression of  the  seal  used  to 
seal the packet shall be sent to the Government Analyst separately by registered post 
or by hand. 

1.  Ins. by No. F. 1-19/59-D, dt. 13-6-1961. 
2.  Ins. by G.S.R 850(E), dt. 07-12-1994. 
3.  Subs. by G.S.R. No. 926 dt. 16-7-1977. 
4.  Ins. by G.S.R 89 (E), dt. 16-2-1985. 
5.  Ins. by G.S.R 292 (E), dt. 29-5-1997.

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1[58. Confiscation of drugs, implements, machinery etc.  (1) Where any person has

been convicted for contravening any of the provisions of Chapter IV of the Act or any 

Rule made thereunder, the stock of the drug in respect of which the contravention has 

been made shall be liable to confiscation. 

(2)  Where  any  person  has  been  convicted  for  the  manufacture  of  any  drug 

deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) 

or  clause  (g)  of  section  17  of  the  Act,  or  adulterated drug  under  section  17B  of  the 

Act,  or  for  manufacture for  sale,  or  stocking  or  exhibiting for  sale  or  distribution of 

any drug without a valid licence as required under clause (c) of section 18 of the Act, 

any  implements or  machinery used in  such  manufacture, sale  or  distribution and  any 

receptacle,  packages,  or  coverings  in  which  such  drug  is  contained  and  the  animals, 

vehicles, vessels or other conveyances used in carrying such drug shall also be liable 

to confiscation.] 

2[58A. Procedure for  disposal of  confiscated drugs. 

(1)   The Court shall refer

the confiscated drugs to the Inspector concerned for report as to whether they are of 

standard quality or contravene the provisions of the Act or the Rules in any respect. 

(2)  If  the  Inspector,  on  the  basis  of  Government  Analyst‘s  report  finds  the 

confiscated drugs to be not of standard quality or to contravene any of the provisions 

of the Act or the Rules made thereunder, he shall report to the Court accordingly. The 

Court  shall thereupon order  the  destruction of  the  drugs.   The  destruction shall  take 

place under the supervision of the Inspector in the presence of such authority, if any, 

as may be specified by the Court. 

(3) If the Inspector finds that the confiscated drugs are of standard quality and do 

not contravene the provisions of the Act or the Rules made thereunder, he shall report 

to the Court accordingly.  3[The Court may then order the Inspector to give the stocks 

of  confiscated  drugs  to  hospital  or  dispensary  maintained  or  supported  by  the 

Government or by Charitable Institutions].] 

1.  Subs. by S. O. 289, dt. 3-2-1973. 
2.  Ins. by No. F. 1-9/62-D (GSR 6), dt. 2-12-1964. 
3.  Subs. by G.S.R 59 (E), dt. 7-2-1995.

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PART VI 

SALE OF DRUGS OTHER THAN  HOMOEOPATHIC MEDICINES 

59. (1) The State Government shall appoint Licensing Authorities for the purpose 

of this Part for such areas as may be specified. 

1[(2) Applications for the grant or renewal of a licence  2[to sell, stock, exhibit or 
offer for sale or distribute] drugs, other than those included in Schedule X,  3[shall be 
made in Form 19 accompanied by a fee of rupees one thousand and five hundred or 
Form 19A accompanied by a fee of rupees five hundred, as the case may be, or in the 
case of drugs included in Schedule X shall be made in Form 19C accompanied by a 
fee of rupees five hundred, to the licensing authority:] 

Provided  that  in  the  case  of  an  itinerant  vendor  or  an  applicant  who  desires  to 
establish  a  shop  in  a  village  or  town  having  population  of  5,000  or  less,  the 
application in Form 19-A shall be accompanied by a fee of rupees ten . 

(3) 3[A fee of rupees one hundred and fifty] shall be paid for a duplicate copy of 
a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those 
included in  Schedule X,  or  for  a  licence  2[to  sell,  stock,  exhibit or  offer  for  sale  or 
distribute] drugs, included in Schedule X, if the original is defaced, damaged or lost: 

Provided  that  in  the  case  of  itinerant  vendor  or  an  applicant  who  desires  to 
establish a shop in a village or town having a population of 5,000 or less, the fee for a 
duplicate copy of a licence if the original is defaced, damaged or lost, shall be rupees 
two. 

(4) Application for renewal of a licence 2[to sell, stock, exhibit or offer for sale or 
distribute]  drugs,  after  its  expiry  but  within  six  months  of  such  expiry  3[shall  be 
accompanied by a fee of rupees one thousand and five hundred plus an additional fee 
at  the rate  of rupees five hundred per month or part  thereof in  Form 19,  rupees five 
hundred plus an additional fee at the rate of rupees two hundred and fifty per month 
or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate 
of rupees two hundred and fifty per month or part thereof  in Form 19C:] 

Provided that in the case of an itinerant vendor or an applicant desiring to open a 
shop in a village or town having a population of 5,000 or less the application for such 
renewal shall be accompanied by a fee of rupees ten, plus an additional fee at the rate 
of  rupees eight per month or part thereof.] 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
3.  Subs. by G.S.R 601 (E), dt. 24-08-2001.

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1[60. A licensing authority may with the approval of the State Government by an 
order in writing delegate the power to sign licences and such other powers as may be 
specified in the order to any other person under his control.] 

2[61. Forms of licences  to sell  drugs. 

(1) a  licence  3[ to sell, stock, exhibit or
offer for sale or distribute] drugs other than those specified in Schedules C, C (1) and 
X  and  by  retail  on  restricted  licence  or  by  wholesale,  shall  be  issued  in  Form  20, 
Form 20A or Form 20B, as the case may be: 

Provided  that  a  licence  in  Form  20A  shall  be  valid  for  only  such  drugs  as  are 

specified in the licence. 

(2) A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified 
in  Schedule  C  and  C  (1)  excluding  those  specified  in  Schedule  X,  by  retail  on 
restricted licence or by wholesale shall be issued in Form 21, Form 21A or Form 21B, 
as the case may be: 

4[Provided that a licence in Form 21A shall not be granted for drugs specified in 
Schedules C and shall be valid for only such Schedule C (1) drugs as are specified in 
the licence.] 

(3 )A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified 
in Schedule X by retail or by wholesale shall be issued in Form 20F or Form 20G as 
the case may be.] 

62. Sale at more than one place. 

If  drugs are sold or stocked for sale at  more
than  one  place,  separate  application  shall  be  made,  and  a  separate  licence  shall  be 
issued, in respect of each such place: 

5[Provided  that  this  shall  not  apply  to  itinerant  vendors  who  have  no  specified 
place  of  business  and  who  will  be  licensed  to  conduct  business  in  a  particular  area 
within the jurisdiction of the licensing authority.] 

1.  Amended by F. 1-16/57-D, dt. 15-6-1957. 
2.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
4.  Subs. by  G.S.R 487 (E), dt. 2-7-1984. 
5.  Added by Notfn. No. F. 10-21/49-D, dt. 10-3-1953.

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1[62A. Restricted licences  in  Forms 20A and 21A. 

(a) Restricted licences in
Forms  20A  and  21A  shall  be  issued  subject  to  the  discretion  of  the  Licensing 
Authority, to  dealers or  persons in  respect  of  drugs whose  sale  does  not  require the 
supervision of a qualified person. 

(b) Licences to itinerant vendors shall be issued only in exceptional circumstances 
for  bona  fide  travelling  agents  of  firms  dealing  in  drugs  or  for  a  vendor  who 
purchases  drugs  from  a  licensed  dealer  for  distribution  in  sparsely  populated  rural 
areas where other channels of distribution of drugs are not available. 

(c)  The licensing authority may issue a licence in Form 21A to a travelling agent 
of  a  firm  but  to  no  other  class  of  itinerant  vendors  for  the  specific  purpose  of 
distribution  to  medical  practitioners  or  dealers,  samples  of  biological  and  other 
special products specified in Schedule C: 

Provided  that  travelling  agents  of  licensed  manufacturers,  agents,  of  such 
manufacturers and importers of  drugs shall  be  exempted from taking out  licence  for 
the  free  distribution  of  samples  of  medicines  among  members  of  the  medical 
profession, hospitals, dispensaries and the medical institution or research institutions. 

1[62-B. Conditions to be satisfied before a licence in Form 20A or Form 21A is
(1)  A  licence  in  Form  20A  or  Form  21A  shall  not  be  granted  to  any

granted. 
person,  unless  the  authority  empowered  to  grant  the  licence  is  satisfied  that  the 
premises in  respect of  which the licence is  to  be  granted are  adequate and equipped 
with  proper  storage  accommodation for  preserving  the  properties  of  drugs  to  which 
the licence applies: 

Provided  that  this  condition  shall  not  apply  in  the  case  of  licence  granted  to 

itinerant vendors. 

(2)  In  granting  a  licence  under  Rule  62A  the  authority  empowered to  grant  it 

shall have regard to: 

(i)   the   number   of   licences   granted   in   the   locality   during   one   year 

immediately preceding; and 

(ii) the occupation, trade or business carried on by such applicant : 

1.  Ins. by Notfn. No. F. 1-9/60-D, dt. 3-7-1961.

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Provided that the licensing authority may refuse to grant or renew a licence to any 
applicant or licensee in respect of whom it is satisfied that by reason of his conviction 
of an offence under the Act or these Rules or the previous cancellation or suspension 
of any licence granted thereunder, he is not a fit person to whom a licence should be 
granted under this rule. 

(3) Any person who is aggrieved by the order passed by the licensing authority in 
sub-rule (1) may, within 30 days from the date of the receipt of such order appeal to 
the  State  Government  and  the  State  Government  may,  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his  views  in  the  matter  make  such  order  in  relation thereto  as  it  thinks 
fit.] 

1[62C. Application for licence to sell drugs by wholesale or to distribute the same
from a motor vehicle.  (1) Application for the grant or renewal of a licence to sell by
wholesale  or  to  distribute  from  a  motor  vehicle  shall  be  made  to  the  Licensing 
Authority  in  Form  19AA  and  shall  be  accompanied  by  2[a  fee  of  rupees  five 
hundred]: 

Provided that if the applicant applies for the renewal of a licence after its expiry 
but  within  six  months  of  such  expiry  ,  the  fee  payable  for  renewal  of  such  licence 
shall be 2[rupees five hundred plus an additional fee at the rate of rupees two hundred 
and fifty per month or part thereof]. 

(2) A fee of 2[rupees one hundred and fifty] shall be paid for a duplicate copy of a 

licence issued under this rule, if the original is defaced, damaged or lost.] 

3[62D.  Form  of  licences  to  sell  drugs  by  wholesale  or  distribute  drugs  from  a
motor  vehicle.  A  licence  shall  be  issued  for  sale  by  wholesale  or  for  distribution
from a  motor vehicle of drugs other than those specified in  Schedule and  Schedule 
C(1) in Form 20BB and of drugs specified in Schedule C and Schedule C(1) in Form 
21BB : 

Provided that such a licence shall not be required in a case where a public carrier 

or a hired vehicle is used for transportation or distribution of drug.] 

3[63. Duration of licence.  An original licence or a renewed licence to sell drugs,
unless sooner suspended or  cancelled, shall  be  2[valid for a  period of  five years on 
and from the date on which] it is granted or renewed: 

1.  Ins. by  Notfn. No. 1-9/60-D dt. 3-7-1961. 
2.  Subs. by Notfn. No. G.S.R 601 (E), dt. 24-8-2001. 
3.  Amended by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.

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1[Provided that if the application for renewal of licence in force is made before its 
expiry or if the application is  made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application.  The licence shall be deemed to have expired if application for its renewal 
is not made within six months after its expiry].] 

2[63A. Certificate  of renewal of a  sale licence.  The certificate of renewal of  a

sale  licence  in  Forms  20,  20A,  20B,3[20F,  20G],  21,  21A  and  21B  shall  be 
issued in Form 21C.] 

4[63B. Certificate of renewal of licence.  A certificate of renewal of a licence in

Form 20BB or Form 21BB shall be issued in Form 21CC.] 

5[64. Conditions to be satisfied before a licence in Form  8[20, 20B, 20F,20G,
(1)A licence in Form  3[20, 20B, 20F, 20G, 21 or 21B]

21 or 21B] is granted . 
6[to  sell, stock, exhibit or offer for  sale  or distribute] drugs shall not be  granted  7[or 
renewed]  to  any  person  unless  the  authority  empowered  to  grant  the  licence  is 
satisfied  that  the  premises  in  respect  of  which  the  licence  is  to  be  granted  7[or 
renewed] are adequate, equipped with proper storage accommodation for preserving 
the properties of the drugs to which the licence applies and are in charge of a person 
competent in the opinion of the licensing authority to supervise and control the sale, 
distribution and preservation of drugs : 

Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be 
granted 7[or renewed] unless the licensing authority is satisfied that the requirements 
prescribed for a pharmacy in Schedule N have been complied with: 

3[Provided further that licence in Form 20F shall be granted 7[or renewed] only 
to a pharmacy and in areas where a pharmacy is not operating, such licence may be 
7[granted or renewed] to a chemist and druggist.] 

Explanation.  For the purpose of this rule the term ‗Pharmacy‘ shall be held to

mean to  include every  store  or  shop or  other place :  (1)  where drugs are  dispensed, 
that is, measured or weighed or made up and supplied ; or (2) where prescriptions are 
compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed 
within it, or affixed to or used in connection with it, a sign bearing the word or words 
―Pharmacy‖, ―Pharmacist‖,   ―Dispensing Chemist‖  or  ―Pharmaceutical  Chemist‖;  or 
(5)  which, by  sign,  symbol or  indication within or  upon  it  gives the  impression that 
the  operations  mentioned  at  (1),  (2)  and  (3)  are  carried  out  in  the  premises;  or  (6) 
which is advertised in terms referred to in (4) above. 

1.  Amended by S. O. No. 2139, dt. 12-8-1972. 
2.  Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964. 
3.  Ins. by G.S.R 462 (E), dt. 22-6-1982. 
4.  Ins. by Notfn. No. F.1-10/62-D,dt. 10-4-1964. 
5.  Subs. by Notfn. No.F.1-16/57-D,dt. 15-6-1957 and No. F. 1-19/59-D, dt. 13-6-1961. 
6.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
7.  Subs. by  No. G.S.R 681(E), dt. 6-6-1988. 
8. Subs. by G.S.R 462 (E), dt. 22-6-1982.

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 Drugs and Cosmetics Rules 1945 

(2) In granting 1[or renewing] a licence under sub-rule (1) the authority empowered 

to grant it shall have regard 

2[(i)  to the average number of licences granted 1[or renewed] during the 

period of 3 years immediately preceding, and] 

(ii)    to  the  occupation,  trade  or  business  ordinarily  carried  on  by  such 

applicant during the period aforesaid: 

Provided that the licensing authority may refuse to grant or renew a licence to any 
applicant or licensee in respect of whom it is satisfied that by reason of his conviction 
of an offence under the Act or these rules, or the previous cancellation or suspension 
of  any  licence  granted  1[or  renewed]  thereunder,  he  is  not  a  fit  person  to  whom  a 
licence  should  be granted  1[or renewed]  under  this  rule.   Every  such  order  shall  be 
communicated to the licensee as soon as possible: 

3[Provided  further  that  in  respect  of  an  application  for  the  grant  of  a  licence  in 
Form 20B or Form 21B or both, the licensing authority shall satisfy himself that the 
premises in respect of which a wholesale licence is to be granted 1[or renewed] are:- 

(i) of an area of not less than ten square meters; and] 

4[(ii) in the charge of a competent person, who— 

(a) is a Registered Pharmacist, or 

(b)  has  passed  the  matriculation  examination  or  its  equivalent 
examination from a recognised Board with four years‘ experience in dealing 
with sale of drugs, or 

(c)  holds  a  degree  of  a  recognised      University  with  one  year‘s 

experience in dealing with drugs:] 

5[Provided also that,- 

(i) in respect of an application for the grant of a licence in Form 20 or Form 
21 or both, the licensing authority shall satisfy itself that the premises are of an 
area] of not less than 10 square meters, and 

(ii) in respect of an application for the grant of a licence 

(A) In Form 20 or Form 21 or both, and 

(B) In Form 20 B or Form 21B or both, 

the licensing authority shall satisfy itself that the premises are of an area not less  than 
15 square meters: 

1. Ins. by G.S.R 681(E), dt. 6.6.1988. 
2.  Subs. by Notfn. No. F. 1-19/59-D, dt. 13-6-1961. 
3.  Ins. by G.S.R 681(E), dt. 6.6.1980. 
4.  Substituted. G.S.R 351(E), dt. 26-4-2000. 
5.  Ins. by G.S.R 91(E), dt. 25-2-1997. 

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 Drugs and Cosmetics Rules 1945 

Provided also  that  the  provisions of  the  preceding proviso shall  not  apply  to  the 
premises  for  which  licences  have  been  issued  by  the  licensing  authority  before  the 
commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.] 

1[(3) Any person who is aggrieved by the order passed by the licensing authority 
in sub-Rule (1) may, within 30 days from the date of receipt of such order, appeal to 
the  State  Government  and  the  State  Government  may,  after  such  enquiry  into  the 
matter  as  it  considers  necessary  and  after  giving  the  appellant  an  opportunity  for 
representing his views in the matter, make such an order in relation thereto as it thinks 
fit.] 

65. Condition of licences.  Licences in  2[Forms 20, 20-A, 20-B, 20-F, 20-G, 21
and 21-B] shall be subject to the conditions stated therein and to the following general 
conditions 

2[(1)  Any  drug  shall,  if  compounded  or  made  on  the  licensee‘s  premises  be 
compounded or made by or under the direct and personal supervision of a 3[registered 
Pharmacist].] 

(2) The supply, otherwise than by way of wholesale dealing, 4[* * *] of any drug 
supplied  on  the  prescription  of  a  Registered  Medical  Practitioner  shall  be  effected 
only by or under the personal supervision of a 3[registered Pharmacist]. 

5[(3) (1) The supply of any drug  6[other than those specified in Schedule X] on a 
prescription  of  a  Registered  Medical  Practitioner  shall  be  recorded  at  the  time  of 
supply  in  a  prescription register  specially  maintained  for  the  purpose  and  the  serial 
number of the entry in the register shall be entered on the prescription.  The following 
particulars shall be entered in the register:_

(a) serial number of the entry, 

(b) the date of supply, 

(c) the name and address of the prescriber, 

7[(d)  the  name  and  address  of  the  patient,  or  the  name  and  address  of  the 

owner of the animal if the drug supplied is for veterinary use, 

(e) the name of the drug or preparation and the quantity or in the case of a 

medicine made up by the licensee, the ingredients and quantities thereof, 

(f)    in  the  case  of  a  drug  specified  in  2[Schedule  C  or  8[Schedule  H  and 
Schedule H1]] the name of the manufacturer of the drug, its batch number and 
the date of expiry of potency, if any, 

(g)  the  signature  of  the  3[registered  Pharmacist]  by  or  under  whose 

supervision the medicine was made up or supplied: 

1.  Amended by F.1-9/60-D dt. 3-7-1961. 
2.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R 676 (E), dt.  6-9-1994. 
4.  Omitted by  No. G.S.R 462(E), dt. 22-6-1982. 
5.  Subs. by S. O. 2139, dt. 5-6-1972. 
6.   Ins. by G.S.R. 462(E), dt. 22-6-1982. 
7.  Subs. by G.S.R. 926 dt. 16-7-1977. 
8.  Subs. by G.S.R 588 (E), dt.  30-08-2013.

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 Drugs and Cosmetics Rules 1945 

Provided that in the case of drugs which are not compounded in the premises and 

which  are  supplied  from  or  in  the  original  containers,  the  particulars  specified  in 

items  (a)  to  (g)  above  may  be  entered  in  a  cash  or  credit  memo  book,  serially 

numbered and specially maintained for this purpose: 

Provided  further  that  if  the  medicine is  supplied  on  a  prescription on  which  the 

medicine  has  been  supplied  on  a  previous  occasion  and  entries  made  in  the 

prescription register, it  shall  be  sufficient if  the  new  entry  in  the  register includes a 

serial number, the date of  supply, the quantity supplied and a  sufficient reference to 

an  entry  in  the  register  recording  the  dispensing  of  the  medicine  on  the  previous 

occasion: 

Provided also that it shall not be necessary to record the above details in the 

register or in the cash or credit memo particulars in respect of− 

(i)  any  drugs  supplied  against  prescription  under  the  Employees  State 

Insurance Scheme if all the above particulars are given in that prescription, and 

(ii) any drug other than that specified in  1[Schedule C or  4[Schedule H and Schedule 

H1]] if it is supplied  in  the  original  unopened  container  of  the  manufacturer  and  

if  the prescription is duly stamped at the time of supply with the name of the supplier 

and  the  date  on  which  the  supply  was  made  and  on  condition  that  the  provisions  of 

sub-rule (4)(3) of this rule are complied with. 

5[(h) the supply of a drug specified in Schedule H1 shall be recorded in a separate 

register  at  the  time  of  the  supply  giving  the  name  and  address  of  the  prescriber,  the 

name of the patient, the name of the drug and the quantity supplied and such records 

shall be maintained for three years and be open for inspection.] 

(2) The option to maintain a prescription register or a cash or credit memo book 

in respect of drugs and medicines which are supplied from or in the original container, 

shall be made in writing to  the Licensing Authority at  the time  of application for the 

grant or renewal of the licence to sell by retail: 

Provided that the Licensing Authority may require records to be maintained only 

in prescription register if it is satisfied that the entries in the carbon copy of the cash 

or credit memo book are not legible.] 

2[(4) (1) The supply by retail, otherwise than on a prescription of a drug specified 

in Schedule C  3[* * *] shall be recorded at the time of supply either− 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 
2.  Ins. by Notfn. No. 1-63/61-D, dt. 17-7-1963. 
3.  Omitted by G.S.R 462 (E), dt. 22-6-1982. 
4. Subs. by G.S.R 588 (E), dt.  30-08-2013. 
5. Ins. by G.S.R 588 (E), dt.  30-08-2013.

72 

 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(i)      in  a  register  specially  maintained  for  the  purpose  in  which  the  following 

particulars shall be entered : 

(a)  serial number of the entry, 

(b)  the date of supply, 

(c)  the name and address of the purchaser, 

(d)  the name of the drug and the quantity thereof, 

(e)  in  the  case  of  a  drug  specified  in  Schedule  C,  the  name  of  the 

manufacturer, the batch number and the date of expiry of potency, 

(f)  the  signature  of  the  person  under  whose  supervision  the  sale  was 

effected, or 

(ii)     in  a  cash  or  credit  memo  book,  serially  numbered  containing  all  the 

particulars specified in items (b) to (f) of sub-clause (i) above. 

NOTE:  The entries in the carbon copy of the cash or credit memo which is retained 

by the licensee shall be maintained in a legible manner.

(2) The option to maintain a register or a cash or credit memo book shall be made 
in  writing  to  the  Licensing  Authority  at  the  time  of  application  for  the  grant  or 
renewal of a licence to sell by retail: 

Provided that the Licensing Authority may require records to be  maintained in a 
register if  it  is  satisfied that  the  entries  in  the  carbon  copy  of  the  cash/credit memo 
book are not legible. 

(3)(i)  The supply by retail of any drug shall be made against a cash/credit memo 

which shall contain the following particulars : 

(a)  Name, address and sale licence number of the dealer, 

1[(b) Serial number of the cash/credit memo, 

(c)   the name and quantity of the drug supplied.] 

(ii)  Carbon copies  of  cash/credit memos  shall  be  maintained by  the  licensee  as 

record. 

1.  Ins. by G. S. R. No. 245, dt. 21-2-1976.

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 Drugs and Cosmetics Rules 1945 

1[(4)(i) Records of purchase of a drug intended for sale or sold by retail shall be 
maintained  by  the  licensee  and  such  records  shall  show  the  following  particulars, 
namely: 

(a) the date of purchase, 

(b)  the  name  and  address  of  the  person  from  whom  purchased  and  the 

number of the relevant licence held by him, 

(c) the name of the drug, the quantity and the batch number, and 

(d) the name of the manufacturer of the drug. 

(ii) Purchase bills including cash or credit memo shall be serially numbered by the 

licensee and maintained by him in a chronological order.] 

2[(5)(1)  Subject  to  the  other  provisions  of  these  Rules  the  supply  of  a  drug  by 
wholesale shall be made against a cash or credit memo bearing the name and address 
of the licensee and his licence number under the Drugs and Cosmetics Act in which 
the following particulars shall be entered 

(a) the date of sale, 

(b)  the  name,  address  of  the  licensee  to  whom  sold  and  his  sale  licence 
number.  In case of sale to an authority purchasing on behalf of Government, or 
to  a  hospital,  medical,  educational  or  research  institution  or  to  a  Registered 
Medical  Practitioner  for  the  purpose  of  supply  to  his  patients  the  name  and 
address  of  the  authority,  institution  or  the  Registered  Medical  Practitioner  as 
the case may be, 

(c) the name of the drug, the quantity and the batch number, 

(d) the name of the manufacturer, 

3[(e) the signature of the competent person under whose supervision the sale 

was effected.] 

(2)  Carbon  copies  of  cash  or  credit  memos  specified  in  clause  (1)  shall  be 

preserved as records for a period of three years from the date of the sale of the drug. 

1.  Subs. by G.S.R 1242 (E), dt. 17-9-1979. 
2.  Amended by F. 1-63/62-D, dt. 17-7-1963. 
3.  Ins. by G.S.R 496 (E), dt. 9-6-1995.

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(3)  (i)  Records of  purchase of  a  drug intended for resale or  sold by  wholesale 
shall  be  maintained  by  the  licensee  and  such  records  shall  show  the  following 
particulars, namely:- 

(a) the date of purchase, 

(b) the  name, address and the  number of the  relevant licence held by  the 

person from  whom purchased, 

(c) the name of the drug, the quantity and the batch number, and 

(d) the name of the manufacturer of the drug. 

(ii)  Purchase bills including cash  or  credit memos shall  be  serially numbered by 

the licensee and maintained by him in a chronological order.] 

(6) The licensee shall produce for inspection by an Inspector appointed under the 
Act  on  demand  all  registers  and  records  maintained  under  these  Rules,  and  shall 
supply  to  the  Inspector  such  information  as  he  may  require  for  the  purpose  of 
ascertaining  whether  the  provisions  of  the  Act  and  Rules  thereunder  have  been 
observed. 

(7)  Except  where  otherwise  provided  in  these  Rules,  all  registers  and  records 
maintained  under  these  Rules  shall  be  preserved  for  a  period  of  not  less  than  two 
years from the date of the last entry therein. 

(8)  Notwithstanding anything  contained in  this  Rule  it  shall  not  be  necessary  to 
record particulars in a  register specially maintained for the purpose if the particulars 
are  recorded  in  any  other  register  specially  maintained  under  any  other  law  for  the 
time being in force. 

2[(9)  (a)  Substances specified in  3[Schedule H and Schedule H1]  or  Schedule X 
shall  not  be  sold  by  retail  except  on  and  in  accordance  with  the  prescription  of  a 
Registered Medical Practitioner and  in  the  case  of  substances  specified  in  Schedule 
X, the prescriptions shall be in duplicate, one copy of which shall be retained by the 
licensee for a period of two years. 

(b)  The  supply  of  drugs  specified  in  3[Schedule  H  and  Schedule  H1]  or 
Schedule X  to  Registered Medical Practitioners, Hospitals, Dispensaries and Nursing 
Homes  shall  be  made  only  against  the  signed  order  in  writing  which  shall  be 
preserved by the licensee for a period of two years.] 

1.  Subs. by G.S.R 1242(E), dt. 17-9-1979. 
2.  Subs. by G.S.R 462(E), dt. 22-6-1982. 
3. Subs. by G.S.R 588(E), dt. 30-8-2013.

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(10)   For the purposes of clause (9) a prescription shall  

(a)  be  in  writing  and  be  signed  by  the  person  giving  it  with  his  usual 

signature and be dated by him; 

1[(b)  specify  the  name  and  address of  the  person for  whose treatment  it  is 
given, or the name and address of the owner of the animal if the drug is meant 
for veterinary use;] 

(c) indicate the total amount of the medicine to be supplied and the dose to 

be taken. 

(11)     The  person  dispensing  a   prescription  containing  a   drug  specified  in 
5[Schedule H and Schedule H1]  2[and  Schedule X]  shall  comply  with  the  following 
requirements in addition to other requirement of these rules. 

(a)   the  prescription  must  not  be  dispensed  more  than  once  unless  the 

prescriber has stated thereon that it may be dispensed more than once; 

(b)   if the prescription contains a direction that it may be dispensed a stated 
number of times or at  stated intervals it  must not be dispensed otherwise than 
in accordance with the directions; 

(c)    at the time of dispensing there must be noted on the prescription above 
the signature of the prescriber the name and address of the seller and the date 
on which the prescription is dispensed. 

4[(11-A)   No person dispensing a prescription containing substances specified in 
3[5[Schedule H and Schedule H1] or X], may supply any other preparation, whether 
containing the same substance or not, in lieu thereof. 

3[(12) Substances specified in Schedule X kept in retail shop or premises used in 

connection therewith shall be stored— 

(a) under lock and key in cupboard or drawer reserved solely for the storage 

of these substances; or 

(b)  in  a  part  of the premises separated from the  remainder of  the  premises 

and to which only responsible persons have access;] 

1.  Subs.  by G. S. R. No. 926, dt. 24-6-1977. 
2.  Ins. by  G.S.R 462 (E), dt. 22-6-1982. 
3.  Subs., by  G.S.R 462 (E), dt. 22-6-1982. 
4.  Ins. by SO 2139, dt. 5-6-1972. 
5. Subs. by G.S.R 588(E), dt. 30-8-2013.

76 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1 [*   *     *   *    *] 

2[(15)(a) The description ―Drugstore‖ shall be displayed by such licensees who do 

not require the services of a 3[Registered Pharmacist]. 

(b)  The  description  ―Chemists  and  Druggists‖  shall  be  displayed  by   such 
licensees  who  employ  the  services  of  a  3[Registered  Pharmacist]  but  who  do  not 

maintain a ―Pharmacy‖ for compounding against prescriptions. 

(c)  The  description  ―Pharmacy‖,  ―Pharmacist‖,  ―Dispensing  Chemist‖  or 

―Pharmaceutical  Chemist‖  shall  be  displayed  by  such  licensees  who  employ  the 

services of  a  3[Registered Pharmacist] and  maintain a  ―Pharmacy‖ for  compounding 

against prescriptions: 

3[Explanation:- For the purpose of this rule,- 

(i)  ―Registered  Pharmacist‖    means  a  person  who  is  a  registered 

Pharmacist  as  defined  in  clause  (i)  of  section  (2)  of  the  Pharmacy  Act,  1948 

(Act No. 8 of 1948): 

Provided  that  the  provisions  of  sub-clause  (i)  shall  not  apply  to  those 

persons  who  are  already  approved  as  ―qualified  person‖  by  the  licensing 

authority on or before 31st December, 1969: 

(ii)  ―Date  of  Expiry  of  potency‖  means  the  date  that  is  recorded  on  the 

container,  label  or  wrapper  as  the  date  up  to  which  the  substance  may  be 

expected to  retain  a  potency  not  less  than  or  not  to  acquire  a  toxicity  greater 

than that required or permitted by the prescribed test].] 

4[(16)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

1.  Sub-Rules (13) and (14) omitted by G.S.R 462 (E), dt. 22-6-1982. 
2.  Subs. by Notfn. No. F. 1-16/57-D, dt. 15-6-1957. 
3.  Subs. by G.S.R 676 (E), dt. 6-9-1994. 
4.  Subs. by Notfn. No. F. 1-14/68-D dt. 26-10-1968.

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 Drugs and Cosmetics Rules 1945 

1[(17) No drug shall be sold or stocked by the licensee after the date of expiration 

of potency recorded on its container, label or wrapper, or in violation of any statement 

or direction recorded on such container, label or wrapper: 

Provided that any such drugs in respect of which the licensee has taken steps with 

the manufacturer or his representative for the withdrawal, reimbursement or disposal 

of  the  same,  may  be  stocked  after  the  date  of  expiration  of  potency  pending  such 

withdrawal, reimbursement or  disposal, as  the  case  may  be,  subject to  the  condition 

that  the  same  shall  be  stored  separately  from  the  trade  stocks  2[and  all  such  drugs 

shall be kept in  packages or cartons, the top of which shall display prominently, the 

words ―Not for sale‖].] 

3[(18) No drug intended for distribution to the medical profession as free sample 
which bears a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 

96,  and  no  drug  meant  for  consumption  by  the  Employees‘  State  Insurance 

Corporation,  the  Central  Government  Health  Scheme,  the  Government  Medical 

Stores  Depots,  the  Armed  Forces  Medical  Stores  or  other  Government  institutions, 

which  bears  a  distinguishing  mark  or  any  inscription  on  the  drug  or  on  the  label 

affixed to the container thereof indicating this purpose shall be sold or stocked by the 

licensee on his premises:] 

5[Provided  that  this  sub-rule  shall  not  be  applicable  to  licensees  who  have  been 

appointed  as  approved  chemists,  by  the  State  Government  in  writing,  under  the 

employees‘  State  Insurance  Scheme,  or  have  been  appointed  as  authorised  agent  or 

distributor,  by  the  manufacturer  in  writing,  for  drugs  meant  for  consumption  under 

the Central Government Health Scheme, the Government Medical Stores Depots, the 

Armed  Forces  Medical  Stores  or  other  Government Institutions for  drugs  meant  for 

consumption under those schemes  6[or  have  been appointed as  authorised Depots or 

Carrying  and  Forwarding  agent  by  the  manufacturer  in  writing,  for  storing  free 

samples  meant  for  distribution  to  medical  profession]  subject  to  the  conditions  that 

the stock shall be stored separately from the trade stocks and shall maintain separate 

records of the stocks received and distributed by them.] 

1.  Ins. by Notfn. No. F. 1-55/61-D, dt. 22-8-1964. 
2.  Ins. by S. O. No. 903, dt. 28-2-1976. 
3.  Ins.  by Notfn. No. 1-113/69-D, dt. 23-12-1969. 
4. Subs. by G.S.R. 676(E) dt. 6-9-1994. 
5.  Subs. by G.S.R. 496(E) dt. 9-6-1995. 
6.  Ins. by G.S.R 352(E), dt. 26-4-2000. 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(19) The supply by retail of any drug in a container other than the one in which 
the manufacturer has marketed the drug, shall be made only by  dealers who employ 
the  services  of  a  2[Registered  Pharmacist]  and  such  supply  shall  be  made  under  the 
direct  supervision  of  the  2[Registered  Pharmacist]  in  an  envelope  or  other  suitable 
wrapper or container showing the following particulars on the label: 

(a) name of the drug, 

(b) the quantity supplied, 

(c) the name and address of the dealer.] 

3[(20) The  medicines for  treatment of  animals kept  in  a  retail  shop  or  premises
for treatment of animals only‘

shall be labelled with the words ‗Not for human use 
and shall be stored 

(a)  in  a  cupboard  or  drawer  reserved  solely  for  the  storage  of  veterinary 

drugs, or 

(b)   in a part of the premises separated from the remainder of the premises 

to which customers are not permitted to have access.] 

4[(21)  (a)  The  supply  of  drugs  specified  in  Schedule  X  shall  be  recorded  at  the 
time of supply in a register (bound and serially page numbered) specially maintained 
for the purpose and separate pages shall be allotted for each drug. 

(b) The following particulars shall be entered in the said register, namely:-- 

(i) Date of transaction; 

(ii) Quantity received, if any, the name and address of the supplier   and the 

number of the relevant licence held by the supplier; 

(iii) Name of the drug; 

(iv) Quantity supplied; 

(v) Manufacturer‘s name; 

(vi) Batch No. or Lot No; 

(vii) Name and address of the patient/purchaser; 

(viii)  Reference  Number  of  the  prescription  against  which  supplies  were 

made; 

(ix) Bill No and date in respect of purchases and supplies made by him; 

(x)  Signature  of  the  person  under  whose  supervision  the  drugs  have  been 

supplied.] 

1.  Ins. by G. S. R. 444 dt. 28-4-1973. 
2.  Subs. by G.S.R 676 (E), dt. 6-9-1994. 
3.  Added by G. S. R. No. 926 dt. 16-7-1977. 
4.  Ins. by G.S.R 462 (E), dt. 22-6-1982.

79 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[65A.  Additional information to be furnished by an applicant for liscence or a
licensee to the Licensing Authority.  The applicant for the grant of a licence or any
person  granted  a  licence  under  this  Part  shall,  on  demand,  furnish  to  the  licensing 
authority, before the grant of the licence or during the period   the licence is in force, 
as the case may be, documentary evidence in respect of the ownership of occupation 
or rental or other basis of the premises, specified in the application for licence or in 
the licence granted, constitution of the firm, or any other relevant matter which may 
be required for the purpose of verifying the correctness of the statements made by the 
applicant or the licensee, while applying for or after obtaining the licence, as the case 
may be.] 

66. Cancellation and suspension of licences. 

(1) The Licensing Authority may,

after giving the licensee an opportunity to show cause why such an order should not 
be passed by an order in writing stating the reasons therefor, cancel a  licence issued 
under  this  Part  or  suspend  it  for  such  period  as  he  thinks  fit,  either  wholly  or  in 
respect of some of the substances to which it relates, if in his opinion, the licensee has 
failed to  comply with any of  the  conditions of the licence or  with any  provisions of 
the Act or Rules thereunder: 

1[Provided that, where such failure or contravention is the consequence of an act 
or omission on the part of an agent or employee, the licence shall not be cancelled or 
suspended if the licensee proves to the satisfaction of the licensing authority−  

(a) that the act or omission was not instigated or connived at by him or, if the 
licensee  is  a  firm  or  company,  by  a  partner  of  the  firm  or  a  director  of  the 
company, or 

(b)  that  he  or  his  agent  or  employee  had  not  been  guilty  of  any  similar  act  or 
omission  within  twelve  months  before  the  date  on  which  the  act  or  omission  in 
question took place, or where his agent or employee had been guilty of any such act 
or omission the licensee had not or could not reasonably have had, knowledge of that 
previous act or omission, or 

(c)  if  the  act  or  omission was  a  continuing act  or  omission, he  had  not  or could 

not reasonably have had knowledge of that previous act or omission, or 

(d) that he had used due diligence to ensure that the conditions of the licence or 

the provisions of the Act or the Rules thereunder were observed.] 

2[(2) A licensee whose licence has been suspended or cancelled may, within three 
months of the date of order under sub-rule (1), prefer an appeal against that order to 
the State Government, which shall decide the same.] 

3[66A. Procedure for disposal of  drugs in the event  of  cancellation of licence.— 
(1)  In  case  a  licensee,  whose  licence  has  been  cancelled,  desires  to  dispose  of  the 
drugs he has in his possession in the premises in respect of which the licence has been 
cancelled, he shall apply in writing to the licensing authority for this purpose, giving 
the following particulars, namely:— 

1.  Ins. by S. O. 2139, dt. 12-8-1972. 
2.  Subs. by G. S. R. 926 dt. 16-7-1977. 
3.  Ins. by G.S.R 1242 (E), dt. 17-9-1979.

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 Drugs and Cosmetics Rules 1945 

(a)  the name and address of the person to whom the drugs are proposed to 
be  sold  or  supplied  together  with  the  number  of  the  licence  for  sale  or 
manufacture, as the case may be, held by him, 

(b)   the  names of  drugs together with their quantities, batch numbers, the 
names and addresses of their manufacturers and the dates of their expiry, if any, 
proposed to be sold to the person mentioned in clause (a). 

(2) The licensing authority may, after examination of the particulars referred to in 
sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where 
the drugs are stocked, grant the necessary permission for their disposal.] 

       6

[****] 

1[PART VIA 

SALE OF HOMOEOPATHIC MEDICINES 

67A.      (1)  The  State  Government  shall  appoint  Licensing  Authorities  for  the 

purpose of this Part for such areas as may be specified. 

(2) Application for the grant or renewal of a licence  2[to sell, stock or exhibit or 
offer for sale or distribute] Homoeopathic medicines shall be  made in Form 19-B to 
the Licensing Authority and shall be  accompanied by  a  3[fee  of  rupees two hundred 
and fifty]: 

4[Provided that if the applicant applies for renewal of licence after its  expiry but 
within six months of such expiry the fee payable for renewal of such licence shall be 
3[rupees two hundred and fifty plus an additional fee at the rate of rupees fifty or part 
thereof]. 

5[(3)  If  the  original  licence  is  either  defaced,  damaged  or  lost,  a  duplicate  copy 

thereof may be issued on payment of a 3[fee of rupees fifty].] 

67B. A Licensing Authority may, with the approval of the State Government, by 
an order in writing, delegate the power to sign licences and such other powers, as may 
be specified, to any other person under his control. 

67C. Forms of licences to sell drugs.  (1)   A licence 2[to sell, stock or exhibit or
offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall 
be issued in Form 20C or 20D as the case may be. 

1.  Added by Notfn. No. F. 1-35/64-D, dt. 18-8-1964. 
2.  Subs. by G.S.R 788(E) dt. 10-10-1985. 
3.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
4.  Amended by S. O. 2139 dt. 12-8-1972. 
5.  Added by G. S. R. 665, dt. 28-5-77. 
6. Rule 67 omitted by SO 289 (E), dt. 20-12-1972.

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 Drugs and Cosmetics Rules 1945 

67D. Sale at more than one place. 

If drugs are sold or stocked for sale at more
than one place, a  separate application shall be made and a  separate licence shall be 
obtained in respect of each place. 

67E. Duration of licences.  An original licence or a renewed licence unless it is
sooner suspended or cancelled shall be 1[valid for a period of five years on and from 
the date on which]  it is granted or renewed : 

2[Provided that if the application for renewal of a licence in force is made before 
its expiry or if the application is made within six month of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application  and  the  licence  shall  be  deemed  to  have  expired  if  application  for  its 
renewal is not made within six months after its expiry.] 

3[67EE. Certificate  of renewal.  The certificate  of renewal of a  sale licence in

Forms 20C and 20D shall be issued in Form 20E.] 

67F.  Condition  to  be  satisfied  before  a  licence  in  Form  20C  or  Form  20D  is 
granted.-(1)  A  licence  in  Form  20C  or  Form  20D  to  4[to  sell,  stock  or  exhibit  or 
offer  for  sale  or  distribute]  Homoeopathic  medicines  shall  not  be  granted  to  any 
person  unless  the  authority  empowered  to  grant  the  licence  is  satisfied  that  the 
premises in respect of which the licence is to be granted are clean and in the case of a 
licence  in  Form  20C  the  sale  premises  is  in  charge  of  a  person  who  is  or  has  been 
dealing  in  Homoeopathic  medicines  and  who  is  in  the  opinion  of  the  Licensing 
Authority competent to deal in Homoeopathic medicines: 

5[Provided   that   no   registered   Homoeopathic   medical   practitioner   who   is 
practising  Homoeopathy  in  the  premises  where  Homoeopathic  medicines  are  sold 
shall deal in Homoeopathic medicines.] 

(2) Any person who is aggrieved by the order passed by the Licensing Authority 
under  sub-rule  (1)  may  within  30  days  from  the  date  of  the  receipt  of  such  order 
appeal  to  the  State  Government  and  the  State  Government  may,  after  such  enquiry 
into the matter as it considers necessary and after giving the appellant an opportunity 
for representing his case, make such order in relation thereto as it thinks fit. 

1.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
2.  Subs. by S. O. 2139 dt. 5-6-1972. 
3.  Added by Notfn. No. F. 1-14/67-D, dt. the 3-2-1969. 
4.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
5.  Ins. by Notfn. No. G.S.R 680 (E), dt. 5-12-1980.

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67G. Conditions of licence.  Licence in Form 20C or 20D shall be subject to

the conditions stated therein and to the following further conditions, namely: 

(1) The premises where the Homoeopathic medicines are stocked for sale or 

sold are maintained in a clean condition. 

(2)  The  sale  of  Homoeopathic  medicines  shall  be  conducted  under  the 

supervision of a person, competent to deal in Homoeopathic medicines. 

(3)  The  licensee  shall  permit  an  Inspector  to  inspect  the  premises  and 
furnish  such  information  as  he  may  require  for  ascertaining  whether  the 
provisions of the Act and the Rules made thereunder have been observed. 

(4)  The  licensee  in  Form  20D  shall  maintain records  of  purchase and  sale 
of  Homoeopathic  medicines  containing  alcohol  together  with  names  and 
addresses of parties to whom sold. 

1[(5) The licensee in Form 20C shall maintain records of purchase and sale 
of Homoeopathic medicines containing alcohol.   No records of sale in respect 
of  Homoeopathic  potentised  preparation  in  containers  of  30  ml.  or  lower 
capacity and in respect of mother tinctures made up in quantities up to 60 ml. 
need be maintained.] 

2[(6) The licensee shall maintain an  Inspection Book in  Form 35  to enable 

an Inspector to record his impressions and the defects noticed.] 

3[67GG. Additional information to be furnished by an applicant for licence or a
licensee to the Licensing Authority.  The applicant for the grant of a licence or any
person  granted  a  licence  under  this  Part  shall,  on  demand  furnish  to  the  Licensing 
Authority, before the grant of the licence or during the period the licence is in force 
as the case may be, documentary evidence in respect of the ownership or occupation 
or rental or other basis of the premises, specified in the application for licence or in 
the  licence  granted,  constitution  of  the  firm,  or  any  other  relevant  matter,  which 
may be required for the purpose of verifying the correctness of the statements made 
by the applicant or the licensee, while applying for or after obtaining the licence, as 
the case may be.] 

1. Ins. by Notfn. No. F. 1-59/68-D, dt. the 19-11-1969. 
2.  Ins. by G.S.R 331 (E), dt. 8-5-1984. 
3.  Ins. by S. O. 2139 dt. 5-6-1972.

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67-H.  Cancellation  and  suspension  of  licences.  (1)  The  Licensing  Authority

may, after giving the licensee an opportunity to show cause why such an order should 

not  be  passed  by  an  order  in  writing  stating  the  reasons  therefor,  cancel  a  licence 

issued under this Part or suspend it for such period as he thinks fit, if in his opinion, 

the licensee has failed to comply with any of the conditions of the licence or with any 

provisions of the Act or Rules made thereunder: 

1[Provided that, where such failure or contravention is the consequence of an act 

or omission on the part of an agent or employee, the licence shall not be cancelled or 

suspended if the licensee proves to the satisfaction of the Licensing Authority−

(a)  that the act or omission was not instigated or connived at by him or, if 

the licensee is a firm or company, by a partner of the firm or a director of the 

company, or 

(b)   that he or his agent or employee had not been guilty of any similar act 

or omission within twelve months before the date on which the act or omission 

in question took place, or where his agent or employee had been guilty of any 

such  act  or  omission,  the  licensee  had  not  or  could  not  reasonably  have  had, 

knowledge of that previous act or omission, or 

(c)   if the act or omission was a continuing act or omission that he had not 

or could not reasonably have had knowledge of that previous act  or omission, 

or 

(d)  that  he  had  used  due  diligence  to  ensure  that  the  conditions  of  the 

licence or the provisions of the Act or the Rules thereunder were observed.] 

2[(2) A licensee whose licence has been suspended or cancelled may, within three 

months of the date of the order under sub-rule (1), prefer an appeal against that order 

to the State Government, which shall decide the same.] 

1.  Ins. by S. O. 2139 dt. 5-6-1972. 
2.  Amended by G.S.R. 926 dt. 16-7-1977.

84 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PART   VII 

1[MANUFACTURE   FOR    SALE  OR  FOR  DISTRIBUTION] OF   DRUGS  

OTHER THAN HOMOEOPATHIC MEDICINES 

68. Manufacture on more than one set of premises. 

If drugs are manufactured
on more than one set of premises a separate application shall be made and a separate 
licence shall be issued in respect of each such set of premises. 

2[68-A.  Grant  or  Renewal  of  Licences  by  the  Central  Licence  Approving 
Authority.—  (1)  Notwithstanding  anything  contained  in  this  Part,  on  and  from  the 
commencement of  the  Drugs and  Cosmetics (Amendment) Rules,1992, a  licence for 
the manufacture for sale or  distribution of drugs as specified from time to time by the 
Central  Government  by  notification  in  the  Official  Gazette,  for  the  purpose  of  this 
rule,  shall  be  granted  or  renewed,  as  the  case  may  be,      by  the  Central  Licence 
Approving Authority (appointed by the Central Government):] 

                        Provided that the application for the grant or renewal of such licence 
shall be made to the Licensing Authority. 

(2)  On  receipt of  the  application for  grant  or  renewal of  a  licence, the  licensing 

authority shall,- 

(i)  verify the statement made in the application form; 

(ii)  cause  the  manufacturing  and  testing  establishment  to  be  inspected  in 

accordance with the provisions of rule 79; and 

(iii)  in  case  the  application  is  for  the  renewal  of  licence,  call  for  the 

information(s) of the past performance of the licensee. 

(3) If the licensing authority is satisfied that the applicant is in a position to fulfil 
the requirements laid down as in these Rules, he shall prepare a  report to that effect 
and forward it along with the application  3[and   the   licence   (in   triplicate)  to   be 
granted and renewed, duly completed] to the Central Licence Approving Authority: 

Provided that if the licensing authority is of the opinion that the applicant is not in 
a  position to fulfil the requirements laid  down in  these Rules, he  may, by  order, for 
reasons to be recorded in writing, refuse to grant or renew the licence, as the case may 
be. 

(4)  If on  receipt  of the  application  and  the  report  of the  licensing  authority 
referred to in sub-rule (3) and after taking such measures including inspection of the 
premises by the Inspector, appointed by the Central Government under section 
21   of   the   Act,   with  or  without  an  expert  in  the  concerned  field  if  deemed 
necessary,  the Central Licence Approving Authority, is satisfied that the applicant 

1.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
2.  Ins. by G.S.R 923 (E), dt. 14-12-1992. 
3.  Subs. by G.S.R 89 (E), dt. 14-2-1996.

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

is  in  a  position  to  fulfil the requirements laid down in these Rules, he may grant or 
renew the licence, as the case may be: 

Provided  that  if  the  Central  Licence  Approving  Authority  is  of  the  opinion  that 
the applicant is not in a position to fulfil the requirements laid down in these rules, he 
may, notwithstanding the report of the licensing authority, by order, for reasons to be 
recorded in writing, reject the application for grant or renewal of licence, as the case 
may be.] 

1[68B.  Delegation of  Powers  by  the  Central  Licence Approving Authority.—The 
Central  Licence  Approving  Authority  may  with  the  approval  of  the  Central 
Government,  by  notification  delegate  his  powers  of  signing  licences  and  any  other 
powers under the rules to any person under his control having same qualifications as 
prescribed  for  controlling  authority  under  Rule  50A  for  such  areas  and  for  such 
periods as may be specified.] 

2[69.  Application for  licence  to  manufacture drugs  other  than  those  specified in 
Schedules C and C(I) to the Drugs and Cosmetics Rules.      3[(1) Application for grant 
or renewal of 4[licence to manufacture for sale or for distribution] of drugs, other than 
those  specified  in  Schedules  C  and  C(I)  shall  be  made  to  the  licensing  authority 
appointed  by  the  State  Government  for  the  purpose  of  this  Part  (hereinafter  in  this 
Part referred to as the licensing authority) and shall be made 

(a) in the case of repacking of drugs excluding those specified in Schedule 

X for sale or distribution in, Form 24B; 

(b)  in  the  case  of  manufacture of  drugs  included in  Schedule X,  in  Form 

24F; 

(c) in any other case, in Form 24.] 

5[(2)(a)  Every  application  in  Form  24B  shall  be  made  up  to  ten  items  for  each 
category of drugs categorised in Schedule M and shall be accompanied by a  licence 
fee of rupees five hundred plus and an inspection fee of rupees two hundred for every 
inspection or for the purpose of renewal of the licence. 

1.  Ins. by G.S.R 89 (E), dt. 14-02-1996. 
2.  Amended by Notfn. F. 1-22/59-D, dt. 9-4-1960. 
3.  Subs. by G.S.R 462 (E), dt. 22-06-1982. 
4  Subs. by G.S.R.788 (E), dt. 10-10-1985. 
5.  Subs. by G.S.R 601(E), dt. 21-8-2001.

86 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(b)  Every  application  in  Form  24F  shall  be  made  up  to  ten  items  for  each 
category of drugs categorised in Schedule M and shall be accompanied by a  licence 
fee  of  rupees  six  thousand  and  an  inspection  fee  of  rupees  one  thousand  and  five 
hundred for every subsequent inspection or for the purpose of renewal of licence. 

(c) Every application in Form 24 shall be made up to ten items for each category 
of  drugs  3[referred  to  in  Schedule  M  relating  to  pharmaceuticals  products  and 
Schedule  MIII  relating  to  medical  devices  and  in-vitro  diagnostics]  and  shall  be 
accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of  one 
thousand  and  five  hundred for every inspection or for the purpose of renewal of the 
licence.] 

1[(3)  If  a  person applies for  the renewal of  a  licence after the  expiry  thereof but 
within six months of such expiry the fee payable for the renewal of such licence shall 
be−]

2[(i)  in  the  case  of  Form 24B  a  licence fee  of  rupees five  hundred plus  an 
additional  fee  at  the  rate  of  rupees  two  hundred  and  fifty  per  month  or  part 
thereof in addition to an inspection fee of rupees two hundred; 

(ii)  in  the  case  of  Form  24F  a  licence  fee  of  rupees  six  thousand  plus  an 
additional fee  at  the  rate  of  rupees one  thousand per  month or  part  thereof in 
addition to an inspection fee of rupees one thousand; 

(iii)  in  the  case  of  Form  24  a  licence  fee  of  rupees  six  thousand  plus  an 
additional fee  at  the  rate  of  rupees one  thousand per  month or  part  thereof in 
addition to an inspection fee of rupees one thousand and five hundred.] 

1[(4)  A  fee  2[rupees  one  thousand  shall  be  paid]    for  a  duplicate  copy  of  the 
licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original 
is defaced, damaged or lost.] 

2[(5)  Applications  for  manufacture  of  more  than  ten  items  of  each  category  of 
drugs  as  categorized  under  Schedule  M  and  M-III  or  for  manufacture  of  additional 
items  of  drugs  by  licensees  in  Form  24  or  Form  24F  shall  be  accompanied  by  an 
additional  fee  at  the  rate  of  rupees  three  hundred  for  each  additional  item  of  drug. 
Applications  in  Form  24B  for  licence  to  manufacture  for  sale  and  distribution  for 
repacking  for  more  than  10  items  of  each  category  or  for  manufacture  of  additional 
item of drug shall be accompanied by additional fee of rupees one hundred for each 
additional item of drugs as cetegorized in Schedule M and M-III]. 

1.  Subs. by G.S.R 462 (E), dt. 22-6-1982. 

2.  Subs. by G.S.R 26 (E), dt. 19-1-2006. 

3.  Subs. by G.S.R 640 (E), dt. 29-6-2016.

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(6)  Where  an  application  under  this  Rule  is  for  the  manufacture  of  drug 
formulations  falling  under  the  purview  of  new  drug  as  defined  in  rule  122E,  such 
application  shall  also  be  accompanied  with  approval,  in  writing  in  favour  of  the 
applicant, from the licensing authority as defined in clause (b) of rule 21.] 

2[69A.  Loan  Licences.⎯3[(1)  Application  for  the  grant  or  renewal  of  loan 
licences to manufacture for sale or for distribution of drugs other than those specified 
in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each 
category of drugs 5[referred to in Schedule M relating to pharmaceuticals products and 
Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be made 
in Form 24A accompanied by a licence fee of rupees six thousand and an inspection 
fee of rupees one thousand and five hundred to the licensing authority: 

Provided that if the applicant applies for the renewal of a licence after its expiry 
but within six months of such expiry, the fee payable for renewal of such licence shall 
be  accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of 
rupees one thousand and five hundred plus an additional fee at the rate of rupees one 
thousand per month or part thereof.] 

4[Explanation.- For the purpose of this rule a loan licence means a licence which 
the    Licensing  Authority  may    issue  to    an    applicant  who    does  not    have  his  own 
arrangements for manufacture but who intends to avail himself of the manufacturing 
facilities owned by a licensee in Form 25.] 

(2)  The  Licensing  Authority  shall,  before  the  grant  of  a  loan  licence,  satisfy 
himself  that  the  manufacturing  unit  has  adequate  equipment,  staff,  capacity  for 
manufacture, and facilities for testing, to undertake the manufacture on behalf of the 
applicant for a loan licence. 

3[(3)  Subject  to  the  provisions  of  sub-rule  (2),  application  for  manufacture  of 
more than ten items for each category of drug on a loan licence shall be accompanied 
by an additional fee of rupees three hundred per additional item specified 5[referred to  
in  Schedule  M  relating  to  pharmaceuticals  products  and  Schedule  MIII  relating  to 
medical devices and in-vitro diagnostics]. 

1.  Ins. by G.S.R 311 (E), dt. 1-5-2002. 
2.  Amended by Notfn. No. F. 1-16/57-D, dt. 15-6- 1957. 
3.  Subs. by G.S.R 601(E) dt. 24-8-2001. 
4.  Subs. by G.S.R 724(E) dt. 07-11-2013. 
5.  Subs. by G.S.R 640 (E), dt. 29-6-2016.

88 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(4)    If  the  Licensing  Authority  is  satisfied  that  a  loan  licence  is  defaced, 
damaged  or  lost  or  otherwise  rendered  useless,  he  may,  on  payment  of  a  2[fee  of 
rupees one thousand] issue a duplicate licence.] 

3[*   *   *   *  *] 

4[70. Form of licence to repack or manufacture drugs other than those specified 

in  Schedules C  and  C(1).- 
  Licences  for repacking of drugs against application in Form 24-B shall be granted in 
Form  25-B,  licences  for  manufacture  of  drugs  included  in  Schedule  X  and  against 
application in  Form 24-F shall be  granted in  Form 25-F and licences for manufacture 
of drugs against application in Form 24 shall be granted in Form 25.] 

5[70A. Form of loan 6[licence to manufacture for sale or for distribution] of drugs 

other  than  those  7[specified  in  Schedules  C,  C(1)  and  X].⎯ 
A  loan  6
7[specified in Schedules C, C(1) and X] shall be issued in Form 25A.] 

[licence  to manufacture for sale or for distribution] or drugs other than those 

8[71.   Conditions  for  the  grant  or  renewal  of  a  licence  in  Form  25  9[or  Form 

25F].⎯ 

Before a licence in Form 25 9[or Form 25F] is granted or renewed, the  
following conditions shall be complied with by the applicant.- 

(1)    The  manufacture  shall  be  conducted  under  the  active  direction  and 
personal supervision of competent technical staff consisting at least of one person 
who is a whole-time employee and who is 

(a)  a  graduate  in  Pharmacy  or  Pharmaceutical  Chemistry  of  10[a 
University  established  in  India  by  law  or  has  an  equivalent  qualification 
recognised  and  notified  by  the  Central  Government  for  such  purpose]   and 
has had at least eighteen months practical experience after the graduation in 
the  manufacture  of  drugs.      This  period  of  experience  may,  however,  be 
reduced by six months if the person has undergone training in manufacture of 
drugs for a period of six months during his University  course; or 

(b)    a    graduate    in    Science    of     10[a    University    established 
in   India   by   law   or   has   an   equivalent   qualification   recognized   and 
notified by the Central Government for   such   purpose] who for the purpose 
of   his degree   has   studied   Chemistry   as  a   principal   subject   and  has 

1.  Ins. by  Notfn. No. F.1-20/64-D, dt. 26.10.1968. 
2.  Subs. by Notfn. No. G.S.R. 601 (E), dt. 24.8.2001. 
3.  Rule 69 omitted by G.S.R. 944 (E), dt. 21-9-1988. 
4.  Subs. by Notfn. No. G.S.R. 462 (E), dt. 22.6.1982. 
5.  Ins. by Notfn. No. F.1-16/57 D,  15-6-1957 & No. F.1/22/59-D, dt. 9.4.1960. 
6.  Subs. by Notfn. No. G.S.R. 788 (E), dt. 10-10-1985. 
7.  Subs. by Notfn. No. G.S.R. 462 (E), dt. 22-6-1982. 
8.  Subs. by Notfn. No. F.1-16/57-D, dt. 15-6-1957. 
9. Ins. by G.S.R. 462(E), dt. 22-6-1982. 
10.  Subs. by Notfn. No. G.S.R. 71 (E), dt. 30-1-1987.

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had at least three years practical experience in the manufacture of drugs after 
his graduation; or 

(c) a graduate in Chemical Engineering or Chemical Technology or Medicine 
of  1[a University established in India by law or has an equivalent qualification 
recognised  and  notified  by  the  Central  Government  for  such  purpose]  with 
general  training  and  practical  experience,  extending  over  a  period  of  not  less 
than three years in the manufacture of drugs, after his graduation; or 

2[(d) holding any foreign qualification the quality and content of training of 
which are comparable with those prescribed in clause (a), clause (b) or clause 
(c) and is permitted to work as competent technical staff under this Rule by the 
Central Government:] 

Provided  that  any  person  who  was  immediately  before  the  29th  June,  1957, 
actively  directing  and  personally  supervising  the  manufacture  of  drugs  and  whose 
name was accordingly entered in any licence granted in Form 25 3[or Form 25F] as it 
existed before the date shall be deemed to be qualified for the purposes of this rule: 

4[Provided further that  for drugs other than  those specified in  Schedules C,  C(1) 
and  X  and  meant  for  veterinary  use,  the  whole-time  employee  under  whose 
supervision the manufacture is conducted shall be a graduate in Veterinary Science or 
Pharmacy or  General Science or Medicine of a University recognized by the Central 
Government  and  who  has  had  at  least  three  years  practical  experience  in  the 
manufacture  of  drugs  excluding  graduate  in  Pharmacy  who  shall  have  at  least 
eighteen months practical experience in the manufacture of drugs:] 

5[Provided 6[also] that the Licensing Authority may, in the matter of manufacture 
of  disinfectant  fluids,  insecticides,  liquid  paraffin,  medicinal  gases,  non-chemical 
contraceptives, plaster of  Paris  and  surgical  dressings, for  the  manufacture of  which 
the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the 
manufacture of  the  substance under  the  active  direction  and  personal  supervision of 
the  competent  technical  staff,  who,  although  not  having  any  of  the  qualifications 
included  in  clause  (a),  (b)  or  (c)  of  this  rule,  has,  in  the  opinion  of  the  Licensing 
Authority, adequate experience in the manufacture of such substance.] 

1.  Subs. by  G.S.R. 71(E), dt. 30-1-1987. 
2. Added by Notfn. NO. F. 1-19/59-D, dt. 13-6-1961. 
3.  Ins. by. G.S.R. 462 (E), dt. 22-6-1982. 
4.  Ins. by. G.S.R. 93 (E), dt. 24-2-1999. 
5.  Added Notfn. No. F. 1-14/68-D, dt. the 26-10-1968. 
6. Sub. by. G.S.R. 93 (E), dt. 24-2-1999.

90 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(2)   The   factory   premises   shall   comply   with   the   conditions   prescribed  in 

Schedule M. 

(3)  The  applicant  shall  provide  adequate  space,  plant  and  equipment  for  the 
manufacturing operations; the  space,  plant  and  equipment recommended for  various 
operations are given in Schedule M. 

1[(4)  The  applicant  shall  provide  and  maintain  adequate  staff,  premises  and 
laboratory equipment for  carrying out  tests  of  the  strength, quality  and  purity  of  the 
substances at a testing unit, which shall be separate from the manufacturing unit and 
the  head  of  the  testing  unit  shall  be  independent  of  the  head  of  the  manufacturing 
unit : 

Provided  that  the  manufacturing  units,  which,  before  the  commencement of  the 
Drugs  and  Cosmetics  (Amendment)  Rules,  1977,  were  making  arrangements  with 
institutions  approved  by  the  Licensing  Authority  for  such  tests  to  be  carried  out  on 
their behalf may continue such arrangements up to the 30th June, 1977 : 

Provided further  that  for  tests  requiring sophisticated instrumentation techniques 
or  biological or  microbiological methods other than sterility the  Licensing Authority 
may  permit  such  tests  to  be  conducted  by  institutions  approved  by  it  4 [ under 
Part XV(A) of these rules] for this purpose.] 

2[(4A)  The  head  of  the  testing  unit  referred  to  in  condition  (4)  shall  possess  a 
degree  in  Medicine  or  Science  or  Pharmacy  or  Pharmaceutical  Chemistry  of  a 
University  recognized  for  this  purpose  and  shall  have  experience  in  the  testing  of 
drugs, which in the opinion of the licensing authority is considered adequate.] 

(5)  The  applicant  shall  make  adequate  arrangements  for  the  storage  of  drugs 

manufactured by him. 

3[(6)  The  applicant  shall,  while  applying  for  a  licence  to  manufacture  patent  or 
proprietary medicines, furnish to the Licensing Authority evidence and data justifying 
that the patent or proprietary medicines 

(i)  contain the constituent ingredients in therapeutic/prophylactic quantities 
as  determined in  relation to  the  claims  or  conditions for  which  the  medicines 
are recommended for use or claimed to be useful; 

1.  Subs. by G.S.R. 926 dt. 16-7-1977. 
2.  Ins. by  G.S.R. 681(E), dt. 5-12-1980. 
3.  Ins. by G.S.R. 515 dt. 10-4-1976. 
4. Ins. by G.S.R. 1172 dt. 23-8-1977.

91 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(ii) are safe for use in the context of the vehicles, excipients, additives and 
pharmaceutical aids used in the formulation and under the conditions in which 
the formulation for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification; and] 

1[(v) have the approval, in writing, in favour of the applicant to manufacture 
drugs formulations falling under the purview of new drug as defined in Rule 
122-E, from the Licensing Authority as defined in clause (b) of rule 21.] 

2[(7)  The  licensee  shall  comply  with  the  requirements  of  Good  Manufacturing 

Practices as laid  down in Schedule M.] 

6[(8) The applicant shall make application for grant of licence for a drug formulation 
containing single active ingredient only in proper name.] 

3[71A. Conditions for the grant or renewal of a licence in Form 25B. Before a licence  in  
Form  25B  is  granted  or  renewed  the  following  conditions shall be complied with by the 
applicant :- 

(1)  the  repacking  operation  shall  be  carried  out  under  hygienic  conditions  and 

under the supervision of a competent person; 

4[(2)   the   factory   premises  shall   comply   with   the   conditions  prescribed  in 

Schedule M; and] 

5[(3)   the  applicant  shall  have  adequate  arrangements  in  his  own  premises  for 
carrying  out  tests  for  the  strength,  quality  and  purity  of  the  drugs  at  a  testing  unit 
which shall be separate from the repacking unit:] 

6[(4) The application for grant of licence for a drug formulation containing single 

active ingredient shall be made only in proper name:] 

Provided that the repacking units, which before the commencement of the Drugs 
and  Cosmetics  (Second  Amendment)  Rules,  1977,  were  making  arrangements  with 
institutions approved by the licensing authority for such tests to be carried out on their 
behalf, may continue such arrangements up to the 31st July, 1977: 

1.  Ins. by G.S.R. 311 (E), dt. 1-5-2002. 
2.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
3.  Ins. by  No. F.1-22/59-D, dt.  9-4-1960. 
4.  Amended by  S.O. 2139 dt. 12-8-1972. 
5.  Amended by G.S.R. 926  dt. 16-7-1977. 
6. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

92 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  further  that  for  tests  requiring  sophisticated instrumentation techniques 
or biological or microbiological methods the licensing authority may permit such test 
to  be  conducted by  institutions approved by  it  under Part XV(A)  of  these  Rules  for 
this purpose.] 

Explanation.−A person who satisfies the following minimum qualifications shall 

be deemed to be a ―competent person‖ for the purposes of rule 71A or 74A of these 
rules, namely: − 

(a) a person who holds the Diploma in Pharmacy approved by the Pharmacy 
Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is 

registered under the said Act, or 

(b)  a  person who  has  passed  the  Intermediate examination with  Chemistry 
as  one  of  the  principal  subjects  or  an  examination  equivalent  to  it  or  an 
examination recognized by the Licensing Authority as equivalent to it; or 

(c)    a    person    who    has    passed    the    Matriculation    examination    or    an 
examination recognized by the Licensing Authority as equivalent to it and has 
had   not  less   than   four  years‘  practical  experience  in   the   manufacture, 
dispensing or repacking of drugs.] 

1[71B.  Conditions  for  the  grant  of  renewal  of  a  licence  in  Form  25A.−  Before  a 

licence in Form 25A is granted or renewed, the applicant shall, while applying for a 
licence  to    manufacture  patent  or    proprietary  medicines,  furnish  to    the  Licensing 
Authority evidence and data justifying that the patent or proprietary medicines:- 

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as 
determined  in  relation  to  the  claims  or  conditions  for  which  the  medicines are 
recommended for use or claimed to be useful; 

(ii)  are  safe  for  use  in  the  context  of  the  vehicles,  recipients,  additives  and 
pharmaceutical aids  used  in  the  formulations and  under  conditions in  which  the 
formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; and 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification. 

2[Provided  that  the  application  for  grant  of  a  licence  for  a  drug  formulation 

containing single active ingredient shall be made only in proper name.] 

1.  Ins. by G.S.R. 515 (E), dt. 24-3-1976. 
2. Ins. by G.S.R. 570 (E), dt. 7-8-2014.

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1[72.   Duration   of   licence.–An   original   licence   or   a   renewed   licence   in 

Form 25,  2[Form 25B or Form 25F] unless sooner suspended or cancelled shall be 
3[valid  for  a  period  of  five  years  on  and  from  the  date  on  which]  it  is  granted  or 
renewed: 

4[Provided that  if  the  application for  the  renewal of  a  licence is  made  before  its 
expiry, or if the application is made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application and the licence shall be deemed to have expired if the application for its 
renewal is not made within six months of its expiry.] 

2[73. Certificate of renewal.– The certificate of renewal of a licence in Form 25 or 

Form 25F shall be issued in Form 26 or Form 26E respectively]. 

5[73A.   A  certificate  of  renewal  of  loan  licence.-  The  certificate  of  renewal  of  a 

loan licence in Form 25A shall be issued in Form 26A.] 

5[73AA.  Duration  of  loan  licence.–  An  original  loan  licence  in  Form  25A  or  a 

renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 
3[valid  for  a  period  of  five  years  on  and  from  the  date  on  which]  it  is  granted  or 
renewed:] 

6[Provided that  if  the  application for  the  renewal of  a  licence  is  made  before its 
expiry, or if the application is made within six months of its expiry, after payment of 
additional fee, the licence shall continue to be in force until orders are passed on the 
application and the licence shall be deemed to have expired if the application for its 
renewal is not made within six months of its expiry.] 

7[73B.   Certificate of renewal of licence in Form 25B.–The certificate of renewal 

of a licence in Form 25B shall be issued in Form 26B.] 

1.  Subs. by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 
2.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
4.  Amended by  S.O. 2139 dt. 12-8-1972. 
5.  Amended by Notfn. No. F.1-10/62-D, dt. 10-4-1964. 
6.  Amended by S.O. 2139 dt. 12-8-1972.  
7.  Ins. by  S.O. 1196, dt. 6-5-1960.

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1[74. Conditions of licence in Form 25.−A licence in 2[Form 25 and Form  
25F] shall  be  subject  to  the  conditions  stated  therein  and  to  the  following  
further conditions, namely : 

(a)  the  licensee  shall  provide  and  maintain  staff,  premises  and  the 

equipment as specified in rule 71; 

(b)  the  licensee  shall  comply  with  the  provisions  of  the  Act  and  of  these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules  subsequently  made  under  Chapter  IV  of  the  Act;  provided  that  where 
such  further  requirements  are  specified  in  the  Rules,  these  would  come  into 
force, four months after publication in the Official Gazette; 

(c) the licensee shall either in his own laboratory or in any other laboratory 
approved  by  the  Licensing  Authority  4 [ under  Part  XV  (A)  of  these  rules] 
test each  batch or  lot  of  the  raw  material  used  by  him  for  the  manufacture of 
his products and also each batch of the final product and shall maintain records 
or registers  showing  the  particulars  in  respect  of  such  tests  as  specified  
in  Schedule  U.    The  records  or  registers  shall  be  retained  for  a  period  of  5 
years from the date of manufacture; 

(d)  the  licensee  shall  keep  records  of  the  details  of  manufacture  as  per 
particulars  given  in  Schedule  U  of  each  batch  of  the  drugs  manufactured  by 
him and such records shall be retained for a period of five years; 

(e)  the  licensee  shall  allow  an  3[ Inspector  appointed  under  the  Act],  to 
enter, with  or  without  prior  notice,  any  premises and  to  inspect the  plant  and 
the  process  of  manufacture  and  the  means  employed  in  standardizing  and 
testing the drugs; 

(f)  the  licensee  shall  allow  an  3[ Inspector  appointed  under  the  Act]  to 
inspect  all  registers  and  records  maintained  under  these  rules  and  to  take 
samples  of  the  manufactured  drugs  and  shall  supply  to  such  Inspector  such 
information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 
provisions of  the Act and the rules thereunder have been observed; 

(g) the licensee shall, from time to time, report to  the Licensing Authority 
any changes in the expert staff responsible for the manufacture or testing of the 
drugs and any material alterations in the premises or plant used for the purpose 
which have been   made   since   the   date of the last inspection made on behalf 
of the licensing authority; 

1.  Subs. by  Notfn. No. F. 1-20/64-D (S.O. 3868), dt. 26-10-1968. 
2.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Amended by G.S.R. 444 dt. 28-4-1973. 
4. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.

95 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[ (h)  the  licensee  shall,  on  request, furnish to  the  Licensing Authority, the 
Controlling Authority or to such authorities as the   Licensing Authority or the 
Controlling Authority may direct from every batch, or batches of drugs as the 
Licensing  Authority  or  the  Controlling  Authority  may  from  time  to  time 
specify,  a  sample  of  such  quantity  as  may  be  considered  adequate  by  such 
authority for any examination and, if so required, also furnish full protocols of 
tests which have been applied;] 

(i) if the Licensing Authority  2[or the Controlling Authority] so directs and 
if  requested  by  the  licensee  who  had  also  furnished  prima  facie  reasons  for 
such directions, the licensee shall not sell or offer for sale any batch in respect 
of  which  a  sample  is  or  protocols  are  furnished  under  clause  (h)  until  a 
certificate  authorizing  the  sale  of  the  batch  has  been  issued  to  him  by  or  on 
behalf of the Licensing Authority 2[or the Controlling Authority; 

(j) the licensee shall on being informed by the Licensing Authority 2[or the 
Controlling Authority] that any part of any batch of the drug has been found by 
the Licensing Authority 2[or the Controlling Authority]not to conform with the 
standards  of  strength,  quality  or  purity  specified  in  these  rules  and  on  being 
directed so to do, withdraw the remainder of the batch from sale, and, so far as 
may in the particular circumstances of the case be practicable, recall all issues 
already made from that batch; 

(k) the licensee shall maintain an Inspection Book in Form 35 to enable an 

Inspector to record his impressions and the defects noticed; 

1[(l)  the  licensee  shall  maintain  reference  samples  from  each  batch  of  the 
drugs manufactured by him in a quantity which is at least twice the quantity of 
the  drug  required to  conduct all  the  tests  performed on  the  batch.   In  case  of 
drugs  bearing  an  expiry  date  on  the  label,  the  reference  samples  shall  be 
maintained for a period of three months beyond the date of expiry or potency. 
In  case of  drugs where no  date of expiry of  potency is  specified on the label, 
the reference samples shall be maintained for a period of three years from the 
date of manufacture;] 

2[(m)   the licensee, who has been granted a licence in Form 25F, shall- 

(i)     forward  to the licensing authority of the concerned States  of 
manufacture and  supply of  the  drug  a  statement of  the  sales  effected to 
manufacturers, wholesalers, retailers, hospitals, dispensaries and  nursing 
homes and Registered Medical Practitioners every three months; 

(ii)     maintain   accounts    of    all   transactions  giving    details    as 
indicated below in a register bound and serially page numbered and such 
records shall be retained for a period of five years or one year after the 
expiry of potency, whichever is later:- 

1.  Subs. by G.S.R. No. 444  dt. 31-3-1973. 
2. Ins. by G.S.R. No. 444  dt. 31-3-1973. 
3.  Ins. by G.S.R. 462 (E), dt. 22-6-1982.

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

A.   Accounts of   the drugs   specified   in   Schedule   X   used   for   the 
manufacture: 

1.    Date of issue. 

2.    Name of the drug. 

3.    Opening balance of stock on the production day. 

4.    Quantity received, if any, and source from where received. 

5.    Quantity used in manufacture. 

6.    Balance quantity on hand at the end of the production day. 

7.    Signature of the person in charge. 

B.  Accounts of production: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Quantity of raw material used in manufacture. 

5.    Anticipated yield. 

6.    Actual yield, 

7     Wastage, 

8.    Quantity of the manufactured goods transferred. 

C.  Accounts of the manufactured drugs: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Opening Balance. 

5.    Quantity manufactured. 

6.    Quantity sold. 

7.    Name of the purchaser and his address. 

8.    Balance quantity at the end of the day. 

9.    Signature of the person in charge. 

(n)  the  licensee shall  store  drugs specified in  Schedule X  in  bulk form 
and when any of such drug is required for manufacture in a place other than 
its  place  of  storage  it  shall  be  kept  in  a  separate  place  under  the  direct 
custody of a responsible person;] 

1[(o)   the  licensee  shall  comply  with  the  requirements  of   2[Good 
in  Schedule  L-I  and]  ‗Good 

Laboratory  Practices  as 
Manufacturing Practices‘ as laid down in Schedule M.] 

laid  down 

3[(p)  No  advertisement  of the  drugs  specified in  Schedule  H,  Schedule 
H1 and Schedule X shall be made except with the previous sanction of the 
Central Government.] 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
2.  Ins by G.S.R. 780 (E), dt. 10-11-2008. 
3. Ins by G.S.R. 289 (E), dt. 15-04-2015. 

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 Drugs and Cosmetics Rules 1945 

74A. Conditions  for  licence  in  Form  25B._  A  licence  in  Form  25B  shall  be 

subject to the conditions stated therein and to the following conditions:_

(a)  the repacking of drugs shall at all times be conducted under the personal 
supervision of  at  least  one  person who  is  approved as  a  competent person by 
the Licensing Authority; 

(b)  the licensee shall either provide and maintain adequate arrangements in 
his own premises for carrying out tests of the strength, quality and purity of the 
drugs  repacked  or  make  arrangements  with  some  institution  approved  by  the 
Licensing  Authority  3[under  Part  XV  (A)  of  these  rules]  for  such  tests  to  be 
regularly carried out on his behalf by the institution; 

(c)  the licensee shall make adequate arrangements for the storage of drugs; 

2[(d)  the licensee shall comply with the provisions of the Act and of these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules subsequently made under Chapter IV of the Act: 

Provided  that  where  such  further  requirements  are  specified  in  the  Rules, 
these  would  come  into  force  four  months  after  publication  in  the  Official 
Gazette.] 

(e)    the  licensee  shall  allow  any  4[Inspector  appointed  under  the  Act]  to 
enter  with  or  without  notice,  any  premises  where  the  packing  of  drugs  in 
respect of which the licence is issued is carried on, to inspect the premises and 
to take samples of repacked drugs; 

2[(f)  the licensee shall, either in his own laboratory or, in any other laboratory 
approved  by  the  Licensing  Authority,  test  each  batch  or  lot  of  raw  material 
used by     him for repacking and also each batch of the product thus repacked 
and  shall    maintain  records  or  registers  showing  the  particulars  in  respect  of 
such tests as  specified  in  Schedule  U.  The    records  or  registers  shall  be 
retained  for  a    period of five years from the date of repacking.  The licensee 
shall  allow  the  Inspector to  inspect all  registers and  records maintained under 
these rules and shall supply to the Inspector such information as he may require 
for  the  purpose  of  ascertaining  whether  the  provisions  of  the  Act  and  these 
rules have been observed;] 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1988. 
2.   Subs. by Notfn. No. F.1-20/64-D, dt. 26-10-1968. 
3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977. 
4. Subs. by G.S.R. 444 (E), dt. 31-3-1973.

98 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(g)   the licensee shall maintain an Inspection Book, in Form 35, to enable 

an Inspector  to record his impressions and the defects noticed;] 

2[(h)   the licensee shall maintain reference samples from each batch of the 

drugs manufactured by him in a quantity which is at least twice the quantity of 

the  drug  required to  conduct all  the  tests  performed on  the  batch.   In  case  of 

drugs  bearing  an  expiry  date  on  the  label,  the  reference  sample  shall  be 

maintained for a period of three months beyond the date of expiry of potency. 

In  case of  drugs where no  date of expiry of  potency is  specified on the label, 

the reference samples shall be maintained for a period of three years from the 

date of manufacture. 

4[(i) No advertisement of the drugs specified in Schedule H, Schedule H1 or 

Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 

Government.] 

3[74B.Conditions of licence in Form 25A. 

(1) The licence in Form 25A

shall  be  deemed  to  be  cancelled  or  suspended,  if  the  licence  owned  by  the 

licensee  in  Form  25,  whose  manufacturing facilities  have  been  availed  of  by 

the licensee, is cancelled or suspended, as the case may be, under these rules. 

(2)  The  licensee shall  comply  with  the  provisions of  the  Act  and  of  these  rules 

and  with  such  further  requirements  if  any,  as  may  be  specified  in  any  rules 

subsequently  made  under  Chapter  IV  of  the  Act;  provided  that  where  such  further 

requirements are specified in the rules, these would come into force four months after 

publication in the Official Gazette. 

(3) The licensee shall test each batch or lot of the raw material used by him for 

the  manufacture  of  his  products  and  also  each  batch  of  the  final  product  and  shall 

maintain  records  or  registers  showing  the  particulars  in  respect  of  such  tests  as 

specified in Schedule U.  The records or registers shall be retained for a period of five 

years from the date of manufacture.  The licensee shall allow an Inspector to inspect 

all registers and records maintained under these rules and shall supply to the Inspector 

such  information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 

provisions of the Act and these rules have been observed. 

1.  Ins. by Notfn. No. 1-14/68-D, dt. 26-10-1968. 
2.  Ins. by G.S.R. 444 (E) dt. 31-3-1973 . 
3.  Subs. by Notfn. No. F. 1-14/68-D, dt. the 26-10-1968. 
4.  Ins. by G.S.R. 289 (E) dt. 15-4-2015.

99 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

(4) The licensee shall either- 

(i)  provide  and  maintain  to  the  satisfaction  of  the  Licensing  Authority 
adequate  staff  and  adequate  laboratory  facilities  for  carrying  out  test  of  the 
strength, quality and purity of the substances manufactured by him, or 

(ii)  make  arrangements  with  some  institution  approved  by  the  Licensing 
Authority  7[under Part XV (A)  of  these  rules]  for  such  tests  to  be  regularly 
carried out on his behalf by the institution. 

1[(5)   The licensee shall maintain reference samples from each batch of the drugs 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  label  the  reference  samples  shall  be  maintained  for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry of potency is specified on the label, the reference samples shall be maintained 
for a period of three years from the date of manufacture.] 

2[(6)   The licensee shall  maintain an  Inspection Book in  Form 35  to  enable an 

Inspector to record his impressions and the defects noticed.] 

8[(7)  No  advertisement  of  the  drugs  specified  in  Schedule  H,  Schedule  H1  or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government.] 

3[75.   Form of  application for licence to  manufacture for sale or distribution of 
drugs specified in Schedules C and C(1) and X 4[excluding those specified in Part XB 
and Schedule X]._(1) Applications for the grant or renewal of licence to manufacture 
for sale or distribution of drugs specified in Schedules C and C(1)  4[excluding  those 
specified in  Part X-B  and  Schedule X],  shall  be  made to  the  Licensing Authority in 
Form 27 and 5[shall be made up to ten items for each category of drugs 6[referred to in 
Schedule  M  relating  to  pharmaceuticals  products  and  Schedule  M-III  relating  to 
medical devices and in-vitro diagnostics] and  shall  be  accompanied by  a  licence fee 
of rupees six thousand and an inspection fee of rupees one thousand and five hundred 
for every inspection or for the purpose of renewal of licences:] 

Provided that  if  the  applicant applies  for  renewal  of  licence  after  its  expiry  but 
within six months of such expiry, the fee payable for renewal of the licence shall be 
5[a  licence fee  of  rupees six  thousand plus an  additional fee  of  rupees one  thousand 
per  month  or  a  part  thereof  in  addition to  an  inspection fee  of  rupees  one  thousand 
and five hundred.] 

(2)  Application  for  grant  or  renewal  of  licence  to  manufacture  for  sale  or 
distribution  of  drugs  specified  in  Schedules  C,  C(1)  and  X  shall  be  made  to  the 
licensing  authority  in  Form  27-B,  and  5[shall  be  made  up  to  ten  items  for  each 
category  of  drugs   6[referred to in Schedule M relating to pharmaceuticals products 
and  Schedule M-III  relating  to  medical  devices  and  in-vitro  diagnostics]    and    shall  
be  accompanied  by  a  licence  fee  of  rupees  six  thousand  and  an  inspection  fee  of 
rupees one thousand five hundred for every inspection or for the purpose of renewal 
of licences]: 

1.  Ins. by G.S.R.. No. 444, dt. 28-4-1973.           7. Subs. by G.S.R. 1172(E), dt.  23-8-1977. 
2.  Ins. by G.S.R. 331 (E), dt. 8-5-1984.               8. Ins. by G.S.R. 289(E), dt.  15-4-2015. 
3.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
4.  Subs. by G.S.R. 28(E), dt.  22-1-1993. 
5.  Subs. by G.S.R. 601(E), dt. 24-8-2001. 
6.  Subs. by G.S.R. 640(E), dt. 29-6-2016.

100 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  that  the  applicant  shall  possess  a  licence  in  Form  28  to  manufacture 

such drugs: 

Provided further that  if  the  application for  renewal of  a  licence is  made after its 
expiry but within six months of such expiry, the fee payable for renewal of the licence 
shall  be  1[rupees  six  thousand  plus  an  additional  fee  of  rupees  one  thousand  per 
month  or  part  thereof  in  addition  to  an  inspection fee  of  rupees  one  thousand five 
hundred.] 

2[(3) The application for grant or renewal of licence to manufacture for sale or for 
distribution  of  drugs  in  4[Large  Volume  Parenterals,  Sera  and  Vaccine  and 
Recombinant DNA (r-DNA) derived drugs]  shall  be made  to  the licensing authority 
appointed under this Part in Form 27D and  1[shall be made up  to  ten  items for each 
category of drugs categorized in Schedule M and shall be  accompanied  by  a  licence 
fee  of  rupees  six  thousand  and  an  inspection  fee  of  rupees  one  thousand  five 
hundred for every inspection or for the purposes of renewal of licences:] 

Provided that  if  the  application for  renewal  of  a  licence is  made  after  its  expiry 
but within six months of such expiry, the fee payable for renewal of the licence 1[shall 
be rupees six thousand plus an additional fee of rupees one thousand per month or a 
part  thereof  in  addition  to  the  inspection  fee  of  rupees  one  thousand  and  five 
hundred.] 

1[(4) A fee of rupees one thousand shall be paid for duplicate copy of the licence 
issued  under  sub-rule  (1),  sub-rule  (2)  or  sub-rule  (3),  as  the  case  may  be,  if  the 
original licence is defaced, damaged or lost. 

(5) If the licensee applies for manufacture of more than ten items of each category 
of  drugs,  the  application  shall  be  accompanied  by  an  additional  fee  at  the  rate  of 
rupees  three  hundred  for  each  additional  item  of  drugs  5[referred to in Schedule M 
relating to pharmaceuticals products and Schedule M-III relating to medical devices 
and in-vitro diagnostics].] 

3[(6)  Where  an  application  under  this  Rule  is  for  the  manufacture  of  drug 
formulations falling under the purview of new drugs as defined in Rule 122-E, such 
application  shall  also  be  accompanied  with  approval,  in  writing,  in  favour  of  the 
applicant, from the licensing authority as defined in clause (b) of Rule 21.]] 

1.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
2.  Ins. by G.S.R. 119 (E), dt. 11-3-1996. 
3.  Ins. by G.S.R. 311 (E), dt. 1-5-2002. 
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 
5. Subs. by G.S.R. 640 (E), dt. 29-6-2016.

101 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 
1[75A.    Loan    licences.−(1)  Applications    for    the    grant    or    renewal    of    loan 
2[licences for  the  manufacture for  sale or  for  distribution] of  drugs specified in 
Schedules C and C(1) 3[excluding those specified in Part X-B and Schedule X] shall 
be made in Form 27-A to the licensing authority and  4[shall be   made upto ten items 
for  each  category  of  drugs  14[referred to in  Schedule  M relating  to  pharmaceuticals 
products and Schedule M-III relating to medical devices and in-vitro diagnostics] and 
shall be accompanied by a fee of rupees  six thousand and an inspection fee of rupees 
one thousand  and  five  hundred  for  every  inspection  or  for  the  purpose  of  renewal 
of licences:] 

5[Provided that if the applicant applies for the renewal of a licence after its expiry 
but within six months of such expiry the fee payable for renewal of the licence shall 
be 4[rupees six thousand and an inspection of fee of rupees one thousand five hundred 
plus an additional fee at the rate of rupees one thousand] per month or a part thereof.] 

11[Explanation. − For the purpose of this rule a loan licence means a licence which 
a licensing authority may issue to an applicant who intends to avail the manufacturing 
facilities owned by a licensee in Form 28.] 

12[(1A)   The application  for grant or renewal of loan license to manufacture for 
sale or  distribution of  drugs  in ‗Large Volume  Parenterals‘,  ‗Sera  and Vaccine‘ and 
‗Recombinant DNA (r-DNA) derived drugs‘ shall be made to the licensing authority 
appointed  under  this  Part,  in  Form  27DA  and  be  made  upto  ten  items  for  each 
category of drugs categorized in Schedule M and accompanied by a license fee of six 
thousand rupees and an inspection fee of one thousand five hundred rupees for every 
inspection or for the purpose of renewal of licenses: 

Provided that if the application for renewal of a license is made after its expiry but 
within six months of such expiry, the fee payable for renewal of the license shall be 
six thousand rupees plus an additional fee of one thousand rupees per month or a part 
thereof in addition to the inspection fee of one thousand and five hundred rupees;] 

(2)        The  licensing  authority,  shall,  before  the  grant  of  a  loan  licence,  satisfy 
himself  that  the  manufacturing  unit  has  adequate  equipment,  staff,  capacity  for 
manufacture and  facilities  for  testing  to  undertake the  manufacture on  behalf  of  the 
applicant for a loan licence. 

13[***] 
4[(3) Subject to the provisions of sub-rule (2), the application for manufacture of 
more than ten items of each category of drugs on a loan license, shall be accompanied 
by  an  additional  fee  at  the  rate  of  rupees  three  hundred  for  each  additional  item  of 
drugs. 

(4)    If the licensing authority is satisfied that a loan licence is defaced, damaged 
or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of 
loan licence.] 

6[*  *   *  *   *] 
7[76. 8[Forms of licence to manufacture drugs specified in Schedules C and C(1), 
9[excluding  those  specified  in  Part  XB  and  Schedule  X],  or  drugs  specified  in 
Schedules  C,  C(1)  and  X  and  the  conditions  for  the  grant  or  renewal  of  such 
licences.- 10[A licence to manufacture for sale or for distribution of drugs specified in 

1.  Ins. by F.1-16/57-D, dt. 15-6-1957. 
2.  Subs. by G.S.R 788 (E), dt. 10-10-1985. 
3.  Subs. by G.S.R 28 (E), dt. 22-1-1993. 
4.  Subs. by G.S.R 601 (E), dt. 24-8-2001. 
5.  Amended by S.O.2139 dt. 13-8-1972. 
6.  Rule 75B omitted by G.S.R. 944 (E), dt. 21-9-1988. 
7.  Amended by F- 1- /57-D, dt. 15-6-1969. 
8.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
9.  Subs. by G.S.R. 28 (E) , dt. 22.1.1993. 
10.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
11. Subs. by G.S.R. 724 (E), dt. 7-11-2013. 
12. Ins. by G.S.R. 574 (E) , dt. 17.7.2012.  
13. Proviso omitted by G.S.R. 574 (E) , dt. 17.7.2012. 
14. Subs. by G.S.R. 640 (E), dt. 29-06-2016.

102 

 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Schedules  C  and  C(1)  other  than  4[Large Volume  Parenterals, Sera and Vaccine 
and Recombinant DNA (r-DNA) derived drugs] specified in Part X B and Schedule 
X shall be issued in Form 28 and a licence to manufacture for sale or distribution of 
drugs specified under Schedules C and C(1) (other than 4[Large Volume  Parenterals, 
Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs]  specified in  Part 
X-B)  and  Schedule  X  shall  be  issued  in  Form  28B.  A  licence  to  manufacture  for 
sale  or  for  distribution  of  4[Large  Volume    Parenterals,  Sera  and  Vaccine  and 
Recombinant DNA (r-DNA) derived drugs] shall be issued in Form 28-D. Before a 
licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following 
conditions shall be complied with by the applicant:- 

(1)     The manufacture will be conducted under the active direction and personal 
supervision of  competent  technical  staff  consisting  at  least  of  one  person  who  is  a 
whole time employee and who is 

(a)  a  graduate in  Pharmacy or  Pharmaceutical  Chemistry of  1[a  University 
established  in  India  by  law  or  has  an  equivalent  qualification  recognized  and 
notified  by  the  Central  Government  for  such  purpose]  and  has  had  at  least 
eighteen  months‘  practical experience after  the  graduation in  the  manufacture 
of drugs to  which this licence applies; this period of experience may however 
be reduced by six months if the person has undergone training in manufacture 
of  drugs  to  which  the  licence  applies  for  a  period  of  six  months  during  his 
University course; or 

(b)  a  graduate  in  Science  of  1[a  University  established in  India  by  law  or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government for  such  purpose] who  for  the  purpose of  his  degree  has  studied 
Chemistry  3[or Microbiology] as a  principal subject and has had at  least  three 
years‘  practical  experience  in  the  manufacture  of  drugs  to  which  this  licence 
applies after his graduation; or 

(c) a  graduate in Medicine of  1[a  University established in  India by  law or 
has  an  equivalent  qualification  recognized  and  notified  by  the  Central 
Government  for  such  purpose]  with  at  least  three  years‘  experience  in  the 
manufacture  and  pharmacological  testing  of  biological  products  after  his 
graduation; or 

2[(d) a graduate in Chemical Engineering of a University recognised by the 
Central  Government  with  at  least  three  years‘  practical  experience  in  the 
manufacture of drugs to which this licence applies after his graduation; or 

(e)  holding  any  foreign  qualification the  quality  and  content  of  training  of 
which are comparable with those prescribed in clause (a), clause (b), clause (c) 
or  clause (d)  and  is  permitted to  work  as  competent technical staff under this 
Rule by the Central Government.] 

1.  Subs. by G.S.R. 71(E), dt. 30-1-1987. 
2.  Ins. by F.1-19/59-D, dt. 13-6-1967. 
3. Ins. by G.S.R. 245(E), dt. 3-2-1976. 
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 

103 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

Provided  that  any  person  who  was  approved  by  the  licensing  authority  as  an 
expert responsible for the manufacture of drugs for the purpose of rule 76 read with 
Rule 78 as these Rules were in force immediately before the 29th June, 1957, shall be 
deemed to be qualified for the purposes of this rule: 

1[Provided  that  for  the  drugs  specified  in  Schedules  C  and  C(1)  meant  for 
veterinary use, the whole time employee under whose supervision  the manufacture is 
conducted may be a graduate in Veterinary Science or general science or medicine or 
pharmacy of a University, recognized by the Central Government and who has had at 
least three years‘ experience in the manufacture of biological products: 

5[Provided  also  that  for  medical  devices,  the  whole  time  employee  under  whose 

supervision the manufacture or testing is conducted shall be—  

(i)  a  graduate  in  Pharmacy  or  Engineering  (in  appropriate  branch)  from  a 
University recognised by the Central Government for such purposes and has 
had  at  least  eighteen  months  practical  experience  in  the  manufacturing  or 
testing of devices to which this licence applies after his graduation; or  
(ii)  a  graduate  in  science,  from  a  University  recognised  by  the  Central 
Government for such purposes, with Physics or Chemistry or Microbiology 
as one of the subject and has had at least three years practical experience in 
the manufacturing or testing of devices to which this licence applies after his 
graduation; or  

(iii)  a diploma in Pharmacy or Engineering (in appropriate branch) from a Board 
or Institute recognised by the Central Government or the State Government, 
as the case may be, for such purposes and has had at least four years practical 
experience  in  the  manufacturing  or  testing  of  devices  to  which  this  licence 
applies after his diploma; or  

(iv)  having  a  foreign  qualification,  the  quality  and  content  of  training  of  which 
are comparable with those specified in clause (i), clause (ii) and clause (iii) 
and is permitted to work as competent technical staff under this rule by the 
Central Government.] 

6[(2) The applicant proposing to manufacture pharmaceutical products shall comply 
with the provisions referred to in Schedule M. 

(2A)  The  applicant  proposing  to  manufacture  medical  devices  and  in-vitro 
diagnostics  shall  comply  with  the  quality  management  system  as  referred  to  in 
Schedule M-III. 

(3)  The  applicant  shall  provide  adequate  space,  plant  and  equipment  for 
pharmaceutical products as referred to in Schedule M and for Medical devices and in-
vitro diagnostics as referred to in Schedule M-III.] 

3[(4)  The  applicant  shall  provide  and  maintain  adequate  staff,  premises  and 
laboratory equipment for carrying out such tests of the strength, quality and purity of 
the  substances as  may  be  required to  be  carried  out  by  him  under  the  provisions of 
Part  X  of  these rules  including proper housing for  animals used  for  the  purposes of 
such tests, the testing unit being separate from the manufacturing unit and the head of 
the testing unit being independent of the head of the manufacturing unit: 

Provided  that  the  manufacturing  units  which  before  the  commencement  of  the 
Drugs  and  Cosmetics  (Amendment)  Rules,  19774,  were  making  arrangements  with 
institutions  approved  by  the  Licensing  Authority  for  such  tests  to  be  carried  out  on 
their behalf may continue such arrangements upto the 30th June, 1977 : 

Provided further that  for tests  requiring sophisticated instrumentation techniques 
or  biological or  microbiological methods other than sterility the  Licensing Authority 
may  permit  such  tests  to  be  conducted  by  institutions  approved  by  it  2[under  Part 
XV (A) of these rules] for this purpose. 
1.  Ins. by F.1-6/62-D (SO 2889), dt. 2-7-1969. 
2.  Ins. by G.S.R 1172 (E), dt. 23-8-1977. 
3. Sub. by G.S.R 926 (E), dt. 24-6-1977. 
4. These rules came in to force on 28th May, 1977 vide G.S.R 665 (E), dt. 6-5-1977. 
5. Sub. by G.S.R 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R 109 (E), dt. 22-2-1994. 
6. Sub. by G.S.R 640 (E), dt. 29-6-2016.

104 

 
 
 
 Drugs and Cosmetics Rules 1945 

1[(4A)  The  head  of  the  testing  unit  referred  to  in  condition  (4)  shall  possess  a 
degree  in  Medicine  or  Science  or  Pharmacy  or  Pharmaceutical  Chemistry  of  a 
University  recognized  for  this  purpose  and  shall  have  experience  in  the  testing  of 
drugs, which in the opinion of the Licensing authority is considered adequate.] 

(5)  The  applicant  shall  make  adequate  arrangements  for  the  storage  of  drugs 

manufactured by him. 

2[(6)   The applicant shall furnish to the Licensing Authority, if required to do so, 
data  on  the  stability  of  drugs  which  are  likely  to  deteriorate  for  fixing  the  date  of 
expiry which shall be printed on the labels of such drugs on the basis of the data so 
furnished.] 

3[(7)  The  applicant  shall,  while  applying  for  licence  to  manufacture  patent  or 
proprietary medicines, furnish to the Licensing Authority evidence and data justifying 
that the patent or proprietary medicines− 

(i) contain the constituent ingredients in therapeutic/prophylactic quantities 
as determined in relation to the claims or conditions for which the medicines are 

recommended for use or claimed to be useful; 

(ii)    are  safe  for  use  in  the  context  of  the  vehicles,  excipients,  additives  and 
pharmaceutical  aids  used  in  the  formulations  and  under  the  conditions  in  which  the 
formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; 

(iv)  contain  such  ingredients  and    in    such  quantities  for    which  there    is 

therapeutic   justification.;] and 

4[(v) have the approval, in writing, in favour of the applicant to manufacture drug 
formulations falling under the purview of new drug as defined in Rule 122E, from the 
licensing authority as defined in clause (b) of rule 21.] 

5[(8)  The licensee of pharmaceutical products shall comply with the requirements 
of  ‗Good  Manufacturing  Practices‘  as  laid  down  in  Schedule  M  and  the  licensee  of 
Medical  Devices  and  in-vitro  diagnostics  shall  comply  with  the  requirements  of 
―Quality Management System‖ as laid down in Schedule M-III..] 

1.  Ins. by G.S.R 681 (E), dt. 5-12-1980. 
2.  Ins. by G.S.R 444 dt. 31-3-1973. 
3.  Ins. by G.S.R 515 dt. 24-3-1976. 
4.  Ins. by G.S.R 311 (E), dt. 1-5-2002. 
5.  Subs. by G.S.R 640 (E), dt. 29-06-2016. Previously Ins. by G.S.R 735 (E), dt. 24-6-1988.

105 

 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Explanation:-  For  the  purpose  of  this  rule,  6[―Large  Volume  Parenterals‖  sera  and 
vaccines  and  recombinant  DNA  (r-DNA)  derived  drugs,]  shall  mean  the  sterile  solutions 
intended for parenteral administration with a volume of 100 ml. or  more (and shall include 
anti-coagulant  solutions) in  one container of the finished dosage form intended for single 
use.] 
      7[(9)  The  applicant  shall  make  application  for  grant  of  licence  for  a  drug  formulation 
containing single active ingredient only in proper name.] 

2[76A.    Forms    of  loan  licenses  to  manufacture  for  sale  or  for  distribution  drugs 
specified in Schedule C and C(1) excluding drugs specified in Schedule X or of Large 
Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, 
and conditions for the grant or renewal of such license.— A loan license to manufacture 
for sale or for distribution of drugs specified in Schedules C and C(1), excluding  drugs specified 
in  Schedule  X,  and  Large  Volume    Parenterals,  Sera  and  Vaccine  and  Recombinant    DNA(r- 
DNA)  derived  drugs  specified  in  Part  XB  shall  be  issued  in  Form  28A  and  a  loan  license  to 
manufacture  for  sale  or  for  distribution  of  Large  Volume    Parenterals,  Sera  and  Vaccine  and 
Recombinant  DNA (r-DNA) derived drugs shall be issued in Form 28DA, and the applicant shall, 
while  applying  for  a  licence  to  manufacture  patent  or  proprietary  medicines,  furnish  to  the 
Licensing Authority evidence and data justifying that the patent or proprietary medicines-  

(i) contain  the constituent  ingredients  in  therapeutic/prophylactic quantities  as 
determined  in  relation  to  the  claims  or  conditions  for  which    the  medicines  are 
recommended for use or claimed to be useful; 

(ii) are safe for use in the context of the vehicles, excipients, additives and 
pharmaceutical  aids  used  in  the  formulations,  and  under  the  conditions  in 
which the formulations for administration and use are recommended; 

(iii) are stable under the conditions of storage recommended; and 

(iv)  contain  such  ingredients  and  in  such  quantities  for  which  there  is 

therapeutic justification.] 

7[Provided that the application for grant of a licence for a drug formulation 

containing single active ingredient shall be made only in proper name.] 

3[77.  Duration  of  licence. 
Form  28D  or  renewed  licence  in  Forms  26,  26F,  and  Form  26H],  unless  sooner 
suspended or cancelled shall be 5[valid  for a period of five years on and from the date 
on which] it is granted or renewed: 

An  original  licence  in  4[Form  28,  Form  28B  and

1.  Ins. by G.S.R. 119 (E), dt. 11-3-1996. 
2.  Subs. by G.S.R. 574 (E), dt. 17-7-2012.Earlier Subs. by G.S.R. 788 (E), dt. 10-10-1985 and Subs. by G.S.R. 

462 (E), dt. 22-6-1982. 

3.  Amended by No. G.1-10/62-D, dt. 10-4-1964. 
4.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
5.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
6. Subs. by G.S.R. 26 (E), dt. 19-1-2006. 
7. Ins. by G.S.R. 570 (E) dt. 7-8-2014. 

106 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[Provided that if the application for the renewal of a  licence is  made before its 
expiry, or if the application is made  within  six months of its  expiry  after  payment 
of   additional fee, the licence shall continue to be in force until orders are passed on 
the application and the licence shall be deemed to have expired if the application for 
its renewal is not made within six months of its expiry.]] 

2[78.  Conditions  of  licence.−A  licence  in  3[Form  28,  Form  28B  or  Form  28D] 
shall  be  subject  to  the  special  conditions,  if  any,  set  out  in  Schedule  F  or 
ScheduleF(1), as the case may  be, which relate  to the substance in  respect of which 
the licence

is granted and to the following general conditions:−

(a)  (i)  The  licensee  shall  provide  and  maintain  an  adequate  staff  and 
adequate  premises  and  plant  for  the  proper  manufacture  and  storage  of  the 
substances in respect of which the licence is issued; 

(ii) Without prejudice to the generality of the foregoing requirement, every 
holder of a licence who for any purpose engaged in the culture or manipulation 
of  pathogenic  spore-bearing  micro-organisms shall  provide  to  the  satisfaction 
of  the  Licensing  Authority  separate  laboratories  and  utensils  and  apparatus 
required  for  the  culture  or  manipulation  of  such  micro-organisms,  the 
laboratories,  utensils  and  apparatus  so  provided  not  being  used  for  the 
manufacture of any other substance; 

4[(b) The licensee shall provide and maintain staff, premises and equipment 

as specified in Rule 76;] 

5[(c)(i)  The  licensee  shall  maintain  records  of   manufacture  as  per 

particulars given in Schedule U; 

(ii)  The  licensee  shall  either  in  his  own  laboratory  or  in  any  laboratory 
approved  by  the  Licensing  Authority  6 [ under  Part  XV  (A)  of  these  rules] 
test each  batch or  lot  of  the  raw  material  used by  him  for  the  manufacture of 
his product and also each batch of the final product and shall maintain records 
or registers  showing  the  particulars  in  respect  of  such  tests  as  specified  
in Schedule  U.    The  records  or  registers  shall  be  retained  in  the  case  of  
a substance for  which  a  potency  date  is  fixed  for  a  period  of  two  years  from 
the expiry  of  such  date,  and  in  the  case  of  other  substances  for  a  period  of 
five years from the date of manufacture;] 

(d)  The  licensee  shall  allow  an  7[Inspector  appointed  under  the  Act]  to 
enter,  with  or  without  prior  notice,  any  premises  where  the  manufacture  is 
carried on  and  to inspect the premises, and in the case of substances specified 
in Schedules C  and C(1), to  inspect the  plant  and  the  process of  manufacture 
and the means employed for standardizing and testing the substance;] 

1.  Amended by S.O. 2139 dt. 12-8-1972. 
2.  Amended by F.1-6/62-B, dt. 2-6-1969. 
3.  Subs. by G.S.R. 119 (E), dt. 11-3-1996. 
4.  Amended by F.1-16/57-D (SO 2136), dt. 15-6-1957. 
5.  Amended by F.1-20/64-D (SO 3868), dt. 26-10-1968. 
6. Ins. by G.S.R. 1172 (E), dt. 23-8-1977. 
7. Subs. by G.S.R. 444 (E), dt. 31-3-1973.

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 Drugs and Cosmetics Rules 1945 

(e)  The  licensee  shall  allow  an  1[Inspector  appointed  under  the  Act]  to 
inspect  all  registers  and  records  maintained  under  these  Rules  and  to  take 
samples  of the  manufactured product  and  shall  supply  to  such  Inspector  such 
information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 
provisions of the Act and Rules thereunder have been observed;] 

(f)  The  licensee  shall  from  time  to  time  report  to  the  Licensing  Authority 
any changes in the expert staff responsible for the manufacture or testing of the 
substance  and  any  material  alterations  in  the  premises  or  plant  used  for  that 
purpose  which  have  been  made  since  the  date  of  the  last  inspection  made  on 
behalf of the Licensing Authority before the issue of the licence; 

1[(g)  The  licensee  shall  on  request  furnish  to  the  Licensing  Authority, 
Controlling Authority or  to  such  authorities as  the  Licensing Authority or  the 
Controlling  Authority  may  direct,  from  every  batch  of  drug  as  the  Licensing 
Authority or the Controlling Authority may from time to time specify, a sample 
of  such  quantity  as  may  be  considered  adequate  by  such   Authority  for  any 
examination and, if  so  required, also  furnish, full  protocols of  the  tests  which 
have been applied;] 

2[(h) If the Licensing Authority or the Controlling Authority so  directs, the 
licensee shall not sell or offer for sale any batch in respect of which a sample 
is,  or  protocols  are  furnished  under  the  last  preceding  sub-paragraph  until  a 
certificate  authorising  the  sale  of  the  batch  has  been  issued  to  him  by  or  on 
behalf of the Licensing Authority or the Controlling Authority;] 

1[(i) The licensee shall on being informed by the Licensing Authority or the 
Controlling  Authority  that  any  part  of  any  batch  of  the  substance  has  been 
found by the Licensing Authority or the Controlling Authority not to conform 
with the standards of strength, quality or purity specified in these rules and on 
being directed so to do, withdraw the remainder of that batch from sale and so 
far as  may  in  the particular circumstances of the case be practicable recall  all 
issues already made from that batch;] 

(j)  No  drug  manufactured  under  the  licence  shall  be  sold  unless  the 
precautions  necessary  for  preserving  its  properties  have  been  observed 
throughout the period after manufacture; 

3[(k) The licensee shall comply with the provisions of the Act and of these 
rules  and  with  such  further  requirements,  if  any,  as  may  be  specified  in  any 
rules  subsequently  made  under  Chapter  IV  of  the  Act,  provided  that  where 
such  further  requirements  are  specified  in  the  rules,  these  would  come  into 
force four months after publication in the Official Gazette;] 

1.  Subs. by G.S.R 444, dt. 28-4-1973. 
2. Amended by F.1-16/57-D, dt. 15-6-1957. 
3. Amended by F.1-14/68-B (SO 3868), dt. 26-10-1968.

108 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Drugs and Cosmetics Rules 1945 

1[(l)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impression and defects noticed.] 

2[(m) The licensee shall maintain reference samples from each batch of the drugs 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  label,  the  reference  samples  shall  be  maintained  for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry is specified on the label the reference samples shall be maintained for a period 
of three years from the date of manufacture.] 

3[(n) The licensee, who has been granted a license in Form 28B shall−

(i)   forward     to   the   licensing  authority  of   the   concerned  States     of 
manufacture  and    supply  of  the  drug  a  statement  of  the  sales  effected  to 
manufacturers,  wholesalers,    retailers,    hospitals,    dispensaries    and    Nursing 
Homes and Registered Medical Practitioners every three months; 

(ii)  maintain accounts of  all  transactions giving details as  indicated below 
in  a  register  bound  and  serially  page  numbered  and  such  records  shall  be 
retained  for  a  period  of  five  years  or  one  year  after  the  expiry  of  potency, 
whichever is later. 

A.     Accounts of the drugs specified in Schedule X used for the manufacture:- 

1.    Date of issue. 

2.    Name of the drug. 

3.    Opening balance of stock on the production day. 

4.    Quantity received, if any, and source from where received. 

5.    Quantity used in manufacture. 

6.    Balance quantity on hand at the end of the production day. 

7.    Signature of the person in charge. 

1.  Subs. by F.1-14/68-B (SO3868), dt. 26-10-1968. 
2.  Ins. by G.S.R. 444, dt. 28-4-1973. 
3.  Ins. by G.S.R. 462 (E), dt. 22-6-1982.

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 Drugs and Cosmetics Rules 1945 

B.   Accounts of Production: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Quantity of raw material used in manufacture. 

5.    Anticipated yield. 

6.    Actual yield. 

7     Wastage. 

8.    Quantity of the manufactured goods transferred.  

C.   Accounts of the manufactured drugs: 

1.    Date of manufacture. 

2.    Name of the drug. 

3.    Batch Number. 

4.    Opening Balance. 

5.    Quantity manufactured. 

6.    Quantity sold. 

7.    Name of the purchaser and his address. 

8.    Balance quantity at the end of the day. 

(o)  The  licensee  shall  store  drugs  specified  in  Schedule  X  in  bulk  form 
and when any of such drug is required for manufacture in a place other than its 
place of storage it shall be kept in a separate place under the direct custody of a 
responsible person.] 

1[(p)   The   licensee   shall   comply   with   the   requirements   of  3[‗Good 
Manufacturing Practices‘ as laid down in Schedule L-1 and Good Manufacturing 
Practices‘ as laid down in Schedule M.] 

4[(q) No advertisement of the drugs specified in Schedule H, Schedule H1 or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government.] 

2[78A.  Conditions  of  license  in  5[Form  28A  or  Form  28DA]-  (1)  The  license  in 
5[Form  28A  of  Form  28DA]  shall  be  deemed  to  be  cancelled  or  suspended,  if  the 
licence  owned  by  the  licensee  in  6[5[Form  28  or  Form  28D]  whose  manufacturing 
facilities  have  been  availed of  by  the  licensee is cancelled or suspended, as the case 
may be, under these rules. 

1.  Ins. by G.S.R. 735 (E), dt. 24-6-1998. 
2.  Amended by F.1-14/68-D (S.O. 3868), dt. 26-10-1968. 
3. Ins. by G.S.R. 780 (E), dt. 10-9-2008. 
4. Ins. by G.S.R. 289 (E), dt. 15-4-2015. 
5. Subs. by G.S.R. 574 (E), dt. 17-7-2012. 
6. Subs. by G.S.R. 592 (E), dt. 13-8-2008. 

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(2) The  licensee  shall  comply with  the  provisions of  the  Act,  and  of  these  rules 
and  with  such  further  requirements  if  any,  as  may  be  specified  in  any  rules 
subsequently  made  under  Chapter  IV  of  the  Act,  provided  that  where  such  further 
requirements are specified in the rules, those would come into force four months after 
publication in the Official Gazette. 

(3)     The licensee shall test each batch or lot of the raw material used by him for 
the  manufacture  of  his  products  and  also  each  batch  of  the  final  product  and  shall 
maintain  records  or  registers  showing  the  particulars  in  respect  of  such  tests  as 
specified  in  Schedule  U.      Records  or  registers  shall  be  retained,  in  the  case  of  a 
substance for which a potency date is fixed, for a period of two years from the expiry 
of  such date and in the case of  other substances, for a  period of  five years from the 
date of manufacture.  The licensee shall allow an Inspector to inspect all registers and 
records  maintained  under  these  rules  and   shall   supply  to   the   Inspector  such 
information as he may require for the purpose of ascertaining whether the provisions 
of the Act and these rules have been observed. 

(4)     The licensee shall either (i) provide and maintain to the satisfaction of the 
Licensing Authority adequate staff and adequate laboratory facilities for carrying out 
tests of the strength, quality and purity of the substances manufactured by him, or (ii) 
make  arrangements  with  some  institution  approved  by  the  Licensing  Authority  for 
such tests to be regularly carried out on his behalf by the institution.] 

1[(5)   The licensee shall furnish to the Licensing Authority, if required to do so, 
data  on  the  stability  of  drugs  which  are  likely  to  deteriorate  for  fixing  the  date  of 
expiry which would be printed on the labels of such drugs on the basis of the data so 
furnished.] 

2[(6)  The  licensee  shall  maintain reference samples  from  each  batch  of  the  drug 
manufactured  by  him  in  a  quantity  which  is  at  least  twice  the  quantity  of  the  drug 
required to conduct all the tests performed on the batch.   In case of drugs bearing an 
expiry  date  on  the  labels,  the  reference samples  shall  be  maintained for  a  period  of 
three months beyond the date of expiry of potency.  In case of drugs where no date of 
expiry of potency is specified on the label, the reference samples shall be maintained 
for a period of three years from the date of manufacture.] 

3[(7)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

4[(8)  No  advertisement  of  the  drugs  specified  in  Schedule  H,  Schedule  H1  or 
Schedule  X  shall  be  made  except  with  the  previous  sanction  of  the  Central 
Government. 

5[79. Inspection  before  grant or  renewal  of  licence.−Before a licence  under 

1. 
Ins. by G.S.R. 444, dt. 28-4-1973. 
2.  Subs. by G.S.R. 574 (E), dt. 17-7-2012. 
3. 
Ins. by G.S.R. 331 (E), dt. 8-5-1984. 
4. 
Ins. by G.S.R. 289 (E), dt. 15-4-2015. 
5.  Subs. by G.S.R. 923 (E), dt. 14-12-1992.

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this Part is granted or renewed the Licensing Authority or Central Licence Approving 
Authority,  as   the   case   may   be,     shall   cause   the   establishment  in   which   the 
manufacture is  proposed to  be conducted or being conducted to be inspected by  one 
or  more  Inspectors  appointed  under  this  Act  with  or  without  an  expert  in  the 
concerned  field.  The  Inspector  or  Inspectors  shall  examine  all  portions  of  the 
premises, plant and appliances and also inspect   the process of manufacture intended 
to  be  employed or  being  employed along  with   the  means  to  be  employed or  being 
employed  for  standardizing  and  testing  the  drugs  to  be  manufactured  or  being 
manufactured and enquire into the professional qualifications of the technical staff to 
be employed. He shall also examine and verify the statements made in the application 
in  regard to  their  correctness, and  the capability of  the  applicant to  comply with  the 
requirements  of  competent  technical  staff,  manufacturing  plants,  testing  equipments 
and  the  ‗Requirements of  Good  Manufacturing Practices‘  and  the  ‗Requirements of 
Plant  and  Equipment‘  as  laid  down  in  Schedule  M  read  with  the  Requirements  of 
Maintenance of Records as laid down in Schedule U.] 

1[80.  Report  by  Inspector.−The  Inspector     shall  forward  a  detailed  descriptive 
report    giving    his    findings   on    each    aspect   of    inspection   along    with   his 
recommendations after completion of his inspection in accordance with the provisions 
of  Rule  79,  to  the  Licensing  Authority  or  Central  Licence  Approving  Authority,  as 
the case may be.] 

81.  Procedure  of  Licensing  Authority.−(1) If  the  Licensing  Authority  5[or 
Central Licence Approving Authority, as the case may be,] after such further enquiry, 
if  any,  as  he  may  consider necessary, is  satisfied that  the  requirements of  the  Rules 
under the Act have been complied with and that the conditions of the licence and the 
Rules under the Act will be observed, he 2[shall issue a licence  under this Part]. 

(2)     If the Licensing Authority 5[or Central Licence Approving Authority, as the 
case  may  be,] is  not  so  satisfied, he  shall reject  the  application and  shall inform the 
applicant  of  the  reasons  for  such  rejection  and  of  the  conditions  which  must  be 
satisfied before a licence can be granted and shall supply the applicant with a copy of 
the inspection report. 

3[82. Further application after rejection. −If  within a period of six months from 
the  rejection  of  an  application  for  a  licence  the  applicant  informs  the  Licensing 
Authority  5[or  Central  Licence  Approving  Authority,  as  the  case  may  be,]  that  the 
conditions  laid  down  have  been  satisfied  and  deposits  an  inspection  4[fee  of  rupees 
two  hundred  and  fifty]  the  Licensing  Authority  5[or  Central  Licence  Approving 
Authority, as the case may be,] may, if after causing a further inspection to be made, 
he is satisfied that the conditions for the grant of a licence have been complied with, 
5[in respect of drugs notified under Rule 68-A] issue a licence in Form 28 2[or Form 
28-B]. 

1. Subs. by G.S.R. 923 (E), dt. 14-12-1992. 
2.  Ins. by G.S.R. 462 (E), dt. 22-6-1982. 
3.  Ins. by F.1-16/57-D, dt. 15-6-1957. 
4.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
5. Ins. by G.S.R. 923 (E), dt. 14-12-1992.

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83.    Renewal.−On  application  being  made  for  renewal,  the  licensing  authority 
may cause an inspection to be made and, if satisfied that the condition of the licence 
and the Rules under the Act are, and will continue to be observed, 1[he shall prepare a 
report to that effect in respect of those drugs which have been notified by the Central 
Government under Rule 68-A and forward it along with the application to the Central 
Licence  Approving  Authority],  and  shall  issue  a  certificate  of  renewal  3[under  this 
Part]. 

3[83-A.    Certificate of renewal of a loan licence.−The certificate of renewal of a 
loan licence in 8[Form 28A or Form 28DA] shall be issued in Form 26A or Form 26J 
respectively.] 

4[83-AA.   Duration of loan licence.−An original loan licence in  8[Form 28A or 
Form  28DA]  or  a  renewed  loan  licence  in  8[ Form  26A  or  Form  J],  unless  sooner 
suspended  or  cancelled,  shall  be  5[valid  for  a  period  of  five  years  on  and  from  the 
date on which] it is granted or renewed: 

6[Provided that if the application for the renewal of a  licence is  made before its 
expiry, or if the application is made within six months of its expiry, after payment of 
the additional fee, the licence shall continue to be in force until orders are passed on 
the application and the licence shall be deemed to have expired if the application for 
its renewal is not made within six months of its expiry].] 

84.   The provisions of this Part shall apply to the manufacture of drugs for sale 

notwithstanding that such drugs are manufactured for sale outside India. 

7[6[84-A.    Provision for appeal to the State Government or Central Government 

by  party  whose  licence  has  not  been  granted  or  renewed.−   
Any person who is aggrieved by the order passed by the Licensing Authority   or the 
Central Licence Approving Authority, as the case may be, refusing to 2[grant or renew 
a licence under this Part], may  within thirty  days  from  the  date of  receipt of such 
order,  appeal  to  the  State  Government  or  Central  Government,  as  the  case  may 
be,  and  the  State Government  or  the  Central  Government may,  after such  enquiry 
into  the  matter,] as  is  considered  necessary  and  after  giving  the  said  person  an  
opportunity    for  representing his views, may pass such order in relation thereto as it 
thinks fit.] 

1.  Ins. by G.S.R. 923 (E), dt. 14-12-1992. 
2.  Subs. by G.S.R. 119 (E), dt. 11-3-1996.. 
3.  Ins. by F1-16/57-B, dt. 15-6-1957. 
4.  Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964. 
5.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
6.  Subs. by S.O. 2139, dt. 12-8-1972. 
7.  Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993. 
8. Subs. by G.S.R. 574 (E), dt. 17-5-2012. 

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6[84AA.  Additional information to  be  furnished  by  an  applicant for  licence  or  a
licensee  to  the  licensing authority.   The  applicant  for  the  grant  of  a  licence  or  any
person  granted  a  licence  under  this  Part  shall,  on  demand,  furnish  to  the  Licensing 
Authority, before the grant of the licence or during the period the licence is in force, 
as the case may be, documentary evidence in respect of the ownership or occupation 
on rental or other basis of the premises, specified in the application for licence or in 
the  licence granted, constitution of  the  firm or  any  other relevant matter  which may 
be required for the purpose of verifying the correctness of the statements made by the 
applicant or the licensee, while applying for or after obtaining the licence, as the case 
may be.] 

1[84B.    Prohibition for the manufacture for sale of cyclamates and preparations
containing   cyclamates.  No   person   shall   manufacture   for   sale   cyclamates   and
preparations containing cyclamates.] 

2[85.   Cancellation   and   suspension   of   licences.  (1)   The   Central   Licence
Approving Authority may, after giving the licensee an opportunity to show cause why 
such an order should not be passed, by an order in writing stating the reasons therefor, 
cancel a  licence issued under this Part, or suspend it  for such period as he thinks fit 
either  wholly  or  in  respect  of  any  of  the  drugs  to  which  it  relates  3[or  direct  the 
licensee  to  stop  manufacture,  sale  or  distribution  of  the  said  drugs  and  4[thereupon 
order the destruction of drugs and] the stock thereof in the presence of  an Inspector], 
if in his opinion, the licensee has failed to comply with any  of the conditions of the 
licencee or with any provisions of the Act or rules made thereunder. 

(2)     The Licensing Authority may, for such licences granted or renewed by him, 
after giving the licensee an opportunity to show cause why such an order should not 
be passed, by an order in writing stating the reasons therefor, cancel a licence issued 
under  this  Part  or  suspend  it  for  such  period  as  he  thinks  fit,  either  wholly  or  in 
respect of  some of  the substances to  which it  relates,  3[or direct the licensee to stop 
manufacture,  sale  or  distribution  of  the  said  drugs  and  4[thereupon  order  the 
destruction of drugs and] the stock thereof in the presence of   an Inspector] if, in his 
opinion, the licensee has failed to comply with any of the conditions of the licence or 
with any provisions of the Act or rules made thereunder.] 

5[(3)  A  licensee  whose  licence  has  been  suspended  or  cancelled  by  the  Central 
Licence Approving Authority or  Licensing Authority under sub-rule (1) or   sub-rule 
(2), as  the case may be, may within ninety days of the receipt of a copy of the order 
by  him prefer an  appeal to  the Central Government or  the  State Government, as  the 
case may be, and the Central Government or the State Government may after giving 
the licensee an opportunity of being heard, confirm, reverse or modify such order.] 

1.  Ins. by  S.O.2358, dt. 26-8-1972. 
2.  Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993. 
3.  Ins.  by G.S.R. 20 (E), dt. 11-1-1996. 
4. Ins. by (Corrigenda) G.S.R. 514 (E), dated 5.11.1996. 
5. Ins. by 615 (E), dt. 9-8-1994 as corrected by G.S.R. 55 (E), dt. 7-2-1995. 
6. Ins. by S.O. 2139, dt. 5-6-1972.

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1[PART VIIA 
2[MANUFACTURE  FOR  SALE  OR  FOR DISTRIBUTION] 
OF HOMOEOPATHIC  MEDICINES 

85A . Manufacture   on   more   than   one   set   of   premises. 

 If   Homoeopathic

medicines are manufactured in more than one set of premises a separate application 

shall be made and a separate licence shall be obtained in respect of each such set of 

premises. 

85B.  Application   for   licence   to   manufacture   Homoeopathic   medicines.  (1)
Application  for  grant  or   renewal  of   2[licence  to   manufacture  for  sale   or   for 

distribution]  of  Homoeopathic  medicines  shall  be  made  to  the  Licensing  Authority 

appointed  by  the  State  Government  for  the  purpose  of  this  Part  (hereinafter  in  this 

Part referred to as the Licensing Authority) and shall be made in Form 24-C. 

3[(2)   The application in Form 24-C shall be accompanied– 

(a)   by   a   fee   of   4[rupees   two   hundred]   for   the   manufacture   of 

Homoeopathic  mother  tinctures  and  potentised  preparations and  an  inspection 
fee of 4[rupees one hundred] for the first inspection or  4[rupees fifty] in case of 

inspection for renewal of licence; 

(b) by a fee of 4[rupees two hundred] for the manufacture of Homoeopathic 
potentised preparations only, and an inspection fee of 4[rupees one hundred] for 
the  first  inspection  or  4[rupees  fifty]  in  case  of  inspection  for  renewal  of 

licence; 

(c)  by  a  fee  of  4[rupees  two  hundred]  for  the  manufacture  of  potentised 

preparations from back potencies by  pharmacies which are already licensed to 
sell  Homoeopathic  medicines  by  retail  and  an  inspection  fee  of  4[rupees  one 
hundred]  for  the  first  inspection  or  4[rupees  fifty]  in  case  of  inspection  for 

renewal of licence. 

1.  Ins. under G.S.R. 1185 (E), dt. 18-8-1964. 
2.  Sub. by G.S.R. 788 (E), dt. 10-10-1985. 
3.  Sub. by G.S.R. 245, dt. 11-2-1976. 
4.  Subs. by G.S.R. 601 (E), dt. 24-8-2001.

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1[(3)  If  a  person  applies  for  renewal  of  a  licence  after  its  expiry  but  within  six 

months of such expiry, the fee payable for the renewal of such a licence shall be_

(a)  2[rupees  two  hundred]  plus  an  additional  fee  at  the  rate  of  2[rupees 
one hundred] per month or part thereof and an inspection fee of  2[rupees fifty] 
for  the  manufacture  of  Homoeopathic  mother  tinctures  and  potentised 
preparations; 

4[(b)2[rupees  two  hundred] plus  an  additional fee  at  the  rate  of  2[rupees 
one hundred] per month or part thereof and an inspection fee of  2[rupees fifty] 
for the manufacture of Homoeopathic  potentised preparations only;] 

(c) 2[rupees two hundred] plus an additional fee at the rate of 2[rupees one 
hundred] per month or part thereof and an inspection fee of  2[rupees fifty] for 
the manufacture of Homoeopathic mother tinctures and potentised preparations 
from  back  potencies  by  pharmacies  who  are  already  licensed  to  sell 
Homoeopathic medicines by retail.] 

(4) A fee of 2[rupees fifty] shall be paid for a duplicate copy of the licence for the 
manufacture  of  Homoeopathic  mother  tinctures  and  potentised  preparations  issued 
under sub-rule (1) if the original is defaced, damaged or lost,  while the fee to be paid 
for  such  a  duplicate  copy  of  the  licence  for  the  manufacture  of  Homoeopathic 
potentised preparations only shall be 2[rupees fifty]. 

3[(5)  Applications by  licensee  to  manufacture additional items  of  Homoeopathic 
medicines  shall  be  made  to  the  Licensing  Authority  and  such  applications  shall  be 
accompanied by a fee of 2[rupees fifty] for each additional item.] 

85C.  Application  to  manufacture ‗New  Homoeopathic  medicines.‘ 

Subject  to

the other provisions of these Rules 

(1) no ‗New Homoeopathic medicine‘ shall be  manufactured unless it  is 

previously approved by the Licensing Authority mentioned in Rule 21; 

(2)  the  manufacturer  of  ‗New  Homoeopathic  medicine‘,  when  applying 
to  the  Licensing  Authority  mentioned  in  sub-rule  (1)  shall  produce  such 
documentary and other evidence as may be required by the Licensing Authority 
for  assessing  the  therapeutic  efficacy  of  the  medicine  including  the  minimum 
provings carried out with it. 

1.  Subs. by G.S.R. 245, dt. 3-2-1976. 
2.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
3.  Ins. by G.S.R. 13 (E), dt. 7-1-1983. 
4. Subs. by G.S.R. 779 (E), dt. 18-7-1980.

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 Drugs and Cosmetics Rules 1945 

(3)     While  applying  for  a  licence  to   manufacture  a   ‗New  Homoeopathic 
medicine‘  an  applicant  shall  produce  along  with  his  application  evidence  that  the 
‗New Homoeopathic medicine‘ for the manufacture of which application is made has 
already been approved. 

Explanation.−The term ‗New Homoeopathic medicine‘ in this rule shall have the 

same meaning as in rule 30AA. 

1[85D.  Form  of  licence  to  manufacture  Homoeopathic  medicines.—Licence  for 
manufacture  of  Homoeopathic  medicines  is  a  licence  to  manufacture  potentised 
preparations  from  back  potencies  by  Pharmacies  who  are  already  licensed  to  sell 
Homoeopathic medicines by retail and shall be granted in Form 25C.] 

85E. Conditions  for  the  grant  or  renewal  of  a  licence  in  Form  25C−Before  a 
licence in Form 25C is granted or renewed the following conditions shall be complied 
with by the applicant:— 

(1) The manufacture of Homoeopathic medicines shall be conducted under the 
direction  and  supervision of  competent technical  staff  consisting  at  least  of  one 
person who is a whole time employee 2[and who is— 

(a)  a  graduate in  Science with  Chemistry as  one of  the  subjects with three 

years‘ experience in manufacture of Homoeopathic Medicines; or 

(b) a graduate in Pharmacy with 18 months of experience in the manufacture 

of Homoeopathic medicines; or 

(c)  holds  qualification  as  defined  under  sub-clause  (g)  of  clause  (1)  of 
section  2  of  Homoeopathy  Central  Council  Act,  1973  (59  of  1973)  with  18 
months of experience in the manufacture of Homoeopathic medicines: 

Provided that  the  persons who are  already in  employment with five years‘ 
experience  in  the  manufacture  of  Homoeopathic  medicines  and  whose  name 
was accordingly entered in any licence granted in Form 25C for manufacture of 
different classes of Homoeopathic medicines included in them shall be deemed 
to be qualified for the purpose of this rule.] 

3[(2)   The   factory   premises   shall   comply   with   the   requirements   and 

conditions specified   in Schedule M-I: 

1.  Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969. 
2.  Subs. by G.S.R. 812 (E), dt. 14-11-1994 as corrected by G.S.R. 517 (E), dt. 26-6-1995. 
3.  Subs. by G.S.R. 570 (E), dt. 12-6-1987.

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Provided  that  where  the  Licensing  Authority  considers  it  necessary  or 
expedient  so  to  do,  it  may  having  regard  to  the  nature  and  extent  of 
manufacturing  operations,  relax  or  suitably  alter  the  said  requirements  or 
conditions in any particular case for reasons to be recorded in writing.] 

(3)  The  applicant for  manufacture of  Homoeopathic mother  tinctures shall 
either  (i)      provide  and  maintain  adequate  staff,  premises  and  laboratory 
equipment for identifying the raw materials and for testing the mother tinctures 
wherever  possible,  or  (ii)  make  arrangements  with  some  institution  approved 
by  the  Licensing Authority  2[under  Part  XV(A)  of  these  rules]  for  such  tests, 
wherever possible, to be regularly carried out on his behalf by that institution. 

(4) The premises where Homoeopathic medicines are manufactured shall be 

distinct and separate from the premises used for residential purposes. 

(5) Homoeopathic medicines shall not be manufactured simultaneously with 

drugs pertaining to other systems of medicine. 

(6)   The   applicant   shall   make   arrangements   for   proper   storage   of 

Homoeopathic medicines manufactured by him: 

1[Provided that in  case  potentised preparations are  made in  a  Pharmacy holding 
licence in Form 20-C, the conditions (2) and (3) shall not apply.   The licensee shall 
ensure  to  the  satisfaction of  the  Licensing Authority that  the  products manufactured 
by it, conform to the claims made on the label.] 

3[85-EA.  Inspection before grant or renewal of licence.--  Before a licence under 
this  Part  is  granted  or  renewed in  Form  25C  or  Form  26C,  the  Licensing Authority 
shall cause the establishment, in which the manufacture is proposed, to be conducted 
or  being  conducted,  to  be  inspected  by  one  or  more  Inspectors   shall  examine  all 
portions  of  the  premises,  plant  and  appliances  and  also  inspect  the  process  of 
manufacture intended to be employed or being employed along with the means to be 
employed  or  being  employed  for  standardizing  and  testing  the  substances  to  be 
manufactured and inquire into the professional qualifications of the technical staff to 
be employed. He shall also examine and verify the statements made in the application 
in  regard to  their  correctness, and  the capability of  the  applicant to  comply with  the 
requirements  of  competent  technical  staff,  manufacturing  plants,  testing  equipments 
and  the  requirements of  plant  and  equipment  as  laid  down  in  Part  I  of  Schedule  M 
read with the requirements of maintenance of records as laid down in Schedule U. 

1.  Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969. 
2.  Ins. by  G.S.R. 1172 (E), dt. 23-8-1977. 
3.  Ins. by  G.S.R. 493 (E), dt. 9-6-1995.

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85EB. Report by Inspector.–The Inspector or Inspectors shall forward a detailed 
descriptive report giving his or their findings on each aspect of inspection along with 
his  or  their  recommendations  after  completion  of  his  or  their  inspection  to  the 
Licensing Authority. 

85EC.  Grant  or  refusal  of  licence.– (1)  If  the  Licensing  Authority  after  such 
further enquiry, if any, as he may consider necessary is satisfied that the requirements 
of the rules under the Act have been complied with and that conditions of the licence 
and  the  rules  under  the  Act  shall  be  observed,  he  shall  grant  or  renew  a  licence  in 
Form 25C or Form 26C. 

(2)     If the Licensing Authority is not so satisfied, he shall reject the application 
and shall inform the applicant of the reasons for such rejection and of the conditions 
which must be satisfied before a licence can be granted or renewed and shall supply 
the applicant with a copy of inspection report.] 

85ED.  Further  application  after  rejection.  .–If  within  a  period  of  six  months 
from the rejection of an application for a licence, the applicant informs the Licensing 
Authority that the conditions laid down have been fulfilled and deposits an inspection 
fee of  1[rupees two hundred and fifty], the Licensing Authority may, if, after causing 
further  inspection  to  be  made,  he  is  satisfied  that  the  conditions  for  the  grant  of 
licence have been complied with, issue a licence in Form 25C or Form 26C. 

85EE.  Appeal  to  the  State  Government.–Any  person  who  is  aggrieved  by  the 
order  passed  by  the  Licensing  Authority  refusing  to  grant  or  renew  a  licence  under 
this Part may within ninety days from the date of receipt of such order, appeal to the 
State Government and the State Government may, after such enquiry into the matter 
as  is  considered  necessary  and  after  giving  the  said  person  an  opportunity  for 
representing the case, pass such order as it thinks fit.] 

85F.  Duration  of  licence.–An  original  licence  or  a  renewed  licence  unless  it  is 
sooner suspended or cancelled shall be  1[valid for a period of five years on and from 
the date on which] it is granted or renewed: 

2[Provided that if the application for renewal of a licence in force is made before 
its expiry or if the application is made within six months of its expiry, after payment 
of  additional fee,  the licence shall continue to  be  in force until orders are  passed on 
the application and the licence shall be  deemed to have expired if application for its 
renewal is not made within six months of its expiry.] 

85G. Certificate of renewal.–The certificate of renewal of a licence in Form 25-C 

shall be issued in Form 26-C. 

1.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
2.  Subs. by  S.O. 2139, dt. 12-8-1972. 

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85H.  Conditions  of  licence.–A  licence  in  Form  25-C  shall  be  subject  to  the 

conditions stated therein and to the following further conditions, namely : 

(a) the licensee shall provide and maintain staff and premises as specified in 

Rule 85-E; 

(b)  the  licensee  shall  allow  an  1[Inspector  appointed under  the  Act]  to  enter, 
with  or  without  prior  notice,  any  premises  where  the  manufacture  of  a 
Homoeopathic medicine in respect of which the licence is issued is carried on, to 
inspect  the  premises  and  to  take  samples  of  the  manufactured  Homoeopathic 
medicines; 

(c)  the  licensee  shall  allow  an  Inspector  to  inspect  all  registers  and  records 
maintained under these rules  and  shall  supply  to  the Inspector such information 
as  he  may  require for  the  purpose  of  ascertaining whether the  provisions of  the 
Act and the rules made thereunder have been observed; 

2[(d) the licensee shall maintain an Inspection Book in Form 35 to enable an 

Inspector to record his impressions and defects noticed;] 

(e)  the  licensee  shall  comply  with  the  following  conditions  in  respect  of 

mother tinctures manufactured by him_

(i) the crude drug used in the manufacture of the mother tincture shall be 
identified  and  records  of  such  identification  shall  be  kept  3[for  a  period  of 
five years]; 

(ii)  the  total  solids  in  the  mother  tincture  shall  be  determined  and 

records of such tests shall be kept 3[for a period of five years]; 

(iii)  the  alcohol content  in  the  mother  tincture  shall  be  determined and 

records of the same shall be maintained 3[for a period of five years]; 

(iv)  the  containers  of  mother  tinctures  shall  preferably  be  of  glass  and 
shall be clean and free from any sort of impurities or adhering matter.   The 
glass shall be neutral as far as possible; 

(v)    in    the    process    of    manufacture    of    mother    tinctures    hygienic 
conditions  shall  be  scrupulously  observed  by  the  licensee.    Storage  and 
handling conditions shall also be properly observed by the licensee according 
to Homoeopathic principles; 

1.  Amended by G. S. R.  444, dt. 28-4-1973. 
2.  Amended by F-1-14/ 68-D, dt. 26-10-1968. 
3.  Ins. by G.S.R. 13(E), dt. 7-1-1983.

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1[(ea) no colour shall be added to any Homoeopathic medicines : 

Provided  that  caramel  may  be  added  to  combination  of  Homoeopathic 

preparations with syrup base;] 

(f)  records  shall  be  maintained  of  Homoeopathic  medicines  containing 
alcohol  and  the  quantities  sold  together  with  names  and  addresses  of  parties  to 
whom sold.2 [Such records shall be maintained for a period of five years.] 

3[85HH. Additional information to be furnished by an applicant for the licence or a 
licensee  to  the  Licensing  Authority.–The  applicant  for  the  grant  of  licence  or  any 
other  person  granted  a  licence  under  this  Part  shall,  on  demand,  furnish  to  the 
Licensing Authority, before the grant of the licence or during the period the licence is 
in  force,  as  the  case  may  be,  documentary  evidence  in  respect  of  the  ownership  or 
occupation  in  rental  or  other  basis  of  the  premises,  specified  in  the  application  for 
licence or in the licence granted, constitution of the firm or any other relevant matters 
which may be required for the purpose of verifying the correctness of the statements 
made  by  the  applicant  or  the  licensee,  while  applying  for  or  after  obtaining  the 
licence, as the case may be.] 

85-I. Cancellation and suspension of licences.– (1)   The Licensing Autority may, 
after giving the licensee an opportunity to show cause why such an order should not 
be passed, by an order in writing stating the reasons therefor, cancel a  licence issued 
under this Part or suspend it for such period as he thinks fit, either wholly or in respect 
of some of the substances to which it relates if, in his opinion, the licensee has failed 
to comply with any of the conditions of the licence or with any provisions of the Act 
or Rules made thereunder. 

4[(2)  A licensee whose licence has been suspended or cancelled may, within three 
months of the date of the order under sub-rule (1),  prefer an appeal against that order 
to the State Government, which shall decide the same.] 

MANUFACTURE  FOR  EXAMINATION, TEST  OR  ANALYSIS 

PART VIII 

86.  Conditions  relating  to  manufacture  for  examination,  test  or  analysis.–The 
provisions of Section 18 of the Act shall not apply to the manufacture of any drug in 
small  quantities  for  the  purpose  of  examination,  test  or  analysis  if  the  conditions 
prescribed in this Part are fulfilled. 

87.  Labelling.–Any  drug  manufactured  for  the  purpose  of  examination,  test  or 
analysis shall be kept in containers bearing labels indicating the purpose for which it 
has been manufactured. 

88. Labelling of  drugs supplied to other persons.–If any drug manufactured for 
the  purpose  of  examination, test  or  analysis  is  supplied  by  the  manufacturer  to  any 
other  person, the  container shall bear  a  label on  which  shall  be  stated the  name and 
address of the manufacturer, the accepted scientific name of the substance if known, 
or if not known a reference which will enable the substance to be identified and the 
purpose for which it has been manufactured. 

1.  Ins. by G.S.R. 680 (E), dt. 5-12-1980. 
2.  Ins. by G.S.R. 13 (E), dt. 7-1-1983. 
3.  Ins. by S. O. 2139, dt. 12-8-1972. 
4.  Subs. G.S.R. 926, dt. 16-7-1977.

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89.  Licence.–If  the  person  proposing  to  manufacture  a  drug  for  the  purpose  of 
examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect 
of  such  drugs  he  shall,  before  commencing  such  manufacture,  obtain  a  licence  in 
Form 29: 

1[Provided that in the case of a drug the composition of which is such that the drug 
is  not  generally  recognized  among  experts  qualified  by  scientific  training  and 
experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall 
be granted unless the applicant produces a certificate from the ―Licensing Authority‖ 
mentioned in Rule 21, to the effect that there would be no objection to such licence 
being granted. 

90.  Form  of  application.– 2[(1)]  An  application  for  a  licence  in  Form  29  shall 
be  made  to  the  Licensing  Authority  appointed  by  the  State  Government  for  the 
purpose of  this  Part  (hereafter in  this  Part  referred to  as  the  Licensing Authority) in 
Form  30  and  shall  be  made  by  or  countersigned  by  the  head  of  the  institution  in 
which,  or  a  director  of  the  firm  or  company  by  which,  the  substance  will  be 
manufactured. 

4[(2) Every application in Form 29 shall be accompanied by a fee of  3[rupees two 

hundred fifty]. 

91.  Duration of licence.–A licence in Form 29 shall, unless sooner cancelled, be 
in force for a period of one year from the date of issue, and may thereafter be renewed 
for periods of one year at a time. 

92. Conditions of licence. −A licence in Form 29 shall be subject to the following 

conditions 

(a)  the  licensee  shall  use  the  drugs  manufactured  under  the  licence 
exclusively for purpose of examination, test or analysis, and shall carry on the 
manufacture  and  examination,  test  or  analysis  at  the  place  specified  in  the 
licence; 

(b)  the  licensee  shall  allow  any  3[inspector  appointed  under  the  Act] 
to enter, with or without notice, the premises where the drugs are manufactured 
and  to  satisfy  himself  that  only  examination,  test  or  analysis  work  is  being 
conducted; 

(c) the licensee shall keep a record of the quantity of drugs manufactured 
for  examination,  test  or  analysis  and  of  any  person  or  persons  to  whom  the 
drugs have been supplied; 

(d)  the  licensee  shall  comply  with  such  further  requirements,  if  any, 
applicable  to  the  holders  of  licences  in  Form  29  as  may  be  specified  in  any 
rules  subsequently made  under the  Act  and  of  which  the  Licensing Authority 
has given him not less than one month‘s notice; 

(e) the licensee shall maintain an Inspection Book to enable an Inspector to 

record his impressions and defects noticed. 

93. Cancellation of licences.-  
(1)  The Licensing Authority may after giving the licensee an opportunity to show 
cause  why  such  an  order  should  not  be  passed,  by  an  order  in  writing  stating  the 
reasons therefor, cancel a licence issued under this Part, either wholly or in respect of 
some of the substances to which it relates, if, in his opinion, the licensee has failed to 
comply with any  of the conditions of the licence or with any provision of the Act or 
Rules thereunder 

1.  Ins. under F. 1-19/59-D (SO 1449), dt. 13-6-1961. 
2.  Re-numbered by  S.O. 903, dt. 28-2-1976. 
3.  Subs.  by G.S.R. by 444, dt. 31.3.1973. 
4. Ins. by S.O 903, dt. 28-2-1976.

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1[(2) A licensee whose licence has been suspended or cancelled may appeal to the 

State Government within three months of the date of the order.] 

PART IX 

LABELLING  AND  PACKING  OF  DRUGS  OTHER  THAN 
HOMOEOPATHIC  MEDICINES 
94.  Exemption of certain drugs from certain provisions of this Part.— (1) Labels 
on  packages  or  containers of  drugs  for  export  shall  be  adapted  to  meet  the  specific 
requirements of  the  law  of  the  country  to  which  the  drug  is  to  be  exported  but  the 
following  particulars  shall  appear  in  a   conspicuous  position  on  the  innermost 
container  in  which  the  drug  is  packed  and  every  other  covering  in  which  that 
container is packed: 

  (a) name of the drug; 
 (b) the name, address of the manufacturer and the number of the licence under 

which the drug has been manufactured; 
 (c) batch or lot number; 
(d) date of expiry, if any: 

2[Provided that where a drug, not classified under Schedule F, Schedule F(1) and 
Schedule  X,  5[or  blood  products  defined  under  rule  122EA]  is  required  by  the 
consignee to be not labelled with the name and address of the manufacturer, the labels 
on  packages  or  containers  shall  bear  a  code  number  as  approved  by  the  Licensing 
Authority mentioned in Rule 21.] 
        4[Provided further that where a drug classified as Narcotic Drug or Psychotropic 
Substance is to be exported  under a code number,  the same may be permitted by the 
said licensing authority on the following conditions, namely:- 

(i)  Each consignment  of export shall be accompanied  with requisite import license from 

the importing country; 

(ii)  The applicant shall obtain a no objection certificate from the Drugs Controller, India for 
manufacture of such formulations to be exported  with code number  against each export 
order  along  with    certificate  from  the  regulatory  authority  of  the  importing    country 
controlling  Narotic  Drugs  and  Psychotropic    Substances  that  they  do  not  have  any 
objection for the import of the drug with code number; 

(iii) The  State  Licensing  Authority  shall    issue  the  manufacturing    license  for  these 
formulations on each export order on the basis of a No Objection Certificate from Drugs 
Controller, India; 

(iv) A no objection certificate shall be obtained from the drugs Controller, India for export 

of each consignment;  and 

(v)  A no objection certificate shall be obtained  from the Narcotic Commissioner of India, 

Gwalior for export of each consignment of the drug.] 

3[(2) The  provisions of  Rules  96  to  101  inclusive, shall  not  apply to  a  medicine 
made up ready for treatment, whether after or without dilution, which is  supplied on 
the prescription of a registered practitioner provided that: 

(i) the medicine is labelled with the following particulars : – 

(a) the name and address of the supplier; 

(b) the name of the patient and the quantity of the medicine; 

(c) the number representing serial number of the entry in the prescription 
register; 

1.  Subs. by  F.1-10/68-D (S.O 2482), dt.  17-6-1969. 
2.  Ins. by G.S.R. 676 (E), dt. 2-6-1988. 
3.  Subs. by F.1-19/59-D, dt. 13-6-1961. 
4. Ins. by G.S.R. 592 (E), dt. 13-8-2008. 
5. Subs. by 592 (E), dt. 13-8-2008.

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(d) the dose, if the medicine is for internal use; 

1[(e) the  words ―FOR EXTERNEL USE ONLY‖ shall be  printed on the 

label  if the medicine is for external application]. 

(ii) Condition (3) of the conditions in Rule 65 is satisfied.] 

95.  Prohibition  of  sale  or  distribution  unless  labelled.—Subject  to  the  other 
provisions  of  these  Rules,  no  person  shall  sell  or  distribute  any  drug  (including  a 
patent or proprietary medicine) unless it is labelled in accordance with these Rules. 

2[96. Manner of  Labelling .— (1)  Subject to the other provisions of  these Rules, 
the  following particulars shall  be  either  printed  or  written  in  indelible  ink  and  shall 
appear in a  conspicuous manner on the label of the innermost container of any drug 
and on every other covering in which the container is packed, namely :— 

(i) the name of the drug− 

3[(A)    for  this  purpose, the  proper  name  of  the  drug  shall  be  printed or 
written  in  a  more  conspicuous manner  than  the  trade  name,  if  any,  which 
shall be shown immediately after or under the proper name and shall be]— 

(a) for drugs included in the Schedule F or Schedule F (1), the name 

given therein; 

(b)  for  drugs  included  in  the  Indian  Pharmacopoeia  or  the  official 
pharmacopoeias and  official  compendia of  drug  standards prescribed in 
Rule  124,  the  name  or  synonym  specified  in  the  respective  official 
pharmacopoeias  and  official  compendia  of  drug  standards  followed  by 
the letters ‗I.P., or, as the case may be, by the recognized abbreviations 
of the respective official pharmacopoeias and official compendia of drug 
standards; 

(c) for drugs included in  the National Formulary of  India, the name 

or synonym specified therein followed by the letters ‗N.F.I.‘; 

(d)  for  other  drugs,  the  international  non-proprietary  name,  if  any, 
published  by  the  World  Health  Organisation  or  where  an  international 
non-proprietary name  is  not  published, the  name descriptive of  the  true 
nature or origin of the substance; 

4[*  *   *  *  *] 

(ii)  A  correct  statement  of  the  net  content  in  terms  of  weight,    measure, 
volume, number of units of contents, number of units of activity, as the case may 
be, and the weight, measure and volume shall be expressed in Metric system. 

1.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
2  Amended under G.S.R.19, dt. 15-12-1977. 
3.  Subs. by G.S.R. 27(E), dt. 17-1-1981. 
4.  Sub-clause (B) omitted by G.S.R. 94 (E),   dt. 8-2-2000. Earlier ins. by G.S.R. 27 (F), dt.-1-1981.

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(iii) The content of active ingredients−

This shall be expressed− 

(a) for oral liquid preparations in terms of the content per single 

dose, being indicated in 5 millilitres 1[** *]: 

Provided that where the dose is below 5 millilitres the contents of 
active ingredients may be expressed in terms of 1 millilitre; 2[or fraction 
thereof:] 

3[Provided  further  that  where  the  single  dose  is  more  than  5 
millilitres,  the  content of  active  ingredients shall  be  expressed in  terms 
of minimum single dose as approved by the licensing authority;] 

(b)  for  liquid  parenteral  preparations  ready  for  administration  in 
terms of 1 millilitre or percentage by volume or per dose in the case of 
single dose container : 

Provided that if the preparation is contained in an ampoule it will be enough 
if  the  composition  is  shown  on  the  label  or  wrapper  affixed  to  any  package  in 
which such ampoule is issued for sale; 

(c) for drugs in solid form intended for parenteral administration, in terms of 

units or weight per milligram or gram; 

(d)  for  tablets,  capsules,  pills  and  the  like,  in  terms  of  the  content  in  each 

tablet, capsule, pill or other unit, as the case may be; 

(e) for other preparations, in terms of percentage by weight or volume or in 

terms of unitage per gram or millilitre, as the case may be: 

Provided that clause (iii) shall not apply to the pharmacopoeial preparations 
where  the  composition  of  such  preparation  is  specified  in  the  respective 
pharmacopoeia and to a preparation included in the National Formulary of India. 
(iv)  4[The  name  of  the  manufacturer  and  the  address  of  the  premises  of  the 

manufacturer where the drug has been manufactured:] 

Provided that if the drug is contained in an ampoule or a similar small container, 
it  shall  be  enough  if  only  the  name  of  the  manufacturer and  his  principal  place  of 
5[manufacture]  is shown. 

(v) A distinctive batch number, that is to say, the number by reference to which 
details  of  manufacture  of  the  particular  batch  from  which  the  substance  in  the 
container   is    taken    are    recorded    and   are    available    for   inspection,  the    figure 
representing the batch number being preceded by  the words ‗Batch No.‘  or ‗B. No.‘ 
or ‗Batch‘ or ‗Lot No.‘ or ‗Lot‘. 

NOTES 

(1)  In  the  case  of  drugs  manufactured  by  a  continuous  process,  like 
manufacture  of  magnesium  sulphate,  pharmaceutical  chemicals  etc., 
the 
production  resulting  in  one  homogenous  mix  of  the  finished  products  shall  be 
considered as one ―Batch‖. 

1.  Omitted by G.S.R. 285 (E), dt. 16-7-1996. 
2.  Ins. by G.S.R. 681(E), dt. 5-12-1980. 
3.  Ins. by G.S.R. 285 (E), dt. 16-7-1996. 
4.  Subs. by G.S.R. 491 (E), dt. 25-7-1991. 
5.  Subs. by G.S.R. 17 (E), dt. 7-1-1986.

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(2) In the case of powders, liquid orals, ointments etc., one ―Batch Number‖ 

shall be assigned to all the containers filled from one homogenous bulk. 

(3)  In  the  case  of  tablets,  capsules,  lozenges,  troches,  etc.,  one  ―Batch 
Number‖ shall  be  assigned to  the  products manufactured from one  homogenous 
mix ready for compression or filling. 

(4) In the case of parenteral preparations sterilized by steam under pressure, 
one  ―Batch  Number‖  shall  be  assigned  to  all  containers  filled  from  one 
homogenous bulk solution and sterilized in one sterilizer load. 

(5)  In  the  case  of  containers  of  parenteral  preparations  filled  from  one 
homogenous  bulk  solution  and  sterilized  in  more  than  one  sterilizer  load,  the 
―Batch  Number‖ assigned to  the  containers in  the  different sterilizer loads  shall 
be  the  same  ―Batch  Number‖  as  is  assigned  to  the  homogenous  bulk  solution, 
provided the samples taken from all the sterilizer loads pass the sterility test, and 
are kept separate from one another until the report of the sterility test is available. 

Explanation.—  For  the  purpose  of  chemical  and  other  tests,  representative 
samples from  all  containers filled from the homogenous bulk solution should be 
taken. 

(6)  In  the  case  of  parenteral  and  other  sterile  products  filled  aseptically,  a 
―Batch Number‖ shall be assigned to all  containers filled from one homogenous 
mix during one filling operation, the filling operation being completed in a period 
of  not  more  than  a  day  and  during  which  no  schedule  change  in  the  filling 
assembly is made. 

When containers are filled from one homogenous mix, in a number of filling 
operations,  the  ―Batch  Number‖  assigned  to  the  containers  filled  in  individual 
filling  operations  shall  be  the  same  ―Batch  Number‖  as  is  assigned  to  the 
homogenous  mix,  provided  the  samples  taken  from  all  the  different  filling 
operations pass the sterility tests, and are kept separate from one another until the 
report of the sterility test is available. 

Explanation.-For  the  purpose  of  chemical  and  other  tests,  representative 

samples from all containers filled from the homogenous mix should be taken. 

(7)  In  the  case  of  medicinal  gases  produced  by  a  continuous  process  of 

operation a week‘s production from one tank load shall be considered as a Batch. 

(vi)   Every  drug  manufactured in  India  shall  bear  on  its  label  the  number  of  the 
licence  under  which  the  drug  is  manufactured,  the  figure  representing  the 
manufacturing licence number being preceded by the words ―Manufcaturing Licence 
Number‖ or ―Mfg. Lic. No.‖ or ―M.L.‖. 

(vii)   Drugs specified in Schedule P and their preparations including combinations 
with  other  drugs  shall  bear  on  their  labels  the  date  of  manufacture, and  the  date  of 
the  date  of  manufacture
the  period  between 
expiry  of  potency,  and 

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 Drugs and Cosmetics Rules 1945 

and  the  date  of  expiry  shall  not  exceed  that  laid  down  in  the  said  Schedule 
1[under  the  conditions  of  storage  specified  therein.  2[Drugs  and  their 
preparations not included in Schedule P], shall bear on their labels the date of 
their manufacture and also the date of their expiry which shall not exceed sixty 
months from the date of manufacture:] 

Provided  that  this  period  may  be  extended  by  the  Licensing  Authority 
specified in clause (b) of Rule 21 in respect of any specified drug if satisfactory 
evidence is produced by the manufacturer to justify such an extension. 

7[(viii)  Drugs  specified  in  Schedule  C(I)  and  their  preparations  including 
combinations  in  other  drugs  shall  bear  on  their  labels  (a)  the  date  of 
manufacture, and (b) date of expiry of potency fixed by the manufacturer: 

3[4[Provided that  drugs  in  bulk  form  included in  Schedule  C(I)  which  are 
not ready for use and not included in Schedule P need not bear on the label the 
date of expiry of potency:] 

Provided  further  that  no  reference  shall  be  made  to  any  other  licence 
number granted by  any  authority outside India on  any  label or  container or in 
any  covering  in  which  the  container  is  packed  or  in  any  other  matter  or 
advertisement enclosed therewith]. 

(ix) Every drug intended for distribution to the medical profession as a free 
sample shall, while complying with the labelling provisions under clauses (i) to 
(viii),  further  bear  on  the  label  of  the  container  the  words  ‗Physician‘s 
Sample—Not to be sold‘ which shall be overprinted. 

5[(x) If  any  preparation  contains  not  less  than  3  per  cent  by  volume  of 
alcohol  the  quantity  of  alcohol  shall  be  stated  in  terms  of  the  average 
percentage by volume of absolute alcohol in the finished products.] 

6[(xi)  In addition to the other particulars which are required to be printed or 
written  under  these  Rules,  the  label  of  innermost  container  of  the  following 
categories of  drugs and every other covering in  which the container is packed 
shall bear a conspicuous red vertical line on the left side running throughout the 
body of the label which  should  not   be   less   than 1mm in width and without 
disturbing    the    other    conditions    printed    on    the    label    under    these 
rules, namely: — 

1.  Subs. by G.S.R.  17  (E), dt. 7-1-1986. 
2.  Subs. by G.S.R. 285 (E), dt. 16-7-1996. 
3.  Subs. by G.S.R. 487(E), dt. 2-7-1984. 
4.  Subs. by G.S.R. 813 (E), dt. 27-7-1988. 
5.  Ins. by G.S.R. 462 (E), dt. 22-6-1982. 
6.  Ins. by G.S.R. 597 (E), dt. 17-6-1992. 
7. Subs. by G.S.R. 592 (E), dt. 13-8-2008.

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Narcotic  analgestics,  hypnotics,  sedatives,  tranquillisers,  corticosteroids, 
hormones,  hypoglycemics,  antimicrobials,  antiepileptics,  antidepressants, 
anticoagulants,   anti-cancer   drugs   and   all   other   drugs   falling   under 
Schedules ‗G‘, ‗H‘, and ‗X‘ whether covered or not in the above list: 

Provided that the provisions of this clause shall not apply to: − 
(a)  preparations 
intended  for  animal 
treatment; 

(b) preparations intended for external use; 

(c) ophthalmic preparations and ear drops; and 

(d) sterile preparations such as sutures, surgical dressings and preparations 
intended for parenteral use.] 

1[(xii)  Drugs and their preparations including combinations with other drugs 
imported into the country shall also bear on the label, the license number under 
which  the  drug  is  imported,  preceded  by  the  words  ―Import  License‖  and  the 
name and address of the importer.] 

(2)(i)  The  particulars  to  be  printed  or  written  on  the  label  of  a  mechanical 

contraceptive shall be as specified in Schedule R. 

(ii)  The  following  particulars,  in  addition  to  those  specified  under  sub-rule  (1) 
shall  be  either  printed  or  written  in  indelible  ink  and  shall  appear  in  a  conspicuous 
manner on the label of the innermost container and on every other covering in which 
the  container  of  a  contraceptive,  other  than  a  mechanical  contraceptive,  is  packed, 
namely : − 

(a) the date of manufacture; 

(b)     the  date  upto  which  the  contraceptive  is  expected  to  retain  its 

properties; 

(c)  the  storage  conditions  necessary  for  preserving  the  properties  of  the 

contraceptive upto the date indicated in sub-clause (b) : 

Provided that for oral contraceptives it shall be sufficient to display on the label 

of the container the date of manufacture only. 

(3)(i)  The  particulars  prescribed  in  sub-rule  (1)  shall  be  printed  or  written  in 
indelible ink either on the label borne by a container of vaccine lymph or on a label or 
wrapper  affixed  to  any  package  in  which  the  container  is  issued  for  sale.  The  said 
particulars  shall  be  indelibly  marked  on  the  sealed  container  of  surgical  ligature  or 
suture or printed or written in indelible ink on a label enclosed therein. 

(ii)  Nothing  in  these  rules  shall  be  deemed  to  require  the  labelling  of  any 
transparent  cover  or  of  any  wrapper,  case  or  other  covering  used  solely  for  the 
purpose of packing, transport or delivery. 

(4)      Where  by  any  provision  of  these  rules  any  particulars  are  required  to  be 
displayed  on  a  label  on  the  container,  such  particulars  may,  instead  of      being 
displayed  on  a  label,  be  etched,  painted  or  otherwise  indelibly    marked  on  the 
container: 

1. Ins. by G.S.R. 592 (E), dt. 13-08-2008. 

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 Drugs and Cosmetics Rules 1945 

Provided  that,  except  where  otherwise  provided  in  these  rules,  the  name  of  the 
drug or any distinctive letters intended to refer to the drug shall not be etched, painted 
or otherwise indelibly marked on any glass container other  than ampoules. 

Explanation.— For the purpose of this rule, the date of expiry shall be in terms of 
month and year and it shall mean that the drug is recommended till the last day of the 
month.  The date of expiry shall be preceded by the words ‗Expiry date‘.] 

97.  Labelling  of  medicines.—  1[(1)  The  container  of  a  medicine  for  internal  use 

shall— 

(a)     if it contains a substance specified in Schedule G, be labelled with the 
words ―Caution: it  is  dangerous to  take this  preparation except under  medical 
supervision‖  –  conspicuously  printed  and  surrounded  by  a  line  within  which 
there shall be no other words; 

(b)     if it contains a substance specified in Schedule H, be labelled with the 
symbol Rx and conspicuously displayed on the left top corner of the label and 
be also labelled with the following words: 

‗Schedule H drug- Warning: To be sold by retail on the prescription of a 

Registered Medical Practitioner only‘, 

(c)     if  it  contains a  substance specified in  Schedule H,  and  comes within 
the  purview  of  the  2[Narcotic  Drugs  and  Psychotropic  Substances  Act,  1985 
(61  of  1985)]  be  labelled  with  the  symbol  NRx  which  shall  be  in  red  and 
conspicuously displayed on the left top corner of the label, and be also labelled 
with the following words: 

‗Schedule H drug -Warning:   To be sold by retail on the prescription of a 

Registered Medical Practitioner only‘; 

(d)     If it contains a substance specified in Schedule X, be labelled with the 
symbol  XRx  which  shall  be  in  red  conspicuously  displayed  on  the  left  top 
corner of the label and be also labelled  with the following words : - 

‗Schedule X drug -Warning:  To be sold by retail on the prescription of 

a Registered Medical Practitioner only‘. 

4[(e) 

if  it  contains  a  drug  substance  specified  in  Schedule  H1,  the  drug 
formulation shall be labeled with the symbol Rx which shall be in red conspicuously 
displsyed  on  the  left  top  corner  of  the  label,  and  shall  also  be  labelled  with  the 
following words in a box with a red border: 

“SCHEDULE H1 DRUG – WARNING. 

- 

It  is  dangerous  to  take  this  preparation  except  in  accordance  with  the 
medical advice. 

-  Not  to  be  sold  by  retail  without  the  prescription of a  Registered Medical 

Practitioner.] 

(2)  The  container  of  an  embrocation,  liniment,  lotion,  3[ointment,  antiseptic 
cream,]  liquid  antiseptic  or  other  liquid  medicine  for  external  application  shall  be 
labelled with the words: 

―FOR EXTERNAL USE ONLY‖. 

1.  Subs. by G.S.R. 462 (E), dt. 22-6-1982. 
2.  Subs. By G.S.R. 282(E), dt. 16.7.1996. As corrected by G.S.R. 241(E), dt. 15.4.1998. 
3.  Ins. by G.S.R. 850 (E), dt. 7-12-1994. 
4. Subs. by G.S.R. 588 (E), dt. 30-8-2013.

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1[(3)  The container of a medicine made up ready only for treatment of an animal 
shall  be  labelled  conspicuously  with  the  words  ‗Not  for  human  use;  for  animal 
treatment only‘ and shall bear a symbol depicting the head of a domestic animal.] 

2[*   *   *  *   *] 
10[(3A) The container of a medicine  for treatment of food producing animals shall 
be  labeled  with  the  withdrawal  period  of  the  drug  for  the  species  on  which  it  is 
intended to be used:  

Provided that if the specific withdrawal  period has not been validated, the 
withdrawal    period  shall  not  be  less  than  seven  days  for  eggs  or  milk,  twenty  eight 
days for meat from poultry and mammals including fat and offal, five hundred degree 
days for fish meat. 

Explanation:- For the purpose of this Rule, the withdrawal  period is the period of 
interval between the last administration of a veterinary  medicine to animals under the 
normal  conditions  of  use  and  the  production    of  food  stuff  from  such  animals  to 
ensure that food stuffs do not contain residues in quantities in excess of the maximum 
residue limits laid down.] 

3[(4)]  The container of a medicine prepared for treatment of human ailments shall 
if the medicine contains industrial methylated spirit, indicate this fact on the label and 
be labelled with the words : 

―For External Use only‖. 

4[(5) Substances specified in Schedule X in bulk form shall bear a label wherein 

the symbol as specified in sub-Rule (1) shall be given conspicuously in red letters.] 

5[* *   *    *     *] 
6[102.  Non-Sterile  Surgical  Ligature  and  Suture.-     Every  container  of,  and 
wrapper enclosing surgical ligature or suture other than a ligature or suture offered or 
intended to  be  offered  for  sale  as  sterile,  shall  bear  a  label  on  which  are  printed  or 
written in a  conspicuous manner in indelible red ink the words ―Non-sterile surgical 
ligature  (suture)  –  not  to  be  used  for  operations  upon  the  human  body  unless 
efficiently sterilized‖.] 

103.   7[* *   *    *     *] 

(2) The name and address of the manufacturer shall be printed on the label of the 

container of a patent or proprietary medicine. 

8[(3)   The  true  formula  or  list  of  the  ingredients  shall  be  printed  or  written  in 
indelible  ink  on  the  outer  label  of  every  package  containing  patent  or  proprietary 
medicine.] 

9[104  Use  of  letter  I.P.  etc.--The  letters  ‗I.P‘.  and  recognized  abbreviations  of 
pharmacopoeias  and  official  compendia  of  drug  standards  prescribed  under  these 
Rules shall be entered on the label of the drug only for the purpose of indicating that 
the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any 
such pharmacopoeia or official compendium of drug standards recognized under the 
Rules.] 
1.  Subs. by notification No. F.1-6/62-D(S.O.2889),, dt. 2.7.1969. 
2.  Subs. (4) omitted by G.S.R. 462 (E), dt. 22-1-1982. 
3.  Sub-rule (5) re-numbered as sub-Rule (4), by G.S.R. 462 (E), dt. 22-6-1982. 
4.  Ins. by G.S.R. 462 (E), dt. 22-6-1982. 
5.  Rules 98, 99,100 and 101 omitted, by G.S.R. 462 (E), dt. 22-6-1982. 
6. Sub. by F. No. F1-3/51-DS, dt. 15.10.1954. 
7. Sub-rule (1)  omitted by S.O. 2136, dt. 15.6.1957. 
8.  Sub. by S.O. 2136, dt. 15.6.1957. 
9. Sub. by G.S.R. 19, dt. 15.12.1977. 
10. Ins. by G.S.R. 128 (E), dt. 17.1.2012.

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1[104A.  Prohibition  against  altering  inscriptions  on  containers,  labels  or  wrappers  of 
drug. –No person shall alter, obliterate or deface any inscription or mark made or recorded by 
the manufacturer on the container, label or wrapper of any drug: 

Provided  that  nothing  in  this  rule  shall  apply  to  any  alteration,  any  inscription  or  mark 
made on  the  container, label  or  wrapper of any  drug at  the  instance or  direction or  with the 
permission of the Licensing Authority.] 

2[105.  Packing  of  drugs.–(1)  The  pack  sizes  of  drugs  meant  for  retail  sale  shall  be  as 

prescribed in Schedule P1 to these rules. 

(2) The pack sizes of drugs not covered by Schedule P-1 shall be as given below: – 

Unless specified otherwise in Schedule P-1, 

(i) The pack sizes for Tablets/Capsules shall be– 

Where  the  number  of  Tablets  (coated  or  uncoated)/Capsules  (hard  or  soft 
gelatin)  is  less  than  10,  such  packing  shall  be  made  by  the  integral  number.  For 
numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5. 

(ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric only)/60 

ml/100 ml/200 ml/450 ml. 

(iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml. 
(iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml. 
(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm: 

Provided that the provisions of the pack sizes covered under this rule shall not apply to: – 
1.    Pack sizes or dosage forms not covered by the foregoing provisions of this rule. 
2.    The imported formulations in finished form. 
3.    Preparations intended for Veterinary use. 
4     Preparations intended for Export. 
5.   Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in  Liquid Oral forms, 

Unit dose (including applicaps). 

6.      Pack  sizes  of  dosage  forms  meant  for  retail  sale  to  Hospitals,  Registered 

Medical Practitioners, Nursing Homes. 

7.      Physician‘s Samples. 
8.      Pack sizes of large volume Intravenous Fluids: 

4[Provided further that] pack sizes of any of the new drug as and when approved by the 
Licensing  Authority  appointed  under  Rule  21  and  if  not  covered  under  this  rule,  shall  be 
examined  for  the  purpose  of  approval  with  specific  justification  by  the  said  Licensing 
Authority: 

3[4[Provided  also  that]  Oxytocin  injection  meant  for  sale  shall  be  in  single  unit  blister 

pack only:] 

5[Provided also that Diclofenac injection for human use shall be in single unit dose pack 

only.] 

1.  Ins. by G.S.R. 1242 (E), dt. 17-9-1979. 
2.  Ins. by G.S.R. 796 (E), dt. 1-10-1992. 
3.  Sub. by G.S.R. 242 (E), dt. 3-4-2001. 
4. Sub. by G.S.R. 558 (E), dt. 17-7-2015. 
5. Ins. by G.S.R. 558 (E), dt. 17-7-2015. 

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1[105A.  Packings of drugs specified in Schedule X.-  The drugs specified in Schedule X 

shall be marketed in packings not exceeding- 

(i) 100 unit doses in the case of tablets/capsules; 

(ii) 300 ml in the case of oral liquid preparations; and 

(iii) 5 ml in the case of injections: 

Provided that  nothing in this rule shall apply to packing meant for use of a hospital or a 

dispensary subject to the conditions that– 

(i)  such  supplies  are  made  by  the  manufacturers  or  distributors  direct  to  the 

hospital/dispensaries; and 

(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical 

Practitioner.] 

2[106.  Diseases  which  a  drug  may  not  purport  to  prevent  or  cure.—(1)  No  drug  may 
purport or claim to prevent or cure or may convey to the intending user thereof any idea that it 
may prevent or cure one or more of the diseases or ailments specified in Schedule J. 

(2)  No  drug may  purport or  claim to  procure or  assist to  procure, or  may  convey to  the 

intending user thereof any idea that it may procure or assist to procure, miscarriage in women. 

3[* *  *  *]   

4[PART IXA 

LABELLING  AND  PACKINGOF HOMOEOPATHIC  MEDICINES 

106-A. Manner of labelling of  Homoeopathic medicines.—(A) The  following particulars 
shall be either printed or written in indelible ink and shall appear in a conspicuous manner on 
the  label  of  the  innermost  container  of  any  Homoeopathic  medicine  and  on  every  other 
covering in which the container is packed— 

(i)   The words ‗Homoeopathic medicine‘, 

(ii)  The name of the medicine— 

5[(a)   For drugs specified   in the Homoeopathic Pharmacopoeias of India or 
the United States of America or the United Kingdom, or the German Homoeopathic 
Pharmacopoeia, the name specified in that Pharmacopoeia.] 

(b) For other drugs, the name descriptive of the true nature of the drugs. 

1.  Ins. by G.S.R. 462 (E), dt. 22-6-1982. 
2.  Sub. by notification F. 1-16/52-DC (SO 2122), dt. 22-6-1954. 
3. Omitted by G.S.R. 462(E), dt. 22.6.1982. 
4.  Ins. by G.S.R. 1185 (E), dt. 18.8.1964. 
5.  Subs. by G.S.R. 680 (E), dt. 5-12-1980.

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(iii)  The  potency  of  the  Homoeopathic  medicine—For  this  purpose  the  potency 

shall be expressed either in decimal, centesimal or millisimal systems. 

1[(iiiA) In  case of Homoeopathic medicine containing two or more ingredients the 

name of each ingredient together with its potency and proportion expressed in metric 

system shall be stated on the label.] 

2[(iv)  Name and address of the manufacturer when sold in original containers of the 

manufacturer.    In case a Homoeopathic medicine is sold in a container other than that 

of the manufacturer—the name and address of the seller:] 

5[Provided that where such medicines are imported, the name and address of the 

importer shall also be mentioned on the label.] 

(v)   In  case  the  Homoeopathic medicine  contains  alcohol, the  alcohol  content in 

percentage by volume in terms of ethyl alcohol shall be stated on the label: 

           3[Provided  that  in  case  the  total  quantity  of  the  pharmacopoeial  homoeopathic 

medicine in the  container is  30  millilitres  or  less,  it  will  not  be  necessary to  state  the 

content of alcohol on the label.] 

(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall 

display the following particulars: − 

(i)  A  distinctive  batch  number,  that  is  to  say,  the  number  by  reference  to  which 

details of manufacture of the particular batch from which the substance in the container 

is taken are recorded and are available for inspection, the figures representing the batch 

number being preceded by the words ―Batch No.‖ or ―Batch‖ or ―Lot Number‖ or ―Lot 

No.‖ or ―Lot‖ or any distinguishing prefix. 

(ii)   Manufacturing  licence  number,  the  number  being  preceded  by   the  words 

―Manufacturing Licence Number‖ or ―Mfg. Lic. No.‖ or ―M.L.‖. 

4[Explanation.−This  clause  shall  not  apply 

to  a  Homoeopathic  mother  tincture 

manufactured outside India. 

(C)  No  Homoeopathic  medicine  containing  a  single  ingredient  shall  bear  a  proprietary 

name on its label.] 

1.  Subs. by G.S.R. 466 (E), dt. 17-5-1994. 
2.  Sub. by notification F.1-59/68-D, dt. 19-11-1969. 
3.  Subs. by G.S.R. 108 (E), dt. 22-2-1994. 
4.  Ins. by  S.O. 2139, dt. 12-8-1972. 
5. Ins. by G.S.R. 263 (E), dt. 20-4-2009.

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1[106-B.  Prohibition of quantity and percentage.–No Homoeopathic medicine containing 
more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of 
more  than  30  millilitres,  except  that  it  may  be  sold  to  hospitals/dispensaries in  packings  or 
bottles of not more than 100 millilitres.] 

PART X 

SPECIAL PROVISIONS RELATING TOBIOLOGICAL 
AND OTHER SPECIAL PRODUCTS 

2[107. Name of substance.—If any substance specified in Schedule C is advertised or sold 
as a proprietary medicine or is contained in a medicine so advertised or sold, the proper name 
of the substance shall appear on the label in the manner prescribed in this Part. 

3[Explanation.−For  the  purpose  of  this  rule  the  expression  ―proper  name‖  means  the 
proper name stated in Schedule F or if no such name is stated, the name descriptive of the true 
nature and origin of the substance:  

  Provided that in the case of veterinary biological product the expression ―proper name‖ 
means  the  proper  name  stated in  Schedule F  (1)  or  if  no  such name  is  stated,  the  name  or 
synonym  given  in  the  current  edition  for  the  time  being  of  the  4[British  Pharmacopoea 
(Veterinary)]  ,  or,  if  no  such  name  is  stated  either  in  Schedule  F  (1)  or  the  4[British 
Pharmacopoea  (Veterinary)],  the  name  descriptive  of  the  true  nature  and  origin  of  the 
substance approved by the Licensing Authority. 

108. Container.—5[(1) No substance specified in Schedule C shall be sold or offered for 
sale unless it  has been sealed in a previously sterilized container made of glass or any other 
suitable material approved for the purpose by  the Licensing Authority appointed under rule 
21, in such manner as may, in the opinion of the Licensing Authority, suffice to preclude the 
access of bacteria: 

Provided that it shall not be necessary to use a previously sterilized container if the filled 
and sealed container is to be sterilized after the sealing and such sterilizing procedure would 
render  the  product  sterile.   However, the  Licensing Authority may,  for  any  special  reasons, 
direct the licensee to pre-sterile such containers.] 

(2)  When any  such  substance is  issued  in  liquid  form  in  containers which  are  sealed in 
such a manner that portions of the contents can be withdrawn for use on different occasions, 
the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any 
organism which  may  be  accidentally introduced in  the  process of  removing a  portion of  the 
contents of the container: 

6[Provided  that  nothing  in  this  sub-rule  shall  apply  to  a  penicillin  suspension  in  oil 

and wax.] 

1.  Ins. by  G.S.R. 108 (E), dt.  22-2-1994. 
2.  Subs. by  F. 1-5/47-D (SRO 2889), dt. 25-11-1949. 
3.  Subs. by F. 1-6/62-D, dt. 2-7-1969. 
4.  Subs. by G.S.R.647 (E), dt. 28-10-1998. 
5.  Subs. by G.S.R. 245, dt. 21-2-1976. 
6.  Ins. by  SO 115, dt.  04-1-1961. 

134 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1[(3) The container shall comply with such further requirements, if any, as are specified in 

Schedule F or Schedule F (1) as the case may be, in that behalf. 

Drugs and Cosmetics Rules 1945 

(4)  The  Licensing  Authority  may  in  the  case  of  any  particular  preparation  of  any  such 
substance dispense with any of the requirements of this Rule or Schedule F or Schedule F (1) 
as  the  case  may  be,  and  may  make  such  additional  requirements,  as  having  regard  to  the 
nature of the preparation, they may deem necessary.] 

2[109. Labelling.–(1) The following particulars and such further particulars, if any, as are 
specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in 
indelible ink on the label of every phial, ampoule or other container of a  substance specified 
in  Schedule  C  and  on  every  other  covering  in  which  such  phial,  ampoule  or  container  is 
packed— 

(a)  where  a  drug  is  imported,  the  number  of  licence  under  which  it  is  imported, 

preceded by the words ‗Import Licence‘: 

Provided that no reference shall be made to any other import licence number granted 
by any authority outside India on any label or container or in any covering in which the 
container is packed or in any other matter of advertisement enclosed therein; 

(b)  where  a  test  for  potency  in  units  is  required  by  these  rules,  a  statement  of  the 
potency  in  units  defined  in  terms  of  relation  to  the  standard  preparation  specified  in 
Schedule F or F (1), as the case may be : 

Provided that this clause shall not apply in the case of vaccine lymph; 

(c)  where  a  test  for  potency  or  maximum toxicity  is  required the  date  upto  which  the 
substance if  kept under suitable conditions may  be expected to  retain a  potency not less 
than  stated  on  the  label  of  the  container  or  not  to  acquire  a  toxicity  greater  than  that 
permitted by the test, as the case may be.   The date of expiry shall be in terms of month 
and year  and  it  shall  mean that the  drug is  recommended for  use till  the last  day  of  the 
month.  The date of expiry shall be preceded by the words ‗Expiry date‘ : 

Provided  that  nothing  in  these  rules  shall  be  deemed  to  require  the  labelling  of  any 
transparent  cover  or  any  wrapper,  case  or  other      covering  used  solely  for  the  purpose  of 
packing, transport or  delivery. 

(2) The particulars prescribed in clause (a) of the preceding sub-rule shall be printed or 
written in indelible ink either on the label borne by a container of vaccine lymph or on a label 
or  wrapper  affixed  to  any  package  in  which  the  container  is  issued  for  sale.      The  said 
particulars shall be indelibly marked on the sealed container of surgical ligature or suture or 
printed or written in indelible ink on a label enclosed therein. 

1.  Subs. by  F.1-6/62-D (SO 2889), dt. 2-7-1969. 
2.  Subs. by G.S.R.19, dt. 15-12-1977.

135 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(3)  The  following  particulars,  and  such  further  particulars,  if  any,  as  are  specified  in 
Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink 
either  on  the  label  borne  by  the  container of  any  substance specified in  Schedule C  or  on  a 
label  or  wrapper  affixed  to  any  package  in  which  any  such  container  is  issued  for  sale, 
namely:– 

(a)  the  date  on  which  the  manufacture  of  the  particular  batch  from  which  the 
substance in  the container is taken was completed as defined in Schedule F  or  Schedule 
F(1), or if there is no definition in Schedule F or Schedule F(1) as hereafter defined in this 
rule and in the case of vaccine prepared from concentrates, the date of completion of the 
final products and the bottling for issue; 

(b)  where  an  antiseptic  substance  has  been  added,  the  nature  and  the  percentage 

proportion introduced; 

(c)  the  precaution  necessary  for  preserving  the  properties  of  the  contents  up  to  the 

date indicated in clause (c) of sub-rule (1). 

(4) For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of a 

batch is completed shall be— 

(a) in cases where a test for potency or toxicity is required by these rules or not being 
so required, is accepted by the Licensing Authority as sufficient for the purpose of fixing 
the  date  of  completion  of  manufacture,  the  date  on  which  the  substance  was  removed 
from  cold  storage  after  having  been  kept  at   a  temperature  not  exceeding  5°   C 
continuously for a period not exceeding two years   from the time when the last test was 
completed, 

(b) in cases where no such test is required or accepted− 

(i) if the substance is a serum obtained from a living animal, the earliest date on 

which any material contributing to the batch was removed from the animal; 

(ii) if the substance was obtained by the growth of organisms or artificial media, 
the earliest date on which growth was terminated in any of the material contributing 
to the batch: 

Provided that if a  batch of the substance (including all  material contributing to 
this batch) has for a period of not more than three years been kept in cold storage at 
a  temperature  not  exceeding  5°C  continuously  from  the  earliest  practicable  date 
after that on which growth was terminated in  the material  as the case may  be, the 
date  of  removal  from  cold  storage  shall  be  treated  as  the  date  on  which  the 
manufacture of the batch is completed; 

(c) in all other cases, the date on which the substance is filled in the container. 

1[109-A.  Labelling of Medical Devices.– Subject to the other provisions of these rules, the 
following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of 
the medical device or on the outer cover of such medical device and on every outer covering in 
which the medical device is packed, namely:––  
(a)  proper name of the medical device;  
(b)  the details necessary for the user to identify the device and its use;  
(c)  the  name  of  the  manufacturer  and  address  of  the  manufacturing  premises  where  the 

device has been manufactured;  

(d)  the correct statement of the net quantity in terms of weight, measure, volume, number 
of units, as the case may be, and the number of the devices contained in the package shall be 
expressed in metric system; and 

(e)  the date of manufacture and date of expiry; alternately the label shall bear the shelf life 

of the product:  

1.  Sub. by G.S.R. 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R. 109 (E), dt. 22-2-1994. 

136 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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          Provided that in the case of sterile devices the date of sterilisation may be given as 

date of the manufacture of the device:  

          Provided further that the device is made up of stable materials such as stainless steel 

or titanium, and supplied non-sterile, date of expiry may not be necessary;  

(f) 

to  provide,  wherever  required,  an  indication  that  the  device  contains  medicinal  or 

biological substance;  

(g)  to provide, a distinctive batch number or lot number preceded by the word ―Lot No.‖ 

or ―Lot‖ or ―Batch No.‖ or ―B. No.‖;  

(h)  to indicate, wherever required, any special storage or handling conditions applicable to 

the device;  

(i) 

to  indicate,  if  the  device  is  supplied  as  a  sterile  product,  its  sterile  state  and  the 

sterilisation method;  

(j) 

to give, if considered relevant, warnings or precautions for the attention of the user of 

the medical device;  

(k)  to label the device, if the device is intended for single use;  
(l) 

to  overprint  on 

the  container, 

label  of 

the 

the  words  ―FOR  CLINICAL 

INVESTIGATION ONLY‖, if the device is intended for clinical investigation;  

(m)  to  overprint  on  the  label  of  the  device,  the  words  ―Physician‘s  Sample—Not  to  be 
sold‖,  if  a  medical  device  is  intended  for  distribution  to  the  medical  professional  as  a  free 
sample;  

(n)  to  provide,  except  for  imported  devices,  the  manufacturing  licence  number  by 

preceding the words ―Manufacturing Licence Number‖ or ―Mfg. Lic. No.‖ or ―M. L‖;  

(o)  Devices or In-vitro diagnostics which are not sold to customer or patient directly and 
are sold for use by hospitals or diagnostic labs shall provide the information affixing additional 
label or sticker on outer shelf pack; 

(p)  to provide on the label, in case of imported devices, with the approval of the licensing 
authority mentioned in rule 21, the import licence number, name and address of the importer 
and address of the actual manufacturing premises, date of manufacture, (if not already printed 
at the time of import):  
                  Provided  that  the  label  may  bear  symbols  recognised  by  the  Bureau  of  Indian 
Standards or International Organisation for Standardisation (ISO) in lieu of text and the device 
safety  is  not  compromised  by  a  lack  of  understanding  on  the  part  of  the  user  in  case  the 
meaning of the symbol is not obvious to the device user.] 

1[109B. Exemption of certain labelling requirements for medical devices for export from 
India.–– The labels on packages or container of devices for export shall be adopted to meet 
specific requirements of the law of the country to which the device is to be exported, but the 
following particulars shall appear in conspicuous manner on the label of the shelf pack of the 
medical  device  in  which  the  device  is  packed  and  every  other  outer  covering  in  which  the 
container is packed-  

(a)  name of the Device;  
(b) 

the distinctive batch number or lot number preceded by the word ―Lot No.‖ or ―Lot‖ 

or ―Batch No.‖ or ―B.No.‖;  

(c) 
(d) 

the date of expiry, if any;  
the name and address of the manufacturer and address of actual premises where the 

device has been manufactured;  

(e) 

the  manufacturing  Licence  No.  preceded  by 

the 

letters  ―M.L.  No‖  or 

―Manufacturing Licence No‖;  

(f) 

the internationally recognised symbols in lieu of text, wherever required:  

1.  Ins. by G.S.R. 690 (E), dt. 25-9-2014.  

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Drugs and Cosmetics Rules 1945 

              Provided that where a device is required by the consignee not to be labeled with the 
name and address of the manufacturer, the label on the packages or container shall bear a code 
number as approved by the licensing authority and the code number shall bear the name of the 
State or Union territory, in abbreviation, followed by the word ―Device‖ and ―manufacturing 
licence number:  
Provided  further that  where  a  device  is  required  by  the  consignee  not to  be labeled  with the 
code number also, the label on the packages or container shall bear a special code number, as 
requested by the consignee, and approved by the licensing authority under rule 21.] 

1[109C.  Shelf  life  of  the  medical  devices.––  The  shelf  life  of  the  medical  devices  shall  not 
exceed sixty months from the date of manufacture:  

                   Provided that this period may be extended by the licensing authority, in respect of 
any  specified  medical  device,  if  satisfactory  evidence  is  produced  by  the  manufacturer  to 
justify such an extension.] 

110.  Prohibition  of  sale  of  substance  after  prescribed  date.–No  person  shall  sell,  or 
exhibit for sale any substance specified in Schedule C after the date recorded on the container, 
label or wrapper as the date upto which the substance may be expected to retain a potency not 
less than, or not to acquire a toxicity greater than that required or permitted by the prescribed 
test as the case may be. 

2 [*  *   *    *    *] 

1.  Ins. by G.S.R. 109 (E), dt. 22-2-1994. 
2. Rule 110A omitted by G.S.R. 1242(E), dt. 17.9.1979.

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1[111.  Standards.–Every substance specified in  Schedules C  and  C  (1) intended for  sale 

shall conform with the standards of strength, quality and purity specified in these Rules and in 

Schedule F or F(1), as the case may be, and the tests for determining such conformity shall be 

applied to  samples taken  from  the  final  product after  every  manufacturing process has  been 

completed.] 

2[112.  Tests  for  strength  and  quality.–The  tests,  if  any,  required  for  determining  the 

strength  and  quality  of  each  of  the  substances  specified  in  Schedules  C  and  C  (1)  shall  be 
those set out in Schedule F or Schedule F (1) 4[or as specified, as the case may be].] 

3[*   *   *  *    *] 

115.  Application of tests for sterility.–The tests shall be applied− 

(a) to samples taken from each batch of the substance before the operation of filling 

and sealing the containers in which it is to be issued has commenced except preparations, 

which  after  being  sealed  in  the  containers  are  to  be  sterilized  by  heat,  in  a  manner 

satisfactory to the Licensing Authority; and 

(b) to the contents of sample containers when ready for issue. 

4[ *   *   *   *   *] 

119.−(1) If  at  this  examination no  growth  of  micro-organisms is  found  in  any  tube,  the 

sample may be treated as having passed the test. 

(2) If at the examination a growth of micro-organisms is visible, further samples may be 

taken  and  the  tests  may  be  repeated  on  the  further  samples  taken;  but  no  container  the 

contents  of  which  form  part  of  the  batch  shall  be  issued  until  such  further  samples  have 

passed  the  test.   The  process  of  taking  samples  from  the  batch  for  a  test  may  be  repeated 

twice: 

Provided  that  if  the  same  organism  is  visible  in  more  than  one  test  the  batch  shall  be 

treated as not sterile and the material contained in the batch shall not be issued or used as part 

of a further batch unless and until it has been re-sterilized and has passed the tests. 

120.−Notwithstanding anything contained in the last preceding rule,  in any case where— 

(a) a substance is required in an emergency by a registered medical practitioner, but 

the licensee has no filled containers in stock; or 

1. Amended by F.1-6/62-D (SO 2889), dt. 2-7-1969. 
2 Subs. by G.S.R. 663(E), dt. 3.7.1992. 
3. Rules 113 and 114 omitted by G.S.R. 663(E),dt. 3.7.1992. 
4. Rules 116, 117 and 118 omitted by G.S.R. 663 (E), dt. 3-7-1992.

139 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(b)  a  substance  which  in  the  opinion  of  the  Licensing  Authority  is  so  unstable  in 
solution  that  the  delay  occasioned  by  the  completing  of  the  sterility  test  on  filled 
containers  would  render  its  issue  in  active  form  impossible,  the  licensee  may  issue  the 
substance from a batch which has already passed the tests for sterility and freedom from 
abnormal toxicity, without completing the sterility test  on  the filled  containers, provided 
that he complies with the following conditions— 

(i)  the  licensee  shall  before  the  issue  take  samples  in  the  required  proportion 
from the  containers into  which  the  batch is  filled,  and  after  the  required inoculation 
shall examine the tube every day  for five days; 

(ii)  if  at  any  examination  any  growth  is  visible  in  any  of  the  tubes,  he  shall 

immediately notify the Licensing Authority; 

(iii)   he shall keep available for inspection a record of all issues made under this 
Rule  containing such  particulars of  the  circumstances in  which the  issue  is  made  as 
the Licensing Authority may require. 

1[121.  Test  for  freedom  from  abnormal  toxicity.  –The  test  for  freedom  from  abnormal 
toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case of 
each batch of the serum tested by the licensee or by an institution approved by the Licensing 
Authority for the purpose of carrying out the test on its behalf.] 

2[121A. Test for pyrogens–Solution of substances intended for parenteral administration in 
large  volumes  (10  ml  or  more  at  a  time)  shall  be  pyrogen-free and  tested  for  pyrogens.   If 
water or any  other aqueous solvent is  supplied along with the  substances for  preparing such 
solutions, it shall also be pyrogen-free and tested for pyrogens.] 

122. Substances specified in Schedule C(1). –The following provisions shall apply in the 

case of a substance specified in Schedule C (1): – 

3[(a) The container shall comply with the requirements, if any, specified in Schedule 

F or Schedule F (1) 4[or as specified], as the case may be.] 

5 [*  *  *  *   *] 

(c)      The  substance  shall  conform  to  the  standards  of  strength,  quality  and  purity 
specified in Schedule F or Schedule F  (1)  4[or as specified], as the case may be and the 
tests  for  determining  the  strength,  quality  and  purity  of  the  substance  shall  be  those 
specified in Schedule F or Schedule F (1) 4[or as specified,] as the case may be. 

(d) The tests for determining the strength, quality and purity of a substance specified 
in Schedule F or Schedule F (1)  3[or as specified] as the case may be shall be applied to 
samples  taken  from  the   final  product  after  each   manufacturing  process  has  been 
completed. 

(e) The substance should be stored in a cool place and away from light. 

1.  Subs. by G.S.R. 834 (E), dt. 29-12-1999. 
2.  Subs. by SO 1449, dt. 13-06-1961. Earlier Ins. by F.1-27/56-D, dt. 18-12-1956 
3.  Subs. by F.1-6/62-D, dt. 2-7-1969 
4.  Subs. by G.S.R. 663 (E), dt. 3-7-1992 
5. Omitted by G.S.R. 19, dt. 15.12.1977. 

140 

 
 
 
 
 
 
 
 
 
 
 
 
 
  
Drugs and Cosmetics Rules 1945 

1[PART X A. 

IMPORT OF MANUFACTURE OFNEW DRUG FOR CLINICAL 

TRIALS OR MARKETING 

122-A.   Application for  permission to  import new drug.-  2[(1) (a)  No  new drug shall be 
imported,  except  under,  and  in  accordance  with,  the  permission  granted  by  the  Licensing 
Authority as defined in clause (b) of rule 21. 

(b) An application for the grant of permission to import a new drug shall be made in Form 

44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees: 

Provided that where a subsequent application by the same applicant for that drug, whether 
in modified dosage form or with new claims, is made, the fee to accompany such application 
shall be fifteen thousand rupees. 

Provided further that any application received after one year of the grant of approval for 
the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and 
such information and data as required by  3[Appendix I or Appendix IA or Appendix IB] of 
Schedule Y, as the case may be]. 

(2)  The  importer  of  a  new  drug  when  applying  for  permission  under  sub-rule  (1),  shall 
submit  data  as  given  in  3[Appendix  I  or  Appendix  IA  or  Appendix  IB]  to  Schedule  Y 
including  the  results  of  local  clinical  trials  carried  out  in  accordance  with  the  guidelines 
specified in that Schedule and submit the report of such clinical trials in the format given in 
appendix II to the said Schedule: 

Provided that the requirement of submitting the results of local clinical trials may not be 
necessary if the drug is of such a nature that the Licensing Authority may, in public interest, 
decide to grant such permission on the basis of data available from other countries: 

Provided  further  that  the  submission  of  requirements  relating  to  Animal  Toxicology, 
Reproduction  studies,  Teratogenic 
  and 
studies,  Perinatal 
Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for 
several  years  in  other  countries  if  he  is  satisfied  that  there  is  adequate  published  evidence 
regarding the safety of the drug, subject to the other provisions of these rules. 

studies,  Mutagenicity 

2[(3)      The  Licensing  Authority,  after  being  satisfied  that  the  drug  if  permitted  to  be 
imported as  raw  material  (bulk drug  substance) or  as  finished formulation shall  be  effective 
and safe for use in the country, may issue an import permission in Form 45 and/or Form 45- 
A, subject to the conditions stated therein: 

Provided that the Licensing Authority shall, where the data provided or generated on the 
drug  is  inadequate,  intimate  the  applicant  in  writing,  and  the  conditions,  which  shall  be 
satisfied before permission could be considered.] 

122-B.  Application  for  approval  to  manufacture  new  drug   4[***].- 2[(1)(a) No new 
drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined 
in clause (b) of rule 21. 

1. Ins. by  G.S.R. 944 (E), dt. 21-9-1988. 
2. Subs. by G.S.R. 900 (E), dt. 12.12.2001. 
3. Subs. by G.S.R. 918 (E), dt. 30.11.2005. 
4. Omitted by G.S.R. 26 (E), dt. 19.01.2006.

141 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(b)  An  application  for  the  grant  of  approval  to  manufacture  the  new  drug  and  its 
formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of 
Rule 21 and shall be accompanied by a fee of fifty thousand rupees: 

Provided  that  where  the  application  is  for  permission  to  import  a  new  drug  (bulk  drug 
substance) and grant of approval to manufacture its formulation/s, the fee to accompany such 
application shall be fifty thousand rupees only. 

Provided further that where a subsequent application by the same applicant for that drug, 
whether in modified dosage form or with the new claims, is made, the fee to accompany such 
subsequent application shall be fifteen thousand rupees: 

Provided also that any application received after one year of the grant of approval for the 
manufacture  for  sale  of  the  new  drug,  shall  be  accompanied  by  a  fee  of  fifteen  thousand 
rupees  and  such  information  and  data  as  required  by  4[Appendix  1  or  Appendix  1A or 
Appendix IB]  of Schedule Y, as the case may be.] 

(2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the 
Licensing Authority mentioned in the said sub-rule, shall submit data as given in  4[Appendix 
1    or    Appendix  1A  or  Appendix  IB]  to  Schedule  Y  including  the  results  of  clinical  trials 
carried  out  in  the  country  in  accordance  with  the  guideline  specified  in  Schedule  Y  and 
submit  the  report  of  such  clinical  trials  in  the same format given in Appendix II to the said 
Schedule. 

1[(2A) The Licensing authority as defined in clause (b) of rule 21 after being satisfied that 
the drug if approved to be manufactured as raw material (bulk drug substance) or as finished 
formulation shall be effective and safe for use in the country, shall issue approval in Form 46 
and/or Form 46A,  as the case may be, subject to the conditions stated therein: 

Provided that the Licensing Authority shall, where the data provided or generated on the 
drug  is  inadequate,  intimate  the  applicant  in  writing,  and  the  conditions,  which  shall  be 
satisfied before permission could be considered.] 

(3)  When  applying  for  approval  to  manufacture  a  new  drug  under  sub-rule  (1)  or  its 
preparations,  to  the  State  Licensing  Authority,  an  applicant  shall  produce  along  with  his 
application,  evidence  that  the  drug  for  the  manufacture  of  which  application  is  made  has 
already been approved 5[in the name of the applicant] by the Licensing Authority mentioned in 
Rule 21: 

Provided that the requirement of submitting the results of local clinical trials may not be 
necessary  if  the  drug  is  of  such  nature  that  the  6[Licensing  Authority  in  Rule  21]  may,  in 
public  interest,  decide  to  grant  such  permission  on  the  basis  of  data  available  from  other 
countries: 

Provided  further  that  the  submission  of  requirements  relating  to  Animal  Toxicology, 
Reproduction  studies,  Teratogenic  studies, 
  Perinatal    studies,    Mutagenicity    and 
Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed for 
several  years  in  other  countries  if  he  is  satisfied  that  there  is  adequate  published  evidence 
regarding the safety of the drug, subject to the other provisions of these rules. 

2 [*  * *  *  *] 
3[122D.     Permission  to  import  or  manufacture  fixed  dose  combination.-     (1)  An 
application for  permission to  import or  manufacture fixed  dose  combination of  two  or  more 
drugs  as  defined  in  clause  (c)  of  rule  122-E  shall  be  made  to  the  Licensing  Authority  as 
defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees 
and  shall  be  accompanied  by  such  information  and  data  as  is  required  in  Appendix  VI  of 
Schedule Y. 

1. Ins. by G.S.R. 900(E), dt. 12-12-2001. 
2. Rules 122-C omitted, by G.S.R. 900(E), dt. 12-12-2001. 
3. Subs. by G.S.R. 900(E), dt. 12-12-2001. 
4. Subs. by G.S.R. 918(E), dt. 30-11-2015. 
5. Ins. by G.S.R. 26 (E), dt. 19-01-2006. 
6. Subs. by G.S.R. 26 (E), dt. 19-01-2006.

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(2)  The  Licensing  Authority  after  being  satisfied  that  the  fixed  dose  combination  if 
approved to be imported or  manufactured as finished formulation shall be effective and safe 
for  use  in  the  country,  shall  issue  permission  in  Form  45  or  Form  46,  as  the  case  may  be, 
subject to the conditions stated therein: 

Provided that the Licensing Authority shall, where the data provided or generated on the 
fixed  dose  combination  is  inadequate,  intimate  the  applicant  in  writing,  and  the  conditions 
which shall be satisfied before grant of approval/permission could be considered. 

122DA.    Application    for    permission    to    conduct    clinical    trials    for    New 
Drug/Investigational New  Drug.− (1) No  clinical  trial  for  a  new  drug,  whether  for  clinical 
investigation or  any  clinical  experiment by  any  institution, shall be  conducted except  under, 
and  in  accordance  with,  the  permission,  in  writing,  of  the  Licensing  Authority  defined  in 
clause (b) of Rule 21. 

(2) An application for grant of permission to conduct− 

(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing 
Authority  in  Form  44  accompanied  by  a  fee  of  fifty  thousand  rupees  and  such 
information and data as required under Schedule Y. 

(b)  exploratory   clinical  trials  (Phase-II)  on  a  new  drug  shall  be  made  on  the 
basis  of  data  emerging  from  Phase-I  trial,  accompanied  by  a  fee  of  twenty-five 
thousand rupees; 

(c)  confirmatory  clinical  trials  (Phase-III)  on  a  new  drug  shall  be  made  on  the 
basis  of  the  data  emerging  from  Phase-II  and  where  necessary, data  emerging  from 
Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees: 

Provided  that  no  separate  fee  shall  be  required  to  be  paid  along  with  application  for 
import/manufacture of a new drug based on successful completion of phases clinical trials by 
the applicant: 

Provided  further  that  no  fee  shall  be  required  to  be  paid  along  with  the  application  by 
Central  Government  or  State  Government  Institutes  involved  in  clinical  research  for 
conducting trials for academic or research purposes. 

(3)  The  Licensing  Authority  after  being  satisfied  with  the  clinical  trials,  shall  grant 
permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to 
the conditions stated therein: 

Provided that the Licensing Authority shall, where the data provided on the clinical trials 
is  inadequate,  intimate  the  applicant  in  writing,  within  six  months  from  the  date  of  such 
intimation  or  such  extended  period,  not  exceeding  a  further  period  of  six  months,  as  the 
Licensing  Authority  may,  for  reasons  to  be  recorded  in  writing,  permit,  intimating  the 
conditions which shall be satisfied before permission could be considered. 

1[(4) No permission for conduct of clinical trial intended for academic purposes in respect 
of  approved  drug  formulation  shall  be  required  for  any  new  indication  or  new  route  of 
administration or new dose or new dosage form where,-  
(a) the trial is approved by the Ethics Committee; and  
(b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to 
licensing authority.  

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1. Ins. by G.S.R. 313(E), dt. 16-03-2016. 

Drugs and Cosmetics Rules 1945 

(5) The  Ethics  Committee shall however inform  the  licensing  authority  about the  cases 
approved by it and also about cases where there could be an overlap between the clinical trial 
for  academic  and  regulatory  purposes  and  where  the  said  authority  does  not  convey  its 
comments to the Ethics Committee within a period of thirty days from the date of receipt of 
communication from the Ethics Committee, it shall be presumed that no permission from the 
licensing authority is required.] 

 1[Explanation:- —For the purposes of these rules,—  
(a)  ―Clinical  Trial‖  means  a  systematic  study  of  any  new  drug(s)  in  human  subject(s)  to 
generate  data  for  discovering  and/or  verifying  the  clinical,  pharmacological  (including 
pharmacodynamic  and  pharmacokinetic),  and/or  adverse  effects  with  the  objective  of 
determining safety and/or efficacy of the new drug;  
(b)  ―Global  Clinical  Trial‖  means  any  clinical  trial  which  is  conducted  as  part  of  multi-
national clinical development of a drug;  
(c) ―Investigational New Drug‖ means a new chemical entity or a product having therapeutic 
indication but which has never been tested earlier on human being;  
(d) ―New Chemical Entity‖ means an active substances in developmental stage which may be 
specified as a drug under the Act, after undergoing any clinical trial.] 

2[****] 

3[122-DAB-  Compensation in case of injury or death during clinical trial.- 
4[(1)  In  case  of  an  injury  occurring  to  the  subject  during  the  clinical  trial,  free  medical 
management shall be given as long as required or till such time it is established that the injury 
is not related to the clinical trial, whichever is earlier.] 

(2)      In  case,  the  injury  occurring  to  the  trial  subject  is  related  to  the  clinical  trial,  such 
subject  shall  also  be  entitled  for  financial  compensation  as  per  order  of  the  Licensing 
Authority defined under clause (b) of Rule 21, and the financial compensation will be over and 
above any expenses incurred  on the medical management of the subject. 

5[(2A)  In  case,  there  is  no  permanent  injury,  the  quantum  of  compensation  shall  be 

commensurate with the nature of the non-permanent injury and loss of wages of the subject.] 

(3)   In the case of clinical trial related death of the subject, his / her nominee(s) would be 
entitled for financial compensation, as per the order of the Licensing Authority defined under 
clause  (b)  of  Rule  21  and  the  financial  compensation  will  be  over  and  above  any  expenses 
incurred  on the medical  management of such subject. 

(4)      The  expenses  on  medical  management  and  financial  compensation  in  the  case  of 
clinical  trial  injury  or  death  of  the  trial  subject  shall  be  borne  by  the  sponsor  of  the  clinical 
trial. 

(5)  Any injury or death of the subject occurring in clinical trial due to following reasons 
shall  be  considered    as  clinical  trial  related  injury  or  death  and  the  subject  or  his/her 
nominees(s),    as  the  case  may  be,  are  entitled  for  financial  compensation  for  such  injury  or 
death: 

(a)  Adverse effect of investigational product(s); 
(b)  Violation  of  the  approved  protocol,  scientific  misconduct  or  negligence  by  the 

sponsor or his representative or the investigator; 
1. Subs. by G.S.R. 826 (E), dt. 30-10-2015 with following explanation. 

―Explanation.−For the  purpose  of  these  rules  Investigational  New  Drug  means  a  new chemical  entity  or  a 

product having therapeutic indication but which have never been earlier tested on human beings.‖ 
2. Omitted rule 122DAA by G.S.R. 826 (E), dt. 30-10-2015, before omission it stood as under: 

―122DAA. Definition of  Clinical  trial.--For the  purpose of  this Part,   ―Clinical  trial‖ means a systematic study 
of new drug(s) in human subject(s) to generate data for discovering and/or  verifying the  clinical,  pharmacological 
(including  pharmacodynamic  and  pharmacokinetic)  and/or  adverse  effects  with  the  objective  of  determining 
safety and / or efficacy of the new drug.‖ 
3. Ins. by G.S.R. 53 (E), dt. 30-01-2013. 
4. Subs. by G.S.R. 889 (E), dt. 12-12-2014. 
5. Ins. by G.S.R. 889 (E), dt. 12-12-2014. 

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(c) 

Failure of investigational product to provide intended therapeutic effect, where, the 
standard  care,  though  available,  was  not  provided  to  the  subject  as  per  the  clinical  trial 
protocol;  

(d)  Use  of  placebo  in  a  placebo-controlled  trial  where,  the  standard  care,  though 

available, was not provided to the subject as per the clinical trial protocol; 

(e)  Adverse  effects 

  due  to  concomitant  medication  excluding  standard  care, 

necessitated as part of approved protocol; 

For injury to a child in-utero because of the participation of parent in clinical trail; 

(f) 
(g)  Any clinical trial procedures involved in the study. 
(6)    The  sponsor,  whether    a  pharmaceutical  company  or  an  institution  shall  give  an 
undertaking along with the application for clinical trail permission to the Licensing Authority 
defined in clause (b) of  Rule 21, to provide compensation in the case of clinical trial related 
injury or death for which subjects are entitled to compensation. 

(7)    In case, the sponsor fails to provide medical management for the injury to the subject 
and / or financial compensation to the trial subject for clinical trial related injury or financial 
compensation to the subject‘s nominee(s) in case of clinical trial related death of the subject, 
the  Licensing  Authority  may  after  giving  an  opportunity  to  show  cause  why  such  an  order 
should not be passed, by an order in writing, stating the reasons thereof, suspend or cancel the 
clinical  trial  and  /  or  restrict  Sponsor  including  his  representative(s)  to  conduct  any  further 
clinical trials in the country or take any other action deemed fit under the rules.] 

1[122 DAC. Permission to conduct clinical trial:- (1) The Licensing Authority as defined 
in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in 
support of the proposed clinical trial is adequate in all respects, issue permission  for conduct 
of clinical trial, subject to the following conditions, namely:- 

(a)  Clinical    trial    shall    be  conducted    in    compliance  with  the  approved    protocols, 
requirements  of  Schedule  Y  annexed  to  these  rules,  Good  Clinical  Practice  Guidelines  for 
conduct of clinical trials in India and other applicable regulations; 

(b)  Approval of the Ethics Committee shall be obtained before initiation of the study;  
(c)  Clinical trial shall be registered at Clinical Trials Registry of India before enrolling 

the first patient for the study; 

(d)  Annual status report of each clinical trial, as to whether it is ongoing, completed or 
terminated,  shall  be  submitted  to  the  Licensing  Authority  and  in  case  of  termination  of  any 
clinical  trial the  detailed  reasons  for the  same  shall be  communicated    to  the said  Licensing 
Authority; 

(e)  Any  report  of  serious  adverse  event  occurring    during  clinical  trial  to  the  subject, 
after due analysis, shall be forwarded within ten days of its occurrence as per Appendix  XI 
and in compliance with the procedures prescribed in Schedule Y; 

(f) 

In case of an injury or death during the clinical trial to the subject of the clinical trial 
the  applicant  shall  provide  complete  medical  management  and  compensation  in  the  case  of 
trial  related  injury or death in  accordance with  Rule 122 DAB and the procedures prescribed 
under Schedule Y, and the details of compensation provided in such cases shall be intimated to 
the Licensing Authority within thirty days of the receipt of the order of the said authority;  

(g) 

The  premises  of  Sponsor  including    their  employees,  subsidiaries  and  branches, 
their  agents,  contractors    and  sub-contractors    and  clinical    trial    sites  shall    be  open  to 
inspection  by the officers  authorized  by the Central  Drugs Standard  Control Organization, 
who  may  be  accompanied  by  an  officer    of  the  State  Drug  Control  Authority  concerned,  to 
verify compliance to the requirements of Schedule Y, Good Clinical Practices guidelines for 
conduct of clinical trials in India and other applicable regulations; 

1. Ins. by G.S.R. 63 (E), dt. 01-02-2013. 

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(h) 

The  Sponsor  including    their    employees,  subsidiaries  and  branches,  their  agents, 
contractors and sub-contractors and clinical trial sites and the investigator shall allow officers 
authorized by the Central Drug Standard Control Organization, who may be accompanied by 
an officer of the State Drug Control Authority concerned, to enter with or without prior notice, 
any  premises  of  sponsor  including  their  employees,  subsidiaries  and  branches,  their  agents, 
contractors and sub-contractors and clinical trial sites to inspect, search and seize any record, 
data, document, books, investigational drugs etc. related to clinical trials and provide adequate 
replies to any queries raised by the inspecting authority in relation to the conduct of clinical 
trial; 

(2) Notwithstanding the conditions specified in sub-Rule (1), the Licensing Authority, on 
being satisfied that the data submitted along with the application  in support of the proposed 
clinical trial is adequate in all respect, may also impose such additional conditions for issuance 
of  permission  in  respect  of  specific  clinical  trials,  if  considered  necessary,  regarding    the 
objective,  design, subject population,  subject eligibility, assessments, conduct  and treatment  
of such clinical trial. 

(3)    If  any  Sponsor  including  their    employees,  subsidiaries  and  branches,  their    agents, 
contractors  and  sub-contractors,  Investigators  conducting  clinical  trial  and  clinical  trial  sites 
fail to comply with any of the above conditions,  the Licensing Authority, may, after giving an 
opportunity  to  show  cause  why  such  an  order  should  not  be  passed,  by  an  order  in  writing 
stating the reasons thereof,- 

(a)  Issue  warning  letter  giving  details  of  deficiency  found  during  the  inspection,  which 
might  affect  the  right  or  well-being  of  the  clinical  trial  subject  or  the  validity  of  the  study 
conducted at that site; 

(b) Recommend that study may be rejected or discontinued;  
(c) Suspend or cancel the clinical trial permission; 
(d)  Debar    the  Investigator(s),    Sponsor  including  their    employees,    subsidiaries    and 

branches, their agents, contractors and sub-contractors to conduct any clinical trial in future. 

(4)  The  Sponsor  including  their    employees,  subsidiaries  and  branches,  their    agents, 
contractors  and  sub-contractors  and  clinical  trial  Investigators,  against  whom  action  as 
mentioned  in  sub-  Rule  (3)  has  been  taken  by  the  Licensing  Authority,  may,  within  ninety 
days of the receipt of the copy of the order of the Licensing Authority prefer an appeal to the 
Central  Government,  and  the  Central  Government  may,  after  giving  such  appellant  an 
opportunity of being heard, confirm, reverse or modify such order.] 

122DB.      Suspension  or  cancellation  of  Permission/Approval.-  If  the  importer  or 
manufacturer under this Part fails to comply with any of the conditions of the permission or 
approval, the Licensing Authority may,  after  giving an  opportunity to  show cause why  such 
an order should not be passed, by an order in writing stating the reasons therefor, suspend or 
cancel it. 

122DC.   Appeal.-   Any person aggrieved by an order passed by the Licensing Authority 
under  this  Part,  may  within  sixty  days  from  the  date  of  such  order,  appeal  to  the  Central 
Government,  and  the  Central  Government  may,  after  such  enquiry  into  the  matter  as  is 
considered necessary, pass such order in relation thereto as it thinks fit. 

1[122 DD. Registration of Ethics Committee:- (1)   No Ethics Committee shall review and 
accord  its  approval  to  a  clinical  trial  protocol  without  prior  registration  with  the  Licensing 
Authority as defined in clause (b) of Rule21:  

      Provided  that  any  Ethics  Committee,  existing  on  the  date  of  commencement  of  the 
Drugs  and  Cosmetics  (Third  Amendment)  Rules,  2013,  who  has  already  reviewed    and 
accorded approval to clinical trial protocol, shall obtain registration within a period of forty-
five days from the date of commencement of Drugs and Cosmetics  (Third Amendment) Rules, 
2013. 

1. Ins. by G.S.R. 72 (E), dt. 08-02-2013. 

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(2)   An application for registration of Ethics Committee shall be made to the Licensing 
Authority in accordance with the requirements  as specified in the Appendix VIII of Schedule 
Y. 

(3)      The  Licensing  Authority  after  being  satisfied  that  the  requirements  have  been 
complied  with,  may  grant  registration  to  the  Ethics  Committee  subject  to  such  conditions  as 
may be stated therein. 

(4)   The Ethics Committee shall review and accord its approval to a clinical trial and also 
carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y, and the 
Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory 
requirements for safeguarding the rights, safety and well-being of the trial subjects. 

(5)  In the case of any serious adverse event occurring  to the clinical trial subjects during 
the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure 
specified under APPENDIX XII of Schedule Y. 

(6)    The  Ethics  Committee  shall  allow  inspectors  or  officials  authorized  by  the  Central 
Drugs Standard Control Organization to enter its premises to inspect any record, data or any 
document  related  to  clinical  trial  and  provide  adequate  replies  to  any  query  raised  by  such 
inspectors or officials, as the case may be in relation to the conduct of clinical trial. 

(7)  The registration, unless it is suspended or cancelled, shall be valid for a period of three 

years from the date of issue: 

Provided that if the application for re-registration is received by the Licensing Authority 
within three months before the expiry, the registration shall continue to be in force until orders 
are passed by the said authority: 

Provided further that the Licensing Authority shall be informed in writing in case of any 

change in the membership or the constitution of the Ethics Committee takes place. 

(8)    If  the  Licensing  Authority  is  not  satisfied,  he  shall  reject  the  application  and  shall 
inform  the  applicant  of  the  reasons  for  such  rejection  and  the  conditions  which  must  be 
satisfied before the registration can be granted. 

(9)  If the Ethics Committee fails to comply with any of the conditions of registration, the 
Licensing Authority may, after giving an opportunity to show cause why such an order should 
not  be  passed,  by  an  order  in  writing  stating  the  reasons  therefor,  suspend  or  cancel  the 
registration of the Ethics Committee for such period as considered necessary. 

(10)  The  Ethics  Committee  whose  registration    has  been  suspended  or  cancelled  by  the 
Licensing Authority, may, within ninety days of the receipt of the copy of the order, prefer an 
appeal to the Central Government and the Central Government may after giving an opportunity 
of being heard, confirm, reverse or modify such order. 

Explanation:-    For  the  purpose  of  this  Rule  an  Ethics  Committee  is  a  committee 
comprising  of  medical,  scientific,  non-medical  and  nonscientific  members,  whose 
responsibility is to ensure the protection of the rights, safety and will-being of human subjects 
involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, 
the suitability of the investigators, facilities, methods and adequacy of information to be used 
for  obtaining  and  documenting  informed  consent  of  the  study  subjects  and  adequacy  of 
confidentiality safeguards.] 

122E. Definition of  new drug.-   For the  purpose of  this  Part, new  drug shall  mean and 

include- 

1[(a)  A  drug,  as  defined 

including  bulk  drug  substance  2[or 
the  Act 
phytopharmaceutical  drug]  which  has  not  been  used  in  the  country  to  any  significant extent 
under the conditions prescribed, recommended or  suggested  in  the  labelling  thereof  and  has 
not been recognized as  effective and safe by the licensing authority mentioned under rule 21 
for the proposed claims: 

in 

1. Ins. by G.S.R. 591 (E), dt. 17-8-1999. 
2. Ins. by G.S.R. 918 (E), dt. 30-11-2015. 

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Provided  that  the  limited  use,  if  any,  has  been  with  the  permission of  the  licensing 

Drugs and Cosmetics Rules 1945 

authority.] 

(b)  A   drug  already  approved by  the  Licensing Authority mentioned in  Rule  21  for 
certain claims, which is now proposed to be marketed with modified or new claims, namely, 
indications,  dosage,  dosage  form  (including  sustained  release  dosage  form)  and  route  of 
administration. 

(c) A fixed dose combination of two or more drugs, individually approved earlier for 
certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if 
the ratio of  ingredients in an  already marketed combination is  proposed to  be  changed, with 
certain  claims,  viz.  indications,  dosage,  dosage  form  (including  sustained  release  dosage 
form) and route of administration. (See items (b) and (c) of  Appendix VI to Schedule Y.) 

Explanation.- For the purpose of this rule− 

1[(i)   all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs 

unless certified otherwise by the Licensing Authority under Rule 21;] 

(ii)   a new drug shall continue to be considered as new drug for a period  of four years 

from the date of its first approval 2[***].] 

1. Ins. by  G.S.R. 45(E), dt. 24.01.2011. 
2. Omitted by G.S.R. 724(E), dt. 7.11.2013, the following words,- 
   ―or its inclusion in the Indian Pharmacopoeia Whichever is earlier‖. 

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1[PART XB 

REQUIREMENTS FOR THE COLLECTION, STORAGE, 
PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD, 
HUMAN BLOOD COMPONENTS BY BLOOD BANKS 
ANDMANUFACTURE OF BLOOD PRODUCTS 

2[122EA.  Definitions.- (1) In this Part and in the Forms contained in Schedule A and in 
Part XII-B,  3[Part XII-C and Part XIID] of Schedule F, unless there is anything repugnant in 
the subject or context− 

(a)  ―apheresis‖  means  the  process  by  which  blood  drawn  from  a  donor,  after 
separating plasma or platelets, or leucocytes, is re-transfused simultaneously into the said 
donor; 

(b)  ―autologous  blood‖  means  the  blood  drawn  from  the  patient  for  re-transfusion 

unto himself later on; 

(c) ―blood‖ means and includes whole human blood, drawn from a donor and mixed 

with an anti-coagulant; 

(d)  ―blood  bank‖  means  a  place  or  organization  or  unit  or  institution  or  other 
arrangements made by such organization, unit or institution for carrying out all or any of 
the  operations  for  collection,  apheresis,  storage,  processing  and  distribution  of  blood 
drawn from donors and/or for preparation, storage and distribution of blood components; 

(e) ―blood component‖ means a drug prepared, obtained, derived or separated from a 

unit of blood drawn from a donor; 

(f)   ―blood product‖ means a  drug manufactured or obtained from pooled plasma of 

blood by fractionation, drawn from donors; 

4[(fa) ―cord blood bank‖ means a place  or organization or unit for carrying out and 
responsible  for  operations  of  collection,    processing,  testing,  banking,  selection  and 
release of cord blood units;] 

(g) ―donor‖ means a person who voluntarily donates blood after he has been declared 
fit  after  a  medical  examination,  for  donating  blood,  on  fulfilling  the  criteria  given 
hereinafter,  without  accepting  in  return  any  consideration  in  cash  or  in  kind  from  any 
source but does not include a professional or a paid donor. 

Explanation.-  For  the  purposes  of  this  clause,  benefits  or  incentives  like  pins,  plaques, 
badges,  medals,  commendation  certificates,  time-off  from  work,  membership  of  blood 
assurance  programme,  gifts  of  little  or  intrinsic  monetary  value  shall  not  be  construed  as 
consideration; 

(h) ―leucapheresis‖ means the process by which the blood drawn from a donor, after 
leucocyte  concentrates  have  been  separarated  is  re-transfused   simultaneously  into  the 
said donor; 

(i) ―plasmapheresis‖ means the process by which the blood drawn from a donor, after 

plasma has been separated, is re-transfused during the same sitting into the said donor; 

(j) ―plateletpheresis‖ means the process by which the blood drawn from a donor, after 
platelet  concentrates  have  been  separated,  is  re-transfused  simultaneously  into  the  said 
donor; 

(k)  ―professional  donor‖  means  a  person  who  donates  blood  for  a  valuable 
consideration,  in  cash  or  kind,  from  any  source,  on  behalf  of  the  recipient-patient  and 
includes a paid donor or a commercial donor; 

(l)  ―replacement  donor‖  means  a  donor  who  is  a  family  friend  or  a  relative  of  the 

patient-recipient.] 

1.  Ins. by G.S.R. 28(E), dt. 22-1-1993.  
2.  Ins. by G.S.R. 245 (E), dt. 5-04-1999. 
3.  Subs. by G.S.R. 899 (E), dt. 27-12-2011. 
4. Ins. by G.S.R. 899 (E), dt. 27-12-2011.

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4[(m) ―umbilical cord blood‖ is the whole blood including Hematopoietic Progenitor Cells 
collected  from  placental  and  or  Umbilical  cord  blood  vessels  after  the  umbilical  cord  have 
been clamped.] 

122-F.  Form  of  application  for  licence  for  operation  of  Blood  Bank/processing  of 
whole  human  blood  for  components/manufacture  of  blood  products  for  sale  or 
distribution 4[, collection, processing, testing, storage, banking and release of umbilical cord 
blood stem cells.]-   (1) Application for the grant and/or renewal of licence for the operation 
of  a  Blood  Bank/processing  of  human  blood  for  components/manufacture  of  blood 
products  4 [ collection, processing, testing,  storage, banking  and release of umbilical cord blood 
stem cells] shall  be made to the Licensing Authority appointed under Part VII in  1[Form 27-
C or  5[Form 27-E or Form 27-F], as the case may be], and shall be accompanied by 3[licence 
fee of rupees six thousand and an inspection  fee of rupees one thousand and five hundred for 
every inspection thereof or for the purpose of renewal of licence]: 

Provided that if the applicant applies for renewal of licence after its expiry but within six 
months  of  such  expiry  the  fee  payable  for  the  renewal  of  the  licence  3[shall  be  rupees  six 
thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at 
the rate of rupees one thousand per month or a part thereof in addition to the inspection fee]: 

5[Provided further that a licensee holding  a license in Form 28-C, Form 28-E or Form 28-
F  as  the    case  may  be,  for  operation  of  Blood  Bank/  processing  of  whole  human  blood  for 
components / manufacture of blood products / collection, processing testing storage, banking 
and release of umbilical cord blood stem cells shall apply for grant of license under sub Rule 
(1) before the expiry of the said license in Form 27-C, Form 27-E or Form 27-F as the case 
may  be  and  he  shall    continue  to  operate  the  same  till  the  orders  on  his  application  are 
communicated to him.] 

2[***] 
(2)  A fee of 3[rupees one thousand] shall be paid for a duplicate copy of a licence issued 

under this rule, if the original is defaced, damaged or lost. 

(3)  Application  by  a  licensee  to  manufacture  additional  drugs  listed  in  the  application 
shall  be  accompanied  by  a  fee  of   3[rupees  three  hundred]  for  each  drug  listed  in  the 
application. 

(4) On receipt of the application for the grant or renewal of such licence, the Licensing 

Authority shall,– 

(i) verify the statements made in the application form; 
(ii) cause the manufacturing and testing establishment to be inspected in accordance 

with the provision of rule 122-I; and 

(iii)  in  case  the  application is  for  renewal of  licence, call  for  information of  past 

performance of the licensee. 

(5) If the   Licensing Authority is satisfied that the applicant is  in  a  position to  fulfil the 
requirements laid  down  in  the  rules,  he  shall  prepare  a  report  to  that  effect  and  forward  it 
6[along  with  the  application  and  the  licence  (in  triplicate)  to  be  granted  or  renewed,  duly 
completed] to the Central Licence Approving Authority: 

Provided  that  if  the  Licensing  Authority  is  of  the  opinion  that  the  applicant  is  not  in  a 
position to fulfil the requirements laid down in these rules, he may, by order, for reasons to be 
recorded in writing, refuse to grant or renew the licence, as the case may be. 

(6)  If,  on  receipt  of  the  application and  report  of  the  Licensing Authority referred  to  in 
sub-rule  7[(5)]  and  after  taking  such  measures  including  inspection  of  the  premises  by  the 
Inspector, appointed by the Central  Government under section 21  of  the  Act,  and/or  along 

1.   Subs. by  G.S.R. 245(E), dt. 5.4.1999.                                 4. Ins. by  G.S.R. 899 (E), dt. 27-12-2011. 
2.   Explanation omitted by G.S.R. 733 (E), dt. 21.12.2005 earlier Ins. by G.S.R. 89(E), dt. 14-2-1996.   
3.   Subs. by G.S.R. 601(E), dt. 24-8-2001.                               5. Subs. by  G.S.R. 899 (E), dt. 27-12-2011. 
6.   Ins. by G.S.R. 89 (E), dt. 14.2.1996.            
7.   Corrected by corrigendum G.S.R. 447 (E), dt. 10-06-1993.

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with  the  Expert  in  the  field  concerned if  deemed  necessary, the  Central  Licence  Approving 
Authority is satisfied that the applicant is in a position to fulfil the requirements laid down in 
these rules, he may grant or renew the licence, as the case may be: 

Provided  that  if  the  Central  Licence  Approving  Authority  is  of  the  opinion  that  the 
applicant  is  not  in  a  position  to  fulfil  the  requirements  laid  down  in  these  rules  he  may, 
notwithstanding the report of the Licensing Authority, by order, for reasons to be recorded in 
writing, reject  the  application for  grant or  renewal of  licence, as  the  case  may  be,  and  shall 
supply the applicant with a copy of the inspection report. 

122G.  Form  of  Licence  for  the  operation  of  a  Blood  Bank/processing  of  whole 
human blood for components and manufacture of blood products  3[/manufacture of blood 
products/collection,  processing,  testing,  storage,  banking  and  release  of  umbilical  cord 
blood  stem  cells]  and  the  conditions  for  the  grant  or  renewal  of  such  licence.−  2[(1)]  A 
licence  for  the  operation  of  a  Blood  Bank  or  for  processing  whole  human  blood  for 
components  and  3[/manufacture  of  blood  products/collection,  processing,  testing,  storage, 
banking and release of umbilical cord blood stem cells] shall be issued in 1[Form 28C or Form 
28E  or  3[Form  28F  or  Form  26G  or  Form26-I  or  Form  26J,  as  the  case  may  be,  before  a 
license in Form 28C or Form 28E or Form28-F or Form 26G or Form 26-I or Form 26-J], as 
the case may be,] is granted or renewed the following conditions shall be complied with by the 
applicant:- 

1[(i)  The  operation  of  Blood  Bank  and/or  processing  of  whole  human  blood  for 
components  shall  be  conducted  under  the  active  direction  and  personal  supervision  of 
competent technical staff consisting of at least  one person who is whole time employee 
and who is Medical Officer, and possessing- 

(a)    Postgraduate    degree    in    Medicine    -    M.D    (Pathology/Transfusion 

Medicines); or 

(b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion 
Medicines  having  adequate  knowledge  in  blood  group  serology,  blood  group 
methodology  and  medical  principles  involved  in  the  procurement  of  blood  and/or 
preparation of its components; or 

(c)  Degree  in  Medicine (M.B.B.S.) having  experience in  Blood  Bank  for  one 
year  during  regular  service  and  also  has  adequate  knowledge  and  experience  in 
blood group serology, blood group methodology and medical principles involved in 
the procurement of blood and/or preparation of its components, 

the degree or diploma being from a University recognized by the Central Government. 

Explanation.- For  the  purposes of  this  condition, the  experience in  Blood  Bank  for 
one  year  shall  not  apply  in  the  case  of  persons  who  are  approved  by  the  Licensing 
Authority  and/or  Central  Licence  Approving  Authority  prior  to  the  commencement  of 
the Drugs and Cosmetics (Second Amendment) Rules, 1999]. 

(ii)   The  applicant shall provide adequate space, plant and equipment for any or all 
the  operations  of  blood  collection  or  blood  processing.  The  space,  plant  and  equipment 
required for various operation is given in Schedule ‗F‘, Part XIIB and/or XIIC 4[or XIID]. 

(iii) The applicant shall provide and maintain adequate technical staff as specified in 

Schedule F, Part XIIB and/or XIIC 4[or XIID]. 

(iv)  The  applicant  shall  provide  adequate  arrangements  for  storage  of  whole 

human blood, human blood components and blood products. 

(v) The applicant shall furnish to the Licensing Authority, if required to do so, 
data  on  the  stability  of  whole  human  blood,  its  components  or  blood  products 
which are likely to deteriorate, for fixing the date of expiry which shall be printed 
on the labels of such products on the basis of the data so furnished. 

1.  Ins. by GSR 245(E), dt. 5-4-1999. 
2. Renumbered as sub-rule (1) by GSR 733(E), dt. 21-12-2005. 
3. Subs. by GSR 899(E), dt. 27-12-2011.                                     4. Ins. by GSR 899(E), dt. 27-12-2011.

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3[(2) Application for grant or renewal of a licence for operation of Blood Bank or processing 
of human blood components shall be made by the Blood Bank run by the Government, Indian 
Red  Cross  Society,  hospital,  charitable  trust  or  voluntary  organization  approved  by  a  State/ 
Union Territory Blood Transfusion Council only. 

Explanation.–  For  the  purpose  of  this  sub-rule,  ―renewal‖  shall  include  renewal  of  any 
licenceissued  prior  to  the  commencement  of  the  Drugs  and  Cosmetics  (……..Amendment)  
Rules,2005.] 

122H. Duration of licence.-   An original licence in  1[Form 28C or Form 28E  4[or Form 
28F]  or  a  renewed  licence  in  Form  26G  or  Form  26-I]  4[or  Form  26J]  unless  sooner 
suspended  or  cancelled  shall  be  2[valid  for  a  period of  five  years  on  and  from  the  date  on 
which] it is granted or renewed. 

122-I.  Inspection  before  grant  or  renewal  of  licence  for  operation  of  Blood  Bank, 
processing  of    whole  human  blood  for  components  and  manufacture  of    blood 
products.-  Before  a  licence  in  1[Form  28C  or  Form  28E  4[or  Form  28F]    is  granted  or  a 
renewal of licence in form 26G or Form 26-I 4[or Form 26J] is made, as the case may be,] the 
Licensing  Authority  or  the  Central  Licence  Approving  Authority,  as  the  case  may  be,  shall 
cause the establishment in which Blood Bank is proposed to be operated/whole human blood 
for  components  is  processed/  blood  products  are  manufactured  to  be  inspected  by  one  or 
more Inspectors, appointed under the Act and/or along with the Expert in the field concerned. 
The 
the  premises  and 
Inspectors  shall  examine  all  portions  of 
appliances/equipments  and  inspect  the  process  of  manufacture  intended  to  be  employed  or 
being  employed  along  with  the  means  to  be  employed  or  being  employed  for  operation  of 
blood  bank/processing  of  whole  human  blood  for  components/manufacture  of  blood 
products  together  with  their  testing  facilities  and  also  enquire  into  the  professional 
qualification of the expert staff and  other technical staff to  be employed. 

Inspector  or 

122J. Report    by   Inspector.-The  Inspector    or   Inspectors    shall   forward    a   detailed 
descriptive  report  giving  his  findings  on  each  aspect  of  inspection  along  with  his 
recommendation in accordance with the provisions of rule 122-I to the Licensing Authority or 
to the Central Licence Approving Authority. 

122K.   Further  application  after  rejection.-  If  within  a  period  of  six  months  from  the 
rejection  of  application  of  a  licence  the  applicant  informs  the  Licensing  Authority  that  the 
conditions  laid  down  have  been  satisfied  and  deposits  an  inspection  2[fee  of  rupees  two 
hundred and fifty] the Licensing Authority may, if after causing further inspection to be made 
is satisfied that the conditions for the 1[grant or renewal of a licence have been complied with, 
shall grant or renew the licence in Form 28C or Form 28E 4[or Form 28F]: 

Provided that in the case of a drug notified by the Central Government under rule 68-A, 
the application, together with the inspection report and the Form of licence (in triplicate to be 
granted  or  renewed),  duly  completed  shall  be  sent,  to  the  Central  Licence  Approving 
Authority, who may approve the same and return it to the Licensing Authority for issue of the 
licence.] 

122L. Delegation of powers by the Central Licence Approving Authority.-  The Central 
Licence  Approving  Authority  may,  with  the  approval  of  the  Central  Government,  by 
notification  delegate  his  powers  of  signing  licences  and  any  other  power  under  rules  to 
persons under his  control having same qualifications as  prescribed for Controlling Authority 
under rule 50-A, for such areas and for such periods as may be specified. 

122M. Provision for appeal to the State Government by a party whose licence has not 
been granted or renewed.-  Any person who is aggrieved by the order passed by the Licensing 
Authority  or  Central  Licence  Approving  Authority,  as  the  case  may  be,  may  within  thirty 
days  from  the  date  of  receipt  of  such  order,  appeal  to  the  State  Government  or  Central 
Government, as the case may be, after such enquiry into the matter as it considers necessary 
and  after  giving  the  said  person  an  opportunity for  representing his  view  in  the  matter  may 
pass such order in relation thereto as it thinks fit. 

1.  Ins. by G.S.R 245(E), dt. 5-4-1999.                              3. Ins. by G.S.R 733(E), dt. 21-12-2005. 
2.  Subs. by G.S.R 601(E), dt. 24-8-2001.                         4. Ins. by GSR 899(E), dt. 27-12-2011.

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122-N.  Additional  information  to  be  furnished  by  an  applicant  for  licence  or  by  a 
licensee  to  the  Licensing Authority.-    The  applicant  for  the  grant  of  licence  or  any  person 
granted  a licence under the Part shall, on  demand furnish to the Licensing Authority, before 
the  grant  of  the  licence  or  during  the  period  the  licence  is  in  force,  as  the  case  may  be, 
documentary evidence in respect of the ownership or occupation, rental or other basis of the 
premises, specified in the application for licence or in the licence granted, constitution of the 
firm or  any  other  relevant  matter,  which  may  be  required  for  the  purpose  of  verifying  the 
correctness of the statement made by the applicant or the licensee, while applying for or after 
obtaining the licence, as the case may be. 

122-O. Cancellation and suspension of licences.− (1)  The Licensing Authority or Central 
Licence Approving Authority may  for such licences granted or  renewed by  him after giving 
the licensee an opportunity to show cause why such an order should not be passed by an order 
in writing stating the reason thereof, cancel a licence issued under this part or suspend it for 
such period as he thinks fit, either wholly or in respect of some of the substances to which it 
relates  1[or  direct  the  licensee  to  stop  collection,  storage,  processing,  manufacture  and 
distribution  of  the  said  substances  and  2[thereupon  order  the  destruction  of  substances  and] 
stocks  thereof  in  the  presence  of  an  Inspector],  if  in  his  opinion,  the  licensee  has  failed  to 
comply with any  of the conditions of the licence or with any provisions of the Act or Rules 
thereunder. 

(2) A licensee whose licence has been suspended or cancelled may, within three months 
of  the  date  of  the  order  under  sub-rule  (1)  prefer  an  appeal  against  the  order  to  the  State 
Government or Central Government, which shall decide the same. 

122-P. Conditions of  licence.-  3[A  licence in  Form  28C,  Form 28E,  4[Form 28F,  Form 
26G, Form 26-I or Form 28J shall be subject to the special conditions set out in Schedule F, 
Part XII-B  and  Part  XII C, Part XIID,] as the case may be, which relate  to the substance in 
respect  of  which  the  licence  is  granted  or  renewed and  to  the  following general  conditions, 
namely:-] 

(i)  (a)  The  licensee  shall  provide and  maintain adequate staff,  plant  and  premises 
for  the  proper  operation  of  a  Blood  Bank  for  processing  whole  human  blood,  its 
components and/or manufacture of blood products. 

(b) The licensee shall maintain staff, premises and equipment as specified in Rule 
122-G.  The  licensee  shall  maintain  necessary  records  and  registers  as  specified  in 
Schedule F, Parts XII-B and XII-C. 

(c)  The  licensee  shall  test  in  his  own  laboratory  whole  human  blood,  its 
components and blood products and maintain records and registers in respect of such tests 
as specified in Schedule F, Parts XIIB and XIIC 5[or XIID]. The records and register shall 
be maintained for a period of five years from the date of manufacture. 

(d)    The  licensee  shall  maintain/preserve  reference  sample  and  supply  to  the 
Inspector the reference sample of the whole human blood collected by him in an adequate 
quantity to conduct all the prescribed tests. The licensee shall supply to the Inspector the 
reference sample for the purpose of testing. 

1. Subs. by G.S.R. 20(E), dt. 11-1-1996. 
2. Ins. by (Corrigenda) G.S.R. 514 (E), dt. 6-11-1996. 
3. Subs. by G.S.R. 245(E), dt. 5-4-1999. 
4. Subs. by GSR 899(E), dt. 27-12-2011. 
5. Ins. by GSR 899(E), dt. 27-12-2011.

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(ii)  The  licensee  shall  allow  an  Inspector  appointed under  the  Act  to  enter,  with  or 
without  prior  notice,  any  premises  where  the  activities  of  the  Blood  Bank  are  being 
carried out for the processing of Whole Human Blood and/or Blood Products, to inspect 
the  premises  and  plant  and  the  process  of  manufacture  and  the  means  employed  for 
standardizing and testing the substance. 

(iii)  The  licensee  shall  allow  an  Inspector  appointed  under  the  Act  to  inspect  all 
registers    and   records    maintained  under    these   rules   and   to   take    samples   of   the 
manufactured  product  and  shall  supply  to  the  Inspector  such  information  as  he  may 
require  for  the  purpose  of  ascertaining  whether  the  provisions  of  the  Act  and  rules 
thereunder have been observed. 

(iv)  The  licensee  shall  from  time  to  time report  to  the  Licensing  Authority  any 
changes  in  the  expert  staff  responsible for  the  operation  of  a  Blood  Bank/processing of 
whole  human  blood  for components  and/or  manufacture  of  blood  products  and  any 
material alterations in the premises or plant used for that purpose which have been made 
since  the  date  of  last  inspection  made  on  behalf  of  the  Licensing  Authority  before  the 
grant of the licence. 

(v)  The  licensee  shall  on  request  furnish  to  the  Licensing  Authority,  or  Central 
Licence  Approving  Authority  or  to  such  Authority  as  the  Licensing  Authority,  or  the 
Central  Licence  Approving  Authority  may  direct,  from  any  batch  unit  of  drugs  as  the 
Licensing  Authority  or  Central  Licence  Approving  Authority  may  from  time  to  time 
specify,  sample  of  such  quantity  as  may  be  considered  adequate  by  such  Authority  for 
any  examination  and,  if  so  required,  also  furnish  full  protocols  of  the  test  which  have 
been applied. 

(vi)  If  the  Licensing  Authority  or  the  Central  Licence  Approving  Authority  so 
directs,  the  licensee  shall  not  sell  or  offer  for  sale  any  batch/unit  in  respect  of  which  a 
sample  is,  or  protocols  are  furnished  under  the  last  preceding  sub-paragraph  until  a 
certificate authorizing the sales of batch/unit has been issued to him by or on behalf of the 
Licensing Authority or the Central Licence Approving Authority. 

(vii)  The  licensee  shall  on  being  informed  by  the  Licensing  Authority  or  the 
Controlling Authority that any part of any batch/unit of the substance has been found by 
the Licensing Authority or the Central Licence Approving Authority not to conform with 
the standards of strength, quality or purity specified in these Rules and on being directed 
so  to  do,  withdraw, from  sales  and  so  far  as  may  in  the  particular circumstances of  the 
case be practicable recall all issues already made from that batch/unit. 

(viii)  No  drug  manufactured  under  the  licence  shall  be  sold  unless  the  precautions 
necessary  for  preserving  its  properties  have  been  observed  throughout  the  period  after 
manufacture.  Further  no  batch/unit  manufactured  under 
licence  shall  be 
supplied/distributed  to  any  person  without  prescription  of  a  Registered  Medical 
Practitioner. 

this 

(ix) The licensee shall comply with the provisions of the Act and of these Rules and 
with  such  further  requirements,  if  any,  as  may  be  specified  in  any  Rules  subsequently 
made  under  Chapter  IV  of  the  Act,  provided  that  where  such  further  requirements  are 
specified  in  the  Rules,  these  would  come  in  force  four  months  after  publication  in  the 
Official Gazette. 

(x) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector 

to record his impression and defects noticed. 

(xi) The  licensee  shall destroy the  stock of batch/unit  which  does not comply 
with standard tests in such a way that it would not spread any disease/infection by 
way of proper disinfection method. 

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1[(xii) All bio-medical waste shall be treated, disposed of or destroyed as per 
the  provisions  of  the  Bio-Medical  Wastes  (Management  and  Handling)  Rules, 
1996. 

(xiii) The licensee shall neither collect blood from any professional donor or 
paid  donor  nor  shall  he  prepare  blood  components  and/or  manufacture  blood 
products from the blood drawn from such a donor.] 

PART XI 

EXEMPTIONS 

123. The drugs specified in Schedule K shall be exempted from the provisions of Chapter 
IV  of  the  Act  and  the  Rules  made  thereunder  to  the  extent  and  subject  to  the  conditions 
specified in that Schedule. 

PART XII 
STANDARDS

2[124. Standards of drugs: – 

(1) For drugs included in the Indian Pharmacopoeia— 

(a)  The  standards  for  identity,  purity  and  strength  shall  be  those  as  may  be 

specified in the edition of the Indian Pharmacopoeia for the time being in force. 

(b)  In  case  the  standards  for  identity,  purity  and  strength  for  drugs  are  not 
specified in the edition of the Indian Pharmacopoeia for the time being in force but 
are specified in the edition of the Indian Pharmacopoeia immediately preceding, the 
standards  for  identity,  purity  and  strength  shall  be  those  occurring  in  such 
immediately preceding edition of the Indian Pharmacopoeia. 

(2) For other drugs– 

(a)  The  standards  for  identity,  purity  and  strength  shall  be  those  as  may  be 
specified in the edition of the official pharmacopoeia, for the time being in force, of 
any country to which the drug claims to comply with, 

(b)  In  case  the  standards  for  identity,  purity  and  strength  for  drugs  are  not 
specified in the edition of such official pharmacopoeia for  the time being in force, 
but  are  specified  in  the  edition  immediately  preceding,  the  standards  for  identity, 
purity and strength shall be those occurring in such immediately preceding edition 
of such official pharmacopoeia to which the drug claims to comply with. 

(c) For drugs for which standards are not included in the edition of the official 
pharmacopoeia,  for   the   time   being   in   force,   of   any   country   or   in   edition 
immediately  preceding,  but  included  in  the  official  compendia  of  drug  standards, 
namely, the British Pharmaceutical Codex or the National Formulary of the United 
States, for the time being in force, to which the drug claims to comply with.] 

3[124A.  Standards  for  veterinary  drugs.  –For  drugs  intended  for  veterinary  use,  
the standards shall be those given in the current edition for the time being in force of the 
4[British Pharmacopoeia (Veterinary)]. 

1. Subs. by G.S.R. 245(E), dt. 5-4-1999. 
2. Subs. by G.S.R. 19, dt. 15-12-1977. 
3.  Ins. by notification F. 1-6/62-D (SO 2889), dt. 2-7-1969. 
4. Subs. by G.S.R. 647 (E), dt. 28-10-1998.

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1[124B.  Standards  for  patent  or  proprietary  medicines.—  The  standards  for  patent  or 

proprietary medicines shall be those laid down in Schedule V and such medicines shall also 

comply with the standards laid down in the Second Schedule to the Act. 

2[124C. Standards for Surgical Dressings.-The standards for Surgical Dressings shall be 

such as are laid down in Schedule F (II).] 

3[124D.  Standards for Sterilised Umbilical tapes.- The standards for Sterilised Umbilical 

tapes shall be as laid down in Schedule F(III).] 

4[125.  Standards  for  substances  (other  than  food)  intended  to  affect  the  structure  or 

any  function  of  human  body—contraceptives.—(1)  The  standards  for  mechanical 

contraceptives shall be such as are laid down in Schedule R. 

(2)  The  standards  which  other  contraceptives  will  have  to  comply  with  shall  be  in 

conformity  with  the  formulae  approved  as  safe  and  efficacious  by  the  Central Government. 

Such formula shall be displayed on the label of every container of such contraceptive. 

5[125A. Standards for Medical Devices. —The standards for the Medical Devices shall be 

such as are laid down in Schedule R-1.] 

6[126.  Standards  for  substances  intended  to  be  used  for  the  destruction  of  vermin 

or insects which cause 9[***] disease in human beings or animals.- Disinfectants. 

The standards of disinfectants shall be such as are laid down in Schedule O.] 

7[126A Standards for ophthalmic preparations 8[including Homoeopathic ophthalmic 
preparations].—The  standards  for  ophthalmic  preparations  8[including  Homoeopathic 

ophthalmic preparations] shall be those laid down in Schedule FF, and such preparations shall 

also comply with the standards set out in the Second Schedule to the Act.] 

1.  Ins. by G.S.R. 665, dt. 28-5-1977. 
2.  Ins. by G.S.R. 318 (E), dt. 1-5-1984. 
3.  Ins. by G.S.R. 1115 (E), dt. 30-9-1986. 
4.  Amended by F-1-28/65D (SO 886),  dt. 8-3-1966. 
5.  Ins. by G.S.R. 109 (E), dt. 22-2-1994. 
6.  Amended by F.1-20/60-D, dt. 24-1-1964. 
7.  Ins. by F 1-113/60-D (SO 23), dt. 23-12-1969. 
8.  Subs. by G.S.R. 245 (E), dt. 17-6-1996. 
9. Subs heading ―Insecticides‖ and the entry relating thereto omitted by GSR 139, dt. 8-1-1976. 

156 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1[127. List  of colours permitted to  be  used in  drugs.−(1) No  drug shall contain a  colour 

other than specified below :- 

(1)  Natural Colours 
Annatto 

Carotene 

Chlorophyll 

Cochineal 

Curcumin 

Red Oxide of iron 

Yellow Oxide of iron 
2 [Titanium Oxide] 
3[Black Oxide of iron] 
6[Titanium dioxide coated mica pearlescent pigments] 

(2)   Artificial Colours 
Caramel 
4[Riboflavin] 
(3)   Coal Tar Colours 

Common name of  the colour         Colour Index 

Chemical Name

1 

GREEN 
Quinazarine Green S.S. 

Number 

2 

3 

61565 

1, 4-bis (p-Toluino) anthraquinone. 

Alizarin Cyanine Green F. 

61570 

2[Fast Green F.C.F. 

42053 

Disodium   salt   of   1,   4-bis   (O-sulfo-p- 
Toluino) anthra-quinone. 

Disodium     salt     of     4-{[4-(N-ethyl-p 
Sulfobenzylamino)-phenyl-]-(4-hydroxy- 
2- sulfoniumphenyl)-methylene} 
[1-(N-ethyl-N-p-sulfobenzyl]∆ 
2, 5-cyclohexadienimine]. 

5[** *  * *] 

YELLOW 
Tartrazine 

19140                          Trisodium salt of 3-carboxy-5- hydroxy-l- 

p-sulfophenyl-4-p- Sulfophenyl 
azopyrazole. 

Sunset Yellow FCF                       15985                          Disodium  salt  of  1-p-sulfophenyl  azo-2- 

naphthol-6-sulfonic acid. 

1.  Amended by S.O. 289, dt. 20-12-1972. 
2.  Ins. by  X.11013/3/76-DM.S (SO 1074), dt. 19-8-1978. 
3.  Ins. by G.S.R. 370 (E), dt. 7-4-1994. 
4.  Ins. by G.S.R. 681 (E), dt. 6-6-1988. 
5.  ―Green S‖ omitted by G.S.R. 753 (E), dt. 4-11-1999. 
6. Ins. by G.S.R. 76 (E), dt. 8-2-2012.

157 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(1)                                              (2)                                    (3) 

1[Quinoline Yellow WS             47005                   Disodium   salt    of    disulfonic   acid    of    2(2- 

quinolyl)-1, 3-indandione.] 

RED 
2[** ** *] 

Erythrosine                                45430                   Disodium  salt  of  9-0-carboxyphenyl 6-hydroxy 

2,4-5,7-tetriodo-3-isoxanthone 

Eosin YS or Eosine G                45380                   Disodium  of  salt  of  2,4,5,  7-Tetrabromo-  9-p- 

carboxyphenyl-6-hydroxy 3-isoxanthone. 

Toney Red or Sudan III             26100                   1-p-phenylazophenylaze-2-naphthol. 

Ponceau 4 R                               16255                   Trisodium salt of 1-(4-sulpho-1-1- Napthylazo)- 

2 napthol-6 : 8-disulphonic acid. 

Carmoisine                                 14720                   Disodium   salt   of   2-(4-sulpho-1-napthylazo)-1 

napthol-4 sulphonic acid. 

3[*** * *] 

BLUE 

Indigo Carmine 

Acid

73015                   Disodium salt of indigotin-5 : 5 Disu lphonic 

4[Brilliant Blue FCF                    42090                   Disodium salt of   4-[ {4-(N-ethyl-p- 

sulfobenzylamino)-phenyl }-](2- sulfonium 
phenyl)-methylene)-1-(N- ethyl-N-p- 
sulfobenzyl)- ∆ 2, 5-cyclohexadienimine. 

ORANGE 
Orange G

BROWN 
Resorcin Brown

BLACK 
Naphthol Blue Balck

16230                   Disodium salt  of  1-phenylazo-2- naphthol-6, 8- 

disulfonic acid. 

20170                   Monosodium salt of 4-p-sulfophenylazo-2-(2, 4- 

xylylazo-1, 3 resorcinol. 

20470                   Disodium salt  of 8-amino-7-p-nitro- phenylazo- 

2-phenylazo-1-naphthol-3, 6-disulfonic acid. 

1.   Subs. by G.S.R. 11(E), dt. 7-1-1991. 
2.  ‗Amaranth‘ omitted by G.S.R. 753(E) dt. 4.11.1999. 
3.  Fast Red omitted by G.S.R. 753, dt. 4-11-1999. 
4.  Ins. by X.11013/3/76-DM.S, dt. 19-8-1978. 

158 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                   
 
                        
 
 
 
                 
 
 
(4) LAKES 

Drugs and Cosmetics Rules 1945 

The aluminum or calcium salts (lakes) of any of the water-soluble colours listed 
above: 
               5[Provided that disinfectants may also contain colours specified under Schedule 
Q, which are non-staining.] 

(2) The label  on the container of  a  drug containing a  permitted colour shall indicate the 

common name of the colour.] 

128. The following rules are hereby repealed except as respects things done or omitted to 

be done under these rules, namely :--- 

Andhra Pradesh Drugs Rules, 1945. 

Assam Drugs Rules, 1945. 

Bihar Drugs Rules, 1945. 

Bombay Drugs Rules, 1946. 

East Punjab Drugs Rules, 1945. 

C.P. & Berar Drugs Rules, 1945. 

Madras Drugs Rules, 1945. 

Orissa Drugs Rules, 1945. 

Rajasthan Drugs Rules, 1953. 

Saurashtra Drugs Rules, 1953. 

Travancore-Cohin Drugs Rules, 1953. 

United Provinces Drugs Rules, 1945. 

West Bengal Drugs Rules, 1946. 

2[Mysore Drugs Rules, 1954]. 

1[PART XIII 

3[IMPORT AND REGISTRATION OF COSMETICS] 

4[129.  Registration of cosmetic products imported into the country.- No cosmetic shall 
be  imported  into  India  unless  the  product  is  registered  under  the  rules  by  the  licensing 
authority appointed by the Central Government under rule 21 or by any person to whom such 
powers may be delegated under rule 22. 

129A.  Form  and manner of  application  for  Registration  Certificate.-  (1)  An  application 
for issue of a Registration  Certificate for cosmetics intended to be imported  into India shall 
be made in Form 42 either by the manufacturer himself or by his authorised agent or importer 
in India or by the subsidiary in India authorised by the manufacturer and shall be accompanied 
by a fee of two hundred and fifty US dollars or its equivalent to Indian rupees for each brand 
of cosmetic. The application shall be accompanied by a treasury challan as specified in sub-
rule  (3)  along  with  the  information  and  undertaking    as  specified  in  Schedule  D  (III)  duly 
signed by or on behalf of the manufacturer or by his authorised agent or importer in India or 
by the subsidiary in India authorised by the manufacturer. 

1. Ins. by G.S.R. 1183 dt. 17-8-1964.                           5. Ins. by G.S.R. 76 (E), dt. 8-2-2012. 
2. Added by notification F. 1-37/58-D, dt. 21-7-1958. 
3. Subs. by G.S.R. 426 (E), dt. 19-5-2010. 
4. Rules 129 to 129H subs. by G.S.R. 426 (E), dt. 19-5-2010.

159 

 
 
 
 
 
 
 
 
 
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(2)  An authorisation  by  the  manufacturer to  his  agent  in  India  shall be  duly  authenticated 
either  in  India  before  a  First  Class  Magistrate  or  in  the  country  of  origin  before  such  an 
equivalent authority. 

(3) The fees shall be paid through  a challan in the designated branches of Bank of Baroda 
either in US dollars or in equivalent Indian rupees under Head of Account ―0210-MEDICAL 
AND  PUBLIC  HEALTH, 04  PUBLIC  HEALTH,  104-FEES  AND  FINES‖  and  the original 
copy  of  the  treasury  challan  shall  be  submitted  along  with  the  application  for  product 
registration. 

Provided that in the case of any direct payment of fees by a manufacturer in the country of 
origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the 
country  of  origin  to  the  Bank  of  Baroda,  Kasturba  Gandhi  Marg,  New  Delhi,  through  the 
Electronic  Code  of  the  bank  in  the  Head  of  Account  ―0210-MEDICALAND  PUBLIC 
HEALTH, 04 PUBLIC HEALTH, 104-FEES AND FINES‖ and the original receipt of the said 
transfer  shall  be  treated  as  an  equivalent  to  the  bank  challan  subject  to  the  approval  by  the 
Bank of Baroda that they have received the payment. 

(4)  The  applicant  shall  be  liable  for  the  payment  of  testing  fees  directly  to  a  testing 
laboratory  approved  by  the  Central  Government,  as  may  be,  required  for  examination,  tests 
and analysis of cosmetics. 

(5) A fee of one hundred US dollars or its equivalent shall be paid for a duplicate copy  of 

the Registration Certificate, if the original is defaced, damaged or lost. 

129B.  Registration  Certificate  for  the  import  of  cosmetics  manufactured  by  one 
manufacturer.-A single application may be made and a single Registration Certificate in Form 
43 may be issued in respect of import of one or more than one cosmetics manufactured by the 
same manufacturer: Provided that the cosmetics are manufactured at one factory or more than 
one factory functioning conjointly as a single manufacturing unit. 

129C. Grant of Registration Certificate.-  (1) On receipt of an application  for Registration 
Certificate  in  the  form  and  manner  specified  in  rule  129A,  the  licensing  authority  shall,  if 
satisfied, issue a Registration Certificate in form 43 subject to the conditions of the registration 
certificates in form 43: 

Provided  that  if  the  application  is  complete  in  all  respects  and  information  specified  in 
Schedule  D  III  is  in  order,  the  licensing  authority  shall,  within  six  months  from  the  date  of 
receipt of an application, issue such Registration Certificate, and in exceptional circumstances 
and  for  reasons  to  be  recorded  in  writing,  the  Registration  Certificate  may  be  issued  within 
such extended period, not exceeding three months, as the licensing authority may deem fit. 

(2)  If  the  applicant  does  not  receive  the  Registration  Certificate  within  the  period  as 
specified above, he may appeal to the Central Government and the Central Government may 
after such enquiry into the matter, as it considers necessary, may pass such orders in relation 
thereto as it thinks fit. 

129D. Duration of Registration Certificate.- A Registration Certificate, unless it is sooner 
suspended  or  cancelled,  shall  be  valid  for  a  period  of  three  years  from  the  date  of  its  issue: 
Provided  that  if  application  for  a  fresh  Registration  Certificate  is  made  within  six  months 
before the expiry of the said certificate, the existing Registration Certificate shall be deemed to 
continue to remain in force until orders are passed on the application. 

129E. Suspension and cancellation of Registration Certificate.-  If the manufacturer fails 
to  comply  with  any  of  the  conditions  of  the  Registration  Certificate,  the  licensing  authority 
may after giving him an opportunity to show cause why such an order should not be passed, 
by  an  order  in  writing,  stating  the  reasons  therefor,  suspend  or  cancel  the  Registration 
Certificate for such period  as it thinks fit either wholly or in respect of some of the cosmetics 
to  which  it  relates:  Provided  that  a  person  who  is  aggrieved  by  the  order  passed  by  the 
licensing authority under this rule may, within thirty days of the receipt of the order, appeal to 
the Central Government and the Central Government may after such enquiry into the matter as 
it considers necessary and after giving the said appellant an opportunity of being heard pass 
orders as it thinks fit. 

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129F.  Prohibition  of  import  of  certain  cosmetic.-  No  cosmetic,  the  manufacture,  sale  or 
distribution of which is prohibited in the county of origin, shall be imported under the same 
name or under any other name except for the purpose of examination,  test or analysis. 

129G. Standard for imported cosmetics.- No cosmetic shall be imported unless it complies 
with the specifications prescribed under Schedule S and Schedule Q or any other standards of 
quality and safety, applicable to it, and other provisions  under the rules. In case the cosmetic 
is  not  included  under  Schedule  S,  it  shall  meet  with  specifications  under  the  rules  and 
standards applicable to it in the country of origin. 

129H.  Labeling  and  Packing  of  Cosmetics.-  No  cosmetic  shall  be  imported    unless  it  is 
packed  and  labeled  in  conformity  with  the  rules  in  Parts  XV.  Further  the  label  of  imported 
cosmetics shall bear registration certificate number of the product and the name and address of 
the registration certificate holder for marketing the said product in India.] 

130.  Documents  to  be  supplied  to  the  Collector  of  Customs.− Before any  cosmetics  are 
imported,  a  declaration  signed  by  or  on  behalf  of  the  manufacturer  or  by  on  behalf  of  the 
importer  that  the  cosmetics  comply  with  the  provisions  of  Chapter  III  of  the  Act,  and  the 
Rules made there under, shall be supplied to the Collector of Customs. 

131.  Procedure  for  the  import  of  cosmetics.− (1)  If  the  officer  appointed  at  the  post  of 
entry by the Central Government has reason to believe that any cosmetic contravenes any of 
the  provisions of  the  Act  or  the  rules  made  thereunder he  may  take  sample  of  the  cosmetic 
from the  consignment for inspection. If on examination of the sample defects are noticed the 
officer shall advise the Collector of Customs for further action to be taken. 

If the suspected contravention of the provisions of the Act or the Rules is such as may have 
to be determined by test,  the  officer  shall  send  the  sample  to  the  laboratory  established for 
the purpose for performing such tests. The consignment of the said cosmetic shall be detained 
till  such  time  that  the  test  report  on  such  sample  is  received  from  the  Director  of  the  said 
laboratory  or  any  other  officer  of  the  laboratory  empowered  by  him  in  this  behalf  with the 
approval of the Central Government: 

Provided  that  if  the  importer  gives  an  undertaking  in  writing  not  to  dispose  of  the 
cosmetic  without  the  consent  of  the  Collector of  Customs  and  to  return  the  consignment or 
such  portion  thereof  as  may  be  required,  the  Collector  of  Customs  shall  make  over  the 
consignment to the importer. 

(2)  If  the  importer  who  has  given  an  undertaking  under  the  proviso  to  sub-rule  (1)  is 
required  by  the  Collector of  Customs  to  return  the  consignment or  portion  thereof,  he  shall 
return the consignment or portion thereof within ten days of receipt of the notice. 

Further procedure on receipt of the report of analysis 
(3)  If  the  Director  of  the  Laboratory  established  for  the  purpose  by  the  Central 
Government or any other officer of the laboratory empowered by him in this behalf with the 
approval  of  the  Central  Government,  reports  to  the  Collector  of  Customs  or  to  the  officer 
mentioned  in  sub-rule  (1)  above  that  the  sample  of  any  cosmetic  in  a  consignment 
contravenes the provisions of Chapter III of the Act or the Rules made thereunder and that the 
contravention is  such  that  it  cannot  be  remedied  by  the  importer,  the  Collector  of  Customs 
shall  communicate  the  report  forthwith  to  the  importer  who  shall  within  two  months  of 
receiving such  a  communication either  send  back  all  the  cosmetic  of  that  description to  the 
country in which it was manufactured or to the country from which it was imported or hand it 
over to the Central Government which shall cause it to be destroyed: 

Provided  that  the  importer  may  within  thirty  days  of  receipt  of  the  report  make  a 
representation  against  the  report  to  the  Collector  of  Customs  who  shall  forward  the 
representation with a  fresh sample of  the  cosmetic to  the  Drugs Controller, India, who after 

161 

 
 
 
 
 
 
 
 
 
 
 
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obtaining, if necessary, the report of the Director of the Central Drugs Laboratory shall pass 
orders thereon which shall be final. 

(4) If the Drugs Controller or any other officer empowered by him in this behalf with the 
approval  of  Central  Government reports  to  the  Collector of  Customs  after  the  inspection of 
the sample of cosmetic and if necessary, after obtaining a test report thereon that the sample 
of the said cosmetic contravenes in any respect the provisions of Chapter III of the Act or the 
Rules  made  thereunder  but  that  the  contravention  is  such  that  it  can  be  remedied  by  the 
importer, the Collector of Customs shall communicate the report forthwith to the importer and 
permit him to  import the cosmetic on his  giving an  undertaking in  writing not  to dispose of 
the  cosmetic  without  the  permission  of  the  officer  authorised  in  this  behalf  by  the  Central 
Government. 

132.  Exemption  of  cosmetics—Cosmetics  as  may  be  specified  in  Schedule  D  shall  be 
exempted from the provisions of Chapter III of the Act and the Rules made thereunder to the 
extent and subject to the conditions specified in that Schedule. 

133.  Import  through  points  of  entry—No cosmetic  shall  be  imported into  India  except 

through the points of entry specified in rule 43A. 

1[134.  Cosmetic  to  contain  Dyes,  Colours  and  Pigments.-   No  Cosmetic  shall  contain 
Dyes,  Colours  and  Pigments  other  than  those  specified  by  the  Bureau  of  Indian  Standards 
(IS:4707 Part 1 as amended) and Schedule Q. 

The  permitted  Synthetic  Organic  Colours  and  Natural  Organic  Colours  used  in  the 

Cosmetic shall not contain more than:- 

(i)     2 parts per million of arsenic calculated as arsenic trioxide.  
(ii)    20 parts per million of lead calculated as lead. 
(iii)   100   parts   per   million   of   heavy   metals   other   than   lead   calculated   as the 

total of the respective metals.] 

2[134-A  Prohibition  of  import  of  cosmetic  containing  Hexachlorophene.—  No  cosmetic 
containing hexachlorophene shall be imported. 

135.  Import  of  cosmetic  containing  Lead  or  Arsenic  compound  prohibited.—No 
cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes 
of colouring. 

3[135-A.  Import  of  cosmetics  containing  mercury  compounds  prohibited.–No 

cosmetic shall be imported which contains mercury compounds.] 

5[135-B.  Prohibition  of  import  of  cosmetics  tested  on  animals.–No  cosmetic  that  has 
been  tested  on  animals  after  the  commencement  of  the  Drugs  and  Cosmetics  (Fifth 
Amendment) Rules, 2014 shall be imported into the country.] 

136.  Import  of  cosmetic for  personal  use—Small  quantities  of  cosmetics  the  import  of 
which is otherwise prohibited under section 10 of the Act, may be imported for personal use 
subject to the following conditions: — 

(i) The cosmetics shall form part of a passenger‘s baggage and shall be the property of 
and intended for, the bona fide use of the passenger; and 
(ii)  The cosmetics shall be declared to the Customs authorities, if they so direct. 

4[PART XIV 
MANUFACTURE OF COSMETIC FOR SALE 
OR FOR DISTRIBUTION] 

137.  Manufacture  on  more 

than  one  set  of  premises.  —  If  cosmetics  are 
manufactured  on  more  than  one  premises,  a  separate  application  for  each  such  premises 
shall be made and a separate licence obtained for each such premises. 

        1.  Subs. by G.S.R. 811 (E), dt. 14-11-1994.                   2.  Added by G.S.R. 116, dt. 25-1-1975. 

3.  Ins. by  X.11013/76-D & MS, dt. 19-8-1978.            4.  Subs. by G.S.R. 788 (E), dt. 10-10-1985. 
5. Ins. by G.S.R. 718 (E), dt. 13-10-2014.

162 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

138.  Application  for  5 [licence  to  manufacture  cosmetics for sale and distribution]—
3[(1)  Application  for  grant  or renewal  of  5[licence to manufacture any cosmetic for sale or 

for distribution] 1[shall be  made  up  to  ten  items  of each category of cosmetics categorized in 

Schedule MII to the Licensing Authority appointed by the State Government for the purpose 

of  this Part (hereinafter in this Part  referred to  as the  Licensing  Authority)  in  Form  31  and 

shall  be  accompanied  by  a  licence  fee  of  rupees  two  thousand  and  five  hundred  and  an 

inspection fee of rupees one thousand for every inspection 

thereof or for the purpose of  renewal of licence]. 

2[* * * **] 

3[(2) If a  person applies for the renewal of licence after expiry but within six months of 
such  expiry, the  fee  payable for  the  renewal of  such  licence  shall  be  1[rupees two  thousand 

five  hundred  plus  an  additional  fee  at  the  rate  of  rupees  four  hundred  per  month  or  part 

thereof in addition to an inspection fee of rupees one thousand.] 

2[*  *  *   * *] 

(3)  Application  by  a  licensee  to  manufacture  additional  items  of  cosmetics  shall  be 
accompanied by a fee of 1[rupees one hundred for each item subject to a maximum of rupees 

three thousand for each application.] 

2[*  *   *   * *] 
6[(4)  A  fee  of  1[rupees  two  hundred  and  fifty]  shall  be  paid  for  a  duplicate  copy  of  a 

licence under sub-rule (1), if the original is defaced, damaged or lost.] 

4  [138A.  Application for loan licence to manufacture cosmetics.−(1) Application for grant 

or renewal of a loan licence for the manufacture for sale of cosmetics  1[shall be  made up to 

ten items  of  each  category  of  cosmetics  categorized in  Schedule  M-II  in  Form  31-A  to  the 

Licensing Authority and  shall  be  accompanied by  a  licence  fee  of  rupees two  thousand and 

five hundred and an inspection fee of rupees one thousand for every inspection thereof]. 

Explanation.--For  the  purpose  of  this  rule  a  ‗loan  licence‘  means  a  licence,  which  a 

Licensing  Authority  may  issue  to  an  applicant  who  does  not  have  his  own  arrangements to 

manufacture  but  who  intends  to  avail  himself  of  the  manufacturing  facilities  owned  by  a 

licensee in Form 32. 

(2)  If  a  person applies for  the  renewal  of  a   loan   licence  after  the  expiry but within 

six  months  of  such  expiry,  the  fee payable for the renewal   of   such  a  licence   shall    be 

1.  Subs. by G.S.R. 601(E), dt. 24-8-2001. 
2. Omitted by G.S.R. 331(E),dt. 8.5.1984. 
3.  Amended by G.S.R. 245, dt. 21.2.1976. 
4.  Ins. by  G.S.R. 444, dt. 28-4-1973. 
5. Subs. by G.S.R. 788 (E), dt. 10-10-1985. 
6. Subs. by G.S.R. 331(E),dt. 8.5.1984.

163 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[rupees two thousand and five hundred plus an additional fee at the rate of rupees four 

hundred for each month or part thereof.] 

(3)   The  Licensing  Authority  shall  before  the  grant  of  a  loan  licence  satisfy 

himself  that  the  manufacturing  unit  has  adequate  equipment,  staff,  capacity  for 

manufacture and facilities to undertake the manufacture on behalf of the applicant for a 

loan licence. 

(4)  The  loan  licence shall be  granted by  the  Licensing Authority to  only  such 

applicants  who  propose  to  avail  of  the  facilities  of  manufacture  of  cosmetics  in  the 

premises of a manufacturer located in the same State where the applicant is located.  In 

case the manufacture of cosmetic involves any special process of manufacture or use of 

equipment  which  are  not  available  in  the  State  where  the  applicant  is  located,  the 

Licensing Authority after  consulting the  Licensing Authority where the  manufacturing 

unit is located, may grant the loan licence. 

(5)  Subject  to  the  provisions  of  sub-rule  (2),  application  for  manufacture  of 
additional  items  on  a  loan  licence  shall  be  accompanied  by  a  fee  of  1[rupees  one 

hundred for each item subject to a maximum of rupees three thousand per application.] 
(6) A fee of 1[rupees two hundred and fifty] shall  be paid for a duplicate copy of 

a licence issued under sub-rule (1) if the original is defaced, damaged or lost. 

139. Conditions for the grant or renewal of a licence  in Form 32—Before a  licence in 

Form 32 is granted or renewed, the following conditions shall be complied with by applicant:- 

(1) The manufacture shall be conducted under the direction and personal supervision 

of  a  competent  technical  staff  consisting  of  at  least  one  person  who  is  a  whole  time 

employee and who possesses any one of the following qualifications: 

(a)  holds a  Diploma in Pharmacy approved by the Pharmacy Council of India 

under the Pharmacy Act, 1948 (8 of 1948), or 

(b) is registered under the Pharmacy Act, 1948 (8 of 1948), or 

(c)  has  passed  the  Intermediate  Examination  with  Chemistry  as  one  of  the 

subjects  or  an  examination  recognized  by  the  Licensing  Authority  as  equivalent 

to it. 

2[ *  *   * *  *] 

1.  Subs. by G.S.R. 601(E), dt. 24-8-2001. 

2. Omitted by. G.S.R. 331(E), dt. 8.5.1984

164 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[(2) The factory premises shall comply with the requirements and conditions specified in 

Schedule  M-II.] 

2 [ *  *   * *  *] 

(5) The applicant shall either-- 

(i) provide and maintain adequate staff, premises and laboratory equipment for testing 

the cosmetic manufactured, and the raw materials used in the manufacture; or 

(ii)  make  arrangements  with  some  institution  approved  by  the  Licensing  Authority 
3[under Part XV (A) of these rules] for such tests to be regularly carried out in this behalf 
by the institution. 

4[139A.  Form  of  5[licence  to  manufacture cosmetics  for  sale  or  for   distribution].—A 
5[licence to   manufacture cosmetics for sale or for distribution] against application in 
Form 31, shall be granted in Form 32.] 

6[139AA. Inspection before grant or renewal of licence.- Before a licence under this Part 
is granted or renewed in Form 32, Form 32A or Form 33, the Licensing Authority shall cause 
the establishment, in which the manufacture is proposed to be conducted or being conducted, 
to  be  inspected  by  one  or  more  Inspectors  appointed  under  the  Act.  The Inspector or 
Inspectors shall  examine  all  portions  of  the  premises,  plant  and  appliances  and  also  inspect 
the process of manufacture intended to be employed or being employed along with the means 
to  be  employed  or  being  employed  for  standardizing  and  testing  the  substances  to  be 
manufactured  and  enquire  into  the  professional  qualifications  of  the  technical  staff  to  be 
employed. He shall also examine and verify the statements made in the application in regard 
to  their  correctness,  and  the  capability  of  the  applicant  to  comply  with  the  requirements  of 
competent  technical  staff,  manufacturing  plant,  testing  equipments  and  the  requirements  of 
plant and equipments as laid down in Schedule M-II read with requirements of maintenance 
of records as laid down in Schedule U-1.] 

6[139AB.   Report  by  Inspector.-   The  Inspector  or  Inspectors  shall  forward  a  detailed 
descriptive report  giving his or  their findings on each aspect of  inspection along with his or 
their recommendations after completion of his or their inspection to the Licensing Authority.] 

6[139AC.  Grant  or  refusal  of  licence.-  (1)  If  the  Licensing  Authority  after  such  further 
enquiry,  if  any,  as  he  may  consider  necessary  is  satisfied that  the  requirements of  the  rules 
under the  Act  have  been  complied with  and  that  the  conditions of  the  licence  and  the  rules 
under the Act shall be observed, he shall grant or renew a licence in form 32, Form 32-A or 
Form 33. 

1. Subs. by G.S.R. 723 (E), dt. 11-8-1992. 
2. Omitted condition (3) and (4) by G.S.R. 723 (E), dt. 11-8-1992. 
3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977. 
4. Ins. by G.S.R. 444, dt. 28-4-1973. 
5. Subs. by G.S.R. 788 (E), dt. 10-10-1985. 
6. Ins. by G.S.R. 493 (E), dt. 9-6-1995. 

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(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall 
inform  the  applicant  of  the  reasons  for  such  rejection  and  of  the  conditions  which  must  be 
satisfied  before  a  licence  can  be  granted  or  renewed  and  shall  supply  the  applicant  with  a 
copy of inspection report.] 

1[139AD. Further application after rejection.–If within a period of six months from the 
rejection of an application for a licence, the applicant informs the Licensing Authority that the 
conditions  laid  down  have  been  fulfilled  and  deposits  an  inspection  2[fee  of  rupees  two 
hundred  and  fifty],  the  Licensing  Authority  may,  if,  after  causing  further  inspection  to  be 
made,  he  is  satisfied  that  the  conditions  for  the  grant  of  licence  have  been  complied  with, 
issue a licence in Form 32, Form 32-A or Form 33.] 

1[139AE.  Appeal to the State Government.- Any person who is aggrieved by the order 
passed by  the Licensing Authority refusing to grant or  renew a  licence under this Part  may, 
within ninety days from the date of receipt of such order, appeal to the State Government and 
the State Government may, after such enquiry into the matter as is considered necessary and 
after  giving  the  said  person  an  opportunity  for  representing  the  case,  pass  such  order  as  it 
thinks fit.] 

3[139B.  Form  of 

to  manufacture  cosmetics  for  sale  or  for 
distribution].−A  loan  4[licence  to  manufacture  cosmetics  for  sale  or  for  distribution] 
against  application  in Form 31-A shall be granted in Form 32-A. 

4[licence 

loan 

140.   Duration of licence.- An original licence or a renewed licence shall unless sooner 
suspended or cancelled be 2[valid for a period of five years on and from the date on which] it 
is granted or renewed: 

5[Provided  that  if  the  application  for  renewal  of  a  licence  in  force  is  made  before  its 
expiry  or  if  the  application  is  made  within  six  months  of  its  expiry,  after  payment  of 
additional  fee,  the  licence  shall  continue  to  be  in  force  until  orders  are  passed  on  the 
application and the licence shall be  deemed to  have expired, if  application for its  renewal is 
not made within six months of its expiry.] 

141. Certificate  of renewal.−The certificate  of renewal of a  licence in Form 32 shall be 

issued in Form 33. 

1.  Ins. by G.S.R. 493 (E), dt. 9-6-1995. 
2.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
3.  Ins. by G.S.R. 444, dt. 28-4-1973. 
4.  Subs. by G.S.R. 493 (E), dt. 9-6-1995. 
5. Amended by S.O. 2139, dt. 12.8.1972. 

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1[141A. Certificate of renewal of a loan licence—The certificate of renewal of a licence 

in Form 32-A shall be issued in Form 33-A.] 

1[141AA.  Duration of a loan licence.–An original loan licence in Form 32A or a renewed 
loan licence in Form 33-A, unless sooner suspended or cancelled, shall be 2[valid for a period 

of five years on and from the date on which] it is granted or renewed: 

Provided that if the application for the renewal of a licence is made before its expiry, or if 

the  application is  made  within six  months of  its  expiry, after  payment of  the  additional fee, 

the licence shall continue to be in force until orders are passed on the application.  The licence 

shall  be  deemed  to  have  expired  if  the  application  for  its  renewal  is  not  made  within  six 

months of its expiry.] 

142. Conditions of licence—A licence in Form 32 shall be subject to the conditions stated 

therein and to the following other conditions, namely: – 

(a)    the  licensee  shall  provide  and  maintain  staff,  premises  and  equipment  as 

specified in rule 139; 

(b)   the  licensee shall comply  with  the  provisions of  the  Act  and the  Rules  made 

thereunder and with such further requirements, if any, as may be specified in any rules to 

be made hereafter under Chapter IV of the Act; 

3  [(b1)  the  licensee  shall  keep  records  of  the  details  of  each  batch  of    cosmetic 

manufactured  by  him  and  of  raw  materials  used  therein  as  per  particulars  specified  in 

Schedule U(1) and such records shall be retained for a period of three years;] 

(c) the licensee shall test each batch or lot of the raw materials used by him for the 

cosmetics and also each batch of the final product and shall maintain records or registers 

showing the particulars in respect of such tests.  The records or registers shall be retained 

for a period of three years from the date of manufacture; 

(d) the licensee shall allow any  1 [ Inspector appointed under the Act] to enter with 

or without prior notice any premises where the  manufacture of a  substance in  respect of 

which the licence is issued is carried on, to inspect the premises and to take samples of 

the manufactured products under a receipt; 

1.  Ins. by G.S.R. 444, dt. 28-4-1973. 
2.  Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
3.  Ins. by G.S.R. 1594, dt. 28-10-1976. 

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(e)  the  licensee  shall  allow  an  Inspector  to  inspect  all  registers  and  records 
maintained under these rules and shall supply to the Inspector such information as 
he may require for the purpose of ascertaining whether the provisions of the Act 
and the Rules made thereunder have been complied; 

1[(f)   the    licensee    shall   maintain   an   Inspection  Book    in   Form   35   to 

enable an Inspector to record his impression and the defects   noticed: 

2[Provided  that  clauses  (b-1)  and  (c)  shall  not  apply  to  the  manufacture  of 
soap  and  the  procedure  for  testing  of  raw  materials  and  the  records  to  be 
maintained  by  the  manufacturer  of  soap  shall  be  such  as  are  approved  by  the 
Licensing Authority.] 

4[142A. Additional information to be furnished by an applicant for licence or a licensee 
to the Licensing Authority.—The applicant for the grant of a licence or any person granted a 
licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant 
of the licence or   during the period the   licence is in force, as the case may be, documentary 
evidence in  respect of  the  ownership or  occupation on  rental or  other basis of  the  premises, 
specified in  the  application for  licence or  in  the  licence  granted, constitution of  the  firm,  or 
any other relevant matter, which may be required for the purpose of verifying the correctness 
of the statements made by the applicant or the licensee, while applying for or after obtaining 
the licence as the case may be.] 

1[142B. Conditions of licence in Form 32-A.– 

(a) A licence in Form 32-A shall be deemed to be cancelled or suspended, if the 
licence  owned  by  the  licensee,  in  Form  32,  whose  manufacturing  facilities  are 
cancelled or suspended, as the case may be under these rules. 

(b) The licensee shall comply with the provisions of the Act  and these rules and 
with  each  further  requirements,  if  any,  as  may  be  specified  from  time  to  time  in 
Chapter IV of the Act, provided that where such further requirements are specified in 
the  rules,  these  would  come  into  force  four  months  after  publication in  the  Official 
Gazette. 

3[(b1)  The  licensee  shall  keep  records  of  the  details  of  each  batch  of  cosmetic 
manufactured by him and of raw materials used therein as per particulars specified in 
Schedule U(1) and such records shall be retained for a period  of three years.] 

(c)  The licensee shall test each batch or lot of the raw materials used by him for 
the manufacture of  the cosmetics and also each batch of the final product  and  shall 
maintain records of  registration showing the  particulars in  respect of such tests. The 
records  or  registers  shall  be  retained  for  a  period  of  three  years  from  the  date  of 
manufacture. 

1.  Ins. by G.S.R. 444, dt. 28-4-1973. 
2.  Ins. by G.S.R. 681 (E),  dt. 6-6-1988. 
3.  Ins. by G.S.R. 1594, dt. 28-10-1976. 
4.  Ins. by  S.O.2139, dt. 12-8-1972.

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(d) The licensee shall allow an Inspector appointed under the Act to enter with or 
without prior notice any premises where the manufacture of a substance in respect of 
which licence is issued is carried on, to inspect the premises and to take samples of 
the manufactured products under a receipt. 

(e)  The  licensee  shall  allow  an  Inspector  to  inspect  all  registers  and  records 
maintained under these rules and shall supply to the Inspector such information as he 
may require for the purpose of ascertaining whether the provisions of the Act, and the 
rules made thereunder have been complied. 

(f)  The  licensee  shall  maintain  an  Inspection  Book  in  Form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

143.  Cancellation  and  suspension  of  licence.−(1)  The  Licensing  Authority  may,  after 
giving the licensee an opportunity to show  cause why such an order should not be passed, by 
an  order  in  writing  stating  the  reasons  therefor,  cancel  a  licence  issued  under  this  Part  or 
suspend  it  for  such  period  as  he  thinks  fit,  either  wholly  or  in  respect  of  some  of  the 
substances to which it relates, if in his opinion, the licensee has failed to comply with any of 
the conditions of the licence or with any provisions of the Act or the rules made thereunder. 

(2) A licensee whose license has been suspended or cancelled may appeal within a period 
of  three  months  from  the  date  of  the  order  to  the  State  Government  which  shall  after 
considering the appeal, pass orders, and such orders shall be final. 

1[144.    Prohibition  of    manufacture  of    cosmetics    containing  colours    other    than  
those  prescribed.-  No  Cosmetic  shall  be  manufactured  which  contains  Dyes,  Colours  and 
Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I  as 
amended) and Schedule Q. 

The  permitted  Synthetic  Organic  colours  and  Natural  Organic  colours  used  in  the 

Cosmetic shall not contain more than− 

(i)  2 parts per million of arsenic calculated as arsenic trioxide. 

(ii)  20 parts per million of lead calculated as lead. 

(iii) 100 parts per million of heavy metals other than lead calculated as the total of the 
respective metals.] 

2[144A.  Prohibition  of  manufacture  of  cosmetics  containing  Hexachlorophene.—No 

cosmetic containing Hexachlorophene shall be manufactured:] 

1.  Subs. by G.S.R. 811(E), dt. 14-11-1994. 
2.  Ins. by G.S.R. 116, dt. 15.1.1975.

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1[Provided that in the case of soaps Hexachlorophene may be used in concentrations not 

exceeding one per cent weight by weight: 

Provided further that the following cautionary note shall be printed and shall appear in a 

conspicuous manner on the wrapper of package of each soap, namely:- 

―Contains Hexachlorophene – not to be used on babies‖.] 

145.  Use  of  Lead  and  Arsenic  compounds  for  the  purpose  of  colouring  cosmetics 
prohibited.—The use of Lead and Arsenic compounds for the purpose of colouring cosmetics 
is prohibited. 

2[145A.  Form  of  intimation  for  purpose  of  taking  samples  of  cosmetics.—Where 
an  Inspector  takes  a  sample  of  a  cosmetic  for  the  purpose  of  test  or  analysis,  he  shall 
intimate such purpose in writing in Form 17 to the person from whom he takes it.] 

3[145AA. Form of receipt of samples of cosmetics where fair price tendered is refused.- 
Where the fair price, for the samples of Cosmetics taken for the purpose of test  or analysis, 
tendered  under  sub-section  (1)  of  section  23  has  been  refused,  the  Inspector  shall  tender  a 
receipt  therefor  to  the  person  from  whom  the  said  samples  have  been  taken  as  specified  in 
Form 17A.] 

2[145B.  Form  of  receipt  for  seized  cosmetics.−A  receipt  by  an  Inspector  for  the  stock 
of any cosmetic seized under clause (c) of sub-section (1) of section 22 of the Act shall be in 
Form 15.] 

4[145BA.  Manner  of  certifying  copies  of  seized  documents.-The  Drugs  Inspector  shall 
return the documents, seized by  him under clause (cc), or produced before him under clause 
(cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of 
such seizure or production, to the person from whom they were seized or, as the case may be, 
the person who produced them, after copies thereof or extracts therefrom have been signed by 
the  Drugs  Inspector concerned and  the  person from  whom they  were  seized,  or,  as  the  case 
may be, who produced such records.] 

5[145C. Form of order not to dispose of stocks of cosmetics—An order in writing by an 
Inspector under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to 
dispose of any stock of cosmetics in his possession shall be in Form 15.] 

6[145D.    Prohibition  of  manufacture  of  cosmetics  containing  mercury  compounds.–

No cosmetics containing mercury compounds shall be manufactured.] 

1.  Ins. by G.S.R. 1049 (E), dt. 29-8-1986. 
2.  Ins. by  S.O.  2139, dt. 5.6.1972. 
3.  Ins. by G.S.R. 292 (E), dt. 29-5-1997. 
4.  Ins. by G.S.R. 89(E), dt. 16-2-1985. 
5.  Ins. by G.S.R. 1594, dt. 28-10-1976. 
6. Ins. by G.S.R. 1074, dt. 19.8.1978 (w.e.f. 2.9.1978).

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PART XV 

1[LABELLING, PACKING AND STANDARDS OF COSMETICS] 

146.  Prohibition  of  sale  or  distribution.–Subject to  other  provisions  of  these  rules,  no 
person  shall  sell  or  distribute  any  cosmetic  unless  the  cosmetic,  if  of  Indian  origin  is 
manufactured by  a  licensed  manufacturer and  labelled  and  packed  in  accordance with  these 
rules. 

2[147.  Exemption  of  cosmetics  not  manufactured  for  consumption  or  sale  in  India 
from  the  provisions  of  this  Part.–  Labels  on  packages  or  containers  of  cosmetics  not 
manufactured  for  consumption  or  sale  in  India  shall  be  adopted  to  meet  the  specific 
requirements, if any, of the consignee: 

Provided that  where a  cosmetic is  required by  the  consignee to  be  not  labelled with  the 
name and address of the manufacturer, the labels on packages or containers shall bear a code 
number as approved by the Licensing Authority mentioned in rule 21.] 

148.  Manner  of  labelling.–Subject  to  other  provisions  of  the  rules,  a  cosmetic  shall 

carry.– 

(1)  on both the inner and outer labels; 

(a)  the name of the cosmetic, 

3[(b)  the  name  of  the  manufacturer  and  complete  address  of  the  premises  of  the 

manufacturer where the cosmetic has been manufactured. 

            Provided  that  if    the    cosmetic  is    contained  in    a    very    small  size  container 
where  the address  of  the  manufacturer cannot  be  given,  the  name  of  the  manufacturer 
and his principal place of manufacture shall be given along with pin code.] 

(2) On the outer label.– 

A  declaration  of  the  net  contents  expressed  in  terms  of  weight  for  solids,  fluid 
measure for liquids, weight for semi-solids, combined with numerical count if the content is 
sub-divided: 

Provided that this statement need not appear in case of a package of perfume, toilet water 
or the like the net content of which does not exceed 60 ml or any package of solid or semi- 
solid cosmetic the net content of which does not exceed 30 grams. 

(3) On the inner label, where a hazard exists– 

(a) 
(b) 

(c) 

adequate direction for safe use, 
any   warning,   caution   or   special   direction   required   to   be   observed   by   the 
consumer, 
a  statement  of  the  names  and  quantities  of  the  ingredients  that  are  hazardous  or 
poisonous. 

1. Subs. by S.O. 3408, dt. 1.11.1996. 
2.  Subs. by G.S.R. 682 (E), dt. 5-12-1980. 
3.  Subs. by G.S.R. 352 (E), dt. 26-4-2000.

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1[(4) A distinctive batch number, that is to say, the number by reference to which details of 
manufacture  of  the  particular  batch  from  which  the  substance  in  the  container  is  taken  are 
recorded  and  are  available  for  inspection,  the  figures  representing  the  batch  number  being 
preceded  by  the  letter  ―B‖:   

Provided  that  this  clause  shall  not  apply  to  any  cosmetic containing 10 grams or less 
if the cosmetic is in solid or semi-solid state, and 25 millilitres or less if the cosmetic is in a 
liquid state: 

2[Provided further that in  the  case of  soaps, instead of the  batch number, the  month and 

year of manufacture of soap shall be given on the label.] 

1[(5) manufacturing licence number, the number being preceded by the letter ‗M‘.] 

(6)  Where  a  package  of  a  cosmetic  has  only  one  label,  such  label  shall  contain  all  the 

information required to be shown on both the inner and the outer labels, under these Rules. 

5[(7)   The list of ingredients, present in concentration of more than one percent shall be 
listed in the descending order of weight or volume at the time they are added, followed by 
those inconcentration of less than or equal to one percent, in any order, and preceded by the 
words ‗INGREDIENTS‘. 

Provided that this statement need not appear for packs of less than 60 ml of liquid 

and30 gm of solid and semi-solids. 

(8)  Labeling requirement, if any, specified in the relevant Indian  standard as laid down 

by the ‗Bureau of Indian Standards‘ for the cosmetics covered under Schedule S.] 

3[148A.  Prohibition  against  altering  inscriptions  on  containers,  labels  or  wrappers  of 
cosmetics.-  No  person  shall  alter,  obliterate  or  deface  any  inscription  or  mark  made  or 
recorded by the manufacturer on the container, label or wrapper of any cosmetic: 

Provided that  nothing in this rule shall apply to any alteration, inscription or mark made 
on  the  container,  label  or  wrapper  of  any  cosmetic  at  the  instance  or  direction  or  with  the 
permission of the licensing authority.] 

5[148B - Prohibition  against false or misleading claims :- No cosmetic may purport or 

claimto purport or convey any idea which is false or misleading to the intending user.] 

149.  4[Labelling  of  Hair  dyes  containing  Dyes,  Colours  and  Pigments.—Hair  dyes 
containing  Para-Phenylenediamine  or  other  Dyes,  Colours  and  Pigments]  shall  be  labelled 
with the following legend in English and local languages and these shall  appear on both the 
inner and the outer labels. 

―Caution—This  product  contains  ingredients  which  may  cause  skin  irritation  in 
certain cases and so a preliminary test according to the accompanying direction should 
first be made.  This product should not be used for dyeing the eye-lashes or eye-brows; 
as such a use may cause blindness‖. 

Each  package  shall  also  contain  instructions  in  English  and  local  languages  on  the 

following lines for carrying out the test: 

―This  preparation  may  cause  serious  inflammation  of  the  skin  in  some  cases  and  so  a 
preliminary  test  should  always  be  carried  out  to  determine  whether  or  not  special 
sensitivity exists.  To make the test, cleanse a small area of skin behind the ear or upon 
the inner surface of the forearm, using either soap and water or alcohol.  Apply a small 
quantity  of  the  hair  dye  as  prepared  for  use  to  the  area    and    allow    it    to    dry. 
After twenty-four hours,   wash    the    area      gently       with      soap      and  water. If
no    irritation    or     inflammation    is     apparent,    it     may    be    assumed  that 

1.  Subs. by G.S.R. 245, dt. 3-2-1976. 
2.  Ins. by. 681(E), dt. 6-8-1988. 
3.  Ins. by G.S.R. 351 (E), dt. 26-4-2000. 
4.  Subs. by G.S.R. 811 (E), dt. 14-11-1994. 
5.  Ins. by. 46 (E), dt. 22-1-2009.

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no hypersensitivity to the dye exists.  The test should, however, be carried out before each 
and  every  application.    This  preparation should  on  no  account  be  used  for  dyeing  eye- 
brows or eye-lashes as severe inflammation of the eye or even blindness may result.] 
1[149A. Special provisions relating to toothpaste containing fluoride.- 

(i) Fluoride content in tooth paste shall not be more than 1000 ppm and the content 

of fluoride in terms of ppm shall be mentioned on the tube and carton. 

(ii) Date of expiry should be mentioned on tube and carton.] 

150.  Report  of  result  of  test  or  analysis  of  cosmetics.—Test  reports  on  samples  of 

cosmetics taken for test or analysis under these rules shall be supplied in Form 34. 

2[150-A. Standard for cosmetics.- Subject to the provisions of these rules, the standards 

for cosmetics shall be such as may be prescribed in Schedule S.] 

3 [PART XV (A) 
APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS 
ON DRUGS, COSMETICS AND RAW MATERIALS USED IN 
THEIR MANUFACTURE ON BEHALF OF LICENSEES FOR 
MANUFACTURE FOR SALE OF DRUGS / COSMETICS 

150-B.  Application  for  grant  of  testing  drugs/cosmetics— (1)  Application  for  grant  or 
renewal of approval for carrying out tests for identity, purity, quality and strength on drugs or 
cosmetics  or  the  raw  materials  used  in  the  manufacture  thereof  on  behalf  of  licensees  for 
manufacture  for  sale  of  drugs  or  cosmetics,  shall  be  made  in  Form  36  to  the  Licensing 
Authority appointed by the State Government for the purposes of Part VII, VII (A) or XIV of 
these Rules, as the case may be and referred to as the ―approving authority‖ under    this   Part 
and shall be accompanied by an inspection fee of 2[rupees six thousand]  in the case of  testing 
of  drugs specified in  Schedules C  and C  (1) and  2[rupees one  thousand five  hundred] in  the 
case  of  testing  of  drugs  other  than  those  specified in  Schedules C  and  C  (1),  homoeopathic 
drugs and cosmetics: 

Provided  that  the  applicant  shall  furnish  to  the  approving  authority  such  additional 

information as may be required by him in connection with the application in Form 36: 

4[Provided further that if the applicant applies for renewal of approval after its expiry 
but within six months of such expiry, the inspection fee payable shall be rupees six thousand 
in  the  case  of  testing of  drugs  specified in  Schedules C  and  C  (1)  and  rupees one  thousand 
five hundred in the case of testing of drugs other than those specified in  Schedules C and C 
(1),  Homoeopathic medicines and  cosmetics plus  an  additional fee  at  the  rate  of  rupees  one 
thousand per month.] 

4[(2) A separate application shall be made for grant of approval for carrying out tests 
on  additional  categories  of  drugs  or  items  of  cosmetics  and  shall  be  accompanied  by  an 
inspection fee of rupees one thousand five hundred in the case of drugs specified in Schedule 
C and Schedule C(1) and rupees one thousand each in case of drugs other than those specified 
in Schedule C and Schedule C(1), homeopathic medicines and cosmetics. 

1.  Ins. by G.S.R. 223 (E), dt. 19-4-1991. 
2.  Ins. by G.S.R. 510 (E), dt. 26-7-1982. 
3.  Ins. rule 150B to 150K by X.1104/7/76-D&M,  dt. 23-8-1977. 
4.  Subs. by G.S.R. 601(E), dt. 24-8-2001.

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Explanation—For the  purpose  of  this  Part,  the  words  ‗drugs‘  and  ‗cosmetics‘ shall  also 
mean and include the raw materials used in the manufacture of drugs including Homoeopathic 
drugs or cosmetics, as the case may be.] 

150-C. Form in which approval to be granted for carrying out tests on drugs / cosmetics 
on  behalf  of  licensees  for  manufacture  of  drugs/cosmetics  and  conditions  for  grant  or 
renewal  of  such  approval.–  (1)  Approval  for  carrying  out  such  tests  of  identity,  purity, 
quality  and  strength  of  drugs  or  cosmetics  as  may  be  required  under  the  provisions  of 
these  rules,  on  behalf of licensee for  manufacture of  drugs or  cosmetics shall be  granted in 
Form 37. 

(2) Before approval in Form 37 is  granted or renewed, the following conditions 

shall be complied with by the applicant– 

(1) The premises where the tests are being carried out shall be well lighted and 
properly ventilated except where the nature of tests of any drug or cosmetic warrants 
otherwise.    Wherever  necessary,  the  premises  shall  be  air  conditioned  so  as  to 
maintain  the  accuracy  and  functioning  of  laboratory  instruments  or  to  enable  the 
performance of special tests such as sterility tests, microbiological tests, etc. 

(2)  The  applicant  shall  provide  adequate  space  having  regard  to  the  nature  and 

number of samples of drugs or cosmetics proposed to be tested. 

Provided that the approving authority shall determine from time to time whether 

the space provided continues to be adequate. 

(3)  If  it  is  intended to  carry out  tests  requiring the  use  of animals, the  applicant 

shall provide for an animal house and comply with the following requirements– 

(a)    The  animal  house  shall  be  adequate  in  area,  well  lighted  and  properly 

ventilated and the animals undergoing tests shall be kept in air conditioned area. 

(b)    The    animals  shall  be    suitably  housed  in    hygienic  surroundings  and 

necessary provisions made for removal of excreta and foul smell. 

(c) The applicant shall provide for suitable arrangements for preparation of animal 

feed. 

(d) The applicant shall  provide  for  suitable  arrangements for  quarantining  of  all 

animals immediately on their receipt in the institution. 

(e) The animals shall be periodically examined for their physical fitness. 

(f)  The  applicant  shall  provide  for  isolation  of  sick  animals  as  well  as  animals 

under test. 

(g) The applicant shall ensure compliance with the requirements of the 
Prevention of Cruelty to Animals Act, 1960 (59 of 1960). 

(h) The applicant shall make proper arrangements for the disposal of the carcasses 

of animals in a manner as not to cause hazard to public health. 

(4)  The  applicant  shall  provide  and  maintain  suitable  equipment  having  regard  to 
the nature and number of samples of drugs or cosmetics intended to be tested which shall 
be adequate in the opinion of the approving authority. 

(5) The testing of drugs or cosmetics, as the case may be, shall be under the active 
direction of a  person whose qualifications and experience are considered adequate in the 
opinion  of  the  approving authority  and  who  shall  be  held  responsible for  the  reports  of 
test or analysis issued by the applicant. 

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(6)  The  testing  of  drugs  or  cosmetics,  as  the  case  may  be,  for  identity, 
purity,  quality  and  strength  shall  be  carried  out  by  persons  whose  qualifications 
and experience of testing are adequate in the opinion of the approving authority. 

(7)  The  applicant  shall  provide  books  of  standards  recognized  under  the 
provisions of the Act and the Rules made thereunder and such books of reference 
as  may  be required in connection with the testing or  analysis  of  the products  for 
the testing of which approval is applied for. 

150D. Duration of approval. –An approval granted in  Form 37 or  renewed in Form 38, 
unless sooner suspended or withdrawn, shall be 1[valid for a period of five years on and from 
the date on which] it is granted or renewed: 

Provided that if an application for the renewal of an approval in Form 37 is made before 
its expiry or if the application is made within six months of its expiry after the payment of the 
additional  fee,  the  approval  shall  continue  to  be  in  force  until  orders  are  passed  on  the 
applications  and  the  approval  shall  be  deemed  to  have  expired  if  the  application  for  its 
renewal is not made within six months of its expiry. 

150E. Conditions of approval –An approval in Form 37 shall be subject to the following 

general conditions: — 

(a)  The  institution  granted  approval  under  this  Part  (hereinafter referred  to  as  the 
approved institution) shall provide and maintain an adequate staff and adequate premises 
and equipment as specified in rule 150-C 2[and Schedule L-1]. 

(b)  The  approved  institution  shall  provide  proper  facilities  for  storage  so  as  to 

preserve the properties of the samples to be tested by it. 

(c)  The  approved  institution  shall  maintain  records  of  tests  for  identity,  purity, 
quality  and  strength  carried  out  on  all  samples  of  drugs  or  cosmetics  and  the  results 
thereof together with the protocols of tests showing the readings and calculation in  such 
form  as  to  be  available  for  inspection  and  such  records  shall  be  retained  in  the  case  of 
substances for which an expiry date is assigned for a period of two years from the expiry 
of such date and in the case of other substances for a period of six years. 

(d) The approved institution shall allow the Inspector appointed under this Act to 
enter  with  or  without  prior  notice  the  premises  where  the  testing  is  carried  on  and  to 
inspect the premises and the equipment used for test and the testing procedures employed. 
The  institution shall allow the  Inspectors to inspect the  registers and  records maintained 
under  these   Rules  and   shall  supply  to  such  Inspectors  such  information  as  they  may 
require for the purpose of ascertaining whether the provisions of the Act and Rules made 
thereunder have been observed. 

(e)  The  approved  institution  shall  from  time  to  time  report  to  the  approving 
authority  any  changes in  the  person-in-charge of  testing  of  drugs  or  cosmetics or  in  the 
expert staff responsible for  testing as  the  case  may be  and any  material alteration in  the 
premises or  changes in  the  equipment used for  the  purposes of  testing which have  been 
made since the  date  of  last  inspection made on  behalf of the  approving authority before 
the grant or renewal of approval. 

1. Subs. by G.S.R. 601 (E), dt. 24-8-2001. 
2. Ins. by G.S.R. 780 (E), dt. 10-11-2008.

175 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(f) The approved institution shall furnish reports of the results of test or analysis 

Drugs and Cosmetics Rules 1945 

in Form 39. 

(g)  In  case  any  sample  of  a  drug  or  a  cosmetic  is  found  on  test  to  be  not  of 
standard  quality,  the  approved institution shall  furnish  the  approving authority  1[and 
the licensing authority of the State where the manufacturer and/or sender of the drug 
or cosmetic is located] with copy of the test report on the sample with the protocols of 
tests applied. 

(h)  The  approved  institution  shall  comply  with  the  provisions  of  the  Act  and 
Rules made thereunder and with each further requirements, if any, may  be specified 
in the rules subsequently made under Chapter IV of the Act of  which the approving 
authority has given the approved institution not less than four months notice. 

(i)  The  approved  institution  shall  maintain  an  Inspection  Book  to  enable  the 

Inspectors to record his impression or defects noticed. 

150F. Inspection before grant of approval.— Before an approval in Form 37 is granted, 
the approving authority shall cause the institution at which the testing of drugs or cosmetics, 
as  the  case  may  be,  is  proposed  to  be  carried  out  to  be  inspected  jointly  by  the  Drugs 
Inspectors of  the  Central  Drugs  Standard  Control  Organisation and  the  State  Drugs  Control 
Organisation  who  shall  examine  the  premises  and  the  equipment  intended  to  be  used  for 
testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff 
to be employed. 

150G. Report of Inspection.— The Drug Inspector mentioned in rule 150-F shall forward 

to the approving authority a detailed report of the result of the inspection. 

150H.      Procedure  of  approving  authority.—  (1)  If  the  approving  authority  after  such 
further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the 
rules made under the Act have been complied with and that the conditions of the approval and 
the rules made under the Act will be observed, he shall grant an approval in Form 37. 

(2) If the approving authority is not so satisfied, he shall reject  the application and shall 
inform  the  applicant  of  the  reasons  for  such  rejection  and  of  the  conditions  which  must  be 
satisfied before an approval could be granted. 

150-I.  Further  application after  rejection.—  If  within  a  period  of  six  months  from  the 
rejection of an application for approval, the applicant informs the approving authority that the 
conditions laid down have been satisfied and deposits inspection fee of  2[rupees two hundred 
and fifty], the approving authority may, if, after causing a further inspection to be made, he is 
satisfied that the conditions for grant of approval have been complied with, grant the approval 
in Form 37. 

1.  Ins. by G.S.R 93 (E), dt. 24-2-1995. 
2. Subs.by G.S.R 601 (E), dt. 24-8-2001.

176 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

150J. Renewal. – On an application being made for renewal the approving authority may 
cause  an  inspection  to  be  made  and  if  satisfied  that  the  conditions  of  the  approval  and  the 
rules  made  under  the  Act  are  and  shall  continue  to  be  observed  shall  issue  a  certificate  of 
renewal in Form 38. 

150K. Withdrawal and suspension of approvals – (1) The approving authority may, after 
giving the approved institution an opportunity to show cause why such an order should not be 
passed,  by  an  order  in  writing  stating  the  reasons  therefor,  withdraw  an  approval  granted 
under  this  Part  or  suspend  it  for  such  period  as  he  thinks  fit  either  wholly  or  in  respect  of 
some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the 
approved institution has failed to comply with any  of the conditions of the approval or  with 
any provisions of the Act or the Rules made thereunder. 

(2)        Any  approved  institution  whose  approval  has  been  suspended  or  withdrawn  may 
within  three  months  of  the  date  of  the  order,  appeal  to  the  State  Government  which  shall 
dispose of the appeal in consultation with a panel of competent persons appointed by it in this 
behalf and notified in the Official Gazette.] 

MANUFACTURE FOR SALE OF AYURVEDIC (INCLUDING SIDDHA) OR 
UNANI  DRUGS 

1[PART XVI 

151. Manufacture on more than one set of premises.—If Ayurvedic (including Siddha) 
or  Unani  drugs  are  manufactured  on  more  than  one  set  of  premises,  a  separate  application 
shall be made and a separate licence shall be obtained in respect of each such set of premises. 

152.  Licensing  Authorities.—For  the  purpose  of  this  Part  the  State  Government  shall 
appoint such Licensing Authorities and  for  such  areas as  may  be  specified in  this  behalf by 
notification in the Official Gazette. 

153.    Application  for    licence    to    manufacture  Ayurvedic  (including  Siddha)  or  
Unani drugs.— (1) An  application for  the  grant  or  renewal  of  a  licence  to  manufacture for 
sale  any  Ayurvedic  (including  Siddha)  or  Unani  drugs  shall  be  made  in  Form  24-D  to  the 
Licensing Authority along with 2[a fee of rupees one thousand]: 

Provided that in the case of renewal the applicant may apply for the renewal of the licence 

before its expiry or within one month of such expiry: 

Provided further that  the applicant may  apply for renewal after the expiry of one  month 
but  within three  months  of  such  expiry  in  which  case  the  2[fee payable for renewal of such 
licence  shall  be  rupees  one  thousand    and  two  hundred  plus  an  additional  fee  of  rupees  six 
hundred]. 

(ii)  2[A  fee  of  rupees  three  hundred]  shall  be  payable  for  a  duplicate  copy  of  a  licence 

issued under this rule, if the original licence is defaced, damaged or lost. 

1.  Parts XVI, XVII and XVII added by S.O. 642, dt. the 2-2-1970 (w.e.f. 21.2.1970) 
2. Subs. by G.S.R 79 (E), dt. 14-2-2005.

177 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1  [153A. Loan Licence.—(i) An application for the grant of renewal of a loan licence to 
manufacture for  sale  of  any  Ayurvedic (including  Siddha)  or  Unani  drugs  shall  be  made  in 
Form 25-E to the Licensing Authority along with 2[a fee of rupees six hundred.] 

Explanation—For  the  purpose  of  this  rule,  a  loan  licence  means  a  licence  which  a 
Licensing Authority may  issue to  an  applicant who does not have his own arrangements for 
manufacture but intends to avail himself of the manufacturing facilities owned by a licence in 
Form 25-D: 

Provided that in the case of renewal the applicant may apply for the renewal of the licence 

before its expiry or within one month of such expiry: 

Provided further that the applicant may apply for renewal after the expiry of one month, 
but within three months of  such expiry in  which case  2[the  fee payable for renewal of such 
licences shall be rupees six hundred plus an additional fee of rupees three hundred.]] 

(ii)  2[A  fee  of  rupees  one  hundred  and  fifty]  shall  be  payable for  a  duplicate  copy  of  a 

licence issued under this rule, if the original licence is defaced, damaged or lost.] 

154.   Form  of  licence  to  manufacture Ayurvedic  (including  Siddha)  or  Unani  drugs. 
— (1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale 
any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D.  The licence 
shall be issued within a period of three months from the date of receipt of the application. 

(2)  A  licence  under this  rule  shall  be  granted by  the  licensing authority after  consulting 
such expert in Ayurvedic (including Siddha) or Unani Systems of  medicine as the case may 
be, which the State Government may approve in this behalf. 

1[154A.  Form of loan licence to manufacture for sale of Ayurvedic (including Siddha) 
or Unani drugs.— 

(1) A loan licence to manufacture for sale of any Ayurvedic (including Siddha) or 

Unani drugs shall be issued in Form 25E. 

(2)  A  licence  under  this  rule  shall  be  granted  by  the  Licensing  Authority  after 
consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, 
as the case may be, which the State Government may approve in this behalf. 

(3) The Licensing Authority shall, before the grant of a loan licence, satisfy himself 
that the manufacturing unit has adequate equipment, staff, capacity for manufacture and 
facilities for testing, to undertake the manufacture on behalf of the applicant for a loan 
licence.] 

155.   Certificate of renewal—The certificate of renewal of a licence in Form 25-D shall 

be issued in Form 26-D. 

1.  Ins. by G.S.R. 376(E), dt. 20-7-1978. 
2. Subs. by G.S.R 79 (E), dt. 14-2-2005.

178 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [155A.   Certificate of renewal of a loan licence.—The certificate of renewal of a loan 

licence in Form 25-E shall be issued in Form 26-E.] 

2[155B.  Certificate  of  award  of  G.M.P.  of  Ayurveda,  Siddha  and  Unani  Drugs.— 
3[(1)]The certificate  of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha 
or  Unani  drugs  shall  be  issued  to  licensees  who  comply  with  the  requirements  of  Good 
Manufacturing Practice of Ayurveda, Siddha and Unani drugs as laid down in Schedule T.] 

4[(2) The  certificate referred  to  in sub-rule  (1)  shall  be  issued  for  a  period  of five  years 

from the date of issuance of the license.] 

156.   Duration  of  licence—An  original  licence  in  Form  25-D  or  a  renewed  licence  in 
Form  26-D,  unless  sooner  suspended  or  cancelled  shall  be  5[valid  for  a  period  of  6[five 
years] from the date of its issue]: 

Provided that if the application for the renewal of a  licence is  made before its  expiry or 
within one month of its expiry after payment of the additional fee of rupees thirty, the licence 
shall continue to be in force until orders are passed on the application.   The licence shall be 
deemed to have expired, if the application for its renewal is not made within three months of 
its expiry.] 

1 [156A.  Duration of loan licence.—An original loan licence in Form 25-E or a renewed 
loan licence in Form 26-E, unless sooner suspended or cancelled, shall be valid up to the 31st 
December of the year following the year in which it is granted or renewed: 

Provided that  if  the  application for  the  renewal of  a  loan licence is  made  in  accordance 
with rule 153-A, the loan licence shall continue to be in force until orders are passed on the 
application.  The licence shall be deemed to have expired, if the application for its renewal is 
not made within three months of its expiry.] 

157. Conditions for the grant or renewal of a licence in Form 25-D.—Before a licence 
in Form 25-D is granted or renewed in Form 26-D the following conditions shall be complied 
with by the applicant, namely: — 

(1) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried 

out in such premises and under such hygienic conditions as are specified in Schedule T. 

2[(IA)   For issuing of the certificate of Good Manufacturing Practices, the Licensing 
Authority  shall  verify  the  requirements    as  per  schedule  T  and  issue  the  Good 
Manufacturing  Practices  certificate  in  form  26  E-I,  simultaneously  along  with  grant  or 
renewal of licence in form 25D]. 

7[(IB) No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, 
Siddha  or  UnaniTibb  drug  falling  under  clause  (a)  of  section  3  of  the  Act,  except  as 
described in the authoritative books specified in the First Schedule to the Act: 
                   Provided  that  a  formulation  without  any  specific  name,  described  in  the 
authoritative books may be named on the basis of the ingredients of the formulation. 

(IC) The name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) 
of  section  3  of the  Act  shall not  be used  for  naming  any  patent  or  proprietary  medicine 
relating to Ayurvedic, Siddha or UnaniTibb systems of medicine referred to in sub-clause 
(i) of clause (h) of the said section: 
                  Provided that this rule shall not be applicable for single plant-ingredient based 
Ayurvedic,  Siddha  or  UnaniTibb  formulation  licensed  or  to  be  licensed  as  patent  or 
proprietary medicine under sub-clause (i) of clause (h) of section 3 of the Act.] 

1.  Ins.  by  G.S.R. 376 (E),dt. 20-7-1978.                 7. Ins. by  G.S.R. 390 (E),dt. 18.5.2015. 
2.  Subs.  by  G.S.R. 376 (E),dt. 3-5-2010. Earlier Ins.  by  G.S.R. 198 (E), dt. 7-3-2003. 
3. Rule 155B renumbered as sub-rule (1) by G.S.R. 376 (E),dt. 3-5-2010. 
4. Ins.  by  G.S.R. 376 (E),dt. 3-5-2010. 
5. Subs. by G.S.R 79 (E), dt. 14-2-2005. 
6. Subs.  by  G.S.R. 376 (E),dt. 3-5-2010. 

179 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

           (ID) Notwithstanding the period for renewal of licence provided in rules 156 and 
156  A,  the  licensee  of  the  Ayurvedic,  Siddha  or  UnaniTibb  drug,  which  is  not  in 
conformity  with  sub-rules  (1B)  and  (1C),  shall  seek  renewal  of  the  licence  with 
appropriate name of the drug within a period of one year from the date of commencement 
of Drugs and Cosmetics (4th Amendment) Rules, 2015: 
                     Provided  that  this  rule  shall  not  be  applicable  to  any  batch  of  Ayurvedic, 
Siddha or UnaniTibb drugs manufactured prior to the date of commencement of the Drugs 
and Cosmetics (4th Amendment) Rules, 2015. 

       (IE)  Whoever  contravenes  the  provisions  of  rules  (IB)  to  (ID)  shall  be  punishable 
under section 33-I of the Act.] 

(2)  The  manufacture  of  Ayurvedic  (including  Siddha)  or  Unani  drugs  shall  be 
conducted under  the  direction and  supervision of  competent technical staff  consisting at 
least  of  one  person,  who  is  a  whole  time  employee  and  who  possesses  the  following 
qualifications, namely:– 

(a)  A  degree  in  Ayurveda  or  Ayurvedic  Pharmacy,  Siddha  or  Unani  system  of 
medicine, as the case may be, conferred by a University, a State Government or Statutory 
Faculties, Councils and Boards of Indian Systems of Medicines recognized by the Central 
Government or a State Government for this purpose, or 

(b) a diploma in Ayurveda, Siddha or Unani system of medicine granted by a State 

Government for this purpose, or 

(c) a graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of 
a University recognized by the Central Government with experience of at least two years 
in  the  manufacture of  drugs  pertaining to  the  Ayurvedic or  Siddha  or  Unani  systems  of 
medicines, or 

(d)  a  Vaid  or  Hakim  registered  in  a  State  Register  of  Practitioners  of  indigenous 
systems  of  medicines  having  experience  of  at  least  four  years  in  the  manufacture  of 
Ayurvedic or Siddha or Unani drugs, or 

(e) a  qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems 
of  medicines,  possessing  experience  of  not  less  than  eight  years  in  the  manufacture  of 
Ayurvedic or Siddha or Unani drugs as may be recognized by the Central Government. 

(3)    The   competent   technical   staff   to   direct   and   supervise   the   manufacture   of 
Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff 
to  direct  and  supervise  the  manufacture  of  Siddha  drugs  and  Unani  drugs  shall  have 
qualification in Siddha or Unani, as the case may be. 

180 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3[157A. Maintaining of records of raw material  used by licensed manufacturing unit 
of Ayurveda, Siddha and Unani drugs in the preceding financial year.- Each licensed 
manufacturing  unit  of  Ayurveda  or  Siddha  or  Unani  drugs  shall  keep  a  record  of  raw 
material used by each licensed manufacturing unit of Ayurveda, Siddha or Unani drugs as 
the  case  may  be  in  the  proforma  given  in  Schedule  TA  in  respect  of  all  raw  materials 
utilized  by  that  unit  in  the  manufacture  of  Ayurveda  or  Siddha  or  Unani  drugs  in  the 
preceding  financial  year,  and  shall  submit  the  same  by  the  30th  day  of  June  of  the 
succeeding financial year to the State Drug Licensing Authority of Ayurveda, Siddha and 
Unani drugs and to the National Medicinal Plants Board or any agency nominated by the 
National Medicinal Plant Board for this purpose.] 

158.  Conditions  of  licence.—A  licence  in  Form  25D  shall  be  subject  to  the  conditions 
stated therein and to the following further conditions, namely:– 

(a) The licensee shall maintain proper records of the details of manufacture and of 
the  tests,  if  any,  carried  out  by  him,  or  by  any  other  person  on  his  behalf,  of  the  raw 
materials and finished products. 

(b)  The  licensee  shall  allow  an  Inspector  appointed  under  the  Act  to  enter  any 
premises where the manufacture of a substance in respect of which the licence is issued is 
carried on, to inspect the premises, to take samples of the raw material as well as finished 
the products, and to inspect the records maintained under these rules. 

1[(c)   The licensee shall maintain an Inspection Book in Form 35 to enable an 

Inspector to record his impressions and the defects noticed.] 

2[158-A.  Condition  of  loan  licence.—A  licence  in  Form  25E  shall  be  subject  to  the 
conditions stated therein and to the following conditions, namely:— 

(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the 
licence  owned  by  the  licensee  in  Form  25D  whose  manufacturing  facilities  have 
been availed of by the licensee is cancelled or suspended, as the case may be, under 
these rules. 

(b) The licensee shall comply with the provisions of the Act and of the rules and 
with such further requirements, if any, as may be specified in any rules subsequently 
made under Chapter IV-A of the Act, provided that where such further requirements 
are specified in the rules; these would come into force four months after publication in 
the Official Gazette. 

(c)  The  licensee  shall  maintain  proper  records  of  the  details  of  manufacture 
and of the tests, if any, carried out by him, or any other person on his behalf, of the 
raw materials and finished products. 

(d) The licensee shall allow an Inspector appointed under the Act to inspect all 
registers  and  records  maintained under  these  rules  and  shall  supply  to  the  Inspector 
such  information  as  he  may  require  for  the  purpose  of  ascertaining  whether  the 
provisions of the Act and the rules have been observed. 

1[(e)  The  licensee  shall  maintain  an  Inspection  Book  in  form  35  to  enable  an 

Inspector to record his impressions and the defects noticed.] 

1.  Ins. by  G.S.R. 331 (E),dt. 8.5.1984. 
2.  Ins. by  G.S.R. 376 (E), dt. 20.7.1978. 
3.  Ins. by  G.S.R. 512 (E),dt. 9.7.2008.

181 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1[158(B)  Guidelines  for  issue  of  license  with    respect  to  Ayurveda,  Siddha  or 

Drugs and Cosmetics Rules 1945 

Unani drugs.- 

I. (A). Ayurveda, Siddha Unani Medicines under section 3(a):- Ayurveda, Siddha or 
Unani  drugs  includes  all  medicines  intended  for  internal  or  external  use  for  or  in  the 
diagnosis,  treatment,  mitigation  or  prevention  of  disease  or  disorder  in  human  beings  or 
animals, and manufactured exclusively in accordance with the formulae described in the 
authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified 
in the First Schedule; 

(B). Patent or Proprietary medicine under section 3(h);  
(i)  In  relation  to  Ayurvedic,  Siddha  and  Unani  Tibb  system  of  medicine  of  all 
formulations containing only such ingredients mentioned in the formulae described in the 
authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in 
the  First  Schedule,  but  does  not  include  a  medicine which  is  administered  by  parenteral  
route and also a formulation included in the authoritative books as specified in clause (a); 
(ii)  Balya/Poshak/Muqawi/Unavuporutkal/positive  health  Promoter 
formulations 
having ingredients  mentioned in books of First Schedule of the Drugs and Cosmetics Act 
and recommended for promotional  and preventive health. 
(iii)  Saundarya  Prasadak  (Husane  afza)/Azhagh-sadhan  formulation  having  ingredients 
mentionedin Books of First Schedule of the Drugs and Cosmetics Act and recommended 
for oral, skin, hair and body care. 
(iv)  Aushadh  Ghana  (Medicinal  plant  extracts  -  dry/wet)  extract  obtained  from  plant 
mentioned in books of First Schedule of the Act including Aqueous or hydro-alcohol. 

II.(A)  For  issue  of  licence  to  the  medicine    with    respect  to  Ayurvedic,  Siddha  and 
Unani,  the  conditions  relating  to  safety  study  and  the  experience  or  evidence  of 
effectiveness shall be such as specified in columns (5) and (6) of The Table given below:- 

Serial 
number 

Category 

Ingredient 
(S) 

Indication 
(s) 

Safety 
study 

Experience/Evidence of 
Effectiveness 

1 

2 

3 

4 

5 

6 

Published 
Literature 

Proof of 
Effectiveness 

1 

2 

(A) 
Ayurveda, 
siddha and 
Unani drugs, 
given in 158 
B as referred 
in 3(a) 
(B) Any 
change in 
dosage form 
of Ayurveda, 
siddha and 
Unani drugs, 
as described 
in section 3 
(a) of the 
Drugs and 
Cosmetics 

As per 
text 

As per 
text 

Not 
Required 

Required 

Not Required 

As per 
text 

As per 
text 

Not 
Required 

Required 

Not Required 

182 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

As per 
text 

New 

Not 
Required 

If Required 

Required 

Act, 1940 
(C) 
Ayurveda, 
siddha and 
Unani drugs, 
referred in 
3(a) to be 
used for new 
indication 

3 

II.B For issue of license with  respect to Patent or Proprietary medicine. The condition 
relating to Safety studies and experience or evidence of effectiveness shall be specified as 
follows:- 

Serial 
number 

Category 

Ingredient 
(S) 

Indication 
(s) 

Safety 
study 

Experience/Evidence 
of Effectiveness 

2 

3 

4 

5 

6 

Published 
Literature 

As per 
text 

Textual 
Rationale 

Not 
Required 

Of 
Ingredients 

Proof of 
Effectiveness 
Pilot study as 
per relevant 
protocol for 
Ayurveda, 
siddha and 
Unani drugs 

As per 
text 

Existing 

Required 

Required 

 Required 

1 

1 

2 

Patent 
orPropri 
etary 
medicine 

Ayurveda, 
siddha and 
Unani 
drugswith 
any of the 
ingredients 
of Schedule 
E(1) of the 
Drugs and 
Cosmetics 
Act, 1940 

III. For issue of license with  respect to Balya and Poshak medicines the person who 

applied for license is required  to submit the following: 

(i)  Photo-copy  of  the  textual  reference  of  ingredients    used  in  the  formulation  as 

mentioned  in the book of 1st schedule; 

(ii) Conduct safety studies in case the product contains of any of the ingredients  as 
specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda  Siddha 
and Unani Drugs formulations; 

(iii) For textual indications the safety and effectiveness study is not required. 
IV.  For  issue  of  license  with    respect  to  Saundarya  Prasadak  (Husane  afza/Azhagu 

Sodhan) the person who applied for license is required to:- 

(i)    Submit photo-copy of the textual reference of ingredients  used in the formulation 

as mentioned  in the book of 1st schedule;  

1.  Ins. by  G.S.R. 663 (E),dt. 10.10.2010. 

183 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

 (ii)   Conduct safety studies, in case the formulation contains of any of the ingredients  
as  specified  in  the  Schedule  E  (1),  as  per  the  guidelines  for  evaluation  of  Ayurveda,  
Siddha and Unani formulation;  

(iii)  For textual indications the safety and effectiveness study is not required. 
V. For issue of license with respect to medicine Aushadh Ghana extract of medicinal 

plant (dry or wet).  

Serial 
number 

Category 

Ingredien
t (S) 

Indication (s) 

Safety study 

Experience/Evidence of 
Effectiveness 

1 

1 

2 

3 

4 

5 

2 

3 

4 

5 

(A) 
Aqueous 
(Al). 
Aqueous 
(B) Hydro- 
Alcohol 
(B1) 
Hydro- 
Alcohol 

Other 
than 
Hydro/ 
HydroAlc
ohol 

As per 
text 
As per 
text 

As per 
text 

As per text 

Not Required 

New 
Indication** 

Not Required 

As per text 

Not Required 

As 
specified 

New 
Indication** 

As 
specified 

As specified 

Required 

Required 
Acute, 
Chronic, 
mutagenicity
and 
teratogenicit
y 

6 

Proof of 
Effectiveness 

Not Required 

Required 

Not Required 

Required 

Published 
Literature 
Not 
Required 

Not 
Required 

If 
Required 

If 
Required 

If 
Required 

Required 

*   The standard protocol  will also include concept of Anupan, Prakriti & Tridosh etc. 

published by Central 

Research Councils Ayurveda, Siddha, Unani and other Government/Research  Bodies. 
**    New  indication    means  which  is  other  than  mentioned  in  1st  schedule  books  of 

Drugs & Cosmetics Act 1940.] 

1[158C. Form of Free Sale Certificate and Non-Conviction Certificate. – The State 

Drug Controller or Licensing Authority shall, on request  by the Ayurveda, Siddha and 
Unani Drugs manufacturer, issue, within 15 days; from the date of application, Free Sale 
Certificate in Form 26 E2-I for original License holder or in Form 26 E2-II for loan license 
and Non Conviction Certifacate for both original and loan license holder in Form 26 E3 or 
in the format as specified by the importing country or tenderer respectively, after 
fulfilment of all requisite formalities as required in the respective formats.] 

1.  Ins. by  G.S.R. 153 (E),dt. 5.3.2014. 

184 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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159.   Cancellation and suspension of licences— (1) The Licensing Authority may, after giving an 
opportunity to show cause within a period which shall not be less than fifteen days from the date of 
receipt of such notice, why such an order should not be passed, by an order in writing stating the 
reasons therefor, cancel a licence issued under this Part or suspend it for such  period  as  he  thinks 
fit,  either  wholly  or  in  respect  of  some  of  the  drugs  to  which  it relates, if in his opinion, the 
licensee has failed to comply with any of the conditions of the licence or with any provisions of the 
Act and the rules made thereunder. 

(2)  A  licensee  whose  licence  has  been  suspended  or  cancelled  may  appeal  to  the  State 
Government within a period of three months from the date of receipt of the order which shall, 
after considering the appeal, decide the same. 

160.  Identification  of  raw  materials.— Raw  materials  used  in   the  preparation  of 
Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are 
available for their genuineness, and records of such tests as are carried out for the purpose and 
the methods thereof shall be maintained. 

1[PART  XVI (A) 

APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON AYURVEDIC, 
SIDDHA AND UNANI DRUGS AND RAW MATERIALS USED IN THEIR 
MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE 
OF AYURVEDIC, SIDDHA AND UNANI DRUGS 

160-A.    Application  for  grant  of  approval  for  testing  Ayurvedic,  Siddha  and  Unani 
drugs.- Application for grant or renewal of approval for carrying out tests for identity, purity, 
quality and  strength of  Ayurvedic, Siddha and  Unani drugs or  the  raw  materials used in the 
manufacture  thereof  on  behalf  of  licensees  for  manufacture  for  sale  of  the  said  Ayurvedic, 
Siddha and Unani drugs, shall be  made in Form 47 to the Licensing Authority appointed by 
the State Government for the purposes of Part XVI, XVII or XVIII of these rules, as the case 
may be, and referred to as the ‗approving authority‘ under this Part and shall be accompanied 
by  an  inspection  fee  of  six  thousand  rupees  in  respect  of  the  drugs  specified  in  the  books 
prescribed  in First Schedule to the Act. 

1. Subs. by G.S.R.73 (E), dt. 31-01-2003 and earlier Ins. by  G.S.R. 701(E), dt. 27-9-2001.

185 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Provided  that  the  applicant  shall  furnish  to  the  approving  authority  such  additional 

information as may be required by it in connection with the application in Form 47: 

Provided further that if the  applicant applies for renewal of  approval after its  expiry but 
within six months of such expiry, the inspection fee payable shall be six thousand rupees plus 
an additional inspection fee at the rate of one thousand rupees per month in the case of testing 
of Ayurvedic, Siddha and Unani drugs specified in First Schedule to the Act. 

Explanation.  -  For  the  purpose  of  this  Part,  the  words  ―Ayurvedic,  Siddha  and  Unani 
drugs‖ shall also mean and include the raw materials used in the manufacture of Ayurvedic, 
Siddha and Unani drugs, as the case may be. 

160B.    Form  in  which  approval  to  be  granted  for  carrying  out  tests  on  Ayurvedic, 
Siddha and  Unani  drugs  on  behalf  of  licensees  for  manufacture  of  Ayurvedic,  Siddha 
and  Unani drugs and conditions for grant or renewal of such approval.-- (1) Approval for 
carrying  out  such  tests  of  identity,  purity,  quality  and  strength  of  Ayurvedic,  Siddha  and 
Unani drugs as may be required under the provisions of these rules, on behalf of licensee for 
manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48. 

(2) Before approval in Form 48 is granted or renewed, the following conditions shall be 

complied with by the applicants, namely: - 

(i)  The  premises  where  the  tests  are  carried  out  shall  be  well  lighted  and  properly 
ventilated  except  where  the  nature  of  tests  of  any  Ayurvedic,  Siddha  and  Unani  drug 
warrants otherwise. Wherever necessary, the  premises shall be  air-conditioned so  as  to 
maintain  the  accuracy  and  functioning  of  laboratory  instruments  or  to  enable  the 
performance of special tests such as sterility tests and microbiological tests. 

(ii) (a) The  applicant shall  provide adequate space having regard  to  the nature and 

number of samples of drugs proposed to be tested: 

Provided that the approving authority shall determine from time to time  whether 

the space provided continues to be adequate: 

Provided  further  that  separate  section  shall  be  provided  for  (i)  Chemistry,  (ii) 
Pharmacognosy,  (iii) Ayurveda, Siddha and    Unani,   (iv)    Microbiology,  (v)   Sample 
Room,  (vi)  Office-cum-Record  Room,  with  proper  partitions  and  minimum  required 
area is 800 sq. ft. 

1[(b)  The  applicant  shall  provide  a  list  of  persons  who  may  be  employed  with 
him  as  experts,  such  as  Chemist,  Botanist  and  expert  in  Ayurveda/Siddha/Unani  or 
Pharmacist 
Botany, 
a 
recognized  University  or 
Ayurveda/Siddha/Unani/Bachelor  in  Pharmacy  from  a 
equivalent,  with  experience  for  2  years  for  carrying  out  tests  or  analysis  as  per  the 
Ayurvedic, Siddha and Unani Pharmacopoeias]. 

Chemistry, 

possess 

degree 

shall 

who 

in 

The  applicant  shall  provide  adequate  equipment  essential  for  carrying  out tests 
for  identity,  purity,  quality  and  strength  of  Ayurvedic,  Siddha  and  Unani  drugs  as  per 
pharmacopoeial standards or other available standards. 

1. Subs. by  G.S.R. 674 (E), dt. 10-11-2005. 

186 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

List of equipment recommended is given below: 

Chemistry Section 

1.       Alcohol determination apparatus complete set. 
2.       volatile oil determination apparatus. 
3.       Boiling point determination apparatus. 
4.        Melting point determination apparatus. 
5.        Refractometer. 
6.        Polarimeter. 
7.        Viscometer (Ostwalds, Redwood Viscometer). 
8.        Tablet disintegration apparatus. 
9.         Moisture determination apparatus (IC filtrator). 
10.       U.V.Spectro-photometer. 
11.       Muffle furnace. 
12.       Electronic Balance. 
13.       Hot air oven(s) different range of temperature/vacuum oven. 
14.       Refrigerator. 
15.       Glass distillation apparatus/plant. 
16.       Water supply demineralised exchange equipment/distillation equipment. 
17.       Air conditioner. 
18.       LPG Gas cylinder with burners. 
19.       Water bath (temperature controlled). 
20.       Heating mantle(4) or as required. 
21.       TLC apparatus with all accessories. 
22.       Sieves 10 to 120 with sieve shaker. 
23.       Centrifuge machine. 
24.       Dehumidifier. 
25.       pH meter. 
26.       G.L.C. with F.I. detector. 
27.       Silica crucible. 
28.       Tablet friability tester. 
29.       Tablet dissolution tester. 
30.       Other related equipment, reagents, glasswares etc. 

Pharmacognosy Section 

1.      Microscope binocular. 
2.      Dissecting Microscope. 
3.      Microtome. 
4.      Chemical balance. 
5.      Microslide cabinet. 
6.      Aluminium slide trays. 
7.      Hot air oven. 
8.      Occular Micrometer. 
9.      Stage Micrometer. 
10.    Camera Lucida Prism type and mirror type. 
11.    Hot plates. 
12.    Refrigerator. 
13.    LPG Cylinder with burners. 
14.    Other related equipments, reagents, glasswares etc. 

Note:      Instuments  like  HPLC,  HPTLC,  Atomic  Absorption  spectrophotometer  could  be 
arranged by tie up with other laboratories.

187 

 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Microbiology section 

1.    Laminar air flow bench (L.A.F.) 
2.    B.O.D. Incubator. 
3.    Plain Incubator. 
4.    Serological water bath. 
5.    Oven. 
6.    Autoclave/sterilizer. 
7.    Microscope (high power). 
8.    Colony counter. 
9.     Other related equipment and reagents. 

(3).  The  applicant  shall  provide  and  maintain  suitable  equipment  having  regard  to  the 
nature  and  number  of  samples  of  Ayurvedic, Siddha  and  Unani  drugs  intended to  be  tested 
which shall be adequate in the opinion of the approving authority. 

(4) The  testing of  Ayurvedic, Siddha and  Unani drugs, as  the  case  may  be,  for identity, 
purity, quality and strength shall be carried out under the active direction of one of the experts 
stated in  clause (b) of  sub-rule (2) who shall be the  person-in-charge of  testing and  shall be 
held responsible for the reports of test issued by the applicant. 

(5) The  testing of  Ayurvedic, Siddha and  Unani drugs, as  the  case  may  be,  for identity, 
purity,  quality  and  strength  shall  be  carried  out  by  persons  whose  qualifications  and 
experience of testing are adequate as stated in clause (b) of sub-rule (2). 

(6) The applicant shall provide books of standards recognized under the provisions of the 
Act  and  the  rules  made  thereunder  and  such  books  of  reference  as  may  be  required  in 
connection  with  the  testing  or  analysis  of  the  products  for  the  testing  of  which  approval  is 
applied for. 

(7)  The  applicant  shall  provide  list  of  standard  Ayurvedic,  Siddha  and  Unani  drugs 
(Reference  samples)  recognized  under  the  provisions  of  the  Act  and  rules  made  thereunder 
and  such  reference  samples  kept  in  the  laboratory  may  be  required  in  connection  with  the 
testing or analysis of the products of which approval is applied for. 

160C. Duration of approval. -   An approval granted in Form 48 or renewed in Form 49 
unless sooner suspended or withdrawn, shall be valid for a period of three years from the date 
on which it is granted or renewed: 

Provided that if an application for the renewal of an approval in Form 40 is made before 
its expiry or if the application is made within six months of its expiry after the payment of the 
additional inspection fee, the approval shall continue to be in force until orders to the contrary 
are passed on the application and approval shall be deemed to have expired if the application 
for renewal is not made within six months of expiry. 

160D. Conditions of approval.–An approval in Form 48 shall be subject to the following 

conditions, namely: - 

I. The Institution granted approval under this Part (hereinafter referred to as the approved 
laboratory) shall provide and maintain adequate staff and adequate premises and equipment as 
specified in rule 160-B. 

II. The  approved  laboratory  shall  provide  proper  facilities  for  storage  so  as  to  preserve 

the properties of the samples to be tested by it. 

188 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

III.  The  approved  laboratory  shall  maintain  records  of  tests  for  identity,  purity,  quality 
and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the results 
thereof together with the protocols of tests showing the readings and calculation in such form 
as to be available for inspection and such records shall be retained in the case of substances 
for which date of expiry is assigned; for a period of two years from such date of expiry and in 
the case of other substances, for a period of three years. 

IV. The  approved laboratory shall  allow  the  Inspector appointed under  this  Act  to  enter 
with  or  without  prior  notice  the  premises  where  testing  is  carried  out  and  to  inspect  the 
premises and the equipment used for test and the testing procedures employed. The laboratory 
shall allow the Inspectors to inspect the registers and records maintained under these rules and 
shall  supply  to  such  Inspectors  such  information  as  they  may  require  for  the  purpose  of 
ascertaining whether the provisions of the Act and rules made thereunder have been observed. 

V.   The approved laboratory shall from time to time report to the approving authority any 
changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or the expert 
staff responsible for testing, as the case may be, and any material alterations in the premises 
or changes in the equipment used for the purposes of testing which have been made since the 
date of last inspection made on behalf of the approving authority before the grant or renewal 
of approval. 

VI. The  approved  laboratory  shall  furnish  reports  of  the  results  of  tests  or  analysis  in 

Form 50. 

VII.   In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be not 
of  standard quality, the  approved laboratory shall  furnish to  the  approving authority and the 
licensing  authority  of  the  State  where  the  manufacturer  and/or  sender  of  the  Ayurvedic, 
Siddha and Unani drugs is located, a copy of the test report of the sample with the protocols 
of tests applied. 

VIII.  The  approved  laboratory  shall  comply  with  the  provisions  of  the  Act  and  rules 
made thereunder and with such further requirements, if any, as may be specified in the rules 
made from time to time under Chapter IV-A of the Act of which the approving authority has 
given the approved laboratory not less than four months‘ notice. 

IX. The approved laboratory shall maintain an inspection book to enable the Inspector to 

record his impression or defects noticed. 

160-E. Inspection before grant of approval.—  Before an approval in Form 48 is granted, 
the approving authority shall cause the laboratory at  which the testing of  Ayurvedic, Siddha 
and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by 
the Inspectors appointed or designated by the Central Government and State Government for 
this  purpose,  who  shall  examine  the  premises  and  the  equipment  intended  to  be  used  for 
testing of drugs and verify into the professional qualifications of the expert staff who are or 
may be employed by the laboratory. 

160F. Report  of  inspection.—   The  Inspectors appointed by  the  Central Government as 
stated in Rule 160-E shall forward to the approving authority a detailed report of the results of 
the inspection. 

160G.  Procedure  of  approving  authority.  -  (1)  If  the  approving  authority  after  such 
further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the 
rules made under the Act have been complied with and that the conditions of the approval and 
the  rules  made  under  the  Act  have  been  observed,  it  shall  grant  approval  in  Form  48.

189 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(2)  If  the  approving  authority  is  not  satisfied,  it  shall  reject  the  application  and  shall 
inform  the  applicant  of  the  reasons  for  such  rejection  and  of  the  conditions  which  shall  be 
satisfied before approval could be granted. 

160H.  Application after rejection. - If within a period of six months from the rejection of 
an application for approval, the applicant informs the approving authority that the conditions 
laid  down  have  been  satisfied  and  deposits  inspection  fee  of  two  thousand  rupees,  the 
approving  authority  may,  if,  after  causing  a  further  inspection  to  be  made  and  after  being 
satisfied that the conditions for grant of approval have been complied with, grant the approval 
in Form 48. 

160-I.   Renewal. -   On  an  application being  made  for  renewal, the  approving authority 
shall,  after  causing  an  inspection  to  be  made  and  if  satisfied  that  the  conditions  of  the 
approval and the rules made under the Act have been complied with, shall issue a certificate 
of renewal in Form 49. 

160J.  Withdrawal and suspension of approvals. -  (1) The approving authority may, after 
giving the approved laboratory an opportunity to show cause why such an order should not be 
passed,  by  an  order  in  writing  stating  the  reasons  therefor,  withdraw  an  approval  granted 
under  this  Part  or  suspend  it  for  such  period  as  it  thinks  fit  either  wholly  or  in  respect  of 
testing of some of the categories of Ayurvedic, Siddha and Unani drugs to which it relates, if 
in his opinion the approved laboratory had failed to comply with any of the conditions of the 
approval or with any provision of the Act or the rules made thereunder. 

(2)  Any  approved  laboratory,  whose  approval  has  been  suspended  or  withdrawn,  may, 
within three months of the date of the order of suspension or withdrawal, appeal to the State 
Government  which  shall  dispose  of  the  appeal  in  consultation  with  a  panel  of  competent 
persons  appointed  by  the  Department  of  Indian  Systems  of  Medicine  &  Homoeopathy, 
Government of India in this behalf and notified in the Official Gazette.] 

1[PART XVII 

2[LABELLING, PACKING AND LIMIT OF ALCOHOL IN] 
AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS 

161.  2[Labelling,  packing  and  limit  of  alcohol.]—(1)  There  shall  be  conspicuously 
displayed  on  the  label  of  the  container  or  package  of  an  Ayurvedic  (including  Siddha)  or 
Unani  drug,  the  true  list  of  all  the  ingredients  3[with  the  botanical  names  of  plant  based 
ingredients along with plant part(s) and form of ingredients, in which, these are] used  in  the 
manufacture of the preparation together with quantity of each of the ingredients incorporated 
therein  and  a  reference  to  the  method of  preparation thereof as  detailed in  the  standard text 
and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to 
the Act 3[and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list 
of all ingredients with the botanical names of plant based ingredients along with  part(s) and 
form of ingredients, in which, these are used in the formulation, with their quantity]: 

Provided that  if  the  list  of  ingredients contained in  the  medicine  is  large  and  cannot  be 
accommodated on  the  label,  the  same  may  be  printed  separately and  enclosed with  packing 
and reference be made to this effect on the label. 

(2) The container of a medicine for internal use made up ready for the treatment of human 
ailments  shall,  if  it  is  made  up  from  a  substance  specified  in  Schedule  E  (1),  be  labelled 
conspicuously  with  the  words  ‗Caution:  To  be  taken  under  medical  supervision‘  both  in 
English and Hindi language. 

1. Ins. by notification F.1-23/6, dt. 2.2.1970.               3. Ins. by G.S.R. 844(E), dt. 26.11.2012 
2. Subs. by G.S.R. 904(E), dt. 2.11.1992.

190 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(3) Subject to the other provisions of these rules, the following particulars shall be either 
printed or written in indelible ink and shall appear in a conspicuous manner on the label of the 
innermost  container  of  any  Ayurvedic  (including  Siddha)  or  Unani  drug  2[Patent  or 
Proprietary  Ayurveda,  Siddha  or  Unani  drugs]  and  on  any  other  covering  in  which  the 
container is packed', namely− 

(i) The name of the drug.  3[For Ayurveda, Siddha or Unani drugs] this purpose the 
name  shall  be  the  same  as  mentioned  in  the  authoritative  books  included  in  the  First 
Schedule of the Act. 

(ii) A correct statement of the net content in terms of weight, measure or number as 

the case may be. The weight and volume shall be expressed in metric system. 

(iii) The name and address of the manufacturer. 

(iv)  The  number  of  the  licence  under  which  the  drug  is  manufactured, the  figure 
representing   the   manufacturing   licence   number   being   preceded   by   the   words 
‗Manufacturing Licence Number‘ or ‗Mfg. Lic. No.‘ or ‗M.L.‘. 

(v)  A  distinctive  batch  number,  that  is  to  say,  the  number  by  reference  to  which 
details of manufacture of the particular batch from which the substance in the container 
is taken are recorded and are available for inspection, the figure representing  the batch 
number being preceded by the words ―Batch No.‖ or ―Batch‖ or ―Lot Number‖ or ―Lot 
No.‖ or ―Lot‖ or any distinguishing prefix. 

(vi) The date of manufacture. For this purpose the date of manufacture shall be the 

date of completion of the final products, or the date of bottling or packing for issue. 

(vii) The words ―Ayurvedic medicine‖ or ―Siddha medicine‖ or ―Unani medicine‖ as 

the case may be. 

(viii)  The  words  ―FOR  EXTERNAL USE  ONLY‖  if  the  medicine is  for  external 

application. 

(ix) Every drug intended for distribution to the medical profession, as a free sample 
shall,  while  complying  with  the  labelling  provisions under  clauses  (i)  to  (viii),  further 
bear on the label of the container the words ―Physicians sample.  Not to be sold‖ which 
shall be over-printed. 

1[(x)(a) Preparation (Asavas) with high content of alcohol as base 

Name of the drug                               Maximum size of packing 
(i) Karpur Asava                                         15 ml 

(ii) Ahiphenasava                                         15 ml 

(iii) Margamadasava                                     15 ml 

(ix)(b) Preparations containing self-generated alcohol 

Name of the drug                  Maximum content of alcohol 

(Ethyl alcohol v/v) 

(i) Mritsanjivani Sura 

16 per cent 

Maximum 
size   of 
packing
30 ml.

  (ii) Mahadrakshasava                     16 per cent                                   120 ml.]  

1.  Subs.  by G.S.R. 904 (E), dt. 2-11-1992. 
2. Ins. by G.S.R. 844(E), dt. 26.11.2012. 
3. Subs. by G.S.R. 844(E), dt. 26.11.2012.

191 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(4)  Nothing  in  these  rules  shall  be  deemed  to  require  the  labelling  of  any  transparent 
cover  or  of  any  wrapper  case  or  other  covering  used  solely  for  the  purpose  of  packing, 
transport or delivery. 

1[161A.  Exemption  in  labeling  and  packing,  provisions  for  export  of  Ayurvedic 
(including Siddha) and Unani drugs.-   (1) Labels and packages or containers of Ayurvedic, 
Siddha and Unani drugs for  export may  be  adopted to  meet  the  specific requirements of  the 
law of the country to which the said drug is to be exported, but the following particulars shall 
appear in conspicuous position on the container in which drug is  packed and on every other 
covering in which that container is packed, namely : 

(a)   Name   of   the   Ayurvedic,   Siddha   and   Unani   drug   (Single   or   compound 

formulations; 

(b) the name, address of the manufacturer and the number of licence under  which 

the drug has been manufactured; 

(c)  batch or lot number; 

(d)  date of manufacture, along with the date for ―Best for use before‖; 

(e)  main ingredients, if required by the importing  country; 

(f)   for export: 

Provided  that  where  Ayurvedic,  Siddha  and  Unani  Single  or  compound  drug  not 
classified under the  First Schedule or  Schedule E-(I), is  required by  the  consignee to  be  not 
labeled with the name and address of the manufacturer, the labels on packages or containers 
shall bear a code number as approved by the Licensing Authority mentioned in rule 152. 

(2)  the  provisions  of  Rule  161  shall  not  apply  to  a  medicine  made  up  ―ready  for 
treatment‖,  whether  after,  or  without,  alteration,  which  is  supplied  on  the  prescription  of  a 
registered  medical  practitioner  if  the  medicine  is  labeled  with  the  following  particulars, 
namely:– 

(a)  the name and address of the suppliers; 
(b)  the words ―For External Use Only‖, if the medicine is for external application.] 

2[161B.    1.  The  date  of  expiry  of  Ayurveda,  Siddha  and  Unani  medicines  shall  be 
conspicuously displayed on the label of container or package of an Ayurvedic,  Siddhas and 
Unani medicines, and after the said date of expiry,  these medicines shall not be in circulation. 
2. The Shelf-life i.e. for Ayurveda, Siddha and Unani medicines shall be as follows:- 

(i) Shelf life or date of expiry for Ayurvedic medicines. 

Sl. No. 

Name of the Group of Ayurvedic Medicine 

1. 

2. 

3. 

4. 
5. 
6. 
7. 
8. 

Churna, Kwatha Churna 
Gutika (Vati-Gutti, Pills, Tablets except Gutika 
with Rasa) 
(i) Gutika Tablet containing Kasth aushadhi 
(ii) Gutika,Tablet containing Kasth aushadi 
and Rasa,     Uprasa, Metallic Bhasmas, and 
Guggulu. 
Rasaushadhies 
Asava Arista 
Avaleha 
Guggulu 
Mandura - Lauha 

1.  Ins. by  G.S.R. 787 (E), dt. 17-10-2000. 
2. Ins. by  G.S.R. 764 (E), dt. 15-10-2009.

192 

Shelf life and date ofexpiry 
with effect fromthe date of 
manufacture 
2 years 

3 years 

3 years 
5 years 

No expiry date1 
No expiry date1 
3 years 
5 years 
10 years 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

9. 
10. 
11. 
12. 
13. 
14. 
15. 
16. 

17. 

18. 
19. 
20. 
21. 
22. 
23. 

24. 

25. 

26. 

27. 

28. 

29. 

30. 
31. 
32. 

Ghrita 
Taila 
Arka 
Dravaka, Lavana, Ksara 
Lepa Churna 
Dant Manjan Powder 
Dant Manjan Paste 
Lepa Guti 
Lepa Malahar (Ointment)/Liniment/Gels/ lotions 
/creams 
Varti 
Ghana Vati 
Kupipakva Rasayan 
Parpati 
Sveta parpati 
Pisti and Bhasma 
Svarna, Rajata, Lauha, Mandura, Abhraka 
bhasma,Godanti, ShankhaBhasma, etc. 
Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 
Capsules made of soft gelatin (depending upon 
thecontent material) for Kashtha aushadhi 
Capsules of hard gelatin (depending upon the 
content material) -containing Kasth aushdhi with 
Rasa, Bhasma,Parad-Gandhak 
Syrup/liquid oral 
(Kama/Nasa Bindu) Ear/Nasal drops 
Eye drops 
Khand/Granule/Pak 
Dhoopans-Inhalers 
Pravahi Kwatha (with preservatives) 

2 years 
3 years 
1 year 
5 years 
3 years 
2 years 
2 years 
3 years 

3 years 

2 years (one time use) 
3 years 
No expiry date1 
No expiry date1 
2 years 
No expiry date1 

No expiry date1 

5 years2 

3 years 

5 years2 

3 years 
2 years 
1 year 
3 years 
2 years 
3 years 

Note 1. Item at Sr. No.4, 5, 19, 20, 22, 23 have very long shelf life and they became more 
efficacious  with  the  passage  of  time  and  period  of  ten  years  shall  be  mandatory  for  keeping  the 
records of such items. 

Note  2.  Bhasmas  at  Sr.  No.  23,  start  solidifying  after  five  years  and  they  need  one  or  two 

‗Puta‘again before using in the dosage form. 

(ii) Shelf life or date of expiry for Siddha Medicines 

Sl. No. 

Name of the Group of Medicine 

1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. 

Karpam 
Cunnam 
Kalanku 
Kattu 
Parpam 
Centuram 
Karuppu 
Patankam 
Kulampu 
Meluku 
Tinir 
Tiravakam 
Mattirai 

193 

Shelf life and date ofexpiry with effect 
from the date of manufacture 
No expiry date* 
5 years 
No expiry date* 
No expiry date* 
No expiry date* 
No expiry date* 
No expiry date* 
5 years 
5 years 
5 years 
2 years 
2 years 
3 years 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

14. 
15. 
16. 
17. 
18. 
19. 
20. 
21. 
22. 

Tailam 
Ilakam 
Iracayanaam 
Ney 
Manappaku 
Venney 
Vatakam 
Curanam 
Pura Maruntukal 

3 years 
3 years 
3 years 
2 years 
3 years 
3 years 
3 years 
2 years 
5 years 

Note.  *  Items  at  Sr.  No.1,  3,  4,  5,  6,  22  have  very  long  shelf  life  and  they  became  more 
efficacious  with  the  passage  of  time  and  period  of  ten  years  shall  be  mandatory  for  keeping  the 
records of such items. 

(iii) Shelf life or date of expiry for Unani System of Medicines 

Sl. No. 

Name of the Group of Medicine 

1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. 
14. 
15. 
16. 
17. 
18. 
19. 
20. 
21 
22. 
23. 
24. 

Habb (Pills) 
Qurs (Tablets) 
Majoon/Dawa 
Khamira 
Itrifal 
Tiryaq 
Laooq 
Laboob 
Halwa 
Mufarreh/Yaqooti 
Burood/Surma/Kohal 
Kushta 
Raughaniyat 
Marham/Zimad/Qairooti 
Ayarij/Sufoof 
Safoof (Namak wala/containing salt) 
Sharbat/Sikanjabeen 
Jawarish 
Capsule 
Arq 
Qutoor 
Nabeez 
Murabba 
Tila 

Shelf life and date ofexpiry with effect 
from the date of manufacture 
3 years 
3 years 
3 years 
3 years 
3 years 
3 years 
2 years 
2 years 
2 years 
2 years 
3 years 
5 years 
3 years 
3 years 
2 years 
1 year 
3 years 
3 years 
3 years 
1 year 
1 year 
5 years 
1 year 
2 years] 

1[PART XVIII 

GOVERNMENT ANALYSTS AND INSPECTORS 
FOR AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS 

162. Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic 
(including Siddha) or Unani drugs—Subject to the instructions of the controlling authority, it 
shall  be  the  duty  of  an  Inspector  authorised  to  inspect  the  manufacture  of  Ayurvedic 
(including Siddha) or Unani drugs– 

1. Ins. by notification F.1-23/6, dt. 2-2-1970. 

194 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(i)  to  inspect  not  less  than  twice  a  year,  all  premises  licensed  for  manufacture  of 
Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy 
himself that the conditions of the licence and the provisions of the Act and the rules made 
thereunder are being observed; 

(ii)  to  send  forthwith  to  the  controlling  authority  after  each  inspection  a  detailed 
report indicating whether or not the conditions of the licence and the provisions of the Act 
and the rules made thereunder are being observed; 

(iii) to take samples of the drugs manufactured on the premises and send them for test 

or analysis in accordance with these rules; 

(iv)  to  institute  prosecutions in  respect  of  violation of  the  Act  and  the  Rules  made 

thereunder. 

1[162A.   Qualifications   of   the   State   Drug   Licensing   Authority   for   Licensing  
of Ayurvdeda , Siddha and Unani   drugs− (a) The Ayurvedic/ Siddha/ Unani   qualifications 
as per Schedule II of the Indian Medicine Central Council Act, 1970 (84 of 1970)/ B Pharma 
(Ayurveda) of a recognized University. 

(b)  At  least  5  years  experience  in  the  Ayurveda/  Siddha/  Unani  drug  manufacturing  or 
testing of  Ayurvedic, Siddha and  Unani drugs or  enforcement of  provisions of Chapter IVA 
of  the  Drugs  and  Cosmetics  Act,1940  and  Rules  made  thereunder  or  teaching/  research  on 
clinical practice of Ayurveda/ Siddha/ Unani System.] 

163.   Procedure for  despatch of  sample to  Government Analyst  and  its  receipt  by  the 
Government Analyst—(1) Sample for test or analysis shall be sent to the Government Analyst 
by registered post or by hand in a sealed package, enclosed together with a memorandum in 
Form 18-A in an outer cover addressed to the Government Analyst. 

(2) The package as well as the outer cover shall be marked with a distinguishing number. 
(3) A copy of the memorandum and a  specimen impression of the seal used to seal the 

package shall be sent by registered post or by hand to the Government Analyst. 

(4)  On  receipt of  the  package from an  Inspector, the  Government Analyst or  an  Officer 
authorised by  him  in  writing in  this  behalf  shall  open  the  package and  shall  also  record the 
conditions of the seals on the package. 

(5)  After  the  test  or  analysis  has  been  completed,  one  copy  of  the  results  of  the  test  or 
analysis  shall  be  supplied  forthwith  to  the  sender  in  Form  13-A.   A  copy  of  the  result  in 
Form  13A  shall  also  be  sent  simultaneously  to  the  Controlling  Authority  and  to  the  Drugs 
Controller, India. 

2[PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINES TO FUNCTION 
AS CENTRAL DRUGS LABORATORY FOR THE PURPOSE OF TESTING OR 
ANALYSIS OF AYURVEDA, SIDDHA AND UNANI DRUGS 
163.A  Functions  -  The  Pharmacopoeial  Laboratory  for  Indian  Medicine  at  Ghaziabad  shall 
function  as  a  Central  Drugs  Laboratory  for  the  purpose  of  testing  or  analysis  of  Ayurveda, 
Siddha and Unani Drugs. 
Its functions shall be:- 

(1) 

to  develop  Pharmacopoeial    standards  and  draft  monographs  and  amendments 

alongwith standardized methods for the Ayurvedic,  Siddha, Unani drugs; 

(2) 

to act as Central  Appellate Drug Laboratory for testing of Ayurveda,  Siddha and 

Unani drugs, 

(3) 

to analyse or test such samples of Ayurvedic,  Siddha, Unani drugs as may be sent 
to it under sub-section (2) of section 11, or under sub-section (4) or section 25, of the Act; 

(4) 

to  maintain  reference  museum  and  herbarium  for  the  drugs  used  in  Ayurveda, 

Siddha and Unani (ASU) system. 

(5) 

to  run  a  training  centre  for  quality  control  methods  in  the  Ayurveda,  Siddha  or 

Unani systems of medicines;  

(6) 

to carry out such other duties as may be entrusted to it by the Government of India. 

1.  Ins. by  G.S.R. 76 (E), dt. 3.2.2003. 
2.  Ins. by  G.S.R. 352 (E), dt. 1.6.2006.

195 

 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

163B. The functions of the Central Drug Laboratory in respect of Ayurvedic, Siddha and Unani 
drugs  shall  be  carried  out  at  the  Pharmacopoeial  Laboratory  for  Ayurvedic,  Siddha  and  Unani 
medicine, Ghaziabad, (Uttar Pradesh) and the functions of the Director in respect of the said drugs 
shall be exercised by the Director  of the said laboratory. 

163C. Despatch of samples for test or analysis - (1) Samples for testing or analysis of Ayurveda, 
Siddha and  Unani  drugs  under  Sub-section (2)  of  Section  11  or  sub-section  (1)  of  section  25  and 
section  33-H  of  the  Act  shall  be  sent  by  registered  post  in  a  sealed  packet,  enclosed  with  a 
memorandum  in  Form  1  A,  specified in  Schedule  A,  in  an  outer  cover  addressed  to  the  Director, 
Pharmacopoeial Laboratory for Indian Medicine. 

(2) The packet as well as the outer cover, shall be marked with a distinguished number. 

(3) A copy of the memorandum in Form 1A and a specimen impression of the seal used to seal the 
packet  shall  be  sent  separately  by  registered  post  to  the  Director,  Pharmacopoeial  Laboratory  for 
Indian Medicine. 

163D. Recording of condition of seals - On receipt of the packet, it shall be opened by an officer 

authorized in writing on that behalf by the Director,  Pharmacopoeial laboratory for Indian 
Medicine, who shall record the condition of the seal on the packet. 

163E. Report of result of test or analysis - After test or analysis, the result of the test or analysis, 
together with full protocols of the tests applied, shall be supplied  forthwith to the sender in Form 
2A of as specified in the said schedule. 

163F.  Fees - The fees for test and analysis shall be as specified in Schedule B-1 

163G. Signature on certificates - Certificates issued under these rules by the Pharmacopoeial 
Laboratory for Indian Medicine, shall be signed by the Director or by an officer authorized by the 
Central Government to sign such certificates. 

164.  Method  of  test    or  analysis  to  be  employed  in  relation  to  Ayurvedic  (including 
Siddha)  or  Unani  drugs.—The  method  of  test  or  analysis  to  be  employed  in  relation  to  an 
Ayurvedic  (including  Siddha)  or   Unani  drug  shall  be   such  as   may   be   specified  in   the 
Ayurvedic  (including  Siddha)  or  Unani  Pharmacopoeia,  or  if  no  such  pharmacopoeias  are 
available  or  if  no  tests  are  specified  in  such  pharmacopoeias,  such  tests  as  the  Government 
Analyst  may  employ,  such  tests  being  scientifically  established  to  determine  whether  the  drug 
contains the ingredients as stated on the label. 

165. Qualifications of Government Analyst. —A person who is appointed a Government 
Analyst  under  section  33  F  of  the  Act  shall  be  a  person  possessing  the  qualifications 
prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani System, as the case may be, 
conferred by a University, a State Government or Statutory Faculties, Councils and Boards of 
Indian Systems of Medicine recognized by the Central or State Government, as the case may 
be,  for  this  purpose  and  has  had  not  less  than  three  years‘  post  graduate  experience  in  the 
analysis  of  drugs  in  a  laboratory  under  the  control  of  (i)  a  Government  Analyst  appointed 
under the Act, or (ii) a Chemical Examiner to Government, or (iii) the Head of an institution 
specially approved for the purpose by the appointing authority. 

166. Duties of Government Analyst– (1) The Government Analyst shall analyze or test or 
cause to be analyzed or tested such samples of Ayurvedic (including Siddha) or Unani drugs 
as  may  be  sent  to  him  by  Inspectors  or  any  other  persons  or  authority  authorised  by  the 
Central  Government or  State  Government under  the  provisions of  Chapter  IV  A  of  the  Act 
and shall furnish reports of the results of test or analysis in accordance with these rules. 

196 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2) A Government Analyst appointed under section 33F shall from time to time forward 
to  the  Government reports  giving  the  result  of  analytical  work  and  research  with  a  view  to 
their publications at the discretion of the Government.]  

Drugs and Cosmetics Rules 1945 

1[167.  Qualifications of Inspector.–A person who is appointed an Inspector under section 

33G shall be a person who— 

(a)  has  the  qualifications  laid  down  under  rule  49  and  shall  have  undergone 
practical training in  the  manufacture of  Ayurvedic (including Siddha) or  Unani  drug,  as 
the case may be; or 

(b)  has  a  degree in  Ayurvedic or  Siddha or  Unani System or  a  degree in  Ayurveda 
Pharmacy,  as  the  case  may  be,  conferred  by  a  University  or  State  Government  or  a 
Statutory  Faculty,  Council  or  Board  of  Indian  Systems  of  Medicine  recognized  by  the 
Central Government or the State Government for this purpose; or 

(c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted 
by a State Government or an Institution recognized by the Central Government or a State 
Government for this purpose. 

STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS 

2[PART XIX 

168.    Standards  to  be  complied  with  in  manufacture  for  sale  or  for  distribution  of 

Ayurvedic, Siddha and Unani Drugs.- 

Class of Drugs                                        Standards to be complied with

1.            3 [*   *   *]  drugs included in 
Ayurvedic Pharmacopoeia. 

2.            Asavas and Arishtas 

The standards for identity, purity and strength as 
of  Ayurvedic 
editions 
given 
Pharmacopoeia  of  India  for  the  time  being  in 
force. 

the 

in 

The  upper  limit  of  alcohol  as  self  generated 
alcohol  should  not  exceed  12%  v/v  excepting 
those  that  are  otherwise  notified  by  the  Central 
time.]
Government 

from 

time 

to 

1. Amended by G.S.R. 376 (E), dt.  20.7.1978. 
2. Ins. by G.S.R. 519(E), dt. 26.6.1995. 
3.The word ―Single‖ omitted by G.S.R. 422(E), dt. 11.6.2002.

197 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[169. Permitted Excipients.- Permitted Excipients along with their standards i.e. additives, 
preservatives,  antioxidants,  flavouring  agents,  chelating  agents  etc.  permitted  in  the  Indian 
Pharmacopoeia  (IP),  Prevention  of  Food  Adulteration  Act,  1954  and  Bureau  of  Indian  Standard 
Act,  1986  are  permitted  for  use  in  Ayurveda,  Siddha  and  Unani  drugs  with  the  following 
conditions, namely:- 

1.  The  above  excipients  shall  be  used  in  the  permissible  limits  as  prescribed  in  the  Indian 
Pharmacopoeia/ Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of 
Indian Standard Act, 1986 and they shall comply with the respective quality specifications, 
not exceeding any specified limits of usage therein,  and except Hydrogenated vegetable oil. 

2.  Only Natural coloring agents as permitted under rule 26 of Prevention of Food Adulteration 
Rules,  1955  will  be  used  for  Ayurveda,  Siddha  and  Unani  drugs  and  additionally,  colors 
permitted  under  Rule  127  of  the  Drugs  and  Cosmetics  Rules,  1945  shall  be  used  for 
Proprietary Ayurveda, Siddha and Unani drugs as defined in subclause (i) of clause (h) of 
section  3  of  Drugs  and  Cosmetics  Act,  1940,  not  exceeding  any  specified  limits  of  usage 
therein. 

3.  Preservatives and Coloring agents shall be mentioned on the label for the information of the 

consumer as required under rule 161 of the Drugs and Cosmetics Rules, 1945. 

4.  Additives used in various  processes and in  formulating dosage forms shall  be mentioned 
clearly with quantities used, in the application for licenses and the record for the same shall 
be maintained  by the manufacturers. 

5.  Manufacturers shall be responsible to ensure rationality, safety and quantity used of various 

excipients in the formulation. 

6.  If  any  excipients  or  additive  or  preservative  etc.  referred  in  Indian  Pharmacopoeia/ 
Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of Indian Standard 
Act, 1986 is deleted at a particular point of time, this will also be deleted simultaneously for 
the use in Ayurveda, Siddha and Unani drugs. 

7.  Following  artificial  sweeteners    as  per  maximum  limit  indicated  below  may  be  used  in 

various dosage forms of Ayurveda, Siddha, Unani Proprietary Medicines:- 

Artificial  sweeteners  may  be  used  only  in  proprietary  ASU  products  and  the  label  of  such 
products should carry a statutory warning stating the name and quantity of the artificial sweetener 
used.  

The  recommended  Acceptable  Daily  Intake  (ADI)  of  these  sweeteners  as  laid  down  by  US 

FDA is as follows: 

Sr. No. Sucralose  
1 

5 mg/kg body  40 mg/kg body 
weight 

weight 

Aspartame 

Saccharin 
5 mg/kg body 

 Acesulfame K 
15 mg/kg body weight  weight

One third of the above ADI would be permissible for use in Ayurveda, Siddha, Unani Patent 

and Proprietary Drugs. 

8.  Any previous notification issued by the Department of AYUSH regarding  use of excipients 

/ additives or preservatives in Ayurveda, Siddha and Unani medicines stands superseded.] 

1. Subs. by G.S.R. 755 (E), dt.  23.10.2008. Earlier ins. by G.S.R. 285 (E), dt.  11.5.2005. 

198 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

SCHEDULE A 

FORM 1 

(See rule 4) 

Memorandum to the Central Drugs Laboratory 

Serial Number .................................. 

To the Director, Central Drugs Laboratory ...................................................... 

From...................................... 

I send herewith, under the provisions of section 25 (4) of the Drugs and Cosmetics Act, 

1940, sample(s) of a drug purporting to be ....................for test or analysis and request that a 

report of the result of the test or analysis may be supplied to this Court. 

(2)    The distinguishing number on the packet is ............................................ 

(3)  Particulars of offence alleged ................................................................... 

(4)  Matter on which opinion is required ....................................... 

(5)  A fee of Rs ................. has been deposited in Court. 

Date ....................                                                                                                            ……............. 
Magistrate 

1[FORM 1 
(See rule 163C) 

Memorandum to the Pharmacopoeial Laboratory for Indian Medicine (PLIM) 

From .................................. 

(Full name, Designation and Postal address of the sender) 

Serial No...................................... 

To the Director,  

Pharmacopoeial Laboratory for Indian Medicine, 

I send herewith, under the provisions of section 11(2)/section 25(4) and section 33H 
of the Drugs and Cosmetics Act, 1940, sample(s) of a drug purporting to be ....................for 
test  or  analysis  and  request  that  a  report  of  the  result  of  the  test  or  analysis  may  be 
supplied to this Court. 

(2)  The distinguishing number on the packet is ............................................ 

(3)  Particulars of offence alleged ................................................................... 

(4)  Matter on which opinion is required ....................................... 

(5)  A fee of Rs ................. has been deposited in Court. 

Date ....................                                                                                     ……….…............. 

Magistrate/Authorized Signatory] 

1. Ins. by  G.S.R. 352(E) , dt. 1.6.2006. 

199 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 2 

(See rule 6) 

Certificate of test or analysis by the Central Drugs Laboratory 

Certified that the sample bearing number ....................................... ……………….. 

purporting to  be  a  sample  of.  .................................................. received on ....................  with 

memorandum    No ................................................................ dated....................................     from 

............................................... has  been  tested / analysed  and  that  t he  result  of  s uch  t e s t  / 

analysis is as stated below. 

2. The condition of the seals on the packet on receipt was as follows: — 

*3. In the opinion of the undersigned the  sample   is  of    standard   quality is  not  of  
standard  quality  as  defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder for 
the reasons given below:– 

Date……………… Central Drugs Laboratory or other authorised officer 
Details of results of test or analysis with protocols of test applied 

Director 

Director 

Date..................Central Drugs Laboratory or other authorised officer 
*  If opinion is required on any other matter, the paragraph should be suitably amended. 

1[FORM 2A 
(See rule 163E) 

Certificate of test or analysis from the Pharmacopoeial 
Laboratory for Indian Medicine or Governmen Analyst 

Certified that the sample bearing number ....................................... ……………….. 

purporting to  be  a  sample  of.  .................................................. received on ....................  with 

memorandum    No ................................................................ dated....................................     from 

............................................... has  been  tested / analysed  and  that  t he  result  of  s uch  t e s t  / 

analysis is as stated below. 

2. The condition of the seals on the packet on receipt was as follows: — 

*3. In the opinion of the undersigned the sample is  of standard quality as defined in the 
Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given  below. 

Or 

In the opinion of the undersigned the sample is not of standard quality as defined in the 
Drugs and Cosmetics Act, 1940 and Rules thereunder for the reasons given  below. 

―Note: *delete whichever is not applicable.‖ 

Date……………. 
Place……………. 

1. Ins. by  G.S.R. 352(E) , dt. 1.6.2006. 

(Signature of the Analyst Person-in-Charge of testing) 

Name & Designation and Seal……………. 
Name and Address of the laboratory ……………] 

200 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1FORMS 3-7 (Omitted) 

2[FORM 8 

(See rule 24) 

Application for licence to import drugs (excluding those specified in Schedule X) to the 
Drugs and Cosmetics Rules, 1945 

I/We*    .........................................................  (full   address  with  telephone  number,   fax 
number  and  e-mail  address)  hereby  apply  for  a  licence  to  import  drugs  specified  below 
manufactured by M/s ........................................... (full   address   with   telephone   no,   fax      and 
e- mail no.). 

2.   Names of the drugs to be imported: 

(1) 

(2) 

(3) 

3.   I/We*   .....................................................  enclose herewith an  undertaking in  Form 9 

dated …………signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics 
Rules, 1945. 

4.   I/We*    ...................................................   enclose      herewith    a  copy    of Registration 

Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, 

vide   Registration    Certificate   No .....................dated    ..................     issued   through   M/s. 

............................. (name and full address) ................................valid up to ................................ 

5    I/We* ....................................................   hold   a   valid   wholesale   licence   for   sale   or 
distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and 
rules made thereunder. A copy of the said licence is enclosed. 

6.    A fee of ..................has been credited to Government under the Head of Account "0210- 

Medical and Public Health, 04-Public Health, 104-Fees and Fines" under the Drugs and 
Cosmetics Rules, 1945 - Central vide Challan No .........................  dated ................(attached in 
original) 

Signature  ....................... 
Name.............................. 
Designation ................... 
Seal/Stamp of Manufacturer's agent in India. 

Place:   ...... 
Date:  ........... 
*Delete whichever is not applicable.] 

1. Forms 3 to 7 omitted by  Notfn. No. F. 1-16/57-D, dt. 15-6-1957. 
2. Subs. by  G.S.R. 604(E) , dt. 24.8.2001. 

201 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 8A 

(See rule 24) 

Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics 
Rules, 1945 

I/We* ............................... (full address with telephone number, fax number and e-mail 

address)  hereby   apply  for  a  licence  to  import  drugs  specified  below  manufactured  by 
M/s ....................................... (full address with telephone no, fax and e-mail no.). 

2.     Name of the drugs to be imported: 

(1) 

(2) 
(3) 

3.    I/We*  ........................................ enclose    herewith    an    undertaking    in    Form    9 

dated……………signed  by  t h e  manufacturer  a s  required  by  rule  24  of   the  Drugs  a nd 

Cosmetics Rules, 1945. 

4.     I/We*  ........................................... enclose herewith a copy of Registration Certificate 
concerning  the  drugs  to  be  imported  in  India,  issued  under  Form  41  of  the  rules,  vide 
Registration Certificate No        dated            issued   through   M/s. 
................................................ (name    and    full    address)     ............................ …………… 

valid    upto……………………………… 

5.   I/We*  ............................. hold a valid wholesale licence for sale or distribution of drug  or 
licence  to  manufacture drugs,  under  the  provisions of  the  Act  and  rules  made  thereunder. 
A copy of the said licence is enclosed. 

6.         A fee of .......................... has been credited to Government under the Head of Account 

"0210 - Medical and Public Health, 04- Public Health, 104- Fees and Fines" under the 
Drugs and Cosmetics Rules 1945 - Central vide Challan No .......................  dated ................. 
(attached in original). 

Signature ................................. 

Name ..................................... 

Designation ............................. 

Seal/Stamp of Manufacturer's agent in India.] 

Place:   ...... 

Date:  ........... 

*Delete whichever is not applicable. 

1. Subs. by G.S.R. 604(E), dt.24.8.2001. 

202 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 9 

(See rule 24) 

Form of undertaking to accompany an application for an import licence 

Whereas  .............................. of.............................  intends to apply for a licence under the 

Drugs  and  Cosmetics Rules,  1945, for  the  import  into  India,  of  the  drugs  specified below 
manufactured    by    us,    we……………………………of…………………………..hereby  give 
this undertaking that for the duration of the said licence— 

(1) the said applicant shall be our agent for the import of drugs into India; 
(2)  we  shall  comply with  the  conditions imposed on  a  licence  by  1[rules 74  and  78] of 

the Drugs and Cosmetics Rules, 1945; 

(3)we  declare  that  we  are  carrying  on  the  manufacture  of  the  drugs  mentioned  in 
this  undertaking at  the  premises specified below, and  we  shall from  time  to  time  report any 
change  of  premises  on  which  manufacture  will  be  carried  on  and  in  cases  where 
manufacture  is  carried  on  in  more  than  one  factory  any  change  in  the  distribution  of 
functions between the factories; 

(4)  we  shall  comply  with  the  provisions of  Part  IX of  the  Drugs and  Cosmetics  Rules, 

1945; 

(5)  every  drug  manufactured  by  us  for  import  under  licence  into  India  shall  as 
regards strength, quality and purity conform with the provisions of Chapter III of the Drugs 
and  Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945; 

(6)  we  shall  comply  with  such  further  requirements,  if  any,  as  may  be  specified  by 
Rules, by the  Central Government under the  Act and of which the  licensing authority has 
given to the licensee not less than four months' notice. 

Particulars of premises where manufacture is carried on. 

Names of drugs and classes of drugs 

Date.......................                                                   2[Signature, Name, Designation Seal/Stamp 
of manufacturer or on behalf of the manufacturer.] 

1. Subs.  by. G.S.R. 462(E), dt.  22.6.1982. 
2. Subs. by G.S.R. 604(E), dt. 24.8.2001 

203 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

. 

1[FORM 10 
(See rules 23 and 27) 
Licence to import drugs (excluding those specified in Schedule X) to the Drugs and 
Cosmetic Rules, 1945 

Licence Number ..............                                                               Date... ………….. 

1. 

........................................................................................  (Name  and  full  address  of  the 

importer) is  hereby licensed to import into India during the period for which the licence is in 

force,    the  drugs  specified  below,  manufactured  by  M/s  ..................................................   

(name  and  full address)  and  any  other  drugs  manufactured  by  the  said  manufacturer  as  may 

from time to time be endorsed on this licence. 

2.    This licence shall be in force from ...........................  to .............   unless it is sooner 

suspended or cancelled under the said rules. 

3.     Names of drugs to be imported. 

Place : ………. 

Date :  ……….                                                                                                  Licensing Authority 

Seal/Stamp 

Conditions of Licence. 

1.     A  photocopy  of  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the 

premises, and the original licence shall be produced, whenever required. 

2.    Each  batch  of  drug  imported  into  India  shall  be  accompanied  with  a  detailed  batch 
test  report  and  a  batch  release  certificate,  duly  signed  and  authenticated  by  the 
manufacturer  with  date  of  testing,  date  of  release  and  the  date  of  forwarding  such 
reports.  The  imported  batch  of  each  drug  shall  be  subjected  to  examination  and 
testing as the licensing authority deems fit prior to its marketing. 

3.    The  licensee  shall  be  responsible  for  the  business  activities  of  the  manufacturer  in 

India along with the registration holder and his authorised agent. 

4.    The  licensee  shall  inform  the  licensing  authority  forthwith  in  writing  in  the  event  of  
any  change  in  the  constitution  of  the  firm  operating  under  the  licence.  Where  any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed 
to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which  the  change 
takes  place  unless,  in  the  meantime,  a fresh  licence  has  been  taken  from  the  licensing 
authority in the name of the firm with the changed constitution.] 

1. Subs.  by  G.S.R. 604(E) ,dt. 24.8.2001. 

204 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 10A 

(See rules 23 and 27) 

Licence to import drugs specified in Schedule X to the Drugs and Cosmetics  Rules, 1945 

Licence Number .............................                                                 Date……………………. 

...............................................................................................................(Name  and  full  address  of 

the importer) is hereby licensed to import into India during the period for which the licence is 

in force, the drugs specified below, manufactured by M/s ......................................  (name and 

full address) and any other drugs manufactured by the said manufacturer as may from time  to 
time be endorsed on this licence. 

2.       This licence shall be in force from ............................. to .......................... unless it is 

sooner suspended or cancelled under the said rules. 

3.       Names of drugs to be imported. 

Place:...................... 

Date:  ..................... 

*Delete whichever is not applicable. 

Conditions of Licence 

Licensing Authority 

Seal/Stamp. 

1.    A  photocopy  of  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the 

premises, and the original licence shall be produced, whenever required. 

2.    Each  batch  of  drug  imported  into  India  shall  be  accompanied  with  a  detailed  batch 
test  report  and  a  batch  release  certificate,  duly  signed  and  authenticated  by  the 
manufacturer  with  date  of  testing,  date  of  release  and  the  date  of  forwarding  such 
reports.  The  imported  batch  of  each  drug  shall  be  subjected  to  examination  and 
testing as the licensing authority deems fit prior to its marketing. 

3.    The  licensee  shall  be  responsible  for  the  business  activities  of  the  manufacturer  in 

India along with the registration holder and his authorised agent. 

4.    The  licensee  shall  inform  the  licensing  authority  forthwith  in  writing  in  the  event  of 
any  change  in  the  constitution  of  the  firm  operating  under  the  licence.  Where  any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed 
to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which  the  change 
takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from  the  licensing 
authority in the name of the firm with the changed constitution.] 

1.  Subs. by G.S.R. 604(E), dt. 24.8.2001. 

205 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 11 

(See rule 33) 

Licence to import drugs for the purposes of examination, test or analysis 

1   ………………of .......................... is hereby licensed to import from ................................ the 
drugs    specified    below    for    the    purposes    of   examination,    test    or    analysis    at 
...............................or in such other places as the licensing authority may from time to time 
authorise. 

2. This  licence  is  subject  to  the  conditions  prescribed  in  the  Rules  under  the  Drugs  and 

Cosmetics  Act, 1940. 

3.  This  licence  shall,  unless  previously  suspended  or  revoked,  be  in  force  for  a  period  of 

one  year from the date specified below:– 

Name of drugs 

Quantities which may be imported 

Date.............................                                                                                      Licensing Authority 
Seal/Stamp 

1 [ F O RM  1 1 A 

(See rule 33A) 
Licence to import drugs by a Government Hospital or Autonomous Medical Institution for 
the treatment of patients 

Licence No  …………….                                                                     Date………………. 
Dr. ........................................................... ……………………………………………Designation 
…………………………………………………………………………………………………..of 
……………………………………………………………………………………………………. 
(Name of College/Hospital/Autonomous Institution) 

is hereby licenced to import from M/s ..............................(name and full address) the drugs 
specified below for the purpose of treatment of patients for the disease (name of the disease) 
.................... at ............................. or in such other places as the licensing authority may from 
time to time authorise. 

2.     This licence shall, unless previously suspended or revoked, be in force for a period of 

one year from the date of issue specified above. 

3.     Names  of drugs to be imported: 

Name of drugs 

Quantities which may be imported 

Place : ............ 
Date :............. 

Licensing Authority 
Seal / Stamp 

1.       The   licence   shall   be   displayed   in   the   Office   of   the   Medical   Superintendent  of 

Government Hospital / Head of Institution of Autonomous Medical Institution. 

2.      The  licensee  shall  store  the  drugs  imported  under  this  licence  under  proper 

Conditions of Licence 

storage conditions. 

3.       The  drugs  imported under  this  licence  shall  be  exclusively used  for  the  treatment 
of  patients,  and  a  record  shall  be  maintained  in  this  regard,  by  a  registered  pharmacist 
giving  the  full  name(s)  and  address(es)  of  the  patients,  diagnosis,  dosage  schedule,  total 
quantity  of  drugs  imported  and  issued,  and  shall  be  countersigned  by  the  Medical 
Superintendent  of  the  Government  Hospital  or  Head  of  the  Autonomous  Medical 
Institution which shall be produced, on demand by an Inspector appointed under the Act.] 
___________________________________________________________________________ 
1. Subs. by G.S.R.. 604(E), dt.   24.8.2001. 

206 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 12 

(See rule 34) 

Application for licence to import drugs for purpose of examination, test or analysis 

I,… …………………………………resident     of  ……………………………….   by 
occupation……………….  hereby apply for a licence to import the drugs specified below for 

the purposes of examination, test or analysis at .............................. from ..........................and 
I undertake to comply with the conditions applicable to the licence. 

1[A fee of rupees ......................  has been credited to Government under the head of 

Account ―0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines‖ under the 
Drugs  and  Cosmetics  Rules,  1945—Central  vide  Challan  No…….dated………(attached  in 
original).] 

Name of drugs 

Quantities which may be imported 

Place…….. 

Date………    

1.  Subs.  by  G.S.R. .604(E), dt. 24.8.2001. 

   L i c e n s i n g   A u t h o r i t y                                                                                 

1[FORM 12A 

(See rule 36, Second Proviso) 

Application for the issue of a permit to import small quantities of drugs for personal 
use 

I,       ......................................... resident       of       ..............................................................by 
occupation................................................. hereby   apply   for  a  permit  to  import  the  drugs 
specified below for personal use from .................................................................... 

I attach a prescription from a registered medical practitioner in regard to the need for the 

said drugs. 

Name of drugs 

Quantities which may be imported 

Date...............................                                                             Signature........................... 

1. Added by Notifn No. F.1-36/54-DS, dt: 3.3.1955. 

207 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 12AA 
(See rule 34A) 

Application for licence to import small quantities of new drugs by a Government Hospital or 
Autonomous Medical Institution for the treatment of patients. 

I,  .................. ……………       (name and designation)  ............................... …………….. 

of  …………………………………  (name  of  the  Hospital/Autonomous  Medical  Institution) 
hereby  apply  for  a  licence  to  import  small  quantities  of  new  drugs  specified  below  for  the 
purpose of treatment of patients for the disease  ..................................................... (name   of   the 
disease)……  …  …………  at……………………………….(name  and  place  of  the  hospital) 
and  I  undertake to  comply  with  the  conditions applicable  to  the  licence  and  other  provisions 
of the Drugs and Cosmetics Act, 1940 and the rules made thereunder, from time to time. 

1.       A fee of rupees .............  has  been  credited  to  Government  under  the  Head  of 
Account  "0210-Medical  and  Public  Health,  04-  Medical  and  Public  Health,  104-  Fees 
and  Fines"  under  the  Drugs  and  Cosmetics  Rules,  1945  -  Central  vide  Challan 
No……………..dated ......................  (attached in original). 

2.     Name of new drugs to be imported: 

Name of drugs 

Quantities which may be imported 

Place: ………..                                               Signature…………………….. 

Date: ………..                                                Name………………………… 

Seal/Stamp…………………. 

Certified  that  the  drugs  specified  above  for  import  are  urgently  required  for  the 

treatment of patients suffering from and that the said drug(s) is/are not available  in India. 

Certificate 

Place…………..                                                                                       Signature ............... …….. 
Date .................                              Medical Superintendent of the Government Hospital / Head of 
Autonomous Medical Institution 

Seal / Stamp.] 

1.     Subs.  by. G.S.R. 604(E), dt. 24.8.2001. 

208 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 12B 
(See rule 36, Second Proviso) 

Permit for the import of small quantities of drugs for personal use 

…………………………of    ............................................... is    hereby   permitted   to 

import from......................................... the drugs specified below for personal use. 

2. This  permit  is  subject  to  the  conditions  prescribed  in  the  Rules  under  the  Drugs  and  

Cosmetics Act, 1940. 

3. This  permit  shall,  unless  previously  suspended  or  revoked,  be  in  force  for  a  period  of 

six months from date specified below. 

Name of drugs 

Quantities which may be imported 

Date……………..                                                                                                Licensing Authority] 

FORM 13 

(See rule 46) 

Certificate of test or analysis by Government Analyst under section 25 (1) of the Drugs and 
Cosmetics Act, 1940 

1.    Name of Inspector from whom received ................................ 

2.   Serial No. and date of Inspector's memorandum............................ 

3.   Number of sample ................................................... 

4.   Date of receipt .................................... 

5.   Name of drugs purporting to be contained in the sample .......................... 
6.   Condition of seals on the 2[packet or on portion of sample or container]  .......................... 

7.   Result of test or analysis with protocols of test or analysis applied ............................. 

In    the    opinion     of     the      undersigned     the    sample    referred    to     

above  (is  of  standard/is  not  of  standard)  quality  as  defined  in  the  Drugs  and 
Cosmetics  Act,  1940  and  Rules  thereunder for the reasons given below. 

for the reasons given below:- 

Date...................                                                                                              Government Analyst. 

1. Subs. by. G.S.R. 753(E), dt. 4.11.1999. 
2. Subs. by G.S.R. 59(E), dt. 7.2.1995. 

209 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 13A 

[See rule 163 (5)] 

Certificates of tests or analysis by Government Analyst under section 33H of the Drugs and 
Cosmetics Act, 1940 

1. Names of Inspector from whom received ................................................... 

2. Serial No. and date of Inspector's memorandum ........................................... 

3. Number of sample......................................................................................... 

4. Date of receipt ................................................................. 

5. Names of ingredients purporting to have been  used  in the preparation of the sample….. 

6. Condition of seals on the package ...................................................................... 

7. Results of test or analysis …………………………………………………….. 

2[In the opinion of the undersigned the sample referred to above is of standard/is not of standard 

quality as defined in the Drugs and Cosmetics Act, 1940 and the rules made thereunder for the 
reasons given below] 

Date...................                                                                                           Government Analyst..] 

FORM 14A 

(See rule 47) 

Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and 
Cosmetics Act, 1940 

1.   Full name and address of the applicant .................................................................... 

2.   Occupation................................................................ 

3.   Name of drug purporting to be contained in the sample .......................................... 

4.      Name  and  full  address  of  the  pharmacy  or  concern  where  the  drug  was 
purchased……………. 

5.   Date on which purchased.............................................................................. 

6.   Reasons why the drug is being submitted for test or analysis…………………………. 
3 [7. A fee of rupees  ............................................................ vide Schedule B of the Drugs and 

Cosmetics  Rules,  1945,  has  been  credited  to  Government  under  the  head  of  account  "080— 
Medical—Miscellan e ou s—Fees   und er    th e    Drug s    and    Co smetics   Ru les,   194 5— 
Central/State"—vide treasury receipt attached.] 

I  hereby  declare  that  the  drug  being  submitted  for  test  was  purchased  by  or  for  me.  I 
further  declare  that  the  sample  of  the  drug  being  sent  for  test  or  analysis  is  exactly  as  it  was 
purchased and has not been tampered with in any way to reduce its potency. 

Date..............................                                                                                    Signed.... ……. 

1.   Added by Notfn. No. F 1-23/67-D (S.O. 642), dt. 2.2.1970. 
2. Ins. By G.S.R. 376(E), dt: 3..5.2010. 
3. Added by Notfn. No. F. 1-3/51-D.S., dt. 15-10-1954 

210 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 14-B 

(See rule 47) 

Certificate of test or analysis by Government Analyst under Section 26 of the Drugs and 
Cosmetics Act, 1940 

1.   Name of person from whom sample received ............................................. 

2.   Date of receipt .......................................................................................... 

3.   Name of drug purporting to be contained in the sample ..................................... 

4.   Opinion  of   the   Government  Analyst—The  sample  referred  to   above   is/is   not   of 
standard quality as defined in the Drugs and Cosmetics Act, 1940 and Rules thereunder. 

Date...................                                                                              Government Analyst…………. 

1[FORM 15 

(See rules 54 and 145C) 

Order under section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not 
to dispose of stock in his possession 

Whereas,  I  have  reasons  to  believe  that  the  stocks  of  drugs/cosmetics  in  your 
possession,  detailed  below  contravene the  provisions of  section  18  of  the  Drugs  and  Cosmetics 
Act, 1940; 

Now, therefore, I hereby require you under clause (c) of sub-section (1) of section 22 of 

the said Act not to dispose of the said stock for a period of .................. days from the date of this 

order. 

Date.....................                                                                                   Inspector…………… 

Details of stock of drugs/ cosmetics 

Date...........................                                                                              Inspector...................] 

2[FORM 16 

(See rules 55 and 145-B) 

Receipt for stock of drugs or cosmetics for record, register, document or material object 
seized under section 22 (1) (c) or (cc) of the Drugs and Cosmetics Act, 1940. 

The  stock  of  drugs  or  cosmetics  for  records,  registers,  documents  or  material  objects 
detailed  below  has  /  have  this  day  been  seized  by  me  under  the  provisions  of  clause  (c)  or 
clause (cc) of sub-section (1) of section 22 of the Drugs and Cosmetics Act. 1940 (23 of 1940) 
from the premises of ............................................ situated at............................................ 

Date.........................                                                                 Inspector. ....................... 

Details of drugs, cosmetics, records, registers, documents or material objects seized. 

Date...........................                                                               Inspector. ..........................] 

1.   S u b s .   by  G.S.R. 1594, dt. 28.10.1976. 
2. Subs.  by. G.S.R. 926 , dt. 24-6-1977. 

211 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [FORM 17 

(See rules 56 and 145A) 

Intimation to person from whom sample is taken 

this 

have 

I 
of  ………………………….situated 
at............................................ samples of the drugs / cosmetics specified below for the purpose of 
test or analysis. 

premises 

taken 

from 

day 

the 

Date.........................                                                                 Inspector. ....................... 

Details of samples taken 

Date.........................                                                                          Inspector. ................] 

2[FORM 17A 

(See rules 56A and 145AA) 

Receipt for samples of drugs or cosmetics taken where fair price tendered thereof under 
sub- section (I) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused 

To ................................... 

Whereas I, this...............  day of ......... 3[20] ..........., have   taken from  the   premises  
of…….. situated at................................ samples of drugs/cosmetics as specified below:- 

Details of Samples………………………… 

And whereas  I had offered to pay you rupees ......................  as the fair price of the 

samples of drugs/cosmetics taken: 

And whereas, you have refused to accept the fair price tendered thereof. 

Now,  therefore, I  give  you  the  receipt  as  the  fair  price  tendered  for  the  samples  of  the 

drugs/cosmetics taken by me. 

Date:  .....................                                                                                   Inspector      …..   …..] 

______________________________________________________________________________________________________________________ 

1.  Subs. by S.O. 2139, dt. 5.6.1972. 
2. 
Ins. by G.S.R.  292(E) , dt. 29.5.1997. 
3.  Subs. by G.S.R. 592(E) , dt. 13.8.2008. 

212 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 18 

(See Rule 57) 

Serial No. of Memorandum ................................................................................... 

Memorandum to Government Analyst 

From: 

To 

The Government Analyst 
………………………… 
………………………… 
The  portion  of  sample  /  container  described  below  is  sent  herewith  for  test  or  analysis 
under  the  provisions of  clause  (i)  of  sub-section (4)  of  Section 23  of  the  Drugs  and  Cosmetics 
Act, 1940. 

The portion of sample/container has been marked by me with the following mark. 
Details  of  portion  of  sample  or  container  with  1[name  of  drug/cosmetic]  which  it 

purports to contain— 

Date.....................                                                                     Inspector. .................... 

2[FORM 18A 
(See Rule 163 (1)) 

Memorandum to Government Analyst 

Serial No…….. 
From 
To 

The Government Analyst 
………………………… 
………………………… 
The portion of sample /  container described below is sent herewith for test or analysis 

under the provisions of Section 33H of the Drugs and Cosmetics Act, 1940. 

The portion of sample / container has been marked by me with the following mark. 

Details of portion of sample or container with name of ingredients from which it  is 

claimed to be made. 

Date.........................                                                                 Inspector. ......................... 

1.  Subs.  by  G.S.R. 370(E), dt. 7.4.1994. 
2. Added by Notfn. No. F 1-23/67-D,  dt. 2-2-1970. 

213 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 19 
[See rule 59 (2)] 
Application for grant or renewal of a 2[licence to sell, stock or exhibit or offer for sale, 
or distribute] of drugs other than those specified in Schedule 

1 .  I /  We* ...................................hereby apply for licence to sell by wholsesale/retail drugs 

specified  in  Schedules  C  and  C(1)  excluding  those  specified  in  Schedule  X  *and/or  drugs 
other than those specified in Schedules C, C(1) and X to the Drugs and Cosmetics Rules, 1945 
*and also to operate a pharmacy on the premises situated at........................................................ 

2. ** The sale and dispensing of drugs will be made under the personal supervision of the 

registered pharmacists namely:- 

(Name) .............................................. (Qualification)………………………………………… 

(Name) ................................................(Qualification)…………………………………………… 

3. Categories of drugs to be sold .................................................................................... 
4.***  Particulars of special storage accommodation ................................................................. 

5. A fee of rupees ......................................... has been credited to the Government account  under 
the head of account ...................................... 

Date........................................                                                  Signature ......................... ] 

* Delete whichever is not applicable. 
**  To be deleted if drugs will be sold only by wholesale. 
***Required only if products requiring special storage are to be sold. 

1. Subs. by G.S.R. 462(E), dt. 22.6.1982. 
2. Subs. by  G.S.R. 788(E), dt. 10.10.1985. 

FORM 19A 

[See rule 59 (2)] 

Application for the grant or renewal of a restricted  1[licence to sell, stock or exhibit or offer 
for sale, or distribute] drugs by retail by 2[***] dealers who do not engage the 
services of a registered pharmacist 

1.      I/We ............................................. of. ..................................................hereby 

apply for a licence to sell by  retail   
(i)        3[Drugs other than  those  specified  in  Schedule C,  C1  and  X]  on the  premises situated 
at……/2[***]  
or  (ii)   4 [Drugs  specified in  Schedule C(1)] on  the  premises situated    at    …………………/ 
4[Drugs specified in Schedule C(1)] as vendor in the area…………………… 

2. Sales  shall  be  restricted  to  such  drugs  as  can  be  sold  without  the  supervision  of  a 

registered pharmacist  under the Drugs and Cosmetics Rules. 

3. Names or classes of drugs proposed to be sold ................................................... 
*4.  Particulars  of  the  storage  accommodation  for  the  storage  of  5[Schedule  C(1)]  on  the 

premises referred to above. 

**5.  The  drugs  for  sale  will  be  purchased  from  the  following  dealers  and  such  other 

dealers as may be endorsed on the licence by the Licensing Authority from time to time. 

Name of the dealers........................................Licence No.................................... 

214 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. A fee of rupees  2[***]/#twenty has been credited to Government under the head of 
account................................................................................ 

Drugs and Cosmetics Rules 1945 

Date...............................                                                           Signature ........................ 

*Delete whichever is not required. 

**Applies only to an itinerant vendor. 
# Rupees five for itinerant vendors and  applicant from a village or town having a population of 5000 
or less, and rupees twenty for other restricted licence. 

1. Subs.  by   G.S.R. 788(E) ,dt.  10.10.1985. 
2. Omitted by. G. S. R. 231(E) , dt. 4.6.1996. 
3. Subs. by G.S.R. 462(E), dt. 22.6.1982. 
4. Subs. by.G.S.R. 487(E) , dt. 2.7.1984. 

1[FORM 19AA 

(See rule 62C) 
Application for grant or renewal of a 2[licence to sell, stock or exhibit or offer for sale 
by wholesale, or  distribute] drugs from a motor vehicle 

I / W e *                                                                             of                                      hereby 

apply  for  2[licence  to  sell,  stock  or  exhibit  or  offer  for  sale    by  wholesale,  or  distribute] 
drugs specified in Schedules C and C (1) and /or drugs other than those specified in Schedules C 
and  C  (1) from the  vehicle  bearing registration no._                             assigned under the  Motor 
Vehicles Act, 1939. 

2.   Categories of drugs to be sold / distributed    

3. A fee of rupees                                                       has been credited to Government under 

the head of account    

*4.Particulars  of  the  storage  accommodation  for  the  storage  of  drugs  specified  in 

Schedules C and C (1) on the vehicle referred to above. 

Date   

Signature   

*Delete if not required. 
 1.     Ins. by. G.S.R. 42 (E), dt.  25.1.1979. 
2.     Subs. by.G.S.R. 788(E), dt. 10.10.1985. 

FORM 19B 
(See rule 67A) 

Application for 1[licence to sell, stock or exhibit or offer for sale,  or distribute] 
Homoeopathic medicines 

1 . I /  We*  ....................... of................................. hereby apply for a licence to sell by 

*wholesale/*retail Homoeopathic medicines on the premises situated at ....................................... 

**2.  The  sale  and  dispensing  of  Homoeopathic  medicines  shall  be  made  under  the 

personal supervision of the following competent person in -charge. 

Name .......................... 

3 .   A  f ee  o f  rup e e s   ................has been  credited  to  Government under the  head  of 

account....................................................... 

Date.........................                                                                  Signature ...................... 

*Delete whichever is not required. 
** To be deleted if Homoeopathic medicines will be sold by wholesale. 

1. Subs.  By  G.S.R. 788(E),  dt.10.10.1985. 

215 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 19C 

[See rule 59(2)] 

Application for grant or renewal of a 2[licence to sell, stock, exhibit or offer for sale, 
or distribute] of drugs specified in Schedule . 

1.   I/We* ........................................ of................................hereby apply for a licence to 

sell  by *wholesale/*retail drugs specified in Schedule X to the Drugs and Cosmetics Rules, 
1945. We operate a pharmacy on the premises, situated at ...................... 

2.    ** The sale and dispensing of drugs will be made under the personal supervision of 

the registered pharmacists mentioned below:- 

(Name) ............................................... (Qualification) 

(Name) ................................................(Qualification) 

3.        Name of drugs to be sold. 

4.      *** Particulars of storage accommodation. 

5.     A fee of rupees  .......................................... has been credited to Government account 

under the head of account .................................... 

Date ................                                                              Signature ........................... 

* Delete whichever is not applicable. 

** To be deleted if drugs will be sold only by wholesale. 

***Required only if products requiring special storage are to be sold.] 

___________________________________________________________________________ 
1. Subs.  by  G.S.R. 462(E),  dt. 22.6.1982. 
2. Subs. by G.S.R. 788(E), dt. 10.10.1985. 

FORM 20 

[See rule 61(1)] 
1[Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than 
those specified in 2[Schedules C, C(1) and X] 
1.    ................................................ is hereby 1[licensed to sell, stock or exhibit or offer for 
sale, or distribute] by retail  drugs other than those specified in  2[Schedules C, C (1) and X] 
of the Drugs and Cosmetics Rules 1945, *and to operate a pharmacy on the premises situated 

at.......................... subject to the conditions specified below and to provisions of the Drugs and 

Cosmetics Act, 1940 and the Rules thereunder. 

2  The licence shall be in force from ........................................ to ........................... 

3. Name (s) of qualified person (s) in charge .................................................... 

4. Categories of drugs.................................................. 

Name of the dealer…………………….Licence No……………………. 

Date....................................                                                        Licensing Authority ....... ………. 

* Delete whichever is applicable 

Conditions of Licence 

1.       This  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open  to 

the public. 

2.       The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and 

the Rules thereunder for the time being in force. 

3.       The  licensee  shall  report  to  the  Licensing  Authority  any  change  in  the  qualified  staff 

in charge within one month of such change. 

216 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

4.       No  drug  shall  be  sold  unless  such  drug  is  purchased  under  cash  or  credit  memo  from 

a duly licensed dealer or a duly licensed manufacturer. 

5.       The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  constitution  of  the  firm  operating  under  the  licence.        Where  any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be 
deemed  to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which 
the  change  takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from 
the Licensing Authority in the name of the firm with the changed constitution. 

_  
1.  Subs. by G.S.R. 788(E), dt. 10.10.1985 
2.  Subs. by.G.S.R.  462(E), dt. 22.6.1982 

FORM 20A 

[See rule 61 (1)] 

Restricted  1[Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail 
other than those specified in 2 [Schedules C, C (1) and X] for 3[***] dealers who do not 
engage the services  of a registered pharmacist 

1.     ......................................is hereby 1[licensed to sell, stock or exhibit or offer for sale, or 
Distribute] on the premises situated at   3[***] .......................the following drugs being drugs 
other  than  those specified  in  2[Schedules C,  C  (1) and  X]  of  the  Drugs  and  Cosmetics  Rules, 
1945,  subject  to  the  conditions  specified  below  and  to  the  provisions  of  the  Drugs  and 
Cosmetics Act, 1940 and the Rules made thereunder. 

2. The licence shall be in force from ........................................ to .......................... 

3  The  licensee  can  deal  only  in  such  drugs  as  can  be  sold  without  the  supervision  of 

qualified person under the Drugs and Cosmetics Rules, 1945. 

4  [***] 

Name of the dealer ........................................ 

Licence No ............................ 

Date......................... 

Licensing Authority 

Conditions of Licence 

1.    This  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open  to 

the public. 3[***]. 

2.    The   licensee   shall   comply   with   the   provisions  of   the   Drugs  and   Cosmetics   Act, 

1940 and the Rules thereunder for the time being in force. 

3.    No  drug  shall  be  sold  unless  such  drug  is  purchased  under  a  cash  or  credit  memo 

from a duly licensed dealer or a duly licensed manufacturer. 

4.    The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  constitution  of  the  firm  operating  under  the  licence.   Where  any  change  in 
the  constitution  of  the  firm  takes  place,  the  current  licence    shall  be  deemed  to  be 
valid  for  a  maximum  period  of  three  months  from  the  date  on  which  the  change 
takes   place   unless,   in   the   meantime,   a   fresh   licence   h as   been   taken   from   the 
Licensing Authority in the name of the firm with the changed constitution. 

1. Subs.  by.G.S.R. 788(E), dt. 10.10.1985 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 
3.  Omitted by G.S.R. 231 (E) , dt. 4.6.1996 
4  Sl. No. 4 omitted by G.S.R. 504(E) dt. 18.7.2002. 

217 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 20B 

[See rule 61 (1)] 
1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other 
than those specified in 2[Schedules C, C(I) and  X] 

1 ............................................... is   hereby  1[licensed  to  sell,  stock  or  exhibit  or  offer  for 
sale,  or  distribute] by  wholesale  drugs other  than  those  specified in  2[Schedules C,  C(1)  and  X] 
on the premises situated at ............... subject to the conditions specified below and to the 

provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder. 

2. The licence shall be in force from ................................to ............................... 

Date...............................                                                                    Licence No……………… 

Licensing Authority. 

Conditions of Licence 

1.          This  licence  shall  be  displayed  in  a  prominent  place  in  part  of  the  premises  open  to 

the public. 

2.         The  licensee  shall  comply  with  the  provisions  of  the  Drugs  and  Cosmetics  Act, 

1940 and the Rules thereunder for the time being in force. 

3 [3        (i)  No  drug  shall  be  sold  unless  such  drug  is  purchased  under  a  cash  or  credit 

memo        from a duly licensed dealer or a duly licensed manufacturer. 
(ii)    No sale of any drug shall be made to a person not holding the requisite 1[licence 
to  sell,  stock  or  exhibit  for  sale,  or  distribute]  the  drug.  Provided  that  this  condition 
shall not apply to the sale of any drug to— 

(a)     an officer or authority purchasing on behalf of Government, or 

(b)     a  hospital, medical, educational or  research institution or  a  registered medical 
practitioner for the purpose of supply to his patients, or 
4[(c)    a    manufacturer    of    beverages,    confectionery    biscuits    and    other 
non-medicinal  products,  where  such  drugs  are  required  for  processing  these 
products.] 

5[***] 

5. 

 The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change in  the  constitution of  the  firm  operating under the licence.  Where any  change 
in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be 
valid  for  a  maximum period of  three  months from  the  date  on  which  the  change  takes 
place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing 
Authority in the name of the firm with the changed constitution. 

1. Subs.  by.G.S.R. 788(E), dt. 10.10.1985. 
2. Subs. by G.S.R. 462(E) , dt. 22.6.1982. 
3. Subs.  by Notfn. No. F. 1/63/61-D, dt. 17.7.1963. 
4.Ins. by S.O.23, dt:23.12.1969.  
5.Clause 4 ommited by S.O. 289, dt:20.12.1992. Earlier clause 4 added by Notfn. F. No. 1-113/69-D, dt. 23.12.1969. 

1[FORM 20BB 
(See rule 62-D) 

2[Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute] drugs other than those 
specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from 
a motor vehicle 

1 .   … … … …   i s   h e r e b y   2[l i c e n s e d   to sell, stock or exhibit or offer for sale by 
wholesale, or  distribute] drugs  other  than  those  specified   in     Schedule     C     and     Schedule 
C(1)    from   the   vehicle    bearing   registration no.____________________   assigned  under 
under  Motor  Vehicles  Act,  1939,  subject  to  the   conditions  specified  below  and  to  the 

218 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. 

2.  The licence shall be in force from                                        to   

3. Categories of drugs ....................................................... 

Date:………..                                                                                    Licence No…………….. 

Conditions of Licence 

Licensing Authority. 

1.    This licence shall be displayed in a prominent place on the vehicle. 

2.    The  licensee  shall  comply  with  the  provisions  of  the  Drugs  and  Cosmetics  Act,  1940 

and the Rules made thereunder for the time being in force. 

3 

(i)  No drugs shall be sold by wholesale or distributed unless such drug is purchased under 
a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. 

(ii)  No  sale  by  wholesale  or  distribution  of  any  drug  shall  be  made  to  a  person  not 
holding  the  requisite  2[licensed to  sell,  stock  or  exhibit  or  offer  for  sale  by  wholesale, or 
distribute] the drug: 

Provided that this condition shall not apply to the sale of any drug to— 

( a)      an officer or authority purchasing on behalf of the Government, or 

( b)       a  hospital, medical,  educational or  research  institution or  a      registered 

medical practitioner for the purpose of supply to his   patients, or 

(c)       a  manufacturer of  beverages, confectionery, biscuits  and  other  non-medical 

products, where such drugs are required for processing these products. 

4.      The licensee shall inform the Licensing Authority in writing in the event of change in the 
constitution of the firm operating under the licence.   Where any change in the constitution 
of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be  valid  for  a  maximum 
period  of  three  months  from  the  date  on  which  the  change  takes  place  unless,  in  the 
meantime, a  fresh licence has been taken from the Licensing Authority in the name of the 
firm with the changed constitution. 

5.    The licensee shall inform the Licensing Authority in writing in the event of any change in 

ownership of the vehicle specified in this licence within seven days of such change. 

_  
1. Added by Notfn. No. X. 11013/7/76-D&MS (G.S.R. 42(E)), dt. 25.1.1979. 
2.  Subs. by G.S.R .788(E), dt.10.10.1985 

1 [FORM 20-C 

(See rule 67-C) 
2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by 
retail 

1.     ……………………is hereby  2[l i c e n s e d   to sell, stock or exhibit or offer for sale 
by  wholesale,  or  distribute]by          retail          Homoeopathic          medicines          on         the 
premises      situated at ......................subject  to   the   conditions   specified   below   and   to   the 
provisions of the  Drugs and Cosmetics Act, 1940 and the Rules made thereunder. 

2. The licence shall be in force from ............................... to ....................... 

3. Name of the competent person in-charge. 

Date..................................                                                                            Licensing Authority 

Conditions of Licence 

1.      The  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open  to 

the public. 

2.     The    licensee     shall     comply     with    the    provisions     applicable   to    homoeopathic 

219 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

medicines  under  the  Drugs  and  Cosmetics  Act,  1940  and  the  Rules  made  thereunder 
for the time being in force. 

3.     The  licensee  shall  report  to  the  Licensing  Authority  any  change  in  the  competent 

staff within one month of such change. 

3[4. This licence authorises the sale of Homoeopathic medicines made from one earlier potency 

up to a quantity of 30 ml at a time.] 

4[5.  Where  any  change  in  the  constitution  of  the  firm  takes  place,  a  licensee  shall  inform  the 
Licensing Authority in writing about the same and the current licence shall be valid only 
for  a  period  of  three  months  from  the  date  on  which  the  change  takes  place  unless, in 
the meantime, name of the firm with the changed constitution.] 

1. Added by Notfn. No. F. 1-35/64-D (G.S.R. 1185), dt. 18.8.1964. 
2.  Subs. by.G.S.R. 788(E), dt. 10.10.1985. 
3. Added by.Notfn. No. F. 1-59/68-D (S.O. 4816), dt. 19.11.1969. 
4. Added. G.S.R. 665, dt. 28-5-1977. 

1[FORM 20D 
(See rule 67C) 

2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by 
wholesale 
1.    .......................................... is hereby 2[licensed to sell, stock or exhibit or offer for 
sale,   or   distribute]   by   wholesale   Homoeopathic   medicines   on   the   premises   situated 

at..........................................................subject to the conditions specified below and to the 

provisions of the Drugs and Cosmetics Act,. 1940 and the Rules made thereunder. 

2. The licence shall be in force from .............................................to…………………….. 

Date.............................                                                                                  Licensing Authority. 

Conditions of Licence 

1.    This licence shall be displayed in a prominent place on the premises. 

2.    The   licensee   shall  comply   with  the   provisions  as   applicable  to   Homoeopathic 
medicines  under  the   Drugs  and  Cosmetics  Act,  1940  and  the   Rules  made  thereunder 
for the time being in force. 

3.    No  sale  of  any  drug shall be  made to  a  person not  holding the requisite  2[l i c e n s e d   to 
sell, stock or exhibit or offer for sale, or distribute] the drug.   Provided that this conditions 
hall  not  apply  to  the  sale  of  any  drug  to  (a)  an  authority  purchasing  on  behalf  of 
Government,  or  (b)  a  hospital,  medical,  educational  or  research  institute  or  a 
Homoeopathic medical practitioner for the purpose of supply to his patients. 

3[4 The licensee shall inform the Licensing Authority in writing in the event of any change in 
the constitution of the firm operating under the licence and the current licence shall be valid 
only  for  a  period of  three months from the  date  on  which the  change takes place  unless, in 
the meantime, a fresh licence has been taken from the Licensing Authority in the name of the 
firm with the changed constitution.] 

_  
1.         Added by Notfn. No. F.1-35/64-D, dt. 18.8.1964. 
2.         Subs.  by.G.S.R. 788(E), dt. 10.10.1985. 
3.        Added by G.S.R. 665, date 28.5.1977. 

220 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [FORM 20E 
(See rule 67 EE) 
Certificate of renewal of  2[Licence to sell, stock or exhibit or offer for sale,  or distribute] 
Homoeopathic medicines 

1.          Number of  licence  and  date  of  issue ..................................................…………. 
Certified that licence no ..... in  Form  20C  /  20D  granted  on  the  ..................... to................. 

for sale of Homoeopathic medicines at the premises situated at ...................has been renewed 

for a period from ......... to ............................. 

2.         Name of competent persons in-charge. 

Date...........................                                                                                    Licensing Authority. 

1. Added by Notfn.  No. F. 1-14/67-D, dt. 3.2.1969. 
2. Subs.  by  G.S.R. 788 (E), dt. 10.10.1985 

1[FORM 20F 

[See rule 61(3)] 

Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X 

1.  ………..is hereby  licensed  to  sell,  stock  or  exhibit  for  sale  or  distribute  by  retail 
drugs  specified  in  Schedule  X  to  the  Drugs  and  Cosmetics  Rules,  1945  on  the  premises 
situated at……………………………………………………….. 

2.          Names of drugs. 

3.         This licence shall be in force from............ …………….to........…………… 

4.         Name(s) of registered pharmacist in-charge. 

5.         The  licence  is  subject  to  the  conditions  stated  below  and  the  provisions  of  the 

Drugs  and Cosmetics Act, 1940 and the Rules made thereunder. 

Date:..........................  
Licence No……….. 

Licensing Authority…….. 

Conditions of Licence 

1.    This licence  shall be displayed in a prominent place in a part of the premises open to the 
public. 

2.   The  licensee  shall  report  to  the  licensing  authority  any  change  in  the  qualified  staff 
in charge within one month of such change. 

3.   No  drug  shall  be  stocked  or  sold  unless  such  drug  has  been  purchased  under  cash/credit 
memo from a duly licensed dealer or a duly licensed manufacturer. 

4.   The  licensee  shall  inform  the  licensing  authority  in  writing  in  the  event  of  any  change 
in  the  constitution  of  the  firm  operating  under  the  licence.  Where  any  change  in  the 
constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be  valid  for  a 
maximum  period  of  three  months  from  the  date  on  which  the  change  takes  place  unless 
in  the  meantime,  a  fresh  licence  has  been  taken  from  the  licensing  authority  in  the  name 
of the firm with the changed constitution. 
.  
1.   Ins. by  G.S. R. 462(E) , dt.  22.6.1982 corrected vide corrigendum G.S.R. 373(E) , dt.  2.5.1983. 

221 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [FORM 20G 

[See rule 61(3)] 

2[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale 
drugs specified in Schedule X 
1.      ………………….is  hereby   2[licensed  to  sell,  stock  or  exhibit  or  offer  for  sale,  or 
distribute] by  wholesale  drugs  specified  in  Schedule  X  to  the  Drugs  and  Cosmetics  Rules, 
1945 on the premises  situated at…………………………………………………….. 

2.         Names of drugs…………………………………… 

3.         This licence shall be in force from................. to ............................. 

4.         The  licence  is  subject  to  the  conditions  stated  below  and  the  provisions  of  the 

Drugs and Cosmetics Act, 1940 and the Rules made thereunder. 

Date:.......................... 
Licence No……….. 

Licensing Authority…….. 

1.    This  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open  to 

Conditions of license 

the public. 

2.    The  licensee  shall  comply  with  the  provisions  of  the  Drugs  and  Cosmetics  Act,  1940 

and the rules made thereunder. 

3.    No  drug  shall  be  stocked  or  sold  unless  such  drug  has  been  purchased  under  a  cash  or 

credit memo from a duly licensed dealer or a duly licensed manufacturer. 

4.    The  licensee  shall  forward  to  the  licensing  authority  copies  of  the  invoices  of  sales 

made to the retail dealers. 

5.    No  sale  of  any  drug  by  wholesale  shall  be  made  to  a  person  not  possessing  the  requisite 
2 [licence to sell, stock or exhibit or offer for sale, or distribute] drugs specified in Schedule 
X : 

Provided that this condition shall not apply to the sale of any drug to - 

(a)  an officer or authority purchasing on behalf of Government; 

(b)  a  hospital,  medical,  educational  or  research  institution,  nursing  home,  Registered 
Medical  Practitioner  for  the  purpose  of  supply  to  its/his  patients  or  manufacturer 
holding  a  licence  in  Form  25-E  or  28-B  to  manufacture  the  drugs  containing  drugs 
included in Schedule X. 

3  [The   licensee shall  inform the  licensing  authority in  writing  in  the  event  of  any  change  in 
the constitution of the firm operating under the licence, where any  change in the constitution 
of the firm takes place, the current licence shall be deemed to be valid for a maximum period of 
three  months  from  the  date  on  which  the  change  takes  place  unless  in  the  meantime,  a  fresh 
licence  has  been  taken  from  the  licensing  authority  in  the  name  of  the  firm  with  the  changed 
constitution.]] 

________________________________________________________________________ 
1. Ins.  by. G..S. R. 462(E) , dt.  22.6.1982. 
2.  Ins.  by. G.S..R. 788(E) , dt. 10.10.1985. 
3. Ins.  by  370(E),  dt.  7.4.1994. 

222 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 21 

[See rule 61 (2)] 
1[Licence to sell, stock or exhibit or offer for sale,or distribute] by retail drugs specified in 
Schedules C and C (1) 2[excluding those specified in Schedule X] 

3[1........................................................  is  hereby  1[licensed  to  sell,  stock  or  exhibit  or 
offer for sale, or distribute] by retail the following categories of drugs specified in Schedules 
C  and  C  (1)  2[excluding  those  specified  in  Schedule  X]  to  the  Drugs  and  Cosmetics  Rules, 
19454  and  to  operate  a  pharmacy  on  the  premises  situated  at  .....................  subject  t o  the 
conditions specified below and to the provisions of the Drugs and Cosmetics Act, 1940 and 
the Rules thereunder.] 

2.  The licence shall be in force from ....................to ....................... 
3.  Name(s) of registered pharmacists in charge ................................... 
3[4. Categories of drugs .......................................................................] 

Date........................................                                                                         
Licence No ....................... 

Licensing Authority 

*Delete if not applicable. 

Conditions of License 

1.    This  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open 
to the public. 

2.    The   licensee   shall   report   to   the   Licensing   Authority   any   change   in   the   qualified 

staff in charge within one month of such change. 

4  [***]   

4.  If  the  licensee  wants  to  sell,  stock  or  exhibit  for  sale,  or  distribute,  during  the 
currency of  the  licence, additional categories of drugs listed in  Schedules C  and  C(I) 
2[excluding  those  specified  in  Schedule  X]  but  not  included  in  this  licence,  he  should 
apply  to  the  Licensing  Authority  for  the  necessary  permission.  This  licence  will  be 
deemed  to  extend  to  the  categories  of  drugs  in  respect  of  which  such  permission  is 
given. This permission shall be endorsed on the licence by the Licensing Authority. 
5 [5.  No  drug  shall  be  sold  unless  such  drug  is  purchased  under  a  cash  or  credit  memo 

from a duly licensed dealer or a duly licensed manufacturer.] 

6. The licensee shall inform the Licensing Authority in writing in the  event of any change in 
the  constitution  of  the  firm  operating  under  the  licence.  Where  any  change  in  the 
constitution of  the  firm  takes  place,  the  current licence  shall  be  deemed to be valid for a 
maximum period of three months from the date  on which the change takes place, unless in 
the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing  Authority  in  the  name  of 
the firm with the changed constitution. 

__________________________________________________________________________ 
1.   Subs.  by G.S.R.788(E),  dt. 10.10.1985. 
2.     Subs. by G.S.R. 462(E), dt. 22.6.1982 
3.    Amended by. S.O. 2139 ,dt. 12-8-1972. 
4.   Omitted by. G.S.R. 17(E) , dt. 7.1.1986. 
5.   Inerted. by  Notfn.  No. F. 1-63/61, dt. 17.7.1963 

223 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 21A 

[See rule 61 (2)] 

1[Licence to sell, stock or exhibit or offer for sale, or distribute] by retail drugs specified in 
2[Schedule C (1)] 3[excluding those specified in Schedule X]  4[***] for dealers who do not 
engage the services of a registered pharmacist 

1.      ……………………is hereby  1[licensed  to  sell,  stock  or  exhibit  or  offer  for  sale,  or 
distribute] by retail on the premises situated at  4[***] the following drugs being drugs specified 
in  2[Schedule  C  (1)]  3[excluding  those  specified  in  Schedule  X]  to  the  Drugs  and  Cosmetics 
Rules,  1945,  subject  to  the  conditions  specified  below  and  to  the  provisions  of  the  Drugs  and 
Cosmetics Act, 1940 and the Rules thereunder. 

2. The licence will be in force from…………………………………..     . 
3. Particulars of   2[Schedule C (1)]  3[excluding those specified in Schedule X]   drugs to be 

sold. 

5  [***] 

Name of  dealer(s)………………. 

Date ............................. 

Licence No……….. 

Licensing Authority 

1.  This  licence  shall  be  displayed  in  a  prominent  and  conspicuous  place  in  a  part  of  the 

Conditions of Licence. 

premises open to the public 6[***] 

7[***] 

3.  The  licensee  shall  deal  only  in  such  drugs  as  can  be  sold  without  the  supervision  of 
a "qualified person" as defined in the Explanation to sub-rule (15) of rule 65 of the Drugs 
and Cosmetics Rules, 1945. 

4.     No  drug  shall  be  sold  unless  such  drug  is  purchased  under  cash  or  credit  memo 

from duly licensed manufacturer. 

5.     The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change   in   the   constitution   of   the   firm   operating  under   the   licence. Where   any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be 
deemed  to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which 
the  change  takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from 
the Licensing Authority in the name of the firm with the changed constitution. 

_________________________________________________________________________ 
1 Subs. by  G.S.R.788(E), dt. 10.10.1985. 
2  Ins. By S.O. 1458, dt:27.4.1965. 
3. Ins. by G.S.R. 462(E), dt. 22.6.1982. 
4. Amended. by  G.S.R 487(E), dt. 2.7.1984. 
5. Item 4 omitted  G.S.R. 504(E), dt. 18.7.2002 
6. Certain words omitted by  G.S.R. 231 (E), dt. 4.6.1996 
7. Condition No. 2 omitted by G.S.R. 17 (E), dt:7.1.1986. 

224 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 21B 

[See rule 61(2)] 

1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale drugs specified in 
Schedules C and C (1)  2[excluding those specified in Schedule X 

1.     …………………is  hereby   1[licensed  to  sell,  stock  or  exhibit  or  offer  for  sale,  or 
distribute] by  wholesale on the premises situated at  the following categories of drugs specified 
in  Schedule.  C  and  C  (1)  2 [excluding  those  specified  in  Schedule  X]  to  the  Drugs  and 
Cosmetics Rules, 1945. 

Categories of drugs 

2. This licence shall be in force from ................................. to………………………. 
3[2A.  The  sale  shall    be  made  under  the  personal    supervision  of  a  competent  person. 

(Name of the competent person)]. 

3.  This  licence  is  subject  to  the  conditions  stated  below  and  to  the  provisions  of  the 

Drugs and Cosmetics Act, 1940 and the rules thereunder. 

Licence No ...…….. 

Date............................                                                                           Licensing Authority. 

Conditions of Licence 

1.    This  licence  shall  be  displayed  in  a  prominent  place  in  a  part  of  the  premises  open 
to the public. 
4[2.***]                                         

3.   If   the   licensee   wants   to   sell,   stock   or   exhibit  for   sale   or   distribute  during  the 
currency  of  the  licence  additional  categories  of  drugs  listed  in  Schedules  C  and  C  (1) 
2[excluding   those   specified   in   Schedule   X]   but   not   included   in   this   licence,   he 
should  apply  to  the  Licensing  Authority  for  the  necessary  permission.       This  licence 
will   be   deemed  to   extend  to   the  categories  of   drugs  in   respect  of   which  such 
permission   is   given.   This   permission   shall   be   endorsed   on   the   licence   by   the 
Licensing Authority. 

5 [4.  (i)   No  drug  shall  be  sold  unless  such  drug  is  purchased under  a  cash  or  credit  memo 

from a duly licensed dealer or a duly licensed manufacturer. 

(ii)  No  sale  of  any  drug  shall  be  made  for  purposes of  resale  to  a  person not  holding  the 
requisite licence to sell, stock or exhibit for sale or distribute the drug: 

Provided that this condition shall not apply to the sale of any drug to — 

(a)  an officer or authority purchasing on behalf of Government, or 

(b)  a  hospital,  medical,  educational  or  research  institute  or  a  registered  medical 
practitioner for the purpose of supply to his patients, or 

6[(c)  a  manufacturer  of  hydrogenated  vegetable  oils,  beverages,  confectionary  and  other 
non-medicinal  products,  where  such  drugs  are required for processing these products.] 

7[5.***]                                         
8[6.  The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any  change 
in  the  constitution  of  the  firm  operating  under  the  licence.  Where  any  change  in  the 
constitution of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be  valid  for 
a  maximum period  of  three  months  from  the  date  on  which  the  change  takes  place  
unless,  in   the  meantime,  a  fresh  licence  has  been  taken  from  Licensing  Authority  in  the 
name of the firm with the changed constitution. 

________________________________________________________ 
1. Subs. by. G.S.R.788(E), dt. 10.10.1985. 
2. Subs. by.G.S.R.462(E), dt. 22.6.1982 
3. Ins. by.G.S.R. 681(E), dt. 6.6.1988. 
4. Condition no. 2 omitted by.G.S.R. 17(E), dt. 7.1.1986 
5 Added by. Notfn. No. F. 1-63/61 -D, dt. 17.7.1963. 
6.Added by Notfn. No. F. 1-113/69-D, dt. 23.12.1969. 
7. Condition 5 omitted by S.O. 289, dt 20.12.1973 (w.e.f. 3.2.1973) 
8. Ins. By S.O. 1458, dt:27.4.1965. 

225 

 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 21BB 
[See Rule 62D] 

Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) 
to the Drugs and Cosmetics Rules, 1945 from a motor vehicle. 

1.    ............................... is hereby licensed to sell by wholesale, or to distribute drugs 
specified in   Schedule C  and Schedule C(1) from    the vehicle bearing registration no. 
..................................... assigned under Motor Vehicles Act, 1939, subject to the conditions 
specified below  and  to  the  provisions of  the  Drugs  and  Cosmetics  Act,  1940  and the  Rules 
made thereunder. 

2. The licence shall be in force from ............................ to ....................... 

3. Categories of drugs .................................................................... 

Date ....................                                                                              Licence No…………… 

Conditions of licence 

Licensing Authority……….. 

1.    This licence shall be displayed in a prominent place on the vehicle. 

2.    No  drugs  to  which  this  licence  applies  shall  be  sold  by  wholesale  or  distributed  unless 
the  precautions  as  are  published  by  the  Licensing  Authority   from  time  to  time  in  the 
Official Gazette have been observed throughout the  period   during which it has been in the 
possession of the licensee. 

3.    If  the  licensee  wants  to  sell  by  wholesale  or  distribute  during  the  currency  of  the 
licence,  additional  categories  of  drugs  listed  in  Schedules  C  and  C  (1)  not  included 
in  this  licence,  he  shall  apply  to  the  Licensing  Authority  for  necessary  permission. 
This  licence  shall  be  deemed  to  extend  to  the  categories  of  drugs  in  respect  of 
which  such  permission  is  given.         This  shall  be  endorsed  on  the  licence  by  the 
Licensing Authority. 

4.    (i)  No  drugs  shall  be  sold  by  wholesale  or  distributed  unless  such  drug  is  purchased 

under a cash or credit memo from a duly licensed manufacturer. 
(ii) No sale for wholesale or distribution of any drug shall be made for the purpose of resale 
to  a  person,  not holding the requisite licence  to  sell,  stock or  exhibit for sale or distribute 
the drug: 

Provided that this condition shall not apply to the sale of any drug to— 

(a)  an officer or authority purchasing on behalf of the Government, or 

(b) a   hospital,   medical,   educational  or   research   institution  or   a   registered   medical 

practitioner for the purpose of supply to his patients, or 

(c)  a   manufactures   of   hydrogenated   vegetable   oils,   beverages,   confectionery   and 
other   non-medical  products,   where   such   drugs   are   required   for   processing   their 
products. 

5.    The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change    in    the    constitution    of    the    firm    operating    under    the    licence.    Where    any 
change    in   the   constitution    of   the    firm    takes   place,    the   current   licence   shall   be 
deemed    to    be    valid    for    a    maximum    period    of    three    months    from    the    date    on  
which the  change  takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  
taken  from 
the Licensing Authority in the name of the firm with the changed constitution. 

6.    The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  ownership  of  the  vehicle  specified  in  this  licence  within  seven  days  of 
such change.] 

1.     Added by Notfn. No. 11013/7/76DSMS (G.S.R. 42(E), dt. 25.1.1979. 

226 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM  21C 

(See rule 63A) 

Certificate of renewal of  1[licence to sell, stock or exhibit or offer for 
sale, or distribute] drugs 
Number of licence and date of issue……………………………………………………………… 
1.       Certified that licence No ......................... in 2[Form 20, 20A, 20B, 20F, 20G, 21, 

21A or 21B], granted on the.....................to ................ for sale of the following drugs at the 

premises situated at................... has been renewed for a period from ............................to ............ 

2.     Categories or particulars of drugs .................................................... 

3.      Name (s) of registered pharmacist(s) in-charge............................ 

Date.....................................                                                                             Licensing Authority. 

1.     Subs. by G.S.R.  788(E),dt. 10.10.1985. 
2.     Subs. by  .S.R. 462(E),dt. 22.6.1982. 

1[FORM 21CC 

(See rule 63B) 

Certificate of renewal of 2[licence to sell, stock or exhibit or offer for sale by wholesale, 
or distribute] drugs from a motor vehicle 

Number of licence and date of issue…………………………………………………………….. 

1. Certified that licence no……………….in Form 20-BB or Form 21-BB granted on the 

…………………………….to…………………………………………..for  sale by wholesale or 
distribution    of  the    following    drugs    from   
the    vehicle    bearing  registration 
No………………………………. assigned  under  the  Motor  Vehicles  Act,    1939  has  been 
renewed for a period from……………………………..to ………………………………………… 

2.  Categories of the drugs: 

………………………. 

………………………. 

Date……………..                                                                                          Licensing Authority. 
____________________________________________________________________________ 
1.  Subs. by   G.S.R. 788(E), dt.10.10.1985. 
2. Added by Notfn. No. 11013/7/76DSMS (G.S.R. 42(E), dt. 25.1.1979. 

FORM 22 

(See rule 67) 

(Omitted by S.O. 289, dt. 20.12.1972) 

FORM 23 

(See rule 67) 

(Omitted by S.O. 289, dt. 20.12.1972) 

FORM 24 

(See rule 69) 
Application for the grant of or renewal of a 1[licence to manufacture for sale or for distribution] 
of  drugs other than those specified in 2[Schedules C and C (1) and X] 

227 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 . I / We ................................................of. ....................................... hereby apply for the 

grant / renewal of a licence to manufacture on the premises situated at  ..........................  the 
following drugs being drugs other than those specified in 2[Schedules C and C (1) and X] of the 
Drugs and Cosmetics Rules, 1945. 

2. Names of drugs categorized according to Schedule M. 

3.  Names,  qualifications  and  experience  of  technical  staff  employed  for  manufacture 

and testing. 

4.  A fee of rupees  ...................................................... has been credited to Government 

under the head of account ....................................................................... 

Date....................................                                                      Signature .................... 

Note: The application should be accompanied by a plan of the premises. 

1. 

1. Subs. by. G.S.R. 788(E), dt. 10.10.1985. 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 

FORM 24A 

(See rule 69A) 

Application for grant or renewal of a loan 1[licence to manufacture for sale or for distribution] 
of drugs other than those specified in  2[Schedules C and C (I)  and X] 

1 . I /We*.........................................................of# ............................................hereby apply 

the  grant/renewal  of  a 

the  premises  situated 
for 
at...................................................................  C/o§ 
the  under- 
mentioned  drugs,  other  than  those  specified  in    2 [Schedules  C  and  C(1)  and  X]  to  the 
Drugs and Cosmetics Rules, 1945. 

................................................ 

to  manufacture  on 

licence 

loan 

Names of drugs (each substance to be separately specified). 

2. The names, qualifications and experience of the expert staff actually connected with the 

manufacture and testing of the specified products in manufacturing premises. 

3.    I/We enclose– 

(a)  A  t ru e  c o p y    of  a  let t e r  fr om  m e /u s  to  the  m a nufac t u r i n g  c o nce r n  wh os e 
manufacturing capacity is intended to be utilized by me/us. 

(b)  A  true  copy  of  a  letter  from  the  manufacturing concern  that  they  agree  to  lend  the 
services  of  their  expert  staff,  equipment  and  premises  for  the  manufacture  of  each  item 
required  by  me/us  and  that  they  will  analyse  every  batch  of  finished  product  and 
maintain  the  registers  of  raw  materials,  finished  products  and  reports  of  analysis 
separately in this behalf. 

(c)  Specimens of labels, cartons of the products proposed to be manufactured. 

4.    A fee of rupees........................................................................has   been   credited   to 

Government under the head of account .................................................................... 

Date......................................................                                         Signature ................…………. 

* Enter here the name of the proprietor, partners of Managing Director as the case may be. 
#Enter here the name of the applicant firm and the address of the principal place of business. 
§ Enter here the name and address of the manufacturing concern where the manufacture will be 
actually carried out and also the Licence number under which the latter operates. 
1. Subs. by G.S.R. 788(E), dt. 10.10.1985. 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 

228 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
1[FORM 24B 

(See rule 69A) 
Application for grant or renewal of licence to repack for sale or distribution of drugs, 
being drugs other than those specified in Schedules C and C (1) 2[excluding those 
specified in Schedule X] 

1 . 1 /   We  ………………of……………………….hereby  apply  for  grant/renewal       of       a 
licence   to   repack   the   following   drugs   at   the   premises   situated at…………... 

2. Names of the drugs to be repacked ....................................................................... …. 

3. Name, qualification and experience of competent staff ............................................ 

4.   A  fee  of  rupees  ………… ……………  h as  been  cr edit ed  to  Gover n m e nt  under  the 
h e a d  o f   account ......................................... …………………………………………. 

Date..........................................                                                                Signature of applicant. 

NOTE :—The application shall be accompanied by a plan of the premises. 

_________________________________________________________________________ 
1. Ins. By S.O. 1196, dt:6.5.1960.  
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 

1 [FORM 24C 
(See rule 85B) 

Application for the grant or renewal of a 2[licence to manufacture for sale or for 
distribution of] Homoeopathic medicines or a licence to manufacture potentised 
preparations from back potencies by licensees holding licence in Form 20C 

3 [ 1 .   I  /  W e *  ....................................... of  ........................................ holder of licence 

no ....................................................... in  Form  20-C  hereby  apply  for  the  grant/renewal  of 
licence  to  manufacture  the  undermentioned  Homoeopathic  mother  tinctures/potentised 
preparations on the premises situated at………………………… …………………………………. 

Name of the Homoeopathic preparations .................................................. …………………. …. 
( E a c h  i t e m  t o  b e  separately specified)]. 

2. Names, qualifications and experience of technical staff employed for manufacture and 

testing of Homoeopathic medicines. 

3. A fee of rupees ......................................... has been credited to Government under head 

of account ............................................................................................................... 

Date.....................................                                                               Signature............................... 

Note  1. Delete whichever portion is not applicable. 

2. The application should be accompanied by a plan of the premises. 

_______________________________________________________________________ 
1. Amended  by  Notfn. No. F. 1-598-D, dt. 19.11.1969 
2. Subs. by. G.S.R.788(E) dt. 10.10.1985. 
3. Subs. by. G.S.R. 13(E) dt. 7.1.1983. 

229 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [FORM 24D 

(See rule 153) 
Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic/ 
Siddha or Unani drugs 

1 .   I / W e ........................................... of.....................................................hereby apply for the 

grant /  renewal of  a  licence  to  manufacture Ayurvedic (including Siddha) or Unani drugs on 
the premises situated at.......................................................... ……………………………. 

2. Names of drugs to be manufactured (with details) 

3. Names,  qualifications  and  experience  of  technical  staff  employed  for  manufacture  and 
testing of Ayurvedic (including Siddha) or Unani drugs ............................................. 

4. A fee of rupees ............................... has been credited to the Government under the head 

of account .................................... and the relevant Treasury Challan is enclosed herewith.  

Date............................................                                  Signature ...................................... 

Note—The application should be accompanied by a Plan of the premises.] 

(applicant) 

1. Added by  Notfn. No. 1-23/67-D,dt. 2.2.1970. 

1[FORM  24E 
(See rule 154A) 

Application for grant or renewal of a loan licence to manufacture for sale 
Ayurvedic (including Siddha) or Unani Drugs 
1.    I  /  We * ...........................................................................of**................................ hereby 

apply for the grant / renewal of a loan licence to manufacture Ayurvedic (including Siddha) or 

Unani  Drugs on the premises situated    at...................………………………………………….. 
C/o*** ............................................................................………………………………………… 

2. Names of drugs to be manufactured (with details). 

3. The  names,  qualifications  and  experience  of  technical  staff  actually  connected  with 
the  manufacture    and  testing  of Ayurvedic    (including    Siddha)    or  Unani    drugs    in 
the manufacturing premises. 

4. I / We* enclose, 

(a)  A  true  copy  of  a  letter  from  me/us  to  the  manufacturing  concern  whose 

manufacturing capacity is intended to be utilized by me / us. 

(b)  A  true  copy  of  a  letter  from  the  manufacturing  concern  that  they  agree  to 
lend   the   services   of   their   competent   technical   staff,   equipment   and   premises 
for   the   manufacture   of   each   item   required   by   me/us   and   that   they   shall 
maintain   the   registers   of   raw   materials   and   finished   products   separately   in 
this behalf. 

(c)  Specimen of labels, cartons of the drugs proposed to be manufactured. 

5.     A fee of Rs ...................................................... has been credited to Government under 
t h e  h e ad  o f  a c c o un t .................................... and the relevant Treasury Challan is enclosed 
herewith. 

Date ......................................                                                   Signature ...................... ………] 

(applicant) 

230 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

* Enter here the name of the proprietor, partners or Managing Director as the case may be. 
**Enter here the name of the applicant firm and the address of the principal place of 
business. 
*** Enter here the name and address of the manufacturing concern where the manufacture will 
be actually carried out and also the licence number under which the letter operates. 
______________________________________________________________________ 
1. Added by   G.S.R. 376 (E),  dt. 20.7.1978. 

1 [FORM 24F 

(See rule 69) 
Application for the grant or renewal of a 2[licence to manufacture for sale or for distribution of] 
drugs specified in Schedule X and not specified in Schedules C and C(1) 

1.         I/We ......................  of ....................................hereby apply for the grant/renewal 

of licence to manufacture on premises situated at ............................ the undermentioned drugs, 

specified in Schedule X to the Drugs and Cosmetics Rules, 1945. 

2.         Names of drugs. 

3.          Names,    qualifications    and    experience    of    technical    staff    employed    for 

manufacture  and  testing. 

4.          A fee of rupees...... has been credited to Government account under the head of 

account.................................................... 

Date:..........                                                                                Designation .............. ……….] 

Signature ................ ………. 

1.     Subs. by .G.S.R. 462(E) ,dt. 22.6.1982. 
2.     Subs. by  G.S.R. 788(E) dt. 10.10.1985. 

231 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM  25 

(See rule 70) 

1[Licence to manufacture for sale or for distribution of] drugs other than those specified in 
2[Schedules C and C(1) and X] 

Number of Licence and date of issue ................................................................ 

1 ........................................................................ is     hereby  licensed  to     manufacture  the 
following  categories  of  drugs  being  drugs  other  than  those  specified  in   2[Schedules  C 
and    C  (1) and X] to the  Drugs and   Cosmetics   Rules,   1945, on    the     premises    situated 
at................................................................................. under   the  direction   and  supervision  of  the 
following 3[competent technical staff]: 

(a)   3[Competent technical staff]. (Names)…………………………………………… 
(b)  Names of Drugs (each item to be separately specified)..................................…. 

2.     The licence authorises the sale by way of wholesale dealing and storage for sale by the 
licensee  of  the  drugs  manufactured  under  the  licence,  subject  to  the  conditions  applicable  to 
licence for sale. 

3.  The licence shall be in force from................................................ to ................... 

4. The licence is subject to the conditions stated below and to such other conditions as may 

be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 1940. 

Date ..................................... 

Signature ............ 

Designation .......... 

4[*Licensing Authority/ 

*Central Licence Appoving Authority.] 

*Delete whichever is not applicable. 

Conditions of Licence 

1.    This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises   and   shall   be   produced   at   the   request   of   an   Inspector   appointed   under   the 
Drugs and Cosmetics Act, 1940. 

2.    Any  change  in  the  expert  staff  named  in  the  licence  shall  be  forthwith  reported  to 
the Licensing Authority. 

3.    If  the  licensee  wants  to  manufacture  for  sale  additional  items  of  drugs  not  included 
above    he    should    apply    to    the    Licensing    Authority    for    the    necessary    endorsement    as 
provided   in   Rule   69(5).     This   licence   will   be   deemed   to   extend   to   the   categories   so 
endorsed. 

4.   The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  constitution  of  the  firm  operating  under  the  licence.  Where  any change  
in   the   constitution   of   the   firm   takes   place,   the   current   licence   shall   be deemed  
to   be   valid   for   a   maximum   period   of   three   months   from   the   date   on   which  the  
change   takes   place   unless,   in   the   meantime,   a   fresh   licence   has   been   taken   from the 
Licensing Authority in the name of the firm with the changed constitution. 
_  
1. Subs. by. G.S.R. 788(E) ,dt. 10.10.1985 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 
3. Subs. by G.S.R. 231(E), dt. 4.6..1996. 
4  Subs. by G.S.R. 923(E), dt. 14.12.1992. 

232 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM 25A 

(See rule 70A) 
Loan 1[licence to manufacture for sale or for distribution of] drugs other than those specified 
In 2[Schedules C and C (1) and X] 

1.   Number of licence and date of issue ............................................................ 

2..................................................... of ................................. is   hereby   granted   a   loan 

licence to manufacture the following drugs other than those specified in 2[Schedules C and C(1) 
and X] t o  t h e  Drugs and   Cosmetics Rules, 1945,  on the premises situated at  C/o  under  the 
direction  and  supervision of the following  3[competent technical staff]: 

(a)    3[competent technical staff] (Names):……………………. 
(c)     Names of drugs .................................. 

3.  The  licence  authorises  the  sale  by  way  of  wholesale  dealing  and  storage  for  sale  by 
the licensee  of the drugs manufactured under the licence  subject to the conditions applicable to 
licences for sale. 

4.  The  licence  is  subject  to  the  conditions  stated  below  and  to  such  other  conditions  as 
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 
1940. 

Date...............................                                                                        Signature …………. 

Conditions of Licence 

Designation .. ….. 

1.  This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises   and   shall   be   produced   at   the   request   of   an   Inspector   appointed   under   the 
Drugs and Cosmetics Act, 1940. 

2.      Any  change  in  the  3[competent technical  staff]  named  in  the  licence  shall  be  forthwith 

reported to the Licensing Authority. 

3.     If  the   licensee  wants   to     undertake     during   the     currency     of  the   licence   the 
manufacture   for   of   sale   additional   drugs   he   should   apply   to   the   Licensing   Authority 
for   the   necessary   endorsement   to   the   licence   as   provided   in   Rule   69-A.   This   licence 
will be deemed to extend to the drugs so endorsed. 

4.    The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change   in   the   constitution   of   the   firm   operating   under   the   licence.        Where   any 
change   in   the   constitution   of   the   firm   takes   place,   the   current   licence   shall   be 
deemed   to   be   valid   for   a   maximum   period   of   three   months   from   the   date   on   which 
the   change   takes   place   unless,   in   the   meantime,   a   fresh   licence   has   been   taken   from 
the Licensing Authority in the name of the firm with the changed constitution. 

1. Subs. by G.S.R. 788(E) , dt.10.10.1985. 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 
3. Subs. by. G.S.R. 231(E) ,dt. 4.6.1996. 

1[ FORM  25B 

(See rule 70) 

Licence to repack for sale or distribution of drugs being drugs other than those specified in 
Schedules C and C (1) 2[excluding those specified in Schedule X] 

Number of licence and date of issue. 

1.   ……..  ................................... of .....................................is  hereby   granted   a licence to 

repack    the    following    drugs    for    sale    or    distribution    on    the    premises    situated 
at................................. under the supervision of the following competent staff. 

233 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(a) Names of drugs to be repacked. 

(b)  Names of competent staff. 

2. The licence shall be in force from ......................................... to ............................ 

3. The  licence  authorises  the  sale  by  way  of  wholesale  dealing  by  the  licensee  and 
storage  for  sale  by  the  licensee  of  the  drugs  repacked  under  the  licence  subject  to  conditions 
applicable to licences for sale. 

4. The  licence  is  subject  to  the  conditions  stated  below  and  to  such  other  conditions  as 
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 
1940. 

Date......................................                                                                       Signature ... ………….. 

Conditions of Licence 

1.      This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises  and  shall  be  produced  at  the  request  of  an  Inspector  appointed  under  the 
Drugs and Cosmetics Act, 1940. 

2.     Any  change  in  the  expert  staff  named  in  the  licence  shall  be  forthwith  reported  to 

the Licensing Authority. 

3.     If  the  licensee  wants  to  repack  for  sale  or  distribution  additional  items  he  should 
apply   to   the   Licensing   Authority   for   the   necessary   endorsement   to   this   licence. 
This licence will be deemed to extend to only those items so endorsed. 

4.     The  drugs  repacked  under  this  licence  shall  bear  on  their  label,  apart  from  other 
particulars  required  by  these  Rules,  the  name  and  address  of  the  licensee  and  the 
number  of  the  licence  under  which  the  drug  is  repacked  preceded  by  the  words 
"Rpg. Lic. No.". 

5.     The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  constitution  of  the  firm  operating  under  the  licence.       Where  any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be 
deemed  to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which 
the  change  takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from 
the Licensing Authority in the name of the firm with the changed constitution. 

1.  Added by Notfn. No. F. 1-22/59-D, dt. 9-4-1960. 
2.    Subs. by G.S.R. 462(E),  dt. 22.6.1992. 

1[FORM 25C 
(See rule 85D) 

2[Licence to manufacture for sale or for distribution of] Homoeopathic medicines 

Number of Licence and date of issue ..................................................................... 

3 [*1.   ……….……….  of.................... who   holds   a  licence   in   Form  20-C   is   hereby 
licensed to  manufacture undermentioned Homoeopathic Mother Tinctures/ potentised and  other 
preparations on the premises situated at .... under the direction and supervision of the following 
technical staff: 

Names of the Homoeopathic preparations. 
(Each item to be separately specified). 

Names of the Technical Staff.................................................... ] 

2. The licence shall be in force from ............................................ to ................... 

3. The licence is subject to the conditions stated below and to such other conditions as 
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 
1940. 

234 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Date......................................                                                                                   Signature……. 

Designation…. 

Conditions of Licence 

1.    This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises  and  shall  be  produced  at  the  request  of  an  Inspector  appointed  under  the 
Drugs and Cosmetics Act, 1940. 

2.    Any  change  in  the  expert  staff  named  in  the  licence  shall  be  forthwith  reported  to 

the Licensing Authority. 

4[3. The licensee shall inform the Licensing Authority in writing in the event of any change  in 
the  constitution  of  the  firm  operating  under  the  licence.  Where  any  change  in  the 
constitution of  the  firm  takes  place,  the  current licence  shall  be  deemed to be valid for a 
maximum period of three months from the date on which the change takes place unless, in 
the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing  Authority  in  the  name  of 
the firm with the changed constitution.] 

*Delete the words ―who holds  a licence in Form 20C‖ in case this is not applicable. 

1. Added by Notfn No. F.1-36/64-D, dt:18.8.1964  
2. Subs. by.. G.S.R.788(E) , dt. 10.10.1985. 
3.  Subs. by. G.S.R. 13(E) , dt. 7.1.1983. 
4.  Added by S.O. 903, dt. 28.2.1976. 

1[FORM 25D 

(See rule 154) 

Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs 

No. of Licence…………………………………………………………… 

1.  ….  ..................................... is  /  are  hereby licensed to  manufacture the  following 
Ayurvedic     (including     Siddha)     or     Unani     drugs     on     the     premises     situated 
at.................................................................................................. under      the      direction      and 
supervision of the following technical staff: — 

(a)  Technical staff (Names). 

(b)  Names of drugs (each item to be separately specified). 

2. The licence shall be in force from .............................................. to ................... 

3. The licence is subject to the conditions stated below and to such other conditions as may 

be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 1940. 

Date of issue: …………….                                                                         Signature ............... 

Conditions of Licence 

Designation ............ 

1.      This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises   and   shall   be   produced   at   the   request   of   an   Inspector   appointed   under   the 
Drugs and Cosmetics Act, 1940. 

2.    Any  change  in  the  Technical  staff  named  in  the  licence  shall  be  forthwith  reported 

to the Licensing Authority. 

3.    This  licence  shall  be  deemed  to  extend  to  such  additional  items  as  the  licensee  may 
intimate   to   the   Licensing   Authority   from   time   to   time,   and   as   may   be   endorsed   by 
the Licensing Authority. 

4.    The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change   in   the   constitution   of   the   firm   operating   under   the   licence.        Where   any 
change   in   the   constitution   of   the   firm   takes   place,   the   current   licence   shall   be 

235 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

deemed   to   be   valid   for   a   maximum   period   of   three   months   from   the   date   on   which 
the   change   takes   place   unless,   in   the   meantime,   a   fresh   licence   has   been   taken   from 
the Licensing Authority in the name of the firm with the changed constitution.] 

1. Added by Notfn. No. 1-23/67 –D (S.O. 642), dt. 2-2-1970. 

1 [FORM 25E 

(See rule 154A) 

Loan Licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs 

1.   Number of Licence……………………………………………………………………. 

2 .......................................................... of. ........................................... is    hereby    granted    a 

loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs, on the 

premises  situated  at .................................................... C/o.....................................................under 

the direction and supervision of the following expert technical staff: 

(a) Technical staff (Names)………………………………. 

(b) Names of drugs (each item to be separately specified) 

3. The licence shall be in force from .................................... to………………………………… 

4. The licence is subject to the conditions stated below and to such other conditions as may 

be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 1940. 

Date of Issue................................................. 

Signature .................... 

Designation ................. 

Conditions of Licence 

1.      This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  approved 
premises  and  shall  be  produced  on  the  request  of  an  Inspector  appointed  under  the 
Drugs and Cosmetics Act, 1940. 

2.     Any  change  in  the  technical  staff  named  in  the  licence  shall  be  forthwith  reported  to 

the Licensing Authority. 

3.     This  licence  shall  be  deemed  to  extend  to  such  additional  items  as  the  licensee  may 
intimate  to  the  Licensing  Authority  from  time  to  time,  and  as  may  be  endorsed  by 
the Licensing Authority. 

4.     The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in  the  constitution  of  the  firm  operating  under  the  licence.       Where  any 
change  in  the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be 
deemed  to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on  which 
the  change  takes  place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from 
the Licensing Authority in the name of the firm with the changed constitution. 

______________________________________________________________________ 

1.  Added by G.S.R. 376 (E), dt. 20.7.1978 

1 [FORM 25F 
(See rule 70) 
2[Licence to manufacture for sale or for distribution of] drugs specified in Schedule X and 
not specified in Schedules C and C(I) 

1.       ................................................... of .......................is hereby licensed to manufacture at 

the premises situated at……………………………the following drugs specified in Schedule X to 
the Drugs and Cosmetics Rules, 1945. 

236 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

2.          Names of drugs. 
3.          Names of approved 3[competent technical staff] 

4.          The  licence  authorises  the  sale  by  way  of  wholesale  dealing  and  storage  for  sale 
by   the   licensee   of   the   drugs   manufactured   under   the   licence   subject   to   the 
conditions applicable to licence for sale. 

5.          The licence shall be in force ................... to.................................... 

6.          The licence is subject to  conditions stated below and to  other conditions as  may 
be  specified  in  the  rules  for  the  time  being  in  force  under  the  Drugs  and  Cosmetics  Act, 
1940. 
Date of issue.....................                                                             Signature ............................. 

Licence No .....................                                                           Designation ......................... 

4[*Licensing Authority/Central Licence Approving Authority.] 

*Delete whichever portion is not required. 

Conditions of Licence 

1.   The licence and any certificate of renewal in force shall be kept on the licensed premises 
and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics 
Act, 1940. 

2. If the licensee wishes to undertake during the currency of the licence the manufacture 
of  any  drug  specified  in  Schedule  X  not  included  above,  he  should  apply  to  the  Licensing 
Authority  for  the  necessary  endorsement  of  this  licence.  This  licence  shall  be  deemed  to 
extend to only those items so endorsed. 
       3.  Any  change  in  the  3[competent  technical  staff]  shall  be  forthwith  reported  to  the 
Licensing Authority. 

4. The licensee shall inform the Licensing Authority in writing in the event of any change in 
the  constitution  of  the  firm  operating  under  the  licence.    Where  any  change  in  the 
constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be  valid  for  a 
maximum period of three months from the date on which the change takes place  unless, in the 
meantime, a  fresh licence has been taken from the Licensing Authority in  the name of the firm 
with the changed constitution. 

5.          The  licensee  shall  furnish  to  the  Licensing  Authority  copies  of  the  invoices  of 

sales made to dealers. 

6.          The  licensee  shall  not  manufacture  drugs  covered  by  this  licence  for  use  as 

'Physician's Samples'.] 
________________________________________________________________________________________ 
1. Subs. by G.S.R. 462(E) dt. 22.6.1982. 
2. Subs. by  G.S.R.788(E) dt. 10.10.1985. 
3. Subs. by  G.S.R.231(E) dt. 4.6.1996. 
4. Subs. by G.S.R. 923(E) dt. 14.2.1992. 

1 [FORM 26 
(See rules 73 and 83) 

Certificate of renewal of licence to manufacture for sale of drugs other than those specified in 
Schedule X 

1.      Certified   that   licence   No ........................................................................ granted   on 

the.................. to ....................... for the manufacture of the following categories of drugs being 

*drugs other than those specified in Schedules C,  C (1) and X/*drugs specified by Schedules C 
and C (1) excluding those specified in Schedule X to   the   Drugs  and   Cosmetics  Rules,   
1945,  at the   premises  situated  at       ........................................................ has been renewed 
from....................... to..................... 

2.     Name(s) of  approved  2[competent technical staff] ............... 

237 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3[3    Names of the drugs (each item to be separately specified) .......................  

Date........                                                                                            Designation ................... 

4[Licensing Authority/ *Central Licence Approving Authority.] 

Signature ............................. 

*Delete whichever portion is not required.] 

1. Subs. by  G.S.R. 462(E) dt. 22.6.1982. 
2. Subs. by  G.S.R.231(E) dt. 4.6.1996 
3. Ins. By  G.S.R. 370(E) dt. 7.4.1994. 
4.  Subs.  by  G.S.R.  923(E),  dt.  14.12.1992. 

1[FORM 26A 

(See rules 73A and 83A) 
Certificate of renewal of loan licence to manufacture for sale of drugs other than 
those specified in Schedule X 

1.          Certified   that   a  loan   licence  No ............................................................granted  on 
the..............................................  to...........................................  for  the  manufacture  of  the 
*drugs  other  than  those  specified  in  Schedules  C,  C  (1)  and  X  the  undermentioned drugs 
being drugs specified in Schedules C and C (1) excluding those specified in Schedule X, to     
the      Drugs      and      Cosmetics     Rules,       1945,       at      the      premises       situated 
at.............................. C/o .........................has been renewed from ......................... to................... 

2.         Names of the drugs (each substance to be separately specified). 
3.        Names of the approved 2[competent technical staff] 

Date ............................. 

* Delete whichever is not applicable. 

1.Ins.  by  G.S.R. 46 2 (E), dt. 22 .6.1982. 
2. Subs. by G.S.R.231(E) dt. 4.6.1996. 

Signature………..  
Designation………] 

1[FORM 26B 

(See rule 73B) 

Certificate of renewal of licence to repack for sale or distribution of drugs being drugs other than 
those specified in Schedules C and C (1) 2[excluding those specified in  Schedule X] 

1.      Certified that licence No ................................................... granted on the....................... 

to......................................for the  repacking of  the  following drugs at  the premises situated     
at .........................................has     been     renewed     from ..................... 
to...........................................................Names of drugs to be repacked .................................... 

2.     Names of competent staff. ................................................. 

Date : .....                                                                                                        Signature……… 

Designation………. 

238 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

                          3[*Licensing Authority. 
*Central  licence Approving Authority.] 

* Delete whichever is not applicable.] 

1    Added by Notfn. No. F.1-22/5 9-D, dt.  9.4.1964. 
2   Subs. by  G.S.R. 462(E) dt. 22.6.1982. 
3. Ins. by G.S.R. 923(E) dt. 14.12.1992 

FORM 26C 

(See rule 85G) 

Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines 

1.   Certified that licence No ........................ granted        on        the………………………. 
to…………     for   the  manufacture  for  sale  of  the  Homoeopathic  mother  tinctures/potentised 
preparation at the premises    situated    at ............... has       been       renewed       for  a     period 
from the ...................................................................... to ...................................... …… 

2.         Name of the technical staff .................................................................. …… 
1[3.      Names of the drugs (each item to be separately specified) ............................ ] 

Date……………….. 

1. Ins. by G.S.R. 370(E) dt. 7.4.1994. 

Signature .......……….. 
Designation .. ……… 

1[FORM 26D 
(See rule 155) 

Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs 

1.       Certified        that        licence        No ................................................... granted        on 

the………………to  Shri/  Messers ........................................................................ for  the 
manufacture     of     Ayurvedic/Siddha/Unani     drugs          at              the     premises     situated 
at………………….has been renewed from………………………….to .................................... 

2.        Names of technical staff ................................................................ 
2[3.     Names of drugs (each item to be separately specified).]] 

Date ………..                                                                                                 Signature……….. 
Designation……….. 

____  
1. Ins. by  F. No.1 -23/67-D, dt. 2-2-1970. 
2. Ins. by G.S.R 376 (E), dt. 20.7.1978 

1[FORM 26E 
(See rule 155A) 
Certificate of renewal of loan licence to manufacture for sale of 
Ayurvedic / Siddha or Unani Drugs 

1.       Certified       that        loan       Licence       No ....................................granted  on 
the……………………………………to………………………………………………...……… 
for  the  man ufacture  ofAyurvedic/  Siddha  or      Unani   drugs  at  the    premises        situated 
at.............................................................. C/o ........................................... has   been   renewed 
from..............................................................to ..................................................... ……………. 

239 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

2   Names of technical staff. 

Date: …………                                                                                           Signature............  
Designation……….. 

1. Added by  G.S.R. 376(E), dt. 20.7.1978. 

1[FORM 26E-I 

(See rule  157B) 
Certificate of Good Manufacturing Practices (GMP) to manufacture of 
Ayurveda, Siddha or Unani drugs 

Certified that manufacturing unit licensee, namely ...................... situated at  ................ 

State   ..................   Licence No ...........................   comply    with   the   requirements    of  Good 
Manufacturing Practices of  Ayurveda-Siddha-Unani drugs as laid  down in  Schedule T  of the 
Drugs and Cosmetics Rules, 1945. 

This certificate is valid for a 2[period of five years and the Good Manufactruing Practices 
(GMP) is valid for the various dosage forms or Rasaushadhis, as follows:] 

Date :.......                                                                                                  Signature……….. 

Place  : . . ..                                                                                                                    Designation…… 

Licensing Authority for Ayurveda/ Siddha/ Unani Drugs.] 
_________________________________________________________________________________________________________________ 

1.subs. by G.S.R.198(E),   dt. 7.3.2003. Earlier Ins. by G.S.R. 561(E), dt. 23.6.2000. 
2.Subs. by G.S.R. 376(E), dt. 3.5.2010 

1[FORM 26E2-I 

(See rule  158C) 

State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines 

Name of the State or Union territory…….. 

Free Sale Certificate 

It is certified that M/s. …….(Name of the company)……..situated at ………. (Address) 
......................  is  holding  valid  Ayurvedic/Siddha/Unani  Drug  Manufacturing  License 
Number...............  valid  till  ……and  certificate  of  Good  Manufacturing  Practices  for  the 
State  or  Union  territory  of  ……The  manufacturer  has  applied for renewal  of  license  on 
..................(to be mentioned, if application for renewal of license has not been rejected).    

It 

is 

also 

certified 

at 
………..(Address)……..in  which  the  Ayurvedic  or  Unani  or  Sidhha  products  are 
manufactured,  conforms  to  the  requirement  of  Good  Manufacturing  Practices  and  is 
subjected to inspection as per rules. 

the  manufacturing 

siuated 

plant 

that 

The  firm  has  been  permitted  under  License  Number………..to  manufacture  and 
market the following products (attach list of products, if multiple) freely for sale  in India 
under the provisions of the Drugs and Cosemtics Atc, 1940 and the rules thereunder. 

(i)………… 
(ii)………… 
(iii)……….. 

Date :.......                                              (Seal of issuing Officer)   … … … … … … … …  

240 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

( Signature and Name) 

State Drug Controller/Licensing Authority 

Address……………………………………… 

Name of State or Union territory…………]                                                                                                                    

_________________________________________________________________________________________________________________ 

1.Ins. by G.S.R. 153 (E), dt. 5.3.2014. 

1[FORM 26E2-II 

(See rule  158C) 

State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines 

Name of the State or Union territory…….. 

Free Sale Certificate 

It is certified that M/s. …….(Name of the company)……..situated at ………. (Address) 
......................  is  holding  valid  Ayurvedic/Siddha/Unani  Drug  Manufacturing  Loan 
License Number............... valid till ……and the valid certificate of Good Manufacturing 
Practices for the State or Union territory of ……The manufacturer has applied for renewal 
of loan  license on ..................(to be mentioned, if application for renewal of license has 
not been rejected).    

It 

is 

also 

certified 

at 
………..(Address)……..in  which  the  Ayurvedic  or  Unani  or  Sidhha  products  are 
manufactured,  conforms  to  the  requirement  of  Good  Manufacturing  Practices  and  is 
subjected toinspection as per rules. 

the  manufacturing 

siuated 

plant 

that 

The firm has been permitted under Loan License Number………..to manufacture 
and market the following products (attach list of products, if multiple) freely for sale  in 
India  under  the  provisions  of  the  Drugs  and  Cosemtics  Atc,  1940  (23  of  1940)  and  the 
rules thereunder. 

(i)………… 
(ii)………… 
(iii)……….. 

Date :.......                                                      (Seal of issuing Officer) … … … … … … .  

( Signature and Name) 

State Drug Controller/Licensing Authority 

Address……………………………………… 

Name of State or Union territory…………  ]                                                                                                                  

_________________________________________________________________________________________________________________ 

1.Ins. by G.S.R. 153 (E), dt. 5.3.2014. 

1[FORM 26 E3 

(See rule  158C) 

State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines 

Name of the State or Union territory…….. 

Non-Conviction Certificate 

It is certified that M/s. …….(Name of the company)……..situated at ………. (Registered 
Address)  ......................  is  holding  valid  Ayurvedic/Siddha/Unani  Drug  Manufacturing 
License  Number...............  in  Form  25D/25E  valid  till  ……and  certificate  of  Good 

241 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Manufacturing  Practices/valid  Good  Manufacturing  Practices  certificate  of  principal  or 
original  manufacturer  for  the  State  or  Union  territory  of  ……The  manufacturer  has 
applied  for  renewal  of  license  on  ..................(date  to  be  mentioned,  if  application  for 
renewal of license has not been rejected).    

As per the records of the State Drug Controller or Licensing  Authority, as it may 
be, and affidavit (Annexure I) given by the company, the firm has not been conicted under 
the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules thereunder in the State or 
Union territory of …….., during the last three years of the issuing of this certificate.  

This certificate shall be valid only for six months from the date of issue. 

Date :.......                                  (Seal of issuing Officer) … … … … … … … … … … … … .  

( Signature and Name) 
State Drug Controller/Licensing Authority for 
Ayurveda, Siddha and Unani Medicines. 

Address……………………………………… 
Name of State or Union territory…………]   

1[ANNEXURE-1 

(Proforma of Affidavit to be submitted on stamp paper of Rs. 50 attested by 
Magistrate not below the rank of first class) 

I, …………S/O………….age…….working as ……….of………..(Name and address of 
the company)……from ……to……do hereby solemnly affirm and declare as under: 

1.  That I, in the capacity of Authorized Signnatory of ……(name and address of the 
company)….,am duly competent to depose and verify the present affidavit. 

2.  That I apply for Non-conviction Certificate on behalf of M/s.  ………….. 
3.  Thar I declare that I am aware of the details of my organization asnd day to day 

activities from….to…. 

4.  That I hereby undertake that the Non-Conviction Certificate, if issued, will be 

utilized for the bona fide purpose only. 

5.  I declare that the aforesaid firm is not convicted under the Drugs and Cosmetics Act, 

1940 and rules thereunder during the last three years. 

6.  That it is my true statement. 

………………………. 
Signatature of Deponent 

Verification 

Verified  at………….(Palce  and  State)……….….today  on  this………..…..day 
of…..(month)….(Year)…..that  the  contents  of  the  above  affidavit  are  true  to  my 
knowledge  and  belief  and  no  part  of  it  is  false  and  nothing  has  been  concealed 
therefrom. 

………………………. 
Signature of Deponent] 

Witness with Address 
1. 
2. 

_________________________________________________________________________________________________________________ 

1.Ins. by G.S.R. 153 (E), dt. 5.3.2014. 

242 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 26F 

(See rules 73 and 83) 

Certificate of renewal of licence to manufacture for sale of  drugs specified in Schedule X 

1.  Certified that licence No ................................ granted on the ................ to .............. 

for  the  ma nu facture  o f  drugs  sp ec ified  in  Sc hed u le  X  to  th e  Dru g s  an d  Cosmetics 
Rules, 1945, at the premises situated at…………………………..      has        been        renewed 
from……………………………………. to………………………… 

2.          Names of drugs (each substance to be separately specified). 
3.          Names of the approved 2[competent technical staff]. 

Date:……… 
Date of issue…… 

Signature…………. 
Designation………. 
3[*Licensing Authority/Central Licence Approving Authority]   

*Delete whichever is not applicable. 

1.  Ins. by. G.S.R. 462(E) ,dt. 22.6.1982. 
2. Subs. by G.S.R. 231(E), dt. 4.6.1996. 
3. Subs. by G.S.R. 923(E), dt. 14.12.1992. 

1[FORM 26G 

(See rules 122F) 
Certificate of renewal of licence to operate a Blood Bank for processing of 
whole human blood and/or* for preparation for sale or distribution of its 
components 

1.   Certified  that  Licence No ....................... .   granted  on …………….. to M/s………………. 
.......................................... for  the  operation  of  a  Blood  Bank  for processing  of  whole  human  
blood  and*/or    for  preparation  of  its  components  at  the premises situated  
at........................................... is hereby renewed with effect from……….. to .................. 

2.       Name(s) of items : 

1. 

2. 

3. 

3.      Name(s) of competent Technical Staff: 

1. 

2. 

3. 

Dated…………. 

[*Licensing Authority/Central Licence Approving Authority]    

Signature…………. 
Designation………. 

* Delete whichever is not applicable. 
1. Subs. by G.S.R 245(E) dt. 5.4.1999. 

243 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 26H 

(See rules 68A, 76, 77, 78) 

Certificate of renewal of licence to manufacture for sale of 2[Large Volume 
Parenterals/Sera and Vaccines/recombinant DNA (r-DNA)derived drugs] specified in 
Schedules C and C(I) excluding those specified in Schedule X 

1.     Certified that licence No............................... granted  on the .................. to ............ for 
the  manufacture of  following  2[ Large  Volume  Parenterals/Sera and  Vaccines/recombinant 
DNA (r-DNA) derived drugs]  at  the  premises situated at................................. has been renewed 
from........to……… 

2.  Name(s) of drug(s) ........................................ ………………………………………. 

(each item to be separately specified). 

3.       Name(s) of competent technical staff: 

(a) responsible for manufacturing                                   (b) responsible for testing 

1. 
2. 
3. 
4. 

Date:……… 

1. 
2. 
3. 
4. 

[*Licensing Authority/Central Licence Approving Authority]    

Signature…………. 
Designation………. 

         * Delete whichever is not applicable. 

1. 

Ins. by G.S.R. 119(E), dt. 11.3.1996. 

2.  Subs. By G.S.R. 26 (E), dt: 19.1.2006.  

1[FORM 26-I 

(See rules 122-I) 

Certificate of renewal of licence for manufacture of blood product. 

1.           Certified that licence no ..................... granted  on the .................. to M/s.  ........... for 

the manufacture of blood products at the premises situated at .............................is hereby 
renewed with effect from .........……… to………………… 

2. 

Name(s) of item (s): 

1. 
2. 
3. 

3. 

Name(s) of competent technical staff: 

(a) responsible for manufacturing 

(b) responsible for testing 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

244 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date:……… 

Drugs and Cosmetics Rules 1945 

[*Licensing Authority/Central Licence Approving Authority]   

Signature…………. 
Designation………. 

_ * Delete whichever is not applicable. 
1. Ins. by G.S.R 245(E), dt. 5.4.1999. 

1[FORM 26-J 

(See rules 122G, 122H, 122I, 122P) 

Certificate of renewal of licence for collection, processing, testing, storage, banking and 
release of umblical cord blood stem cells. 

Certified that licence no ..................... granted  on the .................. to M/s.  ........... for 

collection, processing, testing, storage, banking and release of umblical cord blood stem cells at 
the premises situated at .............................is hereby renewed with effect from .........…………..… 
to………………… 

1.  Name(s) of competent technical staff: 

1…………….. 
2…………….. 
3…………….. 

Date:……… 

[*Licensing Authority/Central Licence Approving Authority]   

Signature…………. 
Designation………. 

* Delete whichever is not applicable. 
1. Ins. by G.S.R 899(E), dt. 27.12.2011. 

1[FORM 26J 

(See rules 83A and 83AA) 

Certificate of renewal of loan licence to manufacture for sale of Large Volume 
Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in 
Schedules C and C(I) excluding those specified in Schedule X 

Certified that licence no ..................... granted  on the .................. to M/s.  ........... for the 
manufacture of following Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-
DNA) derived drugs at the premises situated at .............................has been renewed from 
.........…………..… to………………… 

2.  Name(s) of drug (s)……………(Each item to be separately specified) 

3.  Name(s) of competent technical staff: 
(a) responsible for manufacturing 

(b) responsible for testing 

1. 

2. 

3. 

4. 

Date:……… 

1. 

2. 

3. 

4. 

[*Licensing Authority/Central Licence Approving Authority]   

Signature…………. 
Designation………. 

* Delete whichever is not applicable. 
1. Ins. by G.S.R 574(E), dt.17.6.2012. 

245 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

FORM  27 

Application for grant or renewal of a 1[licence to manufacture for sale or for distribution] of 
drugs specified in Schedules C and C (1) 2[excluding those 
specified in 3[Part XB and] Schedule X] 

1 . I /  We  ........................................................ hereby  apply  for  the  grant  /  renewal  of  a 
licence    to    manufacture      on    the    premises      situated    at    the  undermentioned  drugs,  being 
drugs specified in Schedules C and C (1) 2[excluding those specified in 3[Part XB and] Schedule 
X] to the Drugs and Cosmetics Rules, 1945. 

Names of  drugs……..………(each item to be separately specified). 

2.    The  names,  qualifications  and  experience  of  the  expert  staff  responsible  for  the 

manufacture and testing of the above mentioned drugs. 

(a) Name (s) of staff responsible for test .................................... 

(b) Name (s) of staff responsible for manufacture.......................... 

3.       The premises and plan are ready for inspection/ will be ready for inspection on….. 

4.    A fee of rupees .................................................... and an inspection fee of rupees 
………………has been credited to Government under the head of account……………. 

Date .........................................                                                                      Signature……… 

Designation…... 

Note-The application shall be accompanied by a plan of premises. 
_  
1. Ins.  by. G.S.R. 788(E), dt. 10.10.1985.            3. Ins. by G.S.R. 28(E), dt. 22.1.1993. 
2. Subs. by G.S.R. 462(E), dt. 22.6.1982. 

FORM 27A 

(See rule 75A) 

Application for grant or renewal of a loan 1[licence to manufacture for sale or for distribution 

of] drugs specified in Schedules C and C(1)  2[excluding those specified in 

Part XB and Schedule X] 

1.     I  /  We* .....................................of# .................................................... …..hereby    apply 
for the    grant/ renewal    of    Loan    Licence    to    manufacture    on    the    premises    situated 
at C/o$………………………………………. the   undermentioned  drugs,  being  drugs specified 
in Schedules C and C (1) 2[excluding those specified in Part XB and Schedule X] to  the  Drugs 
and Cosmetics Rules. 

Names of drugs (each substance to be separately specified). 

2.    The names, qualifications and  experience of the expert staff  actually connected with 

the manufacture and testing of the specified products in the manufacturing premises. 

(a) Name (s) of expert staff responsible for manufacture .................................. 

(b) Name (s) of the expert staff responsible for testing ........................................... 

3.      I /We enclose: 

(a)  A  true  copy  of  a  letter  from  me  /  us  to  manufacturing  concern  whose 

manufacturing capacity is intended to be utilized by me / us. 

(b)  A  true  copy  of  a  letter  from  the  manufacturing  concern  that  they  agree  to 
lend  the  services  of  their  competent  technical  staff,  equipment  and  premises 
for  the  manufacture  of  each  item  required  by  me  /  us  and  that  they  shall 

246 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

will  analyse every  batch of  finished product and maintain  the  registers of  raw 
materials, finished products and reports of analysis separately on this behalf. 

(c)  Specimens of labels, cartons of the drugs proposed to be manufactured. 

4. A fee of Rs ........................................................ has  been  credited  to  Government  under 

the head of account .......................................................... ……………………………………. 

Date .......................................                                                          Signature .................. …… 

Designation……………….. 

* Enter here name of the proprietor, partners or Managing Director, as the case may be. 

# Enter here name of the applicant firm and the address of the principal place of business. 
$  Enter here the name and address of the manufacturing concern where the manufacture will be 
actually carried out and also the licence number under which the latter operates. 

1.  Subs. by G.S.R. 788(E) ,dt. 10.10.1985. 
2. 
Ins. By G.S.R. 462(E), dt: 22.6.1982. 

1[FORM 27B 
Application for grant or renewal of a 2[licence to manufacture for sale or for distribution of] 
drugs specified in Schedules  C, C(I) and X 

1.         I/We ................... of ........................... hereby  apply  for  the  grant/renewal  of  a  licence 
to  manufacture  on  the  premises  situated  at……………………………  the  undermentioned 
drugs, specified in Schedules C, C(I) and X to the Drugs and Cosmetics Rules, 1945. 

2.         Names of drugs. 

3.         The names, qualifications and experience of the expert staff responsible for 

the manufacture and testing of the abovementioned drugs. 

(a)  Name(s) of staff responsible for testing: 

(b) Name(s) of staff responsible for manufacture: 

4.         The premises and plant* are ready for inspection/will be ready for inspection on ..... 

5.          A fee of rupees  .......................................... and an inspection fee of rupees ......... has 

been credited to the Government under the head of account ...................................................... 

Date..................                                                                                  Signature…………… 

Note: The application shall be accompanied by a plan of the premises.] 

* Delete whichever is not applicable. 

1. Subs. by G.S.R. 462(E) dt. 22.6.1982. 
2. Subs. by G.S.R. 788(E) ,dt. 10.10.1985. 

247 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM  27C 

(See rule 122-F) 

Application for grant/renewal* of licence for the operation of a Blood Bank for processing of 
whole blood and/or* preparation of Blood Components 

1.    I/We, ................................ of M/s ..................................................... hereby apply for the 

grant of licence/renewal of licence number ................................................ dated………….to 
operate a Blood Bank, for processing of whole blood and/or* for preparation of its components 
on the premises  situated at ………………………………………………….. 

2.     Name(s) of the item(s) 

1. 

2. 

3. 

3.   The name(s), qualification and experience of competent Technical Staff are as under: 

(a)    Name(s) of Medical Officer. 

(b)    Name(s) of Technical Supervisor 

(c)    Name(s) of Registered Nurse. 

(d)    Name(s) of Blood Bank Technician. 

4. The premises and plant are ready for inspection/will be ready for inspection on..... …. 

5. A  licence  fee  of rupees  .................... and  an  inspection fee  of  rupees .................. has been       
credited to the Government under the Head of  Account.......................... (receipt enclosed) 

Dated. ...........                                                                                   Name and Designation……… 

Signature .... ………………… 

* Delete whichever is not applicable. 

Notes: 

1.    The  application  shall  be  accompanied  by  a  plan  of  the  premises,  list  of  machinery  and 
equipment   for   collection,   processing,   storage   and   testing   of   whole   blood   and   its 
components,  memorandum of  association/constitution of  the  firm,  copies  of  certificate 
relating  to  educational  qualifications  and  experience  of  the  competent  technical  staff  and 
documents relating to ownership or tenancy of the premises. 

2.    A  copy  of  the  application  together  with  the  relevant  enclosures  shall  also  be  sent  to 
the  Central  Licence  Approving  Authority      and  to  the  Zonal/Sub-Zonal  Officers 
concerned of the Central Drugs Standard Control Organization]. 

_______________________________________________________________________ 
1. Subs. by  G.S.R. 245(E),  dt. 5.4.1999. 

1[FORM 27D 
(See rule 75) 

Application for grant or renewal of a licence to manufacture for sale or for distribution of 
2[Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] 
excluding those specified in Schedule X 

1.     I/We ............................ of ..................................hereby  apply  for  grant/renewal  of  a 
licence to manufacture for sale or distribution on the premises situated at……………..…the 
undermentioned 2[Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) 
derived drugs], specified in  Schedules C  and C(1) to the Drugs and Cosmetics Rules, 1945. 

2.     Name(s) of drug(s) ......................................... (each item to be separately specified). 

248 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.    The name(s), qualifications and experience of the competent technical staff responsible 

for the manufacture of the above mentioned drugs. 

Drugs and Cosmetics Rules 1945 

(a) Name(s) of staff responsible for testing ................... 

(b) Name(s) of staff responsible for manufacturing ............. 

4.      The    premises    and    plant    are    ready    for    inspection/will  be    ready    for    inspection 

on……………………… 

5.        A fee of rupees .............................. and an inspection fee of rupees .............has    been 

credited to the Government under the Head of Account...................... 

Date: ............                                                                             Signature .............................. 

Designation......................... 

Notes: 

1.        The  application  is  to  be  accompanied  by  a  plan  of  the  premises,  list  of  machinery  and 
testing,  memorandum  of 
for  manufacture 
equipment 
association/constitution   of    the    firm,   copies   of    qualification   and   experience   of 
competent technical staff and documents relating to ownership or tenancy of the premises. 

employed 

to  be 

and 

2.     A  copy  of  the  application  together  with  the  relevant  enclosures  shall  also  be  sent 
each  to  the  Central  Licence  Approving  Authority  and  concerned      Zonal/Sub-Zonal 
Officers of Central Drugs Standard Control Organization]. 

_  
1. 
Ins. by. G.S.R.119(E), dt. 11-3-1996. 
2.  Subs. By G.S.R.26 (E) dt: 19.1.2006. 

1[FORM 27DA 
(See rule 75A) 

Application for grant or renewal of a loan licence to manufacture for sale or for distribution of 
Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs 
excluding those specified in Schedule X 

1.     I/We* ............................ of #..................................hereby  apply  for  grant/renewal  of  a 

loan licence to manufacture on the premises situated at c/o @……………..…the 
undermentioned drugs being Large Volume Parenterals/Sera and Vaccines/recombinant DNA 
(r-DNA) derived drugs specified in  Schedules C, C(1) excluding those specified in Schedule X 
to the Drugs and Cosmetics Rules, 1945. 

2.     Name(s) of drug(s) .................................. (each item to be separately specified). 

3.    The name(s), qualifications and experience of the competent technical staff responsible 

for the manufacture of the above mentioned drugs. 

(a) Name(s) of competent technical staff responsible for testing ................... 

(b) Name(s) of competent technical staff responsible for manufacturing ............. 

4. I /We enclose: 

(a)  A  true  copy  of  a  letter  from  me  /  us  to  manufacturing  concern  whose 

manufacturing capacity is intended to be utilized by me / us. 

(b)  A  true  copy  of  a  letter  from  the  manufacturing  concern  that  they  agree  to 
lend  the  services  of  their  competent  technical  staff,  equipment  and  premises 
for  the  manufacture  of  each  item  required  by  me  /  us  and  that  they  shall 
will  analyse every  batch of  finished product and maintain  the  registers of  raw 
materials, finished products and reports of analysis separately on this behalf. 

(c)  Specimens of labels, cartons of the drugs proposed to be manufactured. 

5.  A fee of rupees ..............................has been credited to the Government under the Head of 

Account......................] 

249 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Date: ............                                                                             Signature .............................. 

Designation......................... 

*  Enter here name of the proprietor, prtners or managing director, as may be. 
#  Enter here nam of the applicant firm and the address of the principal place of business. 
@  Enter  here  the  name  and  address  of  the  manufacturing  concern  where  the  manufacture 
will be actually carried out and also the license number under which the latter operates.  

_  

1. 

Ins. by. G.S.R. 574 (E), dt.07-7-2012. 

1[FORM 27E 

(See rule 122F) 

Application for grant/renewal* of licence to manufacture blood products for 

sale or distribution 

1.         I/We ........................ of  M/s .................................................... hereby   apply   for   
the grant of licence/renewal of licence number ................................................ dated………..    
to manufacture Blood products on the premises situated at .......................... ………………. 

2.          Name(s) of the item(s) 

1. 
2. 
3. 
4. 

3.        The name(s), qualification and experience of competent Technical Staff are as under: 

(a)   responsible for manufacturing                                 (b) responsible for testing 

1.                                                                                      1. 

2.                                                                                     2. 

3.                                                                                      3. 

4.         The premises and plant are ready for inspection/will be ready for inspection on....... 

5.         A licence fee of rupees ………… ..... ……………….and an  inspection  fee  of  rupees 
............................................................................. has been  credited  to  the  Government  under  the 
Head of Account.................................................. (receipt enclosed) 

Dated. ...........                                                                        Name and Designation........ …. 

Signature .... …………. 

* Delete whichever is not applicable. 

Notes: 

1.      The application shall be accompanied by a plan of the premises, list   of       machinery and 
equ i p m ent      f or      m a n u f act ure      of      b l o od      p r o d u c ts ,      m e m or a n d um      o f 
association/constitution  of 
to  educational 
qualifications  and  experience  of  the  competent  technical  staff  and  documents  relating  to 
ownership or tenancy of the said premises. 

the  firm,  copies  of  certificate  relating 

2.      A  copy  of  the  application  together  with  the  relevant  enclosures  shall  also  be  sent  to 
the  Central  Licence  Approving  Authority     and  to  the  Zonal/Sub-Zonal  Officers 
concerned of the Central Drugs Standard Control Organization]. 

1. Ins.  by G.S.R. 245(E), dt. 5-4-1999. 

250 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 27F 

(See rule 122F) 

Application for grant/renewal* of licence for collection, processing, testing, 
storage, banking and release of umblical cord blood stem cells 

1.         I/We ........................ of  M/s .................................................... hereby   apply   for   
the grant of licence/renewal* of licence number ................................................ dated………..    
for collection, processing, testing, storage, banking and release of umblical cord blood stem 
cells on the premises situated at .......................... ………………. 

2.  Name(s), qualification and experinec of competent technical staff are as under: 

1. Medical Director 
2.Laboratory In-charge 
3.Technical Supervisor 
4.Cord Blood Bank Technician (s) 

3.  The premises and plant are ready for inspection/will be ready for inspection on....... 

4.  A licence fee of rupees ………… ..... ……………….and an  inspection  fee  of  rupees 
Head 

............has 
credited 
Account.................................................. (receipt enclosed) 

Government 

under 

been 

the 

the 

to 

of 

Dated. ...........                                                                        Name and Designation........ …. 

Signature .... …………. 

* Delete whichever is not applicable. 

Notes: 
1.      The application shall be accompanied by a plan of the premises, list   of       machinery and 
equ i p m ent      f or      m a n u f act ure      of      b l o od      p r o d u c ts ,      m e m or a n d um      o f 
to  educational 
association/constitution  of 
qualifications  and  experience  of  the  competent  technical  staff  and  documents  relating  to 
ownership or tenancy of the said premises. 

the  firm,  copies  of  certificate  relating 

2.      A  copy  of  the  application  together  with  the  relevant  enclosures  shall  also  be  sent  to 
the  Central  Licence  Approving  Authority     and  to  the  Zonal/Sub-Zonal  Officers 
concerned of the Central Drugs Standard Control Organization]. 

1. Ins.  by G.S.R. 899(E), dt. 27-12-2011. 

FORM 28 

(See rule 76) 
1[Licence to manufacture for sale or for distribution of] drugs specified in 
Schedules C and C (1) 2[excluding those specified in Schedule X]  

Number of Licence and date of issue ................................................................. 

1.    ……………………………….      is  hereby  licensed  to  manufacture  at  the  premises 
situated at    the  following  drugs,  being  drugs  specified  in  Schedules  C  and  C  (1)  2[excluding 
those specified in Schedule X] to the Drugs and Cosmetics Rules, 1945. 

Names of drugs ......................................................... 
2.     Names of approved 3[competent technical staff]. 

3.     The licence authorises the sale by way of wholesale dealing and storage for sale by 
the licensee  of the drugs manufactured under the licence  subject to the conditions applicable to 
licences for sale. 

4.   The licence will be in force from .........................................to ....................... 

251 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.   The licence  is  subject to  the  conditions stated below and  to  such other conditions as 
may  be  specified  in  the  Rules  for  the  time  being  in  force  under  the  Drugs  and  Cosmetics 
Act,1940. 

Drugs and Cosmetics Rules 1945 

Date:……… 

Signature…………. 
Designation………. 
4[*Licensing Authority/Central Licence Approving Authority]   

*Delete whichever is not applicable 

Conditions of Licence 

1     This licence and  any  certificate  of renewal in  force  shall be  kept on the approved 
premises  and  shall  be  produced  at  the  request  of  an  Inspector  appointed  under  the  Drugs  and 
Cosmetics Act, 1940. 

2        If  the  licensee  wants  to  undertake  during  the  currency  of  the  licence  the  manufacture 
any  drug  specified  in  Schedules  C  and  C  (1)  2[excluding  those  specified  in  Schedule  X]  not 
included  above,  he  should  apply  to  the  Licensing Authority  for  the  necessary endorsement as 
provided in rule 75(3). This licence will be deemed to extend to the items so endorsed. 

3             Any  change  in  the  3[competent  technical  staff]  shall  be  forthwith  reported  to  the 
Licensing Authority. 

4       The licensee shall inform the Licensing Authority in writing in the event of any change in 
the  constitution  of  the  firm  operating  under  the  licence.     Where  any  change  in  the 
constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be  valid  for  a 
maximum  period  of  three  months  from  the  date  on  which  the  change  takes  place  unless, 
in  the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing  Authority  in  the  name 
of the firm with the changed constitution. 

1. Subs. by G.S.R. 788(E), dt. 10.10.1985. 
2. Ins. by G.S.R. 462(E), dt. 22.6.1982. 
3. Subs. by G.S.R. 231(E), dt. 4.6.1996 
4. Subs. by G.S.R. 923(E), dt. 14.12.1992. 

FORM 28A 

(See rule 76-A) 
Loan 1[Licence to manufacture for sale or for distribution of] drugs specified in Schedules C 
and C (1)  2[excluding those specified in Schedule X] 

1. Number of licence and date of issue ............................................................ 

2.  …………………………………….  of............................................ ……………..is 
hereby granted a loan licence to manufacture on the premises  situated  at ……………...        C/o 
............................................................................ the  following  drugs  being  drugs  specified  in 
Schedules C  and  C  (1)  2[excluding those  specified in  Schedule X]  to  the  Drugs  and  Cosmetics 
Rules, 1945. 

Names of Drugs ...................................................... 
3.      Names of  3[competent technical staff] ................................................ 
4[3A.     The licence shall be in force from ............................................ to.................... 

4.      The  licence  authorises  the  sale  by  way  of  wholesale  dealing  by  the  licensee  and 
storage  for  sale  by  the  licensee  of  the  drugs  manufactured  under  the  licence  subject  to  the 
conditions applicable to licence for sale. 

5       The  licence  is  subject  to  the  conditions  stated  below  and  to  such  other  conditions  as 
may be specified in the Rules for the time being in force under the Drugs and Cosmetics Act, 
1940. 

252 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Date of issue: ………. 

Signature…………  

Designation ................ 

Conditions of Licence 

1.           This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  
on  the approved  premises  and  shall  be  produced  at  the  request  of  
an  Inspector appointed under the Drugs and Cosmetics Act, 1940. 

2.           If    the   licensee   wishes   to   undertake   during   the   currency   of   the  
licence    to  manufacture  any  drugs  specified  in  Schedules  C  and  C  (1) 
2[excluding  those  specified  in  Schedule  X]  not  included  above,  he  should 
apply  to  the  Licensing  Authority  for  the  necessary  endorsement  to  the 
licence  as  provided in rule 75A. This licence will be deemed to extend to 
the items so endorsed. 

3.          Any   change   in   the   3[competenet technical staff]   shall   be   

forthwith   reported   to   the Licensing Authority. 

4.      The licensee shall inform the Licensing Authority in writing in the event of 
any change  in  the  constitution  of  the  firm  operating  under  the  licence.  
Where  any  change    in    the    constitution  of  the  firm  takes  place,  the 
current  licence    shall  be  deemed  to  be  valid  for  a  maximum  period  of 
three  months  from  the  date  on  which the change takes place unless, in the 
meantime, a fresh licence has been taken from the Licensing Authority in 
the name of the firm with the changed constitution. 

1. Subs. by G.S.R 788(E), dt. 10-10-1985. 
2. Ins. by G.S.R. 462(E), dt. 22.6.1982. 
3. Subs. by G.S.R.231(E) dt. 4.6.1996. 
4. Added by Notfn. F. No. 1-10/62-D, dated 10.4.1964. 

1 [FORM 28B 

(See rule 76) 
2[Licence to manufacture for sale or for distribution of] drugs specified in 

Schedules C, C(I) and X 

No of  Licence………………………………………………………………………… 

1.       .............................................................. is  hereby  licensed  to  manufacture 
at  the premises situated at .................................................. the  following  drugs  specified 
in  Schedules C, C(I) and X to the Drugs and Cosmetics Rules, 1945. 

Name of  drugs……………………………………………… 
2.          Names of 3[competent technical staff] 

3.          The licence authorises the sale by way of wholesale dealing and storage for 
sale  by  the  licensee  of  the  drugs  manufactured  under  the  licence  subject  to  the 
conditions applicable to licence for sale. 

4.         The licence will be in force...................to .................................... 

5.         The licence is subject to conditions stated below and to other conditions as 
may  be specified in the rules for the time being in force under the Drugs and 
Cosmetics Act, 1940. 

Date:……… 

Signature…………. 
Designation………. 
4[*Licensing Authority/Central Licence Approving Authority]   

*Delete whichever is not applicable 

253 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
Conditions of Licence 

1.  The licence and any certificate of renewal in force shall be kept on the approved 
premises and shall be produced at the request of an Inspector appointed under the Drugs 
and Cosmetics Act, 1940. 

2.   If  the  licensee  wishes  to  undertake  during  the  currency  of  the  licence  
the  manufacture  of  any  drug  specified  in  Schedule  X  not  included  above,  he  should 
apply  to  the  Licensing  Authority  for  the  necessary  endorsement  as  provided    in  Rule 
75(4).  This licence will be deemed to be applicable to the items so endorsed. 

3.  Any  change  in  the  1[competent  technical  staff]  shall  be  forthwith  reported  to  
the Licensing Authority. 
4.    The  licensee  shall  inform the  Licensing Authority in  writing in  the  event  of  any 
change in the constitution of the  firm operating under licence.    Where any  change in 
the  constitution  of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be 
valid for  a maximum period of three months from the date on  which the  change takes 
place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing 
Authority in the name of the firm 
changed 
with 
constitution. 

the 

5. The  licensee  shall  furnish  to  the  Licensing  Authority  copies  of  the  invoices  

of sales made to dealers. 

6. The  licensee  shall  not  manufacture drugs  specified in  Schedule X  covered  by 

this licence for use as ―Physicians Samples‖.] 
__________________________________________________________________ 
1. Subs. by G.S.R. 462(E) dt. 22.6.1982. 
2. Subs. by G.S.R.788(E) dt. 10.10.1985. 
3. Subs. by G.S.R.231(E) dt. 4.6.1996. 
4. Subs. by G.S.R. 923(E) dt. 14.12.1992. 

1[FORM 28C 
(See rule 122-G) 

Licence to operate a Blood Bank for collection, storage and processing of whole 
human blood and/or* its components for sale or distribution 

l.  Number of licence................     date of issue ........................... at the premises 

situated at 
……………………………………………………………………………………. 

2.    M/s .......................................... is  hereby  licensed  to  collect,  store,  process  and 

distribute whole blood and/or its components. 

3.   Name(s) of the item(s) : 

1. 

2. 

4.   Name(s) of the Competent Technical Staff: 

1. 

2. 

3. 

5.                  The    licence    authorises    licensee    to    collect,    store,    distribute    and  
processing    of  whole  blood  and/or  blood  components  subject  to  the  conditions 
applicable to this licence. 

6.          The licence shall be in force from ................ …………….to..………….. 

7.         The  licence  shall  be  subject  to  the  conditions  stated  below  and  to  such  
other  conditions  as    may    be    specified    from    time    to    time    in    the    Rules    made  
under  Drugs  and Cosmetics Act, 1940. 

Dated: …… 

254 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Signature……………………… 

Name and Designation ............. 

*Licensing Authority/ 
*Central Licence Approving Authority 

* Delete whichever is not applicable 

Conditions of Licence 

1.          The  licensee  shall  neither  collect  blood  from  any  professional  donor  
or  paid donor    nor    shall    he    prepare    blood    components    from    the    blood   
collected    from such a donor. 

2.          The  licence  and  any  certificate  of  renewal  in  force  shall  be  displayed  
on   the  approved    premises    and    the    original    shall    be    produced   at    the   
request   of   an Inspector appointed under the Drugs and Cosmetics Act, 1940. 

3.          Any  change  in  the  technical  staff  shall  be  forthwith  reported  to  the 
Licensing 

Authority and/or Central Licence Approving Authority. 

4.          The  licensee  shall  inform  the  Licensing  Authority  and/or  Central  
Licence approving   Authority   in   writing   in   the   event   of   any   change   in   the   
constitution   of the   firm   operating   under   the   licence.   Where   any   change   in   
the      constitution      of      the  firm      takes     places,      the      current     licence     shall      be   
deemed   to   be   valid   for   maximum 
period    of    three    months    from    the    date    on    which    the    change    has    taken   
place unless,   in   the   meantime,   a   fresh   licence   has   been   taken   from   the   
Licensing Authority    and/or    Central    Licence    Approving    Authority    in    the   
name    of    the    firm with the changed constitution.] 

1.Ins. by G.S.R. 245(E), dt. 
5.4.1999. 

1[FORM 28D 
(See Rules 76) 

Licence to manufacture for saleor for distribution  of 2[Large Volume 

Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] specified in 
Schedules C and C(I) excluding those specified in Schedule X 
............................................... 
of 
Number 
issue………………………. 

licence 

date 

and 

of 

at................................................. 

1.      ................................. is  hereby  licensed  to  manufacture  at  the  premises 
situated 
  Volume  
the 
Parenterals/Sera  and  Vaccines/recombinant DNA (r-DNA) derived drugs] specified in 
Schedules  C  and  C(1)  excluding  those  specified  in  Schedule  X  to  the  Drugs  and 
Cosmetics Rules, 1945. 

following 

2[Large 

2.        Name(s) of drug(s).......................(each item to be separately specified). 
3.         Name(s) of competent technical staff: 

(a) responsible for manufacturing                          (b) responsible for testing 

1.                                                                          1. 
2.                                                                          2. 

4.         The licence authorises the sale by way of wholesale dealing and storage 
for sale 

255 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
by the licensee of the drugs manufactured under the licence, subject to the conditions 
applicable to licence for sale. 

5.                  The  licence  shall  be  in  force  from...................................................... to 
...................... 

6.          The  licence  shall  be  subject to  the  conditions stated below and  to 
such other 
conditions  as  shall  be  specified  in  the  rules  for  the  time  being  in  force  under  the 
Drugs and 
Cosmetics 
Act, 1940. 
Date:  ……..                                                                                               

Signature……… 

Designation…... 

* Delete whichever is not applicable 

*Licensing Authority/*Central Licence Approving Authority 

Conditions of Licence 
1.          The  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  
approved premises    and    shall    be    produced    at    the    request    of    an    Inspector   
appointed   under the Drugs and Cosmetics Act, 1940. 

2.       If  the  licensee  wishes  to  undertake  during  the  currency  of  the  licence  
to  manufacture  of  any  drug  specified  in  Schedule  C  and/or  C(I)  excluding  those 
specified    in  Schedule      X  not  included  above,  he  should  apply  to  the  Licensing 
Authority  and  or  Central Licence  Approving Authority for the  necessary endorsement 
as  provided  in  the  rules.  This licence  shall  be  deemed  to  extend  to  the  items  so 
endorsed. 

3.          Any  change  in  the  competent technical  staff  named in  the  licence  shall be 
forthwith reported to the Licensing  Authority and/or Central Licence Approving 
Authority.  

4.        The  licensee  shall  inform  the  licensing  authority  and/or  Central  Licence 
Approving Authority  in  writing  in  the  event  of  any  change  in  the  constitution of 
the  firm operating  under the licence.  Where any  change in the constitution of  the  firm 
takes  place,  the  current licnece  shall  be  deemed  to  be valid  for a  maximum period of 
three months from the date on which the change takes place unless, in the meantime, a 
fresh licence has been applied along with prescribed fee and necessary documents to the 
Licensing  Authority  and/or  Central  Licence  Approving  Authority  in  the  name  of  the 
firm with the changed constitution.] 
____________________________________________________________________ 
Ins. by G.S.R. 119(E), dt: 11.3.1 99 6. 
1. 
2.  Subs. By  G.S.R. 26(E), dt: 19.1.2006.  

1[FORM 28DA 
(See Rules 76A, 78A, 83AA) 

Loan licence to manufacture for sale or for distribution  of Large Volume 
Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding 
those specified in Schedule X 

Number 
of 
issue………………………. 

licence 

............................................... 

and 

date 

of 

1.       ................................. of …………………..is  hereby  granted  a loan license  to 
manufacture  o n  
the  premises  situated  at....................c/o.............................  the  
following drugs being   2[Large  Volume  Parenterals/Sera  and   Vaccines/recombinant 

256 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

DNA  (r-DNA)  derived  drugs]  specified  in  Schedules  C  and  C(1)  excluding  those 
specified in Schedule X to the Drugs and Cosmetics Rules, 1945. 
2.        Name(s) of drug(s).......................(each item to be separately specified). 
3.         Name(s) of competent technical staff: 

(a) responsible for manufacturing                          (b) responsible for testing 

1.                                                                                                                  1. 

2.                                                                                                                 2. 

4.   The licence authorises the sale by way of wholesale dealing and storage for 
sale by the licensee of the drugs manufactured under the licence, subject to the 
conditions applicable to licence for sale. 

5.    The  licence  shall  be  in  force  from......................................................  to 
...................... 

6.          The  licence  shall  be  subject to  the  conditions stated below and  to 
such other conditions as shall be specified in the rules for the time being in 
force under the Drugs and Cosmetics Act, 1940. 

Date:  ……..                                                                                             

Signature……… 

Designation…... 

* Delete whichever is not applicable 

*Licensing Authority/*Central Licence Approving Authority 

Conditions of Licence 

1.          The  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the  
approved premises    and    shall    be    produced    at    the    request    of    an    Inspector   
appointed   under the Drugs and Cosmetics Act, 1940. 

2.       If  the  licensee  wishes  to  undertake  during  the  currency  of  the  licence  
to  manufacture  of  any  drug  specified  in  Schedule  C  and/or  C(I)  excluding  those 
specified    in  Schedule      X  not  included  above,  he  should  apply  to  the  Licensing 
Authority  and  or  Central Licence  Approving Authority for the  necessary endorsement 
as  provided  in  the  rules.  This licence  shall  be  deemed  to  extend  to  the  items  so 
endorsed. 

3.          Any  change  in  the  competent technical  staff  named in  the  licence  shall be 
forthwith reported to the Licensing  Authority and/or Central Licence Approving 
Authority.  

4.        The  licensee  shall  inform  the  licensing  authority  and/or  Central  Licence 
Approving Authority  in  writing  in  the  event  of  any  change  in  the  constitution of 
the  firm operating  under the licence.  Where any  change in the constitution of  the  firm 
takes  place,  the  current licnece  shall  be  deemed  to  be valid  for a  maximum period of 
three months from the date on which the change takes place unless, in the meantime, a 
fresh licence has been applied along with prescribed fee and necessary documents to the 
Licensing  Authority  and/or  Central  Licence  Approving  Authority  in  the  name  of  the 
firm with the changed constitution.] 
____________________________________________________________________ 
1. Ins. by G.S.R. 574(E), dt: 17.7.2012. 

1 [FORM 28E 

(See rule 122 G) 

Licence to manufacture and store blood products for sale or distribution. 

l.      Number of licence ............ date of issue ................................ at the premises 

situated at………………………………….................................................................... 

257 

 
 
 
 
 
 
 
 
 
 
2.      M/s ........................................ is  hereby  licensed  to  manufacture, store,  sell  or 

Drugs and Cosmetics Rules 1945 

distribute the following blood products:- 

3.  Name(s) of the item(s) : 

1. 
2. 

3. 

4.  Name(s) of the competent technical staff: 

(a) responsible for manufacturing 

(b) responsible for testing 

1. 

2. 

3. 

1. 

2. 

3. 

5.    The  licence  authorises  licensee  to  manufacture,  store,  sell  or  distribute  

the blood products, subject to the conditions applicable to this licence. 

6.  The licence shall be in force from ................ to........................ 

7. The   licence    shall   be   subject   to   the   conditions  stated   below    and   to   such  
other conditions  as  may  be  specified  from  time  to  time  in  the  rules  made  under  
Drugs  and Cosmetics Act, 1940. 

Dated.: ........                                                                            Signature.......... 
……………….. 

*Licensing Authority/ *Central Licence Approving Authority 

Name and Designation .. 
………. 

* Delete whichever is not applicable 

Conditions of License 

1.  The   licensee   shall   not   manufacture   blood   products   from   the   blood   drawn  
from any professional donor or paid donor. 

2.   The  licence  and  any  certificate  of  renewal  in  force  shall  be  displayed  on  
the approved      premises      and      shall      be      produced      at      the      request      
of      an Inspector appointed under the Drugs and Cosmetics Act, 1940. 

3.      Any    change    in    the    technical    staff    shall    be    forthwith    reported    to    the  
Licensing Authority and/or Central Licence Approving Authority. 

4.     The   licensee    shall    inform   the    Licensing   Authority   and/or    Central   
Licence Approving    Authority    in    writing    any    change    in    the    constitution   
of    the    firm operating   under   the   licence.         In   the   event   of   any   change  
in   the   constitution   of the    firm,    the    licence    shall    be    deemed    to    be    
valid    for    a    period    of    three months   from   the   date   on   which   the   change   
takes    place    unless,    in    the    meantime, a    fresh    licence    has    been    taken   
from    the    Licensing    Authority    and/or    Central Licence    Ap provin g    Auth 
ority       in    the    name    of    the    firm    with    the    ch anged constitution.] 
_  
1. Ins. by G.S.R. 245(E), dt. 5.4.1999. 

1 [FORM 28F 

(See rules 122 F to 122-I, 122K, 122P) 

Licence To Collect, Process, Test, Store, Banking And Release Of Umbilical 
Cord Blood Stem Cells. 

258 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

l.      Number of licence ............ date of issue ................................ at the premises 

situated at………………………………….................................................................... 

2.      M/s ........................................ is  hereby  licensed  to  collect, process, test, store, 

banking and release of umbilical cord blood stem cells. 

3.  Name(s) of competent technical staff : 

1. 
2. 

3. 
4. 

4.   The   licence   authorises  licensee  to   collect, process, test, store, banking and 

release of umbilical cord blood stem cells. 

5.    The licence shall be in force from ................ to........................ 

6.   The  licence   shall  be  subject  to   the  conditions  stated   below  and  to   such  
other conditions  as  may  be  specified  from  time  to  time  in  the  rules  made  under  
Drugs  and Cosmetics Act, 1940. 

Dated.: ........                                                                            Signature.......... 
……………….. 

*Licensing Authority/ *Central Licence Approving Authority 

Name and Designation .. 
………. 

* Delete whichever is not applicable 

Conditions of License 

1.  Umbilical  cord  blood  specific  for  an  individual  will  be  collected  after  signing  an 
agreement  with  the  parent(s),  whose  child‘s  umbilical  cord  blood  is  to  be  collected, 
and the cord blood bank. 

2.  Umbilical  cord  blood  shall  be  collected  from  hospitals,  nursing  homes,  birthing 
centres  and  from  any  other  place  where  a  consenting  mother  delivers,  under  the 
supervision  of  the  qualified  Registered  Medical  Practitioner  responsible  for  the 
delivery. 

3. The licence and any certificate of renewal in force shall be displayed on  the approved 
premises and the original shall be produced at the request of an inspector appointed under 
the Drugs and Cosmetics Act, 1940.          

4 . Any    change    in    the    technical    staff    shall    be    forthwith    reported    to    the  
Licensing Authority and/or Central Licence Approving Authority. 

5.  The      licensee      shall      inform    the      Licensing      Authority    and/or      Central   
Licence Approving    Authority    in    writing    any    change    in    the    constitution   
of    the    firm operating   under   the   licence.         In   the   event   of   any   change  
in   the   constitution   of the    firm,    the    licence    shall    be    deemed    to    be    
valid    for    a    period    of    three months   from   the   date   on   which   the   change   
takes    place    unless,    in    the    meantime, a    fresh    licence    has    been    taken   
from    the    Licensing    Authority    and/or    Central Licence    Ap provin g    Auth 
ority       in    the    name    of    the    firm    with    the    ch anged constitution.] 
_  
1. Ins. by G.S.R. 889(E), dt. 27.12.2011. 

FORM 29 

(See rule 89) 

Licence to manufacture drugs for purposes of examination, test or analysis 

259 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
1. …......................of………………… is       hereby        licensed       to  

manufacture   the   drugs specified   below for   purposes   of examination,  test  or  
analysis at……………………………… 

2. This  licence  is  subject  to  the  conditions  prescribed  in  Part  VIII  of  the 
Drugs  and Cosmetics Rules, 1945. 

3. This licence shall be in force for one year from date specified below. 

Names of drugs 

Date  :  ………                                                                        Licensing 
Authority……………… 

FORM 30 

(See rule 90) 

Application for licence to manufacture drugs for purposes of examination, test 
or analysis 

1.    …………………………………….of .............. …………………by occupation 

..................... hereby apply for licence to manufacture the drugs specified below for 

purposes of examination, test or analysis at and I undertake to comply with the 

conditions applicable to the licence. 

Names of Drugs 

Date.........................................                                                         
Signature………………….. 

1[FORM 31 

(See rule 139) 

Application for grant or renewal of a 2[licence to manufacture cosmetics for sale or  for 
Distribution] 

1 . 1 /  We......................................... of. ........................ hereby apply for grant 

/renewal of a licence to manufacture on the premises situated at.......... the following 
cosmetics :- 

2. Names of Cosmetics ...................................................................... 

3.   Names, qualifications and experience of technical staff employed for 

manufacture and testing .......................................................... ……… 

4. A fee of rupees  ...........................................has  been  credited  to 

Government  under the head of account........................................................ 

Date......................................                                                                 Signature………….. 
Note:  The application should be accompanied by a plan of the premises. 

1. Added by Notfn No.F.1-36/64-D (G.S.R.1183), dt:17.8.1964. 
2.  Subs.  by  G..S.R .788 (E), dt. 10.10.1985. 

1[FORM  31A 
(See rule138A) 
Application for grant or renewal of loan 2[licence to manufacture cosmetics for sale or 
for distribution] 

260 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.        I  /  W e  ...............................................of. .............................hereby         apply         

for grant/r enewal  of   a   loan   licence   to   ma nufacture  co smetics   for  sale   on  
the    premises  s  i  t  u  at  e  d  at………………………….C/o  ..............……………….the 
following cosmetics :— 

2.         Names of Cosmetics.............................................................. 

3.  The  names,  qualifications and  experience  of the  expert  shall  actually  connected 

with  the manufacture and testing of the specified products in the manufacturing 
premises. 

4. I /We enclose− 

(a)   A  true  copy  of  a  letter  from  me  /  us  to  the  manufacturing concern 

whose manufacturing capacity is intended to be utilized by me / us. 

(b)   A true copy of a letter from the *manufacturing concern that they agree to 
lend  the  services  of  their  competent  technical  staff,  equipment  and  premises  for 
the manufacture of each item required by me / us and that they will analyse every 
batch  of  and  maintain  the  registers  of  raw  materials  ,  finished  products  and 
reports of  analysis   separately in  this behalf. 

(c)    specimen of labels, cartons of the products proposed to be manufactured. 

5. A fee of rupees ......................................................... has  been  credited  to 

Government  under the head of account.......................................................... 

Date………….                                                                                         Signature………… 

*Enter here the name and address of the manufacturing concern where the manufacture 
will be actually carried out and also their licence number. 

1. Ins. by G.S.R. 444, dt. 28-4-1973. 
2.  Subs. by G.S.R. 788(E), dt. 10.10.1985. 

1[FORM  32 
(See rule140) 

2[Licence to manufacture cosmetics for sale or for distribution] 

Number of Licence and date of issue 

1  ...…………………is    hereby    licensed   to    manufacture    on   the   premises   
situated at 

........................................... the   following   cosmetics   under   the   supervision  of   the  
following technical  staff:- 

(a) Names of cosmetics. 

(b) Names of technical staff 

2. The licence shall remain in force from…………..to…………(both days inclusives) 

3. The licence is subject to the conditions stated below and to such other conditions 

as may be specified in the Drugs and Cosmetics Rules, 1945. 

Date..........................................                                                          Signature .............. 

Designation ............ 

Conditions of 
Licence 
1.    This   licence   and   any   certificate   of   renewal   in   force  shall  be   kept   on   the  
approved  premises    and    shall    be    produced    at    the    request    of    an    Inspector  
appointed   under   the Drugs and Cosmetics Act, 1940. 

261 

 
 
 
 
 
 
 
 
 
 
 
 
2.    Any      change      in      the      technical      staff      shall      be      forthwith     
reported      to the Licensing Authority. 

Drugs and Cosmetics Rules 1945 

3.    If  the  licensee  wants  to  manufacture  for  sale  of  additional  items  he  should  
apply  to the   Licensing   Authority   for   the   necessary   endorsement   to   the   licence  
as   provided   in rule 138 (3). This licence shall be deemed to extend to the cosmetics so 
endorsed. 
3[4.  The  licensee  shall  inform  the  Licensing  Authority  in  writing  in  the  event  of  any 
change  in the  constitution of  the  firm  operating  under  the  licence. Where  any  change 
in  the  constitution of  the  firm  takes  place,  the  current  licence  shall  be  deemed  to  be 
valid  for  a  maximum  period of  three  months from the  date  on  which the  change takes 
place  unless,  in  the  meantime,  a  fresh  licence  has  been  taken  from  the  Licensing 
Authority in the name of the firm with the changed constitution.] 

1.  Added by Notfn No.F.1-36/64-D, dt:17.8.1964. 
2. Subs.  by G.S.R. 788 (E), dt.  10.10.1985. 
3.  Added by S.O. 903, dt. 10-2-1976. 

1[FORM 32A 

(See rule 139B) 
Loan 2[licence to manufacture cosmetics for sale or for distribution] 

1.      Number of Licence and date of issue………………………… 

2 .     ................................................of. ............................................. is  hereby  granted 
a  loan  licence  to    manufacture the    following    cosmetics    on  the    premises   situated 
the  
at..............................................................C/o............................................ 
direction  and personal supervision of the following technical staff: 

under 

(a)  Names of technical staff.  

(b) Names of cosmetics. 

3.      The licence shall remain in force from ........................... to .................. 

4.          The  licence  is  subject  to  the  conditions  stated  below  and  to  such  other 
conditions  as are specified in the rules for the time  being in force under the Drugs and 
Cosmetics Act, 1940. 

Date....................................                                                      Signature .................. 

Designation .............. 

Conditions of 
Licence 

1.      This  licence  and  any  certificate  of  renewal  in  force  shall  be  kept  on  the 
approved  premises    and    shall    be    produced    at    the    request    of    an    Inspector  
appointed   under   the Drugs and Cosmetics Act, 1940. 

2.    Any  change  in  the  technical  staff  shall  be  forthwith  reported  to  the  
Licensing Authority. 

3.  If  the licensee wants to  manufacture for  sale additional items  he  should apply to 
the Licensing   Authority   for   the   necessary   endorsement   to    the   licence    as   
provided   in rule    138A(5).This    licence    shall    be    deemed    to    extend    to    
the    cosmetics    so endorsed.] 
____________________________________________________________________ 
1. Ins. by  G.S.R. 444, dt. 28-4-1973. 
2. Ins. by G.S.R. 788 (E), dt. 10.10.1985. 

1[FORM 33 
(See rule 141) 

Certificate of renewal of  licence to manufacture cosmetics for sale 

262 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.   Certified  that  licence No………………….granted on  the………………………. 

to………………………f or  th e  ma nu factu re  fo r  sale  o f  the  fo llowin g  cosmetics   
at       the premises  situated  at……………………has  been  renewed 
from……………and shall expire on…………………………… 

2.   Names of cosmetics. 

3.  Names of technical staff 

Date……………..                                                                               Signature…………….. 

_____________________________________________________________________________________ 
1. Ins. by G.S.R. 1183, dt. 17.8.1964. 

Designation……………] 

1[FORM 33A 

(See rule 141-A) 

Certificate of renewal of loan licence to manufacture cosmetic for sale 

1.      Certified   that    loan    licence    No………….granted on the ……………….. 
.  to……………………for    the        manufacture      for      sale        of  the        following 
cosmetics      at  the  premises  situated  at  C/o………………………………………has 
been  renewed from…………………………………to ....................................................... 

2.   Names of cosmetics. 

3.   Names of technical staff. 

Date………                                                                                            Signature……….. 

Designation………] 

1.  Added by G.S.R. 444, dt. 28-4-1973. 

1[FORM 34 
(See rules 131 and 150) 

Certificate of test or analysis of cosmetic by the Central Drugs Laboratory or the 
Government Analyst 

1.    Name of the officer or Inspector from whom received ........................................ 
2.   Serial number and date of the Officer's  /  Inspector's memorandum .................. 
3.   Number of sample .................................................... 
4.   Date of receipt ........................................................ 
5.   Name of the Cosmetic purporting  to  be contained in  the sample…………. 
6.   Condition of seals on the 2[packet or on portion of sample or container] 

7.   Results of test or analysis :— The sample of cosmetics— 

(a)  contains a prescribed colour only/does not contain a prescribed colour. 

(b) does not contain harmful ingredients/ contains harmful ingredients 

(c) conforms/does not conform to claims m,ade on the label as to the nature and quality 

of the cosmetics. 

3[(d) contains not more than …………….parts per million of Lead and ………..parts 
per million of Arsenic……………../contains more than ………………parts per 
million of Lead and ………parts per million of Arsenic.] 

Date…… 

Director………………….. 
Central Drugs Laboratoy/Government Analyst] 

263 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1. Added by Notfn No.F.1-36/64-D (G.S.R 1183), dt:17.8.1964. 
2. Subs. by G.S.R. 59(E), dt.  7.2.1995. 
3. Subs. by G.S.R. 510(E), dt. 26.7.1982. 

1[FORM  35 

2[See Rules 65, 67-G, 74, 74A, 74B, 78, 78A, 85H, 122P, 142, 142-B, 
150E, 158 and 158A] 

Form in which the Inspection Book shall be maintained 

(A) The cover of the Inspection Book shall contain the following particulars, namely :— 

1.    The name and address of the licensee.......................................................... 

2.    Licence number and the date upto which the licence is valid ............................. 

(B)  (i) The pages of the Inspection Book shall be  serially numbered and duly 

stamped by  the Licensing  Authority.  The  pages,  other  than  the  first  and  the  last 

pages,  shall  have  the following particulars:-- 

Name and designation of the Inspector who inspects the premises of the licensee:− 

Date of Inspection........................  

Observations of the Inspector ................. 

(ii) The first and last pages of the Inspection Book shall be endorsed by the Licensing 

Authority with the following words, namely:— 

Inspection Book maintained by M/s……………………………………………… 

situated at ………… for licence number ………… in Form ……….. under the 
Drugs and Cosmetics Rules, 1945. 

Signature of the Inspector 

Seal and Signature of the Licensing Authority. 

Notes:-  
(i) Printed copy of the Inspection Book may be obtained by the licensee from   the 
Licensing Authority on payment. 

(ii) The Inspection Book shall be maintained at the premises of the licensee. 

(iii)  The  observations  made  by  the  Drug  Inspector  shall  be  in  triplicate.      The 
original  copy  shall  be  retained  in  the  Inspection  Book  to  be  maintained  in  the 
premises  of  the  licensee.  The  duplicate  copy  shall  be  sent  to  the  Licensing 
Authority. The triplicate copy shall be taken as record by the Inspector. 

1. Added by  Notfn. No.F.1-14/68-D (G.S.R. 3869), dt. 26.10.1968. 
2. Subs. by  G.S.R. 592(E), dt: 13.8.2008. 

1[FORM 36 
(See rule 150B) 

Application for grant or renewal of approval for carrying out tests on drugs/ 
cosmetics or raw materials used in the manufacture thereof on behalf of licensees 
for manufacture for sale of drugs /cosmetics 

(1)  *I/We………………………………….of………………………….hereby  apply 
for the  grant  or  renewal  of  approval    for  carrying  out  tests  of  identity,  purity,  
quality  and  strength  on  the  following  categories  of  drugs  /  items  of  cosmetics  or 

264 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
raw  materials  used  in the  manufacture  thereof on  behalf of licensees for manufacture 
for sale of drugs / cosmetics. 

Drugs and Cosmetics Rules 1945 

(2)      *Categories of drugs, items of cosmetics: 

(a)        Drugs other than those specified in Schedules C and C (1) and also  
excluding Homoeopathic Drugs:- 

1.    Crude vegetable drugs. 

2.    Mechanical contraceptives. 

3.    Surgical dressings. 
4.    Drugs requiring the use of ultravoilet / 

Infra Red. or Chromatography. 

5.    Disinfectants. 

6.    Other drugs. 

(b)         Drugs specified in Schedules C and C (1):— 

1.    Sera, Vaccines,  Antigens, Toxins, Antitoxins,  

Toxoids, Bacteriophages and similar 
Immunological Products. 

2.   Antibiotics. 

3.   Vitamins 

4.   Parenteral preparations. 

5.   Sterilized surgical ligature / suture. 

6.   Drugs requiring the use of animals for their test. 

7.   Drugs requiring microbiological tests. 

8.    Drugs requiring the use of Ultravoilet/ Infra Red/ Spectrophotomete 
or Chromatography. 

9.    Other drugs. 

(c)        Homoeopathic drugs.  

(d)       Cosmetics. 

(3)        Name,  qualifications  and  experience  of  expert  staff  employed for  testing 

and the person-in-charge of testing. 

(4)       List of testing equipments 
provided. 

(5)       *I/We enclose a plan of the testing premises showing the location and area 

of the different sections thereof. 

(6)      An inspection fee of rupees ........................................................has  been  
credited  to Government under the Head of Account................................................... 

Date..........................                                                                                 Signature………] 

* Delete whichever is not applicable 

1. 

Ins. by  Notfn. No .X. 11014/7/76-D&MS (G.S.R 1172), dt. 23-8-1977. 

1[FORM 37 

(See rule 150C) 

Approval for carrying out tests on drugs / cosmetics and raw materials used in their 
manufacture on behalf of licensees for manufacture for sale of drugs /cosmetics 

Number of approval and date of issue:………………………… 

265 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(1)  Approval  is  hereby  granted  to ............................................................... …….for 
carrying out tests for identity, purity, quality  and  strength on  the  following categories 
of drugs/items of cosm etic s   a n d  the  ra w  m a terials   use d  in  the  m a nufac ture  
thereof  on  the  pre m ise s situated .......................................................................... 

Categories of drugs / items of cosmetics 
………………………….. 
………………………….. 
………………………….. 

 (2)  Names   of   2[competent  technical  staff]  employed  for  testing   and   the  

person-in- charge of testing. 

(3) The approval shall be in force from ......................................... to........................ 

(4)  The  approval  is  subject  to  the  conditions  stated  below  and  such  other 

conditions  as may be specified in the rules for the time being in force under the Act. 

Date.....................................                                         Signature ................................... 

Designation ................................ 

Conditions of 
Approval 

(1)  This  approval  and  any  certificate  of  renewal  in  Form  38  shall  be  kept  in  the 
approved  premises  and  shall  be  produced  at  the  request  of  the  Inspectors  appointed 
under the Act. 

(2)  If the approved institution wishes to undertake during the currency of the 
approval the testing of any other category of drugs or items of cosmetics it should 
apply  to the approving authority for necessary endorsement as provided in rule 
150-B.This approval will be deemed to extend to the item so endorsed. 

(3)  Any  change  in  the  analytical  staff  or  in  the  person-in-charge  of  the  testing 

shall be forthwith reported to the approving authority. 

3[(4)  The  approved institution shall  inform the  approving authority in  writing in  the 
event  of  any  change  of  the  constitution  of  the  institution  operating  under  this  Form. 
Where any change in the constitution of the institution takes place, the current approval 
shall  be  deemed  to  be  valid  for  a  maximum  period  of  three  months  from  the  date  on 
which  the  change takes  place  unless in  the  meantime, a  fresh  approval  has been taken 
from  the  approving  authority  in  the  name  of  the  institution  with  the  changed 
constitution.] 

1.Ins. by G.S.R.1172, dt:23.8.1977. 
2. Subs. by. G.S.R. 231(E), dt. 4.6.1996. 
3. Ins. by G.S.R. 681 (E), dt. 5-12-1980. 

1[FORM 38 
(See rule 150J) 

Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw 
materials used in the manufacture thereof on behalf of licensees for manufacture for 
sale of drugs / cosmetics 

(1) Certified that  approval number .................................. granted  on the 

..............................................................................................  for  carrying  out 
tests  of  
identity,  purity,  quality  and  strength  on  the  following  categories  of  drugs/  items  
of cosmetics and the raw materials used in the manufacture  thereof  at  the  premises 
situated at…………………………has been  renewed from…………….to ................... 

            Categories of drugs/items of cosmetics 

……………………….. 

               …………………………… 

266 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
(2) Names of 2[competent technical staff] and person-in-charge of testing. 

Date ...............................                                                            Signature.......………. 

Designation………….. 

________________________________________________________________________ 

1. Ins. By G.S.R. 1172, dt:23.8.1977. 
2.Subs. by. G.S.R.231(E) ,dt. 4.6.1996. 

1[FORM 39 
[See rule150E(f)] 

Report of test or analysis by approved institution 

(1)    Name     of     manufacturer    from  whom    sample     received  together  
with     his manufacturing licence number under the Act and under the rules 
made thereunder. 

(2)    Reference  number  and  date  of  the  letter  from  the  manufacturer  under 

which  the sample was forwarded. 

(3)    Date of receipt of the sample. 

(4)    Name of drug / cosmetics / raw material purporting to be contained in the 

sample. 

(5)    Details  of  raw  material/final  product  in  bulk/final  product  (in  finished  

pack)*  as obtained from the manufacturer: 

(a)    Original  manufacturer's  name  in  the  case  of  raw  materials  

and  drugs repacked. 

(b)  Batch number. 
2[(c) Batch size as represented by sample.]  

(d) Date of manufacture, if any. 

(e) Date of expiry, if any. 

(6) Results of test or analysis with protocols of test or analysis applied. 

In  the  opinion  of  the   undersigned,  the  sample  referred  to   above  is   *of  
standard  quality/is  not  of  standard  quality  as  defined  in  the  Act  and  the  rules  made 
thereunder for the reasons given below. 

Date..................................                                             ...................................................... 

Signature of Person-in-charge of 
testing 

Note:- Final product includes repacked material. 

*Delete whichever is not applicable 
1. Ins. By G.S.R. 1172, dt:23.8.1977. 
2. Subs. by. G.S.R. 681(E), dt. 6.6.1988. 

1[Forms 40 to 43 

(Pertaining  to  Ayurveda,  Siddha  and  Unani  drugs  replaced  by  Forms  Nos 
.47 to 50.) 

[1. Ins.  by G.S.R. 701(E), dt. 27.9.2001 ] 

1[FORM  40 
(See rule 24-A) 

Application for issue of Registration Certificate  for import of drugs into India under 
the Drugs and Cosmetics Rules 1945 

267 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

I/We* ……………………………… (Name  and   full  address)  hereby  apply   for  the  
grant  of Registration  Certificate  for the  manufacturer, M/s……….……. (full address with 
telephone, fax and E-mail address of the foreign manufacturer) for his premises, and 
manufactured drugs meant for import into India. 

1.        Names of drugs for registration. 
2[***] 
2.     I/We enclose herewith the information and undertakings specified in Schedule 

D  (1) and     Schedule     D(II)     duly     signed     by     the     manufacturer     for     
grant     of Registration Certificate for the premises stated below. 

3.      A  fee  of_______________for  registration  of  premises,  the  particulars 
of w hich are  g iv en  belo w,    o f  the  man u factu rer  h as    b een    cred ited  to  th e 
Government under the Head of Account "0210-Medical and Public Health, 04-Public 
Health,  104-Fees  and  Fines‖  under  the  Drugs  and  Cosmetics  Rules,  1945-Central vide 
Challan No.________ dated__________________(attached in original). 

4.              A    fee    of__________________for    registration    of    the    drugs    for  
import   as specified  at  Serial  No.  2  above  has  been  credited  to  the  Government 
under  the    Head    of  Account  "0210-Medical  and  Public  Health,  04-Public  Health, 
104-Fees  and  Fines"  under  the  Drugs    and    Cosmetics    Rules,    1945-Central    vide  
Challan  No._______,  dated___________. (attached in original). 

5.         Particulars of premises to be registered where manufacture is 

carried on: Address (es)………………..  

Telephone No……………….. 

  Fax……………………………         

  E-mail……………………….  

I/We*   undertake   to   comply   with   all   terms   and   conditions   required   to  
obtain Registration Certificate and to keep it valid during its validity period. 

Place:  

Date:  

Signature 
 Name  
Designation ____________________ 
Seal/Stamp of manufacturer or his authorised Agent 
in India. 

(Note:  In case the applicant is an authorised agent of the manufacturer in India, the Power of 
Attorney is to be enclosed). 

*Delete whichever is not applicable. 
__________________________________________________________________ 
1.  Ins. by   G.S.R.  604(E) dt. 24-8-2001 (w.e.f. 1-1-2003). 
2. Figures 1,2,3 omitted by G.S.R. 35(E), dt. 20.1.2005. 

1[FORM 41  

(See rule 27 A) 

Registration 

Certificate 

Registration Certificate to be issued for import of drugs into India under Drugs 
and Cosmetics Rules, 1945 

Registration Certificate No………….                                            Date……  

268 

 
 
 
 
 
 
 
  
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

M/s ___________________________________ (Name and full address of registered 
office) having   factory   premises  at……..(full  address)  has  been  registered  under 
rule  27-A  as  a manufacturer and is hereby issued this Registration Certificate. 

2.          Name (s) of drugs which may be imported under this Registration Certificate: 

2[***] 

3.     This      Registration      Certificate      shall      be      in      force      from      
__________ to_unless it is sooner suspended or cancelled under the rules. 

4.      This Registration Certificate is issued through the office of the manufacturer 

or  his  authorised  agent  in  India  M/s    (name  and  full   address)________  who  
will   be responsib le  for th e  business activities  of  th e  manufacturer, in India in all 
respects. 

5.      This   Registration   Certificate   is   subject   to   the   conditions,   stated   below  
and   to such    other    conditions   as    may    be    specified    in    the    Act    and    the   
rules,   from   time to time. 

Place………. 
Date…………. 

Licensing Authority 
Seal/Stamp 

Conditions of the Registration Certificate. 

1.    The  Registration  Certificate  shall  be  displayed  at  a  prominent  place  by  the 

authorised agent. 

2.      No drug shall be registered unless it has a free sale approval in the country of 

origin, and/or in other major countries. 

3.    The  manufacturer  or  his  authorised  agent  in  India  shall  comply  with  the 
conditions of      the      import      licence      issued      under      the      Drugs      and     
Cosmetics      Rules, 1945. 

4.    The  manufacturer  or  his  authorised  agent  in  India  shall  inform  the  licensing 
authority forthwith  in  the  event  of  any  administrative  action  taken  due  to  adverse    
reaction,  viz.  market  withdrawal, 
restrictions,  or  cancellation  of   
regulatory 
authorization,   and/or   not   of   standard   quality   report   of   any   drug pertaining    
to     this     Registration    Certificate     declared  by  the  Regulatory     Authority of   the   
country   of   origin or by any Regulatory Authority of any other country, where the drug 
is marketed/sold or distributed. 

The  dispatch  and  marketing  of  the  drug  in  such  cases  shall  be  stopped 
immediately,  and  the  licensing  authority  shall  be  informed  immediately.  Further 
action  in  respect  of  such  stopped  marketing  of  drug  shall  be  followed  as  per  the 
direction of  the  licensing authority. In such  cases,  action  equivalent  to  that  taken  with 
reference to  the  concerned drug in  the  country of origin or in the  country of  marketing 
shall  be  followed  in  India  also,  in  consultation  with  the  licensing  authority.    The 
licensing  authority  may,  however,  direct  any  further  modification to  this  course  of 
action,  including  the  withdrawal  of  the  drug  from  Indian  market  within  48  hours 
time period. 

5.   The  manufacturer or  his  authorised  agent  in  India  shall  inform  the  licensing 
authority within 30 days in writing in the event of any change in manufacturing process, 
or in packaging, or  in  labelling  or  in  testing,  or  in  documentation  of  any  of  the 
drugs    pertaining  to  this Registration Certificate. 

In  such  cases,  where  there  shall  be  any  major  change/modification  in 
manufacturing, or in processing or in testing, or in documentation as the case may be, 
at  the  discretion  of  the licensing  authority,  the  manufacturer or  his  authorised  agent  in 

269 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

India  shall  obtain  necessary  approval  within  30  days  by  submitting  a  separate 
application along  with  the  registration fee,  as specified in clause (ii) of sub-rule (3) of 
rule 24-A. 

6.         The   manufacturer   or    his    authorised    agent    in    India    shall    inform    the  
licensing  authority  immediately  in  writing  in  the  event  of  any  change  in  the 
constitution of the firm and / or  address  of  the  registered  office  /  factory  premises  
operating    under    this    Registration  Certificate.  Where  any  such  change  in  the 
constitution  of  the  firm  and/or address takes  place,  the  current  Registration  Certificate 
shall  be  deemed  to  be  valid  for  a  maximum  period  of  three months from the  date  
on which   the   change   has   taken   place    unless,   in   the    meantime,   a    fresh   
Registration Certificate   has   been   taken   from   the   licensing   authority   in   the   
name   of   the   firm with    the    changed    constitution    of    the    firm    and/or    
changed    address    of    the registered office or factory premises.] 
1.  Ins. by G.S.R. No.604(E), dt. 24-8-2001 (w.e.f. 1-1-2003) 
2. Figures 1,2,3 omitted by G.S.R. 32, dt. 20.1.2005. 

1[FORM  42 
(See rule 129A) 

Application for issue of Registration Certificate  for import of cosmetics into India 
under the Drugs and Cosmetics Rules, 1945 
I/We* ……………………………… (Name  and   full  address)  hereby  apply   for  the  
grant  of Registration  Certificate  for the  manufacturer, M/s……….……. (full address with 
telephone, fax and E-mail address of the foreign manufacturer) for his premises, and 
manufactured cosmetics meant for import into India. 

1. Name of cosmetics along with their brand name and pack size(s) and variants for 

registration.  

(1) ……………… 
(2)………………. 
(3)………………. 

                                                    (4)……………….. 
                                                    (5)……………….. 
                                                    (6)………………... 

2.        I/We*  enclose  herewith  the  information  and  undertakings  specified  in 
Schedule D  (III) duly signed by the manufacturer for grant of Registration Certificate 
for the premises stated below. 

3.          A  fee  of_______________for  registration  of  c o s m e t i c s   f o r   i m p o r t  
a s   s p e c i f i e d   a t   s e r i a l   n o .   2   a b o v e   h a s   b een      cred ited  to  th e  C e n t r a l  
Government under the Head of Account "0210-Medical and Public Health, 04-Public 
Health,  104-Fees  and  Fines‖  under  the  Drugs  and  Cosmetics  Rules,  1945-Central vide 
Challan No.________ dated__________________(attached in original). 

4.     Particulars of premises to be registered where manufacture is carried on:  

Address (es)………………..  
  Telephone No……………….. 

  Fax………………..      

  E-mail……………………….  

I/We*   undertake   to   comply   with   all   terms   and   conditions   required   to  
obtain Registration Certificate and to keep it valid during its validity period. 

Place:……. 

Date:…….. 

Signature……………..  
 Name………………… 
Designation…………. 
Seal/Stamp of manufacturer or his authorised Agent in India. 

270 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
(Note:  In case the applicant is an authorised agent of the manufacturer in India, the Power of 
Attorney is to be enclosed). 

*Delete whichever is not applicable. 
__________________________________________________________________ 
1.  Ins. by   G.S.R.  4 2 6 (E) dt. 19-5-2010, read with corrigendum G.S.R263(E) dt:30.3.2011, corrigendum G.S.R. 
733(E) dt:29.9.2011, corrigendum G.S.R.270(E) dt:30.3.2012 and corrigendum G.S.R. 733(E) dt:29.9.2012.  

1[FORM 43  

(See rule 129C)  

Registration Certificate 

Registration Certificate to be issued for import of cosmetics into India under 
Drugs and Cosmetics Rules, 1945 

Registration Certificate No………….                                            Date……………..…  

M/s ___________________________________ (Name and full address of registered 
office)…………….having   factory   premises  at  … … … … . . ( full  address)  has  been 
registered  under  rule  1 2 9 A  as  a manufacturer and is hereby issued this 
Registration Certificate. 

2.          Name (s) of cosmetics, along with thrir brand names and pack size(s) and variants 
which may be imported under this Registration Certificate: 

(1)…………………… 
(2)…………………… 
(3)…………………… 

3.     This      Registration      Certificate      shall      be      in      force      from …… 
to…………..unless it is sooner suspended or cancelled under the rules. 

4.      This Registration Certificate is issued through the office of the manufacturer or  
his  authorised  agent or importer in India or by the subsidiary in India authorized by 
the manufacturer, namely.-M/s (name  and  full   address)________  who shall  be 
responsib le  for  th e  business activities  of  th e  manufacturer, in India in all 
respects. 
5.      This   Registration   Certificate   is   subject   to   the   conditions,   stated   below  
and    to  such     other      conditions      as      may      be     specified     in     the      Drugs  and 
Cosmetics Act, 1940 and the rules made thereunder, from time to time in this regard.. 

Place………. 
Date…………. 

Conditions of the Registration Certificate. 

Licensing Authority 
Seal/Stamp 

1. 

  The  Registration  Certificate  shall  be  produced  by 

the  authorised 
importer/distributor/agent  as  and  when  required  by  the  licensing  authority/regulatory 
authority. 

2.    The  manufacturer  or  his  authorised  importer/distributor/agent  in  India  shall 
inform  the  licensing  authority  forthwith  in  the  event  of  any  administrative  action 
taken  namely,  market  withdrawal,  regulatory  restrictions,  or  cancellation      of   
authorization,      and/or      not      of      standard      quality      report      of      any      cosmetic 
pertaining     to     this     Registration     Certificate     declared     by     the     Regulatory    
Authority of   the   country   of   origin   or   by   any   Regulatory   Authority   of   any   
other   country, where the cosmetic is marketed/sold or distributed. 

The  dispatch  and  marketing  of  the  cosmeti c   in  such  cases  shall  be  stopped 
immediately,  and  the  licensing  authority  shall  be  informed  immediately.  Further 
action  in  respect  of  such  stopped  marketing  of  drug  shall  be  followed  as  per  the 

271 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

direction of  the  licensing authority. In such  cases,  action  equivalent  to  that  taken  with 
reference  to  the  concerned  cosmetic  in  the  country  of  origin  or  in  the  country  of 
marketing shall be followed in India also, in consultation with the licensing  authority.  
The  licensing  authority  may,  however,  direct  any  further  modification  to  this 
course  of  action,  including  the  withdrawal  of  the  c o s m e t i c   from  Indian  market 
within  48 hours time period. 

3.  The  manufacturer or  his  authorised agent/importer/distributor  or subsidiary  in 
India  shall  inform  the  licensing  authority  within  30  days  in  writing  in  the  event  of 
additional variants/additional cosmetic category/additional manufacturing location or 
any  change  in  labeling  or    in    testing,    or    in    documentation  of    any  of  the 
c o s m e t i c pertaining  to  this Registration Certificate. 

In  such  cases,  where  there  shall  be  additional  variants/additional  cosmetic 
category/additional manufacturing location, as the case may be, at the discretion of the 
licensing 
authorised 
agent/importer/distributor/subsidary  in  India  shall  apply  for  necessary  approval  within 
30 days by submitting a separate application along with the registration fee. 

manufacturer 

authority, 

the 

his 

or 

4.         The   manufacturer   or    his    authorised    agent    in    India    shall    inform    the  
licensing  authority  immediately  in  writing  in  the  event  of  any  change  in  the 
constitution of the firm and / or  address  of  the  registered  office  /  factory  premises  
operating    under    this    Registration  Certificate.  Where  any  such  change  in  the 
constitution  of  the  firm  and/or address takes  place,  the  current  Registration  Certificate 
shall  be  deemed  to  be  valid  for  a  maximum  period  of  three months from the  date  
on which   the   change   has   taken   place    unless,   in   the    meantime,   a    fresh   
Registration Certificate   has   been   taken   from   the   licensing   authority   in   the   
name   of   the   firm with    the    changed    constitution    of    the    firm    and/or    
changed    address    of    the registered office or factory premises.] 

1.  Ins. by   G.S.R.  4 2 6 (E) dt. 19-5-2010, read with corrigendum G.S.R263(E) dt:30.3.2011, corrigendum G.S.R. 
733(E) dt:29.9.2011, corrigendum G.S.R.270(E) dt:30.3.2012 and corrigendum G.S.R. 733(E) dt:29..2012.  

(See rules 122A, 122B, 122D and 122 DA) 

1[FORM 44 

Application for grant of permission to import or manufacture a New Drug or to 
undertake clinical trial. 

I/We*………………………………………… of   M/s. ........................ ………….. 

(address) hereby  apply  for  grant  of  permission  for  import of  and/or  clinical  trial  or 
for  approval  to  manufacture  a  new  drug  or  fixed  dose  combination  or  subsequent 
permission  for  already  approved  new  drug.  The  necessary  information /  data    is  given 
below : 

1.   Particulars of new drug :  
(1) Name of the drug. 
(2) Dosage form. 
(3) Composition of the formulation : 
(4)  Test specification. 

(i)   active ingredients.  
(ii)  inactive ingredients. 

(5) Pharmacological classification of the drug. 
(6) Indications for which proposed to be used. 
(7) Manufacturer of the raw material (bulk drug substances).  
(8) Patent status of the drug. 

2.  Data  submitted  along  with  the  application  (as  per  Schedule  Y  with  indexing 
and  page numbers:) 

A.  Permission to market a new drug : 

272 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(1)       Chemical and Pharmaceutical information.  
(2)       Animal Pharmacology. 
(3)       Animal Toxicology. 
(4)       Human / Clinical Pharmacology (Phase I).  
(5)       Exploratory Clinical Trials (Phase II). 
(6)       Confirmatory Clinical Trials (Phase III) (including published review 
articles)  
(7)       Bio-availability, dissolution and stability study data. 
(8)       Regulatory status in other countries.  
(9)       Marketing information : 

(a) Proposed product monograph.  
(b) Drafts of labels and cartons. 

(10)       Application for test licence. 
2[(11)      New Chemical Entity and Global Clinical Trial- 

(a) Assessment of risk versus benefit to the patients 
(b) Innovation vis-à-vis existing therapeutic option 
(c) Unmet medical need in the country.] 

B.  Subsequent   approval   /   permission   for   manufacture   of   already   approved   new  

drug   :  

(a) Formulation: 

(1)  Bio-availability / bio-equivalence protocol.  
(2)  Name of the investigator/center. 
(3) Source of raw material (bulk drug substances) and stability study data.  

(b) Raw material (bulk drug substances): 
(1) Manufacturing method. 
(2) Quality control parameters and/or analytical specification, stability report. 
(3) Animal toxicity data. 

C.      Approval / Permission for fixed dose combination:  

(1) Therapeutic Justification. 

(authentic literature in 3[pre-reviewed journals]/text books) 
(2) Data on pharmacokinetics/pharmacodynamics combination. 
(3)  Any  other data  generated by  the  applicant on  the  safety  and 

efficacy  of  the combination. 

D.   Subsequent Approval or approval for new indication - new dosage form:  
(1) Number and date of Approval / permission already granted. 
(2) Therapeutic justification for new claim / modified dosage form 
(3) Data generated on safety, efficacy and quality parameters. 

A total fee of rupees ............................................ (in words) ............................. has been 

credited to the Government under the Head of Account............................... (Photocopy  of  
receipt is enclosed). 

Dated : .....                                                                                                Signature…….  
Designation……………. 

Note: *Delete whichever is not applicable. 
_  
1. Forms 44 to 46 A ins. by No.G.S.R. 900 (E), dt. 12.12.2001. 
2. Ins. By G.S.R. 826 (E), dt. 30.10.2015. 
3. Subs by G.S.R. 26(E), dt. 19.1.2006. 

273 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 45 

(See rules 122 A, 122 D and 122 DA) 

Permission to import Finished Formulation of a New Drug  

Number of the permission and date of issue…………………………………………….. 
M/s ..................................................................... of………………………………………. 
(address) is hereby permitted to import the following new drug formulation under rule 
122 A /122 D/122 DA of the Drugs and Cosmetics Rules, 1945.  

(1) Name of the New Drug : 
(2) Dosage form :  
(3) Composition :  
(4) Indications : 

Dated:...............                                                              
Signature............................ 

Name and designation of Licensing Authority 

Conditions for Grant of Approval / Permission. 

(1)     The  formulation  shall  conform  to  the  specifications  approved  by  the 
Licensing Authority. 
(2)   The  proper  name  of  the  drug  shall  be  printed  or  written  in  indelible  ink 
and  shall  appear  in  a  more  conspicuous  manner  than  the  trade  name,  if  any,  which 
shall  be  shown  immediately  after  or  under  the  proper  name  on  the  label  of  the 
innermost  container  of  the  drug  or  every  other  covering  in  which  the  container  is 
packed. 

(3)    The  label  of  the  innermost  container  of  the  drug  and  every  other  covering  in 
which the container  is  packed  shall  bear  a  conspicuous  red  vertical  line  on  the  
left   side  running throughout  the  body  of  the  label  which  shall  not  be  less  than  1 
mm  in  width  and  without  disturbing  the  other  conditions  printed  on  the  label  to 
depict it as prescription drug. 

(4)  The label on the immediate container of the drug as well as the packing in which 

the container is enclosed should contain the following warning: 

"WARNING : To be sold by retail on the prescription of a ..............................   Only." 

2[(5)   Post  marketing  surveillance  study  shall  be  conducted  during  initial period 
of  two years of  marketing of the new drug formulation, after getting the protocol 
and the names of the investigator duly approved by the Licensing Authority.] 
(6)    All  reported  adverse  reactions  related  to  the  drug  shall  be  intimated  to  the 
Drugs  Controller,  India  and  Licensing  Authority  and  regulatory  action  resulting  from 
their review should be complied with. 

(7)   No claims except those mentioned above shall be made for the drug without the 

prior approval of the Licensing Authority. 

(8)    Specimen  of  the  carton,  labels,  package  insert  that  will  be  adopted  for 
marketing  the drug in the country shall be got approved from the Licensing Authority 
before the drugs is marketed. 

(9)   Each consignment of imported drug shall be accompanied by a test/analysis 
report. 

_  
1. Ins. by No.G.S.R. 900 (E), dt. 12.12.2001. 
2. Subs by G.S.R. 101(E), dt. 18.2.2011. 

274 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 45A 
(See rules 122A and 122DA) 
Permission to import raw material (new bulk drug substance) 

Number of the permission and date of  issue……………………………………………. 
M/s ...................................................................................of……………………(address) 
is  hereby permitted to import the following raw material (new bulk drug substances) 
under rule 122 A / 122DA of the Drugs and Cosmetics Rules, 1945, namely :- 

Name of the raw material (new bulk drug substances):  

(1) ............................................ 
(2)   .............................................  
(3) ............................................ 

Dated  ..................                                                                             Signature .............. 

Name and Designation of the Licensing Authority…………… 

Conditions for Grant of Approval / Permission 

(1)      The raw material (new bulk drug substance) shall conform to the test 

specifications as approved by the Licensing Authority. 

(2)      For manufacture of raw material (new bulk drug substance) or its 
formulation in the country, separate approval under rule 122-B shall be obtained 
from the Licensing Authority. 

(3)     The permission to import shall not be used to convey or imply that the raw   
material 

(new bulk drug) is categorized as "life saving or essential drug."] 
_  
1. Ins. By G.S.R. 900 (E), dt. 12.12.2001. 

1[FORM 46 

(See rules 122 B, 122 D and 122 DA) 

Permission / Approval for manufacture of new drug formulation 

Number of permission and date of issue ....................... ………………………………. M/s 
of ............................................ (address) is hereby granted Permission/Approval to 
manufacture  following  new  drug  formulation  under  rule  122B/122D/122DA of  the 
Drugs  and Cosmetics Rules, 1945, namely :- 

(1)   Name of the formulation:  
(2)   Dosage form: 
(3)   Composition:  
(4)   Indications: 

Dated …………….                                                          Signature ......  

Name and designation of Licensing Athority……….  

Conditions for Grant of Approval / Permission. 
(1)   The  formulation  shall  conform  to  the  specifications  approved  by  the 
Licensing Authority. 
(2)   The proper name of the drug shall be printed or written in indelible ink and 
shall appear in  a  more conspicuous manner than the  trade name, if  any, which shall 
be  shown  immediately  after  or  under  the  proper  name  on  the  label  of  he 
innermost  container  of  the  drug  or  every  other  covering  in  which  the  container  is 
packed. 

275 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(3)   The  label  of  the  innermost  container  of  the  drug  and  every  other  covering 
in  which the container is packed shall bear a conspicuous red vertical line on the left 
side running throughout  the  body  of  the  label  which  shall  not  be  less  than  1  mm  in 
width  and  without disturbing the other conditions printed on the label to depict it 
as prescription drug. 

(4)    The  label  on  the  immediate  container  of  the  drug  as  well  as  the  packing  in 

which the container is enclosed should contain the following warning: 

"WARNING : To be sold by retail on the prescription of a ........................... only." 

2[(5)    Post  marketing  surveillance  study  shall  be  conducted  during  initial 
period  of  two  years  of  marketing  of  the  new  drug  formulation,  after  getting  the 
protocol and the  names of the investigator duly approved by the Licensing Authority.] 

(6)   All  reported  adverse reactions related  to  the  drug  shall  be  intimated  to  the 
Drugs  Controller,  India  and  Licensing  Authority  and  regulatory  action  resulting  from 
their review should be complied with. 

(7)   No claims except those mentioned above shall be made for the drug without 

the prior approval of the Licensing Authority. 

(8)    Specimen  of  the  carton,  labels,  package  insert  that  will  be  adopted  for 
marketing the drug in the country shall be got approved from the Licensing Authority 
before the drug is marketed. 
_  
1. Ins. by G.S.R. 900 (E), dt. 12.12.2001. 
2. Subs by G.S.R.101(E), dt. 18.2.2011. 

1[FORM 46A 
(See rules 122 B and 122 DA) 
Permission/ Approval for manufacture of raw material 
(new bulk drug substance) 

............................................  of...........................................  (address) 

Name of the permission/ approval and date of issue .................................. 
M/s 
granted Permission/Approval  to  manufacture  the  following  raw  material  (new  
bulk    drug  substance)  under  rule  122B  /  122DA  of  the  Drugs  and  Cosmetics  Rules, 
1945. 

is  hereby      

Name of the raw material (new bulk drug substance):  
(1) .................................................................. 
(2)    ................................................................  
(3)  …............................................................... 

Dated ..............                                                           Signature .......................... 

Name and designation of Licensing Authority. 

Conditions for Grant of Permission /Approval 

(1)    The    raw    material    (new      bulk    drug  substance)  shall    conform  to    the  

specifications approved by the Licensing Authority. 

(2)    The  raw  material  (new  bulk  drug  substance)  can  be  sold  to  only  those 
manufacturers who  have  permission, in  writing,  from  Licensing  Authority,  either  to  use 
the  drug  for  development  purpose/clinical  trial-bio-equivalence study  or  to  manufacture 
the formulation. 

(3)   For manufacture of the formulation in the country, separate approval under  

rule 122B shall be obtained from the Licensing Authority.] 

1. Ins. by No.G.S.R. 900 (E), dt. 12.12.2001. 

276 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[FORM 47 
(See rule 160 A) 
Application for grant or renewal of approval for carrying out tests on Ayurvedic, 
Siddha and Unani drugs or raw materials used in the manufacture thereof on 
behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani 
drugs 

1.      *I/We................................................  of .................................... hereby          apply     

for     the grant/renewal of approval for carrying out tests of identity, purity, quality and 
strength on the following  categories  of  Ayurvedic,  Siddha  and  Unani  drugs  or  raw  
materials    used  in  the  manufacture  thereof  on  behalf  of  licensee  for  manufacture  for 
sale of Ayurvedic, Siddha and Unani drugs. 
2. *Categories of Ayurvedic, Siddha and Unani drugs other than those specified in the 
First Schedule to this Act for which testing will be carried out: 

AYURVEDA AND SIDDHA 

UNANI 

1. 

2. 

3. 
4. 

5. 

6. 

7 

8. 

9. 

Asava and Arista 

Arka-Tinir 

Avaleha and Paka-Ilakam 
Kavatha Curna-Kutinir Curanam 

Guggulu 

Ghrita-Ney 

Churna-Curanam 

Taila-Tailam 

Dravaka-Tiravakam 

10.  Lavana-Uppu 

11.  Kshara-Saram 

12.  Lepa-Pacai 

13.  Vati, Gutika-Kulikai 
14.  Vartti 

15.  Netrabindu (Aschyotan) 

16.  Anjana-Kanmai 

17.  Sattva-Sattu 

18.  Kupipakva Rasayana-Kuppi Centuram 

19.  Parpati 

20.  Pishti 

21.  Bhasma-Parpam 

22.  Mandura-Atai kutinir 

1. 

2. 

3. 
4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 
14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

Nabeez, Khal (Sirka) 

Majoon and its sub-categories 

Itrifal, Jawarish, Khameera, 

Laooq, Halwar 

Sufoof, Zuroor, Sunoon. 
Namak, Khar 

Raughan 

Zimad 

Habb (Pill) 

Shiyaf 

Qutoor (drops) 

Kohal (Surma), Kajal 

Satt, Usara 

Kushta 

Joshanda (Single drugs) 
Sharbat Sikanjabeen 

Sayyal, Arq (Distillates) 

Qurs (Tablet) 

Marham, Qairooti 

Humool, Furzaja 

Bakhoor 

Nabati Advia 

Maadni Advia 

Asjad Advia 

23.  Rasay oga-C entur am                                          23.    Haiwani Advia 
24.  Lauha                                                                24.    Jauhar 
25.  Ghana Sattva                                                    25.    Natool 
26.  Kvath Pravahi- Kutinir                                     26.    Nashooq, Naswar 
27.  Panak (Syrup)-Manappaku                               27.    Shamoom 

277 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
28.  Tablet-Mattirai                                                 28.    Saoot (Nasal drops) 
29.  Capsule                                                              29.    Mazoogh 

Drugs and Cosmetics Rules 1945 

30.  Ointment- Kalimapu                                        30.    Tila 
31.  Phalavarti                                                          31.    Lashooq 
32.  Dhoomravarti/Doopan                                      32.    Gulqand 
33.  Kshar Sutra/Kshar Varti                                   33.    Fateela 
34.  Single drugs:                                                     34.    Ghaza, Utban, Sasbhh 

(a) Plant based 

(b) Mineral based 

(c) Metal based 

(d) Animal based 

(e) Synthetic 

(f) Any other Ayurvedic, Siddha, Unani formulation 

35.  Pushp (Phool)                                                   35.    Capsule 
36.  Nasya                                                                36.    Huqna 
37.  Swarasa (Fresh juice)                                        37.    Naurah 
38.  Karna Bindu (Ear drops)                                  38.    Latookh 
39.  Any  other  dosage  of    Patent and                39.    Vajoor (Throat paint) 

Proprietary and Ayurvedic, Siddha, 

Unani Drug 

(3)        Names, qualifications and   experience of experts employed for testing and 

40.    Mazmazah (Mouth washer) 

the person in-charge of testing. 

(4)        List of testing equipment provided. 

(5)     *I/We enclose a plan of the testing premises showing the location and area 

of the different sections thereof. 

(6)     An inspection fee of rupees  .......................... has been credited to Government 
under the head of account .............................  

Dated………… 

*Delete which is not applicable. 

Signature………. 
Full address of the Applicant 

1. Ins. by G.S.R. 701(E),  dt. 27.9.2001 and subs. by G.S.R. 73(E), dt. 31.1.2003.  

1[FORM 48 
(See Rule 160 B) 

Approval for carrying out tests or analysis on Ayurvedic, Siddha and Unani drugs or 
raw materials used in the manufacture thereof on behalf of licensees for manufacture 
for sale of Ayurvedic, Siddha and Unani drugs 

Number of approval and date of issue………………… 

1. Approval is hereby granted to  .........................................................for     carrying 
out  tests  in  identity,  purity,  quality  and  strength  on  the  following  categories  of 
Ayurvedic,  Siddha  or  Unani  drugs  and  the  raw  materials  used  in  the  manufacture 
thereof on the premises situated at .............................................................. 

278 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
Categories of Ayurvedic, Siddha and Unani drugs. 

…………………………………………… 
…………………………………………… 
…………………………………………… 

2.    Name of experts employed for testing and the person-in-charge of testing 

………………………………(experts) and……………………… (person in-charge). 

3.   The approval shall be in force from ......................... to..................................... 

4.        The  approval  is  subject  to  the  conditions  stated  below  and  such  other 

conditions as may be specified in the rules for the time being in force under the Act. 

Date ............................                                                         Signature ..................... 

Place ...........................                                                         Designation .................... 

Seal of State Licensing Authority 

Conditions of approval 

(1)        This approval and any certificate of renewal in Form 49 shall be displayed 
in   the   approved   premi ses      and   s h all   be   produced   at   the   request   of   the 
Inspectors appointed under the Act. 

(2)        If the applicant wishes to undertake during the currency of the approval the 
testing  of  any  other  category  of  Ayurvedic,  Siddha  or  Unani  drugs  it  should  apply  to 
the  approving  authority  for  necessary  endorsement  as  provided  in  Rule  160A.  This 
approval will be deemed to extend to the items so endorsed. 

(3)        Any  change  in  the  experts  or  in  the  person  in-charge  of  the  testing 

shall be forthwith reported to the approving authority. 

(4)        The applicant shall inform the approving authority in writing in the event of 
any  change  of  the  constitution of  the  laboratory operating under  this  Form.  Where  any 
change  in  the  constitution  of  the  laboratory  takes  place,  the  current  approval  shall  be 
deemed to be valid for a maximum period of three months from the date on which the 
change  takes  place  unless  in  the  meantime,  a  fresh  approval  has  been  taken  from  the 
approving authority in the name of the laboratory with the changed constitution.] 

_  

1.Ins. by G.S.R. No.702(E) dt. 27-9-2001 and subs.by.G.S.R.73(E), dt.31.01.2003. 

1[Form 49 

(See rule 160- I) 
Certificate  of renewal for carrying out tests or analysis on Ayurvedic,  Siddha or 
Unani drugs or raw materials used in the manufacture thereof on behalf of licensees 
for manufacture for sale of Ayurvedic, Siddha or Unani drugs 

1.   Certified that approval number  ........................... g r an t ed  o n  th e   ........... 
day o f ...................................................................................... 20….    for    carrying    out 
tests   of   identity,   purity,   quality   and   strength   on   the   following   categories   of 
Ayurvedic,  Siddha  or  Unani,  drugs  and  the  raw  materials  used  in  the  manufacture 
thereof  at  the  premises  situated  at 
...............................  has  been  renewed  from 
………. to................ (date).  

Catagories of Ayurvedic, Siddha or Unani drugs: 
………………………………………………. 

2.   Name of  experts and  the person-in-charge of testing……………………..  
(experts) and………………….(person in charge) 

279 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date:  ....................                                                          Signature ........................... 

Drugs and Cosmetics Rules 1945 

Place : ................. 

Designation ......... 
Seal of State Licensing Authority ] 

1. Ins. by G.S.R. No.701(E) dt. 27-9-2001 and subs. by G.S.R.73(E) dt. 31.01.2003. 

1[FORM 50 
[See rule 160 D(f)] 

Report of test or analysis by approved Laboratory 

(1)   Name   of manufacturer   from   whom   sample   received   together   with   his 
manufacturing     licence     number     under     the     Act     or     the     rules     made 
thereunder. 

………………………………………………………………………………………… 

(2)   Reference number and date of the letter from the manufacturer under which the 

same was forwarded. 

………………………………………………………………………………………… 

(3)   Date of receipt of the sample 

…………………………………………………………………………………………… 

(4)    Name of Ayurvedic, Siddha and Unani drug of raw material purporting to be 

contained in the sample. 

…………………………………………………………………………………………… 

(5)     Details  of  raw  material  of  final  product  (in  bulk  finished  pack)*  as  obtained 

from the manufacturer: 

(a) 

 Original  manufacturer's  name  in  the  case  of  raw  materials  and  drugs 
repacked…… ……………………………. 
(b)       Batch number…………………………………  

(c)      Batch size as represented by sample…………….. 

(d)      Date of manufacture, if any   .......………………… 

(e)      Date of expiry, if any…………………………………. 

(6)   Results of  test or analysis with  protocols of test  or analysis applied or  as 

per Ayurvedic, Siddha or Unani Pharmacopoeial standards. 

(7)    Other  specific  tests  for  identity,  purity,  quality  and  strength  of  Patent 

and Proprietary drugs. 

In  the  opinion  of  the  undersigned,  the  sample  referred  to  above  is  of  standard 
*quality/is not of standard quality as defined in the Act or the rules made thereunder for 
the reasons given below 

…………………………………………………………………………………………… 
Date……. 
Place….. 

(Signature of the person-in-charge of testing) 
(F. No……………………………..) 
Name and Designation and Seal………… 
Name and Address of the Laboratory…… 
License No…………….. 

Note: Final product includes repacked material. 
*Delete whichever is not applicable. 

1. Ins. by G.S.R. 701(E) dt. 27-9-2001 and  subs. by  G.S.R.73(E) dt. 31.1.2003 

280 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [SCHEDULE B 

(See rules 7 and 48) 

Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories 
: 

1.         I.  Fees for test and assay of Drugs requiring use of animals 

Rupees 

1000 
1000 

1000 
400 

400 

2000 

500 
2000 
600 
300 
300 
500 

300 
200 

800 
250 
2000 

400 

300 

300 
2000 
100 
200 
300 
400 

Adrenocorticotrophic  hormone assay 
Gonadotrophic hormone for LH activity 

FSH Activity 
Posterior pituitary extract or its synthetic substitute for 
oxytocin activity 
Vasopressor activity 

Insulin and insulin in combination for hypoglycaemic activity 

Hyaluronidase 
Glucagon 
Heparin for anticoagulant activity 
Protamine sulphate 
Depressor or Histamine like substane 
Pyrogen test 

Antigenecity or foreign protein test 
Abnormal  or undue toxicity or safety test 

Determination of Lethal doses, LD10 or LD 50  in mice 
Skin sensitivity/eye irrigation 
Implantation test 

2. 

Microbiological tests and assays - 

Bioassay of Antibiotic 

Microbiological assay of vitamins 

Phenol coefficient 
Preservatives – Microbial challenge test 
Sterility test – Parenteral preparations 
Surgical dressings 
Syringes and needles 
Transfusion and infusion sets or assemblies 
Other sterile devices 

1.  Subs. by G.S.R. No.478(E), dt.  7-8-1998. 

281 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.   Identification tests - 

(a)  Chemical Methods 
(b)  Microscopical 
(c) 
(d) 

IR Spectroscopy 
UV Spectroscopy 

(e) 

Chromotography 

Paper 
Thin layer 

(i) 
(ii) 
(iii)  Column 
(iv)  GLC 
(v) 
HPLC 
(vi)  Gel Filtration 

(f) 

Electrophoresis 

4. 

(a) 

(b) 
(c) 

(d) 

(e) 

(i)  Paper and Cellulose  acetate 
(ii) Polyacrylamide Gel,  starch gel, agar gel 

Physical tests – 

Optical rotation, specific gravity,    refractive index, 
weight per  ml, fluorescence. 
Viscocity 
pH, Solubility, loss on drying, net content, ash, sulphated  ash 
etc. 
Absorbancy, wt/unit area  (surgical), foreign matter, extractive 
value, thread count etc. 
Uniformity of weight 
(i) Tablets 
(i) Capsules 

(f) 

(g) 

Acid value, iodine value, peroxide value, 
Soponification  value, acetyl value. 
Disintegration tests – 

(i)   Ordinary tablets 
(ii)  Capsule 
(iii)  Sugar Coated tablets 
(iv)  Enteric coated tablets 

(h) 
(i) 
(j) 

(k) 

(l) 

Dissolution test 
Uniformity of content. 
Wt. per unit area (powder), particle size, count, methoxy 
value. 
Limit test for impurities 

Related substances 
(i)  T LC method 

(A) Without reference standard 
(B) With reference  standard 

282 

50 
50 
150 
100 

100 
150 
100 
250 
500 
300 

200 
300 each 

75 each 

100 
20 each 

30 each 

15 
20 

100 each 

20 
30 
50 
100 

250 
500 
200 each 

100 each 

150 
250 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(ii) Gas Liquid Chromatography 

(A) Without reference standard 
(B) With reference standard 

(iii)High pressure Liquid Chromatography 

(A)Without reference standards 
(B)With reference standards 

250 
350 
100 
500 
500 

(m)     Water (Karl Fisher)                                                                          200 

(5)      Assays - 

(a) General chemical methods                                                          100 for each 

ingredient 

(b) Non-aqueous/instrumental                                                          200 for each 

ingredient 

(c) Chromatography 

(i)      TLC 
(ii)     Column 
(iii)    GLC 
(iv)    HPLC 
(v)     Gel filtration 

(d)   Nitrogen determination 
(e)    Medicinal gases 

(6) 

Polymorph test - 

250 
200 
350 
500 
400 

200 
400 

300 

(Content of polymorph A in  chloramphenicol palmitate) 
Surgical sutures (Depending on number of tests to be carried) 
Other miscellaneous tests 

200-500 
100-500 

II 

Fees for Sera and Vaccine – 
Sterility test 
Abnormal toxicity test 
Specific toxicity test 
Inactivation test (Rabies) 
Potency testing of rabies vaccine 
Potency testing of pertussis fraction of DPT vaccine 
Potency testing of tetanus fraction of DPT/DT/TT vaccine 

100 
400 
800 
200 
2025 
2025 
2500 

Potency testing of diphtheria Fraction of DPT/DTE vaccine. 
Testing of antisera for the specific titre 
Potency testing measles/Mumps/Rubella vaccine 

2700 
1000 
760 each 

Testing of Oral Polio Vaccine (OPV) – 
Potency 
Identity 
Stability 
Potency testing of Japanese Encephalitis Vaccine 
Potency testing of Snake 
Venom serum 
Identity testing for vaccines/sera 
Cell culture (Other than OPV) 
Other than cell culture 

4550 
1000 
800 
3900 
400 
for each venom 

400 
100 

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Drugs and Cosmetics Rules 1945 

Estimation of volume/pH/total solids/No. of 
organisms/Physical checking. 
Estimation of total proteins/aluminium 
content/phenol/formaldehyde/thiomersal/moisture.                         200 each 
Pyrogen  testing                                                                                 500 
Stability test for vaccines other than Oral Polio Vaccine               4550 

50 each 

III 

Cosmetics                                                                                400 – 1500 
(The exact amount of the fee shall be determined by the 
Director of Laboratory or the Government Analyst, as the case 
may be). 
IV        Rubber Condoms 

IV        Homoeopathic medicines: 

1. Identification test for raw material of botanical origin (other 

than assay of constituents). 

2. Identification test for raw material of chemical origin (other 

than assay) 

1000 

125 

100 

3. Limit test for drugs of chemical origin                                                150 
4. Assay of total alkaloids or of drugs of chemical origin                       100 
100 
5. Identification test for drugs of animal origins or 

microbiological. 

6. Fees for testing of Mother tincture, lower potencies upto 3x or 

100 

equivalent. 

7.  U.V. or I.R. or H.P.C.L. defect determination 

Determination of Biochemic drug through atomic absorbance 
spectrophotometer. 

75 
75 

Note :- 

1. For tests not listed in the Schedule, charges will be determined by the Director or 

the Government Analyst of the laboratory / institute as the case may be. 

2. For the tests relating to Ayurvedic, Unani and Siddha medicines, charges will be 
determined by the Adviser (Indigenous System of Medicine), Director or Government 
Analyst of the Laboratory / Institute, as the cased may be.] 

1.       Subs by G.S.R. 478 (E), dt:7.8.1998. 

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Drugs and Cosmetics Rules 1945 

1[SCHEDULE B(1) 
(See rules 163F) 

FEES FOR THE TEST OR ANALYSIS BY THE PHARMACOPOEIAL LABORATORY FOR 
INDIAN MEDICINE (PLIM) OR THE GOVERNMENT ANALYST 

1. 
2. 

3. 
4. 
5. 

6. 
7. 
8. 
9. 

10. 
11. 

12. 
13. 

14. 
15. 

16. 
17. 
18. 

19. 
20. 
21. 
22. 

23. 
24. 

25. 

26. 
27. 

Type of testing/analysis 

Test for sterlity 

(1) 

Abnormal toxicity or undue toxicity or safety test 

Determination of lethal does LD 50 to 10 on mice 

Chemical test for each ingredient 

Disinfectants 

Any other test requiring animal experimentation 

Microbiological assay 

Microscopic examination of single drugs 

Microscopic examination of raw material of compound 
drug 

Chemical identification as per Pharmacopoeia 

Disintegration of tablets and capsules 
(a) ordinary 
(b) sugar coated 
(c) enteric coated 

Psysiochemical Assays 

Test other than assay (limit tests for impurities, ash 
content, total solids, acid value, saponification value, 
loss on drying etc.) for each test. 

Optical rotation 

Refractive index 

Arsenic testing 

Paper chromatography 

Thin layer chromatography 

Column chromatography 

Gas liquid chromatography 

HPTLC restricted to single drugs qualitative 

Atomical absorption spectrophotometry for Hg, Pb, As, 
Cd 

Cosmetics/ tails/ creams 

Identification test for raw material of plant origin (other 
than assay of constitutents) 

Identification test for raw material of chemical origin 
(other than assay) 

Limit test for drug of chemical origin 

Other miscellaneous tests 

285 

Cost of testing or  
analysis in Rupees 
(2) 
250.00 

750.00 

2500.00 

500.00 

1000.00 

500.00 

750.00 

250.00 

500.00 

250.00 

100.00 
200.00 
400.00 

300.00 

100.00 

250.00 

250.00 

250.00 

250.00 

300.00 

2500.00 

1000.00 

1000.00 

500.00 

500.00 

125.00 

100.00 

150.00 

1000.00 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
Note:  Sample  testing  charges  will  be  determined  /  revised  by  the  Director  or  Government  Analyst  of  the 
Pharmacopoeial  laboratory  for  Indian  Medicine,  as  the  case  may  be,  in  consultation  with  the  Department  of 
Ayurveda, Yoga, Unani, Siddha and Homoeopathy, Ministry of Health and Family Welfare. 

1[SCHEDULE C 

(See rules 23, 61 and 76 and Part X) 

Biological and Special Products 

1.        Sera. 
2.        Solution of serum proteins intended  for injection. 
2[3.        Vaccines for parenteral injections. 
4.        Toxins. 
5.        Antigen. 
6.        Antitoxins. 
7. 

Neo-arsphenamine and analogous substances used for the specific treatment of infective 
diseases. 

8.        Insulin. 
9.        Pituitary (Posterior Lobe) Extract. 
10.       Adrenaline and Solutions of Salts of Adrenaline. 

3[11.       Antibiotics and preparations thereof in a  form to be administered parenterally.] 
4[12        Any other preparation which is meant for parenteral administration as such or after being 

made up with a solvent or medium or any other sterile product and which- 

(a)    requires to be stored in a refrigerator; or 
(b)   does not require to be stored in a refrigerator.] 

13.       Sterilized surgical ligature and sterilized surgical suture. 
2[14.       Bacteriophages. 
5[15       Ophthalmic preparations.] 
6[16        Sterile Disposable Devices for single use only.] 

1.         Amended by Notfn. No. F. 1-30/47-A, dt. 5-1-1950 
2.         Amended by  Notfn. No. F. 1-8/60-D, dt. 31-8-1960 
3.         Subs. by No. G.S.R. 487(E) ,dt. 2.7.1984. 
4.         Amended by Notfn. No. F. 1-14/68-D, dt. 26-10-1968 
5.         Ins. by Notfn. No. G.S.R. 1242(E) ,dt. 17.9.1979 
6.         Ins. by Notfn. No. G.S.R. 109(E) ,dt. 22.2.1994. 

286 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
1[SCHEDULE C (1)  
(See Rule 23, 61 and 76) 

Other Special Products 

1     Drugs belonging to the Digitalis group and preparations containing drugs belonging to   the 

Digitals group not in a form to be administered parenterally. 

2     Ergot and preparations containing Ergot not in a form to be administered parenterally. 

3  Adrenaline and preparations containing Adrenaline not in a form to be administered 

parenterally. 

4     Fish Liver Oil and preparations containing Fish Liver Oil. 

5  Vitamins  and  preparations  containing  any  vitamins  not  in  a  form  to  be  administered 

parenterally. 

6  Liver  extract  and  preparations  containing  liver  extract  not  in  a  form  to  be  administered 

parenterally. 

7  Hormones  and   preparations  containing  Hormones  not   in   a   form   to   be   administered 

parenterally. 

8     Vaccine not in a form to be administered parenterally. 

2[9.   Antibiotics and preparations thereof not in a form to be administered parenterally.] 
3[10.  In-vitro Blood Grouping Sera. 

11.  In-vitro Diagnostic  Devices for HIV, HbsAg and HCV.] 

1. Amended by. Notfn. No. F. 1-22/59-D, dt. 9-4-1960 
2. Subs. by.G.S.R.487(E) ,dt. 2-7-1984. 
3. Ins. By G.S.R. 601(E), dt. 27.8.2002. 

287 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

SCHEDULE D 
[See Rule 43] 

Extent and conditions of  exemption 

All provisions of Chapter III of the Act and rules 
thereunder  subject  to  the  condition  that  if  the 
substance is imported in bulk, the importer shall 
certify  that  the  substance  is  imported  for  non- 
medicinal uses, and if imported otherwise than in 
bulk, each container shall bear a label indicating 
that  the  substance  is  not  intended  for  medicinal 
1[Further, 
use  or 
is  of  commercial  quality. 
permission  from  licensing  authority  as  defined  in 
clause (b) of rule 21 has to be obtained for import 
of  the  substance  for  non-medicinal  use  without 
registration and import license.] 

All provisions of Chapter III of the Act 
and rules thereunder. 

1. 

Class of drugs 
Substances not intended for 
medicinal use 

2[***] 
3[***] 

4[5. 

(i) 

(ii) 

(iii) 

(iv) 

The following substances, which are 
used both as articles of food as well 
as drugs:- 
All condensed or powdered milk 
whether pure, skimmed or malted, 
fortified with vitamins and minerals. 
Farex, Oats, Lactose and all other 
similar cereal preparations whether 
fortified with vitamins or otherwise 
excepting those for      parenteral 
use. 
Virol, Bovril, Chicken essence and 
all  other similar predigested foods. 

Ginger, Pepper, Cumin, Cinnamon 
and all other similar spices and 
condiments unless they are 
specifically labelled as 
conforming to the standards in the 
5[Indian Pharmacopoeia or the 
official  pharmacopoeias and the 
official compendia of the drug 
standards prescribed under the 
Act and rules made thereunder]. 

1. Ins. By G.S.R 724 (E), dt:7-11-2013. 
2. Serial no 2, 3, omitted by Notfn. No. F-1-6/62-D (S.O.2889), dt: 2-7-1969. 
3. Serial no 4, omitted by G.S.R.604 (E) ,dt. 24-8-2001 
4. Amended by Notfn. F. 1-53/55-D, dt. 7.1.1957. 
5.Amended by G.S.R. 19, dt: 15-12-1977. 

288 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Drugs and Cosmetics Rules 1945 

Class of drugs               Extent and conditions of exemption 

1[6. 

and 

cosmetics 
Drugs 
imported 
for 
manufacture  and  export 
in 
by  units 
―Special 
Economic 
Zones‖ as notified by the 
Government  of 
India 
from  time to time. 

situated 

2[7. 

Custom Made Devices 

The  provisions  of  Chapter  III  of  the  Act  and  rules 
thereunder  which  required  them  to  be  covered  by     an 
import  licence,  import  registration  and  import  through 
notified port of entry, subject to the conditions that these 
drugs and cosmetics shall not be diverted for sale in the 
country: 

Provided  that  such  imported  drugs  and    cosmetics 
may  be  permitted  to  the  domestic  area  if  they  meet  the 
requirements  of  standard  procedure  for  import  and 
registration as  required under Chapter III  of  the  Act and 
rules thereunder. 

in  accordance  with 

All provisions of Chapter III of the Act and the rules 
made thereunder, subject to the condition that the device is 
specifically  made  in  accordance  with  a  duly  qualified 
medical  practitioner‘s  written  prescription  under  his 
specific  design 
responsibility, 
characteristics  and  is  intended  for  the  sole  use  of  a 
particular  patient  and  the  label  should  bear  the  word 
―custom made device.‖        Explanation.––Mass produced 
devices  which  only  need  adoption  to  meet  the  specific 
requirements  of  the  medical  practitioner  or  any  other 
professional  user  shall  not  be  considered  to  be  custom 
made devices.] 

1. Ins.  by  G.S.R. 528(E),  dt. 8.7.2003. 
2. Ins. By G.S.R 690 (E) dated 25-09-2014. 

289 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE D(I) 

(See rule 21 (d) and rule 24 A) 

Information and undertaking required to be submitted by the manufacturer or his authorized 
agent with the Application Form for a  Registration Certificate. The format shall be properly 
filled in for each application in Form 40. The detailed information, secret in nature, may be 
furnished on a Computer Floppy. 

1.           Particulars of the manufacturer and manufacturing premises 

1.1 

Name and address of the manufacturing premises (Telephone No., 
Fax  No., E-mail address)  to be registered. 

1.2        Name(s) and address(es) of the Proprietor /Partners / Directors. 
1.3 

 Name and address of the authorized Agent in India, responsible for 

the  business  of the manufacturer. 

1.4 

 A brief profile of the manufacturer‘s business activity, in domestic as well as 
global   market. 

1.5    A copy of Plant Master File (duly notarised) 

1.6  A copy of Plant Registration / approval Certificate issued by the Ministry of 

Health/National   Regulatory Authority of the foreign country concerned (duly 
notarised) 

1.7   A brief profile of the manufacturer‘s research activity. 

2.            Particulars of the manufactured drugs to be registered under Registration 

Certificate. 

2.1 

Names of drugs (Bulk/Formulation/Special product) to be registered meant for 
import into and use in India. 

2.2       A  copy of the approved list showing the bulk drugs/formulations/special 

products  mentioned in 2.1 above are permitted for manufacturing / marketing 
in the country of origin (duly notarized). 

2.3 

2[A copy of Good Manufacturing Practice (GMP) certificate as per WHO – 
GMP guidelines or Certificate of Pharmaceutical Products (CPP) or written 
confirmation for active substances exported to European Union which is 
equivalent to GMP certificate issued as per WHO – GMP guidelines, by the 
National Regulatory Authority of the country of origin or a copy of the 
certificate equivalent to GMP certificate as per WHO GMP guidelines issued 
by National Regulator of United States of America or Japan or Australia or 
Canada or the European Union for the purpose of marketing of the drugs in 
their country, in relation to bulk drugs or formulations or special product 
meant for import into India.] 

2.4  The domestic prices of the drugs to be registered in India, in the currency of the 

country of origin. 

2.5 

 The name(s)  of the drug(s) which are original research products of the 
manufacturer. 

Ins. by  G.S.R. No.604(E) , dt. 24-8-2001 (w.e.f. 1-1-2003). 

1. 
2.  Subs. by G.S.R. No. 897(E) , dt. 21-9-2016.

290 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.        Undertaking to declare that: - 

3.1. We shall comply with all the conditions imposed on the Registration Certificate, 

read   with rules 74 and 78 of the Drugs and Cosmetics rules, 1945. 

3.2   We declare that we are carrying on the manufacture of the drugs mentioned in 
this Schedule, at the premises specified above, and we shall from time to time 
report any change of premises on which manufacture will be carried on and in 
cases where manufacture is carried on in more than one factory any change in 
the distribution of functions between the factories. 

3.3  We  shall  comply  with  the  provisions of  Part  IX  of  the  Drugs  and  Cosmetics 

Rules, 1945. 

3.4   Every  drug  manufactured  by  us  for  import  under  the  Registration  Certificate 
into  India  shall  be  as  regard  strength,  quality  and  purity  conforms  with  the 
provisions of Chapter III of Drugs and Cosmetics Act, 1940 and Part IV of the 
Drugs and Cosmetics Rules 1945, and their amendments from time to time. 

3.5   We shall from time to time report for any change or manufacturing process, or 
in  packaging,  or  in  labelling,  or  in  testing,  or  in  documentation of  any  of  the 
drugs, pertaining to the Registration Certificate, to be granted to us. Where any 
change  in  respect  of  any  of  the  drugs  under  the  Registration  Certificate  has 
taken place, in respect of any of the above matters, we shall inform the same to 
the licensing authority in writing within 30 days from the date of such changes. 
In  such  cases,  where  there  will  be  any  major  change/modification  in 
manufacturing or  in  processing or  in  testing,  or  in  documentation, as  the  case 
may  be,  at  the  discretion of  the  licensing  authority, we  shall  obtain  necessary 
approval  within  30  days  by  submitting  a  separate  application,  alongwith  the 
registration fee as specified in clause (ii) of sub rule (3) of rule 24-A. 

3.6   We  shall  from  time  to  time  report  for  any  administrative action  taken  due  to 
adverse  reaction,  viz.  market  withdrawal regulatory restriction, or  cancellation 
of  authorization and/or ―not  of  standard quality report‖  of  any  drug  pertaining 
to  the  Registration  Certificate  declared  by  any  Regulatory  Authority  of  any 
country  where  the  drug  is  marketed/sold  or  distributed.  The  despatch  and 
marketing  of  the  drug  in  such  cases,  shall  be  stopped  immediately  and  the 
licensing authority shall be  informed immediately. Further action in respect of 
stop  marketing  of  drug  shall  be  taken  as  per  the  directions  of  the  licensing 
authority.  In  such  cases,  action  equivalent  to  that  taken  with  reference  to  the 
concerned drug(s) in the country of origin or in the country of marketing will be 
followed  in  India  also,  in  consultation  with  the  licensing  authority.  The 
licensing authority may direct any further modification to this course of action, 
including the withdrawal of the drug from Indian market within 48 hours time 
period. 

3.7   We shall comply with such further requirements, if any, as may be specified, by 

the Government of India, under the Act and the rules made there under. 

3.8   We shall allow the licensing authority and/or any person authorized by him in 
that behalf to enter and inspect the manufacturing premises and to examine the 
process/procedure and documents in respect of any drug manufactured by us for 
which the application for Registration Certificate has been made. 

291 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.9   We shall allow the licensing authority or any person authorized by him in that 
behalf to take samples of the drugs concerned for test, analysis or examination, 
if considered necessary by the licensing authority. 

Place: 
Date: 

1. Ins. by G.S.R. 35(E), dt. 20.1.2005. 

Signature of the manufacturer 

1 [or his authorized agent] 
Seal / Stamp 

292 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
SCHEDULE D(II) 
[See rule 21 (d) and rule 24 A] 

Information required to be submitted by the manufacturer or his authorized agent with the 

Application Form for the registration of a bulk drug/formulation/special product for its import into 

India.  

The format shall be properly filled in and the detailed information, secret in nature, may be furnished 

on a Computer Floppy 

1.          GENERAL 

1.1.  Name of the drug/formulation/special product, a brief description and the 

therapeutic class to which it belongs. 

1.2  Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical 

Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale 
approval issued by the Regulatory Authorities of other major countries. 
1.3     Drugs Master File (DMF) for the drug to be registered (duly notarised). 
1.4    1[GMP certificate as per WHO-GMP format, or Certificate of Pharmaceutical Products 
(CPP),  or  written  confirmation  for  active  substances exported  to the  European Union 
which is equivalent to GMP certificate issued as per WHO  – GMP guidelines, by the 
National Regulatory Authority of the country of origin or a duly notarised copy of the 
certificate  equivalent  to  GMP  certificate  as  per  WHO-GMP  guidelines  issued  by 
United States of America or Japan or Australia or Canada or the European Union for 
the purpose of marketing of the drug in their country.] 

1.5  List of countries where marketing authorization or import permission for the said drug is 

granted with date (respective authorisation shall be enclosed). 

1.6  List of countries where marketing authorisation or import permission for the said drug is 

cancelled/withdrawn with date. 

1.7  List of countries where marketing authorisation or import permission for the said drug is 

pending since (date). 

1.8     Domestic price of the drug in the currency followed in the country of origin. 
1.9     List of countries where the said drug is patented. 

2.    CHEMICAL AND PHARMACEUTICAL INFORMATION OF DRUGS. 

2.1      Chemical name. 

Code name or number, if any. 
Non-proprietary or generic name, if any. 
Structure. 
Physico-chemical properties. 

2.2  Dosage form and its composition. 

Qualitative and Quantitative composition in terms of the active substances(s) and 
excipient(s). List of active substance(s) separately from the constituent(s) of excipients. 

2.3  Specifications of active and inactive ingredient (s) including pharmacopoeial references. 
2.4    Source of active ingredient(s), name and address. 

2.5    Tests for identification of the active ingredient(s), 

Method  of  its  assays  and  tests  for  impurity  profile  with  reference  standards  for  the 
impurities (Protocol to be submitted alongwith reference standards for the impurities /  
relative substances). 

2.6  Outline method and flow chart of manufacture of the bulk drug or finished formulation 

or special product. 

2.7  Detailed test protocol for the drug with pharmacopoeial reference or in- house 
specification as approved by the registration authority, in the country of origin. 

293 

 
 
 
 
 
 
 
 
 
2.8   Stability data including accelerated stability and real time stability analysis. 

Drugs and Cosmetics Rules 1945 

           1. Subs. by G.S.R. 897 (E), dt. 21.9.2016. 

2.9        Documentation on pack size. 
2.10      Numerical expression on EAN bar code on the labels and cartons, 
2.11      Safety documents on containers and closures. 
2.12      Documentation on storage conditions. 
2.13  Three samples of medicinal product/drug and outlet packing are to be submitted with 

batch certificates. Additional samples as well as reference substances with batch 
certificates including date of manufacture, shelf life, and storage conditions of reference 
substance may be required both during registration procedure and during validity of 
registration decision. 

2.14  Batch test reports/certificate of five consecutive production batches in details of the 

medicinal product are to be submitted for every site of manufacturing premises. 

2.15      Manner of labelling as per rule 96 of the Drugs and Cosmetics Rules 1945. 
2.16      Package insert. 
2.17      Details of safety handling procedure of the drug. 
2.18      Details of PMS study report for marketing period not exceeding five years. 

. 

3.    BIOLOGICAL AND BIOPHARMACEUTICAL INFORMATION  OF DRUGS 

3.1          Biological control tests applied on the starting material, if applicable. 
3.2         Biological control tests applied on the intermediate products, if applicable. 
3.3         Biological control tests applied on the finished medical products, if applicable. 
Stability of the finished products in terms of biological potency of the drug, if 
3.4 
applicable. 

3.5         Sterility tests, if applicable, specification and protocol therein. 
3.6         Pyrogen tests, if applicable, specification and protocol therein. 
3.7         Acute and sub-acute toxicity tests, if applicable specification and protocol therein. 
3.8         Bio-availability studies and bio-equivalence data, if applicable. 
3.9         Data relating to the environmental risk assessment for r-DNA products. 
3.10       Other information relevant under the section. 

4.      PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF DRUGS. 

Executive summary of the product is to be submitted mentioning the specific and general 

pharmacological actions of the drug and pharmacokinetic studies on absorption, metabolism, 
distribution and excretion. A separate note is to be given on acute and sub-acute toxicity studies 
and long term toxicity studies. Specific studies on reproductive toxicity, local toxicity and 
carcinogenic activity of the drug is to be elaborated, as far as possible. 

5       CLINICAL DOCUMENTATION 

A new drug as defined under rule 122-E of the Drugs and Cosmetics Rules, 1945 is 

required to be permitted separately by the licensing authority under rule 122-A of the said rules 
prior to its registration. Such a new drug requires a brief summary and clinical documentation, 
alongwith permission under 122-A of the said rules for its Registration Certificate. 

6.          LABELLING AND PACKAGING INFORMATION OF DRUGS. 

6.1        Labels should conform as per the specifications under the Drugs and Cosmetics 

294 

 
 
 
 
 
 
 
 
 
 
 
 
 
Rules 1945. 

Drugs and Cosmetics Rules 1945 

6.2 

6.3 

Package insert should be in English and shall indicate the following therapeutic 
indications: - 
Posology and method of administration. 
Contra-indications. 
Special warnings and special precautions for use, if any.  
Interaction with other medicaments and other forms of interaction. 
Pregnancy and lactation, if contra-indicated. 
Effects on ability to drive and use machines, if contra-indicated. 
Undesirable effects/side effects. 
Antidote for overdosing. 

Package insert should indicate the following pharmaceutical information: -  
List of excipients. 
Incompatibilities. 
Shelf life in the medical product as packaged for sale. 
Shelf life after dilution or reconstitution according to direction.  
Shelf life after first opening the container. 
Special precautions for storage. 
Nature and specification of the container. 
Instructions for use/handling. 

7           SPECIFIC INFORMATION REQUIRED FOR THE SPECIAL PRODUCTS (to be 
supplied, separately in Annexures, as ‗A‘, ‗B‘ and ‗C‘) 

The information submitted above is true to the best of my knowledge and belief. 

Place: 
Date : 

Signature of the manufacturer 
1  [or his authorized agent] 

Seal/Stamp 

NB:  1.        Any  change  in  the  process  of  manufacture,  method  of  testing,  labelling,  packaging, 
designing of the sale pack, medical literature and documentation is to be intimated to the 
licensing  authority  forthwith  and  permission  to  be  obtained  from  him  within  30  days 
time period. 

2. 

Information  relating  to  Serial  No.4  and  Serial  No.5  are  not  applicable  for  drugs 
figuring  in  Indian    Pharmacopoeia and  also  for  the  drugs  figuring  in  United  States  of 
Pharmacopoeia,  European  Pharmacopoeia,  and  British  Pharmacopoeia  provided  such 
drugs  have  already  been  approved  for  marketing  in  India  for  the  applicant  under 
rules 122A, 122B, 122C or 122D of the Drugs and Cosmetics Rules 1945. 

1.Ins. by G.S.R. 35(E), dt. 20.1.2005. 

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Drugs and Cosmetics Rules 1945 

ANNEXURE A 
(See Schedule D-II, item No.7) 

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II  

SPECIFIC INFORMATION REQUIRED FOR THE BLOOD PRODUCTS  

          A product dossier showing the: 

1.  Details of source Plasma, its viral screening, storage and transport from Collection Centres to 

Fractionation Centre. Regulatory status of Collection Centres. 

2.     Details of Fractionation Centre, Regulatory Status, Method of Fractionation and Control 

Processes. 

3.  Details  of  viral  inactivation  process  for  enveloped  and  non-enveloped  virus(es)  and  viral 
validation studies to assess the viral load of the product. Testing of viral screening at any stage is 
to be highlighted with the details of the kits used with their respective sensitivity and specificity. 

4.  Bulk  filtration prior  to  pharmaceutical packing  giving  the  full  details  of  Micro-filtration or 

nanofiltration followed. 

5.     Complete details of pharmaceutical processing and utilization. 

6.  Test  protocol  of  the  product  showing  the  specifications  and  pharmacopoeial method 

followed for various testing parameters. 
Specific batch test  report for at  least  3  batches showing the specifications of each  testing 
parameter. 

7.     Pack size and labelling. 

8.     Product insert. 

9 

Specimen Batch Release Certificate issued by the National Regulatory Authority of the 
country of origin. 

Specific  processings  like  safe  handling,  material  control,  area  control,  pasteurization, 
stability  studies,  storage  at  quarantine  stage  and  finished  stage  and  packaging  should  be 
highlighted in the product dossier. 

The information submitted above is true to the best of my knowledge and belief. 

Place:  
Date: 

Signature of the manufacturer 
Seal / Stamp 

NB:  1.  Any  change  in  the  process  of  manufacture,  method  of  testing,  labelling,  packaging, 
designing  of  the  sale  pack,  medical  literature  and  documentation is  to  be  intimated  to  the 
licensing  authority  forthwith  and  permission to  be  obtained from  him  within  30 days time 
period. 

296 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

ANNEXURE-B 

(See Schedule D-II, item No.7) 

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II SPECIFIC 
INFORMATION REQUIRED FOR THE DIAGNOSTIC KITS 

A          Product dossier showing the : 

1.  The  details  of  source antigen or  antibody as  the  case  may  be  and  characterization  of  the 
same.  Process  control  of  coating  of  antigen  or  antibody  on  the  base  material  like 
Nitrocellulose paper, strips or cards or ELISA wells etc. 

Detailed composition of  the  kit  and  manufacturing flow  chart  process of  the  kit showing 
the    specific  flow    diagram  of    individual  components  or    source  of    the  individual 
components. 

2.  Test  protocol  of  the  kit  showing  the  specifications  and  method  of  testing.  In  house 
evaluation  report  of  sensitivity,  specificity  and  stability  studies  carried  out  by  the 
manufacturer. 

3.  The report of evaluation in details conducted by the National Control Authority of country 

of origin. 

Specimen batch test report for at least consecutive 3 batches showing specification of 
each testing parameter. 

4.  The detailed test report of all the components used/packed in the finished kit. 

5.  Pack size and labelling. 

6.  Product insert. 

Specific  evaluation  report, if  done  by  any  laboratory in  India,  showing the  sensitivity  and 
specificity of the kit. 

Specific  processing  like  safe  handling,  material  control,  area  control,  process  control, 
stability  studies,  storage  at  quarantine  stage  and  finished  stage,  packaging  should  be 
highlighted in the product dossier. 

The information submitted above is true to the best of my knowledge and belief. 

Place:  
Date: 

NB:  1.Any  change  in  the  process  of  manufacture,  method  of  testing,  labelling,  packaging, 
designing of the sale  pack,  medical  literature and documentation is to  be  intimated to the 
licensing authority forthwith and permission to be obtained from him within 30 days time 
period. 

Signature of the manufacturer 
Seal / Stamp 

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Drugs and Cosmetics Rules 1945 

ANNEXURE-C 

(See Schedule D-II, item No.7) 

INFORMATION TO BE SUBMITTED IN SCHEDULE D-II  

SPECIFIC INFORMATION REQUIRED FOR VACCINES 

A     Product dossier showing the: 

1.    History, source, date of receipt, storage, identity and characterization of the seed strain. 

2.   Detailed flow chart of manufacturing process showing all the details of in-process control 
on  toxicity,  potency  study  and  stability  data  of  the  final  bulk  and  the  final  finished 
product including the storage temperature. 

3.   Complete details of chemical and pharmaceutical data for the product. 

Composition and dosage form – method of manufacture with detailed flow chart – control 
of starting material – control tests on intermediate and finished products – certificate of 
analysis of finished products – validation of critical manufacturing steps. 

4.   Test protocol of the vaccines showing the specification and method of testing 

including pharmacopoeial specification. 

5.  Specimen batch test report for at least consecutive three batches showing the 

specification of each testing parameter. 

6.   The detailed test reports of all the components used / packed in the finished vaccine. 

7.   Pack-size and labelling. 

8.  Product insert 

9. Specimen batch release certificates issued by the National Regulatory Authority of the 

country of origin. 

10.  Summary of pre-clinical and clinical data including :  

(a)  Prescribing information. 
(b) 

 Pharmacological and toxicological data pertaining to tests on animals 
Characterisation of immuno response and safety study in human use, in 
specific conditions. 

Specific  information  on  source  of  seed  strain,  its  characterization,  inactivation,  etc.  and 
processings  like  safe  handling,  material  control,  area  control,  process  control,  stability  studies, 
storage  at  quarantine  stage  and  finished  state,  packaging  should  be  highlighted  in  the  product 
dossier. 

Specimen  production  and  quality  control  protocols  for  at  least  three  consecutive  lots 
showing    the    specifications  for   each    quality    control    parameter    including    pharmacopoeial 
requirement shall be submitted for study. 

The information submitted above is true to the best of my knowledge and belief. 
Place: 

Date: 

Signature of the manufacturer 
Seal / Stamp 

298 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

NB:  1.     Any change in the process of manufacture, method of testing, labelling, packaging, 

designing of the sale pack, medical literature and documentation is to be intimated to the 
licensing authority forthwith and permission to be obtained from him within 30 days time 
period. 

2.  All vaccines shall be new drugs unless certified otherwise by the liencesing authority 
approved under rule 21 of the Drugs and Cosmetic Rules, 1945. A copy of approval 
of the vaccine issued by the said licensing authority is to be enclosed, prior to issue of 
Registration Certificate of the said vaccines. 

1[SCHEDULE D (III) 
(See rule 129 A) 
INFORMATION AND UNDERTAKING REQUIRED TO BE SUBMITiED BY THE 
MANUFACTURER OR HIS AUTHORISED IMPORTER/DISTRIBUTOR/AGENT WITH THE 
APPLICATION FORM FOR A REGISTRATION CERTIFICATE. 

(The format shall be properly filled in for each application in form 42) 

1. PARTICULARS OF THE MANUFACTURER AND MANUFACTURING PREMISES.- 
(a)  Name and address of the manufacturer  and manufacturing  premises to be registered along with 

telephone numbers, Fax numbers and e-mail address. 

(b)  Name(s) and address of the Partners/Directors. 
(c)  Name and address of the authorised importer/distributor/agent in India, responsible for the business 

of the manufacturer. 

(d)  A brief profile of the manufacturer ‘s business activity, in domestic as well as global market. 
2. 

  PARTICULARS  OF  THE  COSMETICS  TO  B  E  RE  G  IST  E  RED  UNDER 
REGISTRATION CERTIFICATE.- 

(a)  Names of cosmetics along with their brands name, category, pack sizes and variants to be 

registered and meant for import into and use in India. 

(b)  Particulars of the manufacturing licenses/registration/marketing authorizations (if any) under which 
the cosmetics are being manufactured in the country of origin along with the copy of the licenses/ 
marketing authorization/registration issued by the Regulatory Authority of that country. 

(c)  List of countries where marketing  authorization  or import permission for the said cosmetic has 

been granted. 

3. CHEMICAL INFORMATION OF COSMETICS.- 
(a)  Name(s) of ingredients in the nomenclature of standard references, along with percentages 

contained in the cosmetic. 

(b)  Specification and testing method for testing of the cosmetic(s).  
(c)  Manner of labelling as per Drugs and Cosmetics Rules, 1945. 
(d)  Package insert (if any). 

4. UNDERTAKINGTO DECLARETHAT.- 
(a)  We shall comply with all the conditions imposed on the Registration Certificate for the import of 

cosmetics as required under the provisions of Drugs and Cosmetics rules, 1945. 

(b)  We declare that we are carrying on the manufacture of the cosmetics mentioned in this Schedule, at 
the premises specified above, and we shall from time to time report any change of premises on 
which manufacture will be carried on and in cases where manufacture is carried on in more than 
one factory any change in the distribution  of functions between the factories. 

(c)  We shall comply with the provisions of Part XIII of the Drugs and Cosmetics Rules, 1945.  
(d)  Every cosmetic manufactured by us for import under the Registration Certificate into India shall 

conform to the specifications given in the Drugs & Cosmetics Rules, 1945 as amended  from time 
to time.  

(e)  We shall inform to the licensing authority, within 30 days in the event of any change in variants or 
in category or in manufacturing location or in labelling or in documentation of any of the cosmetic 
pertaining to the certificate to be granted to us. 

1. Ins. By G.S.R. 426 (E) dated 19-05-2010, read with corrigendum G.S.R. 263(E) dated 30-05-2011, corrigendum G.S.R. dated 
29-09-2011, corrigendum G.S.R. 270(E) dated 30-03-2012 and corrigendum G.S.R. 733(E), dated 29-09-2012. 

299 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(f)  We shall from time to time report for any administrative  action taken due to adverse reaction, viz. 
market withdrawals/regulatory restriction, or cancellation of authorisation and/or ―not of standard 
quality  report‖  of  any  cosmetic  pertaining  to  the  Registration  Certificate  declared  by  any  
Regulatory  Authority  of  any  country  where  the  cosmetic  is  marketed/sold  or  distributed.  The 
despatch and marketing of the cosmetic in such cases, shall be stopped and the licensing authority 
shall be informed immediately. 

(g)  We shall comply with such further requirements, if any, as may be specified, by the Government of 

India, under the Act and the Rules, made thereunder. 

(h)  We shall allow the licensing authority or any person authorised by him in that behalf to take 
samples of the cosmetics for testing if considered necessary by the licensing authority. 

The information submitted above is true to the best of my/our knowledge and belief. 
Place: 
Date: 

Signature of the manufacturer or his authorized agent 
Seal/Stamp. 

1[***] 

2

[SCHEDULE E(1) 

[See rule 161 (2)] 

List of poisonous substances under the Ayurvedic (including Siddha) 
and Unani Systems of Medicine 
A.  AYURVEDIC SYSTEM 

I 

1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 

 13 

II 
14 

Drugs of vegetable origin 
Ahipena (Except seeds) 
Arka 
Bhallataka 
Bhanga (Except seeds) 
Danti 
Dhattura 
Gunja (seed) 
Jaipala (seed) 
Karaveera 
Langali 
Parasika Yavani 
Vatsanabha 
Vishamushti 

Papaver somniferum Linn. 
Calotropis procera (Ait.) R.Br. ex.  
Semecarpus anacardium Linn. F. 
Cannabis sativa Linn. (Except seeds) 
Baliospermum montanum Mull. Arg. 
Datura metal Linn.. 
Abrus precatorium Linn. (seed) 
Croton tiglium Linn. 
Rerium indicum Mill. 
Gloriosa superba Linn. 
Hyoscyamus niger Linn. 
Acontium chasmanthum Stapf ex Holm. 
Strychnox nuxvomica Linn. 

Shringivisha 

Acontium chasmanthum Stapf ex Holm. 

Drugs of Animal Origin. 

Sarpa Visha 

Snake poison. 

Drugs of Mineral Origin 
III 
 15 
Gauripashana 
 16 
Hartala 
 17  Manahashila 
 18 
Parada 
 19   Rasa Karpura 
 20 
Tuttha 
 21 
Hingula 

Arsenic. 
Arseno sulphide. 
Arseno sulphide. 
Mercury. 
Hydrargyri subchloridum. 
Copper sulphate. 
Cinnabar. 

1 ―Schedule E‖ omitted No.G.S.R. 462(E),dt 22-6-1982. 
2.  Subs. By G.S.R. 683(E) dated 19-08-2010. 

300 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

B. SIDDHA SYSTEM 

Abini 
Alari 
Attru thummatti 
Umathai 
Etti 
Ganja (except seed) 
Kalappaki Kizahangu 
Kodikkalli (exempted for external use) 
Kattu Thumatti 
Kunri (except root) 
Cheramkottai 
Thillai 
Nabi 
Nervalam 
Pugaielai 

1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
10 
11. 
12. 
13. 
14. 
15. 
16.  Mancevikkalli 

Papaver somniferum Linn. 
Nerium indicum Mill. 
Citrullus colocynthis (L.) Schrad 
Datura stramonium Linn. 
Stychnos nux vomica Linn. 
Cannabis sativa Linn. 
Glorisa superba Linn. 
Euphorbia tirucalli Linn. 
Cucumis trigonus Roxb. 
Arbus precatorius Linn. 
Semecarpus anacardium Linn f. 
Exoecoria agallocha Linn. 
Aconitum ferox Wall. 
Croton tiglium Linn. 
Nicotiana tabacum Linn. 
Euphorbia species 

I Drugs of vegetable origin 

C.  UNANI SYSTEM          

1.       Afiyun (except seed)                                          Papaver somniferum Linn. 
2.       Bazrul-banj                                                    Hyoscyamus niger Linn. 
3.       Bish                                                             Aconitum chasmanthum Strapfex Holmes.  
4.       Bhang                                                            Cannabis sativa Linn. 
5.       Charas                                                              Canabis sativa Linn.  
6.       Dhatura seeds                                               Datura metal Linn (seeds).   
     Strychnos nuxvomica Linn.  
7.       Kuchla 
     Conium maculatum Linn. 
8.       Shokran 

II        Drugs of Animal origin 

 Sanp (head)                                             Snake (head). 

9. 
10.  Telni makkhi                                           Mylabris cichori Linn. 

Mylabaris pustulata Thund. 
Mylabris macilenta . 

III 

Drugs of Mineral origin 

1.  Darchikna 
2.  Hira 
3.  Ras Kapoor 
4. 
5. 
6. 

Shingruf 
Zangar 
Sammul-Far  

7. 

Tootiya 

Para 

8. 
9.  Hartal 

Hydrargryi perchloridum. 
Diamond. 
Hydrargryi Subchloridum (calomel). 
Hydrargryi bisulphuratum. 
Cupri subacetas. 
(Abyaz, Asfar, Aswad and Ahmar) 
(white, yellow, black and red, Arsenic). 

Copper Sulphate. 
Copper Sulphate 

Hydrargyrum. 
Arsenic trisulphide (yellow).] 

301 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

SCHEDULE F 
(See rule 78 and Part X) 

1[***] 

2[PART XII B 

REQUIREMENTS FOR THE FUNCTIONING AND OPERATION OF A 

BLOOD BANK AND / OR FOR PREPARATION OF BLOOD COMPONENTS. 

I. BLOOD BANKS / BLOOD COMPONENTS 

A.    GENERAL 

1. 

2. 

 Location and Surroundings :  The  blood bank shall be located at a place which 
shall  be  away  from  open  sewage,  drain,  public  lavatory  or  similar  unhygienic 
surroundings. 

 Building  :     The  building  (s)  used  for  operation  of  a   blood  bank  and/or 
preparation of blood components shall be  constructed in such a manner so as to 
permit  the  operation  of  the  blood  bank  and  preparation  of  blood  components 
under hygienic conditions and shall avoid the entry of insects, rodents and flies. 
It  shall  be  well  lighted,  ventilated  and  screened   (mesh),  wherever  necessary. 
The  walls and floors of  the rooms, where collection of  blood or preparation of 
blood  components  or  blood  products  is  carried  out  shall  be  smooth,  washable 
and  capable  of  being  kept  clean.  Drains  shall  be  of  adequate  size  and  where 
connected  directly  to  a  sewer,  shall  be  equipped  with  traps  to  prevent  back 
siphonage. 

3. 

 Health,  clothing  and  sanitation  of  staff:    The  employees  shall  be  free  from 
contagious  or  infectious  diseases.  They  shall  be  provided  with  clean  overalls, 
head-gears, foot-wears and gloves, wherever required. There shall be adequate, 
clean and convenient hand washing and toilet facilities. 

B.      ACCOMMODATION FOR A BLOOD BANK. 

A blood bank shall have an area of 100 square meters for its operations and an 
additional  area  of  50  square  meters  for  preparation  of  blood  components.  It  shall  be 
consisting of a room each for – 

(1) 

registration and medical examination with adequate furniture and facilities for 
registration and selection of donors; 

(2)     blood collection (air-conditioned); 

1.  Part  I  to  Part  XIIA  omitted  by  G.S.R.  663  (E),  dated  03-07-1992  corrected  vide  corrigendum  G.S.R. 
27(E) dated 22-01-1993. 
2. Part XIIB and Part XIIC, were sub. By G.S.R. 245 (E) dated 05-04-1999, previously Part XIIB and XIIC, 
were substituted for Part XIIB by G.S.R. 28(E) dated 22-01-1992 and before that Part XIIB was added by 
notification number F 1-17/67-D, 24-06-1967. 

302 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(3) 

blood  component  preparation.  (This  shall  be  air-conditioned  to  maintain 
temperature between 20 degree centigrade to 25 degree centigrade); 

(4)     laboratory for blood group serology (air-conditioned); 

(5) 

laboratory  for  blood  transmissible diseases  like  Hepatitis,  Syphilis,  Malaria, 
HIV-antibodies (air-conditioned); 

(6)     sterilization-cum-washing; 

(7)     refreshment-cum-rest room (air-conditioned); 

(8)     store-cum-records. 

NOTES : 

(1)      The  above  requirements  as  to  accommodation  and  area  may  be  relaxed,  in 
respect  of  testing  laboratories  and  sterilization-cum-washing  room,  for  reasons  to  be 
recorded  in  writing  by  the  Licensing  Authority  and/or  the  Central  Licence  Approving 
Authority,  in  respect  of  blood  banks  operating  in  hospitals,  provided  the  hospital 
concerned has  a  pathological laboratory  and  a  sterilization-cum-washing room  common 
with other departments in the said hospital. 

(2)    Refreshments to  the donor after  phlebotomy shall be  served so  that  he is kept 

under observation in the blood bank. 

C    PERSONNEL 

Every  blood bank  shall  have  following categories of  whole time  competent technical 

staff:- 

(a)      Medical Officer, possessing the qualifications specified in condition (i) of rule 122-G. 

(b)     Blood Bank Technician(s) possessing – 

(i)   Degree   in   Medical   Laboratory   Technology   (M.L.T)   with   six   months‘ 
experience in the testing of blood and/or its components; or 

(ii)   Diploma   in   Medical   Laboratory  Technology  (M.L.T)   with   one   year‘s 
experience in the testing of blood and / or its components, the degree or diploma being 
from a University / Institution recognized by the Central Government or State 
Government. 

(c)     Registered Nurse(s); 

(d)     Technical supervisor (where blood components are manufactured), possessing- 

(i)   Degree   in   Medical   Laboratory   Technology   (M.L.T)   with   six   months‘ 
experience in the preparation of blood components; or 

(ii)   Diploma   in   Medical   Laboratory   Technology   (M.L.T)   with   one   year‘s 
experience in the preparation of blood components, 

the degree or diploma being from a University / Institution recognized by the Central 
Government or State Government. 

303 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTES : 

Drugs and Cosmetics Rules 1945 

(1)  The  requirements  of  qualification  and  experience  in  respect  of  Technical  Supervisor 
and Blood Bank Technician shall apply in the cases of persons who are approved by 
the  Licensing  Authority  and/or  Central  Licence  Approving  Authority  after  the 
commencement of the Drugs and Cosmetics (Amendment) Rules, 1999*. 

(2)  As regards, the number of whole time  competent technical  personnel, the blood bank 
shall  comply  with  the  requirements  laid  down  in  the  Directorate  General  of  Health 
Services Manual. 

(3) 

It shall be the responsibility of the licensee to ensure through maintenance of records 
and other latest techniques used in  blood banking system that  the personnel involved 
in  blood  banking  activities  for  collection,  storage,  testing  and  distribution  are 
adequately  trained  in  the  current  Good  Manufacturing  Practices/Standard  Operating 
Procedures for  the  tasks  undertaken by  each  personnel. The  personnel shall  be  made 
aware  of  the  principles  of  Good  Manufacturing  Practices  /  Standard  Operating 
Procedures that affect them and receive initial and continuing training relevant to their 
needs. 

D.      MAINTENANCE 

The premises shall be maintained in a clean and proper manner to ensure adequate cleaning 

and maintenance of proper operations.  The facilities shall include:- 

(1) 

(2) 

Privacy  and  thorough  examination  of  individuals  to  determine  their  suitability  as 
donors. 
Collection of  blood  from  donors  with  minimal  risk  of  contamination of  exposure to 
activities and equipment unrelated to blood collection. 

(3)       Storage of blood or blood components pending completion of tests. 

(4) 

Provision  for  quarantine,  storage  of  blood  and  blood  components  in  a  designated 
location, pending repetition of  those  tests  that  initially  give  questionable serological 
results. 

(5) 

Provision for quarantine, storage, handling and disposal of products and reagents not 
suitable for use. 

(6)       Storage of finished products prior to distribution or issue. 

(7) 

Proper collection, processing, compatibility testing, storage and distribution of blood 
and blood components to prevent contamination. 

(8)  Adequate  and  proper  performance  of  all  procedures  relating  to  plasmapheresis, 

plateletpheresis and leucapheresis. 

(9)       Proper conduct of all packaging, labelling and other finishing operations. 

(10)     Provision for safe and sanitary disposal of – 

(i)   Blood and/or blood components not suitable for use, distribution or sale. 

(ii)  Trash and items used during the collection, processing and  compatibility 
testing of blood and / or blood components. 

*Note : 2nd Amendment Rules, 1999 (w.e.f. 5-4-1999) 

304 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

E.      EQUIPMENT 

Equipment used in the collection, processing, testing, storage and sale/distribution of 
blood and its  components shall be  maintained in a  clean  and proper manner and so 
placed  as  to  facilitate  cleaning  and  maintenance. The  equipment shall  be  observed, 
standardized  and  calibrated  on  a  regularly  scheduled  basis  as  described  in  the 
Standard Operating Procedures Manual and shall operate in the manner for which it 
was  designed  so  as  to  ensure  compliance  with  the  official  requirements  (the 
equipments) as stated below for blood and its components. 

Equipment that  shall  be  observed, standardized and  calibrated with  at  least  the  following 

frequencies: 

EQUIPMENT                            PERFORMANCE                          FREQUENCY                                FREQUENCY 

OF 

CALIBRATION 

1.       Temperature 

Recorder 

Compare against 
thermometer 

2 

Refrigerated centrifuge         Observe speed 

and 
temperature 

Daily 

Each day 
of use 

As  often  as 
necessary 

As   often   as 
necessary 

3 

Hematocrit centrifuge                                  –                                          –                  Standardise 

before        initial 
use,  after  repair 
adjustments 
or 
and annually. 

4, 

5. 

General lab. 
Centrifuge 

– 

– 

Tachometer, 
every 6 months. 

Automated 
typing 

Blood 

Observe controls for 
correct results 

Each day 
of use 

– 

6.       Haemoglobinometer            Standardize   against 
cyanamethemoglob 
ulin standard 

7. 

8. 

Refractiometer  or 
Urinometer 

Standardize against 
distilled water 

Blood   container 
weighing device 

Standardize   against 
container  of  known 
weight. 

−ditto−                                    – 

− ditto − 

− ditto – 

– 

As   often   as 
necessary 

9 

Water Bath 

Observe temperature 

− ditto − 

−ditto− 

10  Rh    view    box 
(wherever 
necessary) 

–ditto–                                    − ditto −                    − ditto− 

305 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

11  Autoclave 

Observe temperature 

12 

Serologic rotators 

Observe controls for 
correct results 

Each day 
of use 

-- ditto-- 

13 

Laboratory 
thermometers 

– 

– 

As    often    as 
necessary 

Speed as often 
as necessary. 

Before initial 
use 

14      Electronic thermometers                             –                            Monthly                                  – 
15  Blood agitator                      Observe weight of the 

first container of blood 
filled for correct results 

F.     SUPPLIES AND REAGENTS: 

Each day of use        Standardize    with 
container 
of 
known  mass  or 
before 
value 
initial  use,  and 
after 
repairs  or 
adjustments. 

All supplies and reagents used in the collection, processing, compatibility, testing, storage 
and distribution of blood and blood components shall be stored at proper temperature in a 
safe and hygienic place, in a proper manner and in particular:– 

(a)  all  supplies  coming  in  contact  with  blood  and  blood  components  intended  for 
transfusion shall  be  sterile,  pyrogen-free, and  shall  not  interact  with  the  product  in 
such  a  manner  as  to  have  an  adverse  effect  upon  the  safety,  purity,  potency  or 
effectiveness of the product. 

(b)   supplies and reagents that do not bear an expiry date shall be stored in a manner that 

the oldest is used first. 

(c)  supplies and reagents shall be used in a manner consistent with instructions provided 

by the manufacturer. 

(d)  all  final  containers  and  closures  for  blood  and  blood  components  not  intended  for 

transfusion shall be clean and free of surface solids and other contaminants. 

(e) 

 each  blood  collecting  container  and  its  satellite  container(s),  if  any,  shall  be 
examined  visually  for  damage  or  evidence  of  contamination  prior  to  its  use  and 
immediately after filling. Such examination shall include inspection for breakage of 
seals,  when  indicated,  and  abnormal  discoloration.  Where  any  defect  is  observed, 
the  container  shall  not  be  used  or,  if  detected  after  filling,  shall  be  properly 
discarded. 

(f)  representative samples of each lot of the following reagents and/or solutions shall be 
tested  regularly  on  a  scheduled  basis  by  methods  described  in  the  Standard 
Operating Procedures Manual to determine their capacity to perform as required, 

306 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Reagents and solutions                                               Frequency of testing alongwith controls 

Each day of use 
Anti-human serum 
Blood grouping serums 
Each day of use 
Lectin                                                                        Each day of use 
Antibody screening and reverse 
Each day of use 
grouping cells 
Hepatitis test reagents                                               Each  run 
Syphilis serology reagents                                        Each run 
Enzymes                                                                    Each day of use 
HIV I and II reagents                                                Each run 
Normal saline (LISS and PBS)                                 Each day of use 
  Bovine Albumin                                                        Each day of use.  

G.  GOOD  MANUFACTURING  PRACTICES  (GMPs)  /STANDARD  OPERATING 

PROCEDURES (SOPs): 

Written Standard Operating Procedures shall be maintained and shall include all steps 
to  be  followed  in  the  collection,  processing,  compatibility  testing,  storage  and  sale  or 
distribution  of  blood  and/or  preparation  of  blood  components  for  homologous  transfusion, 
autologous  transfusion  and   further   manufacturing  purposes.  Such   procedures  shall   be 
available to the personnel for use in the concerned areas. The Standard Operating Procedures 
shall inter alia include: 

1.   (a)    criteria used  to determine donor suitability. 

(b) 

methods of performing donor qualifying tests and measurements including minimum 
and  maximum  values  for  a  test  or  procedure,  when  a  factor  in  determining 
acceptability; 

(c) 

solutions and methods used to prepare the site of phlebotomy so as to give maximum 
assurance of a sterile container of blood; 

(d)    method of accurately relating the product (s) to the donor; 
(e) 

 blood  collection  procedure,  including  in-process  precautions  taken  to  measure 
accurately the quality of blood drawn from the donor; 

(f)  methods of component preparation, including any time restrictions for specific steps 

in processing; 

(g)  all  tests  and  repeat  tests     performed  on  blood  and  blood  components  during 

processing; 

(h)  pre-transfusion  testing,  wherever  applicable,  including  precautions  to  be  taken  to 

identify accurately the recipient blood components during processing; 

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(i)     procedures of managing adverse reactions in donor and recipient reactions: 

(j) 

storage temperatures and methods of controlling storage temperatures for blood and 
its components and reagents; 

(k)     length of expiry dates, if any assigned for all final products; 

(l)      criteria for determining whether returned blood is suitable for re-issue; 

(m)     procedures used for relating a unit of blood or blood component from the donor to 

its final disposal; 

(n) 

quality control procedures for supplies and reagents employed in blood 
collection, processing and re-transfusion testing; 

(o)      schedules and procedures for equipment maintenance and calibration; 

(p)      labelling procedures to safeguard its mix-ups, receipt, issue, rejected and in-hand; 

(q) 

(r) 

(s) 

procedures of  plasmapheresis, plateletphersis   and leucapheresis if  performed, including 
precautions to be taken to ensure re-infusion of donor‘s own cells; 

procedures for  preparing recovered (salvaged) plasma if  performed, including details  of 
separation, pooling, labelling, storage and distribution; 

all  records  pertinent to  the  lot  or  unit  maintained pursuant to  these  regulations shall  be 
reviewed before the release or distribution of a lot or unit of final product. The review or 
portions  of  the  review  may  be  performed  at  appropriate  periods  during  or  after  blood 
collection,  processing,  testing  and  storage.  A  thorough  investigation,  including  the 
conclusions and follow-up, of any unexplained discrepancy or the failure of a lot or unit 
to meet any of its specification shall be made and recorded. 

(2)  A  licensee  may  utilise  current  Standard  Operating  Procedures,  such  as  the  Manuals  of 
the following organizations, so long as such specific procedures are consistent with, and 
at least as stringent as, the requirements contained in this Part, namely :- 

(i)      Directorate General of Health Services Manual. 

(ii)    Other  Organisations  or  individual  blood  bank‘s  manuals,  subject  to  the 

approval of State Licensing Authority and Central Licence Approving Authority. 

H.   CRITERIA FOR BLOOD DONATION: 

Conditions for donation of blood: 

(1)    General – No person shall donate blood and no blood bank shall draw 

blood  from  a  person,  more  than  once  in  three  months.  The  donor  shall  be  in  good 
health, mentally alert and physically fit and shall not be inmates of jail, persons having 
multiple sex partners and drug-addicts. The donors shall fulfil the following 
requirements, namely: - 

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1[(a)     the donor shall be in the age group of 18 to 65 years;]  
(b)     the donor shall not be less than 45 kilograms; 
( c)    temperature and pulse of the donor shall be normal; 
(d )    the systolic and diastolic blood pressure are within normal limits without 

medication; 
 haemoglobin which shall not be less than 12.5 grams; 
the donor shall be free from acute respiratory diseases; 

(e) 
(f) 
(g)    the donor shall be free from any skin diseases at the site of phlebotomy; 
(h)  the donor shall be free from any disease transmissible by blood transfusion, 
insofar as can be determined by history and examination indicated above; 
(i)  the arms and forearms of the donor shall be free from skin punctures or scars 
indicative  of   professional  blood  donors  or   addiction  of   self   injected 
narcotics. 

(2)      Additional qualifications of donor – No person shall donate blood, and no 
blood bank shall draw blood from a donor, in the conditions mentioned in column (1) 
of the Table given below before the expiry of the period of deferment mentioned in the 
column (2) of the said Table. 

Table: Deferment of blood donation 

CONDITIONS                                PERIOD OF DEFERMENT 

(1) 

(2)_ 

(a) 
(b) 
(c) 
(d) 
(e) 

Abortions 
History of Blood transfusion 
Surgery 
Typhoid 
History of Malaria and duly 
treated 
Tattoo 
Breast feeding 
Immunization (Cholera, 
Typhoid, Diphtheria, Tetanus, 
Plague, Gammaglobulin) 
Rabies vaccination 
(k)  History of Hepatitis in 
family or close contact 

(f) 
(h) 
(i) 

(j) 

6 months 
6 months 
12 months 
12 months after recovery 
2   months (endemic) 
3 years (non endemic area) 
6 months 
12 months after delivery 
15 days 

1 year after vaccination 

12 months 

  (l)      Immunoglobulin                                   12 months  

(3)   No person shall donate blood and no blood bank shall draw blood from a person, 

suffering from any of the diseases mentioned below, namely:– 

(a)       Cancer 
(b)      Heart disease 

1.  Subs. By G.S.R 101 (E), dt:18-2-2011 

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(c)      Abnormal bleeding tendencies 
(d)       Unexplained weight loss 
(e)      Diabetes-controlled on insulin 
1[(f)       Hepatitis infection] 
(g)  Chronic nephritis 
(h)      Signs and symptoms, suggestive of AIDS 
(i )      Liver diseases 
(j)      Tuberculosis 
(k)      Polycythemia Vera. 
(l)       Asthma 
(m)    Epilepsy 
(n)      Leprosy 
(o)      Schizophrenia 
(p)      Endocrine disorders 

I.          GENERAL EQUIPMENTS AND INSTRUMENTS. 

1.          For blood collection room: 

(i)   Donor beds, chairs and tables: These shall be suitably and comfortably 

cushioned and shall be of appropriate size. 

(ii)   Bedside table 
(iii)  Sphygmomanometer and stethoscope 
(iv)  Recovery beds for donors. 
(v)  Refrigerators,  for  storing  separately  tested  and  untested  blood, 
maintaining temperature between  2  to  6  degree  centigrade with  digital 
dial  thermometer,  recording  thermograph  and  alarm  device,  with 
provision for continuous power supply. 

(vi)   Weighing devices for donor and blood containers. 

2.     For haemoglobin determination: 

(i)  Copper sulphate solution (specific gravity 1.053) 
(ii)  Sterile lancet and impregnated alcohol swabs. 
(iii) Capillary tube (1.3 x 1.4 x 96 mm for Pasteur pipettes) 
(iv)  Rubber bulbs for capillary tubings. 
(v)  Sahli‘s haemoglobinometer / Colorimetric method. 

3.       For temperature and pulse determination. 

(i)  Clinical thermometers 
(ii) Watch (fitted with a second-hand) and a stop-watch. 

4.       For blood containers: 

(a)  Only disposable PVC blood bags shall be used (closed system) as per 

specifications  of IP/USP/BP. 

(b)  Anti-coagulants: The anti-coagulant solution shall be sterile, pyrogen-free 
and  of the following composition that will ensure satisfactory safety and 
efficacy   of the whole blood and/or for all the separate blood components. 

(i)       Citrate Phosphate Dextrose Adenine solution (CPDA) or Citrate Phosphate 
Dextrose Adenine – 1 (CPDA-1) – 14 ml solution shall be required for  

1. Subs. by G.S.R. No. 40(E), dated 29-01-2001. 

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100 ml of blood. 

Note 1.- (i) In case of single/double/triple/quadruple blood collection bags used for 

blood  component preparations, CPDA blood collection bags may be used. 
(ii)  Acid Citrate Dextrose solution (A.C.D. with Formula-A) I.P. – 15  ml solution 

shall  be required for 100 ml of blood, 

(iii) Additive solutions such as SAGM, ADSOL, NUTRICEL may be used for 

storing and retaining Red Blood Corpuscles up to 42 days. 

Note 2.- The licensee shall ensure that the anti-coagulant solutions are of a licensed 

manufacturer and the blood bags in which the said solutions are contained have 
a certificate of analysis  of the said manufacturer. 

5.  Emergency equipments/items: 

(i)       Oxygen cylinder with mask, gauge and pressure regulator. 
(ii)     5 per cent Glucose or Normal Saline. 
(iii)    Disposable sterile syringes and needles of various sizes. 

(iv)    Disposable sterile I.V. infusion sets. 
(v)  Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or  

Dexamethasone, Metoclorpropamide injections. 

(vi)    Aspirin. 

6.   Accessories: 

(i) 

Such  as  blankets,  emesis  basins,  haemostats,  set  clamps,  sponge  forceps,  gauze, 
dressing jars, solution jars, waste cans. 
(ii)       Medium cotton balls, 1.25 cm adhesive tapes. 
(iii)      Denatured spirit, Tincture Iodine, green soap or liquid soap. 
(iv)      Paper napkins or towels. 
(v)        Autoclave with temperature and pressure indicator. 
(vi)      Incinerator 
(vii)     Stand-by generator 

7.          Laboratory equipment: 

(i) 

Refrigerators,  for  storing  diagnostic  kits  and  reagents,  maintaining  a  temperature 
between  4  to  6  degree  centigrade  (plus/minus  2  degrees  centigrade)  with  digital 
dial thermometer having provision for continuous power supply. 

(ii)        Compound Microscope with low and high power objectives. 

(iii)       Centrifuge Table Model. 

(iv)       Water bath: having range between 37 degree centigrade to 56 degree centigrade. 

(v)        Rh viewing box in case of slide technique. 

(vi)       Incubator with thermostatic control. 
(vii)      Mechanical shakers for serological tests for Syphilis. 

(viii)     Hand-lens for observing tests conducted in tubes. 

(ix) 
(x) 

Serological graduated pipettes of various sizes. 
Pipettes (Pasteur). 

(xi)      Glass slides. 

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(xii)      Test tubes of various sizes / micrometer plates (U or V type). 

(xiii)  Precipitating tubes 6mm x  50mm of different sizes and glass beakers of different 

sizes. 

(xiv)     Test tube racks of different specifications. 
(xv)      Interval timer electric or spring wound. 
(xvi)      Equipment and materials for cleaning glass wares adequately. 
(xvii) 

Insulated  containers  for  transporting  blood,  between  2  degree  centigrade  to  10 
degree centigrade temperatures, to wards and hospitals. 

(xviii)      Wash bottles. 
(xix)        Filter papers. 
(xx)         Dielectric tube sealer. 
(xxi)        Plain and EDTA vials. 
(xxii)       Chemical balance (wherever necessary). 
(xxiii)      ELISA reader with printer, washer and micropipettes. 

J.      SPECIAL REAGENTS : 

(1)          Standard blood grouping sera Anti A, Anti B and Anti D with known controls. 

Rh typing sera shall be in double quantity and each of different brand or if 
from the same supplier each supply shall be of different lot numbers. 

(2)          Reagents for serological tests for syphilis and positive sera for controls.  
(3)          Anti Human Globulin Serum (Coomb‘s serum). 
(4)          Bovine Albumin 22 percent Enzyme reagents for incomplete antibodies.  
1[(5)          ELISA or RPHA test kits for Hepatitis and HIV I & II. 
(6)          Detergent and other agents for cleaning laboratory glass wares. 

K.      TESTING OF WHOLE BLOOD : 

(1) 

(2) 

(3) 

It  shall  be  responsibility of  the  licensee  to  ensure  that  the  whole  blood 
collected, processed and supplied conforms to the standards laid down in 
the Indian Pharmacopoeia and other tests published, if any, 
by the Government. 

Freedom from HIV antibodies (AIDS) Tests. – Every licensee shall get 
samples of every blood unit tested, before use, for freedom from HIV 1 and 
HIV II antibodies either from laboratories specified for the purpose by the 
Central Government or in his own laboratory. The results of such testing 
shall be recorded on the label of the container. 

Each blood unit shall also be tested for freedom from 2[(Hepatitis B 
surface antigen and Hepatitis C Virus antibody)] VDRL and malarial 
parasite and results of such testing shall be recorded on the label 
of the container. 

NOTES     (a)     Blood samples of donors in pilot tube and the blood samples of the 

Recipient shall be preserved for 7 days after issue. 

(b)     The blood intended for transfusion shall not be frozen at any stage. 

(c)     Blood containers shall not come directly in contact with ice at any stage. 

1. Subs. By G.S.R. 733(E) dated 21-12-2005 
2. Subs. by G.S.R. 40(E) dated 29-01-2001 

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L     RECORDS : 

Drugs and Cosmetics Rules 1945 

The records which the licensee is required to maintain shall include inter alia the 

following particulars, namely: 

(1)  Blood donor record:  It shall indicate serial number, date of bleeding, name, 
address  and  signature  of  donor  with  other  particulars  of  age,  weight, 
haemoglobin,  blood  grouping,  blood  pressure,  medical  examination,  bag 
number  and  patient‘s  detail  for  whom  donated  in  case  of  replacement 
donation,  category  of  donation  (voluntary  /  replacement)  and  deferral 
records and signature of Medical Officer In-charge. 

(2)   Master records for  blood and  its  components: It  shall  indicate  bag  serial 
number, date of collection, date of expiry, quantity in ml. ABO/Rh Group, 
results  for  testing  of  HIV  I  and  HIV  II  antibodies,  Malaria,  V.D.R.L. 
1[(Hepatitis  B  surface  antigen  and  Hepatitis  C  Virus  antibody)]  and 
irregular  antibodies  (if  any),  name  and  address  of  the  donor  with 
particulars, utilization  issue  number,   components prepared or  discarded 
and signature of the Medical Officer in charge. 

(3)   Issue Register: It shall indicate serial number, date and time of issue   bag 
serial number, ABO/RH Group, total quantity in ml, name and address of 
the recipient, group of recipient, unit/institution, details of cros-matching 
report, indication for transfusion. 

(4  )  Records of  components supplied: Quantity supplied; compatibility  report, 

details of recipient and signature of issuing person. 

(5)  Records of ACD/CPD/CPD-A/SAGM bags giving details of manufacturer, 

batch number, date of supply, and results of testing. 

(6)   Register   for   diagnostic   kits   and   reagents   used:   name   of   the 

kits/reagents, details of batch number, date of expiry and date of use. 

(7)   Blood bank  must issue the  cross matching report of the  blood to the 

patient together with the blood unit. 

(8)   Transfusion adverse reaction records. 

(9)  Records  of  purchase,  use  and  stock  in  hand  of  disposable  needles, 

syringes, blood bags, shall be maintained. 

NOTE :   The above records shall be kept by the licensee for a period of five 

years. 

M.      LABELS : 

The labels on every bag containing blood and/or component shall contain the 

following particulars, namely; 

(1) The proper name of the product in a prominent place and in bold letters on the bag. 

(2)  Name and address of the blood bank 

(3)  Licence number 

1 Subs. by G.S.R. 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001). 

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(4)  Serial number 

(5)   The date on which the blood is drawn and the date of expiry as prescribed under 

Schedule P to these rules. 

(6)   A colored label shall be put on every bag containing blood. The following color 

scheme for the said labels shall be used for different groups of blood: 

Blood Group                   Colour of the label 

O                                          Blue 
A                                        Yellow 
B                                          Pink 

                    AB                                       White  

(7)   The results of the tests for  1[(Hepatitis B surface antigen and Hepatitis C Virus 
antibody)]  syphilis,  freedom  from  HIV  I  and  HIV  II  antibodies  and  malarial 
parasite. 

(8)  The Rh. Group. 

(9)   Total  volume of blood, the preparation of blood, nature and percentage of anti- 

coagulant. 

(10) Keep continuously temperature at 2 degree centigrade to 6 degree centigrade for 
whole human blood and/or components as contained under III of Part XII B. 

(11)  Disposable transfusion sets with filter shall be used in administration equipment. 

(12)   Appropriate  compatible   cross-matched  blood  without  atypical   antibody  in 

recipient shall be used. 

(13)  The  contents  of  the  bag  shall  not  be  used  if  there  is  any  visible  evidence  of 

deterioration like haemolysis, clotting or discoloration. 

(14)  The  label  shall  indicate  the  appropriate  donor  classification  like  ―Voluntary 

Donor‖ or ―Replacement Donor‖ in no less prominence than the proper name. 

NOTES : 

1.  In  the  case  of  blood  components,  particulars  of  the  blood  from  which  such 
components have  been  prepared  shall  be  given  against  item  numbers  (5),  (7),  (8), 
(9) and (14). 

2.  The  blood  and/or  its  components  shall  be  distributed  on  the  prescription  of  a 

Registered Medical Practitioner. 

II.      BLOOD DONATION CAMPS. 

A blood donation camp may be organized by – 

1. Subs.  by G.S.R 40(E), dt. 29.1.2001. 

314 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(a)          a licensed designated Regional Blood Transfusion Centre ; or 

(b)          a licensed Government blood bank; or 

(c)        the Indian Red Cross society; or 

NOTES: 

(i)   ―  Designated  Regional  Blood  Transfusion  Centre‖  shall  be  a  center  approved 
and designated by a Blood Transfusion Council constituted by a State Government 
to collect, process and distribute blood and its components to cater to the needs of 
the  region  and  that  center  has  also  been  licensed  and  approved  by  the 
Licensing  Authority  and Central Licence Approving Authority for the purpose. 

(ii) The designated Regional Blood Transfusion Centre, Government blood bank and 
Indian Red Cross Society shall intimate  within a  period of  seven days, the venue 
where the blood camp was held and details of group wise blood units collected in 
the said camp to the Licensing Authority and Central Licence Approving Authority. 

For    holding    a    blood    donation    camp,    the    following    requirements    shall   

be fulfilled/complied with, namely: - 

(A)  Premises, personnel etc. 

(a)  Premises  under  the  blood  donation  camp  shall  have  sufficient  area  and 
the location shall be  hygienic so  as to allow  proper operation, maintenance 
and cleaning. 

(b)    All  information  regarding  the  personnel  working,  equipment  used  and 
facilities  available  at    such  a  Camp  shall  be  well  documented  and  made 
available for inspection, if required, and ensuring - 

(i)      Continuous and uninterrupted electrical supply for equipment used in the 

Camp; 

(ii)     Adequate lighting for all the required activities;  
(iii)     Hand-washing facilities for staff; 
(iv)  Reliable communication system to the central office of the 

Controller/ Organizer of the Camp; 

(v)     Furniture and equipment arranged within the available space;  
(vi)    Refreshment facilities for donors and staff; 
(vii)    Facilities for medical examination of the donors;  
(viii)    Proper disposal of waste. 

(B)    Personnel for Out-door Blood Donation Camp: 

To collect blood from 50 to 70 donors in about 3 hours or from 100 to 

200 donors in 5 hours, the following requirements shall be fulfilled / complied with: 

(i) 

one Medical Officer and two nurses or phlebotomists for 
managing 6-8 donor tables; 
(ii)        two medico social workers;  
(iii)       three blood bank technicians;  
(iv)       two attendants; 

315 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(v) 

vehicle  having  a  capacity  to  seat  8-10  persons,  with  provision  for 
carriage  of donation goods including facilities to conduct a blood 
donation camp; 

(C)            Equipments : 

1.          BP apparatus. 
2.          Stethoscope. 
3.          Blood bags (single, double, triple, quadruple). 
4.          Donor questionnaire. 
5.          Weighing device for donors. 
6.          Weighing device for blood bags. 
7.          Artery forceps, scissors. 
8.          Stripper for blood tubing. 
9.          Bed sheets, blankets/mattress. 
10.        Lancets, swab stick/tooth picks. 
11.        Glass slides. 
12.        Portable Hb meter/copper sulphate. 

13.        Test tube (big) and 12x100mm (small). 

14.        Test tube stand. 

15.        Anti-A, Anti-B and Anti-AB, Antisera and Anti-D. 

16.        Test tube sealer film. 

17.        Medicated adhesive tape. 

18.        Plastic waste basket. 

19.        Donor cards and refreshment for donors. 

20         Emergency medical kit. 

21 

Insulated  blood  bag  containers  with  provisions  for  storing  between  2 
degree centigrade to 10 degree centigrade. 

22.        Dielectric sealer or portable tube sealer. 

23.        Needle destroyer (wherever necessary). 

III. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD BY A  BLOOD 

BANK 

The Blood components shall be prepared by  blood banks as  a  part of the 
Blood Bank services. The conditions for grant or renewal of licence to prepare blood 
components shall be as follows: - 

A.    ACCOMMODATION: 

(1)  Rooms with adequate area and other specification, for preparing blood 

components depending on quantum of workload shall be as specified in item 
B under the heading ―1. BLOOD BANKS/BLOOD COMPONENTS‘ of this 
Part. 

(2)  Preparation  of  Blood  components  shall  be  carried  out  only  under  closed 
system  using  single  double,  triple  or  quadruple  plastic  bags  except  for 
preparation of Red Blood Cells Concentrates, where single bags may be used 
with transfer bags. 

B.     EQUIPMENT : 

316 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(i)         Air Conditioner; 

(ii)        Laminar air flow bench; 

(iii)       Suitable refrigerated centrifuge;  

(iv)       Plasma expresser; 

(v)        Clipper and clips and/or dielectric sealer; 

(vi)       Weighing device; 
(vii)      Dry rubber balancing material;  
(viii)     Artery forceps, 
scissors; 
(ix) 

Refrigerator    maintaining  a    temperature    between    2    degree  
centigrade    to    6  degree  centigrade,  a  digital  dial  thermometer  with 
recording thermograph and alarm device, with provision for continuous 
power supply; 

(x)        Platelet agitator with incubator (wherever necessary); 
(xi) 

Deep  freezers  maintaining  a  temperature  between  minus  30  degree 
centigrade  to  minus  40  degree  centigrade  and  minus  75  degree 
centigrade to minus 80 degree centigrade; 

(xii)      Refrigerated Water bath for Plasma Thawing; 
(xiii) 

Insulated    blood    bag    containers    with    provisions    for    storing    at  
appropriate temperature for transport purposes; 

C.   PERSONNEL: 

The  whole  time  competent  technical  staff  meant  for  processing  of  Blood  Components  (that  is 
Medical Officer, Technical Supervisor, Blood Bank Technicians and Registered Nurse) shall be as 
specified  in  item  C,  under  the  heading  ―  1.  BLOOD  BANKS/BLOOD  COMPONENTS‖ of  this 
Part. 

D.   TESTING FACILITIES: 

General:  Facilities for A, B, AB and O groups and Rh(D) grouping. 1[(Hepatitis B  surface  antigen 
and  Hepatitis C  Virus antibody)], VDRL, HIV  I  and  HIV  II antibodies and malarial parasites 
shall be mandatory for every blood unit before it is used for the  preparation  of  blood  components. 
The  results  of  such  testing  shall  be  indicated  on  the label. 

E.      CATEGORIES OF BLOOD COMPONENTS: 

(1)        CONCENTRATED HUMAN RED BLOOD CORPUSCLES: 

The product shall be known as ―Packed Red Blood Cells‖ that is Packed Red Blood Cells 
remaining after separating plasma from human blood. 

General Requirements: 

(a) 

Storage:  Immediately after processing, the Packed Red Blood Cells shall 
be  kept  at  a  temperature  maintained  between  2  degree  centigrade  to  6 
degree centigrade. 

(b)          Inspection:    The  component  shall  be  inspected  immediately  after 
separation  of  the  plasma,  during  storage  and  again  at  the  time  of  issue. 
The product shall not be issued  if  there  is  any  abnormality  in  color  or  
physical  appearance  or  any indication of microbial contamination. 
Suitability  of  Donor:  The  source  of  blood  for  Packed  Red  Blood  Cells  shall 
be  obtained  from  a  donor  who  meets  the  criteria  for  Blood  Donation  as 
specified  in  item  H  under  the  heading  ―I.  BLOOD  BANKS/BLOOD 
COMPONENTS‖ of this Part. 

(c) 

1. Subs. by G.S.R. 40(E), dt. 29.1.2001. 

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(d)  Testing  of  Whole  Blood:  Blood  from  which  Packed  Red  Blood  Cells  are 
prepared shall  be  tested  as  specified in  item  K  relating  to  Testing  Of  Whole 
Blood  under  the  heading ―I.  BLOOD  BANKS/BLOOD COMPONENTS‖ of 
this Part. 

(e)  Pilot  samples:  Pilot  samples  collected  in  integral  tubing  or  in  separate  pilot 

tubes shall meet the following specifications: 

(i)  One  or  more  pilot  samples  of  either  the  original  blood  or  the 
Packed  Red  Blood  Cells  being  processed  shall  be  preserved  with 
each unit of Packed Red Blood Cells which is issued. 

(ii) 

 Before  they  are  filled,  all  pilot  sample  tubes  shall  be  marked  
or identified so as to relate them to the donor of that unit or Packed 
Red Blood Cells. 

(iii)  Before  the  final  container  is  filled  or  at  the  time  the  final 
product  is prepared, the pilot samples tubes accompanying a unit 
of  Packed Red  Blood  Cells,  shall  be  attached  in  a  tamper-proof 
that  shall  conspicuously  identify  removal  and  re-
manner 
attachment. 

(iv)  All  pilot  sample  tubes,  accompanying  a  unit  of  packed  red 
blood  cells,  shall  be  filled  immediately  after  the  blood  is 
collected or at the time the final product is prepared, in each case, 
by the person who performs the collection of preparation. 

F.      Processing: 

(i) 

Separation:    Packed  Red  Blood  Cells  shall  be  separated  from 
the whole blood, -- 

(a)     if the whole blood is stored in ACD solution within 21 days, and 

(b) 

if  the  whole  blood  is  stored  in  CPDA-1  solution,  within  35  days, 
from  the  date  of  collection.  Packed  Red  Blood  Cells  may  be 
prepared  either  by  centrifugation  done  in  a  manner  that  shall  not 
tend  to  increase  the  temperature  of  the  blood  or  by  normal 
undisturbed  sedimentation  method.  A    portion  of    the    plasma,  
sufficient  to  ensure  optimal  cell preservation, shall be left with the 
packed Red Blood Cells. 

(ii) 

to 

the  manufacturer  submits  data 

Packed  Red  Blood  Cells  Frozen:    Cryophylactic  substance  may 
the  Packed  Red  Blood  Cells  for  extended 
be  added 
than  minus  65  degree 
manufacturer‘s  storage  not  warmer 
centigrade  provided 
the 
satisfaction  of  the  Licensing  Authority  and  Central  Licence 
Approving Authority, as adequately demonstrating through in-vivo 
cells  survival  and  other  appropriate  tests  that  the  addition  of  the 
substance,  the  material  used  and  the  processing  methods  results 
in  a  final  product  meets  the  required standards of safety, purity 
and  potency  for  Packed  Red  Blood  Cells,  and  that  the  frozen 

to 

318 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

product  shall  maintain  those  properties  for  the  specified  expiry 
period. 

(iii) 

Testing:  Packed  Red  Blood  Cells  shall  conform  to  the  standards 
as laid down in the Indian Pharmacopoeia. 

(2)        PLATELETS CONCENTRATES: 

The product shall be known as ―Platelets Concentrates‖ that is platelets 
collected from one unit of blood and re-suspended in an appropriate volume of original 
plasma. 

General Requirements: 

(i)    Source: The source material  for platelets  shall be platelet  rich plasma or 

buffy coat which may be obtained from the whole blood or by plateletpheresis. 

(ii)   Processing : 

(a) 

(b) 

Separation  of  buffy-coat  or  platelet-rich  plasma  and  platelets  and  re-
suspension  of  the  platelets  shall  be  in  a  closed  system  by  centrifugal 
method with appropriate speed, force and time. 

Immediately after collection, the  whole blood or  plasma shall be  held in  
storage  between  20  degree  centigrade  to  24  degree  centigrade. When 
it  is  to  be  transported  from  the  venue  of  blood  collection  to  the 
processing  laboratory,  during  such  transport  action,  the  temperature  as 
close  as  possible  to  a  range  between  20  degree  centigrade  to  24  degree 
centigrade    shall    be    ensured.    The    platelet    concentrates    shall    be 
separated  within  6  hours  after  the  time  of  collection  of  the  unit  of 
whole blood or plasma. 

(c)  The time and speed of centrifugation shall be demonstrated to produce an 
unclamped product, without visible haemolysis, that yields a count of  not 
less  than  3.5  x  1010    (3.5  x  10  raised  to  the  power  of  10)  and 4.5 x 1010  
(4.5 x 10 raised to the power ten) i.e. platelets per unit from a  unit of 350 
ml  and  450  ml  blood  respectively.  One  percent  of  total  platelets 
prepared shall be tested of which 75 per cent of the units shall conform to 
the above said platelet count. 

(d)  The  volume  of  original  plasma  used  for  re-suspension  of  the  platelets 
shall  be  determined  by  the  maintenance  of  the  pH  of  not  less  than  6 
during  the  storage  period.  The  pH  shall  be  measured  on  a  sample  of 
platelets  which  has  been  stored  for  the  permissible  maximum  expiry 
period at 20 degree centigrade to 24 degree centigrade. 

(e) 

Final  containers  used  for  platelets  shall  be  colorless  and  transparent to 
permit  visual  inspection  of  the  contents.  The  caps  selected  shall 
maintain a  hermetic  seal  to  prevent contamination of  the  contents. The 
container  material  shall  not  interact   with  the  contents,  under  the 
normal conditions of the storage and use, in such a manner as to have an 
adverse  effect  upon  the  safety,  purity,  potency,  or  efficacy  of  the 
product.  At  the  time  of  filling,  the  final  container  shall  be  marked  or 
identified by number so as to relate it to the donor. 

(iii) 

Storage:        Immediately  after  re-suspension,  platelets  shall  be 
placed  in storage  not  exceeding  for  a  period  of  5  days,  between  
20    degree  centigrade  to  24  degree  centigrade,  with  continuous 
gentle  agitation  of  the  platelet  concentrates  maintained  throughout 
such storage 

319 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(iv) 

Testing:  The  units  prepared  from  different  donors  shall  be  tested  at 
the end of the storage period for – 

(a)      Platelet count; 

(b) 

 pH of not less than 6 measured at the storage temperature of 
the unit; 

(c)     measurement of actual plasma volume; 

(d)    one  percent  of  the  total  platelets  prepared  shall  be  tested 

for sterility; 

(e) 

(f) 

the tests of functional viability  of the  platelets  shall be  done 
by swirling movement before issue. 

if the results of the testing indicate that the product does not 
meet the specified requirements, immediate  corrective action 
shall be taken and records maintained; 

(v)  Compatibility  Test:    Compatible    transfusion  for    the    purpose    of  
variable number of Red Blood Cells, A, B, AB and O grouping shall be 
done if the platelets concentrate is contaminated with red blood cells. 

(3)        GRANULOCYTE CONCENTRATES: 

(i)  Storage:   It   shall   be   kept   between   20   degree   centigrade   to   24  

degree centigrade for a maximum period of 24 hours; 

(ii)  Unit of granulocytes shall not be  less than 1 x 1010   (i.e. 1 x 10 raised to 

the power of 10) when prepared on cell separator; 

(iii)    Group specific tests/HLA test wherever required shall be carried out. 

(4)        FRESH FROZEN PLASMA: 

Plasma  frozen  within  6  hours  after  blood  collection  and  stored  at  a  temperature 
not  warmer  than  minus  30  degree  centigrade,  shall  be  preserved  for  a  period  of 
not more than one year. 

(5)        CRYOPRECIPITATE: 

Concentrate  of  anti-hemophiliac  factor  shall  be  prepared  by  thawing  of  the  fresh 
plasma frozen stored at minus 30 degree centigrade. 

(a)     Storage: 

Cryoprecipitate shall be preserved at  a temperature not higher than minus 30 
degree  centigrade  and  may  be  preserved  for  a  period  of  not  more  than  one 
year from the date of collection. 

(b)     Activity: 

Anti-hemophiliac factor activity in the final product shall be not less than 80 
units per bag. One percent of the total cryoprecipitate prepared shall be tested 
of  which  seventy  five  percent  of  the  unit  shall  conform  to  the  said 
specification. 

F  PLASMAPHERESIS,   PLATELETPHERESIS,   LEUCAPHERESIS,   USING   A 

CELL  SEPARATOR. 

An area of 10 square meters shall be provided for apheresis in the blood bank. 

The  blood banks specifically permitted to  undertake the  said  apheresis on  the  donor 
shall  observe  the  criteria  as  specified  in  item  H  relating  to  Criteria  for  blood  donation    ―I. 
Blood Banks/Blood Components‖ of this Part. The written consent of the donor shall be taken 
and the donor must be explained, the hazards of apheresis. The Medical Officer shall certify 
that  the  donor  is  fit  for  apheresis  and  it  shall  be  carried  out  by  a  trained  person  under 
supervision of the Medical Officer. 

320 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(A)        PLASMAPHERESIS, PLATELETPHERESIS AND LEUCAPHERESIS: 

The  donors  subjected  to  plasmapheresis,  plateletpheresis and  leucapheresis  shall,  in 
addition  to  the  criteria  specified  in  item  H  relating  to  the  CRITERIA  FOR  BLOOD 
DONATION, under the heading  ―I. BLOOD BANKS/BLOOD COMPONENTS‖ of this Part 
being  observed,  be  also  subjected  to  protein  estimation  on  post-pheresis/first  sitting  whose 
results  shall  be  taken  as  reference  for  subsequent/sitting. It  shall  also  be  necessary  that  the 
total plasma obtained from such donor and periodicity of Plasmapheresis shall be according to 
the standards described under validt. Standard Operating Procedures. 

NOTE : 

(i)  At  least  48  hours  must  elapse  between  successive  apheresis  and  not  more 

than twice in a week. 

(ii) 

 Extracoporeal  blood  volume  shall  not  exceed  15%  of  donor‘s  estimated 
blood volume. 

(iii) 

 Platelet  pheresis  shall  not  be  carried  out  on  donors  who  have  taken 
medication containing Asprin within 3 days prior to donation. 

(iv) 

If  during  plateletpheresis  or  leucapheresis,  RBCs  cannot  be  re-transfused 
then at least 12 weeks shall elapse before a second cytapheresis procedure 
is conducted. 

(B)     MONITORING FOR APHERESIS: 

Before starting apheresis procedure, hemoglobin or haematocrit shall be done. Platelet count, 
WBC  counts,  differential  count  may  be  carried  out.  In  repeated  plasmapheresis,  the  serum 
protein shall be 6 gm./ml. 

(C)     COLLECTION OF PLASMA: 

The quantity of plasma separated from the blood of donor shall not exceed 500 ml. per sitting 
and once in a fortnight or shall not exceed 1000 ml per month. 

I. REQUIREMENTS  FOR  MANUFACTURE  OF  BLOOD  PRODUCTS 

PART XII C 

The  blood  products  shall  be  manufactured  in  a  separate  premises  other  than  that 
meant for  blood bank. The requirements that  are  essential for  grant or  renewal of  licence  to 
manufacture blood  products  such  as  Albumin,  Plasma  Protein  Fraction,  Immunoglobins and 
Coagulation Factor Concentrates, shall be as follows, namely: - 

A.      GENERAL REQUIREMENTS: 

1. Location and surroundings, buildings and water supply: 

The  requirements  as  regards  location  and  surrounding,  buildings  and  water 
supply  as  contained  in  paragraphs  1.1.1,  1.1.2,  1.1.3  of  Part  1  of  Schedule  M  shall 
apply mutatis mutandis  to the manufacture of blood products. 

2. Disposal of waste and infectious materials: 

321 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(i)    The  requirements  as  regards  disposal  of  waste  and  infectious  materials  as 
contained  in  paragraph  1.1.4  of  Part  1  of  Schedule  M  shall  apply  mutatis 
mutandis  to the manufacture of blood products. 

(ii)  Proper  facility  shall  also  be  provided  for  potentially  infectious  materials, 
particularly  HIV  I  &  HIV  II  1[(Hepatitis  B  surface  antigen  and  Hepatitis  C 
Virus  antibody)]  through  autoclaving,  incineration  or  any  other  suitable 
validt. methods. 

3.  Health, clothing and sanitation personnel: 

(i)    The  requirement  as  contained  in  paragraph  3  of    Part  I  of 

Schedule M shall be complied with. 

(ii)  The   personnel   working   in   the   manufacturing   areas   shall   be 
vaccinated against Hepatitis B virus and other infectious transmitting 
diseases. 

4.   Requirements for manufacturing area for Blood Products: 

(i)  For  the  manufacture  of  blood  products,  separate  enclosed  areas  specifically 
designated for the purpose shall be provided. These areas be provided with air locks for 
entry and shall be essentially dust free and ventilated with an air supply. Air supply for 
manufacturing area shall be filtered through bacteria retaining filters (HEPA Filters) and 
shall be at a pressure higher than in the adjacent areas. 

The  filters  shall  be  checked  for  performance  on  installation  and  periodically 

thereafter, and records thereof shall be maintained. 

(ii)      Interior  surfaces  (walls,  floors  and  ceilings)  shall  be  smooth  and  free  from 
cracks,  they shall not shed matter and shall permit easy cleaning and disinfection. Drains 
shall be excluded from aseptic areas. 

1. Subs. by G.S.R. 40(E) dated 29-01-2001 

322 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Routine  microbial  counts  of  the  manufacturing  area  shall  be  carried  out  during 
manufacturing  operations.  The  results  of  such  counts  shall  be  checked  against  well 
documented in-house standards and records maintained. 

Access  to  the  manufacturing  areas  shall  be  restricted  to  a  minimum  number  of 
authorized  personnel.  Special  procedures  for  entering  and  leaving  the  manufacturing 
areas shall be prominently displayed. 

(iii)      Sinks  shall  be  excluded  from  aseptic  areas.  Any  sink  installed  in  other  clean 
areas  shall  be  of  suitable  material  such  as  stainless  steel,  without  an  overflow,  and  be 
supplied  with  water  of  potable  quality.  Adequate  precautions  shall  be  taken  to  avoid 
contamination of the drainage system with dangerous effluents and airborne dissemination 
of pathogenic micro-organisms. 

(iv)  Lighting,  air-conditioning,  ventilation  shall  be  designed  to  maintain  a 
satisfactory temperature and relative humidity to minimize contamination and to take account 
of the comfort of personnel working with protective clothing. 

(v)   Premises used for the manufacture of blood products shall be suitably designed and 

constructed to facilitate good sanitation. 

(vi)  Premises  shall  be  carefully  maintained  and  it  shall  be  ensured  that  repair  and 
maintenance operations do not present any hazard to the quality of products. Premises shall 
be  cleaned  and,  where  applicable,  disinfected  according  to  detailed  written  validt. 
procedures. 

(vii)  Adequate  facilities  and  equipments  shall  be  used  for  the  manufacture  of  blood 

products derived from blood plasma. 

(viii) All containers of blood products, regardless of the stage of manufacture, shall be 
identified by securely attached labels. Cross contamination shall be prevented by adoption 
of the following measures, namely: – 

(a)   processing and filling shall be in segregated areas; 

(b)     manufacture  of  different  products  at  the  same  time  shall  be 
avoided; 

(c)   simultaneous filling of the different products shall be avoided; 

(d)  ensure  transfer,  containers/materials  by  means  of  airlocks,  air 
extraction,  clothing  change  and  careful  washing  and  decontamination  of 
equipment; 

(e)      protecting  containers/materials  against  the  risk  of  contamination 
caused  by  re-circulation  of  untreated  air  or  by  accidental  re-entry  of 
extracted air; 

(f)    using  containers  that  are  sterilized  or  are  of  documented  low 

―bioburden‖, 

(ix) Positive pressure area shall be dedicated to the processing area concerned; (x) Air-

handling units shall be dedicated to the processing area concerned; 

(xi) Pipe work, valves and vent filters shall be properly designed to facilitate cleaning 
and  sterilization.  Valves  on  fractionation/reacting  vessels  shall  be  completely  steam 
sterilisable. Air vent filters shall be hydrophobic and shall be validated for their designated 
use. 

5.  Ancillary Areas : 

(i)   Rest and refreshment rooms shall be separated from other areas. 

323 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(ii)   Facilities  for  changing  and  storing  clothes  and  for  washing  and  toilet 
purposes  shall  be  easily  accessible  and  appropriate  for  the  number  of  users. 
Toilets shall not be connected directly with production or storage areas. 

(iii)  Maintenance  workshops  shall  be  separated  from  production  areas. 
Wherever parts and tools are stored in the production area, they shall be kept in 
rooms or lockers reserved for that use. 

(iv)      Animal  houses  shall  be  well  isolated  from  other  areas  with  separate 

entrance. 

B.   COLLECTION AND STORAGE OF PLASMA FOR FRACTIONATION 

(a)      Collection: 

(1)  Plasma  shall  be  collected  from  the  licensed  Blood  Banks  through  a 
cold  chain  process  and  stored  in  frozen  condition  not  warmer  than  minus 
twenty degree centigrade. 

(2)  Individual  plasma  shall  remain  in  quarantine  till  it  is  tested  for 

1[( Hepatitis B and Hepatitis C Virus antibody)], HIV I and HIV II. 

(3)  A  sample  from  pooled  –  lot  plasma  of  about  10-12  units  of  different 
donors shall be tested for 1[(Hepatitis B and Heptitis C Virus antibody)]  HIV I 
and HIV II and if the same sample found negative, only then it shall be taken 
up for fractionation. 

(b)        Storage Area : 

(1)  Storage  areas  shall  be  of  sufficient  space  and  capacity  to  allow  orderly 
storage  of  the  various  categories  of  materials,  intermediates,  bulk  and  finished 
products,    products    in    quarantine,   released,    rejected,    returned,    or    recalled 
products. 

(2)      Storage  areas  shall  be  designed  or  adopted  to  ensure  good  storage 
conditioning.  In  particular,  they  shall  be  clean,  dry  and  maintained  within 
temperature  required  for  such  storage  and  where  special  storage  conditions  are 
required  (e.g.  temperature,  humidity),  these  shall  be  provided,  checked  and 
monitored. 

(3)  Receiving and dispatch bays shall protect materials and products from the 
weather  and  shall  be  designed  and  equipped  to  allow  containers  of  incoming 
materials to be cleaned, if necessary, before storage. 

(4)    Where  quarantine  status  is  ensured  by  storage  in  separate  areas,  these 
areas  shall  be  clearly  marked  and  their  access  restricted  only  to  authorized 
personnel. 

(5)    There shall be  separate  sampling area for  raw materials. If  sampling is 
performed  in  the  storage  area,  it  shall  be  conducted  in  such  a  way  so  as  to 
prevent contamination or cross-contamination. 

(6)      Segregation  shall  be  provided  for  the  storage  of  rejected,  recalled,  or 

returned materials or products. 

(7)   Adequate facility shall be provided for supply of ancillary material, such 
as  ethanol,  water,  salts  and  polyethylene  glycol.  Separate  facilities  shall  be 
provided for the recovery of organic solvents used in fractionation. 

1. Subs. by G.S.R 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001) 

324 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

C.  PERSONNEL : 

(1)      Manufacture : 

The  manufacture  of  blood  products  shall  be  conducted  under  the  

active direction and personal supervision of competent technical staff,  
consisting  of  at 

least  one  person  who  shall  be  a  whole  time  employee,  with  one  year 
practical experience  in  the  manufacture  of  blood  products  /  plasma  
fractionation  and possesses –- 

(a)   Post-graduate  degree  in  Medicine–M.D.  

(Microbiology/Pathology/ Bacteriology/Immunology/Biochemistry); 
or 

(b) Post-graduate degree in Science (Microbiology); or 
(c) Post-graduate degree ib Pharmacy (Microbiology), from a 
recognized University or Institution. 

2.       Testing : 

the 

The  head  of 

testing  unit  shall  be 

the 
manufacturing  unit  and  testing  shall  be  conducted  under  the  active 
direction and personal supervision of  competent  technical  staff  consisting 
at  least  one  person  who  shall  be  a  whole time employee. The Head of the 
testing unit shall have eighteen months practical experience in the testing of 
drugs, especially the blood products and possesses – 

independent  of 

(a)    Post-graduate    degree     in     Pharmacy     or     Science–

(Chemistry/ Microbiology/ Bio-chemistry); or 

(b)    Post-graduate   degree   in   Medicine–

M.D(Microbiology/Pathology/ Biochemistry), from a recognized 
University or Institution. 

D.   PRODUCTION CONTROL : 

(1)      The  production  area  and  the  viral  inactivation  room  shall  be 
centrally air- conditioned and  fitted  with  HEPA filters  having Grade C 
(Class 10,000) environment as given in the Table below. 

(2)      The  filling  and  sealing  shall  be  carried  out  under  aseptic 
conditions  in  centrally  air-conditioned  areas  fitted  with  HEPA  Filters 
Grade A or, as the case may be, Grade B (Class 100) environment given 
in the said Table. 

                             TABLE 

AIR CLASSIFICATION SYSTEM FOR MANUFACTURE OF STERILE 
PRODUCTS. 

Grade 

Maximum number of particles 
permitted  per  m3

0.5 – 5 micron     Less than 5 micron 

Maximum number of Viable 
Micro-organism permitted per 
m3 

325 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A (Class 100) 

3500 

None 

Less than 1 

Drugs and Cosmetics Rules 1945 

(Laminar - Airflow 

workstation) 

B (Class 100) 

3500 

C (Class 10,000) 

3,50,000 

None 

2000 

Less than 5 

Less than 100 

(3)      The  physical  and  chemical  operations  used  for  the  manufacture  of 
plasma fractionation shall maintain high yield of safe and effective protein. 

(4)    The  fractionation  procedure  used  shall  give  a  good  yield  of  products 
meeting  the  in-house  quality  requirements  as  approved  by  the  Licensing 
Authority  and  Central  Licence  Approving  Authority  reducing  the  risk  of 
microbiological contamination and protein denaturation to the minimum. 

(5)    The  procedure  adopted  shall  not  affect  the  antibody  activity  and 
biological half- life or biological characteristics of the products. 

E.      VIRAL INACTIVATION PROCESS : 

The  procedure  used  by  the  licensee  to  inactivate  the  pathogenic  organisms  such 
as enveloped   and   non-enveloped  virus,   especially   infectivity   from   HIV   I   &  
HIV  II, 1[(Hepatitis  B  surface  antigens and  Hepatitis  C  Virus  antibody)], the  viral 
inactivation and  validation methods adopted by  the licensee, shall be  submitted for 
approval to the Licensing Authority and Central Licence Approving Authority. 

NOTES: 

(1) No preservative (except stabilizer to prevent – protein denaturation such as 
glycine, sodium chloride or  sodium caprylate) shall  be  added  to  Albumin, 
Plasma  Protein  Fraction,  Intravenous  Immunoglobulins  or  Coagulation 
Factor Concentrates without the prior approval of Licensing Authority and 
Central Licence Approving Authority. 

(2)  The  licensee  shall  ensure  that  the  said  stabilizers  do  not    have  deleterial 
effect  on  the final  product in  the  quantity   present so  as  not  to  cause  any 
untoward or adverse reaction in human beings. 

F.  QUALITY CONTROL: 

Separate 

facilities  shall  be  provided 

for  Quality  Control  such  as 
Hematological,  Bio-chemical,  Physico-chemical,  Microbiological,  Pyrogens, 
Instrumental  and  Safety  testing.  The    Quality    Control    Department  shall    have  
inter  alia  the  following  principal  duties, namely :- 

(1)  To prepare detailed instructions for carrying out test and analysis. 

(2)  To  approve  or  reject  raw  material,  components,  containers,  closures,  in-
process materials, packaging material, labelling and finished products. 

(3)  To  release  or  reject  batch  of  finished  products  which  are  ready  for  

distribution.  

(4)  To evaluate the adequacy of the conditions under which raw materials, semi-

finished products and finished products are stored. 

1. Subs. by G.S.R 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001) 

326 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(5)  To evaluate the quality and stability of finished products and when necessary of 

raw materials and semi-finished products. 

(6) To review production records to ensure that no errors have occurred or if errors 

have occurred that they have been fully investigated. 

(7)  To  approve  or  reject  all  procedures,  or  specifications  impacting  on  the  identity, 

strength, quality and purity of the product. 

(8)  To  establish  shelf-life  and  storage  requirements  on  the  basis  of  stability  tests 

related to storage conditions. 

(9) To establish and when necessary revise, control procedures and specifications. 
(10) To review complaints, recalls, returned or salvaged products and investigations 
conducted there under for each product. 
(11) To review Master Formula Records/Cards periodically. 

G.  TESTING OF BLOOD PRODUCTS: 

The  products  manufactured  shall  conform  to  the  standards  specified  in  the 
Indian  Pharmacopoeia  and  where  standards  of  any  product  is  not  specified  in  the 
Pharmacopoeia,  the  standard    for    such    product    shall    conform  to    the    standard  
specified    in    the    United    States  Pharmacopoeia  or  the  British  Pharmacopoeia.  The 
final  products  shall  be  tested  for  freedom  from  HIV  I  and  HIV  II  antibodies 
1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)]. 

H.  STORAGE OF FINISHED PRODUCT : 

(i)  The  final  products shall  be  stored  between  two  degree  centigrade to  eight 
degree  centigrade,  unless  otherwise  specified  by  the  Central  Licence  Approving 
Authority. 

(ii)  The  shelf-life  assigned  to  the  products  by  the  licensee  shall  be  submitted 

for approval to the Licensing Authority and Central Licence Approving Authority. 

I.   LABELLING : 

The    products    manufactured   shall    be    labelled    as    specified   in    the   
Indian Pharmacopoeia, the British Pharmacopoeia or the United Stated Pharmacopoeia 
which  shall be  in  addition  to  any  other  requirement  stated  under  Part  IX  or  Part  X 
of  these  rules.  The  labels  shall  indicate  the  results  of  test  for  1[(Hepatitis  B  surface 
antigen and Hepatitis C Virus antibody)]  freedom from HIV I and HIV II antibodies. 

J.     RECORDS: 

The  licensee  shall  maintain  records  as  per  Schedule  U  and  also  comply  with 
Batch manufacturing  records as specified in Paragraph 9 of Part -I of Schedule M and 
any other requirement as  may be directed by Licensing Authority and Central Licence  
Approving Authority. 

K.   MASTER FORMULA RECORDS: 

The  licensee  shall  maintain  Master  Formula  Records  relating  to  all 

manufacturing  and quality  control  procedures  for  each  product,  which  shall  be 
prepared  and  endorsed  by  the Competent Technical Staff, i.e. Head of the 
manufacturing unit. The Master Formula Records shall contain: – 

(i)      the  patent  or  proprietary  name  of  the  product  along  with  the  generic 

name,  if any, strength and the dosage form; 

(ii)      a  description or  identification  of the final containers, packaging materials, 

labels and closures to be used; 

1. Subs. by G.S.R 40(E), dt. 29.1.2001(w.e.f. 1.6.2001) 

327 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(iii)   the identity, quantity and quality of each raw material to be used irrespective 
of  whether  or  not  it  appears  in  the  finished  product.  The  permissible 
overage that may be included in a formulated batch shall be indicated; 

(vi) 

(iv)  a description of all vessels and equipments and the sizes used in the process; 
(v)  manufacturing and control instructions along with parameters  for critical 
steps such as mixing, drying, blending, sieving and sterilizing the product; 
the theoretical yield to be expected from the formulation at different 
stages of manufacture and permissible yield limits; 
 detailed  instructions  on  precautions  to  be  taken  in  the  manufacture  and 
storage of drugs and of semi finished products; and 
the  requirements in-process quality  control tests  and  analysis to  be  carried 
out  during    each    stage    of    manufacture  including    the    designation  of  
persons    or  departments  responsible  for  the  execution  of  such  tests  and 
analysis. 

(vii) 

(viii) 

II. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS FROM BULK 
FINISHED PRODUCTS 

Where 

the  blood  products,  such  as  Albumin,  Plasma  Protein  Fraction, 
Immunoglobulins  and  Coagulation  Factor  Concentrates  are  manufactured  through  the 
manufacturing  activities  of  filling  and  sealing  the  blood  products  from  bulk  powder 
or solution or both, the requirements as they apply to the manufacture of  blood products 
from  whole  blood  shall  apply  mutatis  mutandis  to  such  manufacture of  blood  products, 
unless  other  requirements  have  been  approved  by  the  Central  Licence  Approving 
Authority.] 

1[PART XIID 

REQUIREMENTS FOR COLLECTION, PROCESSING, TESTING, STORAGE, 
BANKING AND RELEASE OF UMBILICAL CORD BLOOD DERIVED STEM CELLS 

(A) GENERAL REQUIREMENTS 
1.   Location, Surroundings and Building: The building (s) for storage of Umbilical cord blood 
shall be so situated and shall have such measures as to avoid risk of contamination from external 
environment  including    open  sewage,  drain,  public  lavatory  or  any  factory  which  produces 
disagreeable  or  obnoxious  odour  or  fumes,  excessive  soot,  smoke,  chemical    or  biological 
emissions. 
2.   Buildings and premises: (1) The premises used for processing and storage shall be designed, 
constructed and adapted and maintained  to ensure that the above operations and other ancillary 
functions  are  performed  smoothly  under  hygienic  conditions  and  in  sterile  areas  wherever 
required.  They shall also conform to the conditions laid down in the Factories Act, 1948 (63 of 
1948). 
The premises shall be: 

(a)  Adequately  provided  with  working  space  to  allow  orderly  and  logical  placement  of 
equipment, material and movement of personnel so as to maintain  safe operations and 
prevent contamination; 

(b)  Designed / constructed / maintained to prevent entry of insects, pests, birds, vermins and 
rodent. interior surfaces (walls, floors, ceilings and doors) shall be smooth and free from 
cracks,  and  permit  easy  cleaning,  painting  and  disinfection,  and  in  aseptic  areas  the 
surfaces shall be impervious, non-shedding, non-flaking  and non-cracking; 

(c)  Flooring  shall  be  unbroken  and provided  with  a cove  both at  the junction  between the 

wall and the floor as well as the wall and the ceiling. 

1. Inserted by G.S.R. 899(E) dated 27-12-2011 

328 

 
 
 
 
 
 
 
 
 
 
 
(d)  Provided  with  light  fitting  and  grills  which  shall  flush  with  the  walls  and  not  hanging 

Drugs and Cosmetics Rules 1945 

from the ceiling to prevent contamination; 

(e)  If  provided  with fire escapes, these shall  be  suitably  installed in the  walls  without  any 

gaps; 

(f)  Provided  with  the  furniture  in  aseptic  areas  which  is  smooth,  washable  and  made  of 

stainless steel or any other appropriate non shedding material other than wood; 

(g)  Provided with separate areas for processing and storage of products to prevent mix- ups, 

product contaminations and cross contamination; 

(h)  Provided with defined environmental conditions for temperature, humidity,  ventilation 

and air filtration. Classifications shall be defined and, if appropriate, monitored. 

(2) A periodical record of cleaning and renovating of the premises shall be maintained.  

3.  Disposal of waste and infectious materials: 

(a)  Waste materials awaiting disposal shall be stored safely; 
(b)  The  disposal  of  sewage  and  effluents  from  the  facility  shall  be  in  conformity  with  the 

requirements of the Pollution Control Board; 

(c)  All bio-medical  waste shall be dealt with in accordance with the provisions of the Bio-

medical Waste Management and Handling  Rules, 1996.  

4. Health, clothing and Sanitation of personnel: 

(a)  All personnel shall undergo medical examination prior to employment and shall be free 
from  infectious  and  contagious    diseases  and  thereafter    they  should    be  medically 
examined  periodically  at  least  once  a  year  and  for  this  purpose  records  shall  be 
maintained thereof: 

(b)  All personnel, prior to and during employment, shall be trained in practices which ensure 
personal  hygiene  and  a  high  level  of  personal  hygiene  shall  be  observed  by  all  those 
engaged in the collection, processing, banking of umbilical cord blood; 

(c)  All persons shall wear clean body coverings appropriate for their duties before entering  
the  Processing  Zone  and  the  Change  Rooms  with  adequate  facilities  shall  be  provided 
prior to entry into any specific zone; 

(d)  Smoking, eating, drinking is prohibited inside the Laboratory; 
(e)  All personnel working in the Laboratory shall be protected against virus infections.  

5. Requirements for Processing, Testing and Storage Areas for Umbilical cord blood stem cells: 

(a)  Separate dedicated areas specifically designed for the purpose and the workload shall be 

provided: 

(b)  There shall be separate areas for designated work purposes namely:- 

(i)  Cord blood Reception: cord blood reception  area with space for transient storage of 
units  and  physical  examination  shall  have  adequate  facilities  for  registration,    date 
entry and generation of bar-coded labels.   Air condition area of at lease 10.00 Sq. 
meters shall be provided; 

(ii)  Cord  blood  processing  area:  The  room  shall  be  clean  and  have  an  air  handling 
System to provide a Class 10,000 environment.   Entry to this area shall be through 
air  lock.  The  room  will  house  Class  100  biological    safety  cabinets  for  Umbilical 
cord blood processing.   The temperature of the clean room shall be maintained  20 
ºC  to  25ºC  and  with  a  positive  differential  pressure  of  10-15  pascals  and  Relative 
humidity of 50-60% Minimum area shall be 10.00 Sq. meters for the activity; 

(iii) Haematology  and  Serology  Laboratory:  The  laboratory  shall  be  equipped  and 
utilized for the purpose of independently testing of Umbilical Cord Blood for ABO 
grouping  and  Rh  Typing,  Total  Nucleated  Cell  Count,  Progenitor  cell  count  and 

329 

 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

viability test. The room shall be air-conditioned and area of at least 10.00 Sq. meters 
shall be provided. 

(iv) Transfusion Transmissible Disease Screening Laboratory: The Laboratory shall  be 
equipped  and utilized for screening  tests on maternal blood for infectious diseases 
viz. HIV I & II; Hepatitis B & C virus, syphilis, malaria, CMV and HTLV. The room 
shall be air-conditioned and area of at least 10.00 Sq. meters shall be provided. 

(v)  Sterility  Testing  Laboratory:  The  laboratory  shall  be  used  for  performing  Sterility 
tests on Umbilical Cord blood unit. The premises may be classified depending on the 
testing method used.  The room shall be air-conditioned with adequate and ancillary 
area  for media  prepar ation,  sterilization, incubation and decontamination.  Area of 
at least 10.00 Sq. meters shall be provided. 

(vi) HLA Typing  Laboratory:   The Umbilical  Cord blood unit  shall  have arrangements 
for  HLA  typing  and  genetic  disease  testing.    In-house  testing  can  be  done  by 
providing  a well demarcated laboratory from the processing area for evaluation of 
possible  genetic  disease  and  HLA  typing.    The  area  shall  have  Class  100,000 
environment  and  air-conditioned  and  area  of  at  least  10.00  Sq.  meters  shall  be 
provided. 

(vii) 

Sterilization-cum-washing:  Appropriate  facility  shall  be  provided  within  the 
premises  for  proper  washing  and  sterilization.  This  facility  would    be  optional  for 
laboratories using entirely disposable items. 

(viii)  Records  and  Store  Rooms:  There  shall  be  designed  record  room(s)    and  store 
room(s)  of  at  least  10.00  Sq.  meters  each.    The  access  to  record  room  shall  be 
permitted  only  to  authorized  person.  The  room  will  have  adequate  protective 
facilities as the documents  and records  are to be preserved  for long years. 

(ix) Cryogenic  Storage room: A minimum space of 20.00 sq. meters shall be provided by 
the  licensee.    The  cryogenic  storage  room  shall  have  provision  for  temperature 
monitoring  of  storage  vessels,  liquid  nitrogen  level  in  storage  vessels  and  oxygen 
meter.  The  service  space  between  each  liquid  nitrogen  storage  vessel,  supply 
cylinders  and  connecting  hose  should  be  minimum  1.00  sq.  Meters.      Separate 
storage space for other accessories required shall be provided. The room shall be air-
conditioned. 

(x)  General  Storage  area:  General  storage  area  shall  be  provided  to  store  all  the 
consumables, under conditions deemed optimum for storage by manufacturers. 

B.  COLLECTION  AND  STORAGE  OF  PROCESSED  UMBILICAL  CORD  BLOOD 
COMPONENT 
1. Collection: 

(a)  Umbilical  Cord  blood  unit  specific  for  an  individual  will  be  collected  after  signing  an 
agreement with the parents, whose child‘s Umbilical Cord blood is to be collected and 
the cord blood bank. Private and Public Umbilical Cord blood banking to have different 
agreements; 

(b)  Umbilical Cord blood  shall be collected  from hospitals, nursing homes, birthing centers 
and from any other place where a consenting mother delivers, under the supervision  of 
the qualified  Registered Medical  Practitioner responsible for the delivery; 

(c)  The  cord  blood  shall    be  collected  aseptically  in  a  disposable  PVC  bag,  containing 
adequate quantity of sterile, pyrogen free anti-coagulant and sealed effectively and such 
PVC Bags shall be procured from licensed manufacturer; 

(d)  The  Umbilical  Cord  blood  would  be  collected  from  a  premises  operating    in  hygienic 

condition to allow proper operation, maintenance and cleaning. 

2. Transportation: 

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Drugs and Cosmetics Rules 1945 

(a)  Umbilical  Cord  blood  shall  be  transported    from  the  birthing  center  to  the  designated 

laboratory under and as per procedure prescribed by the cord blood bank; 

(b)  The transportation procedure shall be validated to ensure optimum survival of the Stem 

Cells; 

(c)  The transportation temperature should be between 18 to 28ºC; 
(d)  The time period between collection and processing shall not exceed 72 hours. 

3. Storage: 

(a)  The Umbilical Cord blood shall be stored at room temperature between 20 to 25ºC in the 

reception area prior to processing; 

(b)  Samples pending tests for specific transfusion transmittable infectious diseases shall be 

stored in a segregated manner. 

Note:-  Temperature  range between 4 to 37 degrees Celsius,  for the whole time period of transit 
may be allowed beyond the 18ºC to 28ºC in exceptional cases. The effects of deviation of transit 
temperature from the optimum, on the product shall be adequately explained by the licensee in 
the client education booklet. 

C. PERSONNEL 

Cord  blood  bank  shall  have  following  categories  of  whole  time  competent  technical  staff, 
namely:- 
1.  Medical  Director:-    The  operation  of  cord  blood  bank  shall  be  conducted  under  the  active 
directions  and  supervision  of  a  Medical  Director  who  is  a  whole  time  employee  and  is 
possessing  a  Post  Graduate  degree 
[Pathology/Transfusion 
Medicine/Microbiology]  and  has  experience  /  training  in  cord  blood  processing  and 
Cryogenic Storage. 

in  medicine  –  MD 

2.  Laboratory  In-charge:  The  laboratory  in-charge  shall  have  Post  Graduate  qualification  in 
Physiology or Botany or Zoology or Cell Biology or Microbiology or Biochemistry or Life 
Sciences  or  Graduate  in    Pharmacy  and  one  year  working  experience  in  pathological 
laboratory licensed by the local health authority or any microbiology laboratory of a licensed 
drug manufacturing / testing unit and or experience / training in cord blood processing and 
cryogenic storage. 

3.  Technical Supervisor (cord blood processing):- The technical supervisor shall have a:  

(a)  Degree  in  Physiology  or  Botany  or  Zoology,  Pharmacy  or  Cell  Biology  or  Bio 
Sciences  or  Microbiology  or  Biochemistry  or  Medical  Laboratory  Technology 
(M.L.T.)  with  minimum  of  three  years  of  experience  in  the  preparation  of  blood 
components  and / or experience or training  in  cord blood processing and Cryogenic 
Storage; or 

(b)  Diploma in Medical Laboratory Technology (M.L.T.) with five years experience in 
the  preparation  of  blood  components  and  experience  or  training  in  cord  blood 
processing and Cryogenic Storage shall be essential. 
4. Cord Blood Bank Technician(s):-  The technicians employed shall have a: 

(a)  A degree in Physiology or Botany or Zoology or Pharmacy or Cell Biology or Bio 
Science  or  Microbiology  or  Biochemistry  or  Medical  Laboratory  Technology 
(M.L.T.)  with  six  months  experience  and  or  training  in  cord  blood  processing  and 
cryogenic storage; or  

(b)  Diploma in Medical Laboratory Technology (MLT) with one year experience in the 
testing of bloodand / or its components and / or experience or training in cord blood 
processing and Cryogenic Storage. 

D.  AIR HANDLING SYSTEM 

1.  Air  handling  for  sterile  areas  shall  be  different  from  those  for  other  areas.  The  filter 
configuration in the air handling system shall be suitably designed to achieve the grade of 

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air as given  in the Table I. The environmental microbiological monitoring of clean areas 
shall be in accordance to the recommended limits given in Table II. 

2.  The Processing area shall have HVAC system and fitted with HEPA Filters having Grade 

C (Class 10,000) environment as given in Table I. 

3.  The entire processing shall be done conforming to Grade A (Class 100) Standard of air 

quality. 

TABLE  I 
AIR BORNE PARTICULATE CLASSIFICATIONS FOR MANUFACTURE OF STERILE 
PRODUCTS 

Grade  Maximum number of permitted particles per cubic meter equal to or above 

At rest (b) 

In Operation (a) 

A 
B(a) 
C(a) 
D(a) 

0.5µm 

3,500 
3,500 
3,50,000 
35,00,000 

5 µm 

0 
0 
2000 
20,000 

0.5 µm 

3,500 
3,50,000  
35,00,000 
Not defined 

5µm 

0 

   2000 

20,000 
Not defined 

Notes:- 

(a)  In order to reach the B, C and D air grades, the number of air changes shall be related to 
the size of the room and the equipment and personnel present in the room. The air system 
shall be provided  with the appropriate filters such as HEPA for grades A, B and C.  The 
maximum  permitted number of particles in the ―at  rest‖ condition shall approximately  
be as under:- 
[Grade  A  and  B  corresponds  with  class  100  or  M  3.5  or  class  5];  Grade  C  with  Class 
10,000 or M 5.5 or ISO Class 7; Grade D with Class 1,00,000 or M 6.5 or ISO Class 8. 
(b)  The requirement  and limit for the area shall depend on the nature of the operation carried 

out. 

TABLE  II 

RECOMMENDED LIMITS FOR MICROBIOLOGICAL MONITORING OF 

CLEAN AREAS ―IN OPERATION‖ 

Grade 

Air samples 
Cfu/m3 

Settle Plates 
(dia 90mm) 
cfu/2hrs 

Contact 
plates (dia 55 
mm) cfu per 
plate 

Glove points 
(Five fingers) 
cfu per glove 

A 

B 
C 
D 

Less than 
1 
10 
100 
500 

Less 
than 1 
5 
50 
100 

Less 
than 1 
5 
25 
50 

Less 
than 1 
5 
- 
- 

Notes:- 
(a) These are average values. 
(b) Individual settle plates may be exposed for not less than two hours in Grade B, C and 
D areas and for not less than thirty minutes in Grade A area. 

E. QUALITY CONTROL 
1.  Facilities shall be provided for Quality Control such as Haematological, Microbiological and 

Instrumental testing. 

332 

 
 
 
 
 
 
 
 
 
 
 
 
2.  Following duties shall be performed under the function of quality control:  

Drugs and Cosmetics Rules 1945 

(a)  To prepare detailed instructions for carrying  out such tests and analysis; 
(b)  To approve or  reject raw materials  and consumables,  used in  any  step,  on  the  basis of 

approved specifications; 

(c)  Haematological    tests  like  Total  Nucleated  Cell  Counts,  Mononuclear  Cell  Count, 
Enumeration of the population of Stem Cells, Stem Cell viability shall be performed on 
samples of processed Umbilical cord blood unit; 

(d)  Microbiological  Tests  shall  be  done  on  Maternal  Blood  samples  for  freedom  from 
Hepatitis  B  Surface  Antigen,  Hepatitis  C  Virus  antibody,  HIV  I  and  II  antibodies. 
Syphilis, Malaria, CMV and HTLV.  Bacterial and Fungal Culture shall be done on the 
umbilical cord blood samples; 

(e)  Instruments  which  would  be  used  to  process  test  and  store  the  UCB  unit  would  be 
validated  before  commissioning    and  calibrated  from  time  to  time  to  check  their 
conformity to specific standards according to an approved and valid protocol; 

(f)  The  environmental  monitoring  of  the  clean  rooms  would  be  done  at  periodic  intervals 

according to an accepted and validated protocol; 

(g)  All tests mentioned above shall be done in house except tests under itme numbers (e), (f) 
and  test  for  enumeration  of  Stem  Cell  Population,  HLA  typing  and  Genetic  Disease 
Testing which may be outsourced to a competent  third party approved by the licensing 
authority. 

F. SCREENING TESTS 

1. The maternal blood sample shall be tested for 

(a) Hepatitis B;  
(b) Hepatitis C;  
(c) HIV 1 & 2;  
(d) Syphilis; 
(e) Malaria;  
(f) CMV; 
(g) HTLV 

2. The Umbilical Cord Blood shall be tested for 
(a) Total Nucleated Cell count; 
(b) Total Mononuclear Cell Count; 
(c) Progenitor Cell (CD34+) enumeration;  
(d) Cell Viability; 
(e) ABO Group and Rh Type; 
(f) Sterility as regards Bacterial and Fungal contamination status;  
(g) HLA Matching (Only for allogenic Cord Blood Units). 

G. STORAGE 

1.  The  Umbilical  cord  blood  shall  be  cryopreserved  using  a  controlled  rate  freezing  or 
equivalent validated procedures. The frozen storage shall be at minus 196ºC and shall not 
be warmer than minus 150ºC. 

2.  There will be no shelf life for this class of product. 

H. REFERENCE SAMPLES 
1.  At  least  two  reference  samples  shall  be  collected  from  cord  blood  unit  product  prior  to 
cryopreservation  and stored at minus 196ºC and shall not be warmer than minus 150ºC. 
2.  At  least  one  additional  reference  sample  shall  be  stored  at  minus  76ºC  or  colder  for  the 

purposes other than viability analysis. 

I. LABELLING 
1. Initial label placed during collection shall specify:  

333 

 
 
 
 
 
 
 
(a)  Human Umbilical Cord Blood; 
(b)  Approximate  Volume  or  weight  of  contents  in 

Drugs and Cosmetics Rules 1945 

  the  collection 

  bag  [UCB+ 

Anticoagulant]; 
(c)  Mother ‘s name; 
(d)  Place of collection; 
(e)  Date and time of collection;  
(f)  Collected by; 
(g)  To be labeled in bold, ―ROOM TEMPERATURE ONLY– DO NOT REFRIGERATE, 

DO NOT IRRADIATE‖; 
(h)  Manufacturing license number. 

2.  Label  at  completion    of  processing  and  before  issue    -    Cryogenic  Storage  Label  [Statutory 
label] shall indicate the following:- 

(a)  Name of product:- Human Progenitor Cell [HPC] – Cord Blood;  
(b)  Volume or weight of contents; 
(c)  Percentage of Cryoprotectant [DMSO]; 
(d)  Percentage of any other additive / preservant; 
(e)  Date of collection [birth] ………………………;  
(f)  Date of processing ……………………………..;  
(g)  Name of manufacturer………………………….;  
(h)  Manufacturing license number; 
(i)  Storage temperature – not less than, - 196ºC and shall not be warmer than minus 150ºC, 
(j)  Unique Traceability Number and / or BAR Code. 

3.  Issue label at the time of release of Cord Blood Unit shall indicate the following namely:- 

(a)  Name of manufacturer; 
(b)  License number; 
(c)  All details of the Cryogenic Storage Label; 
(d)  The results of Total Nucleated Cells, Progenitor Cell percentage {CD34+), Viability; 
(e)  Results of Transfusion Transmittable diseases testing on maternal blood; 
(f)  ABO Group and Rh Type; 
(g)  Date of processing; 
(h)  Result of HLA typing (allogenic); 
(i)  Statement ―properly identify intended Recipient and Product‖; 
(j)  A statement indicating that leukoreduction filters should not be used; 
(k)  Statement ―Do not irradiate‖ 
(l)  Name and address of receiving hospital. 

J. RECORDS OR DOCUMENTATION 
1. The licensee shall maintain the following records 

(a)  Client / donor enrolment / agreement record;  
(b)  Collection of unit and transportation record;  
(c)  Master record of stored unit; 
(d)  HLA Matching record;  
(e)  Unit Release Register; 
(f)  Stock  Register  for  Blood  Collection  Bag  Cryoprotectant  and  Preservant,  RBC 

Sedimentation Enhancer; 

(g)  Stock Register for Diagnostic Kits, Reagents and other consumables;  
(h)  Record on feedback after use of cord blood / Adverse reaction record. 

2. The following Standard Operating Procedures shall be maintained  by the licensee, namely:- 

(a)  Umbilical Cord Blood collection; 
(b)  Transportation of the collected Umbilical cord Blood unit;  
(c)  Processing of Umbilical cord blood unit; 
(d)  Cryogenic storage of processed umbilical cord blood unit; 

334 

 
 
 
Drugs and Cosmetics Rules 1945 

(e)  Testing of maternal blood for transfusion transmittable infections;  
(f)  Testing of Umbilical  cord blood for ABO Grouping and Rh Typing; 
(g)  Testing  of Umbilical  cord blood unit  for Total  Nucleated Cell  Count, Mononuclear  

Cell  Count, Progenitor  Cell  (CD34+) enumeration,  and viability; 

(h)  Testing of Umbilical cord blood stem cell unit for sterility;  
(i)  Disposal of bio medical waste; 
(j)  Dispensation of Umbilical cord blood unit; 
(k)  Preventive maintenance Protocol for all Instruments;  
(l)  Acceptance / Rejection procedure of consumables;  
(m) Environment monitoring of classified areas; 
(n)  Any other standard operative procedure as per requirements. 

K. CORD BLOOD RELEASE 
1.  There shall be designated area with adequate space for procedures and records related to cord 

blood unit selection and release. 

2.  The cord blood bank shall obtain written or electronic request from the transplant physician 

or designee for shipment of the cord blood unit. 

3.  Accompanying  documentation at the time of issue from the cord blood bank shall include 
indications,  contra-indications, caution,  instruction  for  handling    and  use  of  the  cord  blood 
unit including  short-term storage and preparation for transplantation. 

4.  Procedure  for  transportation  of  cryopreserved  cord  blood  unit  within  the  facility  shall  be 

designed to protect the integrity of the unit and the health and safety of the personnel. 

5.  Cryopreserved  cord  blood  unit  stored  at  -150ºC  or  colder  shall  be  transported    in  a  liquid 
nitrogen  cooled  dry  shipper  that  contains  adequate  absorbed  liquid  nitrogen  and  has  been 
validated  to  maintain  temperature  below  -150ºC  for  at  least  48  hours  beyond  the  expected 
time of arrival at the receiving facility. 

1[PART XIII] 

GENERAL 

1.   For  the  purposes  of  this  Schedule,  any  test  or  method  of  testing  described  in 
the 2[Indian Pharmacopoeia] shall be deemed to be a method approved by the Licensing 
Authority. 

2.    The  Licensing  Authority  shall  publish  in  the  Official  Gazette  from  time  to 

time particulars of any test or method of testing approved by him. 

1. Renumbered by Notification No. F-18-1/46, dt. 18-6-48 
2. Subs. by G.S.R. 19, dated 15-12-1977 

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Drugs and Cosmetics Rules 1945 

1[SCHEDULE  F(I) 
PART 1–VACCINES 

(A)   PROVISIONS  APPLICABLE TO THE PRODUCION OF BACTERIAL VACCINES: 

1.     Definition. –(1) This part of the Schedule applies to bacterial vaccines made from 
any  micro-organism  pathogenic  to  man  or  other  animal  and  to  vaccines  made  from  other 
micro-organisms which have any antigenic value. 

(2)  For  the  purposes  of  this  part  of  the  Schedule,  a  bacterial  vaccine  means  a  sterile 
suspension of a killed culture of the micro-organism from which the vaccine derives its name 
or  a  sterile  extract  or  derivative of  a  micro-organism, or  a  pure  suspension of  living  micro- 
organisms which have been previously made avirulent. 

2.     Staff   of   Establishment.–A  competent   expert   in   bacteriology   with   sufficient 
experience in the manufacture and standardisation of biological products shall be in charge of 
the establishment responsible for the production of bacterial vaccine and he shall be assisted 
by  a  staff  adequate  for  carrying  out  the  tests  required  during  the  preparation  and 
standardisation of the vaccines. 

3.      Proper  Name.–The proper  name  of  any  vaccine  shall  be  the  name  of  the  micro- 
organism  from  which  it  is  made  followed  by  the  word  ―Vaccine‖  unless  this  Schedule 
otherwise provides or if there is no other special provision in this Schedule, some other name 
as  approved  by  the  Licensing  Authority.  Provided  that  in  the  case  of  the  undermentioned 
preparations the proper name of the vaccine may be as follows: – 

1.    Anthrax Spore Vaccine (Living). 

2.    Blackquarter Vaccine. 

3.    Enterotoxaemia Vaccine. 

4.    Fowl Cholera Vaccine. 

5.    Haemorrhagic Septicaemia Adjuvant Vaccine. 

6.    Haemorrhagic Septicaemia Vaccine (Broth). 
2[7. Multi Component Clostridial Vaccine. 

8.    Hemorrhagic Septicaemia Vaccine – Alum Treated.] 

4.      Records.–Cultures used in the preparation of vaccine before being manipulated into 
a vaccine, should be thoroughly tested for identity by the generally accepted tests applicable 
to the particular micro-organisms. 

The  permanent  records  which  the  licensee  is  required  to  keep  shall  include  amongst 

others, a record of the origin, properties and characteristics of the cultures. 

5.      Combined  Vaccines.–Vaccines  may  be  issued  either  singly  or  combined  in  any 
proportion   in  the  same  container.  In  the  case  of  combination  of  vaccines,  a  name  for  the 
combined  vaccine  may  be  submitted  by  the  licensee  to  the  Licensing  Authority,  and  if 
approved, may be used as the proper name of the vaccine. 

1. Added  by Ministry of Health F.P., W.H and U.D. Notfn. No. F.1-6/62-D (SO. 2889),  dt. 2-7-1969 
2. Ins. by  G.S.R. 659(E) ,dt. 31.8.1994. 

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6.     Preparation– Bacterial  vaccines, simple  or  polyvalent, are  prepared from  selected 
cultures after  careful examination for  their identity,  specificity, purity  and  antigencity. They 
may be prepared in the following manner:.– 

(a)       Formal Cultures or Bacterins.– The selected pure culture strain or strain 
are  grown  in  a  suitable  fluid  medium,  at  an  optimum  temperature,  for  an  appropriate 
period. The pure growth is then exposed to the action of solution of Formaldehyde I.P. in 
suitable concentration and temperature. The product is finally filled in suitable sterilised 
containers which are subsequently sealed. 

(b)        Vaccine  of  Bacterial  Products  or  Bacterial  Derivatives.–These vaccines 
are  prepared  by  growing  the  organisms  on  suitable  media  and  then  deriving  specific 
antigenic constituents of the bacteria by various special methods. 

(c)       Living  Bacterial Vaccines.– They  are  prepared from  non-pathogenic but 
fully  immunogenic  strains  of  micro-organism.  Strict  aseptic  precautions  are  taken 
throughout the preparation against the introduction of microbial contaminants. 

7.   General Standards:. 

(a  )Description.–  Bacterial  vaccines  are  colourless  to  yellowish  brown  liquids 

containing dead or viable bacteria in homogenous suspension. 

(b) Identification.–All types of vaccines confer active immunity in the susceptible 
animals which can be demonstrated by injecting suitable experimental animals with the 
calculated  doses  of  the  product  and  subsequently  determining  the  presence  of  the 
protective  antibodies  in  their  serum  and/or  by  challenging  the  vaccinated  animals  by 
injecting  virulent  strain  of  the  homologous  organisms.  The  protected  animals  should 
survive the challenge. 

(c)  Test  for  Sterility.–All  bacterial  vaccines  shall  be  tested  for  sterility  in 
accordance  with  the  provision  of  Rules  115  to  119  (both  inclusive).  If  the  vaccine 
contains  added  bactericide  or  bacteriostatic,  a  quantity  of  medium  sufficient to  render 
the growth inhibitor ineffective is added to the sample, or a suitable substance is added 
to the sample, or a suitable substance is added in concentration sufficient to render the 
growth inhibitor ineffective but not itself to inhibit the growth of micro-organism. 

(d)        Purity Tests for Living Bacterial Vaccine.–Petri dishes containing suitable 
media  are  streaked  with  the  final  product  and  incubated  at  37˚  C  for  72  hours.  The 
vaccine passes the test if no growth of micro-organisms other than those from which the 
vaccine was prepared is observed.    Other tests include examination for motility of the 
organisms,  fermentation  reactions  and  thermoagglutination test  and  dye-inhibitor  tests 
in case of bruceliza vaccine. 

(e)     Safety  Test.–  The  safety  of  the  vaccine  shall  be  assessed  by  injecting it  in 
appropriate  doses     in  suitable  susceptible  animals.  No  animal  should  show  any 
untoward, general or local reaction within seven days after inoculation. 

(f).  Potency  Test.–Wherever  applicable,  susceptible  experimental  animals  are 
inoculated  with  the  calculated  doses  of  the  final  product.  The  animals  are  challenged 
after the period of immunisation, with virulent infective dose of the homologous culture 
along  with  the  controls. The  potency  of  the  vaccine is  assessed by  the  survival  of  the 
vaccinated animals and the death of the controls. 

8.    Labelling: 

(a)  The label on the ampoule or the bottle shall indicate:.– 

(i) 

Proper name. 

(ii)      Contents in millilitres or doses. 

(iii)     Potency, if any. 

337 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(iv)      Batch number. 

(v)       Expiry date. 

(b)  The label on the outside container shall indicate: 

(i) 

Proper name. 

(ii)       Contents in Millilitres or doses. 

(iii)      Batch number. 

(iv)      Date of manufacture. 

(v)       Manufacturing licence No. 

(vi)      Manufacturer‘s name and address. 

(vii)     ―For animal treatment only‖. 

(viii)    Storage conditions. 

9.        Storage.–-Bacterial  vaccines  shall  be  stored,  protected  from  light  at  temperature 

between 2˚C to 4˚C and shall not be frozen. 

10.  Date of manufacture.– The date of manufacture shall be, unless otherwise specified 

in the individual monograph in this part, as defined in clause (b) of sub-rule (3) of rule 109. 

Anthrax Spore Vaccine (Living) 

1.    Synonyms.–-Avirulent  Anthrax   Spore   Vaccine   or   Bacillus   Anthracis   Vaccine 

(Living). 

2.     Definition.–-The  vaccine  is  a  suspension  of  living  spores  of  an  uncapsulated 

avirulent strain of B  anthracis in 50 per cent glycerine saline. 

3.     Preparation.–-Avirulent B,  anthracis  of  known  antigenicity  is  grown  on  suitable 
medium  at  pH  7.4  in  Roux  flasks.  After  72  hours  incubation  at  37˚  C,  the  pure  sporulated 
culture growth which shows 70 to 80 per cent sporulation is washed with normal saline and 
glycerinated  to  the  extent  of  50  per  cent  by  weight  of  the  culture  washing  and  the  whole 
suspension is  kept at  room temperature for twenty-one days to  allow for  the stabilization  of 
the spores. 

4.     Standard:. 

(a)   Description.–- It is slightly opalescent or pale brown semi-viscous liquid. 

(b)     Identification.–-Uncapsulated B  anthracis  which  is  avirulent  can  be  isolated 

from the vaccine. 

(c)   Sterility test.–- Should comply with the test for sterility described in the general 

monograph on ―Bacterial Vaccine‖. 

(d)   Purity  Test.–-  Complies  with  the  ―Purity  Tests  for  Living  Bacterial  Vaccine‖ 

described under  the general monograph on ―Bacterial Vaccines‖. 

(e)      Safety  Test.–-Four  healthy  adult  guinea-pigs  each  weighing  300-450  g.  not 
previously   treated  with  any  material  which  will  interfere  with  the  test  are  inoculated 
subcutaneously, two  with 0.2  ml.  each  and  two  with  0.5  ml.  each  of  the  unglycerinated 
suspension  respectively.  Four  more  guinea-pigs  are  injected  with  1:5  dilution  of  the 
glycerinated product in the same manner. No untoward reaction should be observed and 
none of the animals should die of anthrax during the period of observation for seven days. 

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(f)  Safety and Potency Test in sheep and goat–Spore count of the glycerinated 
suspension  is  made  after  twenty-one  days  from  the  date  of  glycerination.  Three 
plates for each of the three dilution 105, 106 and 107 are made. 

Eight  sheep  and  eight  goats  each  weighing  not  less  than  18  kg.  are  injected 

subcutaneously in the following manner:– 

two sheep   :       Each  subcutaneously with  10  ml.  of  the  stock  suspension 

(for safety). 

two goats   :        Each subcutaneously with 5 ml. of the stock 

suspension (for safety). 

six sheep   :        Each subcutaneously  with one million spores 

suspended in 50 per cent glycerine saline solution. 

six goats    :       Each subcutaneously with one million spores   suspended in 

50 per cent glycerine saline solution. 

None  of  these  animals  should  die  of  anthrax.  Twenty  one  days  after  vaccination,  the 
animals are  challenged with  100 lethal  doses of  virulent B.  anthracis spores along with  two 
healthy sheep and two goats as controls. 

All the controls should die of anthrax within 72 hours after challenge and at least 66 per 
cent of the vaccinated animals should survive. The animals shall be observed for a minimum 
of ten days from the date of challenge. 

1[(g)  Viable Count.– The vaccine when plated on  suitable media should show 10 

million  viable spores per cattle dose and 5 million spores per sheep dose.] 

5. Labelling and Storage.– Should comply with the requirements for ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

2[6.  Expiry Date.– The date of expiry of the potency of the vaccine shall be not more 
than two years from the date of manufacture if stored in 4o C and six months, if stored at room 
temperature.] 

1.   Synonym.–Blackleg vaccine or Quarter Evil Vaccine. 

Blackquarter Vaccine 

2.    Definition.– Blackquarter Vaccine is a culture of Clostridium chauvoei grown in a 
suitable anaerobic fluid medium and rendered sterile and toxic by the addition of Solution of 
Formaldehyde I.P. in such a manner that it retains its immunising properties. 

3.     Preparation.–Cultures  of    Cl.  Chauvoei  are  grown  in  a  suitable  anaerobic  fluid 
medium and  killed  by  the  addition of  a  suitable  concentration of  Solution  of  Formaldehyde 
I.P. The final product shall be adjusted to pH.7.0. 

4.     Standards:. 

(a)   Description.–It  is  a  yellowish   brown  liquid  containing  dead  bacteria  in 

suspension. 

(b)  Identification.–It  protects  susceptible  animals  against  infection  with  Cl. 

Chauvoei. 

(c)  Sterility  Test.–Should  comply  with  the  test  for  sterility  described  in  the 

general monograph on ―Bacterial Vaccine‖. 

1. Subs. by. G.S.R 659 (E) ,dt.. 31-8-1994. 
2. Ins. by. G.S.R 659 (E) ,dt.. 31-8-1994. 

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(d)   Safety  and  Potency  Tests.–At  least  six  adult  healthy  guinea-pigs  each 
weighing 300 g to 450 g are injected subcutaneously each with 3 ml. of the product 
followed  a  week  later  by  a  second  injection  with  the  same  dose.  They  should  not 
show  any  systemic  reaction  but  may  show  only  a  minimum  of  local  reaction. 
Fourteen  days  after  the  second  injection  six  of  the  vaccinated  guinea-pigs  are 
challenged  intramuscularly  with  25  viable  spores  of  Cl.  Chauvoei  equivalent  to  5 
c.h.d. along with 0.2 ml. of a 5 per cent solution of calcium chloride. Two controls 
are used. The controls should die of the specific  injection and  at  least  4  of the six 
vaccinated animals should survive before the product is passed for issue. 

5.     Labelling and Storage.– Should comply with the requirements of ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

6.      Expiry Date.–- The date of expiry of the potency of the vaccine shall not be more 

than twenty-four months from the date of manufacture. 

Brucella Abortus ( Strain 19 Vaccine) (Living) 

1.      Synonym.–Contagious Abortion Vaccine, (Strain 19) (Living). 

2.      Definition.–Brucella Abortus (Strain 19) Vaccine (Living) is a suspension of a pure 

smooth living culture of Br. Abortus of low virulence in normal saline solution. 

3.      Preparation.–Forty eight to seventy-two hour old growth of Br. Abortus (Strain 19) 
on  potato  agar  medium in  Roux  flasks  washed  with  buffered  normal  saline  solution pH  6.4 
and  the  pure  growth  from  the  flasks  are  pooled  together,  0.5  ml.  of  the  pooled  product  is 
mixed  with  4.5  ml.  of   normal  saline  solution  at  pH  6.4  in  graduated  centrifuge  tube  and 
centrifuge at  3000 r.p.m for  one  hour. The  percentage of  cell  deposit is  assessed by  reading 
the amount of cell deposit obtained. 

The concentrated suspension is then diluted with buffer normal saline solution so that the 

final product contains  0.72  per cent bacterial cell deposit. 

4.   Standard: 

(a)    Description.–It  is  an  almost  white  turbid  liquid  containing  live  bacteria  in 

suspension. 

(b)    Identification.–It  consists  of  Gram-negative  bacilli  capable  of  protecting 

susceptible animals against Brucellosis. 

(c)    Sterility Test.–Should comply with the test for sterility described in the general 

monograph on ―Bacterial Vaccine‖. 

(d)    Purity  Test.–A  smear  of  the  finished  products  is  examined  microscopically 
after  staining  by  Gram‘s  method  for  evidence  of  any  contamination.  When  grown  on 
suitable media, Br. Abortus should be obtained in a pure state. 

(e)     Safety  Test.–Two  healthy  guinea-pigs  each  weighing  300  g.  to  450g.  are 
inoculated  subcutaneously  each  with  1.0  ml.  of  the  final  product.  The  guinea-pigs 
should not show excessive reaction of a toxic nature during the period of observation of 
ten days. 

(f)        Potency  Test.–Each  of  a  group  of  four  healthy  guinea-pigs,  drawn  from  a 
uniform stock and each weighing 300 g. to 450 g. is injected intra-muscularly with 1 ml. 
of  the  vaccine,  and  is  challenged  nine  weeks  after  vaccination  by  the  intramuscular 
injection of 1 ml. of a suspension containing 5,000 fully virulent Br. Abortus organisms. 
Each of a group of two unvaccinated guinea-pigs is similarly injected. After a further six 
weeks,  the  guinea-pigs are  killed  and  cultures are  made  from  their  spleens. More  than 
half of the vaccinated guinea-pigs contain no demonstrable Br. Abortus in the spleen; all 
the controls are infected. 

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(g)          Viable  Count.–The  vaccine  when  plated  on  suitable  media  should  show 
between 14, 000 million and 18,000 million Br. Abortus organisms per ml. At least 80 
per cent brucella organisms should be in the smooth phase. 

4.      Labelling and storage.– Should comply with the requirements of ―Labelling‖ and 
―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. The liquid vaccine 
shall  be  issued  fresh  as  far  as  possible  without  allowing  any  period  of  storage  after 
manufacture. 

5.      Expiry Date–The date of expiry of the vaccine shall be not more than five weeks 

from the date of manufacture. 

Enterotoxaemia Vaccine 

1.       Synonyms.–Clostridium Welchii, Type D, Formal Culture: Pulpy Kidney Vaccine. 

2.        Definition.–Enterotoxaemia  Vaccine  is  a  culture  of  a  highly  toxigenic  strain  of 
Clostridium type D, group is an anaerobic medium rendered sterile and toxic by the addition 
of Solution of Formaldehyde I.P in such a manner that it retains its immunising properties. 

3.     Preparation.– Selected toxigenic strain of Cl. Welchii type D, is grown in a liquid 
medium  under  conditions  which  ensure  maximum  epsilon  toxin  production.  The  culture  is 
checked for  purity and toxicity as  tested in  mice. Solution of  Formaldehyde I.P.  is  added in 
suitable concentration and the formolised culture is kept at 37˚  C till the production is sterile 
and non-toxic. 

4.    Standard: 

(a)       Description-  It  is  a  yellowish  brown  liquid  containing    dead  bacteria  in 

suspension. 

(b)   Identification-   When   injected   into   susceptible   animals   it   stimulates   the 

production of epsilon antitoxin of Cl. Welchii, type D. 

(c)    Sterility  Test-  Complies  with  the  test  for  sterility  described  in  the  general 

monograph on ‗Bacterial Vaccines‘. 

(d)   Safety and Potency Tests- At least eight sheep each weighing not less than 18 
kg. or  twelve rabbits each weighing 1 kg. to 1.5 kg. are used for testing the safety and 
potency  of  each  brew  of  the  vaccine.  Two  sheep  receive  subcutaneously 10  ml.  each 
and the other six sheep receive each 2.5 ml. of the product subcutaneously. The rabbits 
are given subcutaneously a dose of 5 ml. each. The sheep and rabbits are observed for 
five days. They should show only a minimum local reaction and no systemic reaction. 

The sheep receiving 10 ml. are withdrawn from experiments after five days. Each of 
the other six sheep is inoculated with a  second dose of 2.5 ml. fourteen days after the 
first injection. The rabbits are inoculated with 5 ml. as a second dose, after one month 
of  the  first  inoculation.  Ten  days  after  the  second  inoculation  the  sera  of  sheep  or 
rabbits are pooled separately. The pooled serum of each group of animal shall contain 
in each ml. not less than two international units of Cl. Welchii epsilon antitoxin which 
is determined by testing on mice as follows: 

One ml. of the pooled serum is mixed with one ml. of the epsilon toxin of          Cl. 
Welchii type D, containing 300 mouse-minimum-lethal-doses (mouse m.l.d.) and kept at 
room temperature for half an hour. At least two mice each weighing not less than 18 g. 
are each given intravenously 0.2 ml. of the mixture. As control two mice each weighing 
not less than 18 g. should each receive 0.2 ml. of the toxin containing 300 mouse m.l.d 
per ml. diluted with equal volume of normal saline. The control mice should die within 1 
to 2 hours while the mice receiving the mixture of serum and toxin should survive for at 

341 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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least two days. Sera containing one International Unit of epsilon antitoxin per ml. will be 
able to neutralise 150 mouse m.l.d. of epsilon toxin of Cl. Welchii, type D. 

5.     Labelling   and   Storage.–Should   comply   with   the   requirements      regarding 
―Labelling‖ and  ―Storage‖ as laid down in the general monograph on ―Bacterial   Vaccines‖. 

6.    Expiry  Date.–The  expiry  date  of  potency  of  the  vaccine  shall  be  not  more  than 

twelve months from the date of manufacture. 

1.     Synonym.–Pasteurella Septica Vaccine (Avian). 

Fowl Cholera Vaccine (Polyvalent) 

2.        Definition.–Fowl  Cholera  Vaccine  is  a  formolised  pure  broth  culture  of  virulent 

strains of Pasteurella Septica (Avian). 

3.     Preparation.–The strains are grown separately in nutrient broth for 48 hours at 37˚ 
C. The pure growth is killed by the addition of a Solution of Formaldehyde I.P in a suitable 
concentration.  The  cultures  are  then  mixed  in  equal  proportions  and  the  final  vaccine  is 
bottled in suitable containers. 

4.     Standard- 

(a)     Description.–It  is     a     light   yellow   liquid   containing  dead   bacteria   in 

suspension. 

(b)     Identification.–It protects susceptible birds against  P. aviseptica infection. 

(c)     Sterility  test.–Complies  with  the  test  for  ―Sterility‖  described  under  the 

general monograph on ―Bacterial Vaccines‖.. 

(d)     Safety Test.–Two healthy young fowls each weighing not less than 400 g. or 
twelve healthy mice are inoculated subcutaneously each with 1 ml. of the final product. 
The  birds  should  not  show  any  untoward  reaction  during  the  period  of  observation  for 
seven days. 

5.     Labelling and Storage.–Should comply with the requirements of   ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

6.      Expiry Date.–The date of expiry of potency of the Vaccine shall be not more than 

six  months from the date of manufacture. 

Hemorrhagic Septicaemia Adjuvant Vaccine 

1.     Synonym.– Pasteurella Septica Adjuvant Vaccine. 

2.     Definition.–The  vaccine  is  a  homogenous  suspension  of  formolised  agar-washed 

Pasteurella septica with liquid paraffin and lanolin. 

3.   Preparation.–Pure growth of a highly antigenic strain of P. Septica in phase 1 grown 
on  nutrient  agar  medium containing 0.5  per  cent  yeast  extract  is  washed  with  0.5   per  cent 
formol      saline.      The  pooled      suspension      is  diluted      with      normal  saline  to  contain 
approximately  2100  million  P.  Septica  organisms  per  ml.  The  safety  test  of  this  adjusted 
suspension is conducted on four white mice  each weighing not less than 18 g. and observed 
for three days before it is mixed with liquid paraffin and lanolin in suitable proportion. 

The  mixture  is  blended  until  a  homogenous  emulsion  is  obtained  which  is  filled  in 

suitable containers. 

4.  Standard: 

(a)     Description−  It   is   a   white  thick  oily   liquid  containing  dead  bacteria   in 

suspension. 

(b)    Identification.–It protects susceptible animals against infection with P. Septica. 

342 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(c)    Sterility Test.–It complies with the test for ―Sterility‖ described in the general 

Monograph on ―Bacterial Vaccines‖. 

(d)     Safety Test.– Six white mice each weighing not less than 18 g. are inoculated 
intraperitoneally  each  with  0.5  ml.  of  the  vaccine.  None  of  the  mice  should  die  of 
pasteurellosis during the observation period for seven days. 

(e)      Potency Test.–Three susceptible calves in good condition between the ages of 
nine months to three years are injected intramuscularly, each with 2 ml. of the vaccine, in 
the case of animals weighing upto 140 kg.  and 3 ml. for heavier ones. 

Three weeks later these animals along with two healthy animals of the same type and 
species  are  challenged  subcutaneously  with  18  hours  old  broth  culture  of  P.  Septica 
equivalent to at least 50 million  mouse minimum infective dose. Both the controls should die 
of  pasteurellosis  and  at  least  two  out  of  the  three  protected  animals  should  survive  the 
challenge dose for a period of seven days. 

5.   Labelling and storage- Should comply with the requirements   for   ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

6. Expiry Date- The date of expiry of potency of the vaccine shall be not more    than 

twelve  months from the date of manufacture. 

Haemorrhagic Septicaemia Vaccine (Broth) 

1.    Synonym.–Pasteurella Septica Vaccine (Broth). 

2.    Definition.–Haemorrhagic Septicaemia  Vaccine  is  formolised  culture  of  a  virulent 

strain of Pasteurella septica in nutrient broth. 

3.    Preparation.–.Septica culture is grown in nutrient broth at 37˚C. The pure growth is 

killed by the addition of a solution of Formaldehyde I.P. in a suitable concentration. 

4.     Standard: 

(a)  Description.–It is a pale yellow liquid containing dead bacteria in suspension. 

(b)   Identification.–It protects susceptible animals against infection with P.Septica. 

(c)    Sterility Test.–Complies with the test for ―Sterility‖ described under the general 

monograph on  ―Bacterial Vaccines‖. 

(d)   Safety Test.–Four healthy rabbits each weighing 1 kg. to 1.5 kg. are inoculated 
subcutaneously each  with  5  ml.  of  the  product.  There  should  be  no  untoward reaction 
during  the  period  of  observation  for  seven  days.  Alternately  two  rabbits  and  six  mice 
may be employed. The dose for mice will be 0.5 ml. 

5.         Labelling and Storage.–Should comply with the requirements of ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

6.          Expiry Date.–The date of expiry of potency of the vaccine shall be not more than 

six  months from the date of manufacture. 

1.   Synonym.–Equine Abortion Vaccine. 

Salmonella Abortus Equi Vaccine 

2.   Definition.– Equine Abortion Vaccine is a mixture of equal parts of pure formolised 

cultures of smooth laboratory strains of Salmonella abortus equi. 

3.   Preparation.–The strains are grown separately on plain agar in Roux flasks, for 24- 
28 hours at 37˚ C. The pure growth is washed with normal saline solution and the washings 
are  pooled  together.  The  suspension  is  standardised  to  contain  approximately  600  million 
Sal.Abortus  equi  organisms  per  ml.  using  normal  saline  solution  as  diluent.  The  culture  is 
killed  by  the  addition  of  sufficient  quantity  of  solution  of  Formaldehyde  I.P  in  a  suitable 

343 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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concentration and the product is kept at 37˚C for seven days. Potassium alum is added to give a 
final concentration of 1 per cent 

4.    Standard: 

(a)      Description.–It is an opalescent liquid containing dead bacteria in suspension. 

(b)      Identification.–It  protects  susceptible  animals  against  infection  with  Sal. 

Abortus equi. 

(c)      Sterility  Test.–Complies  with  the  test  for  sterility  described  in  the  general 

monograph on   ―Bacterial Vaccines‖. 

(d)      Safety Test- Six white mice each weighing not less than 18 g. are inoculated 
intraperitoneally  each  with  0.5  ml.  of  the  product.  None  of  the  mice  should  die  of 
salmonellosis. The mice are observed for ninety-six hours. 

5.    Labelling and  Storage- Should comply with the  requirements for  ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖. 

6.     Expiry Date- The date of expiry of potency of the vaccine shall be not more than six 

months from the date of manufacture. 

1.     Synonym.– Strangles Vaccine 

Streptococcus Equi vaccine 

2.        Definition.–  Streptococcus  equi  Vaccine  is  a  phenolised  culture  of  a  number  of 

different isolates of Streptococcus equi in glucose serum broth. 

3.   Preparation.–  Equal  proportions  of  forty-eight  hours  old  pure  cultures  of  different 
isolates of Str. Equi in serum glucose both are mixed together.  The suspension is centrifuged 
and  the  deposit  is  washed  with  normal  saline  solution  after  removing  the  supernatant.  The 
washed cells  are suspended in normal saline and heated in a water bath 65˚C for two hours. 
Phenol  and  normal  saline  are  added  to  give  a  final  concentration of  1200  million  Str.  Equi 
organisms per ml. and 0.5 per cent of phenol in the vaccine. 

4.     Standard- 

(a)     Description.–  It  is  a  slightly  opalescent  liquid  containing  dead  bacteria  in 

suspension. 

(b)     Identification.–It protects susceptible animals against infection with Str. Equi. 

(c)      Sterility  Test.–Complies with  the test  for  ―Sterility‖ described in  the  general 

monograph on ―Bacterial Vaccines‖, the nutrient broth being replaced by glucose broth. 

(e)     Safety Test.–Two ponies and two rabbits (each weighing not less than 1 kg.) 
are inoculated each with 10 ml. and 2 ml. respectively of the final product. The animals 
should not show any untoward reaction during the period of observation of seven days. 

5.     Labelling and Storage.–Should comply with the requirements for ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines‖ 

6.     Expiry Date.– The date of expiry of potency of the vaccine shall be not more than 

six months from the date of manufacture. 

Old Adjuvant Vaccine against Pasteurellosis in Sheep and Goats. 

1.      Synonym- Pasteurella Septica Adjuvant Vaccine for ovines and Caprines. 

2.      Definition-  The  vaccine  is  a  homogenous  suspension  of  formolised  agarwashed 

Pasteurella septica of ovine origin with liquid paraffin and lanolin. 

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3.      Preparation−  Pure  growth  of  highly  antigenic  strains  (R1,  R2,  R4)  in  phase  I 
grown  separately  on  nutrient  agar  medium  containing  0.5  per  cent  yeast  extract  is  washed 
with  0.5  per  cent  Normal  saline.  Equal  quantities  of  the  suspension  of  three  strains  diluted 
with  Normal  saline  to  contain  approximately  2100  million  organisms  per  ml.  is  pooled 
together.  The  safety  test  of  this  adjusted  pooled  suspension  is  conducted  in  for  white  mice 
each weighing not less than 18 g. and observed for three days before it is mixed with liquid 
paraffin and lanolin in suitable proportion. 

The  mixture  is  blended  until  a  homogenous  emulsion  is  obtained  which  is  filled  in 

suitable containers. 

4.      Standards: 

(a)  Description-  It  is      a  white  thick  oily  liquid  containing  dead  bacteria  in 

suspension. 

(b) Identification-   It   protects   susceptible   animals   against   infection   with 

P. Septica. 

(c)  Sterility  Test-  Complies  with  the  test  for  sterility  described  in  the  general 

monograph on ―Bacterial Vaccines‖. 

(d) Safety Test-  Six  white  mice  each  weighing not  less  than  18  g.  are  inoculated 
intra-peritoneally  each  with  0.5  ml.  of      the  vaccine.  None  of  the  mice  should  die  of 
Pasteurellosis druing the observation period of seven days. 

The vaccine is also inoculated into six sheep and six goats in a dose of 3 ml. each 
intramuscularly  and  are  observed  for  a  period  of  seven  days.  During  this  period  none 
should die of Pasteurellosis. 

(e) Potency Test- Not being done at present. 

5.       Labelling and Storage- Should comply with the requirements for ―Labelling‖ and 

―Storage‖ as laid down in the general monograph on ―Bacterial Vaccines. 

6.  Expiry  Date-  The  expiry  date  of  Potency  of  the  Vaccine  shall  be  not  more  than 

twelve months from the date of manufacture. 

1[Multicomponent of Clostridial Vaccine 

1.        Synonyms.  –  Combined  anaculture  of  Clostridium  perfringens  type  C  and  D,  C1. 

septicum and CI. oedematiens. 

2.    Definition –  It  consists of four highly antigenic components containing the toxoids 
of  C.  perfringens type  D,  CI.  Perfringens type  C,   Cl.  oedematiens and  CI.  septicum which 
are  prepared  in  double  strength  and  then  combined  in  such  a  proportion that  would  invoke 
adequate anti-toxin response in the vaccinated sheep against each antigen incorporated in the 
vaccine 

3.    Preparation – The above strains are grown separately in suitable liquid media under 
conditions which ensure maximum toxin production. The cultures are checked for purity and 
toxicity in mice. Solution  of Formaldehyde  I.P. of analytical   grade   is   added   to a 0.5 per 
cent   final   concentration and formalized cultures are kept at 37oC till the product is sterilized 
and atoxic. The formalized anacultures are pooled, precipitated by the addition of Aluminium 
Chloride, 20 per cent solution in distilled water to have a final concentration of the chemical 
to  10  per  cent  and  pH  adjusted  to  6.0.the  sedimented  toxoid  is  reconstituted  to  have  its 
original volume in normal saline. 

1. Ins. by G.S.R. No. 659(E) ,dt. 31-8-1994 

345 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4     Standards : 

(a)  Description  –  It  is  whitish  liquid  when  shaken  thoroughly  to  contain  killed 

bacteria and toxoid in suspension. 

(b)   Identification  –   When   injected   to   susceptible  animals   it   stimulates   the 
production of  epsilon  and beta  antitoxins against CI.  perfrigens type  D  and  C  and  also 
antitoxins against CI. septicum  and toxin of CI. Oedematiens. 

(c)  Sterility   Test  –  Complies  with  the  test  of  sterility  described  in  general 

monograph on ―Bacterial Vaccines.‖ 

(d) Safety Test – Four sheeps   each are inoculated with 10   ml. S/C of the product 
and these are observed for 7 days during which period animals shall not show any local 
or systemic reaction. 

(e) Potency Test – Eight sheep each are inoculated with 2 doses of vaccines S/C at 
an interval of 21 days and bled on 10th day after 2nd inoculation for collection of serum 
for  assessing  the  antitoxin  titre  against  each  antigen  incorporated  in  the  vaccine.  The 
post-inoculation serum should contain   not less than 2 i.u. of epsilon and beta antitoxins 
of   CI. perfringens  and 2.5 i.u. of   CI. septicum antitoxin and 4 i.u. of CI.  oedematiens 
antitoxin. 

5.     Labelling  and  storage   -  Shall  comply  with  the  requirements  regarding  labelling 

and storage as laid down in the general monograph on ―Bacterial Vaccine‖. 

6.   Expirty date – The expiry date of potency of vaccine shall not be more than 6 months 

from the date of manufacture. 

Haemorrhagic Septicaemia Vaccine – Alum Treated 

1.      Synonyms – Pasterulla multocida/(Yersinia Multocida) vaccine – Alum treated. 

2.      Definition -- The vaccine is a formalized culture of a virulent strain of Pasteurella 

multocida in nutrient broth treated with potash alum. 

3.      Preparation -- A highly potent strain of Pasteurella multocida type I in Phase I is 
grown  on  nutrient  broth  at  37oC.  The  pure  growth  is  killed  by  the  addition of  a  solution of 
Formalin I.P in suitable concentration (0.5 per cent). This is treated with Potassium Alum I.P 
to give a final concentration of 1 per cent. 

4.           Standard : 

(a) Description – It is a white suspension containing dead bacteria and alum. 

(b)   Identification   –   It   protects   susceptible   animals   against   infection   with 

P. multocida. 

(c)  Sterility  Test   --  It  complies  with  the  test  for  sterility  described  under  general 

monograph on ―Bacterial Vaccines‖. 

(d)  Safety  Test  --  Four  healthy  rabbits  each  weighting  1  to  1.5  kg.  are  inoculated 
subcutaneously  each  with  5  ml.  of  the  product.  There  shall  be  no  untoward  reaction 
during  the  period  of  observation  for  7  days  except  slight  local  swelling.  Alternatively 
two rabbits and six mice may be employed. The dose for mice will be 0.5 ml. 

5.     Labelling  and  Storage  :--  Shall  comply  with  the  requirements  of  labelling  and 

storage as laid down in the general monograph on ―Bacterial Vaccines‖. 

6.     Expiry date – The date of expiry of potency of the vaccine shall be not more than 

six months from the date of manufacture.] 

(B)    PROVISIONS APPLICABLE TO THE PRODUCTION OF VIRAL VACCINES 

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1.     Definition- (i) This part of the Schedule applies to viral vaccines live or inactivated 
made  from  any  virus  pathogenic  to  domestic  animals  and  poultry  and  made  from  other 
modified viruses which have any antigenic value. 

(ii)  For  the  purpose  of  this  Part  of  the  Schedule,  a  virus  vaccine  means  a  sterile 
suspension  or  a  freeze  dried  powder  containing  the  modified  living  or  inactivated  virus 
particles, which in its original unaltered stage, causes disease from which the vaccine derives 
its name and which has been prepared from the blood or tissues of a suitable host in which it 
has been grown in vivo or from tissue culture. 

2.     Staff  of  Establishment-  The  establishment  in  which  viral  vaccines  are  prepared 
must be under the direction and control of an expert in bacteriology with specialized training 
in  virology  and  sufficient  experience  in  the  production  of  viral  vaccines,  and  he  shall  be 
assisted  by  a  staff  adequate  for  carrying  out  the  tests  required  during  the  preparation  and 
standardisation of the vaccines. 

3.     Proper  Name-  The  proper  name  of  any  viral  vaccine  shall  be  the  name  of  the 
disease which is caused by the particular virus from which the vaccine is produced followed 
by the word ―vaccine‖ unless the Schedule otherwise provides, if there is no special provision 
in the Schedule such  other name as is approved by the Licensing Authority. Provided that in 
the  case  of  the  undermentioned  preparations  the  proper  name  of  the  vaccine  shall  be  as 
follows: 

(i)            Fowl Pox Vaccines, Chick Embryo Virus (Living). 
(ii)          Fowl Pox Vaccine, Pigeon Pox Virus (Living). 

(iii)         Horse Sickness Vaccine (Living) 

(iv)          Ranikhet Disease Vaccine (Living) 

(v)           Ranikhet Disease Vaccine F Strain (Living) 
(vi)          Rinderpest Goat Adapted Tissue Vaccine (Living) 
(vii)        Rinderpest Lapinised Vaccine (Living) 

(viii)       Rinderpest Lapinised Avianised Vaccine (Living) 

(ix)          Sheep and Goat Pox Vaccine (Living) 

(x)           Swine fever vaccine (crystal violet) 

(xi)          Swine fever vaccine lapinised (Living). 
1[(xii)      Foot and Mouth Dieseas Vaccine (Inactivated). 
Canine Hepatitis Vaccine (Living).] 
(xiii) 

2[4. Records- The seed virus used in the preparation of vaccine shall, before being used 
for preparing a batch, be thoroughly tested for purity, safety, sterility and antigenicity by the 
generally accepted tests applicable to a particular virus. It shall not be more than five passages 
away from the stock seed virus, unless otherwise prescribed for a particular virus. The stock 
seed  virus  shall  be  maintained  by  seed-lot  system  at  specified  passage  level  and  tested  for 
bacterial,  mycoplasmal and extraneous viral contamination. The permanent record which the 
licensee is required to keep shall include a record of the origin, properties and characteristics 
of the seed virus from which the vaccines are made.] 

5.  Tests-  Viral  vaccine  shall  be  tested  for  sterility,  safety  and  potency  on  suitable  test 

animals and for viability in the case of live vaccines. 

(a)     Sterility Test- All vaccines shall be tested for sterility in accordance with rules 
115  to  119.  If  the  vaccine  contains  added  bactericides  or  bacteriostatic,  a  quantity  of 
medium sufficient to  render the growth inhibitor ineffective is  added to  the sample or  a 
suitable  substance  is  added  in  a  concentration  sufficient  to  render  the  growth  inhibitor 
ineffective but not itself to inhibit the growth of micro-organisms. 

(b)     Safety  Test-  Suitable  laboratory  animals  or  large  animals  or  birds  may  be 
employed      to  test  the  vaccine  for  safety.  Details  of  the  safety  test  are  given  in  the 
individual monograph. 

   1.  Ins. by  G.S.R. 659(E) ,dt. 31-8-1994. 

2.  Subs. by G.S.R. 659(E) ,dt. 31-8-1994. 

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(c)     Potency  Test-  All  virus  vaccines  for  which  potency  test  has  been  prescribed 
shall  be  tested  for  potency  and  only  those  which  pass  the  potency  test  shall  be  issued. 
Details of the potency test are given in the individual monograph. 

6.  Storage-  Live  viral  vaccines  shall  be  stored,  protected  from  light  at  sub-zero 
temperature as required. Other viral vaccines shall be stored at 2 ˚ C to 4 ˚ C but shall not be 
frozen. 

7.    Condition of housing of animals- (i) The animals used in the production of vaccine 

must be housed in hygienic conditions in premises satisfactory for this purpose. 

(ii)     Only  healthy  animals  may  be  used  in  the  production  of  vaccine.  Each  animal 
intended  to  be  used  as  a  source  of  vaccine  must,  before  being  passed  for  the  production of 
vaccine be subjected to a period of observation in quarantine for at least  seven days. During 
the  period of  quarantine the  animal  must  remain  free  from  any  sign  of  disease and  must  be 
well kept. 

1[(iii)  The poultry birds from which eggs and cell culture for production of vaccines are 
obtained should be housed in a manner so as to keep them free from extraneous infection and 
shall be screened at frequent intervals for common bacterial, mycoplasmal and viral infection. 
The record of the tests and their results shall be maintained by the manufacturers.] 

8.     Labelling- The provisions of ―Labelling‖ as laid down for Bacterial Vaccines shall 
also apply to Viral Vaccines. The following additional information shall also be included on 
the label of the outside container: 

(i)      The name and percentage of bacteriostatic agent contained in the vaccine. 

(ii)      If the vaccine as issued for sale contains any substance other than the diluent, 

the nature and strength of such substances. 

9.       Date  of  Manufacture-  For  the  purpose  of  this  part  of  the  Schedule,  the  date  of 
manufacture shall  be  what  is  given  unless  otherwise stated  in  the  individual  monograph, as 
defined in sub-clause (b) of sub-rule (3) of rule 109. 

Fowl Pox Vaccine Chick- Embryos Virus (Living) 

1.     Synonym- Egg adapted Fowl Pox Vaccine (Living). 

2.    Definition-  Fowl-pox  Vaccine,  Chick-Embryo Virus  (Living)  is  a  suspension of  a 
modified  living  virus  (e.g.  Mukteswar  Strain)  prepared  from  the  chorioallantoic  membrane 
(CAM)  of  the  infected  embryo  and  is  either  freeze  dried  or  is  issued  as  glycerinated liquid 
vaccine. 

3.     Preparation- Active chick-embryos obtained from Salmonella pullorum free flock, 
are  used.  1[Twelve  to  thirteen  days  old  embryos  are  injected  with  a  suitable  dilution  of  the 
suspension of the  infected membrane (seed virus) of chick embryo adopted fowl  pox  virus.] 
The suspension of the stock seed virus is dropped on the CAM. After an incubation at 37˚C 
for a suitable period membranes showing discrete or confluent lesions (pocks) are harvested. 
These  are  homogenised  with  adequate  quantity  of  antibiotics  (penicillin  and  streptomycin) 
ampouled in 0.5 ml. quantities and freeze dried. 

4.      Standard- 

(a)     Description- Light mauve coloured scales. 

(b)    Identification-   When reconstituted vaccine is  applied to  scarified area  of  the 
skin of a fowl it produces characteristic lesions of fowl pox. This product should afford 
protection against fowl pox. 

1. Ins. by. GSR 659(E) , dt. 31-8-1994. 

348 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(c)    Moisture Content- Moisture Content in the finished product should not exceed 

1.0 per cent. 

(d)    Safety  Test-  For  testing  each  batch  of  fowl  pox  vaccine  twelve  healthy 
cockerels, or  other suitable young chicken each weighing not less than 400 g.  from the 
same source are taken. This group of twelve birds is immunized at least twenty-one days 
previous to the test,  with fowl pox vaccine. The vaccine under test  is reconstituted in 5 
ml. of 50 per cent glycerine saline and administered to fowls as follows:- 

Three of the test birds are injected subcutaneously with 0.8 ml. or 10 times the field 
doses of the vaccine under test. This group serves to indicate whether the product is free 
from other viruses and bacteria causing septicaemia or not. 

Three of the test birds are injected intratrecheally with 0.3 ml. or 10 times the field 
dose of vaccine under test. This group serves to indicate whether the product is free from 
the virus of infectious laryngotracheitis and similar disease. 

1[Three  of  the  test  birds  are  injected  intranasally  with  0.2  ml.  of  1 0   t i m e s   o f  
t h e   f i e l d   d o s e   o f   the  vaccine  under test.   This group serves to indicate whether the 
product is free from the virus of  infectious laryngotracheitis and similar disease.] 

The  three  remaining  birds  serve  as  controls.  They  are  isolated  and  kept  under 
observation for twenty-one days. The birds that succumb during the period of twenty-one 
days  are  subjected  to  a  careful  postmortem examination. The  product  is  withheld  from 
issue until the vaccine and the test birds are shown to be free from the causative agents 
of any extraneous disease. 

(e)  Sterility test- Complies with the tests for sterility as described under the general 

monograph on ―Viral Vaccines‖. 

(f)  Potency Test- For testing of potency three unsusceptible birds each weighing not 
less than 400 g. are vaccinated using the field dose by the stick method and examined for 
―takes‖. Three weeks after vaccination these birds along with two unvaccinated controls 
are  exposed  to  challenged virus  and  observed for  fourteen days.   The  vaccinated birds 
should not manifest any reaction, while the controls should show active ―takes‖. 

5.     Labelling- Should comply with the requirement for ―Labelling‖ as laid down in the 

general monograph on ―Viral Vaccines‖. 

6.     Storage  and  Expiry  date-  Freeze  dried  vaccine  shall  be  expected  to  retain  its 

potency for periods at temperatures as specified below:- 

-15 ˚ C to - 20˚ C–Twenty-four months. 

2˚ C  to  4˚ C–Twelve months. 
Room temperature– upto one month. 

The liquid vaccine shall be expected to retain its potency for periods and temperatures as 

specified below: 

2˚ C  to  4 ˚C – six months. 

Room temperature– seven days. 

1. 

Ins. by. GSR 659(E) , dt. 31-8-1994. 

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Fowl- Pox Vaccine, Pigeon Pox  Virus (Living) 

1.   Synonym- Fowl Pox Vaccine (Pigeon pox scab). 

2.  Definition-  Fowl  Pox  Vaccine,  Pigeon-pox  Virus  (living)  consists  of  pigeon  pox 

virus in scabs collected from artificially infected pigeons and dried. 

3.  Preparation-  Healthy  pigeon  are  scarified  on  the  legs  and  breast,  with  a  suitable 
dilution  of  the  suspension  of  pigeon-pox  virus.  The  pigeons  reacting  satisfactorily  and 
showing  good  takes  are  selected  and  the  superficial  skin  layer  scraped  by  means  of  sharp 
scalpel.  The  material  so  collected  is  freed  from  feathers,  homogenised  and  dried  or  freeze 
dried.  The dried pulp is powdered, sieved and ampouled in 0.3 g. quantities and sealed 

4.   Standard- 

(a).  Description- Light cream coloured powder. 

(b)   Identification-  When  applied  to   feather  follicles   by   vigorous  rubbing,  it 
produces mild reaction in fowls. The product should afford protection to fowls upto six 
weeks against fowl pox. 

(c)    Safety Test- For testing a  batch of  vaccine, twelve healthy cockerels, or  other 
suitable young chicken from the same source are made available at the same time. This 
group  of  twelve  birds  is  immunised  at  least  twenty-one  days  previous  to  the  test  with 
fowl  pox  vaccine.  The  vaccine  under  test  is  reconstituted  in  10  ml.  of  50  per  cent 
glycerine saline and administered to fowls as follows: - 

Three of the test birds are injected subcutaneously with 0.3 ml. or 10 times the field 
dose of the vaccine to be tested. This group serves to indicate whether the product is free 
from organisms of septicaemia disease. 

Three  of  the  test  birds  are  injected  intranasally  with  0.2  ml.  of  the  vaccine  to  be 
tested. This group serves to indicate whether the product is free from virus of Coryza and 
similar diseases. 

1[Three of  the  test  birds are  injected  intratricheally  with 0.2  ml  or  10  times  of  the 
field dose of vaccine under test. This group serves to indicate whether the product is free 
from the virus of infectious laryngotracheitis and similar diseases.] 

The three remaining birds serve as controls. All the birds under test are isolated and 
held  under  observation  for  twenty-one  days.  All  those  that  succumb  are  subjected  to 
careful  post-mortem examination. The  product  is  withheld  from  issue  until  the  vaccine 
and test birds are shown to be free from the causative agents of any extraneous diseases. 

(d)   Sterility Test- Complies with the tests for sterility described under the general 

monograph on ―Viral Vaccines‖. 

(e)      Potency Test- For testing the potency of a batch of vaccines three susceptible 
birds  each  weighing  not  less  than  400  g.  are  vaccinated  using  the  field  dose  by  the 
follicular  method  and  examined  for   ‗takes‘.  Three  weeks  after  vaccination these  birds 
and two healthy susceptible controls are exposed to challenge virus and are observed for 
fourteen days.   The vaccinated birds shall manifest no reaction, while the controls must 
have active ―takes‖. 

5.   Storage and Labelling-  Should comply with the requirements of ‗Labelling‘ as laid 

down in the general monograph on ‗Viral Vaccines‘. 

6.   Expiry  date-  The  vaccine  shall  be  expected  to  retain  its  potency  for  periods  at 

temperature as specified below:- 

-15 ˚ C  to - 20 ˚C-- two years. 

2˚ C  to  4 ˚C-- twelve months.  
Room temperature- Upto one month.  

1.  Ins. by. GSR 659(E) , dt. 31-8-1994. 

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Fowl Pox Vaccine- Pigeon Pox- Chick Embryos Virus (Living) 

1.      Synonym- Chick embryo adapted pigeon pox vaccine (Living). 

2.      Definition-  Fowl  pox  vaccine  (Pigeon  Pox  virus)  chick  embryo  adapted  virus 
(living)  is  a  suspension  of  a  modified  living  virus  prepared  from  the  chorioallantoic 
membranes of the infected embryos and is freeze dried. 

3.      Preparation- Active chick embryos obtained from Salmonella Pullorum free stock 
are  used.  Twelve  to  thirteen  days  old  embryos  are  injected  with  a  suitable  dilution  of  the 
suspension of the infected membrane (stock seed virus) of chick embryo adapted pigeon pox 
virus.  The  suspension  of  the  stock  seed  virus  is  dropped  on  the  membrane.  The  inoculated 
eggs are incubated at 37 ° C for four days. One of the fourth day embryos that are living, are 
removed to a refrigerator for chilling for about one hour. Membranes showing discrete lesions 
(Pocks)  are  harvested.  These  are  homogenised  with  adequate  quantities  of  antibiotics, 
ampouled in 0.5 ml. quantities and freeze dried. 

4.      Standards- 

(a)           Description- Light mauve coloured scales. 

(b)      Identification- When reconstituted vaccine is applied to scarified area of the 
skin  of  a  fowl,  it  produces  characteristics  lesions  of  Fowl  Pox.  This  product  should 
afford protection against pox. 

(c)      Moisture  content-  Moisture  content  in  the  finished  product  should  not 

exceed 1.0 per cent. 

(d)      Safety test- For testing each batch of chicks aged four to six weeks from the 
same  source  are  taken.  This  groups  of  twelve  birds  is  immunised  at  least  twenty-one 
days previous to the test, with fowl-pox vaccine. The vaccine under test is reconstituted 
in 3 ml. of normal saline solution and administered as under:- 

       Three  of  the  test  chicks  are  injected  subcutaneously  with  0.3  ml.  or  10  times  the 
field dose of the vaccine under test. This group serves to indicate whether the product is 
free from other viruses and bacteria causing of septicaemia or not. 

Three  of  the  test  chicks  are  injected  intratracheally  with  0.3  ml.  or  ten  times  the 
field dose. This group serves to indicate whether the product is free from the viruses of 
infections laryngeotracheitis and similar diseases. 

Three of the test chicks are injected with 0.2 ml 1/N of the vaccine under test. This 
group serves to indicate whether the product is free from the virus of coryza and similar 
diseases. 

The  remaining  three  chicks  serve  as  controls.  They  are  isolated  and  kept  under 
observation   for   twenty-one   days.   The   birds   that   succumb   during   the   period   of 
observation are  subjected  to  careful  post-mortem examination. The  product  is  withheld 
from  issue  until  the  vaccine  and  the  test  birds are  shown to  be  free  from  the  causative 
agents of any extraneous disease. 

In addition to the above, similar groups of pigeons aged six to nine months old are 

also injected in a similar way to eliminate psittacosis. 

(e)   Sterility  Test-  Should  comply  with  the  tests  for  sterility  described  under 

the general monograph on ‗Viral Vaccine‘. 

(f)    Potency test- For testing potency of  a  batch of  vaccine three susceptible 
chicks of three to four weeks of age are vaccinated by feather forthicle method ( a 
few forthicles on one leg are injected) and these are examined for ‗takes‘. 

Three weeks after vaccination these chicks along with two unvaccinated chicks 
are  exposed to  challenge virus  (virulent fowl  pox  virus) and  observed for  fourteen 

351 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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days. The vaccinated chicks should not manifest any reaction while controls should 
show active ‗takes‘. 

5.     Labelling- Should comply with the requirements     for ‗Labelling‘ as laid down in 

the  general monograph on ‗Viral Vaccines‘. 

6       Storage- The  freeze  dried  product is  expected  to  retain  its  potency  for  periods  at 

temperatures as specified below: 

-15 ° C to  20 ° C–two years. 

2° C to 4 ° C–twelve months. 

Room temperature- up to one month. 

1.     Synonym- Sheep Pox vaccine; Goat pox vaccine. 

Sheep Pox Vaccine (Living) 

2.        Definition-  Sheep  pox  vaccine  consists  of  sheep  pox  virus  collected  from  sheep 

artificially infected with sheep pox virus and freeze dried. 

3.     Preparation-  Healthy  yearling  sheep  are  infected  artificially  by  subcutaneous 
infection  on  the  undersurface  of  the  previously  shaved  abdomen  with  200-  300  cc.  of  the 
freeze dried  sheep  pox  virus  (seed  material)  diluted in  1  :  1  Normal saline  solution. On  the 
sixth  or  seventh  day  after  injection  oedematous swelling  develops  in  the  injected  area  with 
thermal reaction. The sheep which develop good swelling are slaughtered and the gelatinous 
material present under the skin in the infected area is collected under sterile conditions. This 
material is mixed with 2 parts by volume of sterile peptone broth of pH 7.2 and homogenised. 
The homogenised suspension is filtered, ampouled in 0.5 ml. quantities and freeze dried. 

4.     Standard: 

(a)       Description- White scales. 

(b)       Identification- Reconstituted  vaccine  when  applied  over  the  scarified  area 
of  the  skin  of  the  abdominal region of  sheep will  produce characteristic  local  lesion of 
pox. 

(c)       Moisture content- The moisture content should not exceed 1.0 per cent. 

(d)          Safety  test-  Two  rabbits  each  weighing  not  less  than  1  kg.  are  injected 
subcutaneously  each  with  1  ml.  of  1  :  100  dilution  of  the  vaccine  in  normal  saline 
solution.  These  animals  are  observed  for  fourteen  days.      The  animals  should  remain 
normal. 

(e)    Sterility Test- Complies with the tests for sterility described under the general 

monograph on ‗Viral Vaccines‘. 

(f)    Potency Test- Four yearling sheep are vaccinated on the inner surface of the ear 
by  scarification  method.  The  contents  of  one  ampoule  of  F.D.  Sheep  Pox  vaccine  are 
constituted in 10 cc. of 50 % glycerin saline solution, characteristic ‗takes‘ develop in the 
scarified area with ulceration and scab formation. Three weeks later these and two more 
susceptible  sheep  (Controls)  are  challenged  by  scarifying  with  a  suspension  of  the 
previous brow  of  the  vaccine  of  the  undersurface of  the  abdomen. The  controls should 
develop typical lesions of pox and the vaccinated should remain normal. 

5.Labelling-  Should  comply  with  the  requirements  of  ‗labelling‘  as  laid  down  in  the 

general monograph in ‗Viral Vaccine‘. 

6.  Storage  and  expiry  date-  The  vaccine  is  expected  to  retain  potency  for  period  and 

temperature as specified below:- 

-15 ° C to – 20 ° C– two years 

2 ° C to 4 ° C–three months. 

Room temperature- Fifteen  days. 

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Horse Sickness Vaccine (Living) 

1.     Synonym-  African  Horse  Sickness  Vaccine,  Mouse  adapted  Polyvalent  Horse 

Sickness Vaccine (Living). 

2.     Definition- Horse sickness vaccine is a suspension of live mouse adapted strains of 
Horse Sickness Virus  (Onderstepoort) prepared from the brains of infected mice and is freeze 
dried. 

3.     Preparation- Thirty  to  thirty-five days  old  white  mice  are  infected intracerebrally 
with 0.05 ml. of a suitable dilution of the seed virus (6 or 7 types, as the case may be). Groups 
of large numbers of mice are injected separately with each type of the virus and are housed at 
27 ° C to 32 ° C. A majority of these become paralytic on the third and fourth day when they 
are sacrificed and their brains collected and stored at –       15 ° C to – 20 ° C till the day of 
processing. For preparing the polyvalent vaccine, equal number of brains collected from mice 
infected  with  different  types  of  the  virus  are  homogenised  with   5-10  times  its  volume  of 
sterile lactose buffer medium   (pH 7.2 ) containing antibiotics. The suspension is centrifuged 
at  1500 r.p.m. for five  minutes. The supernatant liquid is  distributed in ampoules in suitable 
quantities and freeze dried. 

4.     Standard: 

(a)    Description- White scaly material. 

(b)   Identification- This product affords protection to horse against horse sickness. 

(c)    Safety  Test-  Four  healthy  mice  thirty  to  thirty-five  days  old  are  injected 
intraperitoneally with 0.2 ml. of 10:1 dilution of the vaccine and kept under observation 
for ten days. All the mice should remain normal throughout the period of observation. 

(d)   Sterility  Test-  Should  comply  with  the  test  for  sterility  described  under  the 

general monograph on ‗Viral Vaccines‘. 

(e)    Viability Test- Each batch of   vaccine is titrated in tenfold dilutions using four 
mice  of  thirty  to  thirty-five  days  old  for  each  dilution.  Each  mouse  is  injected 
intracerebrally  with  0.05  ml  and  kept  under  observation  for  ten  days.  Mortality  and 
survival  ratios  are  noted  and  LD50  ml  is  determined. The  minimum  acceptable  titre  is 
10–4 LD50   per 0.05 ml. 

(5)      Labelling -  Should comply with  the  requirements of  ‗labelling‘ as   laid  down in 

the general monograph in ‗Viral Vaccines‘. 

(6)   Storage-  The  vaccine  may  be  expected  to  retain  its  potency  for  twelve  months  if 

stored – 15 ° C to 20° C and about six months if stored in refrigerator at 2 °  C to 4°  C. 

1.     Synonym- Antirabic Vaccine (Inactivated) 

Rabies Vaccine (Inactivated) 

2.      Definition-  Rabies vaccine is a suspension of the brain tissue of animals, that have 
been  infected  with  a  suitable  strain  of  rabies  fixed  virus,  inactivated  with  phenol  or  some 
other suitable agent. 

3.     The following particulars relating to this vaccine are the same as those relating to 

Antirabic vaccine described in Part D of Schedule F to these rules, namely:- 

(i) 

Strain of fixed Rabies Virus to be used; 

(ii)    Staff of Establishment; 

(iii)   Condition  and housing of animals; 

(iv)   Precaution to be observed in preparation; 

(v)     Records; 

(vi)   Issue. 

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4.     Preparation- Healthy sheep or  any  other suitable species  of  animal are inoculated 
subdurally  or  intracerebrally  with  an  appropriate  dose  of  suspension  of  a  suitable  strain  of 
rabbit brain passaged rabies fixed virus. The sheep or  animals which get  paralysed from the 
sixth  day  onwards  after  the  inoculation  are  sacrificed  and  their  brains  collected  aseptically. 
Brain tissue is weighed individually and a suspension of suitable concentration of brain tissue 
prepared in buffered saline is  strained through gauze. The suspension treated  with phenol or 
some other suitable inactivating agent is incubated for an appropriate period. 

5.      Standard- 

(a)   Description- A grey to pale yellow opalescent suspension. 

(b) Identification-  Appropriate  doses  protect  mice  against  subsequent intracerebral 

inoculation with suitable strain of fixed rabies virus. 

(c)   Safety test- Not less than five mice, each weighing at least 18 gm., are inoculated 
intracerebrally with not less than 0.03 ml. of the suitably diluted vaccine. None of 
the animals should show symptoms of rabies or die of the disease during period of 
observation of three weeks. 

(d)    Sterility  Test-  Should comply with  the test  for  sterility  described under the 

general monograph on ‗Viral Vaccine‘. 

6.    Labelling- Should comply with the requirements of ‗Labelling‘ as laid down in the 
general  monograph on  ‗Viral  Vaccines‘. In  addition the  label            on  the  container shall 
indicate the percentage of brain tissue present in the vaccine. 

7.    Storage- The vaccine may be expected to retain its potency for about six months if 

stored in refrigerator at 2˚ to 4  ° C. 

Rabies Vaccine (Living) 

1.        Definition-  Rabies  vaccine  (living)  is  a  freeze-dried  suspension  of  chick-embryo 

tissue infected with a suitable attenuated strain of rabies virus. 

2.     Preparation- It may be prepared by the following method. Seed virus consisting of 
a  suspension  of  the  Flury  or  other  suitable  strain  of  chick  adapted  virus  that  has  been 
maintained  by  passage  in  chick  embryos  is  injected  into  the  yolk-sacs  of  fertile  eggs 
incubated  for  a  suitable  period.  After  incubation  for  a  further  ten  days,  the  embryos  are 
harvested  and  grind  in  water  for  injection  to  give  33  percent  suspension. The  suspension is 
centrifuged to  remove coarse particles and the  supernatant fluid is  distributed into  ampoules 
in 3 millilitre quantities, and freeze dried. The vaccine is reconstituted immediately before use 
by adding 3 millilitres of water for injection to the contents of an ampoule. 

3.     Standard- It  complies  with  the  requirements of  general  standard  of  viral  vaccines 

for abnormal toxicity, sterility, and labelling with the following additions. 

(a)     Description- Dry honey-coloured flakes or powder, readily dispersible in water. 

(b)          Identification-  It  protects  guinea  pig  against  a  subsequent  inoculation  of 
rabies street virus. It is distinguished from the inactivated Rabies vaccine by its ability to 
produce rabies encephalitic on intracerebral injection into mice. 

(c)      Safety- The guinea pigs used in the test for potency should not show any marked 
local or systemic reaction during the three weeks following injection with the vaccine. 

(d)       Sterility    Test-   Complies   with    the    tests    for   sterility    described  under    the 
general monograph on ‗Viral Vaccines‘. 

(e)     Potency Test- The contents of an ampoule are dispersed in water for injection to 
give  a  5  per  cent  suspension  and  not  fewer  than  twenty  guinea  pigs,  drawn  from  a 
uniform stock and each weighing 350 g. to 500 g., are each injected intramuscularly with 
0.25 ml. of this suspension. Three weeks later, these guinea pigs and an equal number of 
similar  unvaccinated control guinea  pigs  are  each  inoculated with  0.1  ml.  of  a  suitable 
dilution of canine salivary gland suspension of street virus which is  maintained as a  20 
per cent suspension at 70 ° C or lower. The guinea pigs are observed for thirty days; not 
less than 80 per cent of the control guinea-pigs die of rabies and not less than 70 per cent 
of the vaccinated guinea-pigs are protected. 

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4.     Storage- Freeze-dried vaccine should be stored at refrigeration temperatures of 2 ° 

C to 4 ° C. 

5.     Labelling-  The  life  of  the  vaccine  at  room  temperature  and  at  refrigeration 

temperature should be stated on the label. 

6.  (a) Action and uses- Rabies vaccine (living) is  used for the prophylactic inoculation 
of  dogs  against  rabies;  one  injection  should  provoke  a  serviceable  immunity  lasting  for  at 
least a year. The vaccine has been used to a limited extent on cattle. 

(b)     Dose- By  intramusclar injection: Dogs, the contents of one ampoule reconstituted 

in 3 ml. of water for injection; cattle five times the dog dose. 

Ranikhet Disease Vaccine (Living) 

1.      Synonym-   New   Castle   Disease   Vaccine   (Living);   pheumoenteritis   Vaccine 

(Living). 

2.     Definition- Ranikhet Disease vaccine is a suspension of a modified living virus e.g. 

(Mukteswar strain) prepared from infected embryos and fluids and is freeze dried. 

3.     Preparation- Good  fertile  eggs  obtained  from  Salmonella pullorum free  flock  are 
incubated in an egg incubator. Ten days old vigorous embryos are infected with 0.1 ml. of a 
suitable  dilution  of  a  suspension  of  the  virus.  Inoculation  is  done  in  the  allantoic  cavity. 
Embryos  are  incubated  at  a  suitable  temperature.  Eggs  showing  dead  embryos  twenty-four 
hours after incubation are discarded. After forty-eight hours incubation the  eggs are  candled 
and those showing dead embryos are chilled for a suitable period of time, while embryos alive 
beyond forty-eight hours are discarded.   The fluids and embryos are then collected  and spot 
haemogglutination  carried  out.  The  material  is  homogenised  in  a  blender  and  ampouled  in 
aliquots of 0.5 ml. quantities and freeze-dried. 

4.     Standards- 

(a)    Description- Light brown scales. 
(b)    Identification-  This  product  affords  protection  to  fowls  against  Ranikhet 

Disease. 

(c)    Safety Test- For testing each batch of freeze dried Ranikhet Disease Vaccine, 
twelve healthy young chickens, all from the same source each weighing not less than 100 
g.  are  taken  and  immunised  against  Ranikhet  Disease.  Fourteen  days  later,  these  birds, 
are tested  as  follows with the  contents of  one ampoule suspended in  100  ml.  of  normal 
saline. 

Three  of  the  test  birds  are  injected  subcutaneously  with  0.1  ml.  equivalent  to 
ten times the field dose of the vaccine to be tested. This group serves to indicate whether 
the product is free from viruses or organisms of speticaemia disease. 

Three  of  the  test  birds  are  injected  intratracheally  with  0.1  ml.  equivalent  to  ten 
times the field dose of he vaccine to be tested. This group serves to indicate whether the 
product  is  free  from  the  virus  of  infectious  laryngotracheitis,  1[***]  and  similar 
diseases. 

The three remaining birds serve as controls. 
2[Three  of  the  test  birds  are  injected  intranasally with  0.2  ml  of  the  vaccine to  be 
tested. This group serves to indicate whether the product is free from virus of Coryza and 
similar diseases.] 

All the treated  birds and controls are observed daily  for fourteen days. All the test 
birds that succumb are subjected to careful postmortem examination. The product is not 
issued  until  the  birds  under  test  are  shown  to  be  free  from  the  causative agents  of  any 
extraneous diseases. 

(e) Sterility  Test- Should comply with the test for sterility  described in the general 

monograph on ‗Viral Vaccine‘. 

1. The word ―Coryza‖ omitted by. GSR 659(E) ,dt.. 31-8-1994. 
2. Ins. by  G.S.R. 659(E) ,dt.. 31-8-1994 

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(f)  Potency  Test-  Four  susceptible  birds  eight  to  twelve  weeks  old  and  each 
weighing not less than 400 g. are vaccinated by injecting subcutaneously 1 ml. of a 10-5 
dilution of the product. Two weeks after vaccination these birds and four non-protected 
birds are challenged by injecting subcutaneously each with 1.0 ml. of a 1: 100 dilution of 
virulent virus (liver and spleen suspension) or 1.0 ml. of  a 1 : 100 dilution of fluid from 
the  embryo  infected  with  virulent  Ranikhet  Disease  virus.  The  non-protected  birds 
should  show  symptoms of  Ranikhet  Disease  and  die  and  all  the  protected  birds  should 
remain normal during an observation period of fourteen days. 
5.     Labelling- Should comply with the requirements of ‗Labelling as laid down in the 

general monograph on ‗Viral Vaccines‘. 

         6.        Storage- The vaccine when stored at – 15° C to  20° C. may be expected to retain 
the potency for about one year and about three months if stored in a refrigerator at 2° C to 
4° C. The product should not be used if stored for more than ten days outside the refrigerator. 

Ranikhet Disease Vaccine F strain (Living) 

1.     Synonyms- New castle disease vaccine F Strain (Living). 

2.     Definition-  Ranikhet  disease  vaccine  F.  strain  is  a  suspension  of  a  naturally 
modified  living  virus  (F  strain)  prepared  from  the  infected  embryos,   devoid  of  beaks  and 
eyes and fluids in a frozen state. 

3.  Preparation-  Good  fertile  eggs  obtained  from  Salmonella  pullorum  free  flock  are 

incubated in an egg incubator. Eight days old vigorous embryos are infected with 0.1 ml. of 
1  :  100  suspension  of  Ranikhet  disease  vaccine  F  strain  virus.    Inoculation is  done  via  the 
allantoic cavity. Embryos are incubated at 37° C. Eggs are candled every day upto four days 
and the dead ones are discarded. Final candling   of the embryos is  carried out on the fourth 
day and only the living ones are chilled in a refrigerator for one hour. The fluids embryos are 
collected  separately.  The  fluids  are  tested  for  spot  haemagglutination  and  sterility  test  is 
carried  out.  The  beaks  and  eye  balls  of  the  embryos  are  removed.  The  materials  are 
homogenised with adequate quantities of antibiotics in a cool warning blender and ampouled 
in aliquots of 0.5 ml. quantity and freeze dried. 

4.      Standard- 

(a)        Description- Light brown scales. 
(b)      Identification-   This   product   affords   protection   to   baby   chicks   against 

Ranikhet disease. 

(c)   Moisture content- The moisture content should not exceed 1[1.0] per cent. 
(d)   Potency test-    For testing each batch of the vaccine twelve one-day old chicks 
are given two  drops 1/N o  the field dose of the vaccine (5 ampoules selected  at  random 
may  be  reconstituted  in  50  ml.)  of  cold  normal  saline  solution.  These  are  observed  for 
fourteen days  and the   vaccinated chicks should remain normal throughout the period of 
observation. This serves the safety test also. 

On  the  fourteenth  days  the  vaccinated  chicks  are  challenged  two  drops  with  1:50 
virulent  Ranikhet  disease  virus  alongwith  8  control  chicks.  Four  of  the  controls  receive 
two  drops  1/N  of  the  virulent  virus  while  the  rest  of  the  four  receive  0.5  ml.  of    the 
virulent  virus.  The  control  chicks  should  succumb  to  the  challenge  virus  showing 
symptoms  of  Ranikhet  Disease  while  the  protected  chicks  should  remain  normal 
throughout the observation period of fourteen days. 

(e)   Sterility Test- Should comply with the tests for sterility described in the general 

monograph on ‗Viral Vaccines‘ 

5.    Labelling- Should comply with the requirements of ―Labelling‖ as laid down in the 

general  monograph on ‗Viral Vaccines‘. 

6.    Storage- The vaccine when stored at – 15 ° C  to –20 ° C may be expected to   retain 
the potency for about one year and about three months if stored in a refrigerator at 2 ° C to 
4° C. When removed from the refrigerator, the product should not be used later than ten days. 

1. Ins. by G.S.R. 659(E) ,dt.. 31-8-1994 

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Rinderpest Goat adapted Tissue Vaccine (Living) 

1.      Synonym- Goat-adapted Cattle Plague Vaccine; Goat Tissue Vaccine (Living). 

2.     Definition-  Rinderpest  Goat-adapted  Tissue  Vaccine  is  the  homogenised  freeze 
dried  preparation  of  spleen  pulp  of  goats  artificially  infected  with  the  suitable  strain  of 
rinderpest virus. 

3.     Preparation-  Healthy  susceptible  goats  are  quarantined  for  a  period  of  ten  days. 
After this period  a batch of selected goats are injected subcutaneously with 2 ml. of a suitable 
dilution  of  the  suspension of  the  seed  virus.  The  donor  goats  are  sacrificed  after  a  suitable 
period when the titre of the virus in the animal body is expected to be maximum, usually four 
days,  and  the  spleen  from  animals  free  from  any  pathological change  or  signs are  collected 
under  sterile  conditions.  Smear  from  each  spleen  is  examined  microscopically  to  exclude 
spleen which are contaminated from the production  batch. 

The spleen is freed from fat  and fascia and is  blended into a  smooth pulp in a  grinder. 

The pulp is spread on a shallow dish of glass or stainless steel and is freeze dried. 

The  freeze  dried  pulp  is  then  ground  into  a  fine  powder  and  sieved.  The  powder  is 

ampouled in 0.25 g. or 0.125 g. quantities and freeze dried. 

4.     Standard: 

(a)    Description- Dark brown or chocolate coloured scales or powder. 

(b)    Identification- The  product  affords  protection to  susceptible animals  against 

rinderpest. 

(c)    Moisture content- Not more than 1.0 per cent. 

(d)      Safety  Test-  Each  batch  of  vaccine  shall  be  tested  for  safety  in  laboratory 

animals and cattle or buffalo calves as follows:- 

(i)    Small animals- At least two guinea pigs each weighing 300 g. to 450 g. 
and two adult rabbits each weighing 1 kg. to 1.5 kg. should be injected each with 
1  ml.  of  1:  100  suspension  of  the  vaccine  subcutaneously  and  kept  under 
observation for seven days. None of the animals should die. Alternatively, a batch 
of  six  white  mice  each  weighing  not  less  than  18  g.  may  be  used,  each  mouse 
receiving  0.5  ml.  of   a  dilution  1  :  100  suspension subcutaneously. None  of  the 
animals should die. 

(ii)    Large animals- Either cattle of good grade of susceptibility (hill cattle) 
or  buffalo  calves  may  be  employed.  For  each  batch  of  vaccine,  three  animals 
should be injected  subcutaneously with 1  ml. of 1 :  8000 dilution of the vaccine. 
These animals should be kept under observation for twelve to fourteen days. None 
of the animals should show any untowards reactions. 

(e)    Sterility Test- Complies with the tests for sterility described under the general 

monograph in ‗ Viral Vaccines‘. 

(f)     Potency Test- The animals   receiving   1 ml. of 1 : 8000 dilution of vaccine 
used  under  safety  test  mentioned  above  and  kept  under  observation    for  fourteen  days, 
should be challenged with 1 ml. of 1 per cent   suspension   of stock Rinderpest Virulent 
virus. None of the animals should die of rinderpest within a period of ten days. This test 
serves as a short potency test for each of the batches. 

For conducting a detailed potency test the following procedure may be followed:- 

Dilution  1: 8000,  1: 12,000 and 1 : 16,000 shall be tested and for each dilution 
three susceptible cattle or buffalo calves should be used. Each animal is inoculated 
subcutaneously with 1 ml. of a dilution of the vaccine, followed twelve to fourteen 
days later with a standard challenge dose of virulent rinderpest bull virus containing 

357 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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in 1 ml. of a   1 : 100 suspension of spleen tissue. Two unvaccinated bovines, each 
receiving the same quantity of the challenge dose acts  as controls.   These are kept 
under observation for fourteen days. The end point of protection titre is assessed on 
the  death  or  survival  rate  and  the  dose  contained  in  one  gramme  of  vaccine 
calculated  on  the  basis  of  20  to  40  minimum  protective doses  being  equivalent to 
one vaccinating dose. 

(g)       Virulence and Viability Test- Two to four goats each weighing not less than 
18  kg.  are  injected  with  2  ml.  of  1  :  100  suspension  of  the  vaccine  and  kept  under 
observation for ten days.   These animals should show reaction characterised by pyrexia 
(rise of about 2˚ C) anorexia and dullness. 

5.  Labelling-  Should  comply  with  the  requirement  of  ‗Labelling‘  as  laid  down  in  the 

general monograph on ‗ Viral Vaccines‘. 

6.  Storage-    The  vaccine  may  be  expected to  retain  its  potency  for  twelve  months if 

stored at - 15˚ C to -20˚ C or  about  three  months  if  stored  at 2˚C  to 4 ˚ C. 

Rinderpest Lapinised Vaccine (Living) 

1.     Synonym-  Rabbit  Adapted  Cattle  Plague  Vaccine  (Living)  Lapinised  Vaccine 

(Living). 

2.     Definition- Rinderpest lapinised vaccine is a suspension of a modified living virus 
(e.g.  Nakamura  III  Strain)  prepared  with  the  blood,  spleen  and  mesenteric lymph  glands  of 
infected rabbits and is freeze dried. 

3.  Preparation- Adult rabbits possibly from a known stock, each weighing not less than 
1  kg.  free  from  cocidiosis  and  snuffles,  are  injected  intravenously  with  1  ml.  of  a  suitable 
dilution of  a  suspension of  the  stock seed virus. Donor rabbits are sacrificed after a  suitable 
period when the titre  of the  virus in  the animals is expected to be the maximum usually the 
third day. 

Ten  millilitres  of  blood  is  collected  from  each  rabbit  in  a  defibrinating  flask  under 
aseptic  condition.  Later  the  animals  are  sacrificed  and  the  spleen  and  mesenteric  lymph 
glands collected. Each rabbit is subjected to a thorough post-mortem examination to observe 
lesions of rinderpest infection. 

After  harvesting,  the  blood  and  the  organs  (spleen  and  glands)  are  homogenised  in  a 
suitable proportion if  necessary. Adequate quantities of   penicillin  and streptomycin may  be 
added. The homogenized material is ampouled in suitable quantities and freeze dried. 

4.     Standard- 

(a)     Description- Dark chocolate coloured mass. 

(b)  Identification-  This  product  affords  protection  to  susceptible  animals  against 

rinderpest. 

(c)     Moisture content- Not more than 1.0 per cent. 

(d)     Safety Test- For testing a batch 2 guinea pigs each weighing not less than 300 
g.  are  injected  subcutaneously  with  1  ml.  of  a  1  :  100  suspension  of  the  vaccine. 
Alternatively, a group of six white mice each weighing not less than 18 g. is used. Each 
animal receives subcutaneously 0.5 ml. of 1 : 100 suspension of the vaccine. None of the 
test animals should die within a period of seven days. 

(e)  Sterility Test- Should comply with the tests for sterility described in the general 
monograph on  ‗Viral Vaccines‘. If  antibiotics have been added the inoculum should be 
neutralised before doing the test. 

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(f)     Potency Test- Dilution 1: 100, 1 : 200, 1 : 400 and  1 : 800 shall be tested and 
for each dilution 2 susceptible cattle ( hill bulls) or buffalo calves should be used. Each 
animal  is  inoculated  subcutaneously  with  1  ml.  of  a  dilution  of  the  vaccine,  followed 
twenty-one days later with a standard challenge dose of a virulent rinderpest bulls virus 
contained in  1  ml.  of  a  1  :  100  suspension of  spleen tissue. Two  unvaccinated bovines 
each receiving the same quantity of the challenge virus serve as controls. These animals 
are  kept  under  observation  for  fourteen  days.   The  end  point  of  the  protecting  titre  is 
assessed on the death or survival rate and the dose contained in one gramme of vaccine 
calculated  on  the  basis  of  twenty  minimum  protective  doses  being  equivalent  to  one 
vaccinating dose. 

(g)       Virulence and Viability Test- Four rabbits each weighing   1 to   1.5 kg. are 
injected  subcutaneously  with  1  ml.  of  1  :  100  suspension  of  the  vaccine.  The  animals 
should react typically showing all the symptoms of rinderpest in rabbits. 

5.     Labelling- Should comply with the requirements of ‗Labelling‘ as laid down in the 

general monograph on ‗Viral Vaccines‘. 

6.     Storage- The vaccine may be expected to retain its potency for six months if stored 

at  15 ˚C to –20 ˚C or about a month if stored at 2 ˚C to 4 ˚C. 

Rinderpest Lapinised Avianised  Vaccine (Living) 

1.      Synonym- Lapinised Avianised Vaccine (Living). 

2.    Definition- Rinderpest Lapinised Avianised Vaccine is  a  suspension of  a  modified 
live  rinderpest  virus  of  low  virulence  prepared  either  with  the  whole  chick  embryo  or  the 
viscera of the infected chick embryo. 

3.  Preparation- Twelve or thirteen days old active chick embryos from a flock free from 
Salmonella  pullorum  infection  are  injected  intravenously  with  a  suitable  dilution  of  the 
suspension of the stock seed virus in six per cent glucose solution. The embryos are incubated 
at 38.5˚ C for five days. At the end of this incubation period, eggs which show living embryos 
are selected  for the preparation of the vaccine. The viscera of  the chicks are harvested, care 
being taken to reject the gizzard and gall bladders. The material is homogenised in a blender 
with  adequate  quantities  of  antibiotics (penicillin and  streptomycin added  if  necessary), and 
primary freeze dried done. This freeze dried material is ground into a fine powder, ampouled 
in  suitable  quantities  and  finally  subjected  to  secondary  freeze  drying  and  sealed  under 
vacuum. 

4.    Standard- 

(a)       Description- Pale cream or yellow coloured sterile powder. 

(b)         Identification- This  product  affords  good  grade  of  immunity  to  susceptible 

animals against rinderpest. 

(c)      Moisture content- Not more than 1.0 per cent. 

(d)      Safety  Test-  For  testing  each  batch,  a  group  of  six  mice  each  weighing  not 
less than 18g. is used. Each mouse is injected subcutaneously with 0.5 ml. of  a  1 :  100 
suspension. Alternatively, two guinea pigs each weighing not less than   300 g. and two 
rabbits each weighing not less than 1 kg. are injected with 1 ml. of   1 : 100 suspension 
subcutaneously. These animals should not show any untoward reaction during the period 
of observation for seven days. 

(e)    Sterility  Test-  Should  comply  with  the  test  or  sterility  as  laid  down  in  the 

general monograph on ‗Viral Vaccines‘. 

(f)    Potency  Test-  Healthy  highly  susceptible  cattle  (hill  bulls)  or  buffalo  calves 
should be used for testing the potency of each batch of vaccine in  suitable dilution. For 
each dilution two highly susceptible  animals should be used. Each animal is inoculated 

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subcutaneously with  1  ml.  of  a  dilution of  the  vaccine, followed twenty-one to  twenty- 
eight  days  after  with  a  standard  challenge  dose  of  a  virulent  rindepest  bull  virus 
contained in 1 ml. of a 1 : 100 suspension of spleen tissue. Two   unvaccinated bovines, 
each  receiving      the  same  quantity  of  the  challenge  virus  serve  as  controls.  All  these 
animals are kept under observation for fourteen days.  The end point of protective titre is 
assessed on the death or   survival rate and the dose contained in one gramme of vaccine 
calculated  on  the  basis  of  forty  minimum      protective  doses  being  equivalent  to  one 
vaccinating dose. 

5.     Labelling- Should comply with the requirements of ‗Labelling‘ as laid down in the 

general monograph on ‗Viral Vaccines‘. 

6.     Storage and Expiry date- The vaccine shall be expected to retain its potency for the 

period at temperatures as specified below:- 

-15˚ C to – 20˚ C    .. Six months. 

2˚ C to 4˚ C    .       .. One month. 

Sheep and Goat Pox Vaccine (Living) 

1.  Synonym- Sheep Pox Vaccine. Goat Pox Vaccine (Living). 

2.  Definition- Sheep and Goat Pox Vaccine consists of the virus contained in the scabs 

collected from sheep artificially infected with the virus. 

3.  Preparation- Healthy yearling sheep are infected artificially on the shaved portion of 
the  abdomen  with  a  suitable  dilution  of  the  suspension  of  the  stock  seed  virus  50  per  cent 
glycerine saline solution. The material  from the  semi-dried areas where the pock lesions are 
evident is  collected  and  dried  over  calcium  chloride or  phophorus pentoxide under  vacuum. 
Dry scabs are powdered, sieved, ampouled in suitable quantities and sealed. 

4.  Standard: 

(a)     Description- Light cream coloured powder. 

(b)     Identification- This  product  when  applied to  scarified  area  of  the  skin  of  the 
sheep or goats produces characteristic  local  lesions of pox and should afford protection 
to sheep and goat against Sheep and Goat Pox. 

(c)      Safety  Test-  Two  rabbits  each  weighing  not  less  than  1  kg.  are  injected 
subcutaneously  each  with  1  ml.  of  a  1  :  100  dilution  of  the  vaccine  in  normal  saline 
solution.  These  animals  are  observed  for  fourteen  days.  The  animals  should  remain 
normal. 

(d)     Sterility Test- Complies with the tests for sterility described under the general 

monograph on ‗Viral Vaccines‘. 

(e)     Potency Test- Four yearling sheep are inoculated with 1 : 100 suspension of the 
vaccine in 50 per cent glycerine saline on a scarified area on the abdomen. Fourteen days 
later,  these  and  two  more  susceptible  sheep  are  inoculated  by  the  same  method  with 
stock  virus  and  observed  for  a  period  of  fourteen  days.  The  control  animals  should 
develop typical lesions of pox and vaccinated animals should remain normal. 

5.            Labelling-  Should  comply  with  requirement  of  ‗Labelling‘  as  laid  down  in  the 

general monograph on ‗Viral Vaccines‘. 

6.       Storage and Expiry date- The vaccine shall be expected to retain its potency for 

period   at  temperatures as specified below:- 

-15˚ C to – 20˚ C                    :                    Twenty months. 
2˚ C to 4˚ C                           :                    Three months. 
Room Temperature               :                    Fifteen days. 

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Fowl Spirochaetosis Vaccine ( Chick Embryo Origin) 

1.  Synonym- Tick Fever Vaccine. 

2.  Definition-  The  vaccine  consists  of  a    merthiolated  suspension  of  chorioallantoic 
membrane,  internal  viscera  and  blood  of  chick  embryos  infected  with  a  vaccine  strain  of 
spirochaetes and freeze dried. 

3.  Preparation- Eleven days old developing chick embryos are infected with 0.2 ml. of 
sterile fresh blood containing spirochaetosis via the chorioallantoic membrane. The inoculated 
embryos are incubated at 37 ˚C and candled daily and the dead one are discarded. On     the 
seventh  day  the  living  embryos  are  chilled  in  the  refrigerator  for  two  hours.  The  chilled 
embryos are harvested separately and necrotic lesions in liver noted. Representative samples 
of blood should be examined for teaming spirochaetes. The internal viscera, chorio-allantoic 
membranes  and  the  blood  are  collected.  The  material  is  pooled,  weighed  and  held  in  deep 
freeze at – 15 ˚C to –20 ˚C for a period of one week. Thereafter the material is blended with 
equal quantity of Merthiolate (final concentration of merthiolate in the suspension should be 1 
:  10,  000)  thoroughly  for  three  times,  each  time  the  motor  running  at   full  speed  and  the 
vaccine is ampouled in 2 ml. quantities and freeze dried. 

4.  Standard- 

(a)     Description- Light brownish scales. 

(b)     Identification- The  vaccine affords protection when  inoculated into  the  fowls 

against spirochetosis. 

(c)      Moisture content- The moisture content should not exceed 1.0 per cent. 

(d)      Safety and potency test- Six healthy cockerals ten to twelve weeks old are used 
for  this  purpose.  Each  ampoule  of  vaccine  is  reconstituted  in  10  ml.  of  cold  distilled 
water  and  the  six  cockerals  are  injected  intramuscularly  each  with  1  ml.  of  the 
reconstituted  vaccine    and  the  birds  are  observed  for  a  period  of  ten  days  and  the 
vaccinated  birds  should  remain  normal  throughout  the  period  of  observation.      The 
vaccinated  birds  are  challenged  with  0.2  ml.  intramuscularly  with  virulent  spirochaete 
blood along with two susceptible controls.  Temperature and blood smear examination of 
the challenged birds and controls should be carried out daily for a period of ten days. The 
blood  smears  of  vaccinated  birds  should  remain  negative  for  spirochaetes  during  the 
entire  period  of  observation.  The  controls  should  react  and  show  spirochaetes  in  the 
blood. 

(e)          Sterility  Test-  Complies  with  the  tests  for  sterility  described  in  the  general 

monograph on ‗ Bacterial Vaccine‘. 

5.     Labelling- Should comply with the requirement of ‗Labelling‘ as laid  down in the 

general monograph on ‗Viral Vaccines‘. 

6.       Storage- The vaccine when stored at –15 ˚C to – 20 ˚C may be expected to retain 

the  potency for about one year and about two months if stored in refrigerator at 2 ˚C to 4 ˚C. 

Swine Fever Vaccine Crystal Violet 

1.  Synonym- Crystal Violet Swine fever vaccine, Hog Cholera Vaccine. 

2.  Definition- Swine fever vaccine, crystal violet is a suspension of blood of swine that 
have  been  infected  with  a  suitable virulent  antigenic strain of  swine  fever  virus,  inactivated 
with 0.25 per cent crystal violet ethylene glycol at 37 ˚C for fourteen days. 

3.  Preparation-  Susceptible  healthy  pigs  of  six  to  seen  months  of  age  belonging  to  a 
well established strain or bred are used.   Body weight of   these animals at this age may vary 
according to the breed but optimum weight is considered as between 75 to 100 kg. Animals 
used for production may be procured from well established farms and kept under quarantine 

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for  fourteen  days.     These  are  injected  intramuscularly  with  a  suitable  dilution  of  the 
suspension  of the virulent blood viruses. Bleeding of the clinically injected animals is carried 
out  on  the  sixth  day.  The  defibrinated  blood  from  each  animal  is  strained  and  stored 
separately in sterile glass containers. To the four parts of  defibrinated blood, one part of 0.25 
per cent crystal violet- ethylene glycol is added and the suspension after thorough mixing, is 
stored at 37˚ C (  +0.5) for two weeks. The product is filled in 20 ml. volumes in sterile vials 
and labelled on the completion of tests. 

4.  Standard- 

(a)   Description- Very dark violet suspension. 

(b)   Identification-  This  product  affords  protection  against  swine  fever  but  not 

against African Swine Fever. 

(c)  Safety  Test-  Two  young  pigs  weighing  about  15  to  30  kg.  are  injected 
subcutaneously  each  with  40  ml.  of  the  vaccine  batch  to  be  tested.  In  addition,  one 
unvaccinated susceptible pig is placed in contact. 

(d)   Sterility Test- Should comply with the test for sterility described under general 

monograph on ‗Viral Vaccines‘. 

(e)  Abnormal  toxicity  test-  Two  guinea  pigs  are  given  1  ml.  of  vaccine 

intramuscularly. 

Two guinea pigs are given  2 ml. of the vaccine intraperitoneally. 

Two mice are given 0.5 ml. of the vaccine subcutaneously. 

(f)   Potency Test- Four susceptible   pigs weighing between 20-30 kg. are injected 
with  5  ml.  of  the  vaccine  subcutaneously.  After  twenty-one  days  these  are  challenged 
with  1  ml.  of  suitable  dilution  of  the  challenge  virus  subcutaneously.  The  dose  must 
contain at least 1000 minimum infective doses. At least two control pigs should be used. 

5.  Labelling-  -  Should  comply  with  requirement  of  ‗Labelling‘  as  laid  down  in  the 

general monograph  on ‗Viral Vaccines‘. 

6.  Storage-  The  vaccine  may  be  expected  to  retain  its  potency  for  twelve  months  if 

stored in refrigerator at 2 ˚C to 4 ˚C. 

Swine Fever Vaccine Lapinised (Living) 

1.            Synonym-  Lapinised      swine  fever  vaccine,  freeze  dried  lapinised  swine  fever 

vaccine. 

2.       Definition-  Swine  fever  lapinised  vaccine  consists  of  the  suspension  of  a 

modified live swine fever  virus prepared from spleens of infected rabbits and is freeze dried. 

3.    Preparation- Healthy adult rabbits weighing approximately 1000 gms. or over,  free 
from    coccidiosis snuffles etc. are injected intravenously with a suitable dose of a dilution of 
the modified  rabbit  adapted virus. Rabbits are sacrificed at the height of reaction and spleens 
are collected with sterile precautions. The collection is later homogenised in a blender using 
ten  per  cent  yolk  phosphate  buffer      as  a  diluent.  The  suspension  is  ampouled  in  0.5  ml. 
quantities and freeze dried. 

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4.     Standard- 

(a)  Description- Light scales. 

(b)  Identification- This product affords protection against swine fever. 

(c)   Moisture content- The moisture content should not exceed 1.0 per cent. 

(d)  Safety Test- Six mice are injected each with 0.5 ml. of a 1 : 100 suspension of 

the vaccine. These are kept under observation for seven days. Non should die. 

(e)   Viability Test-   Two healthy rabbits are injected intramuscularly with 1 ml. of 

1 : 100 suspension of the vaccine. These animals show thermal reaction. 

(f)  Sterility  Test-  Should  comply  with  the  test  for  sterility  described  under  the 

general monograph on ‗Viral Vaccines‘. 

(g)  Potency  Test-  The  vaccine  batch  under  test  should  be  tested  on  susceptible 
healthy pigs weighing between 20-30 kg. Two animals for each dilution may be used. 
The  dilutions tested are 1 : 10, 1 : 25, 1 : 50 and 1 : 100. One millilitre of each of these 
dilutions is  injected  subcutaneously. One  healthy, susceptible, unvaccinated in  contact 
animal should be kept along with the vaccinated animals. 

Fourteen  to  twenty-one  days  later  these  animals  along  with  two  controls  are  injected 
subcutaneously with 1 ml. of the challenge virus containing at least 1000 minimum infective 
doses. 

5.  Labelling-  Should  comply  with  requirements  of  ‗Labelling‘  as  laid  down  in  the 

general monograph   on ‗Viral Vaccines‘. 

6.  Storage- The vaccine may be expected to retain its potency for six months if stored at 
temperature  ranging  between  –  10˚  C  to  -  15˚  C  and  for  seven  days  at  2˚  C  to  4˚  C  in  the 
refrigerator. 

1[Foot and Mouth Disease Vaccine (Inactivated) 

1.     Synonym. – Inactivated Tissue culture mono or polyvalent Foot and Mouth Disease 

Vaccine. 

2        Definition.  –  Foot  and  Mouth  Disease  Vaccine  is  a  liquid  product  or  preparation 
containing one or more types of foot and mouth disease virus which have been inactivated in 
such a way that its immunogenic property is maintained. It may  also contain an adjuvant. The 
vaccine is described as monovalent, bivalent, trivalent or polyvalent depending on the number 
of types of virus used. 

3.  Preparation.  –  The  virus  is  propagated  in  suitable  cell  culture.  The  cell  culture  is 
infected  with  an  appropriate  inoculum  of  virus  and  incubated  at  a  suitable  temperature  for 
multiplication  of  virus.  The  virus  is  harvested  and  cellular  debris  removed  by  filteration. 
Inactivation  is  carried  out  by  a  suitable  agent  such  as  formaldehyde  solution  or  aziridine 
compound. The adjuvant may be aluminium hydroxide and/or saponin. In case of inactivated 
gel vaccine the antigen is concentrated by sedimentation at plus 4 degree C. For preparing a 
polyvalent vaccine, monovalent antigens are mixed in appropriate quantities to give the final 
mixture which is the formulated vaccine. 

4.    Standards  : 

(a)     Description  :-  Aluminium  hydroxide  gel  vaccines  settle  down  to  variable 

degree on storage leaving the supernatant clear. 

1. Ins. by G.S.R. No. 659(E) ,dt.. 31-8-1994. 

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(b)    Identification  –  It  protects  cattle  against  Foot  and  Mouth  Disease  due  to 

homologous type/subtype of virus. 

(c)      Sterility test – It shall comply with the tests for sterility as prescribed under the 

―general monograph on ―Viral Vaccines‖. 

(d)     Safety test -   The test is carried out on fully susceptible cattle not less than 12 
months  of  age  and  which  have  not  been  sensitized  either  by  vaccination  or  previous 
infection. Inoculate 3  susceptible cattles  each with 2  ml.  of  finished product at  multiple 
sites  on  tongue  by  intradermal  route  and  observe  for  4  days.  The  same  animals  are 
inoculated on 4th day  with 3  cattle  doses subcutaneously and are observed for a  further 
period of 6 days. The animals should not develop any signs of FMD and remain normal. 

(e) Potency test – Each batch of the vaccine is to be tested in susceptible cattle of 

not less than 15 months of age. The potency test in cattle can be done either by :– 

(i) PD50   Method : The vaccine shall be tested by the determination of PD50  in 
susceptible cattle by challenging animals vaccinated with appropriate dilution of the 
vaccine made in adjuvanted or non-adjuvanted diluent as appropriate. 

A  minimum  of  5  animals  should  be  used  per  dilution  and  2  unvaccinated 
animals  to  be  included  as  controls  to  the  challenge.  All  animals  are  needle 
challenged with 10,000 ID50 of the homologous strain of virus by inoculation on the 
tongue on the 21st day of post-vaccination. 

The control animals are to be similarly challenged. Animals are observed for 10 
days for the development of lesions. Unprotected animals show  generalised  lesions 
due to FMD. Control animals must shown generalized lesions. From the number of 
animals protected in  each group the PD50  content of the vaccine is  calculated. The 
vaccine passes the test if an observed PD50   value of 3 or greater is obtained in the 
test. 

(ii)  Percentage  protection  method  in  which  groups  of  ten  health  susceptible 
cattle are each injected subcutaneously with the vaccinating dose and 14 – 21 days 
later  the  cattle  are  challenged by  intradermal  injection  into  three  separate  sites  on 
the  tongue  with  10,000  ID50    of  the  strain  of  virus  used  in  the  preparation  of  the 
vaccine. The vaccine can be passed if atleast seven out of the ten in the group are 
protected against the development of  generalized infection whereas all the controls 
should react  by developing primary and secondary lesions observable in the mouth 
and feet. 

For other reasons if cattle testing is not possible then the potency of the vaccine may be 
assed  in  guineapigs either by  Lucam ‗C‘  index or  PD50  method by  challenging those  which 
have been previously vaccinated, provided that  the  correlation has been established between 
guinea pig challenge test and cattle challenge results. 

The  estimation  of  the  serum  neutralizing  antibody  titre  cattle  may  be  considered  as  a 

supportive test to evaluate potency of vaccine. 

However, potency testing of  vaccines, in  cattle,  of  batches whenever by  other accepted 

methods of testing is in doubt, at aleast one out of every five batches, be undertaken. 

5  Labelling  :-  It  is  labelled  as  described  under  the  requirements  of  ‗labelling‘  as  laid 
down  in  the  general  monograph,  with  the  additional  requirements  that  the  label  on  the 
container states the virus types used in the preparation. 

6. Storage :- It should be protected from the light and stored between 4o C to 8o C. Under 
these conditions it may be expected to retain its potency for not less than 12 months. Freezing 
of aluminium hydroxide vaccine must be avoided. The frozen product will not be fit for use. 

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Canine Hepatitis Vaccine (Living) 

1.     Synonyms :  Infectious Canine  Hepatitis Vaccine  (Living), Canine  Hepatitis Cell 

Culture Vaccine. 

2.    Definition  :    Canine  Hepatitis  Vaccine  (Living)  is  a  freeze  dried  preparation  of 

tissue culture fluid containing the cell culture adopted canine hepatitis virus. 

3.    Preparation :   Canine  hepatitis  vaccine shall  be  prepared from  virus  bearing cell 

culture fluid. 

Only stock seed virus which has been established as pure, safe and immunogenic shall be 

used in the preparation of the vaccine. 

Immunogenicity test :   Each  lot of stock seed virus shall be tested for immunogenicity 

as follows : 

Thirteen canine hepatitis susceptible dogs, 8-14 weeks old shall be used for the test 
(10  vaccinates  and  3  controls).  Blood  samples  may  be  drawn  from  these  animals  and 
individual serum  samples  tested  for  the  presence  of  antibodies, against canine  hepatitis 
virus. Ten dogs shall be injected subcutaneously with predetermined quantity of the virus 
and  remaining  3  dogs  are  kept  as  unvaccinated  controls.  The  dose  calculation  will  be 
based  on  virus  titration  in  suitable  cell  culture  system.  Not  less  than  14  days  post 
vaccination,  the  vaccinated  and  control  shall  each  be  challenged  intravenously  with 
virulent infectious canine hepatitis virus and observed daily for 14 days. At least 2 out of 
3 controls should die and the survivors shall show the clinical signs of canine hepatitis. 
Nine out of ten vaccinated dogs shall survive and shall not show any signs of infectious 
canine hepatitis during the observation period. 

The stock seed virus shall be tested once in 5 years and maintained under standard 

conditions as prescribed. 

The stock seed virus may be inoculated on a suitable tissue culture system and may 

be incubated for five to seven days. 

The tissue culture fluid is then harvested and titrated in cell culture system for virus 
content. After appropriate dilution and pooling, the material is stored at minus 20o C until 
freeze dried. Each vaccine dose shall contain not less than 103.5   TCID50 dose. 

4.     Standards :- 

(a)  Description. – The dried product is a pinkish cream material readily dispersible 

in water. The reconstituted vaccine is a pinkish liquid. 

(b) 

Identification.-  It  causes  characteristic  cytopathic  effect  in  dog,  pig  and  ferret 
kidney  monolayers.  This  can  be  neutralized  by  specific  antiserum.  When 
inoculated into dogs, the development of specific neutralizing antibodies can be 
demonstrated by suitable serological tests. 

(c)  Moisture content.- In the finished product moisture content shall not exceed 1.0 

per cent. 

(d)  Sterility  Test.--    Shall comply with the  tests of  sterility  as  described under the 

general monograph on ―Viral Vaccines‖. 

(e)     Safety Test.--  Mouse safety test – Vaccine prepared for use as recommended on 

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the label shall be tested. Eight mice shall be inoculated intracerebrally with 0.03 
ml and 8 mice shall be inoculated intraperitoneally with 0.5ml. Both the groups 
shall  be  observed  for  seven  days.  If  unfavourable  reaction  attributable  to  the 
product  occurs  in  two  or  more  mice  in  either  group  during  their  observation 
period, the batch is unsatisfactory. 

(f)  Dog Safety Test.--  Each of the two susceptible pups aged 8 – 14 weeks  shall be 
injected  with  vaccine  equivalent  of  10  vaccinating  doses  from  the  batch 
reconstituted with sterile  diluent and administered in  the  manner recommended 
on  the  label  and  observed  for  21  days.  None  of  the  pups  shall  show  any 
unfavourable reaction during the period of observation. 

(g)     Potency test,  Virus  Titration: –  Samples of  finished product shall be  tested for 
virus titre in suitable cell culture system. The batch shall have a virus titre of not 
less than 103.5 TCID50 dose. 

(h)     Potency test in dog:– Two healthy susceptible dogs of 8-14 weeks of age shall be 
injected  subcutaneously  with  one  Vaccine  dose.  14  days  after  vaccination, 
specific  neutralizing  antibodies  from  both  the  dogs  shall  be  demonstrable  by 
serological tests. 

5  Labelling:          Shall  comply  with  the  requirement  for  labelling  as  laid  down  in  the 

general monograph on ―Viral Vaccines‖. 

6     Storage:            The dry product shall be stored at temperature of minus 20o C or below. 
The vaccine is expected to retain its potency for about 6 months in the 
. 
freezing chamber of the refrigerator (temperature) approximately minus 
8oC 

1  Definition.-        Duck plague vaccine is a suspension of modified living virus prepared 

from infected chick embryos. 

Duck Plague Vaccine 

2     Preparation.-      Fresh  fertile  hen‘s  eggs  obtained  from  salmonella  free  flocks  are 
.                                 incubated  in  an  incubator.  Nine  days  old  embryos  are  injected  with 
0.2 ml of the suitable dilution ( 1 in 100) of the suspension of the virus 
on  the  CAM and  incubated at  37o  C  for  5  days post-inoculation. Dead 
embryos  of  the  3rd,  4th  and  5th  days  post-inoculation  are  harvested. 
The embryos (devoid of head and legs). Clear fluid and the membranes 
are  collected  and  homogenized  in  a  Blender,  ampoulded  in  0.5ml 
quantities and freeze dried. 

3     Standards:- 

(a)       Description.- Light brown scales. 

(b)       Identification.- This product affords protection to the ducks against duck plague. 

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(c) 

Safety  Test.-   Four  healthy,  8  to  12  weeks  old  ducks  weighting  not  less  than  600 
gms  are  inoculated  subcutaneously  with  1ml  of  10-1    dilution  of  the  vaccine  and 
observed for a period of 14 days. During the period of observation, the ducks shall 
not show any untoward reaction. 

(d) 

Sterility test.-     Shall   comply    with   the    test   for   sterility   described   in   the  
general monograph on ―Viral Vaccines‖. 

(e)       Potency Test.-  Six susceptible ducks 8 to 12 weeks old each weighing not less than 
600  gms  are  inoculated  subcutaneously with  1  ml  of  10-3  dilution  of  the  vaccine. 
The  minimum virus  contents in  1  ml.  dose  of  the  vaccine  shall  be  103.5  EID50.  14 
days  later  these  ducks  are  challenged  subcutaneously  each  with  1  ml.  of  10-2 
dilution of the virulent duck plague virus (1000 DEID50)  along with 2 unprotected 
young ducks of about 8-12 weeks age. The unprotected ducks shall show symptoms 
of  duck  plague  and  die  within  10  days,  while  the  protected  ducks  shall  remain 
normal during the observation period of 14 days. 

4.  Labelling.-     Should comply with the requirements of labelling as laid down in the general 

monograph on ―Viral Vaccine‖. 

5.  Storage.-       Vaccine when stored at minus 15o C to minus 20o C may be expected to retain 
its  potency  for  one  year  and  about  three  months  if  stored  in  the  freezing 
chamber of Refrigerator i.e. minus 5o C. 

Avian Encephalomyelitis Vaccine (Living) 

1.     Synonyms.-         Avin-encephalomyelitis Vaccine Freeze dried. 

2.     Definition.-        A virus bearing tissue and fluid suspension from embryonated hen‘s legs. 

3.  Preparation.-      The   stock   seed   virus   which  has  been   established  as   pure,   safe   and 
immunogenic shall be used for preparing the vaccine. 

(i)  Each  lot  of  stock  seed  virus  shall  be  tested  for  pathogenicity  by  chicken 

embryo     inoculation test: 

(a)     One  dose  of  the  seed  lot  shall  be  mixed  with  9  volume  of  sterile  heat 
inactivated specific, antiserum to neutralize vaccine virus in the product. 

(b)  After  neutralization,  0.2  ml  of  serum  vaccine  mixture  shall  be  inoculated 
into  each  of  at  least  20  fully  susceptible  chicken  embryos  (0.1ml  of  the 
inoculum  shall  be  inoculated  on  CAM  of  9-11  days  old  embryos  and 
0.1 ml in the allantoic sac). 

(c)      Eggs  shall  be  candled  for  7  days.  Deaths  occurring during  first  24  hours 
shall be discarded but at least 18 viable embryos shall survive 24 hours post 
inoculation for  a  valid  test.  All  embryos  and  CAMs  from  embryos  which 
die after the first day shall be examined. 

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(d)       If  the  death  or  abnormality  attributable  to  inoculums    occur,  the  seed  lot  is 

unsatisfactory. 

(ii)     Immunogenicity test.- Avian encephalomyelitis susceptible chicks, all of same age 
8 weeks old) shall be used 20 chickens shall be inoculated with the field dose of the 
virus  by  prescribed  route.  Ten  additional  chickens  of  same  age  and  flock  shall  be 
held as unvaccinated controls. 

At  least  21  days  post  vaccination,  the  controls  and  vaccinates  shall  be 
challenged intracerebrally with Virulent avian encephalomyelitis virus and observed 
each  for  21  days.  At  least  80  percent  of  controls  shall  show  signs  of  avian 
encephalomyelitis or die. At least 19 to 20 vaccinates shall remain free from clinical 
avian encephalomyelitis during the observation period for the stock seed virus to be 
satisfactory 

4.       Standards:- 

(a)     Description:-  Greyish white flakes easily dispersible in the diluent. 

(b) 

Identification:-  At least 5–6 days old embryonated eggs (from hens with no history of 
infection  with  avian  encephalomyelitis) shall  be  inoculated  with  0.1  ml  of  undiluted 
vaccine  into  the  yolk  sac  and  kept  in  incubator  and  then  transferred  to  the  brooder 
where they are allowed to hatch. The hatched chicks shall be raised for 7 days. More 
than 5  per cent of hatched chicks shall manifest the typical symptoms (weak-leg, leg 
paralysis tremor etc.) at the end of this period. 

(c)     Moisture Content: -  Shall not exceed 1.0 per cent. 

(d)  Sterility  Test:  -  Shall  comply  with  the  test  for  sterility  described  under  general 

monograph on  ―Viral Vaccines‖. 

(e)  Safety  Test:  -  At  least  25  avian  encephalomyelitis  susceptible  birds  (6-10  weeks  of 
age) shall be vaccinated with 10 field doses by the recommended route and observed 
each  day  for  21  days.  If  unfavourable  reactions  attributable  to  the  vaccine  occur 
during the observation period, the batch of vaccine is unsatisfactory. 

(f)     Potency Test: - 

(i) 

The  vaccine  shall  be  titrated  for  virus  content.  To  be  eligible  for  release,  the 
batch shall have a virus titre of at least 102.5  EID50  per dose. 

(ii)  At  least  10  susceptible chickens shall be  vaccinated with the field  dose of  the 
vaccine by prescribed route and 10 chickens from same batch and source shall 
be kept as unvaccinated controls. 

At  least  21  days  post-vaccination,  both  the  groups  shall  be  challenged 
intracerebrally with Virulent avian encephalomyelitis virus and observed for 21 
days. At least 8 out of 10 controls shall develop recognizable signs or lesions of 
avian encephalomyelitis and at least 8 out of 10 vaccines should remain normal 

5. Labelling:        Shall  comply  with  the  requirement  of  labelling  as  laid  down  in 

general monograph on ―Viral Vaccines‖. 

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Marek’s Disease Vaccine (Living) 

1.       Synonyms.-          Herpes virus of Turkey Vaccine HVT vaccine (Living). 

2.  Definition:-        Marek‘s disease vaccine is  a  suspension of  cell  free fluid containing live 

virus. 

3. 

Preparation.-      The  stock  seed  virus  which  has  been  established  as  pure,  safe  and 
immunogenic in  avian  species  shall  be  used  for  preparing  the  seed  virus 
for vaccine production. 

(i)  Safety Test – The stock seed virus shall be non-pathogenic for chickens as determined by 

the following procedure: 

The  groups  of  at  least  25  chickens  each  at  one  day  of  age  shall  be  used.  These 
chickens shall  be  of  the  same  source and  batch  be  susceptible to  Marek‘s disease 
and be kept in isolated group. 

Group 1:    Each chicken shall be injected with 0.2 ml of 10 times as much viable virus as will 

be contained in one dose of vaccine by intramuscular route. 

Group II :     Shall   serve as  controls. At  least  20 chickens in  each group shall survive for  four 
days  postinjection.  All  chickens  that  die  shall  be  necropsied  and  examined  for 
lesions of Marek‘s disease and cause of death. The test shall be judged according to 
the following : 
At  120  days  o  age,  the  remaining  chicken  in  both  the  groups  shall  be  weighted, 
killed and necropoised. If at least 15 chicken in each of these two groups have not 
survived the 120 days period  if any of the chicken of Group-I have gross lesions of 
Marek‘s  disease  at  necroposy  or  if  the  average  body  weight  of  the  chickens  in 
Group-I is significantly (statistically) different from the average of Group-II at the 
end of 120 days, the lot of stock seed virus is unsatisfactory. 

(ii) 

Purity  test  –  Shall  conducted  in  chickens  and  no  lesions  other  than  those  typical  of 
Turkey Herpes virus shall be evidenced. 

(iii) 

Immunologenicity  test  –  Sixty  susceptible  day  old  chicks  are  used.  Thirty  of  them 
inoculated  with  the  seed  virus  in  a  dose  corresponding  to  the  field  dose  of  the  final 
vaccine  and  14-21  days  later  challenged  by  intrabdominal  route  with  virulent  Marek‘s 
diseas  virus,  alongwith  the  other  30  non-vaccinated  control  chicks.  At  the  end  of  the 
observation  period  when  the  chicks  are  20  weeks  old,  the  surviving  chickens  are 
examined for the presence of antibody against Marek‘s disease by  serological tests and 
postmortem inspection for lesions of Marek‘s disease. 

the  cause  of  death  ascertained  by 
Any  bird  dead 
necropsy/histopathological  examination.  All  the  surviving  birds  are  killed  and  necropsied. 
The protection index (P1) is determined by following procedure : 

thoroughly  examined  and 

is 

1.    Percent MD     = 

No. with MD lesions 
                                  x 100 
No. with MD lesions + No. of –ve Surviviours (effective No.) 

369 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Percent MD in controls – Percent MD in vaccinated 

2.              P.I.        = 

x 100 

Percent MD controls 

Master seed virus should have P.1 of at least 80 per cent. 

Eighty per cent of the chicks in the control group must fall ill specifically. If more than 
80 per cent of the vaccinated chickens do not show symptoms or signs of Marek‘s disease, the 
seed virus is regarded as sufficiently effective and can be used for production of vaccine. 

The  seed  virus  is  propagated  in  duck  embryo  fibro-blast  cell  culture,  chick  embryo 
fibroblast or  any  other suitable cell  culture (specific pathogen free  SPF  flock) and  when the 
peak passage level is attained the cell monolayer is suspended in cold diluent of the following 
composition: 

SPGA Stablizer 

0.218% Sucrose. 

0.0038% monosodium phosphate. 

0.0072% dipotassium phosphate. 

L Monosodium glutanate 0.0049 M. 

1 per cent bovine albumin fraction (V). 

0.25 per cent EDTA (Sterilised by Seitz filteration and stored at minus 10o C). The virus 
is freed from cell by ultrasonication for 3 minutes interrupted after every 30 seconds) at 100 
MA and freeze dried at  times  60o  C preferably in shelf freeze dried  in convenient volumes. 
The  doses  per  ampoule vial  is  calculated  after  titrating  the  freeze  dried  product  in  terms  of 
plaque forming units (PFU) in the corresponding cell monolayers. 

4.       Standards: 

(a) 

 Description: - The cell free freeze dried HVT vaccine look uniformly grayish in colour 
and easily dispersible in the specified diluent. 

(b) 

Identification.  -  The  vaccine  on  inoculation  in  suitable  cell  culture  system  shall  cause 
cytopathic effect typical of Herpes virus of Turkey. Specific antiserum of Herpes virus of 
Turkey shall neutralize the cytopathic effect. 

(c)     Moisture content. - Moisture content shall not exceed one per cent. 

(d)    Sterility  test.  -  Shall  comply  with  the  test  prescribed  in  general  monograph  on  ―Viral 

Vaccines‖. 

(e)  Safety Test.- At  least  25  one  day  old chickens shall be  injected  with ten  times   of   the 
field dose of vaccine by intramuscular route. The chickens shall be observed each day for 
21 days. Chickens dying during the period shall be examined, cause of death determined 
and the results recovered as follows : 

(i)      If at least 20 chickens do not survive the observation period, the test is inconclusive. 

(ii) 

If lesions of any disease or cause of death are directly attributable to the vaccine the 
vaccine is unsatisfactory. 

(f)  Potency test. -  The sample shall be titrated in the cell culture system. A satisfactory batch 
shall contain at least 1500 plaque forming units (PFU) as per dose at the time of release 

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and maintain at least 1000 PFU till the end of expiry period. 

5.     Labelling.  -  Shall  comply  with  the  requirements  of  labelling  as  laid  down  in  general 

monograph on ―Viral Vaccines‖. 

6.     Storage and expiry date. -  The freeze-dried cell free HVT vaccine may be stored at 4oC for 

6 months. 

Goat Pox Vaccine (Living Cell Culture) 

1.     Synonym. -  Goat Pox Vaccine (living), Attenuated Goat Pox Vaccine. 

2.  Definition. -   Goat Pox vaccine is freeze-dried preparation, prepared by growing attenuated 

goat pox virus in kid kidney/testicular cell culture. 

3.     Preparation.  -    Primary  kidney/testicular  cell  cultures  of  disease  free  kid  are  used.  The 
monolayers infected with the seed virus are incubated at 37o C. The cultures are harvested by 
three cycles of freezing and thawings 6 to 7 days post infection when  more than 80 per cent 
cells  show  CPE.    The  suspension  is  centrifuged  at  1000  rpm  for  10  minutes  to  remove 
cellular debris being stored at minus 20o   C.  The suspension is freeze dried after addition  of 
5 per cent Lactalbumin hydrolysate and 10 per cent sucrose. 

4.       Standards: 

(a)    Description. -  Light yellow colour. 

(b)    Identification -  The product affords protection to goat against goat pox. 

(c)     Moisture content. -  The moisture content shall not exceed 1.0 per cent. 

(d)    Safety tests.- 

(i)      Laboratory animals. -   Six mice, 3 guinea pigs and 3 rabbits are inoculated   with 
0.2ml  intraperitoneally, 0.5  ml  and  1.0  ml  subcutaneously, respectively   with  10 
field doses of the vaccine. The inoculated animals during the observation period of 
80 days shall remain normal. 

(ii)  Goat. -  Two susceptible goats of 6 to 8 months of age are inoculated in postaxillary 
region  by  subcutaneous  route  with  one-hundred  field  doses  of  the  vaccine.  The 
inoculated  animals  shall  not  develop  more  than  a  local  reaction  of    2  to  3  cms. 
These animals shall be observed for 10 days. 

(e) 

Sterility  test.-  Shall  comply  with  the  test  for  sterility  described  under  the  general 
monograph on ―Viral Vaccines‖. 

(f) 

Titration in  cell  culture.-   Four randomly selected  samples are inoculated in  kid  kidney 
cell  cultures  using  5  tubes  for  each  dilution. The  titration  shall  be  repeated thrice.  One 
thousands TCID50 is used as a field dose. 

(g)  Potency Test.- The three susceptible goats (8-10 months) are inoculated with 1/10th field 
dose and 3 susceptible goats (8-10 months) with one field dose, subcutaneously.   Three 
in contract controls are also kept with the inoculated goats. These animals are observed 
for  a  period  of  14  days  and  their  body  temperature  recorded  daily.  The  vaccinated 

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animals shall  not show any  termal, local  or  generalized reaction. Twenty one days post 
infection,  the  vaccinated  and  controls  and  challenged  with  10,000  TCID50   of  virulent 
goat  pox  virus  by  intradermal route.  The  temperature  of  these  goats  are  recorded  for  a 
period  of  14  days.  The  vaccinated  goats  shall  not  develop  localized  or  generalized 
reaction  while  control  goats  shall  develop  high  fever,  localized  reaction  or  even 
generalized reaction in some cases. 

5. 

6. 

Labelling  .-    Shall  comply  with  requirements  of  labelling  as  laid  down  in  the  general 
monograph on ―Viral Vaccines‖. 

Storage  and  expiry  date.-   The  vaccine  is  expected  to  retain  its  potency  for  12  months  if 
stored at minus 15o C to minus 20o C and for three months at 2o  C to 4o C. 

Sheep Pox Vaccine (Inactivated) 

1.       Synonym .-  Formal gel sheep pox vaccine. 

2.       Definition .- Sheep pox vaccine is a formaline inactivated gel treated tissue vaccine. 

3. 

Preparation.-      Healthy   susceptible   sheep   of   8-12   months   of   age   are   inoculated 
subcutaneously with 500 ml of the 1:100 dilution of the Russian Virulent Sheep Pox Virus. 
Seven to eight day post inoculation skin of the abdomen alongwith the oedema is collected. 
The  infected  tissues  are  homogenized  in  10  percent  concentration  in  phosphate  buffer 
(pH 7.4-7.6) which after the extraction of the virus is mixed with sterile gel and buffer in the 
following proportion :- 

6 percent aluminium hydroxide gel-50 per cent. 
Phosphate Buffer (pH 7.6)- 35 per cent. 
10 per cent suspension – 15 per cent 

This is later formalized and kept at 20-25oC/10oC for varying periods. 

4.       Standards.- 

(a)  Description .-  It is a greyish white suspension. During storage the gel settles at the bottom, 

upper layer of the suspension is clear. 

(b)     Identification.-  This product affords protection to sheep against sheep pox. 

(c) 

Safety  test.-  This  is  carried  out  by  inoculating  2  white  mice  with  0.2  ml.,  one  guinea  pig 
with  1.0  ml  and  one  rabbit  with  3,0  ml  of  vaccine.  The  animals  should  remain  clinically 
healthy for 10 days. 

(d)  Sterility test.-  This is done by seeding the vaccine on usual bacterial media. The plates and 
tubes are incubated for 10 days at 37o C.  If the pathogenic bacteria are found, the vaccine is 
rejected while with non-pathogenic bacteria the vaccine is passed for field use. 

(e)  Potency  test.-  This  is  done  by  inoculating  4  non  immune  susceptible  sheep  preferably 

exotic breed of 1-2 years with 3 ml of vaccine in the thigh, subcutaneously. 

The  vaccinated  sheep  are  challenged 15  days  after  inoculation alongwith  3  controls  each 
with  0.1  ml  of  virulent virus  containing 200 infective doses   intradermally under the tail. 

372 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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The  sheep  are  observed  for  10  days  and  their  skin  reaction  recorded.  The  vaccine  is 
considered  potent  if  all  the  vaccinated,  sheep  do  not  show  thermal  or  local  skin  reaction. 
Vaccine is  also potent if 3  vaccinated animals do not develop any  reaction and one shows 
abortive skin reaction, while at least 2 of the 3 controls develop typical sheep pox reaction 
at the site of inoculation. 

5. 

Labelling.-   Shall  comply  with  the  requirements of  labelling as  laid  down  in  the  general 
monograph on ― Viral Vaccines‖. 

6.       Storage.-  The vaccine shall be stored at 4o C to 5oC. it keeps well at above temperature upto 

12 months. 

Sheep Pox Vaccine (Living Cell Culture) 

1.       Synonym.- Sheep pox vaccine (Living), attenuated  sheep pox  vaccine. 

2.  Definition.-  Sheep pox vaccine is freeze dried preparation prepared by growing attenuated 

sheep pox virus in lamb kidney/testicular cell cultures. 

3. 

Preparation.-  Primary cell cultures prepared from kidney/testicles of disease free lambs are 
used. The mono layers infected with the  seed virus are incubated at 37o C. The cultures are 
harvested by 3 cycles of freezing and thawing 6 to 7 days post infection when more than 80 
per cent Cells  show C.P.E. The suspension is  centrifuged at  1000 r.p.m. for 10  minutes to 
remove  cellular  debris  before  being  stored  at  minus 20o  C.  The  suspension is  freeze  dried 
after addition of 5 per cent Lactalbumin hydrolysate  and 10 per cent sucrose. 

4.       Standards:- 

(a)     Description.-  Light yellow colour. 

(b)     Identification.-  The product affords protection to sheep against sheep pox. 

(c)     Moisture contents.-  The moisture contents should not exceed 1.00 per cent. 

(d)     Safety tests.- 

(i)      Six mice, 3  guinea pig and 3 rabbits are inoculated with 0.2 ml  intraperitoneally 
0.5ml  and  1.0  ml  subeutaneously,  respectively  containing  10  field  doses  of  the 
vaccine. The  inoculated animals  during  the  observation period  of  10  days  should 
remain normal. 

(ii)     One hundred field doses of the vaccine are inoculated subcutaneously into each of 
2  susceptibles  sheep  in  postaxillary  region.  Inoculated  animals  shall  not  develop 
more than a local reaction of 2 to 3 cms. 

(e)  Sterility  test.  -   Shall  comply  with  the  test  for  sterility  as  described  under  the  general 

monograph on ―Viral Vaccines‖. 

(f) 

Titration   in   cell   culture.   -      Four   randomly   selected   samples   reconstituted   in   a 
maintenance medium are  inoculated in lamb  kidney cell  cultures using 5  tubes for each 
dilution. The titrations shall be repeated thrice. The TCID50  to be calculated by Read and 
Muonch method. One thousand TCID50  is calculated as one field dose. 

(g)  Potency test. -  Three susceptible sheep 8-10 months old are inoculated with 1/10th, field 
dose  and  3  susceptible  sheep  with  one  field  dose,  subcutaneously.  Three  in  contact 
controls are also kept with the inoculated sheep. These animals are observed for a period 

373 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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of  14  days  and  their  temperature  is  recorded  daily.  The  vaccinated  animals  should  not 
show  any  thermal,  local  or  generalize  reactions.  Twenty-one  days  post  infection  the 
vaccinated and controls are challenged with 10,000   ID50  of   virulent sheep poxvirus by 
intradermal route. The temperature of these sheep are  recorded for a  period of  14 days. 
The vaccinated sheep should not develop localised or generalized reaction while control 
sheep should develop high fever, localized reaction or even generalized reaction in some 
cases. 

5. 

6. 

Labelling.-  Shall  comply  with  requirements  of  labelling  as  laid  down  in  the  general 
monograph on ―Viral Vaccines‖. 

Storage   and  expiry  date.-  The  vaccine  is  expected  to  retain  its  potency  for  12  months  if 
stored at minus 15o C to minus 20o C and three months at 2 o C to 4 o C 

Tissue Culture Rinderpest Vaccine 

1.       Synonyms.-  Cell Culture Rinderpest Vaccine. 

2.  Definition.-    Tissue  Culture  Rinderpest  Vaccine  is  a  freeze  dried  preparation  of  live 

modified rinderpest virus adapted to and propagated in cell culture. 

3. 

Preparations.-  Primary or secondary monolayer cultures of the kidney cells (Bovine or any 
other suitable animals) taken from kidney from healthy  animals free from any pathological 
changes  shall  be  used.  When  secondary  cultures  are  used  they  shall  have  retained  their 
original  morphology  and  Karyotype.   Kabete  ‗O‘  stain  of  Rinderpest  virus  developed  by 
East African veterinary Research Organisation (Plowrights strain between the passage levels 
of 99th and 100th passages) shall be used. The virus harvested from cell monolayer culture 
prepared from  the  kidneys of  a  single  calf  or  serially  cultivated  bovine kidneys cells  (Not 
more than 10 passages away from the Primary) inoculated with the same seed and harvested 
together, will be freeze dried with stabilizers in suitable quantities. 

4.       Standards.-  It complies with the requirements of general standards of viral vaccines: 

(a)  Description.-   Dry  light yellow coloured flakes readily soluble in  chilled  and  saline or 

buffered saline. 

(b)     Identifications.- 

(i) 

(ii) 

Protects   cattle   against   a   subsequent   challenge   with   virulent   or   caprinised 
rinderpest virus. 

It  is  titrable  in  tissue culture systems capable of  supporting the  multiplication  of 
this virus. The test shall be made on at least three separate occasions using a cell 
culture derived from different animals. 

(iii)      Specificity test shall be performed using an appropriate scrum neutralization test. 

(c)  Sterility test. -   Each batch shall be tested for bacterial and mycotic sterility as given in 

general monograph on ―Viral Vaccines‖. 

(d)     Innocuity test.-   Shall be made on each batch in at  least  two guinea pigs and six mice. 
These animals shall be observed for at least two weeks for any untoward reaction. 

(e)  Safety and efficacy test.-   The test for safety and efficacy shall be performed using the 
pooled reconstituted contents of not less than 4 ampoules taken at random. The vaccine 

374 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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shall  be  injected  subcutaneously  into  each  of  at  least  two  susceptible  cattle  free  from 
specific antibodies using  the  quantity containing not less than  100  fields  doses and  two 
further cattle and using 1/10th of  the field dose (calculated on the basis of 1000 TCID50 
one field dose). The animals shall be housed with at least two unvaccinated animals and 
observed for a period of three weeks. The vaccine passes the safety test if the cattle show 
no signs of  unusual clinical reactions. 

At  the  end  of  three  weeks  all  the  four  animals  will  be  challenged alongwith two  in  contact 
cattle with a challenge dose of not less than 104 ACID50   of virulent Rinderpest virus. The vaccine 
passes the potency/efficacy test if the in contact animals develop rinderpest and all the vaccinated 
animals remain normal. 

5 Labelling.-   Shall comply with general monograph on ―Viral Vaccines‖. Each ampoule or 

at least 50 percent ampoules in a lot shall contain at least following print : 

(i)      TCRP Volume. 
(ii)     Batch No. with year. 
(iii)    General instructions for use. 

6  Storage .-   The vaccine when stored at minus 20o C and plus 4 degree C will maintain its 

titre for 2 years and 6 months respectively. 

Canine Distemper Vaccine 

1.           Synonyms.-  Cannine Distemper Vaccine (Living)- Freeze-dried. 

2. 

3. 

Definition.-  It is freeze dried preparation of either tissues from chick embryo containing 
eggs adapted strain of cannine distemper virus or the cell culture in which modified virus 
has been cultivated. 

Preparation.- Canine distemper vaccine shall be prepared from virus bearing cell culture, 
fluid  or  infected  chroioalantoic  membrane.  Only  stock  seed  virus  which  has  been 
established as pure, safe and immunogenic shall be used for preparation of vaccine. Stock 
seed virus propagated in chicken embryo shall be tested for pathogen by chicken embryo 
test.  One  volume  of  the  virus  shall  be  mixed  with  9  volume  of  specific  sterile  heat 
inactivated serum to neutralize the virus. Mixture shall be inoculated into twenty (9 to 11 
days  old  )  chicken  embryo  (with  0.1  ml  on  CAM  and  0.1  ml  in  alantoic  sac). 
Embryonated eggs shall be candled for 7 days daily. Death occurring in the first 24 hours 
shall be discarded. CAMS of embryos which die after 24 hours shall be examined. When 
necessary  embryo  sub-culture  shall  be  made  to  determine  the  cause  of  death.  The  test 
should be concluded on the 7th day post inoculation. 

The  surviving embryos and  their CAMS are  examined. If  deaths or abnormality 

due to the inoculums occur, the seed virus is unsatisfactory. 

Immunogenicity test :  Thirteen susceptible dogs 8-14 weeks old shall be used for the test 
(ten  vaccinates  and  3  controls).  Blood  samples  are  drawn  from  these  animals  and 
individual  sample  is  tested  for  antibodies  against  canine  distemper.  Ten  dogs  shall  be 
injected  with  a  predetermined  quantity  of  the  virus  and  remaining  3  dogs  are  used  as 
unvaccinated controls. The dose shall be based on the virus tiltration. At least 21 days post 
infection  the  vaccinated  and  controls  shall  be  challenged  intramuscularly  with  the  same 
dose of virulent canine distemper virus and the animals are observed each day for 21 days. 
At least 2 out of 3 controls should die and survivor should show the symptoms typical of 
canine distemper. At  least  9  out  of  10  vaccinated  animals should survive and should not 
show any clinical signs of canine distemper during the observation period. The stock seed 

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virus  should  be  tested  for  immunogenicity  at  least  once  in  5  years,  if  maintained  under 
suitable  conditions  of  storage.  Eight  days  old  chicken  embryos  from  a  healthy  flock  are 
inoculated   on   their   chorioallantoic   membrane   with   bacteriologically   sterile   virus 
suspension  of  egg      adapted  strain.  After  incubation  for  a  period  of  five  days,  infected 
membrane  and  embryos  are  harvested.  The  individual  embryo  is  tested  for  bacterial 
sterility. Those free from bacterial contamination are made into a 20 percent suspension in 
a  suitable  medium.  The  suspension  is  distributed  in  a  single  dose  quantity  into  the 
ampoules of vials and freeze-dried. 

The ampoules are sealed under vacuum or with pure dry sterile nitrogen before sealing. 
Alternatively, the  virus  may  be  grown  on  the  suitable  cell  culture.  Cells  along  with  the 
suspending fluid  is  harvested, distributed in  single  dose  quantity  in  ampoules and  freeze 
dried. 

4.          Standard.- 

(a) 

(b) 

(c) 

(d) 

(e) 

 Description. -  It  is  a  dry  product,  pinkish  cream  material,  readily  dispersible in 
water or a suitable solvent. 

Identification.  -    It  infects  CAM  of  fertile  eggs.  This  is  neutralized  by  canine 
distemper  antiserum.  It  does  not  cause  distemper  after  injection  into  susceptible 
ferrets or dogs but immunizes them against the disease. 

Moisture  content.  -    Moisture  content  in  the  finished  product  shall  not  exceed 
more than 1.0 per cent. 

Sterility test. -   Shall comply with the test for sterility as described in the general 
monograph on ―Viral Vaccines.‖ 

Safety tests. - (i) Mice safety test:   Reconstituted vaccine as recommended on the 
label shall be tested. 

Eight  mice,  4  weeks  old  shall  be  inoculated  intracerebally  with  0.03  ml  and  8 
mice shall be inoculated intraperitoneally with 0.5ml. Both groups shall be observed for 7 
days, if unfavourable reaction attributable to the product in either 2 or more mice in either 
group is observed during observation period, the batch is unsatisfactory. 

(ii) Dog Safety test.-Inject two healthy dogs eight to fourteen weeks old that have 
previously  been  shown  to  be  free  from  distemper  virus-neutralising  antibodies  by  the 
recommended route with twice  the dose stated  on the  label  and observe for  21  days. No 
significant local or general reaction develops. 

(i)  Potency test. - (i) Titration :  Final samples of finished product shall be tested 
for virus titre, and when tested at any time within the expiry period, it should 
contain not less than 103 ID50 per dose. 

(ii)     It  shall  be  carried  out  in  dogs.  Two  healthy  susceptible  dogs  each  of  8-14 
weeks  of  age  free  from  distemper  neutralizing  antibodies  are  injected 
subcutaneously  each  with  one  vaccination  dose.  Serum  samples  shall  be 
collected from each dog 14 days after vaccination and these shall have specific 
neutralizing antibodies at a dilution of 1: 100. 

6.     Labelling.-  Shall comply with the requirements of labelling as laid down in the general 

monograph on ―Viral Vaccines‖. 

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7.    Storage and expiry date. -  For the freeze-dried product the expiry date is one year 

when stored at minus 20oC. 

Avian Infectious Bronchitis Vaccine (Living) 

1.     Synonyms. -  Avian Infectious Bronchitis Vaccine (Living) freeze-dried. 

2.  Definition. -   It is a freeze-dried product of low virulent Avian Infectious Bronchitis 

Virus grown in embryonated hen‘s eggs of cultivated in cell culture. 

3. 

Preparation.  -   Only  stock  seed  virus  which  has   been  established  as   pure,  safe  
and immunogenic shall  be  used.  Each  jot  of  stock  seed  virus  shall  be  tested  for  other 
pathogens by chicken embryo inoculation tests as follows: - 

A lot of seed virus shall be mixed with 9 volumes of sterile heat inactivated specific 
anti- serum  to  neutralize and  the  vaccine virus  serum  mixture  shall  be  inoculated into 
each of at least 20 fully susceptible chicken embryos of 9-11 days old (0.1 ml on CAM 
and  0.1  ml  in the  allantoic  sac).  Eggs  are  candled  daily  for  7  days.  Deaths  occurring 
during first 24 hours shall be discarded but at least 18 viable embryos shall survive 24 
hours  post inoculation for a  valid test.  All  embryo  and  CAMS from embryos shall be 
examined which die  after 24 hours.  If  necessary embryo subcultures shall  be  made  to 
determine  the  cause  of  death.  The  test  shall  be  concluded  on  the  7th  day  post 
inoculation and surviving embryos including the CAM shall be examined. If death and 
or abnormality attributable to the stock seed virus occur, the seed lot is unsatisfactory. 

Each lot of stock seed virus shall be tested for immunogenicity as below: - 

Bronchitis susceptible chickens of the same age and source shall be used. For each 
method  of  administration  recommended  on  the  label  and  for  each  serotype  against 
which  protection  is  claimed,  20  chicks  shall  be  used  as  vaccinates.  Ten  additional 
chickens  for  each  serotypes  against  which  protection  is  claimed  shall  be  held  as 
unvaccinated controls. 
21  to  28  days post vaccination all  vaccinates and controls shall be  challenged by  eye 
drops with virulent Bronchitis virus. A separate set of vaccinates and controls shall be 
used for each  serotype against which protection is  claimed.  The  challenge virus  shall 
have  a  titre  of at  least  104.6  EID50  per  ml.  Trachea swabs  shall  be  taken  once 5  days 
post  challenge  from  each  vaccinated  and  controls.  Each  swab  shall  be  placed  in  test 
tube containing 3 ml of tryptose phosphate broth and antibiotics. The tubes and swabs 
shall be swirled thoroughly and  stored  at  minus  40o  C  pending  egg  inoculation.  For 
each  chicken  swabs  at  least  5 chicken embryos, 9-11 days old shall be inoculated in 
the allantoic cavity with 0.2 ml of broth from each tube. All the embryos surviving 3rd 
day post inoculation shall be used in evaluation.  A tracheal swab shall be positive for 
virus  recovery  when  any  of  the  embryos  show  typical  infections  bronchitis  virus 
lesions such as stunting, curling, kidney urates, clubbed down or death during 4-7 days 
post inoculation period. 

90 percent of the controls should prove positive for virus recovery. If less than 90 
per  cent  of  the  controls  are  negative  for  virus  recovery,  the  stock  seed  is 
unsatisfactory. The stock  seed  virus  should  be  tested  for  immunogenicity  once  in  
5    years  provided  it    is  maintained under standard conditions of the  bronchitis virus 
storage. 

4.   Standards. - 

(a)     Descriptio: It is greyish-white product easily dispersible in the diluent. 

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(b)      Identification:  (i)     The  contents  of  the  ampoule  are  suspended  as  per  
the  instructions  for  the  field  use.  The  0.2ml  of  the  suspension  shall  be  inoculated  in  the 
allantoic cavity of 9-11 days old chicken embryo and are incubated for 7 days. The lesions 
typical  of infectious bronchitis shall  be  observed in  the  embryos at  the  end  of  incubation 
period. The allantoic fluid shall not agglutinate the chicken RBC's. 

(ii)   Specific    antisera  against  avian  infectious  bronchitis  virus  should  neutralize 

the vaccine virus. 

(c)     Moisture content. -   Moisture content in the finished product should not 
exceed 1.0 per cent. 

(d)        Sterility  test.  -    Complies  with  the  test  for  sterility  as  described  under  the 

general monograph on ―Viral Vaccines‖. 

(e)     Safety  test.  -    Ten  healthy  susceptible  chickens  5-10  days  old  from  the 
same source batch shall be vaccinated with ten field dose of the vaccine and along with five 
chicks from same batch as unvaccinated controls by the prescribed route and observed 7 or 
21  days  post  vaccination.  Neither  severe  respiratory  symptoms  nor  death  shall  occur  to 
more than one experimental chicks, none of the unvaccinated control shall show any clinical 
symptoms. 

(f)       Potency test.  -   The  minimum virus content  of  the freeze-dried product shall 
not  be  less  than  103.5  EID50  per  bird. The  virus  content  of  the  vaccine  shall  be  titrated  as 
below: 

Serial  ten-fold  dilution  of  the  freeze-dried  material  will  be  made  in  tryptose 
phosphate  broth.  Three  to  five  embryonated  eggs  (9-11  days  old)  shall  be  in  inoculated 
with 0.1 ml of each dilution into the allantoic cavity and observed daily for 7 days. 

Deaths  occurring  during  the  first  24  hours  shall  be  discarded.  The  surviving 
embryos are  examined for the  evidence of  infection and  EID50  shall  be  calculated  by  the 
Reed and Muench Method/spearman and Karber method. 

5.        Labelling  .-    Shall  comply  with  the  requirement  of  labelling  as  laid  down  in  the 

general monograph on ―Viral Vaccine‖. 

6.   Storage and expiry date.-  Shall be stored at 4o C for six months]. 

PART II –ANTISERA 

Provisions applicable to the production of all Sera from Living Animals 

1.  Definitions- (i)  This  Part  of  the  Schedule applies to  antibacterial  sera,  anti-viral sera 
and anti-toxic sera which are prepared by injecting bacteria or viruses or their products into 
buffalo-  bulls  or  other  suitable  animals  so  as  to  produce  active  immunity  which  is 
manifested by the formation of anti-body. 

(ii)    For  the  purpose  of  this  Part  of  the  Schedule  an  anti-serum  means  sterile  liquid 
anti- serum  concentrated  and  unconcentrated,   solutions  of  globulins  or  their  derivatives 
or  solid forms which can be reconstituted when necessary. 

2.  Staff of  Establishment- The establishment shall be  under the  direction and control of 
a competent expert in bacteriology and serology with adequate training in immunology and 
standardisation  of  biological  products  and  knowledge  of  animal  management.  He  shall  be 
assisted  by  a  staff  adequate  for  carrying  out  the  tests  required  during  the  course  of 
preparation of the sera and standardisation of the finished products. 

3.      Proper Name- The proper name of he antiserum shall be the recognised scientific 
name  of  the  diseases or  its  causative organism or  some  generally recognised abbreviations 
thereof  preceded  by  the  prefix  ‗anti‘,  and  followed  by  the  word  ‗serum;  as  for  example, 
‗Anti-  Anthrax  serum‘.  The  proper  name  of  any  antitoxin  may  be  formed  from  the  word 
‗Anti-toxin‘ preceded by the name of the organism from which the toxin was prepared, and 
followed, if desired, by a term indicating the source or the strain of that organism provided 
where  there  is  no  special  provision  in  the  Schedule,  the  name  as  approved  by  the 
Licensing Authority may  be adopted. 

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Drugs and Cosmetics Rules 1945 

(1)    The permanent records which the licensee is required to keep shall include 

the following particulars: - 

(a)      As to the culture- Evidence of the identity and specificity of the cultures. 

(b)      As to the procedure used in immunising the animals; 

(i) The method of preparing the cultures or antigen used for immunisation. 

(ii) The dosage and methods employed in administering the culture or antigen. 

(iii) The period in the course of immunisation at which blood is withdrawn 

for the preparation of the serum. 

(c)   Any test which may have been applied to the serum to determine its content 

of specific antibodies or its specific therapeutic potency and purity. 

(2)     If the licensee desired to treat the performance of any tests recorded under sub- 
paragraph  (i)  (c)  of  this  paragraph  as  determining  the  date  of  completion  of  manufacture 
for  the  purpose  of  rule  109  he  shall  submit  full  particulars  of  the  proposed  test  to  the 
Licensing Authority and obtain his approval. 

5. Cultures- The cultures used in immunising the animals shall be at all times open to 
inspection, and specimens shall be furnished for examination at the request of the Licensing 
Authority. 

6.     Quantity - 

(a)       Any antiserum shall be issued for veterinary use in the form of either. 

(i)        Actual  serum,  i.e.,  the  liquid  product  of  decantation  of  the  coagulated 

blood or plasma without any addition, other than antiseptic or subtraction, or 

(ii)   A solution of the purified serum proteins containing the specific 
antibodies. 

(b)     At  the  time  of  issue,  the  liquid  shall  be  clear  or  show  at  the  most  a 
slight opalescence or precipitate. Preparations of the natural serum shall not contain 
more than 10 per cent of solid matter. A solution of serum protein shall not contain 
more than 20 per cent of solid matter. 

1.    Precautions to be observed in preparations- 

(i)        Laboratories  where  sera  are  exposed  to  the  air  in  the  course  of  the 
process  of  preparation  must  be      separated  by  a  sufficient  distance  from  stables 
and  animals houses  to  avoid  the  risk  of  aerial  contamination with  bacteria  from 
animal excreta, and must be rendered fly proof to prevent such contamination by 
insects.  Such  laboratories  must  have  impervious  walls  and  floors  and  must  be 
capable of being readily disinfected when necessary. 

(ii)        A  special  room  with  impervious  walls  must  be  provided  for  the 

collection of blood from the living animals. 

(iii)        An  efficient  system  of  manure  removal  must  be  used  which  will 
prevent  its  accumulation  in  the  vicinity  of  any  room  where  blood  or  serum  is 
collected or handled. 

(iv)    An adequate number of sterilizers must be provided for the sterilization of 
all glassware or other apparatus with which the serum may come into contact in the 
course of its preparation. 

(v)     All  processes  to  which  the  serum  is  subjected  during  and  after  the 
collection from the animals, must be designed to preserve its sterility, but in the case 
of a artificially concentrated sera, it shall suffice that the process of concentration is 

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conducted with scrupulous cleanliness and in such a manner as to avoid unnecessary 
dangerous contamination. 

(vi)    The  laboratories  in  which  the  testing  of  sera  for  potency,  sterility  and 
freedom from abnormal toxicity are carried out must be adequate for the purpose. An 
adequate  supply  of  animals  for  use  in  such  tests  and  suitable  housing  for  such 
animals must be provided. 

(vii)    Provision must be made for complying with any special conditions which 
may  be  laid  down  in  the  Schedule  relating  to  the  production  and  issue  of  the 
particular serum, in respect of which the licence is granted. 

8.    Unhealthy  or  Infected  Animals-  If  an  animal  used  in  the  production  of  sera  is 
found  to  be  suffering  from  an  infection  except  one  produced  by  living  organisms  against 
which it is being   immunized, or shows signs of serious or persistent ill health not reasonably 
attributable to the process of immunisation, the licensee shall immediately report the matter to 
the Licensing Authority and shall, if the authority orders an inspection and the Inspectors so 
directs, cause such animals to be killed and a postmortem examination of it to be made, and 
take steps to prevent any serum obtained from the animal being sold or offered for sale until 
permission is given by the Licensing Authority. If the result of the postmortem is such as to 
bring under suspicion, the health of any of the other animals used for the production of sera, 
the  Licensing Authority may  prohibit the  use  of  those  animals for  the  production of  sera  or 
may  take  such  other  steps  as  may  be  necessary  to  prevent  the  issue  of  sera  which  may  be 
dangerous to animal health. 

Provided  in  the  case  of  emergency,  the  person  in  charge  of  the  establishment  may 
order the destruction of an animal used in the production of sera and suspected of infection, 
and  shall  in  that  case  given  notice  forthwith to  the  Licensing Authority  and  shall  permit  an 
Inspector to be present at the postmortem examination. 

9.    Conditions and Housing of animals: 

(i)  The animals used in the production of sera should be adequately housed under 

hygienic environments. 

(ii)  Only healthy animals free from disease should be used in the preparation of 
sera. 
(iii)  Every animal intended to be used as the source of serum must be subjected 
to a period of observation in quarantine for at least seven days before being 
admitted to the animal sheds in which the serum yielding animals are housed. 

(iv)   In  case of horses and other equidae, every animal used  as  source of  serum 
shall  either  be  actively  immunized  against  tetanus  or  shall  be  passively  immunized 
against  the  disease  by  injection  of  tetanus  antitoxin  in  such  doses  as  to  ensure  the 
constant presence of that antitoxin in the blood during the whole period of the use of the 
animals as a source of serum. 

Anti-Sera and their General Standard 

Anti-sera  contain  the  immune  substances  that  have  a  specific  prophylactic  or 
therapeutic action when injected into animals exposed to or suffering from a disease due to a 
specific microorganism or its toxin.  Anti-sera are classified into three groups. 

(i)       Antitoxic sera (Antitoxin) 

(ii)      Antibacterial sera. 

(iii)     Antiviral sera. 

Antisera  are  usually  issued  in  an  unconcentrated  form  for  animal  use  but  may  be 
concentrated  and  also  freeze  dried.  However,  for  the  purpose  of  the  Schedule  the  word 
‗antisera‘ is also used for the unconcentrated liquid sera only. A suitable bacteriostatic agent 
in  a  concentration sufficient to prevent the  growth of  microorganisms is  added to  the  liquid 
serum. 

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General Standard 

1.     Description-  Liquid  native  or  unconcentrated  antisera  are  yellow  or  yellowish 
brown  in  colour.  They  are  initially  transparent  but  may  become  turbid  with  age.  They  are 
almost odourless except for the odour of any bacteriostatic agent that may have been added. 

2.     Identification- The test for identity is described in the individual monograph. 

3.    Acidity or Alkalinity- All native antisera have a pH of 7.0 to 8.5. 

4.     Abnormal Toxicity- All anti-sera shall comply with the following  tests or freedom 

from abnormal toxicity. 

(a)   Two   healthy   mice   each   weighing   not   less   than   18   g.   are   injected 
subcutaneously each with 0.5 ml. of the sample and observed for five days. None of the 
mice should show any abnormal reaction or die. 

(b)  Two  healthy  guinea  pigs  each  weighing  300  g.  to  450  g.  are  injected 
subcutaneously each with 5 ml. of the sample and observed for seven days. None of the 
guinea-pigs should show any abnormal reaction or die. 

5.      Sterility- All anti-sera shall comply with the tests for sterility described in rules 115 

to 119. 

6.      Potency- The  potency  of  each  preparation, when  the  available  methods  permit,  is 
determined  by  the  appropriate  biological  assay,  and  it  is  described  under  the  individual 
monograph. 

7.      Total Solids- Native antisera should not contain more than 10 per cent solid matter. 

8     Labelling-  Should  comply  with  the  provisions  for  ‗Labelling‘  as  laid  down    for 

‗Bacterial Vaccines.‘ 

9.          Storage-  Liquid  preparations  of  antisera  shall  be  stored,  protected  from  light  at 

temperature between 2 ˚C to 4 ˚C and shall not be frozen. 

10     Date of Manufacture- The date of manufacture shall be unless otherwise specified 

in the individual monograph in this part is as defined in clause (b) of sub-rule (3) of rule 109. 

11.  Containers- All antisera are distributed in sterilised containers of a material which is 

inert towards the substance and which are sealed to exclude micro-organisms. 

12.   Expiry Date- The expiry date of potency of all sera shall not be more than twenty- 

four months after the date of a manufacture. 

1.    Synonym- Bacillus Anthracis Anti-serum. 

Anti-Anthrax Serum 

2.     Definition-  Anti-anthrax  serum  is  the  serum  of  animals  that  confers  a  specific 

protection against Baccillus anthracis. 

3.      Preparation-  The  antiserum  may  be  prepared  in  buffalo  bulls  after  repeated 

injections of  cultures of  B. anthracis of a virulent strain. 

4.              Standard-  It  complies  with  the  requirements  in  the  general  provisions  for 
antisera  under  Description,  Acidity  or  Alkalinity,  Abnormal  Toxicity,  Sterility,  Solids, 
Labelling, Storage and  Expiry date. 

Identification – It protects animals against infection with B. Anthracis 

Anti-Blackquarter Serum 

1.    Synonym- Blackleg Antiserum, Clostridium Chauvoei-Anti serum 

2.    Definition-Anti-Blackquarter serum is the serum of suitable animals containing the 

Substances that have a specific neutralising effect on Clostridium Chauvoei. 

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3.     Preparation-  It   is   prepared   by   injecting   subcutaneously  or   intramuscularly 

increasing doses of formolised cultures of Cl. Chauvoei into buffalo bulls. 

4.      Standards- It  complies  with  the  requirements described in  the  general provisions 
for  antisera  under  Description,  Acidity  or  Alkalinity,  Abnormal  Toxicity,  Sterility,  Solids, 
Labelling, Storage and  Expiry date. 

Identification- It protects susceptible animals against infection with virulent strains of 

Cl. Chauvoei. 

1.       Synonym- Pasteurella Septica Antiserum (Avian). 

Anti-Fowl-Cholera  Serum 

2.    Definition-      Fowl  Cholera  Antiserum  is  the  serum  of  animals  containing  the 
substances  that  confer  a  specific  protection  to  fowls  against  virulent  strain  of  Pasteurella 
Septica (Avian). 

3.    Preparation-  Antiserum  is  prepared  from  buffalo  bulls  after  they  have  been 
subjected  to  an  injection  of  killed  cultures  of  virulent  strain  of  Pasteurella  Septica  (Avian) 
followed by injections of living cultures of the same organism. 

4.    Standard- It complies with the requirements described in the general provision for 
anti-sera  under  Description,  Acidity  or  Alkalinity,  Abnormal  Toxicity,  Sterility,  Solids, 
Labelling, Storage and   Expiry date. 

Identification- It  protects  susceptible  fowls  against  infection  with  Pasteurella  Septica 

(Avian) and its homologous strains. 

Anti- Haemorrhagic Septicaemia Serum 

1.     Synonym- Pasteurella Septica Antiserum. 

2.   Definition-  Anti-Haemorrhagic  Septicaemia   Serum   is   the   serum   of   animals 
containing  the  substances  that  confer  a  specific  protection  to  susceptible  animals  against 
virulent strains of Pasteurella Septica. 

3.    Preparation – The antiserum is prepared from buffalo bulls    after they have been 
subjected to repeated injections of formolised cultures of standard strain  Pasteurella Septica 
with  adjuvants, followed by suitable doses of virulent culture of the organism. 

4.       Standard.-It   complies   with   the   requirements   described   in   the   general 
provisions for antisera under Description, Acidity or Alkalinity, Abnormal Toxicity, Sterility, 
Solids, Labelling, Storage and  Expiry date. 

Identification-  It  protects  susceptible  animals  against  infection  with  homologous 

strains of Pasteurella Septica. 

1.   Synonym- Cattle Plague Antiserum 

Anti-Rinderpest Serum 

2      Definition-  Anti-Rinderpest  Serum  is  the  serum  of  buffalo  bulls     containing  the 
substances that  confer a  specific immunity to  susceptible animals against virulent strains of 
the virus of  rinderpest 

3.   Preparation – The antiserum is prepared from buffalos  who have reacted to a dose 
of  virulent rinderpest virus, which is injected  simultaneously with a  predetermined quantity 
of  anti  rinderpest  serum  so  as  to  control  the  severity  of  the  reaction  (serum-simultaneous- 
method). 

4   Standard- It complies with the requirements described in the general provisions for 
antisera  under  Description,  Acidity  or  Alkalinity,  Abnormal  Toxicity,  Solids,  Labelling, 
Storage and  Expiry date. 

(i)    Identification-   It protects susceptible animals against rinderpest. 

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(ii)    Potency-Five Buffalo-calves of  about one year of  age  in good condition are  used 
for the test. Three are injected subcutaneously with the anti-rinderpest serum under test at the 
rate  of  10  ml.  per  46  kg.  body  weight,  subject to  a  minimum of  20  ml.  per  animal.  These 
together  with  the  two  remaining,  are  simultaneously  injected  subcutaneously at  a  different 
site with 1 ml. of a 1: 100 dilution of spleen suspension of virulent bull-virus. 

The  animals  should  be  observed  for  fourteen  days  during  which  time  the  serum 
treated  animals should exhibit no  symptoms of  rinderpest other than rise in  temperature and 
slight intestinal disturbances, while the controls develop more severe symptoms or die. 

Salmonella Pullorum Anti Serum 

1.  Synonym- Salmonella Pullorum Anti Serum. 

2.  Definition-  Salmonella  Pullorum  anti-serum  is  the  sera  from  fowls  and  contains 
antibodies  against  Salmonella  Pullorum.  It  is  used  for  standardizing  batches  of  Salmonella 
Pullorum  antigens  and  also  used  as  a  control  along  with  the  sera  suspected  for  pullorum 
disease. 

3.   Preparation-  The  serum  is  prepared  after  intravenous  inoculation  with  smooth 

culture suspension of Salmonella Pulloram in healthy birds. 

                     4.  Standards-  It  complies  with  the  requirements  in  the  general  provisions  for  anti- 
sera under Description, Acidity, Alkalinity, Sterility, Solids, Labelling, Storage and   Expiry date. 

                    5  .  Identification-  It  should  give  positive  agglutination  with  Salmonella  pullorum 
antigen. 

                    1.  Synonym- National counterpart of standard anti-Brucella Abortus serum. 

Standard Anti-Brucella Abortus Serum 

2.   Definition-  Standard  Anti-Brucella  abortus  serum  is  the  serum  which  contains 
1000  International  Units  (I.U)  per  ml.  and  is  used  for  standardizing  batches  of    brucella 
antigens and is also used as a control along with the sera suspected for brucellosis. 

3.   Preparation- The  serum  is  prepared  after  intravenous inoculation  of  suspension 
of  smooth  culture  of  B.  abortus  (strain  99)  in  rabbits  or  cattle  and  subsequently  diluting  it 
suitably  with  brucella-free  healthy  serum  so  that  when  tested  with  standardized  Brucella 
abortus tube test antigen, it gives 50% agglutination at 1/500 final serum dilution. 

4.     Standard-  It  complies  with  the  requirements  in  the  general  provision  for  anti- 
sera  under  Description, Acidity,  Alkalinity,  Sterility,  Solids,  Labelling, Storage and   Expiry 
date. 

Identification- It should give agglutination with Brucella antigen. 

PART III- DIAGNOSTIC ANTIGENS 

Provisions Applicable to the Manufacture and Standardisation of 
Diagnostic Agents (Bacterial Origin) 

1    Definition-  This  Part  of  the  Schedule  applies  to  reagents  of  bacterial  origin 

employed for various tests. 

2      Staff  of  establishment-  A  competent  expert  in  bacteriology  with  sufficient 
experience in the manufacture and standardisation of veterinary biological products shall be 
in charge of the establishment responsible for the production of various diagnostic agents of 
bacterial origin and he may be assisted by a staff adequate or carrying out the tests required 
during the preparation and standardisation of various diagnostic agents. 

3     Proper  Name-  The  proper  name  of  any  diagnostic  agent  is  the  name  of  micro- 
oraganism  from  which  it  is  made,  followed  by  the  word  ‗antigen‘  unless  the  Schedule 

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otherwise provides, or, it may be derived from the name of the organism responsible for the 
causation of the disease or if there is no special provision in the Schedule, the name approved 
by the Licensing Authority. In the case of the undermentioned preparations the proper  name 
of the diagnostic agent may be as follows: 

1.    Abortus Bang Ring (A.B.R. ) Antigen. 

2.    Brucella Abortus Coloured Antigen. 

3.    Brucella Abortus Plain Antigen. 

4.    Johnin. 

5.    Mallein. 

6.    Salmonella Abortus Equi ―H‖ Antigen. 

7.    Salmonella Pullorum Coloured Antigen. 

8.    Salmonella Pullorum Plain Antigen. 

9.    Tuberculin. 

4.        Records-  Cultures  used  in  the  preparation  of  diagnostic  agents  of  bacterial 
origin must, before being manipulated into an  agent be  thoroughly tested for  identity  by  the 
generally  accepted  tests  applicable  to  the  particular  micro-organism.  The  permanent  record 
which  the  licensee  is  required  to  keep  shall  amongst  other  include  a  record  of  the  origin, 
properties and characteristics of the cultures. 

5.       Preparation- Diagnostic agents  of  bacterial  origin  are  prepared  from  selected 
cultures  after  their  careful  examination  for  the  identity,  specificity,  purity  and  antigenicity. 
They may be prepared in the following manner: 

(a)     Formolised Antigens- The selected pure culture strain grown in a suitable 
medium  at  an  optimum  temperature  for  an  appropriate  period.  The  pure  growth  is 
then  exposed  to  the  action  of  a  solution  of  Formaldehyde  I.P.  in  a  suitable 
concentration and at an appropriate temperature for a  suitable period. 

(b)    In  some  cases,  the  diagnostic  agents  are  prepared  by   growing  the 
organisms  on  suitable  media  and  then  deriving  specific  protein  constituents  of  the 
bacteria by various methods. 

6.        General Standard:- 

(a)     Description- Diagnostic agents may  be  clear  opalescent or  coloured 

liquids. 

(b)     Identification- Some exhibit specific agglutination when mixed with 
the serum of the animals infected with homologous organisms and others when 
injected into the animal body in appropriate doses cause specific reactions like 
hypersensitiveness,  local  and  general  reaction,  if  the  animal  is  infected  with 
homologous organisms. 

(c)      Sterility Test- All antigens shall be tested for sterility in accordance 

with rules 114 to 119. 

(d)       Standardisation- It  is  carried out  either by  determining the  definite 
concentration in  the  product or  by  observing the  general and  local  reactions in 
healthy  and  artificially  infected  animals  with  various  standard  dilutions  of  the 
product. 

7.     Labelling- As under general provisions for the bacterial vaccines with the addition 

that it  is meant for diagnostic purposes only. 

384 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.     Storage- All antigens are stored, protected from light at a temperature between 2 ˚ C 

Drugs and Cosmetics Rules 1945 

to 4 ˚  C. 

9.     Date of manufacture- The date of manufacture shall be unless otherwise specified 

in the  individual monograph in this part as defined in clause (b) of sub- rule (3) of rule 109. 

Abortus Bang Ring (A.B.R.) Antigen 

1.      Synonym- Milk Ring Test Antigen. 

2.     Definition- The antigen is a suspension of pure growth culture of standard strain of 
Brucella  abortus  strain  99  strained  supravitally  with  2,3,5,  triphenyl  tetrazolium  chloride 
suspended in 0.85 per cent saline containing 1 per cent glycerol and 1 per cent phenol. 

3.     Preparation-  Smooth  strain  of  Brucella  abortus  strain  99  is  grown  in  potato 

infusion agar for 48 to 72 hours in Roux flasks, at 37 ˚   C. Condensation fluid if any is 
pipetted off before washing. Each flask is washed with about 20 ml. of normal saline. The 
pooled  washing  is  filtered  through  a  gauze  and  the  filtrate  is  collected  in  a  measuring 
cylinder. To every 500 ml. of the filtrate 1 g. of 2, 3, 5, triphenyl tetrazolium chloride is added 
immediately. The container is shaken for thirty minutes till the tetrazolium salt is dissolved. 
The product is taken out and kept at 37 ˚ C for two hours. After incubation the product is 
heated at 65˚ C in a water bath for thirty minutes. It is cooled and centrifuged at 3000 r.p.m 
for one hour. The supernatant is pipetted off and sediment is suspended in normal saline 
containing 1 per cent  glycerol and 1 per cent phenol and filtered through sterile cotton wool. 
This forms concentrated antigens. 

Standardization of the Strained Antigen 

An  aliquot  portion  of  the  microbial  suspension  stained  with  phenylte-trazolium  is 
taken,  representing  the  initial  undiluted  suspension.  1  ml.  per  tube  of  this  initial  undiluted 
stained  suspension  is  added  to  six  test  tubes,  followed  by  increasing  quantities  of  the 
glycerolphenol diluent as follows:- 

Tube                      Undiluted Stained Suspension                        Diluent 

1 
2 
3 
4 
5 
6 

1 
1 
1 
1 
1 
1 

0.6 
0.8 
1.0 
1.2 
1.4 
1.6 

The contents of each tube are then diluted tenfold with the same diluent and serve as 
antigen for a tube agglutination test with the Standard Serum (or its national counterpart). In 
this  way,  six  sero-reactions  will  be  carried  out.  During  this  procedure,  the  concentrated 
strained microbial suspension should be kept in the refrigerator at 4 ˚ C. 

The agglutination reactions are read after forty-eight hours at the agglutination titre of 
the Standard Serum, previously determined with the usual unstained antigen in the tube test, 
corresponding to the correct dilution of the standard antigen. 

The next step, therefore, is to dilute the concentrated stained suspension to the same 
extent   as  the  tube  whose  tenfold  dilution  has  given  the  correct  agglutination  titre,  i.e.  the 
concentration of antigen in the tube before the tenfold dilution had been made. 

4.      Standard: 

(a)     Description- It is a red colour liquid containing dead bacteria in suspension. 

385 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(b)     Identification- It shows formation of a specific cherry red coloured ring in the 
cream layer when mixed with pooled samples of milk taken from animals suffering from 
burcellosis. 

(c)        Sterility  Test-  Should  comply  with  tests  for  sterility  described in  the  general 

monograph on ‗Diagnostic Antigen‘. The test shall, however, be done before colouring. 

5.      Labelling  and  Storage-  Should  comply  with  the  requirements of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigens‘. 

6.      Expiry  Date-  The  date  of  expiry  of  potency  shall  be  not  more  than  nine  months 

from the date of manufacture when stored 2 ° C to  4° C. 

Brucella Abortus Coloured Antigen 

1.      Synonym- Brucella abortus Cotton Strain 99 coloured Antigen. 

2.     Definition-  Brucella  Abortus  colured  Antigen,  is  a  suspension  of  pure  smooth 
cultures  of  Brucella  abortus  strain  99    in  phenolised  glycerine  saline,  the    bacteria  being 
coloured by the addition of crystal violet and brilliant green. This antigen is used for plate test 
for serological diagnosis of brucella infection. 

3.     Preparation- Seventy-two hours old growth of Brucella Abortus strain ninety-nine 
in  smooth  form  on  potato  infusion  agar  medium  in  Roux  flasks  is  washed  with  phenolised 
glycerine  saline  (containing  12  per  cent  sodium  chloride,  20  per  cent  glycerine  and  0.5  per 
cent phenol). The  washed growth is filtered through a  pad of  absorbent cotton wool and the 
suspension is coloured by the addition of 1 ml. each of 1 per cent aqueous solution of crystal 
violet and brilliant green for very 250 ml. of the suspension. The product is heated for sixty 
minutes in a water bath at 60° C before it is standardised. 

4.      Standard: 

(a)  Description-   It   is   a   greenish   violet   liquid   containing   dead   bacteria   in 

suspension. 

(b) Identification-It gives specific agglutination when mixed with the serum of the 

animal infected with brucella organism. 

(c) Sterility Test- Should comply with the tests for sterility described in the general 

monograph on ‗Diagnostic Antigens‘ 

(d)  Standardisation- 0.5 ml. of the antigen is mixed with 4.5 ml of normal saline 
solution in Hopkins graduated tube. The mixture is centrifuged at 3000 r.p.m. for sixty 
minutes and the percentage of bacterial cells present in the original antigen is assessed 
by  noting  the  height  of  the  cell  deposit.    The  antigen  is  then  standardised  so  as  to 
contain 10 per cent cell deposit. 

5.     Labelling and  Storage-  Should  comply  with  the  requirements  of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigens‘. 

6.     Expiry  Date-  The  date  of  expiry  of  potency  shall  be  not  more  than  nine  months 

from the date of manufacture when stored at 2 ° C to  4°C. 

1.     Synonym- Brucella Abortus Strain 99 Plain Antigen. 

Brucella Abortus Plain Antigen 

2.     Definition- Brucella Abortus Plain Antigen is a suspension of a pure smooth culture 

of Brucella abortus strain 99 in phenol-saline. 

3.     Preparation-  Seventy-two  hours  old  growth  of  Br.  Abortus  strain  99  in  smooth 
form on potato infusion agar medium in Roux flasks is washed with normal saline solution. 
The washed growth is filtered through a pad of absorbent cotton wool and the suspension is 

386 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
kept  at  60  °  C  per  cent. for  sixty  minutes on  a  water  bath to  kill  the  organisms. It  is  then 
preserved by the addition of phenol in a final concentration of 0.5 per cent. 

Drugs and Cosmetics Rules 1945 

4.       Standard: 

(a)  Description- An opalescent liquid containing dead bacteria in suspension. 
(b)  Identification  –It  gives  specific  agglutination when  mixed  with  the  serum  of 

animals infected with brucella organism. 

(c)    Sterility  Test-  Should  comply  with  the  tests  for  sterility  described  in  the 

general monograph in ‗Diagnostic Antigen‘. 

(d)  Standardisation- Mix the concentrated antigen well and dilute 1 ml. with 
0.5 per cent phenol saline until it corresponds to about Tube 4 of Brown‘s opacity 
tubes.  Further  dilutions  of  the  antigen  adjusted  to  opacity  tube  No.  4  are  made. 
The  particular  dilution  that  gives  50  per  cent  agglutination   with  anti-brucella 
abortus  serum  (  containing  1000  International  Units)  at  1  :  500  final  serum 
dilution, is  assessed as  the  diluting factor for the concentrated antigen. The bulk 
of the concentrated antigens is accordingly diluted for issue as standard antigen. 
5. Labelling  and  Storage-  Should  comply  with  the  requirements  of  ‗Labelling  and 

Storage‘ as laid down in the general monograph on ‗Diagnostic Antigen‘. 

6.  Expiry  Date-  The  date  of  expiry  of  potency  shall  be  not  more  than  nine  months 

from the date of manufacture when stored at  2° C to 4° C. 

Johnin 

1.     Definition- Johnin is a preparation of a fluid medium in which Mycobacterium 
Paratuberculosis  has  been  grown  in  artificial  culture  and  which  has  been  freed  by 
filtration from the bacilli. 

2.     Preparation-   Young  culture  of  selected  strain  of  Myco-Paratuberculosis of 
bovine origin is  grown on  synthetic  medium and  incubated at  37  °  C  for  ten  to  twelve 
weeks. Flasks showing lucurient and pure growth are steamed for three hours thereafter 
kept at room temperature overnight. The contents are filtered through fine meshed sieve. 
The filtrate is concentrated over a steam bath to one-tenth of its original volume and kept 
in cold storage for fourteen days before being filtered through Seitz filter. The product is 
dispensed in ampoules and hermetically sealed. 

3.  Standards:- 

(a)  Description- A yellowish brown to brownish liquid. 

(b)  Identification- It produces hot, painful and oeodemateus swelling at the site 

of  inoculation in  animals    infected with  Myco-paratuberculosis  organism. 

(c)      Sterility  Test-  Should  comply  with  the  test  for  sterility  described  in  the 

general   monograph on  ‗Diagnostic Antigens‘. 

(d) Potency Test- Two animals, previously infected with Myco-paratuberculosis 
and  two  healthy  animals  are  each  injected  intrademally  in  the  neck  region  with  0.1 
ml. of  the product. Forty-eight hours later, the  injection is repeated at  the same site. 
The product should produce a typical reaction in the infected animals in the form of a 
hot  painful and  oedemetous swelling at  the  site  of  inoculation persisting for  at  least 
forty-eight  hours  after  the  second  injection.  Control  animals  should  not  show  such 
reaction. 

4. Labelling  and  Storage- Should  comply  with  the  requirements of  ‗Labelling‘ and 

‗Storage‘ as laid down in general monograph on ‗Diagnostic Antigens‘. 

5.  Expiry Date- The date of expiry of potency shall be not more than two years from 

the date of manufacture when stored at 2 ˚ C to 4 ˚ C. 

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Drugs and Cosmetics Rules 1945 

Malleins 

1.    Definition-   (i)      Malleins   are   preparations   of   fluids   media   in   which   the 
Actinobacillus  mellei  has  been  grown  in  artificial  culture  and  which  have  been  freed  by 
filtration from the bacilli. 

(ii)  For  the  purposes  of   this  Schedule  malleins  are  classified  into  (a)  Mallein- 

subcutaneous and (b)   Mallein intradermo-palpebral (I.D.P.) 

2.   Preparation:- 

(a)   Mallein Subcutaneous- Three to four weeks old pure growth of standard strain 
of  A.  mallei  grown  on  synthetic  medium  is  steamed  for  one  hour  in  Koch‘s  steam 
sterilizer. One part of 5 per cent phenol solution is added to every nine part of the dead 
culture which is then filtered through Seitz filter. 

(b)   Mallein   Concentrated.   -   The   procedure   is   the   same   as   for   Mallein 
Subcutaneous except, that the filtrate is evaporated in porcelain dish over steam to half 
the original volume before addition of phenol. Five per cent phenol solution is added in 
sufficient quantity to  the  concentrated product, to  give  a  final  concentrated of  0.5  per 
cent. 

3.   Standards: 

(a)  Description- A yellowish to brown viscous liquid. 

(b)   Identification-  It  produces  hot  tense,  painful  swelling  when  injected  into  the 

animals infected with  A. mallei organisms. 

(c)    Sterility Test- Should comply with the tests for sterility described in the general 

monograph on  ‗Diagnostic Antigens‘. 

(d)  Potency Test: - 

(i)  Mallein subcutaneous- Two ponies, previously sensitised with             A. 
Mallei and controls, are injected each with 1 ml. of the product subcutaneously in the 
neck  region.  The  animals  are  observed  for  local  reaction  and  rise  in  temperature. 
Local  reaction  is  manifested  by  a  hot  tense,  painful  swelling  becoming  prominent 
within twenty-four hours. The rise in temperature is observed by  recording the body 
temperature  at  the  time  of  inoculation and  subsequently at  short  intervals. A  rise  in 
temperature of 1˚ C or more above normal is indicative of infection. 

(ii)  Mallein    Intra-dermo-Palpebral    (I.D.P.)-    Two    ponies,    previously 
sensitized with  A.  mallei and  two  healthy  ponies are  injected  intradermally with  0.2 
ml.  of  the  product  near  the  rim  of  the  lower  eye  lid  of  one  eye.  Typical   reactions 
such as painful swelling of the palpebral tissue with mucopurulent discharge from the 
eye is indicative of infection. The two healthy ponies should not show such reactions. 

Similar  test  in  other eye  is  performed   with  a  previously determined patient 
mallein  using  as  a  standard.  When  the  local  reactions  produced  by  intradermo 
palpebral  infections  of  the  two  preparations  are  comparable  the  batch  is  passed  for 
issue. 

4.     Labelling  and  Storage-  Should  comply  with  the  requirement  of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigen‘. 

5.     Expiry Date- The date of expiry of potency shall be not more than two years from 

the date of   manufacture when stored at 2 ˚ C to 4 ˚ C. 

Salmonella Abortus Equi ‘H’ Antigen 

1.     Synonym- Equine Abortion Diagnostic Antigen. 

2.     Definition-  Salmonella  Abortus  Equi  Antigen  is  suspension  of  a  pure  smooth 

culture of actively motile Salmonella Abortus equi in formal saline. 

388 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.     Preparation- Standard strain  of  S.abortus equi  is  grown  on  nutrient  agar  in  Roux 
flasks  at  37  ˚  C  for  twenty-four  hours.  The  pure  growth  in  Roux  flasks  is  washed  with 
normal saline and diluted to  contain approximately 800 million organisms per ml. Solution 
of Formaldehyde I.P. is added to give a final concentration 0.5 per cent and the formolised 
product  is  incubated  at  37  ˚  C  for  twenty-four  hours.  The  final  product  is  dispensed  in 
suitable containers. 

4.   Standards:- 

(a) Description- A slightly opalescent liquid containing dead bacteria in suspension. 

(b)  Identification- It  gives  specific  agglutination when  mixed  with  the  serum  of  the 

animals infected with S.abortus equi organisms. 

(c)  Sterility  Test-  Should  comply  with  the  test  for  sterility  described  in  the  general 

monograph on ‗Diagnostics Antigens‘. 

5.     Labelling  and  storage-  Should  comply  with  the  requirements  of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigens‘. 

6.  Expiry Date-  The date of expiry of potency shall be not more than nine months from the 

date of manufacture when stored at 2  ˚ C to 4 ˚ C. 

Salmonella Pullorum Coloured Antigen 

1.     Synonym- Bacillary White Diarrhoes (B.W.D) Antigen. 

2.     Definition-  The  antigen  is  a  suspension  in  a  solution  containing  1  per  cent 
Formaline, 1 per cent KH2PO4  and 0.85 per cent Sodium Chloride of pure smooth culture of 
standard strain of Salmonella Pullorum. 

3    Preparation-  Standard  strain  of  S.  Pullorum  is  grown  on  sulphur  agar  medium  in 
Roux     flasks for five days at 37 ˚ C. The pure growth is washed with 1.0 per cent Formal 
Saline. 

Standardisation 

The  antigenic cell  suspension  is  then  centrifuged  (preferably  in  cold  centrifuge)  for 
half  an  hour  at  4000  rotations  per  minute  and  the  packed  cell  volume  determined.  The 
packed cell is then re-suspended in a solution containing 1 per cent formalin, 1 per cent KH2 
PO4 and 0.85 per cent sodium chloride, 1 ml. of packed cell is suspended in 10 ml. of the 
resuspendiary  solution,  mixed  thoroughly  and  is  passed  through  a  cotton  wool  pad.  The 
turbidity of the antigenic suspension is usually between 100 to 125 times Mac Farland scale 
standard and optimum 3 cc. of a 1 per cent aqueous solution of crystal violet are added to 
100 ml. of the antigenic suspension. After making the dye the antigen    is allowed to stand 
forty-eight hours before use. The average yield per Roux flasks of culture medium is about 
50 ml.  The antigen should be bottled in 10 ml. or 20 ml. quantity in amber-coloured bottles 
and corked with rubber caps and paraffin sealed and preserved until required for use within 
the expiry period. This antigen reacts instantly with the blood of all carrier birds and remains 
permanently negative with that of non-infected birds. 

This antigen gives good reactions with positive sera whose titre is even as low as 1 : 20. 

4.        Standard:- 

(a)   Description- Violet coloured liquid containing dead bacteria in suspension. 

(b)   Identification-  It  gives  specific  agglutination  when  mixed  with  the  serum  of 
birds in infected with S. Pullorum infection. It is used for carrying out plate agglutination 
tests for serological diagnosis for S. Pullorum infection in birds. 

(c)    Sterility Test- Should comply with the test for sterility described in the general 
monograph on   ‗ Diagnostic Antigen‘. The tests shall be done before addition of ‗Crystal 
Violet‘. 

5.    Labelling  and  Storage-  Should  comply  with  the  requirements  of  ‗Labelling‘  and 
‗Storage‘ as laid  down in the general monograph 0n ‗Diagnostic Antigens‘. 

389 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

6.     Expiry  Date-  A  six  month  expiration  date  for  this  antigen  is  recommended. 
However, it is advisable to use fresh ones as far as possible. This antigen should be preserved at 
4  ˚  C  to  6  ˚  C  in  dark  place  in  the  refrigerator  and  should  not  be  exposed  to  hot  weather 
condition for longer  than necessary before use in the field. 

Salmonella Pullorum Plain Antigen 

1.     Synonym- Bacillary White Diarrhoes (B.W.D) Plain Antigen. 
2.     Definition-  The  antigen  is  a  suspension  of  pure  smooth  culture  of  Salmonella 

pullorum in phenol saline. 

3.     Preparation- Forty-eight hours old pure culture of smooth strain of S. Pullorum is 
washed  with  0.5  percent  phenol  saline  and  the  pooled  suspension  is  adjusted  to  contain 
approximately  800  million  organisms  per  ml.  by  the  addition  of  more  carbol  saline.  The 
suspension  is  kept  at  room  temperature  of  twenty-four  hours,  and  dispensed  in  suitable 
containers. 

4.     Standard: - 

(a)   Description- An opalescent liquid containing dead bacteria in suspension. 

(b)   Identification-  It  gives  specific  agglutination  when  mixed  with  the  serum  of 

birds infected with S. Pullorum. 

(c)   Sterility Test- Should comply with the tests for sterility described in the general 

monograph on ‗Diagnostic Antigen‘. 

5.     Labelling  and  Storage-  Should  comply  with  the  requirments  of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigens‘. 

6.     Expiry  Date-  The  date  of  expiry  of  potency  shall  be  not  more  than  nine  months 

from the date of manufacture when stored at 2  ˚ C to 4 ˚ C. 

1. Definitions: 

Tuberculin 

(i)     Tuberculins are preparations of fluid media on which Mycobacterium tuberculosis 

has been grown  in artificial culture and which has been freed by filtration from the bacilli. 

(ii) For  the  purposes  of  the  Schedule  tuberculins  are  classified  in  (a)  Tuberculin- 
Subcutaneous  (b)  Heat  Concentrated  Synthetic  Medium   (H.C.S.M)  Tuberculin  (c)  Avian 
tuberculin. 

2.     Preparation:- 

(a)   Tuberculin  subcutaneous-  Flasks  containing  Henley  and   Dorset  synthetic 
medium are inoculated with standard human strains of Myco-Tuberculosis previously 
grown  on  glycerol-  beef  broth  medium  for  ten  days.  After  ten  to  twelve  weeks  of 
incubation at 37 ˚ C, flasks containing pure growth are steamed for three hours. The 
contents  are  filtered  through  fine  meshed  sieve  and  the  volume  is  made  up  to  its 
original with phenolised distilled water such that the final concentration of phenol is 
0.5 per cent. It is then filtered through Seitz filter. 

(b)   Heat  Concentrated  Sythetic  Medium  (H.C.S.M)  Tuberculin-  To  the  strained 
liquid  obtained  after  sieving  as  in  the  method  of  preparation  of  Tuberculin 
subcutaneous, glycerol is  added in the proportion of 122 ml. per  litre  of the original 
volume  of  medium  used.  The  mixture  is  evaporated  to  one-fifth  of  the  original 
volume on a steam bath.   An equal volume of 1 per cent phenol in distilled water is 
added after  the  mixture is  cooled. The product is  stored at  47  ˚  C  for  fourteen days 
before it is filtered through Seitz filter. It is then dispensed in ampoules. 

(c)    Avian  Tuberculin Concentrated- The  procedure is  the  same  as  for Tuberculin 
Concentrated (H.C.S.M)  except  that  standard  strain  of  Myco-tuberculosis (Avian)  is 
used in its preparation. 

390 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.     Standard:- 

Drugs and Cosmetics Rules 1945 

(a) Description- A yellowish brown viscous liquid. 

(b) Identification-   When   injected   intradermally   into   the   animal   infected   with 
tuberculosis diffused swelling occurs depending upon the allergic status of the animal, the 
magnitude of dose and specificity of the product. In non-infected animals this reaction  is 
not observed. 

(c)        Sterility Test- Should comply with the test for sterility described in the general 

monograph on ‗Diagnostic Antigens‘. 

(d)         Potency  Test-  (i)  Tuberculin  subcutaneous-Six  large  white  guinea-pigs  each 
weighing  not  less  than  300-450  g.  are  individually  inoculated  intramuscularly  with  0.5 
mg. (Moist growth from solid plants) of Mycobacterium tuberculosis three weeks prior to 
test  of  each  batch  of  tuberculin;  the  following  dilutions  of  (a)  test  tuberculin  and  (b) 
standard tuberculin are used:- 

1 in 200, 1 in 400, 1 in 800 and 1 in 1600. 
The  six  sensitized guinea  pigs  are  depilated  on  one  flank  and  after  about  twenty- 
four hours each animal inoculated intradermally with 0.2 ml. of each dilution of the two 
tuberculins in  two  rows. The  reactions are  read  after twenty-four and forty-eight hours. 
When  the  local  reactions  produced  by  the  graded  inter-dermal  injections  of  the  two 
preparations are comparable the brew is passed for issue. 

(ii)    Heat  Concentrated  Synthetic  Medium  (H.C.S.M)  Tuberculin-Six  adult  white 
guinea-pigs  each  weighing  not  less  than  300-450  g.   and  sensitized  three   weeks 
previously with  0.5  mg.  (moist growth from solid  plants)  of  Myco-Tuberculosis bovine 
type, injected intramuscularly are used for test of each batch. The following dilutions of 
(a) test tuberculin and (b) standard tuberculin are used: - 

1 in 500, 1 in 1000, 1 in 2000 and 1 in 4000. 

The  six  sensitized guinea  pigs  are  depilated  on  one  flank  and  after  about  twenty- 
four  hours  each  animal  is  inoculated intradermally with  0.2  ml.  of  each  dilution of  the 
two  tuberculins  in  two  rows.  The  reactions  are  read  after  twenty-four  and  forty-eight 
hours.  When  the  local  reactions  produced  by  the  graded  inter-dermal  injections  of  the 
two preparations are comparable, the test tuberculin is passed for issue. The tuberculin is 
dispensed in ampoules. 

(iii)  Avian  Tuberculin-  Six  adults  fowls,  with  well  developed  wattles,  sensitized  at 
least three weeks previously by intramuscular injection with 10 mg. moist weight (from 
solid  plants)  of  twenty-one  days  old  culture  of  Mycobacterium  tuberculosis  (Avian 
Type) are used for potency test of each batch. In each fowl, one wattle is inoculated with 
0.2 ml. of undiluted test tuberculin and the other wattle with similar quantity of undiluted 
standard   tuberculin.  The  reactions  in  each  fowl  are  read  after  twenty-four  hours  and 
forty-eight hours and if comparable the product is passed for issue. 

4.   Labelling  and  Storage-  Should  comply  with  the  requirments  of  ‗Labelling‘  and 

‗Storage‘ as laid down in the general monograph on ‗Diagnostic Antigens‘. 

5.    Expiry  Date-  The  date  of  expiry  of  potency  shall  be  not  more  two  years  months 

from the date of manufacture when stored at 2 ˚ C to 4 ˚ C. 

PART IV 

GENERAL 

1.        For the purpose of this Schedule any test or method of testing described in the 1[British 
Pharmacopoeia  (Veterinary)]  shall  be  deemed  to  be  a  method  approved  by  the 
Licensing Authority. 

2. 

The  Licensing  Authority  shall  publish  in  the  official  Gazette  from  time  to  time 
particulars of any test or method of testing approved by him.] 

1. Subs.  by G.S.R. 647(E) dated 28-10-1998. 

391 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE F (II) 
(See Rule 124-C) 

STANDARDS FOR SURGICAL DRESSINGS 

Synonyms: 

Bandage  Cloth,  Bleached  Bandage  Cloth,  Rolled  Bandage,  Open  Wove  Bandage, 

Cotton Bandage Cloth. 

Bandage Cloth consists of cotton cloth of plain weave made from machine spun yarn 
of  suitable count  to  comply with  a  bleached count  between 20  tex  and  25  tex  for  warp and 
between 25 tex and 30 tex for weft. The fabric contains no filling, sizing or dressing material. 
It may be supplied uncut and folded or cut to suitable size and rolled. 

Description for uncut bandages: 

Uncut bandages are cotton cloth of plain weave, in one continuous length showing no 
joints or seams, with well-formed selvedges. The cloth is bleached to a  good white, is clean 
and odourless and reasonably free from weaving defects and from seed and leaf debris. 

Description for cut bandage: 

Same as for uncut bandages, except for selvedges which shall not be included in cut 
bandages.  In  addition,  both  the  extremes  and  edges  of  cut  bandages  shall  be  straight  and 
evenly cut, with reasonable freedom and loose threads. 

Threads per dm: – Warp not less than 150 and weft not less than 85. 
Weight in g/m2:  - 57 ± 5. 

Length and Width:   - The length and width shall not be less than 99 per cent each of 
the length and width stated on the label. For cut bandages, each of the bandages in a packing 
complies with this requirement. 

Foreign matter: -  Not more than 2 per cent. 

Fluorescence: 

When  viewed  under  screened  ultra-violet  light,  not  more  than  occasional  points  of 

fluorescence are observed. 

Packing, Labelling and Storage: 

Bandage Cloth shall be packed securely so as to allow normal handling and transport 
without tearing and exposing   the    contents.  In packages of cut and    rolled bandages, each 
bandage shall  also individually be  wrapped in  a  suitable  paper. The  net  content is  stated  on 
the  label  in  terms  of  length  and  width.  Bandage  Cloth  must  be  stored  in  packed  condition 
protected from  dust.  The  packings of  Bandage  Cloth  shall  be  labelled  prominently  with  the 
words ―Non-Sterile‖. 

Absorbent Gauze. 

Synonyms.-  Gauze; Unmedicated Gauze; absorbent Cotton Gauze. 

Absorbent  Gauze  is  cotton  fabric  of  plain  weave,  supplied  in  various  widths  and 
lengths. The Gauze is bleached and free from any sizing, dressing or filling material. The yarn 
used is machine spun cotton yarn, of suitable count to comply with a bleached count between 
17 and 25 tex in the finished fabric. 

1.  Ins. by G.S.R. No.318(E), dt.. 1-5-1985. 

392 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Description: 

Cotton  cloth,  plain  weave,  with  a  simple  selvedge  present  on  both  sides  to  prevent 
unravelling of yarn. The cloth is bleached to a good white, is clean, odourless, reasonably free 
from  fabric  defects  and  adhering  sand  debris  from  cotton  seeds  and  leaves,  or  any  other 
foreign matter. 

Threads per dm:.- Warp not less than 75 and weft not less than 55. 
Weight in g/m2: -  30 ± 5. 

Length and widt:-  Not less than 98 per cent each of the length and width stated on the 

label. 

Absorbency:- Average sinking time not more than 10 seconds. 

Fluorescence:-   When   viewed   under   screened   ultra-violet   light   not   more   than 

occasional points of fluorescence are observed. 

Foreign matter:-  Not more than 1 per cent. 

Sterility:- If sterile, the contents comply with the test for sterility. 

Packing,  Labelling and Storage: 

Absorbent  Gauze  is  folded  and  packed  with  such  materials  and  so  securely  as  to 
protect its absorbency and allow normal handling and transport without tearing and exposing 
the contents. The net content is stated on the label in terms of length and width. The packages 
shall be labelled prominently with the words ―Non-Sterile‖. If sterile, it shall be so stated on 
the label, and the packing method and material shall be such as to maintain the sterility. The 
Absorbent Gauze must also comply with the Sterility  Test. Absorbent Gauze must be stored 
in packed conditions protected from moisture and dust. 

Defect in fabric:. 

METHODS OF TEST 

The sample is unfolded, opened and held against diffused daylight or spread on black 
topped table to locate and identify prominently visible defects in yarn and fabric construction. 
The fabric shall be reasonably free from holes, slubs, snarls and naps as well as the following: 
- 

Odour.- Misty odour, or any  objectionable smell like  that  of chemicals or materials 

used in sizing and bleaching. 

Skewness.-  (For Bandage Cloth only) A condition where warp and weft do not keep 

at right angles to each other. 

Defective  Selvedge. -   The  selvedge tearing  and  allowing yarn  to  unravel and  loop 

formation at selvedge. 

Cracks.-  Prominent steaks of space or gaps between warp or weft yarns. 

Double ends.-  More warp threads woven as one, due to wrong draw. 

Sloughing.-  Entanglement in the fabric of a bulk of yarn that has slipped off the weft 

yarn due to loose widing. 

Measurement of length and width. 

Length is the distance from end to end, along one edge of the fabric, and width is the 

perpendicular distance from one edge to the opposite edge. 

Length. - Fix a meter scale to a table or mark off the division of one metre on a table 
edge. Starting from one end, spread the fabric flat on that table in a single layer keeping one 

393 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

selvedge parallel to the scale; smoothen the fabric without stretching it, to avoid creases, and 
mark  off  with  a  coloured  pencil,  on  the  selvedge  exactly  one  metre.  Shift  the  fabric  and 
measure the same way the second metre and so on for the entire length of the fabric making a 
mark  at  each  metre.  Note  down  the  total  length  in  metres.  Repeat  this  at  the  opposite 
selvedge, as well as on the fabric folded approximately about the middle. The average of the 
three readings is the length. For cut bandages, one measurement at the middle of the bandages 
by folding it length-wise will suffice. 

Width. -   Lay the portion of the fabric to be measured flat and smooth on the tables, 
but  do not  stretch fabric except sufficiently to  render it  creaseless. At the place where mark 
had been made on the selvedge in measuring the length measure the perpendicular distance to 
the opposite selvedge with a  metre scale. Note the  width, repeat this  at  every mark  made in 
measuring  the  length.  The  average  of  all  the  readings  is  the  width  of  the  fabric.  For  cut 
bandages, width shall be measured at every 50 cms., and average reported as width. 

Threads per dm.- (For examples not less than 15 m.  in length). 

Weft. -   At  the third metre from one extreme locate  three places one at  about 5  cm. 
below  the  top  selvedge,  a  second  in  the  middle  and  third  at  about  5  cm.  below  the  top 
selvedge, a second in the middle and third about 5 cm. above the bottom selvedge, all three in 
a  vertical  row.  Take  a  rectangular  plate  (made  of  suitable  material  such  as  plastic  or 
aluminium) with the  rectangular opening of  5  cm.  x  10  cm.  cut  in  it.  Keep the plate  on  the 
fabric horizontally so that the left 5 cm. side and bottom (10 cm. side) edges of the opening 
coincides with a weft and warp yarns respectively; count the number of weft yarns within the 
opening for the length of 10 cm.. Repeat this at the other two selected places, and note down 
the average of three readings. Repeat this at every third metre in the sample and calculate the 
average weft per dm. 

Warp.-  Keep  the  rectangular  plate,  this  time  vertically  with  left  (10  cm.  side)  and 
bottom (5 cm. side) edge of opening coinciding with a weft and warp yarn respectively. Count 
the number of warp yarns within the opening for 10 cm. and note down. Repeat this for about 
10 selected places in the samples taking care that the same set of warp yarns is not counted 
more than twice and calculate the average warp per dm. Magnifying glass mounted on stand 
may be used for counting. 

For  samples  less  than  15  m.  in  length,  locate  as  many  different  places  as  the 
dimension of the fabric permits, the total being not less than 10 for each sample and calculate 
the warp and weft per dm. as above. 

For cut bandages, all the warp threads in the samples are counted, taking care to leave 
5 mm at the cut edge, and weft is counted at every 50 cm. at any place about the middle of the 
bandage. 

Weight per unit area. 

For  samples  not  less  than  15  m.  in  length,  cut  out  pieces  of  fabric  from  the  entire 
length of sample, representative places being taken from areas at  every third or fourth metre 
so  that  the  total  area  of  all  the  pieces  so  collected  is  not  less  than  3  sq.  metre.  Weigh  the 
pieces  accurately,  measure  the  dimension  of  each  of  the  pieces  and  calculate  the  area  and 
weight of all the pieces. From the average area and average of weight thus obtained, calculate 
the area per sq.  metre. 

For samples less than 15 m. length, take pieces in such a manner that the total area of 

the selected pieces is not less than 20 per cent of the total area of the sample. 

For cut bandages, pieces of 50 cm. in length, cut from 5  different cut bandages in a 

packing should be taken and weight calculated as an average of 5 readings. 

Absorbency. - Take a glass trough of approximate size length 30 cm. x width 30 cm. x 
depth 25 cm. with straight thick walls and flat bottom. Fill it almost full with distilled water 
leaving only about 5 cm. from the top rim of trough. Maintain the water at 27o C ± 1o C. 

394 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Cut out from any five places located equidistant down the length of the entire sample, 
square pieces, each weighting one gm. (±10 per cent). Fold each piece in such a manner that a 
square  of  approximately  5  cm.  x  5  cm.  is  obtained.  Keep  one  of  the  folded  test  specimen 
between  two  glass  plates  and  place  1  kg  weight  on  the  top  for  10  minutes.  Remove  the 
weight.  Lift  the  specimen  with  forceps  and  gently  place  it  on  to  the  surface  of  water  (the 
specimen should be lightly pinched in the middle with a blunt forceps having no serrations). 
As  soon as the specimen touches the water surface start a  stopwatch which is  stopped when 
the entire sample disappears below the surface of the water. Record the time taken. Repeat the 
test with the other four-test specimens. Calculate the average time in seconds. 

Foreign Matter 

Dry about 5 g. of the sample to constant weight at 105o C and weigh the dried sample 
accurately.  Extract  the  dried  sample  with  chloroform  for  one  hour  in  an  apparatus  for  the 
continuous  extraction  of  drugs.  Remove  the  extracted  sample  to  a  beaker  and  allow  the 
evaporation of residual chloroform. Wash the material 12 times with hot water, using about 
1000  ml.  for  each  washing  and  wringing  the  material  by  hand  after  each  washing;  pass  all 
water  through  a  fine  sieve  (100  mesh).  Place  the  washed  material  and  any  loose  threads  or 
fibres  from  sieve  in  a  beaker,  cover  with  a  0.5  per  cent  aqueous  solution  of  diastase  and 
maintain  at  50oC  until  free  from  starch.  Allow  to  cool,  filter  the  solution  through  a  sieve; 
return  sample  and  loose  fibre  to  a  beaker.    Repeat  the  washing  process  as  before  with  hot 
water.      Dry  the  material  to  constant  weight  at  105oC,  and  determine  the  loss  in  weight. 
Calculate the percentage of foreign matter, which is equal to the loss in weight, with reference 
to the sample dried to constant weight, at 105o C. 

If the sample is tested with iodine and is known to be free from starch, the treatment 

with solution of diastase and the second series of washing with hot water may be omitted. 

Cloth for manufacture of Plaster of Paris Bandages, cut and uncut. 

Synonyms.-  Bleached Bandage Cloth for Plaster of Paris, Rolled Bandage for Plaster 

of Paris. 

Cloth for Plaster of Paris Bandages shall consist of cotton cloth of leno weave made 

from yarn of suitable count. It may be supplied cut or uncut of various widths and lengths. 

Description 

(a)  For  uncut  bandages.-      Cotton  cloth  of  leno  weave,  in  one  continuous  length 
showing  no  joints  or  seams,  and  with  selvedges.  The  cloth  is  bleached  to  a  good  white,  is 
clean  and odourless and reasonably free from weaving defects as well as  from seed and leaf 
debris; the cloth may be dressed if necessary and if so, shall not dust off when unrolled. 

(b) For cut bandages. -  Same as for uncut bandages except for selvedges which shall 
not  be  included and  the  bandages shall  be  cut  evenly  with  straight edges and  be  reasonably 
free from loose threads. 

Threads per dm: 

Warp. - Average not less than 150/dm;  and Weft.- average not less than 75/dm. 
Weight in gm/m2: - 35 ± 5 

Length and width: 

The length and width for uncut bandages shall not be less than 98 per cent each of the 
length  and  width  stated.  For  cut  bandages  a  tolerance  of  ±5  cm.  in  length  and  ±0.5  cm.  in 
width may be allowed, and each of the bandages in packing complies with these requirements. 

Fluorescene 

When viewed under screened ultra-violet light not more than occasional points of 

fluorescence are observed. 

395 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Packing, Labelling and Storage 

Bandage  Cloth  for  Plaster  of  Paris  shall  be  packed  securely  so  as  to  allow  normal 
handling  and  transport  without  tearing  and  exposing  the  contents.  In  packages  of  cut  and 
rolled  bandages,  each  bandage  shall  also  individually  be  warpped  in  suitable  paper.  The 
package shall be labelled as ―Cloth for Plaster of Paris Bandage‖. The net content is stated on 
the label in terms of number of rolls and length and width. Bandage Cloth for Plaster of Paris 
must be stored in packed condition protected from dust. 

1[SCHEDULE F (III) 

(See rule 124-D)  

STANDARDS FOR UMBILICAL TAPES 

(A) Standards for Sterilised Umbilical Polyster Tape. 

Description. -  A  uniform strand  of  Polyester yarn  prepared by  braiding and  may  be 
finished with a  suitable silicone finishing material,  white to  yellowish-white in colour. Tape 
shall be  sterilized  by  Gamma Radiation or  other suitable method approved by  the  Licensing 
Authority. 

Other  requirements.  -      The  Umbilical  Polyester  Tape  shall  conform  to  the  claims 

made on the label in respect of length and width. 

Tensile strength. -   The Umbilical Polyester Tape shall  have Tensile strength of  not 

less than 4 kg. on straight pull. 

Packing  and  labelling.  -  The  Umbilical  Polyester  Tape  shall  be  packed  in  sealed 
Polythene bags or sealed plastic containers which ensure that when packed, the tape is sterile. 
The packing shall protect the tape from contamination and damage. Every packing offered for 
sale shall bear a clear and permanent marking with the following particulars: - 

(i)   The proper name of the drug i.e. Umbilical Polyester Tape ‗Sterile‘ 

(ii)  Manufacturer‘s name and address. 
(iii)    Batch number. 
(iv)  Licence number under which the tape is manufactured. 
(v)  Date of manufacture and date of expiry. 
(vi)    Length and width of the Tape. 

Storage condition. -  It should be stored in a cool place protected from light. 

(B) Standards for Sterilised Umbilical Cotton Tape– 

Description.  -   A  uniform  strand  of  cotton  yarn  prepared  by  braiding  and  may  be 
finished  with  a  suitable  silicone  finishing  material,  white  to  yellowish-white in  colour.  The 
tape shall be sterilized by Gamma Radiation or by any other suitable method approved by the 
Licesing Authority. 

Other Requirement. -   The Umbilical Cotton Tape shall conform to the claims made 

on the label in respect of length and width. 

Tensile  strength.  -  The  Umbilical  Cotton  Tape  shall  have  a  Tensile  strength  of  not 

less than 4 kg. on straight pull. 

Packing  and  labelling.  -      The  Umbilical  Cotton  Tape  shall  be  packed  in  sealed 
Polythene bags or sealed plastic containers which ensure that when packed the tape is sterile. 
The packing shall protect the tape from contamination and damage. Every packing offered for 
sale shall bear a clear and permanent marking with the following particulars:- 

(i)     The proper name of drug i.e. Umbilical Cotton Tape ―Sterile‖. 

(ii)    Manufacturer‘s name and address. 

1. Ins.  by  G.S.R.  No.1115(E), dt.. 30-9-1986. 

396 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(iii)   Batch number. 

(iv)   Licence number under which the tape is manufactured.  

(v)  Date of manufacture and the date of expiry. 

(vi)   Length and width of the Tape. 

Storage condition.-  It should be stored in a cool place protected from light.] 

1[SCHEDULE FF 
( See rule 126-A) 

Standards for ophthalmic preparations.  

Part-A. Ophthalmic Solutions and suspensions. 

Ophthalmic Solutions and Suspensions shall- 

(a) 

 be  sterile  when  dispensed  or  when  sold  in  the  unopened  container  of  the 
manufacturer,      except      in      case      of      those      ophthalmic      solutions      and 
suspensions which are not specifically required to comply with the test for 
‗Sterility‘ in the Pharmacopoeia; 

(b) 

 contain  one  or  more  of  the  following  suitable  substances  to  prevent  the 
growth of micro-organisms:- 

(i)  Benzalkonium  Chloride,  0.01  per  cent  (This  should  not  be  used  in 

solutions of nitrates or salicylates). 

(ii)      Phenyl mercuric nitrate, 0.001 per cent.  

(iii)     Chlorbutanol 0.5 per cent. 

(iv)     Phenyl ethyl alcohol 0.5 per cent. 

Provided  that  solutions  used  in  surgery  shall  not  have  any  preservative and  be  packed  in 

single dose container. 

Provided  further  that  the  Licensing  Authority  may  in  his  discretion    authorise  the  use  of 
any  other  preservative or  vary  the  concentration prescribed on  being  satisfied  that  its  use affords 
equal guarantee for preventing the growth of micro-organisms:- 

(c)        be free from foreign matter; 

(d) 

 be  contained  in  bottles  made  of  either  neutral  glass  or  soda  glass  specially 
treated  to  reduce  the  amount  of  alkali  released  when  in  contact  of  aqueous 
liquids,  or  in  suitable  plastic  containers  which  would  not  in  any  way  be 
incompatible with the solutions; 

The  droppers  to  be  supplied  with  the  containers  of  ophthalmic  solutions  and  
suspensions  shall  be  made  of  neutral  glass  or  of  suitable  plastic material  
and  when  supplied  separately  shall  be  packed  in  sterile cellophane, or other 
suitable packings; 

(e )      In addition to complying with the provisions of labelling laid down in the rules 

the following particulars shall also be shown on the label:- 

1. Added by Notification No. F-1-13/69-D , dt.. 3-1-1970. 

397 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

 (1)  of the containers 

(i)    The statement ‗Use the solution within one month after opening the 

container‘. 

(ii)    Name and concentration of the preservative, if used.  

(iii)  The words ‗NOT FOR INJECTION‘. 

(2)  of container or carton or package leaflet 
  (i) 

 Special instructions regarding storage, wherever applicable. 

(ii)  A cautionary legend reading as 

―WARNING        (i)      if  irritation  persists  or  increases,  discontinue 

the use and consult the phycian. 

(ii)  Do    not    touch    the    dropper   tip    or    other 
dispensing  tip  to  any  surface  since  this  may 
contaminate solutions‖. 

Part B:   Ophthalmic Ointments 

Ophthalmic Ointments shall- 

(a)    be  sterile  when  dispensed  or  when  sold  in  the  unopened  container  of  the 

manufacturer; 

(b)  be free from foreign matter; 

(c)  in  addition to  complying with  the  provisions for  labelling  laid  down  in  the 
rules  the  following  particulars  shall  be  shown  on  the  container  or  carton  or 
package leaflet- 

(i)      Special instructions regarding storage wherever applicable; 

(ii)       A cautionary legend reading 

―Warning   :-      If   irritation   persists   or   increases   discontinue   the   use   and  
consult Physicians‖]. 

398 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE G] 
(See Rule 97) 

Aminopterin 
L-Asparaginase 

Bleomycin 

Busulphan; its salts 

Carbutamide 
Chlorambucil;its salts 
Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine 

Chlorpropamide; its salts 

Chlorthalidone and other derivatives of Chlorobenzene compound. 
2[(Cis-Platin)] 
Cyclophosphamide; its salts 
2[(Cytarabine)] 
Daunorubicin 
Di-Isopropyl Eluorophosphate 

Disodium Stilboestrol Diphosphate 

Doxorubicin Hydrochloride 

Ethacrynic Acid, its salts 

Ethosuximide 

Glibenclamide 

Hydantoin; its salts; its derivatives, their salts 

Hydroxyurea 

Insulin, all types 
2 [(Lomustine Hydrochloride)] 
Mannomustine; its salts 
Mercaptopurine; its salts 
Metformin; its salts 
Methsuximide 

Mustine, its salts 

Paramethadione 

Phenacemide 

Phenformin; its salts 

5-Phenylhydantoin; its alkyl and aryl derivatives; its salts 

Primadone 
1[(Procarpazine Hydrochloride]) 

1. Subs.. by G.S.R. No.462(E) , dt. 22-6-1982 (w.e.f. 22.6.1982). 
2. Ins. by  G.S.R.  No.626(E) , dt. 2-7-1987 w.e.f. 2-7-1987. 

399 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Quinthazone 

Sarcolysine 
1[(Sodium-2-Mercaptoethanesulfonate] 

Tamoxiten Citrate 

Testolactone  

Thiotepa Tolbutamide 

Tretamine; its salts 

Troxidone 

Antihistaminic substances the following, their salts, their derivatives, 

salts of their derivatives 

Antazoline 

Bromodiphenhydramine 

Buclizine 

Chlorcyclizine 

Chlorpheniramine Clemizole 

Cyproheptadine 

Diphenhydramine 

Diphenylpyraline Doxylamine 

Succinate Isothipendyl 

Mebhydrolin Napadisylate 

Meclozine 

Phenindamine 

Pheniramine 

Promethazine 

Thenalidine 

Triprolidine 

Substances being tetra-N-Subs. derivatives of Ethylene Diamine or Prophylenediamine. 

Note . – Preparations containing the above substances excluding those intended for topical or external 

use are also covered by this Schedule.] 

1.  Subs.. by G.S.R. No.462(E) , dt. 22-6-1982 (w.e.f. 22.6.1982). 

400 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

401 

    1. Abacavir 2. Abciximab 3. Acamprosate calcium 4. Acebutol hydrochloride 5. Aclarubicin 6. Albendazole 1[SCHEDULE - H (See Rules 65 and 97) PRESCRIPTION  DRUGS 38. Artesunate 39. Articaine hydrochloride 40. Atenolol 41. Atracurium  besylate injection 42. Atorvastatin 43. Auranofin 7. Alclometasone dipropionate 8. Actilyse 9. Acyclovir 10. Adenosine 11. Adrenocorticotrophic hormone (acth) 12. Alendronate sodium 13. Alopurinol 14. Alphachymotrypsin 15. 2[Alprazolam 16. Alprostadil 17. Amantadine hydrochloride 18. Amifostine 19. Amikacin sulphate 20. Amiloride hydrochloride 21. Amineptine 22. Aminoglutethimide 23. Amino salicylic acid 24. Amiodarone hydrochloride 25. Amitriptyline 26. Amlodipine besylate 27. Amoscanate 28. Amoxopine 29. Amrinonelactate 30. Analgin 31. Androgenic anabolic, oestrogenic & progestational substances 32. Antibiotics 33. Apraclonidine 34. Aprotinin 35. Organic compound of arsenic 36. Arteether 37. Artemether44. Azathioprine 45. Aztreonam 46. Bacampicillin 47. Baclofen 48. Balsalazide 49. Bambuterol 50. Barbituric acid 51. Basiliximab 52. Benazepril hydrochloride 53. Benidipine hydrochloride 54. Benserazide hydrochloride 55. Betahistine dihydrochloride 56. Bethanidine sulphate 57. Bezafibrate 58. Bicalutamide 59. Biclotymol monohydrate /lactate 60. Bifonazole 61. Bimatoprost 62. Biperiden hydrochloride 63. Biphenyl acetic acid 64. Bitoscanate 65. Bleomycin 66. Primonidine tartrate 67. Bromhexine hydrocloride 68. Bromocriptine mesylate 69. Budesonide 70. Bulaquine 71. Bupivacaine hydrochloride 72. Bupropion 73. Buspirone 74. Butenafine hydrochloride 75. Butorphanol tartrate  
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

402 

  76. Cabergoline 77. Calcium dobesilate 78. Candesartan 79. Capecitabine 80. Captopril 81. Carbidopa 82. Carbocisteine 83. Carboplatin 84. Carboquone 85. Carisoprodol 86. L-carnitine 87. Carteolol hydrochloride 88. Carvedilol 89. Cefadroxyl 90. Cefatoxime sodium 91. Cefazolin sodium 92. 2[Cefdinir 93. Cefepime hydrochloride 94. Cefetamet pivoxil 95. Cefpirome 96. Cefpodoximepoxetil 97. Ceftazidime pentahydrate 98. Ceftizoxime sodium] 99. Cefuroxime 100. Celecoxib 101. Centchroman 102. Centbutindole 103. Centpropazine 104. Cetirizine hydrochloride 105. 2[Chlordiazepoxide 106. Chlormezanone 107.    3[* * *] 108. Chlorpromazine 109. Chlorzoxazone 110. Ciclopiroxolamine 111. Cimetidine 112. Cinnarizine 113. Ciprofloxacin hydrochloride 114. Cisplatin 115. Citalopram hydrobromide 116. Clarithromycin 117. Clavulanic acid 118. Clidiniumbromide 119. Clindamycin 120. Clobazam 121. Clobetasol propenate 122. Clobetasone 17-butyrate 123. 2[Clofazimine] 124. Clofibrate 125. Clonazepam 126. Clonidine hydrochloride 127. Clopamide 128. Clopidogrel bisulphate 129. Clostebolacetate 130. Clotrimazole 131. Clozapine 132. 2[Codeine] 133. Colchicine 134. Corticosteroids 135. Cotrimoxazole 136. Cyclandelate 137. Cyclosporins 138. Daclizumab 139. Danazole 140. Dapsone 141. Desloratadine 142. Desogestrol 143. Dexrazoxane 144. Dextranomer   145. 2[* * *] 146. Dextropropoxyphene 147. 2[Diazepam] 148. Diazoxide 149. Diclofenac sodium/potassium/acid 150. Dicyclomin hydrochloride 151. Didanosine 152. Digoxine 153. Dilazep hydrochloride 154. Diltiazem 155. Dinoprostone 156. 2[Diphenoxylate, its salts] 157. Dipivefrin hydrochloride 158. Di-sodiumpamidronate 159. Disopyramide 160. Docetaxel 161. Domperidone 162. Donepezil hydrochloride 163. Dopamine hydrochloride 164. Dothiepin hydrochloride 165. Doxapram hydrochloride 166. Doxazosin mesylate 167. Doxepin hydrochloride  
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

403 

168. Doxorubicin hydrochloride 169. Drotrecogin-alpha 170. Ebastine 171. Econozole 172. Efavirenz 173. Enalapril meleate 174. Enfenamic acid 175. Epinephrine 176. Epirubicine 177. Eptifibatide 178.  Ergot, alkaloids of whether hydrogenated or not, their homologoues, salts 179. Esomeprazole 180. Estradiol succinate 181. Estramustine phosphate 182. Etanercept 183. Ethacridine lactate 184. 2[Ethambutol hydrochloride] 185. Ethamsylate 186. Ethinyloestradiol 187. 2[Ethionamide] 188. Etidronate disodium 189. Etodolac 190. Etomidate 191. Etoposide 192. Exemestane 193. Famciclovir 194. Famotidine 195. Fenbendazole 196. Fenofibrate 197. Fexofenadine 198. Finasteride 199. Flavoxate hydrochloride 200. 5-fluorouracil 201. Fludarabine 202. Flufenamic acids 203. Flunarizine hdrochloride 204. Fluoxetine ydrochloride 205. Flupenthixol 206. Fluphenazine enanthate and decanoate 207. Flurazepam 208. Flurbiprofen 209. Flutamide 210. Fluticasone propionate 211. Fluvoxamine maleate 212. Formestane 213. Fosfestril sodium 214. Fosinopril sodium 215. Fossphenytoin  sodium 216. Fotemustine 217. Gabapentin 218. Galanthamine hydrobromide 219. Galamine, its salts, its quaternary compound 220. Gancyclovir 221. Ganirelix 222. Gatifloxacin 223. Gemcitabine 224. Gemfibrozil 225. Gemtuzumab 226. Genodeoxycholic acid 227. Gliclazide 228. Glimepiride 229. Glucagon 230. Glycopyrrolate 231. Glydiazinamide 232. Goserelin acetate 233. Granisetron 234. Guanethidine 235. Gugulipid 236. Halogenated hydroxyquinolines 237. Haloperidol 238. Heparin 239. Hepatitis b. Vaccine 240. Hyaluronidase 241. Hydrocorisone 17-butyrate 242. Hydrotalcite 243. Hydroxizine 244. Ibuprofen 245. Idebenone 246. Indapamide 247. Imipramine 248. Indinavir sulphate 249. Indomethacin 250. Insulin human 251. Interferon 252. Intravenous fat emulsion 253. Iobitridol 254. Iohexol 255. Iopamidol 256. Iomeprol 257. Iopromide 258. Irbesartan 259. Irinotecan hydrochloride  
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

404 

260. Iron preparation for parenteral use 261. Isepamicine 262. Isocarboxside 263. Isoflurane 264.    Isonicotnic acid hydrazine and other-hydragine derivatives of isonicotinic acid 265. Isosorbide dinitrate/ mononitrate 266. Isotretinoin 267. Isoxsuprine 268. Itopride 269. 4[***] 270. Ketoconazole 271. Ketoprofen 272. Ketorolactromethamine 273. Labetalol hydrochloride 274. Lacidipine 275. Lamivudine 276. Lamotrigine 277. Latanoprost 278. Lefunomide 279. Lercanidipine hydrochloride 280. Letrozole 281. Leuprolide acetate 282. Levamesole 283. Levarterenol 284. Levobunolol 285. Levocetirizine 286. Levodopa 287. 2[Levofloxacin] 288. Levovist 289. Lidoflazine 290. Linezplid 291. Lithium carbonate 292. Lofepramine decanoate 293. Loperamide 294. Lorazepam 295. Losartan potassium 296. Loteprednol 297. Lovastatin 298. Loxapine 299. Mebendazole 300. Mebeverine hydrochloride 301. Medroxyprogesterone  acetate 302. Mefenamic acid 303. Mefloquine hydrochloride 304. Megestrol acetate 305. Meglumine iocarmate 306. Melagenina 307. Elitracenhydrochloride 308. Meloxicam 309. Mephenesin, its esters 310. Mephentermine 311. 2[Meropenam] 312. Mesterolone 313. Metaxalone 314. Methicillin sodium 315. Methocarbamol 316. Methotraxate 317. Metoclopramide 318. Metoprolol tartrate 319. Metrizamide 320. Metronidazole 321. Mexiletine hydrochloride 322. Mianserin hydrochloride 323. Miconazole 324. 2[Midazolam] 325. Mifepristone 326. Milrinone lactate 327. Miltefosine 328. Minocycline 329. Minoxidil 330. Mirtazapine 331. Misoprostol 332. Mitoxantrone hydrochloride 333. Mizolastine 334. Moclobemide 335. Mometasone furoate 336. Montelukast sodium 337. Morphazinamide hydrochloride 338. Mosapride 339. 2[Moxifloxacin] 340. Mycophenolate mofetil 341. Nadifloxacin 342. Nadolol 343. Nafarelin acetate 344. Nalidixic acid 345. Naproxen 346. Narcotics drugs listed in Narcotic Drugs & Psychotropic Substances Act, 1985  
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

405 

347. Natamycin 348. Nateglinide 349. N-butyl-2-cyanoacrylate 350. Nebivolol 351. Nebumetone 352. Nelfinavir mesilate 353. Netilmicin sulphate 354. Nevirapine 355. Nicergoline 356. Nicorandil 357. Nifedipine 358. Nimesulide 359. Nimustine hydrochloride 360. 2[Nitrazepam] 361. Nitroglycerin 362. Norethisterone enanthate 363. Norfloxacin 364. Octylonium bromide 365. Ofloxacin 366. Olanzapine 367. Omeprazole 368. Ornidazole 369. Orphenadrine 370. Orthoclone sterile 371. Oxazepam 372. Oxazolidine 373. Oxcarbazepine 374. Oxethazaine hydrochloride 375. Oxiconazole 376. Oxolinic acid 377. Oxprenolol hydrochloride 378. Oxybutynin chloride 379. Oxyfedrine 380. Oxymetazoline 381. Oxyphenbutazone 382. Oxytocin 383. Ozothine 384. Paclitaxel 385. Pancuronium bromide 386. Pantoprazole 387. Para-amino benzene sulphonamide, its salts & derivatives 388. Parp-amino salicylic acid, its salts, its derivatives 389. Parecoxib 390. Paroxetine hydrochloride 391. D-penicilamine 392. 2[Pentazocine] 393. Pentoxifylline 394. Pepleomycin 395. Phenelzineh sulphate 396. Phenobarbital 397. Phenothiazine, derivatives of and salts of its derivatives 398. Phenylbutazine 399. Pimozide 400. Pindolol 401. Pioglitazone hydrochloride 402. Piracetam 403. Piroxicam 404. Pituitory gland, active principles of, not otherwise specified in this schedule and their salts 405. Polidocanol 406. Polyestradiol phosphate 407. Poractant alfa 408. Praziquantel 409. Prednimustine iothalamates 410. Prednisolone stearoylglycolate 411. Prenoxdiazinhydro-chloride 412. Promazine hydrochloride 413. Promegestone 414. Propafenon  hydrochloride 415. Propanolol hydrochloride 416. Propofol 417. Protristyline hydrochloride 418. 2[Pyrazinamide] 419. Pyrvinium 420. Quetiapine fumerate 421. Quinapril 422. Quinidine sulphate 423. Rabeprazole 424. Racecadotril 425. Raloxifene hydrochloride  
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E)  dated 7-11-2013 

406 

426. Ramipril hydrochloride 427. Ranitidine 428. Rauwolfia, alkaloids of, their salts, derivatives of the alkaloids or rauwolfia 429. Reboxetine 430. Repaglinide 431. Reproterol hydrochloride 432. Rilmenidine 433. Riluzone 434. Risperidone 435. Ritonavir 436. Ritodrine hydrochloride 437. Rituximab 438. Rivastigmine 439. Rocuronium bromide 440. Ropinirole 441. Rosoxacin. 442. Rosiglitazone meleate 443. Salbutamol sulphate 444. Salicyl-azo-sulphapyridine 445. Salmon calcitonin 446. Saquinavir 447. Satranidazole 448. Secnidazole 449. Septopal beads & chains 450. Serratiopeptidase 451. Sertraline hydrochloride 452. Sibutramine hydrochloride 453. Sildenafil citrate 454. Simvastatin 455. Sirolimus 456. Sisomicin sulphate 457. S-neominophagen 458. Sodiumpico sulphate 459. Sodium cromoglycate 460. Sodium hyaluronate 461. Sodium valproate 462. Sodium and maglumine iothalamates 463. Somatostatin 464. Somatotropin 465. Sotalol 466. 2[Sparfloxacin] 467. Spectinomycin  hydrochloride 468. Spironolactone 469. Stavudine 470. Sucralfate 471. Sulphadoxine 472. Sulphamethoxine 473. Sulphamethoxypyridazine 474. Sulphaphenazole 475. Sulpiride 476. Sulprostone hydrochloride 477. Sumatriptan 478. Tacrine hydrochloride 479. Tamsulosin hydrochloride 480. Trapidil 481. Tegaserod maleate 482. Teicoplanin 483. Telmisartan 484. Temozolamide 485. Terazosin 486. Terbutaline sulphate 487. Terfenadine 488. Terizidone 489. Terlipressin 490. Testosteroneun decoanoate 491. Teratolol hydrochloride 492. Thalidomide 493. 2[Thiacetazone] 494. Thiocolchicoside 495. Thiopropazate, its salts 496. Thymogene 497. Thymosin-alpha1 498. Tiaprofenic acid 499. Tibolone 500. Timolol maleate 501. Tinidazole 502. Tizanidine 503. Tabramycin 504. Tolfenamic acid 505. Topiramate 506. Topotecan hydrochloride 507. 2[Tramadolhydrochloride] 508. Tranexamic acid 509. Tranylcypromine, its salts 510. Trazodone  
 
 
 
 
Drugs and Cosmetics Rules 1945 

1.  Subs.  by  G.S.R. No.160(E),  dated 16.3.2006 . 
2.  Omitted by G.S.R 588(E) dated 30-8-2013 
3.  Omitted by G.S.R 602(E) dated 19-7-2010 
4.  Omitted by G.S.R 724(E) dated 7-11-2013 

Note:-  1.  Preparations  exempted  under  proviso  to  para  2  of  Note  to  Schedule  X  shall  also  be  covered 
by this Schedule. 
2.  The  salts,  esters,  derivatives  and  preparations  containing    the  above  substances  excluding  those 
intended  for  topical  or  external    use  (except  ophthalmic  and  ear  /  nose  preparations  con -  taining 
antibiotics and/ or steroids) are also covered by this Schedule. 
3.  The  inclusion  of  a  substance  in  this  Schedule  does  not  imply  or  convey  that  the  substance  is 
exempted from the provisions of Rule 122A/122B.”  

1[SCHEDULE  H1  
(See Rules 65 and 97)  

Alprazolam 
Balofloxacin 
Buprenorphine 
Capreomycin 
Cefdinir 
Cefditoren 
Cefepime 
Cefetamet 
Cefixime 
Cefoperazone 
Cefotaxime 
Cefpirome 
Cefpodoxime 
Ceftazidime 
Ceftibuten 
Ceftizoxime 
Ceftriaxone 
Chlorodiazepoxide 
Clofazimine 
Codeine 
Cycloserine 
Diazepam 
Diphenoxylate 

Doripenam 
Ertapenem 
Ethambutol Hydrochloride 
Ethionamide 
Feropenam 
Gemifloxacin 
Imipenem 
Isoniazide 
Levofloxacin 
Meropenem 
Midazolam 
Moxifloxacin 
Nitrazepam 
Pentazocine 
Prulifloxacin 
Pyrazinamide 
Rifabutin 
Rifampicin 
Sodium Para-aminosalicylate  
Sparfloxacin 
Thiacetazone 
Tramadol 
Zolpidem 

Note:- Preparations containing the above drug substances and their salts excluding those intended for 
topical  or  extrenal  use  (except  ophthalmic  and  ear  or  nose  preparations)  containing  above  substances 
are also covered by this Schedule. 

1. 

Ins. by  G.S.R 588(E) , dt. 30.8.203.

407 

511. Tretinoin 512. Trifluperazine 513. Trifluperidol hydrochloride 514. Triflusal 515. Trimetazidine dihydrochloride 516. Trimipramine 517. Tripotassium dicitrate bismuthate 518. Tromantadine hydrochloride 519. Urokinase 520. Valsartan 521. Vasopressin 522. Vecuronium bromide 523. Venlafaxine hydrochloride 524. Verapamil hydrochloride 525. Verteporfin 526. Vincristine sulphate 527. Vinblastine sulphate 528. Vindesine sulphate 529. Vinorelbine tatrate 530. Xipamide 531. Zidovudine hydrochloride 532. Ziprasidone hydrochloride 533. Zoledronic acid 534. 2[Zolpidem] 535. Zopiclone 536. Zuclopenthixol  
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1SCHEDULE  I  
(Omited) 

2[SCHEDULE  J 
(See rule 106) 

DISEASES AND AILMENTS (BY WHATEVER NAME DESCRIBED) WHICH A DRUG MAY 
NOT PURPORT TO PREVENT OR CURE OR MAKE CLAIMS TO PREVENT OR CURE. 

1.       AIDS 
2.       Angina Pectoris 
3.       Appendicitis 
4.       Arteriosclerosis 
5.       Baldness 
6.       Blindness 
7.       Bronchial Asthma 
8.       Cancer and Benign tumour 
9.       Cataract 
10.     Change in colour of the hair and growth of new hair. 
11.     Change of  foetal  sex by drugs. 
12.     Congenital malformations 
13.     Deafness 
14.     Diabetes 
15.     Diseases and disorders of uterus. 
16.     Epilepticfits and psychiatric disorders 
17.     Encephalitis 
18.     Fairness of the skin 
19.     Form, structure of breast 
20.     Gangrene 
21.     Genetic disorders 
22.     Glaucoma 
23.     Goitre 
24.     Hernia 
25.     High/low Blood Pressure 
26.     Hydrocele 
27.     Insanity 
28.     Increase in brain capacity and improvement of memory. 
29.     Improvement in height of children/adults. 
30.     Improvement  in  size  and  shape  of  the  sexual  organ  and  in  duration  of  sexual 

performance 

31.     Improvement in the strength of the natural teeth. 
32.     Improvement in vision 
33.     Jaundice/Hepatitis/Liver disorders 
34      Leukaemia 
35.     Leucoderma 
36.     Maintenance or improvement of the capacity of the human being for sexual pleasure. 
37      Mental retardation, subnormalities and growth 
38.     Myocardial infarction 
39.     Obesity 
40.     Paralysis 

1.  Schedule I omitted by  G.S.R 462(E) , dt. 22.6.1982 
2.  Subs. by  G.S.R. 21(E) , dt. 11.1.1996. 

408 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

41.     Parkinsonism 
42.     Piles and Fistulae 
43.     Power to rejuvinate 
44.     Premature ageing 
45.     Premature greying of hair 
46.     Rheumatic Heart Diseases 
47.     Sexual Impotence, Premature ejaculation and spermatorrhoea 
48.     Spondylitis 
49.     Stammering 
50.     Stones in gall-bladder, kidney, bladder 
51.     Vericose Vein.] 

 SCHEDULE K  
(See rule 123) 

Class of Drugs 
1. Drugs falling under clause (b) (i) of Section 3 
of the Drugs and Cosmetics Act, not intended for 
medicinal use. 

1[2.* * *] 

2[2A. Quinine and other antimalarial drugs.      

4[3.* * *] 

4[4.* * *] 

5[5.   Drugs supplied  by a  registered medical  
practitioner  to  his  own  patient  or  any  drug 
in  Schedule  C  supplied  by  a 
specified 
registered  medical  practitioner  at  the  request 
of  another    such  practioner  if  it  is  specially 
prepared  with  reference  to  the  condition    and 
for  the  use  of  an  individual    patient  provided  
the  registered  medical  practitioner  is  not  (a) 
keeping  an open shop or (b) selling  across the 
counter    or  (c)  engaged  in    the  importation, 
manufacture,  distribution  or  sale  of  drugs  in 
India  to  a  degree    which  render  him  liable  to 
the provisions of Chapter IV of the Act and the 
rules thereunder. 

the  Rules  thereunder,  subject 

Extent and Conditions of Exemption 
All  the  provisions  of  Chapter  IV  of  the  Act 
to  the 
and 
conditions  that  the  drug 
is  not  sold  for 
medicinal use or for use in the manufacture of 
medicines  and  that  each  container  is  labelled 
conspicuously  with  the  words  ―NOT  FOR 
MEDICINAL USE.‖ 

3[Persons  selling  the  drugs  by  retail  under 
arrangements  made  by  State  Government  for 
sale  and  distribution  of  the  drugs  will  be 
exempted  from  the  requirement  to  take  out 
licences  for  retail  sale  under  clause  (c)  of 
Section 18 of the Act.] 

All  the  provisions  of  Chapter  IV  of  the  Act 
and the Rules made thereunder,  subject to the 
following conditions : 
5[1.  The  drugs  shall  be  purchased  only  from  a 
dealer  or  a  manufacturer  licensed  under  these 
rules,  and  records  of  such  purchases  showing 
the  names  and  quantities  of  such  drugs, 
together  with  their  batch  numbers  and  names 
and  addresses  of  the  manufacturers  shall  be 
maintained.  Such  records  shall  be  open  to 
inspection by an Inspector appointed under the 
Act,  who  may,  if  necessary,  make  enquiries 
about purchases of the drugs and may also take 
samples for test.] 
2.  In  the    case    of  medicine    containing  a 
substance  specified  in  6[Schedule  G,  H  or  X] 
of the following additional conditions shall be 
complied with:- 
a. 

the  medicine  shall  be  labelled  with  the 

409 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

b. 

c. 

d. 

e. 

name and address of the registered medical 
practitioner by whom it is supplied; 
if  the  medicine  is  for  external  application 
it  shall  be  labelled  with  the  words  7[***] 
―For  external  use  only‖  or,  if  it  is  for 
internal use with the dose; 
the name of the medicine or ingredients of 
the  preparation  and  the  quantities  thereof, 
the  dose  prescribed,  the  name  of  the 
patient  &  the  date  of supply  and  the  name 
of  the  person  who  gave  the  prescription  
shall  be  entered  at  the  time  of  supply  in 
register to be maintained for the purpose; 
the  entry  in  the  register  shall  be  given  a 
number  and  that  number  shall  be  entered 
on the label of the container; 
the register and the prescription,  if any, on 
which  the  medicines  are  issued  shall  be 
preserved for not less than two years from 
the  date  of  the  last  entry  in  the  register  or 
the  date  of  the  prescription,  as  the  case 
may be. 

8[3.  The  drug  will  be  stored  under  proper 
storage conditions as directed on the label.] 

10[5A.      Drugs  supplied  by  a  hospital    or 
  or  supported  by 
dispensary  maintained 
Government or local body 11[***] 

9[4.  No  drug  shall  be  supplied  or  dispensed 
after the date of expiration of potency recorded 
on  its  container,  label  or  wrapper  or  in 
violation  of  any  statement  or  direction 
recorded on such container, label or wrapper.] 
The  provisions  of  Chapter  IV  of  the  Act  and 
the Rules thereunder which require them to be 
covered  by  a  sale  licence,  subject  to  the 
following conditions : 
(1)  The  dispensing  and  supply  of  drugs  shall 
be  carried  out  by  or  under  the  supervision 
of a qualified person; 

(2)  The premises where drugs are supplied  or 
stocked shall be open  to inspection  by an 
Inspector  appointed  under the Drugs  and 
Cosmetics  Act  who  can, if  necessary,  take 
samples for test; 

(3)  The  drugs  shall  be  stored  under  proper 

storage conditions. 

(4)  12[The  drugs  shall  be  purchased  from  a 
manufacturer  or  a  dealer  licensed  under 
these  rules  or  received  as 
transferred 
stocks from hospital stores for distribution. 
Records of such purchases or receipts shall 
be maintained.] 

(5)  13[No  drug  shall  be  supplied    or  dispensed 
after  the  date  of  expiration  of  potency 
recorded on its container, label or wrapper 

410 

 
 
 
Drugs and Cosmetics Rules 1945 

14[5B.  Whole  Human  Blood  IP  and  /  or  its 
components  stored  for  transfusion  by  a  First 
Referral  Unit,  Community  Health  Centre, 
Primary Health Centre and a Hospital. 

in  violation  of  any  statement  or 
or 
direction recorded on such container, label 
or wrapper.] 

The  provisions  of  Chapter  IV  of  the  Act  and 
thereunder  which  require 
the  rules  made 
obtaining  of  a    licence    for  operation    of  a  
Blood    Ban  k  or  processing    Whole  Human  
Blood  and  /  or  its  components,  subject  to  the 
following conditions, namely: - 
(1)  The First Referral Unit, Community Health 
Centre, Primary Health Centre and / or any 
Hospital  shall  be  approved  by  the  State  / 
Union  Territory  Licensing  Authority  after 
satisfying 
the  conditions  and  facilities 
through inspection. 

(2)  The captive consumption of Whole Human 
Blood  IP  or  its  components  in  the  First 
Referral  Unit,  Community  Health  Centre, 
Primary  Health  Centre  and 
/  or  any 
Hospital shall not be more than 2000 units 
annually. 

(3)  The    Whole    Human    Blood    an  d  /  or  its 
components  shall    be  procured  only    from 
Government  Blood  Bank  and  /  or  Indian 
Red  Cross  Society  Blood  Bank  and  /  or 
Regional  Blood  Transfusion  Centre  duly 
licensed. 

(4)  The approval shall be valid for a period of 
two  years  from  the  date  of  issue  unless 
sooner  suspended  or  cancelled  and  First 
Referral  Unit,  Community  Health  Centre, 
/  or  any 
Primary  Health  Centre  and 
Hospital  shall  apply  for  renewal  to  the 
State  Licensing  Authority  three  months 
prior to the date of expiry of the approval. 
(5)  The First Referral Unit, Community Health 
Centre, Primary Health Centre and / or any 
Hospital shall have the following technical 
staff 
its 
components: 
(a)  A  trained  Medical  Officer  for  proper 
cross 
procurement, 
matching  of  blood  and 
its 
components.  He  /  she  shall  also  be 
responsible for identifying haemolysed 
blood  and  ensure  non-supply  of  date 
expired blood or its components. 

storage  of  blood  or 

storage 

/  or 

and 

for 

(b)  A  blood  bank  Technician  with  the 
qualification 
as 
and 
specified  in  Part  XII  B  of  Schedule  F 
or 
laboratory 
experienced 
technician  trained  in  blood  grouping 
and cross matching. 

experience 

an 

411 

 
 
 
Drugs and Cosmetics Rules 1945 

(6)  The First Referral Unit, Community Health 
Centre, Primary Health Centre and / or any 
Hospital  shall  have  an  area  of  10  sq. 
metres.  It  shall  be  well  lighted,  clean  and 
preferably  air-  conditioned.    Blood  bank 
refrigerator  of  appropriate  capacity  fitted 
temperature 
with 
temperature 
indicator  with 
monitoring shall be provided to store blood 
units  between  2°  C  to  8°  C  and  if  the 
components  are  proposed  to  be  stored, 
specialized  equipment‘s  as  specified  in 
Part  XII  B  of  Schedule  F  shall  also  be 
provided. 

and 
regular 

alarm  device 

shall  maintain 

(7)  The First Referral Unit, Community Health 
Centre, Primary Health Centre and / or any 
Hospital 
records  and 
registers including details of procurements 
of  Whole  Human  Blood  IP  and  /  or  blood 
components,  as  required  under  Part  XII  B 
Schedule F. 

(8)  (8)    The  First  Referral  Unit,  Community 
Health Centre, Primary Health Centre and / 
or  any  Hospital  shall  store  samples  of 
donors blood as well as patients sera for a 
period seven days after transfusion. 

The provisions of sub-section (a) (i) of Section 
18 of the Act to the following extent- 

(i) the colour of the drug may be pink, owing 
to  its  being  coloured  with  an  edible  pink 
colouring matter; 

(ii) the    B.  P.  tests    for  readily  carbonisable 
substances  produce  a yellow colour of an 
the  colour 
intensity  about  four 
produced 
sulphate 
with 
conforming to the B.P. standard; 

times 
quinine 

(iii) other Cinchona alkaloids  present shall  not 

exceed six per cent; and 

(iv) the residue on incineration shall not exceed 

0.14 per cent. 

The  provisions  of  sub-clause  (i)  of  clause  (a) 
of  Section  18  of  the  Act  to  the  following 
extent:- 
         Chlorides  present  in  the  salt  shall  not 
exceed 0.12 per cent in the case of the produce 
prepared from sea water.] 
All  provisions  of  Chapter  IV  of  the  Act  and 
the 
Rules thereunder 

412 

15[6.* * *] 

7.Quinine Sulphate 

16[8.* * *] 
17[9. Magnesium Sulphate 

18[10.  The  following  substances  which    are 
used both as articles of food as well as drugs - 
(i)  all  condensed    or  powdered  milk  whether 

 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

pure,  skimmed  or  malted,  fortified  with 
vitamins and minerals or otherwise. 
(ii)  Farex,  Oats,  19[***]  and  all  other  similar 
cereal  preparations  whether  fortified  with 
vitamins  or  otherwise  excepting  those  for 
parenteral use. 

(iii)  Virol,  Bovril,  Chicken  essence  and  all 

other similar predigested foods. 

(iv)  20[Ginger,  Pepper,  Cumin,  Cinnamon  and 
all  other  similar  spices    and  condiments 
unless  they  are  specially  labelled    as  
conforming  to  the  standards  in  the  Indian 
Pharmacopoeia 
  Official 
  or 
Pharmacopoeia  and    official  compendia  
of    drug  standards  prescribed  under  the 
Act and Rules made thereunder.] 

the 

21[11.* * *] 
22[12.  Substances  intended  to  be  used  for 
destruction  of  vermin  or  insects  which  cause 
disease  in  human  beings  or  animals,  viz. 
Insecticides and Disinfectants.] 

25[Aspirin tablets.] 
26[Paracetamol Tablets.]  

24[13.  The  following  household  remedies, 
namely- 
(1) 
(2) 
(3)  Analgesic Balms. 
(4)  Antacid preparations. 
(5)  Gripe Water for use of infants.  
(6) 

Inhalers, 
for 
treatment of cold and nasal congestion. 
(7)  Syrups,  lozenges,  pills  and  tablets  for 

containing 

drugs 

cough. 

(8)  Liniments for external use. 
(9)  Skin  ointments  and  ointments 

for 

burns. 

(10)  Absorbent      cotton      wool,  bandages 

absorbent guaze and adhesive plaster. 

(11)  Castor  Oil,  liquid  Paraffin  and  Epsom 

Salt.  

The  provision  of  Chapter  IV  of  the  Act  and 
Rules  thereunder,  which  require  them  to  be 
covered  by  a  sale  licence  23[subject  to  the 
condition  that  provision  of  condition  (17)  of 
Rule  65  of  the  Drugs  and  Cosmetics  Rules, 
1945 are complied with by the person stocking 
or selling such substances.] 
The  provisions  of  Chapter  IV  of  the  Act  and 
the Rules thereunder which require them to be 
covered  with  a  sales  licence  in  Form  20-A 
subject to the following conditions— 
(a)      The  drugs  are  sold  only  in  a  village 
than  one 
having  population  of  not  more 
is  no 
thousand  persons  and  where 
licensed dealer under the Drugs and Cosmetics 
Act; 
(b)    The  drugs    do  not  contain    any  substance 
specified in 27[Schedules G, H or X]; 
(c) 
unopened 
manufacturers; 
(d)    When  the  drugs  are  sold  under  clause  (a) 
condition  3  under  ―Conditions  of  licence‖  of 
Form 20-B shall not apply. 

  The  drugs  are  sold  in  the  original 
licensed 

containers 

there 

the 

of 

(12)  Eucalyptus Oil 
(13)  Tincture  Iodine,  Tincture  Benzoi  n         
C  o.  and  Mercurochrome  in  containers 
not exceeding 100 ml. 

(14)  Tablets of Quinine Sulphate I.P. 
(15)  Tablets 
of 

Iodochlorohydroxy 

quinoline-250 mg. 

28[14. Mechanical Contraceptives 

The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder,  which  require  them  to  be 

413 

 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

30[14A.  Vaginal 
containing Nonoxynol. 

contraceptive 

pessaries 

31[15.  Chemical  contraceptive  having 
following  composition per tablet : 
(1)  DL-Norgestrel-0.30 mg. 

the 

Ethinyloestradiol-0.03 mg. 

(2)  Levonorgestrel-0.15 mg. 

Ethinyloestradiol-0.03 mg.  

(3)  Centchroman-30mg. 
(4)  32[Desogestrel -0.150mg. 

Ethinyloestradiol 0.030mg. 

(5)  Levonorgestrel 0.1mg. 

Ethinyloestradiol 0.02mg 

33[16. Cosmetics 

34[17. Ophthalmic ointments of the 
Tetracycline group of drugs 

35[18.* * *] 

covered  by  a  sale  licence  29[subject  to  the 
condition that the provisions of condition (17) 
of Rule 65 of the Drugs and Cosmetics Rules, 
1945,  are  complied  with  by 
the  person 
stocking or selling mechanical contraceptives.] 
The provisions  of Chapter  IV of the Act and 
the Rules made thereunder which require them 
to  be  covered  by  a  sale  licence  subject  to  the 
condition  that  the  provisions  of  clause  (17)  of 
Rule  65  of  the  Drugs  and  Cosmetics  Rules, 
1945 are complied with by the person stocking 
or selling this contraceptive.] 
The  provisions  of  Chapter  IV  of  the  Act  and 
the rules made thereunder which required them 
to be covered by a sale licence.] 

are  manufactured 

The  provisions  of  Chapter  IV  of  the  Act  and 
the  Rules  made  thereunder,  which  require 
them  to  be  covered  by  a  licence  for  sale 
provided  that  the  cosmetics  sold,  if  of  Indian 
origin, 
licensed 
manufacturers.] 
Persons  authorised  by  the  Government  to 
distribute  or  sell  the  drugs  under  the  National 
Trachoma  Control  Programme 
shall  be 
exempted from the provisions of Chapter IV of 
the Act and the Rules made thereunder, which 
require  the  drugs  to  be  covered  by  a  sale 
licence.] 

by 

36[19.  Hair  Fixers,  namely  mucilaginous 
preparations containing gums, used by men for 
fixing beard. 

The  provisions  of  Chapter  IV  of  the  Act  and 
the rules thereunder.] 

37[20. Radio Pharmaceuticals. 

38[21. Tablets of Chloroquine Salts. 

All  the  provisions  of  Chapter  IV  of  the  Act 
and the rules made thereunder.] 

The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder,  which  require  them  to  be 
covered by a sale licence, provided the drug in 
strip  pack  is  sold  under  the  Commercial 
Distribution  Scheme  of  the  National  Malaria 
Eradication  Programme  and  duly  labelled  as 

414 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

39[22.  Sales  from  restaurant  cars  of  trains  and 
from  coastal  ships  of  household  remedies, 
which  do  not  require  the  supervision  of  a 
qualified person for their sale. 

own 

attached 

registered 
to 

40[23.  Drugs  supplied  by  (  i  )  Multipurpose 
Primary  Health 
to 
Workers 
Centres/Sub-  Centres,  (ii)  Community  Health 
Volunteers  under  the  Rural  Health  Scheme, 
(iii) Nurses, Auxiliary Nurses,  Midwives  an d 
Lady Health Visitors attached to Urban Family 
Welfare  Centres/Primary  Health  Centres/Sub-
Centres and 41[(iv) Anganwadi Workers]. 
42[24.    Homoeopathic            medicines  supplied 
  Homoeopathic  medical 
by  a 
patient 
practitioner 
or 
his 
  supplied  by  a 
Homoeopathic  medicines 
registered 
  medical 
  Homoeopathic 
practitioner  at  the  request  of  another  such 
practitioner 
registered 
Homoeopathic  medical  practitioner  is  not  (a) 
keeping an open shop, or (b) selling across the 
counter  or,  (c)  engaged  in  the  importation, 
manufacture, 
of 
distribution 
Homoeopathic  medicines  in  India  to  a  degree 
which  renders  him  liable  to  the  provisions  of 
Chapter  IV  of  the  Act  and  the  rules  made 
thereunder 
43[25.  Preparations  applied  to  human  body  for 
the  purpose  of 
like 
mosquitoes. 

  provided 

repelling 

insects 

sale 

the 

or 

44[26. Medicated Dressing 
Bandages for First Aid. 

and 

―National  Malaria  Eradication  Programme-
Ministry  of  Health  and  Family  Welfare, 
Government of India.‖] 

The  provisions  of  Chapter  IV  of  the  Act  and 
the  rules  thereunder  which  require  them  to  be 
covered    by  a    sale    licence,    subject  to  the 
following conditions, namely - 
(a)   the records of purchase and sale of drugs 
shall    be  maintained   by  the  person   in  charge 
of sale of such drugs, which shall be  available  
for inspection by an Inspector appointed under 
the Act; 
(b)    the  place  where  such  drugs  are  stocked 
shall  be  open    to  inspection  by  a  n  Inspector 
appointed under the Act who can, if necessary, 
takes samples for test.] 

All  The  provisions  of  Chapter  IV  of  the  Act 
and  Rules  thereunder,  which  require  them  to 
be  covered  by  a  sale  licence,  provided  the 
drugs are supplied under the Health or Family 
Welfare  Programme  of  the  Central  or  State 
Government.] 

All  the  provisions  of  Chapter  IV  of  the  Act 
and  the  rules  made  thereunder  subject  to  the 
following conditions:— 
(1) The  Homoeopathic      medicines shall be 
purchased      only    from    a      dealer  or  a 
manufacturer  licensed  under  the  Drugs  and 
Cosmetics Rules, 1945. 
(2)  The  premises  where  the  Homoeopathic 
Medicines  are  stocked  shall  be  open 
to 
inspection by an Inspector appointed under the 
Act, who  may, if necessary, ―take samples for 
test.]‖ 

The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder  which  require  them  to  be 
covered  by  a  sale  licence  subject  to  the 
that  such  a  product  has  been 
conditions 
manufactured 
drug 
under 
manufacturing licence. 
The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder  which  require  them  to  be 
covered  by  a  sale  licence  subject  to  the 
that  such  a  product  has  been 
conditions 
drug 
under 
manufactured 
manufacturing licence.] 

valid 

valid 

a 

a 

415 

 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

45[27. Oral    Rehydration Salts (Manufactured 
as  per the following formula) : 

o  Sodium chloride 3.5 g/litre. 
o  Trisodium citrate dehydrate 2.9 g/litre 
o  Potassium Chloride 1.5 g/ litre.  

be 

            May 
Sodium 
bicarbonate(Sodium  hydrogen  Carbonate)  2.5 
g/ litre, when citrate salt is not available. 

replaced 

by 

The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder  which  required  them  to  be 
covered  by  a  sale  licence,  subject  to  the 
that  such  a  product  has  been 
conditions 
manufactured 
drug 
under 
manufacturing Licence.] 

valid 

a 

46[28. White or Yellow Petroleum Jelly 
I.P. (Non-perfumed). 

47[29. Morphine Tablets 

30.  Whole  Human  Blood  collected  and 
transfused   by  Centres    r un  by  Armed  Forces 
Medical Services in border  areas, small  mid-
zonal hospitals  including  peripheral hospitals,  
Field    Ambulances,  Mobile  medical  units  and 
other  field  medical  units 
including  blood 
supply  units  in  border,  sensitive  and  field 
areas. 

The  provisions  of  Chapter  IV  of  the  Act  and 
Rules  thereunder  which  required  them  to  be 
covered  by  a  sale  licence,  subject  to  the 
that  such  a  product  has  been 
condition 
manufactured 
drug 
a 
under 
manufacturing Licence. 

valid 

The  provisions  of  Chapter  IV  of  the  Act  and 
the  rules  made  thereunder  which  require  them 
to  be  covered  by  a  sale  licence,  subject  to  the 
following conditions, namely: - 
(i)      The    drug  shall  be    supplied    by  the 
Palliative  Care  Centres  approved  by  the  State 
Government to terminally ill cancer patients 

(ii) The drug shall be kept under the custody of 
the  Medical  Officer  in  charge  of  the  said 
Centre. 

(iii) The drug shall be purchased from a dealer 
or  a  manufacturer  who  holds  licence  under 
these  rules  and  records  of  such  purchases 
showing  the  names  and  quantities  together 
with  their  batch  numbers  and  names  and 
addresses  of  the  manufacturers  or  dealers  and 
the  names  and  addresses  of  the  patients  to 
whom  supplies  have  been  made  shall  be 
maintained.  Such  records  shall  be  open  to 
inspection by an inspector appointed under the 
Act, who may also take samples for test. 
All  the  provisions  of  Chapter  IV  of  the  Act 
and rules made thereunder which require them 
to be covered by a licence to  operate  a Blood 
Bank  for  collection,  storage  and  processing  of 
whole  human  blood  for  sale  or  distribution 
subject to the following conditions:- 
(i)    These  Centres  shall  collect,  process  and 
transfuse  blood  in  emergent  situations  which 
require 
surgeries/or 
transfusion. 
(ii)    These  Centres  shall  be  under  the  active 
direction  and  personal  supervision  of  a 
the 
qualified  Medical  Officer,  possessing 

lifesaving  emergency 

416 

 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

qualifications  and  experiences  specified  in 
condition (i) of rule 122-G. 

(iii) Each blood unit shall  be tested before use  
for  freedom  from  HIV  I  and  II  antibodies, 
Hepatitis  B  surface  antigen,  malarial  parasites  
and  other  tests  specified under  the  monograph 
―Whole  Human  Blood‖  in  current  edition  of 
Indian Pharmacopoeia 

for 

storage 

(iv)  These  Centres  shall  have  adequate 
and 
facilities 
infrastructure 
transportation of blood.  
(v)  The  blood  collected  and  tested  by  such 
Centres shall be transfused by the Centre itself 
and  may  be  made  available  for  use  of  other 
peripheral  Armed  Forces  hospitals  or  Centres 
during   operational circumstances.] 

The  provisions  of  Chapter  IV  of  the  Act  and 
the  rules  made  thereunder  which  require  them 
to  be  covered  with  a  sale  licence  in  Form  20-
C, subject to the following conditions: - 
(i)      These  homoeopathic  medicines  shall  be 
sold  in  the  original  sealed  small  quantity 
packings of the licensed manufacturers. 

(ii)   These medicines may be stocked and sold 
by retail of medicines licensed under rule 61. 

(iii) These medicines shall be stored separately 
from other allopathic drugs. 

(iv)  These medicines shall be purchased from 
a manufacturer or a dealer licensed under these 
rules. 

(v)  The  purchase  and  sale  records  of  these 
medicines  shall  be  maintained  by  the  dealer 
for minimum period of three years. 

(vi)  These  medicines  shall  be  labelled  in 
generic / pharmacopoeial names only.  

48[31. The  following Homoeopathic 
Medicines, namely: - 

49[(a) *** 

(b) Homoeopathic Ointments, each  50[in 25gm. 
Tube]: 
(i) 
(ii) 
(iii) 
(iv) 

 Arnica Montana 
 Calendula Officinalis 
 Cantharis 
 Rhus Toxicodendron 

(c)  Biochemic  tissue remedies in  tablet  forms, 
in generic names only, each in 20gm. Packing 
in 3X and 6X trituration-  
(i) Calcarea Phosphorica    
(ii) Calcarea Sulphurica           
(iii) Ferum Phosphoricum      
(iv) Kali Muriaticum                 
(v) Kali Phosphoricum 
(vi) Kali Sulphuricum 
(vii) Magnesium Phophoricum  
(viii) Magnesia Sulphurica  
(ix) Natrum Muriaticum 
(x) Natrum Phophoricum 
(xi) Natrum Sulphuricum 
(xii) Silica 

(d)      Homoeopathic  medicines,  mentioned 
below, in pills, each in 30C potency, in sealed  
original packing of manufacturer of 8 gms: 
(i)  Arnica Montana 
(ii)  Aconitum Napellus  
(iii)  Arsenicum Album  

417 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(iv)   Aloe Socotrina 
(v)   Apis Mellifica  
(vi)   Allium Cepa  
(vii)  Bryonia Alba  
(viii)  Borax 
(ix)  Belladonna 
(x)   Cantharis 
(xi)  Carbo Vegatabilis 
(xii)  Cina 
(xiii)  Colocythis 
(xiv)   Calendula Officinalis 
(xv)   Caulophyllum Thalictroides 
(xvi)   Cocculus Indicus 
(xvii)  Chamomilla 
(xviii)  Drosera Rotundifolia  
(xix)  Hypeicum Perforatum  
(xx)   Hepar Sulphur 
(xxi)  Ipecacuanha  
(xxii)  Ledum Palustre  
(xxiii)  Millefolium 
(xxiv)   Mercurius Solubilis 
(xxv)   Nux Vomica 
(xxvi)  Pulsatilla Nigricans 
(xxvii) Podophyllum Peltatum  
(xxviii)  Plantago Major 
(xxix)   Rhus Toxicodendron 
(xxx)   Ruta Graveolens 
(xxxi)   Symphytum Officinalis 
(xxxii)  Veratrum Album 
51[(e)    All biochemic and its combinations (1 
to  28),  in  tablet  forms,  in  sealed  original 
packing of the manufacture.] 

52[32.  First  Aid  kit  supplied  along  with  motor 
vehicle  by  the  manufacturer  or  its  distributors 
at the time of first sale of vehicle. 

53[33. Nicotine gum 54[and Lozenges] 
containing upto 2 mg of nicotine 

55[34.  Production of  Oxygen  93  per  cent  USP, 
produced  from  air  by  the  molecular  sieve 
process,  by  a  hospital  or  Medical  Institute  for 
their captive consumption. 

The  provisions  of  Chapter  IV  of  the  Act  and 
rules  made  thereunder  which  require  them  to 
be  covered  by  a  sale  licence,  subject  to  the 
condition  that  the  drug  items  are  procured 
from a manufacturer or a dealer licensed under 
the rules.] 
The  provisions  of  Chapter  IV  of  the  Act  and 
the Rules made thereunder which require them 
to  be  covered  by  a  sale  license  subject  to  the 
that  such  a  product  has  been 
condition 
drug 
a 
under 
manufactured 
manufacturing license.] 

valid 

The  provisions  of  Chapter  IV  of  the  Act  and 
the Rules made thereunder which require them 
to  be  covered  by  manufacturing  licence  under 
the 
the  production 
facilities  shall  be  open  to  inspection  by  an 
Inspector appointed under the Act, who can, if 
necessary, take samples For test‖.] 

rules,  provided 

that 

418 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

56[35.  Homoeopathic  hair  oils  having  active 
ingredients up to 3X potency only 

58[36. Custom made devices 

a 

under 

The  provisions  of  Chapter  IV  of  the  Act  and 
the  rules  made  thereunder  which  require  them 
to  be  covered  with  a  sale  licence  57[***] 
subject to the condition that such a product has 
been  manufactured 
valid 
manufacturing  licence  and  sold  in  the  original 
sealed packing of the licensed manufacturers.] 
All  provisions  of  Chapter  IV  of  the  Act  and 
the  rules  made  thereunder,  subject  to  the 
condition  that  the  device  being  specifically 
made  in  accordance  with  a  duly  qualified 
medical  practitioner‘s  written  prescription 
under  his  responsibility,  in  accordance  with 
specific  design  characteristics  and  is  intended 
for  the  sole  use  of  a  particular  patient  and the 
label  should  bear  the  word  ―custom  made 
device.‖  
       Explanation.––  Mass  produced  devices 
which only need adoption to meet the specific 
requirements of the medical practitioner or any 
other professional user shall not be considered 
to be custom made devices.] 

           1. Item 2 omitted by Government of India Notification No. F.1-56/47-D, dt.  16.1.1950). 

2. Added by Notification No .F. I-2/47-D dt. 13-2-1950. 
3. Amended by Notification No. F. I-22/59-D dt.. 9-4-1960. 
4. Item 3 and 4 omitted by Notification No. F.I-6/62-D dt. 2-7-1969. 
5. Subs. by G.S.R. 1074, dt: 19.8.1978. 
6. Subs. by G.S.R. 462 (E), dt: 22.6.1982. 
7. Certain words omitted by G.S.R. 462 (E), dt: 22.6.1982. 
8. Ins. by G.S.R. 460 (E), dt: 20.6.1984. 
9. Ins. by G.S.R. 592 (E), dt: 13.8.2008. 
10. Added by notification No. F.1-22/59-D, dt: 9.4.1960. 
11. Certain words omitted by G.S.R. 812 (E), dt: 14.11.1994. 
12. Ins. by G.S.R. 648 (E), dt: 16.9.2002. 
13. Ins. by G.S.R. 592 (E), dt: 13.8.2008. 
14. Ins. by G.S.R. 909 (E), dt: 20.12.2001. 
15. Item 6 omitted by G.S.R. 681 (E), dt: 5.12.1980. 
16. Item 8 omitted by G.S.R.1185 (E), dt: 18.8.1964. 
17. Added by notification No. F.1-19/50-D.S, dt: 30.3.1953. 
18. Added by notification No. DR/Sch.Ddk/F.1-40/54-D.S., dt: 27.1.1955. 
19. Omitted by G.S.R. 665 (E), dt: 6.5.1977. 
20. Subs. by G.S.R. 19, dt: 15.12.1977. 
21. Item 11 omitted by notification No. F.1-36/64-D (G.S.R 1188), dt: 17.8.1964. 
22. Amended by notification No. F.1-20/60-D (S.O.400), dt: 24.1.1964. 
23. Added by G.S.R. 926, dt: 24.6.1977. 
24. Added by notification No. F.1-19/59-D, dt: 13.6.1961. 
25. Subs by S.O. 2139, dt: 5.6.1972. 
26. Subs. by G.S.R. 1060(E), dt: 5.9.1986. 
27. Subs. by G.S.R. 462 (E), dt: 22.6.1982. 
28. Added by notification No. F.1-39/61-D (S.O. 1057), dt: 23.3.1964. 
29. Added by G.S.R. 926, dt: 24.6.1977. 
30. Ins. by G.S.R. 784 (E), dt: 28.8.1989. 
31. Subs by G.S.R. 730 (E), dt: 10.12.1991. 
32. Ins. by G.S.R. 648 (E), dt: 16.9.2002. 
33. Added by notification No. F.1-36/64-D (G.S.R 1183), dt: 17.8.1964. 
34. Added by notification No. F.1-21/63-D (G.S.R 70), dt: 4.1.1965. 
35. Item 18 is omitted by G.S.R. 1594, dt: 28.10.1976. 
36. Added by S.O. 2139, dt: 5.6.1972. 
37. Added by G.S.R. 926, dt: 24.6.1977. 

419 

 
 
 
Drugs and Cosmetics Rules 1945 

38. Added by G.S.R. 697 (E), dt: 11.11.1977. 
39. Ins. by G.S.R. 1241, dt: 15.9.1979. 
40. Ins. by G.S.R. 540 (E), dt: 22.9.1980. 
41. Ins. by G.S.R. 784 (E), dt: 28.8.1989. 
42. Ins. by G.S.R. 680 (E), dt: 5.12.1980. 
43. Ins. by G.S.R. 1060 (E), dt: 5.9.1989. 
44. Ins. by G.S.R. 371 (E), dt: 24.3.1988. 
45. Ins. by G.S.R. 677 (E), dt: 2.6.1988. 
46. Ins. by G.S.R. 753 (E), dt: 4.11.1999. 
47. Ins. by G.S.R. 6 (E), dt: 4.1.2001. 
48. Ins. by G.S.R. 218 (E), dt: 28.3.2001. 
49. Sub-item (a) relating to ―Arnica Montana Hair Oil‖ omitted by G.S.R. 917 (E), dt: 22.12.2009. 
50. Subs. by G.S.R. 592 (E), dt: 13.8.2008. 
51. Ins. by G.S.R. 592 (E), dt: 13.8.2008. 
52. Ins. by G.S.R. 648 (E), dt: 16.9.2002. 
53. Ins. by G.S.R. 549 (E), dt: 16.7.2003. 
54. Ins. by G.S.R. 101 (E), dt: 18.2.2001. 
55. Ins. by G.S.R. 734 (E), dt: 21.12.2005. 
56. Ins. by G.S.R. 917 (E), dt: 22.12.2009. 
57. The words ―in Form 20C‖ omitted by G.S.R. 107 (E), dt: 17.2.2015. 
58. Ins. By G.S.R. 890 (E), dt: 25.9.2014.  

420 

 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE  L  
(Omitted) 

2[SCHEDULE L-I 
(see rules 74, 78 and 150E) 

GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND 
EQUIPMENTS 

1.  General Requirements:- 

(a)  The laboratory or the organisation of which it is a part must be an entity that is legally 

authorised to function and can be held legally responsible. 

(b)  It  is  the  responsibility  of  the  management  to  ensure  that  the  laboratory  carry  out  its 
testing,  calibration,  validation,  and  all  other  technical  activities  in  such  a  way  as  to 
meet Good Laboratory Practices (GLP) requirements. 

(c)  Laboratory  management  shall  have  a  qualified  individual  to  be  known  as  quality 
manager  or  technical  manager  for  carrying  out  all  technical  activities  and  for  the 
implementation of documented quality system and  shall report to the top management 
directly. 

(d)  The  quality  manager  shall  prepare  a  schedule  for  technical  audit  of  the  laboratory  for 
GLP compliance by an expert or experts appointed by the top-management other than 
the in-charge of the laboratory and shall ensure the maintenance of documented quality 
system as per quality manual. 

2.  Premises:- 

(a)  (i) the laboratories shall be designed, constructed and maintained  so as to prevent entry 

of insects and rodents besides cross contamination;  
(ii)  interior  surface  (walls,  floor,  and  ceilings)  shall  be  smooth  and  free  from  cracks, 
and permit easy cleaning and disinfection; 
(iii)  adequate  provision    is  made  not  only  for  space  and  equipment    for  carrying  out 
necessary test but also for utilities like water, power and gas; 
(iv) air ventilation system shall ensure dust free environment. 

(b)  The  laboratories  shall  be  provided  with  adequate  lighting  and  ventilation  and  if 
necessary, air- conditioning to maintain satisfactory temperature and relative humidity 
that  will  not  adversely  affect  the  testing  and  storage  of  drugs  or  the  accuracy  of  the 
functioning of the laboratory equipments or instruments. 

(c)  The  drainage  system  facilities  shall  be  such  as  to  facilitate  proper  maintenance  and 

prevent water logging in the laboratory. 

(d)  Tabletops shall be constructed with acid, alkali and solvent resistant material and shall 

be smooth and free from crevices as far as possible. 

(e)  All  bio-medical laboratory  waste  shall  be  destroyed  as  per  the  provisions  of  the  Bio --

Medical waste (Management and Handling) Rules, 1996. 

(f)  Adequate space with proper storage conditions in the laboratory shall be provided  for 
keeping  reference  and  working    standards  and  be  maintained    by  the  quality  control 
department.  Standard  Operating  Procedure  (SOP)  for  the  maintenance  of  reference 
standards and evaluation of Working and Secondary standards shall be prep ared by the 
laboratory. 

(g)  The  air  circulation  is  maintained  in  the  area  where  sterility  test  is  carried  out  as  per 

Schedule‘M‘. 

(h)  Bio-burden shall be routinely maintained in the controlled and uncontrolled area, (e.g. 

air locks) 

1.  Schedule L omitted by G.S.R. 462 (E), dt: 22.6.1982. 
2. 

Ins. by G.S.R. 780 (E), dt: 10.11.2008. 

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(i)  Animals House:- 

Drugs and Cosmetics Rules 1945 

(i)  Animal  House  shall  have  the  approval  of  the  Committee  for  the  Purpose  of 

Control and Supervision on Experiments on Animals (CPCSEA). 

(ii)  Designed  in  such  a  way  that  there  is  an  arrangement  to  quarantine  the  new 
animals  procured  or  purchased  and  have  a  provision    for  clean  corridor  and 
dirty corridor. 
In  case  of  a  diseased animal  proper  diagnosis  shall  be  done  and  proper record 
of treatment shall be maintained. 

(iii) 

(iv)  Different types of animals shall be housed separately with proper identification. 
(v)  A  Standard  Operating  Procedure  shall  be  prepared  for  breeding  and  care  of 
animals, maintenance, cleaning or sanitation with suitable schedule for cleaning 
of animal cages, racks, floor and other equipments. 
The  animal  house  shall  have  proper  air-conditioning  (temperature  and 
humidity)  with  proper  lighting  and  be  monitored  regularly  and  documented 
periodically. 

(vi) 

3.  Personnel- 

(a)  Staff  in  the  laboratory  shall  possess  necessary  qualification,  proper  traini ng  and  shall 

have adequate, experience for the assigned duties. 

(b)  A training record of all the personnel shall be maintained. 
(c)  Head  of  the  laboratory  must  be  of  high  professional  standing  with  experience  in  drug 

analysis and laboratory management who is responsible for. 
(i)  ensuring the control and maintenance of documents including the quality system as 
per the requirements  of regulatory authorities which involves all raw data, SOPs, 
documentation exhibits, protocols, training charts, etc; 

(ii)  planning  and  organising  the  audit  of  the  quality  system  and  initiation  as  well  as 

follow up action of the corrective actions, if any;  

(iii)  investigation of technical complaints; 
(iv)  taking finai responsibilities for recommending any regulatory action in the event of 

noncompliance of tested samples. 

4.  Equipments:- 

(a)  The laboratory shall be furnished with all types of equipments  as may be necessary for 

carrying out the different activities within the laboratory. 

(b)  The  analytical  instruments  shall  be  housed  in  dust-free  environment  and  whenever 
required,  conditions  of  temperature  and  humidity  shall  be  maintained  and  periodic 
checks on temperature and humidity be made and recorded. 

(c)  The instruments, instrument bench and surrounding areas shall be kept clean and tidy at 

ail times. 

(d)  Instruments requiring calibration shall be calibrated  at regular intervals  and records of 
such calibration or maintenance be maintained and there shall be written instructions in 
the  form  of  Standard  Operating  Procedures  for  the  operation,  maintenance  and 
calibration of instruments.  

(e)  Equipment records shall be maintained  and such records shall contain the following: - 

(i)  name of equipment or machine or apparatus; 
(ii)  manufacturer ‘s name, model number and type of identification;  
(iii)  serial number; 
(iv)  date on which equipment was received in laboratory;  
(v)  current location; 
(vi)  condition when received (e.g. new, used, re-conditioned);  
(vii)  copy of the manufacturer ‘s operating instructions; 
(viii)  frequency of calibration;  

(ix)  frequency of maintenance; 
(x)  log Book (day to day entry including status of the equipment) 
(xi)  staff  responsible  for  monitoring  the  calibration  and  maintenance  status  of  the 

equipment; 

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(xii)  calibrating records; 
(xiii)  list of authorised users or operators, if any; 
(xiv)  history  of  any  damage,  malfunction,  modification  or  upgradation,  repair  and 

calibration; 

(xv)  list of spares and accessories, if any. 

(f)  A progress register for non-functional equipments and action for procurement of spares 

and accessories, monitoring thereof, shall be maintained. 

(g)  A Standard Operating Procedure for preventive maintenance of machine or e quipment 

or apparatus shall be prepared by the laboratory. 

(h)  Other  equipments  such  as  burettes,  pipettes,  volumetric  flasks,  weight  boxes, 
thermometers,  etc.,  shall  be  thoroughly    checked  for  accuracy  of  calibration  before 
acceptance for use. 

(i)  Maintenance  procedure  in  the  form  of  Standard  Operating    Procedures  must  be 
prepared  and  regular  servicing    must  be  performed  by  the  maintenance  engineer  or 
specialist 

(j)  Equipments, instruments giving anomalous results or defective must be labeled as ‗out -
of- order‘ till they are repaired and after instrument is repaired it should be calibrated  
before use. 

(k)  The  maintenance  of  equipments  for  services  like  electricity,  gas,  water,  steam,  and 

compressed gas shall be handled by competent person. 

(l)  Autoclaves must meet the requirements  described for operations, safety and validation 

procedures, and the validation carried out by the laboratory shall be recorded. 

(m) Fume Cupboards.- 

Work  involving  the  evolution  of  harmful  and  obnoxious  vapours  shall  be  carried 
out  in  a  fume  cupboard.  The  exhaust  system  of  the  fume  cupboard  shall  be  checked 
frequently to ensure that it is in order. There should be a water drainage system inside the 
fume cupboard and shall be checked frequently to ensure that there is no water logging and 
it is in order. 

5.   Chemicals and Reagents: 

(a)  The  storage  and  handling  of  chemicals  and  reagents  shall  be  done  in  a  manner 
considering  the  physicochemical  properties  of  these  substances  and  the  hazards 
involved in their use. 

(b)  All reagents and solutions in the laboratory shall be properly identified with a label. 
(c)  A  standardisation  register  shall  be  maintained  by  the  laboratory  along  with  its  raw 
data  and  Standard  Operating    Procedure  for  preparation    and  standardisation    on 
stock  solutions,  standard  solutions,  volumetric    solutions  must  be  prepared  for  the 
guidance of staff. 

(d)  Containers  of  stock  solutions  and  of  standard  solutions  shall  bear  the  following 

details:- 

(i) name of analytical chemist who prepared the solution;  
(ii) date of preparation; 
(iii) Each volumetric solution shall have ―use before date‖ depending upon the 
stability of the solution; and 
(iv) standardization records. 

(e)  The  transfer  of  hazardous  chemicals  and  regents  from  one  container  to  another 
container  shall  be  carried  out  with  suitable  equipment  by  taking  the  ca re  of  safety 
and no make-shift or hazardous methods must be resorted to. 

6.  Good house keeping and safety.- 

(a)  General and specific written down instructions for safety shall be circulated  to each 
staff member and the instructions be revised periodically as appropriate (e.g., poster 
displays, audio- visual material and by seminars/conferences) 

(b)  Standard Operating Procedure for safety, house-keeping and loss prevention shall be 
prepared in accordance with the various rules, and regulations of the Government of 
India and include the following requirements, namely:- 
(i)  safety data sheets must be made available  to staff before testing is carried out;  

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Drugs and Cosmetics Rules 1945 

(ii)  drinking, eating and smoking shall not be permitted in the laboratories; food for 
human consumption shall not be kept in working or storage areas; food meant for 
test  animals  shall  be  handled  by  the  workers  under  the  guidance  of  a  veterinary 
doctor  or  qualified  person.  In  the  animal  house,  the  facilities  for  collection  and 
disposal  of  animal  waste  or  safe  sanitary  storage  of  waste  before  removal  from 
testing be provided; 

(iii)  staff must wear laboratory coats or other protective clothing including gloves and 

face masks and eye protection wherever required; 

(iv)  the  laboratories  shall  have  adequate  first  aid  kit  and  fire  fighting  equipme nts 
located at the right places and the staff must be familiar and trained with the use 
of  fire  fighting  equipment  including  fire  extinguishers,  fire  blankets  and  gas 
masks, 

(v)  operators  carrying  out  sterility  tests  shall  wear  sterilised  garments  including 

headgear, face masks and shoes; 

(vi)  the staff must be educated in the first aid techniques, emergency care and use of 

antidotes; and  

(vii)  safety  rules  in  handling  cylinders  of  compressed    gases  must  be  observed    and 

staff must be familiar with relevant colour identification codes; 

(c)  Protective Precautions to be taken in Laboratories: 

(iv) 

(i)  water showers shall be installed at appropriate places in the laboratory;   
(ii) 
rubber suction bulbs must be used on manual pipettes and siphons; 
(iii)  warnings,  precautions,  and  written    instructions  must  be  given  for  work  with 
violent,  uncontrollable  or  dangerous  reactions  (e.g.  mixing    water  and  acids, 
biological such as infectious agents, etc.); . 
appropriate  facilities  for  the  collection,  storage,  and  disposal  of  wastes  shall  be 
made available; 
staff  must  be  aware  of  methods  for  safe  disposal  of  corrosive  or  dangerous 
products by neutralisation or deactivation and of the need for complete disposal 
of mercury and its salts. 
staff  must  also  be  aware  about  the  safety  precautions  to  be  adopted  while 
handling potassium cyanide and cyanogen bromide. 
a  Standard  Operating  Procedure  for  handling,  collection,  disposal  of  chemical 
and biological wastes be prepared. 
7.  Maintenance, calibration, and validation of equipments:- 

(vii) 

(vi) 

(v) 

(a)  All  equipments,  instruments  and  other  devices  used  in  the  laboratory  shall  use 
appropriate  methods  and  procedures  for  all  tests  or  calibrations  and  they  shall  be 
regularly  calibrated  and  validated.  The  frequency  of  calibration  may  differ  from 
instrument to instrument. 

(b)  The original equipment manufacturer ‘s recommendations along with the experience of 
the  laboratory  staff  and  the  use  of  equipment  per  day  may  also  be  considered    while 
fixing the frequency of calibration. 

(c)  For  most  of  the  equipments  and  instruments,  Standard  Operating  Procedures  for 
calibration and calibration schedule be prepared by the laboratory and a logbook shall 
also be prepared by each laboratory for proper documentation of calibration results. 

8.  Reference materials:- 

(a)  Reference  materials  are  necessary  for  the  testing  and,  or  calibration,  validation  or 
verification  of  a  sample  or  of  equipment,  instruments  or  other  devices  and  all  such 
materials shall be traceable to agency authorised by Government of India or any other 
International body . 

(b)  The  laboratory  shall  prepare  working    standard  by  comparing  with  the  reference 
standards  and  shall  be routinely  checked  for  their  purity  by  selecting  parameters  such 
as identity, loss on drying or on water, impurity and assay, etc. 

(c)  Whenever,  any  new  reference  material  is  received  by  the  laboratory,  a  code  number 
shall be assigned and this code number shall be quoted on the laboratory note book and 
analytical work sheet. The working  standard shall also be provided with identification 

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code. 

Drugs and Cosmetics Rules 1945 

(d)  A  register  pertaining  to  reference  and  working  materials  must  be  maintained  by  the 

laboratory. The following details may be mentioned in the register:  

(i) 
(ii) 
(iii) 
(iv) 
(v) 
(vi) 
(vii) 

source of supply; 
code number of the reference material;  
date of receipt; 
batch number or identification number of the supplying agency;  
details like assay value, water content or any other information provided;  
storage condition  of the material; and 
date of expiry, if any and date of manufacturing if possible 

(e)  All working standards shall be checked at appropriate intervals  or before use to ensure 
that  it  has  not  deteriorated  or  decomposed  during  storage.  These  observations  be 
recorded  in  a  register:  All  the  reference  and  working  standards  shall  be  stored  at 
appropriate storage condition; those requiring storage between 2-8°C shall be stored in 
a refrigerator. Wherever recommended the material may not be allowed to be frozen. 

9.  Microbiological Cultures:- 

(a)  Standard  Operating  Procedure  for  maintenance  of  microbial  culture  and  sub -culture 

must be prepared by the laboratories. 

(b)  If the cultures have become non-viable  or mutant, proper procedure shall be followed 
to destroy these cultures  by autoclaving  under an authorised personnel  for biological 
testing. Preferably not more than five passages may be prepared. 
(c)  All activities be carried out in a aseptic area by authorised person. 
(d)  The laboratories shall perform standard biochemical  tests on the sub-culture  as given  

in literature to ensure their viability. 

10.  Quality system.- 
The quality system shall be designed to ensure the following objectives: - 

(a)  The measurements and calibrations  shall fully conform to the compendial requirements 

and the methods demonstrably based on validation protocols are followed. 

(b)  It shall be effective in providing necessary assurance that the activities or processes or 

techniques or practices comply with planned arrangements. 
(c)  It helps in early detection and correction of non conformities. 
(d)  Remedial  action  on  the  observations  by  internal  and  external  audits  are  taken 

appropriately and 

(e)  It shall have a documented quality policy for the organisation. 

11.  Internal quality system audits.- 

(a)  Internal  audits are done to assure the integrity of the analysis‘  and such audits shall be 
conducted periodically with a predetermined  schedule and procedure with appropriate 
checklist,  to  verify  that  the  operations  continue  to  comply  with  the  requirements  of 
quality  system  and  requirements  of  regulatory  authorities.  Internal  quality  audits  shall 
be carried out by trained and qualified personnel who are independent of the activity to 
be audited. 

(b)  The  periodicity  of  quality  audit  shall  be  fixed  by  the  Head  of  the  laboratory    so  that 

each activity is audited at least once in a year. 

(c)  Head of the laboratory will be responsible for initiation of the corrective action arising 

from audits and verification of corrective action. 

(d)  Whenever any non-compliance or any diversion is noticed by the team in implementing 
quality  policy  or  quality  system,  protocols,    the  same  will  be  attended  by  the  Quality 
Manager. The problem will be analysed and necessary actions will be taken with proper 
documentation.  

(e)  The  Quality  Manager  shall  maintain  all  the  records  of  the  analysis  being  conducted 
which  includes   test  system,  the  type  of  analysis,   date  on  which analysis  is  done,  etc 
and  quality  Manager  shall  also  maintain  copies  of all protocols  pertaining  to  different 
activities being checked by the audit team. 

12.  Management review –  
Quality  system  reviews  shall  be  conducted  by  the  top  management  at  least  once  in  every 

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twelve months and the agenda of review shall generally cover the following: - 

Drugs and Cosmetics Rules 1945 

(i) report or input of internal audits; 
(ii) matter arising from previous reviews;  
(iii) report of external audits, if any; 
(iv) surveillance report, if any; 
(v) result of proficiency testing; 
(vi) complaints or feedback received from users of laboratory services;  
(vii) details of in-house quality control checks; 
(viii) need of amendment of the quality system and documentation;. 
(ix) induction training of new staff; and 
(x) any other requirements of the laboratory. 

13.  Standard Operating Procedures:- 

(a)  Standard  Operating  Procedures  are  written  procedures  for  different  activities  being 

conducted in a laboratory and shall include the following characteristics: 
(i)  they  shall  be  written  in  a  chronological    order  listing  different  steps  leading  to  an 

analysis of drugs or calibration of an instrument: 

(ii)  testing laboratories shall have Standard Operating Procedure manuals and have its 

periodic review; 

(iii)  it  shall  be  user  friendly  documents  and  shall  include  designation  of  the  person 

responsible for intended activity. 

(b)  Standard  Operating  Procedures  in  addition  to  those  recommended  under  various 

(iii) 
(iv) 

(v) 

(vi) 

activities shall also be prepared to the minimum  in respect of the following:   
(i) 
(ii) 

sample handling  and accountability; 
receipt  identification,  storage,  mixing    and  method  sampling  of  the  test  and 
control articles; 
record keeping, reporting,  storage and retrieval of data; 
coding of different studies, handling of data including  use of computerized data 
system; 
operation  of  technical  audit  personnel  in  performing  and  reporting  audits, 
inspections and final report reviews; 
routine 
standardisation of instruments; 
action to be taken in respect of equipment failure;  
analytical data methods; 
the raw data; 
data handling  and storage retrieval;  
health and safety protection; 
animal room preparations;  
animal care; 
storage and maintenance of microbial cultures; 

(vii) 
(viii) 
(ix) 
(x) 
(xi) 
(xii) 
(xiii) 
(xiv) 
(xv)  maintenance  of  sterility  room  (i.e.  constant  maintenance  and  monitoring  of 

inspection  of  cleaning,  maintenance, 

testing,  calibration 

  and 

Aseptic condition of sterility room); 
use and storage of reference standards; 
procurement of stores and equipment;  

(xvi) 
(xvii) 
(xviii)  monitoring of testing of samples; 

(xix)  method  of  retention  of  unexpended  samples,  their  location,  maintenance  and 

disposal; 
document control; 
redressal of technical complaints;  
housing-keeping; 
corrective and preventing action;  

(xx) 
(xxi) 
(xxii) 
(xxiii) 
(xxiv)  working procedure (test methods);  
(xxv) 
calibration Manual; and 
(xxvi) 
training manual. 
14.  Protocols and specifications archive.- 

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Drugs and Cosmetics Rules 1945 

(a)  Every  laboratory  shall  have  a  specification  archive  and.  current  versions  of  all 
necessary specifications shall be kept as per  the requirements of the Act and the rules 
made thereunder and the National Pharmacopoeia (Indian Pharmacopoeia). 

(b)  All updates and corrections must be noted in the master volumes of Pharmacopoeias to 
prevent  the  use  of  obsolete  sections;  supplement  and  addendum  shall  also  be  made 
available in the laboratory. 

(c)  The specification archive shall contain the following :- 

(i) 
(ii) 

list of all the pharmacopoeias; 
a file on patent and proprietary  medicines (non-pharmacopoeial)  test methods 
to  specifications  prepared  and  validated  by  the  manufacturer  or  by  the 
laboratory  itself.  The  test  methods  shall  be  submitted  to  the  ·concerned  Drug 
Control  Authority.  The  validated  test  methods  developed  by  the  manufacturer 
or  the laboratory  shall stand  to  the  requirements  of  compendial    parameters in 
regard  to  its  precision,  accuracy,  reproducibility,  specificity,  linearity,  and 
ruggedness etc. 

15.  Raw data:- 

(a)  Raw  data  refers    to  the  laboratory  work  sheet,  note  books  or  analysis    sheet,  records, 
and  other  activities  and  such  raw  data  shall  include  hand  written  notes,  photographs, 
software,  drawings,    computer    printouts,    spectral  charts,  dictated  observations  or 
recorded    data  from  automated  equipments.  The  raw  data  also  includes    record  on 
receipt  of  animals,  result  of  environmental  monitoring,  calibration,  records  of 
equipments, integrator output from analytical equipment, including  work -sheet used to 
read a note, information from Light Emitting Diode (LED) display of any equipment.  
(b)  A single line shall strike through the data being changed; the correct information shall 
be recorded along with the old data and the reason of change. The analyst making the 
change  shall  be  identified  by  his  signature  with  date.  In  case  of  automated  data 
collection system, the person responsible shall be identified at the time of data output. 
The original entry must be saved and the system have audit trial for all the data. 

(c)  Data  integrity  and  security  shall  be  maintained  and  the  data  shall  not  be  accessible  to 

any unauthorised person. 

16.  Storage and archival.- 

(a)  The  residual  sample  shall  be  retained  in  proper  storage  condition  for  a  period  of  one 

year after the final report. 

(b)  The laboratory must establish and maintain  procedures for the identification collection, 

indexing, retrieval, storage, maintenance, and disposal of all quality documents. 

(c)  All  the  raw  data,  documentation,  Standard  Operating  Procedures,  protocols,  and  final 
reports are to be retained and there shall be archives for orderly storage and expeditious 
retrieval    of  all  raw  data,  documentation,  protocols,  interim    and  final  report.  The 
archive shall provide a suitable environment that will prevent modification,  damage, or 
deterioration and/or loss. 

(d)  The condition under which the original documents are stored must ensure their security 

and confidentiality, 

(e)  Paper documents shall not be kept for long periods under high humidity and raw data in 

the form of tape and discs are to be preserved with care, 

(f)  In case of storage of only optical disc, the life of disc shall be longer than the storage 

time,  

(g)  Raw  data  on  thermal  paper  might  fade  away  with  time;  therefore,  a  photocopy  of  the 

thermal paper shall also be retained in the archive. 

(h)  Time for which records are retained shall be prescribed in the documents. 

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Drugs and Cosmetics Rules 1945 

1[SCHEDULE  M 
(See Rules 71, 74, 76 and 78) 

GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, 
PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS 

Note:   To  achieve  the  objectives  listed  below,  each  licensee  shall  evolve  appropriate 
methodology,  systems  and  procedures  which  shall  be  documented  and  maintained  for 
inspection  and  reference;  and  the  manufacturing  premises  shall  be  used  exclusively  for 
production of drugs 2[and no other manufacturing activity shall be undertaken therein  except 
in respect of units licensed prior to 11th December, 2001]. 

PART 1 

GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS 

1    GENERAL REQUIREMENTS: 

1.1.    Location  and  surroundings.-   The  factory  building(s)    for  manufacture  of 
drugs shall be so situated and shall have such measures as to avoid risk of contamination from 
external  environment  including   open  sewage,  drain,  public  lavatory  or  any  factory  which 
produce disagreeable or obnoxious odour or fumes, excessive soot, dust, smoke, chemical or 
biological emissions. 

1.2.     Buildings  and  premises.-  The  building(s)  used  for  the  factory  shall  be 
designed, constructed, adapted and  maintained to  suit  the  manufacturing operations so  as  to 
permit  production of  drugs  under  hygienic  conditions. They  shall  conform to  the  conditions 
laid down in the Factories Act, 1948 (63 of 1948). 

The premises used for manufacturing, processing, warehousing, packaging, labelling 

and testing purposes shall be – 

(i)   compatible with other drug manufacturing operations that may be carried out 

in the same or adjacent area / section; 

(ii)  adequately  provided  with  working  space  to  allow  orderly  and  logical 

placement of equipment, materials and movement of personnel so as to: 

(a)   avoid  the  risk  of  mix-up  between  different  categories  of  drugs   or 

with raw materials, intermediates and in-process material; 

(b)   avoid the possibilities of contamination and cross- contamination by 

providing suitable mechanism; 

(iii)  designed /  constructed /  maintained to prevent entry  of  insects, pests, birds, 
vermins  and  rodents.  Interior  surface  (walls,  floors  and  ceilings)  shall  be 
smooth  and  free  from  cracks,  and  permit  easy  cleaning,  painting  and 
disinfection; 

1. Subs. by  G.S.R. 894(E) , dt. 11.12.2001.- applicable to manufacturers licensed to manufacture drugs, for  

the period up to 31.12.2003. 

2. Subs. by Act 431(E), dt. 30.6.2005. 

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Drugs and Cosmetics Rules 1945 

(iv)   air-conditioned, where prescribed for the operations and dosage forms under 
production.  The  production  and  dispensing  areas  shall  be  well  lighted, 
effectively  ventilated,  with  air  control  facilities  and  may  have  proper  Air 
Handling  Units  (wherever  applicable)  to  maintain  conditions  including 
temperature  and,  wherever  necessary,  humidity,  as  defined  for  the  relevant 
product.  These  conditions  shall  be  appropriate  to  the  category  of  drugs  and 
nature  of  the  operation.  These  shall  also  be  suitable  to  the  comforts  of  the 
personnel  working  with  protective  clothing,  products  handled,  operations 
undertaken within  them  in  relation to  the  external environment. These  areas 
shall  be  regularly  monitored  for  compliance  with  required  specifications; 

(v)  provided  with  drainage  system,  as  specified  for  the  various  categories  of 
products, which shall be of adequate size  and so designed as to prevent back- 
flow and/or prevent insects and rodents entering the premises. Open channels 
shall  be  avoided in  manufacturing areas and,  where provided, these  shall  be 
shallow to facilitate cleaning and disinfection; 

(vi)   the  walls  and  floors  of  the  areas  where  manufacture  of  drugs  is  carried  out 
shall  be  free  from  cracks  and  open  joints  to  avoid  accumulation  of  dust. 
These shall  be  smooth, washable, coved and  shall  permit  easy  and  effective 
cleaning  and  disinfection.  The  interior  surfaces  shall  not  shed  particles.  A 
periodical    record    of    cleaning    and    painting    of    the    premises    shall    be 
maintained. 

1.3      Water System. - There shall be validt. system for treatment of water drawn from 
own  or  any  other  source  to  render  it  potable  in  accordance  with  standards  specified  by  the 
Bureau  of  Indian  Standards  or  Local  Municipality,  as  the  case  may  be,  so  as  to  produce 
Purified Water conforming to Pharmacopoeial specification. Purified Water so produced shall 
only  be  used  for  all  the  operations  except  washing  and  cleaning  operations  where  potable 
water may be used. Water shall be stored in   tanks, which do not adversely affect quality of 
water   and   ensure   freedom   from   microbiological  growth.   The   tank   shall   be   cleaned 
periodically and records maintained by the licensee in this behalf. 

1.4.    Disposal of waste. - 

(i) 

The  disposal  of  sewage  and  effluents  (solid,  liquid  and  gas)  from  the 
manufactory  shall  be  in  conformity  with  the  requirements  of  Environment 
Pollution Control Board. 

(ii)  All  bio-medical  waste  shall  be  destroyed  as  per  the  provisions  of  the  Bio- 

Medical Waste (Management and Handling) Rules, 1996. 

(iii)  Additional precautions shall be taken for the storage and disposal of rejected 

drugs. Records shall be maintained for all disposal of waste. 

(iv)  Provisions shall   be made for the proper and safe storage of waste materials 
awaiting  disposal.  Hazardous,  toxic  substances  and  flammable  materials 
shall  be  stored  in  suitably  designed  and  segregated,  enclosed  areas  in 
conformity with Central and State Legislations. 

2.      Warehousing Area: 

2.1    Adequate  areas  shall  be  designed  to  allow  sufficient  and  orderly  warehousing  of 
various  categories  of  materials  and  products  like  starting  and  packaging  materials, 
intermediates, bulk and finished products, products in quarantine, released, rejected, returned 
or recalled, machine and equipment spare parts and change items. 

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2.2      Warehousing areas shall be designed and adapted to ensure good storage 
conditions.  They  shall  be  clean,  dry  and  maintained  with  acceptable  temperature 
limits.      Where  special  storage  conditions  are  required  (e.g.  temperature,  humidity), 
these shall be provided, monitored and recorded. Storage areas shall have appropriate 
house-keeping   and   rodent,   pests   and   vermin   control   procedures   and   records 
maintained.  Proper  racks,  bins  and  platforms  shall  be  provided  for  the  storage  of 
materials. 

2.3          Receiving  and  dispatch  bays  shall  protect  materials  and  products  from 

adverse weather conditions. 

2.4.     Where quarantine status is ensured by warehousing in separate earmarked 
areas  in  the  same  warehouse  or  store,  these  areas  shall  be  clearly  demarcated.  Any 
system  replacing  the  physical  quarantine,  shall  give  equivalent  assurance  of 
segregation. Access to these areas shall be restricted to authorized persons. 

2.5.      There shall be a separate sampling area in the warehousing area for active 
raw  materials  and  excipients.  If  sampling  is  performed  in  any  other  area,  it  shall  be 
conducted in such a way as to prevent contamination, cross-contamination and mix-up. 

2.6.          Segregation  shall  be  provided  for  the  storage  of  rejected,  recalled  or 
returned  materials  or  products.  Such  areas,  materials  or  products  shall  be  suitably 
marked and secured. Access to these areas and materials shall be restricted. 

2.7.     Highly  hazardous, poisonous and  explosive materials such  as  narcotics, 
psychotropic drugs and substances presenting potential risks of abuse, fire or explosion 
shall  be  stored  in  safe  and  secure  areas.  Adequate  fire  protection  measures  shall  be 
provided in conformity with the rules of the concerned civic authority. 

2.8.     Printed packaging materials shall  be  stored in  safe, separate  and  secure 

areas. 

2.9.     Separate  dispensing  areas  for  β  (Beta)  lactum,  Sex  Hormones  and 
Cytotoxic substances or any such special categories of product shall be provided with 
proper  supply  of  filtered  air  and  suitable  measures  for  dust  control  to  avoid 
contamination. Such areas shall be under differential pressure. 

2.10.        Sampling  and  dispensing  of  sterile  materials  shall  be  conducted  under 
aseptic conditions conforming to Grade A, which can also be performed in a dedicated 
area within the manufacturing facility. 

2.11.    Regular checks shall be made to ensure adequate steps are taken against 

spillage, breakage and leakage of containers. 

2.12.     Rodent  treatments  (Pest  control)  should  be  done  regularly  and  at  least 

once in a year and record maintained. 

3.          Production area: 

3.1.       The  production area  shall  be  designed to  allow the  production preferably in 

uni-flow and with logical sequence of operations. 

3.2.       In order to avoid the risk of corss-contamination, separate dedicated and self- 
contained  facilities  shall  be  made  available  for  the  production  of  sensitive  pharmaceutical 
products  like   penicillin  or   biological  preparations  with  live   micro-organisms.  Separate 

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dedicated facilities shall be provided for the manufacture of contamination causing and potent 
products such as Beta-Lactum, Sex Hormones and Cytotoxic substances. 

3.3.       Working and in-process space shall be adequate to permit orderly and logical 
positioning  of  equipment  and  materials  and  movement  of  personnel  to  avoid  cross- 
contamination and  to  minimize  risk  of  omission or  wrong  application of  any  manufacturing 
and control measures. 

3.4.       Pipe-work,  electrical  fittings,  ventilation  openings  and  similar  service  lines 
shall be designed, fixed and constructed to avoid  1[accumulation of dust]. Service lines shall 
preferably be identified by colours and the nature of the supply and direction of the flow shall 
be marked/indicated. 

4.          Ancillary Areas: 

4.1        Rest and  refreshment rooms shall be  separate from other areas. These areas 

shall not lead directly to the manufacturing and storage areas. 

4.2        Facilities  for  changing,  storing  clothes  and  for  washing  and  toilet  purposes 
shall  be  easily  accessible and  adequate  for  the  number  of  users.  Toilets,  separate  for  males 
and females, shall not be directly connected with production or storage areas. There shall be 
written instructions for cleaning and disinfection of such areas. 

4.3        Maintenance  workshops  shall  be  separate  and  away  from  production  areas. 
Whenever  spares,  changed  parts  and  tools  are  stored  in  the  production  area,  these  shall  be 
kept  in  dedicated  rooms  or  lockers.  Tools  and  spare  parts  for  use  in  sterile  areas  shall  be 
disinfected before these are carried inside the production areas. 

4.4.       Areas   housing   animals   shall   be   isolated   from   other   areas.   The   other 
requirements  regarding  animal  houses  shall  be  those  as    prescribed in  rule  150-C(3)  of  the 
Drugs and Cosmetics Rules, 1945 which shall be adopted for production purposes. 

5.          Quality Control Area. 

5.1.       Quality  Control  Laboratories  shall  be  independent  of  the  production  areas. 
Separate  areas  shall  be  provided  each  for  physico-chemical,  biological,  microbiological  or 
radio-isotope  analysis.  Separate  instrument  room  with  adequate  area  shall  be  provided  for 
sensitive and sophisticated instruments employed for analysis. 

5.2        Quality   Control   Laboratories   shall   be   designed   appropriately   for   the 
operations to be carried out in them. Adequate space shall be provided to avoid mix-ups and 
cross-contamination. Sufficient and suitable storage space shall be provided for test  samples, 
retained samples, reference standards, reagents and records. 

5.3.         The  design  of  the  laboratory  shall  take  into  account  the  suitability  of 
construction  materials  and  ventilation.  Separate  air  handling  units  and  other  requirements 
shall  be  provided  for  biological,  microbiological  and  radioisotopes  testing  areas.  The 
laboratory shall be provided with regular supply of water of appropriate quality for cleaning 
and testing purposes. 

5.4.      Quality  Control  Laboratory  shall  be  divided  into  separate  sections  i.e.  for 
chemical,  microbiological  and  wherever  required,  biological  testing.  These  shall  have 
adequate  area  for  basic  installation  and  for  ancillary  purposes.  The  microbiology  section 
shall  have  arrangements  such  as  airlocks  and  laminar  air  flow  work  station,  wherever 
considered necessary. 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005. 

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6.          Personnel: 

6.1.      The manufacture shall be conducted under the direct supervision of competent 
technical staff  with  prescribed qualifications and  practical experience in  the  relevant dosage 
form and / or active pharmaceutical products. 

6.2          The  head  of  the  Quality  Control  Laboratory  shall  be  independent  of  the 
manufacturing unit. The testing shall be conducted under the direct supervision of competent 
technical staff who shall be whole time employees of the licensee. 

6.3.      Personnel  for   Quality  Assurance  and   Quality  Control  operations  shall  be 

suitably qualified and experienced. 

6.4.            Written  duties  of  technical  and  Quality  Control  personnel  shall  be  laid  and 

followed  strictly. 

6.5.        Number of personnel employed shall be adequate and in direct proportion to the 

workload. 

6.6.        The  licensee  shall  ensure  in  accordance  with  a  written  instruction  that  all 
personnel  in  production  area  or  into  Quality  Control  Laboratories  shall  receive  training 
appropriate  to  the  duties  and  responsibility  assigned  to  them.  They  shall  be  provided  with 
regular in-service training. 

7.      Health, clothing and sanitation of workers: 

7.1        The  personnel  handling  Beta-lactum  antibiotics  shall  be  tested  for  Penicillin 
sensitivity  before  employment  and  those  handling  sex  hormones,  cytotoxic  substances  and 
other potent drugs shall be periodically examined for adverse effects. These personnel should 
be  moved  out  of  these  sections  (except  in  dedicated  facilities),  by  rotation,  as  a  health 
safeguard. 

7.2        Prior to employment, all personnel, shall undergo medical examination including 
eye  examination,  and  shall  be  free  from  Tuberculosis,  skin  and  other  communicable  or 
contagious diseases. Thereafter, they should be medically examined periodically, at least once 
a  year.  Records  shall  be  maintained  thereof.  The  licensee  shall  provide  the  services  of  a 
qualified physician for assessing the health status of personnel involved in different activities. 

7.3        All persons prior to and during employment shall be trained in practices which 
ensure  personnel  hygiene.  A  high  level  of  personal  hygiene  shall  be  observed  by  all  those 
engaged  in  the  manufacturing  processes.  Instructions  to  this  effect  shall  be  displayed  in 
change- rooms and other strategic locations. 

7.4        No person showing, at any time, apparent illness or open lesions which may 
adversely  affect  the  quality  of  products,  shall  be  allowed  to  handle  starting  materials, 
packaging materials, in-process materials, and drug products until  his condition is  no  longer 
judged to be a risk. 

7.5        All  employees  shall  be  instructed  to  report  about  their  illness  or  abnormal 

health condition to their immediate supervisor so that appropriate action can be taken. 

7.6        Direct contact shall be  avoided between the unprotected hands of  personnel 

and raw materials, intermediate or finished, unpacked products. 

7.7        All  personnel  shall  wear  clean  body  coverings  appropriate  to  their  duties. 
Before entry into the manufacturing area, there shall be change rooms separate for each sex 

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with  adequate  facilities  for  personal  cleanliness  such  as  wash  basin  with  running  water, 
1[clean towels or hand dryers], soaps, disinfectants, etc. The change rooms shall be provided 
with cabinets for the storage of personal belongings of the personnel. 

7.8        Smoking,  eating,  drinking,  chewing  or  keeping  plants,  food,  drink  and 
personal  medicines shall  not  be  permitted  in  production, laboratory, storage  and  other  areas 
where they might adversely influence the product quality. 

8.  Manufacturing Operations and Control: 

8.1        All  manufacturing  operations  shall  be  carried  out  under  the  supervision  of 
technical staff approved by the Licensing Authority.  Each critical step in the process relating 
to the selection, weighing and measuring of raw material addition during various stages shall 
be performed by trained personnel under the direct personal supervision of approved technical 
staff. 

The contents of all vessels and containers used in manufacture and storage during the 
various  manufacturing stages  shall  be  conspicuously labelled  with  the  name  of  the  product, 
batch number, batch size and stage of manufacture. Each label should be initialled and dt. by 
the authorised technical staff. 

Products not prepared under aseptic conditions are required to be free from pathogens 

like Salmonella, Escherichia coli, Pyocyanea, etc. 

8.2.       Precautions against mix-up and cross-contamination: 

8.2.1.    The  licensee  shall  prevent  mix-up  and  cross-contamination of  drug  material 
and  drug  product  (from  environmental  dust)  by  proper  air-handling  system,  pressure 
differential, segregation, status labelling and cleaning. Proper records and Standard Operating 
Procedures thereof shall be maintained. 

8.2.2     The  licensee  shall  ensure  processing  of  sensitive  drugs  like  Beta-Lactum 
antibiotics, sex hormones and cytotoxic substances in segregated areas or isolated production 
areas within the building with independent air-handling unit and proper pressure differentials. 
1[The  effective  segregation  of  these  areas  shall  be  validated  with  adequate  records  of 
maintenance and services]. 

8.2.3     To prevent mix-ups during production stages, material under process shall be 
conspicuously labelled to demonstrate their status. All equipment used for production shall be 
labelled with their current status. 

8.2.4     Packaging lines  shall  be  independent and  adequately segregated. It  shall  be 
ensured that all left-overs of the previous packaging operations, including labels, cartons and 
caps are cleared before the closing hour. 

8.2.5     Before packaging operations are begun, steps shall be taken to ensure that the 
work area,  packaging lines, printing machines, and other equipment are  clean and  free  from 
any  products, materials and spillages. The line clearance shall be  performed according to  an 
approximate check list and recorded. 

8.2.6     The correct details of any printing (for example of  batch numbers or expiry 
dates)  done  separately  or  in  the  course  of  the  packaging  shall  be  rechecked  at  regular 
intervals. All printing and overprinting shall be authorized in writing. 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005. 

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8.2.7     The manufacturing environment shall be maintained at the required levels of 

temperature, humidity and cleanliness. 

8.2.8        Authorised  persons  shall  ensure  change-over  into  specific  uniforms  before 

undertaking any manufacturing operations including packaging. 

8.2.9     1[There  shall  be  segregated  secured  areas   for  recalled  or  rejected  material 

and for such material  which are to be reprocessed or recovered.] 

9.          Sanitation in the Manufacturing Premises: 

9.1        The  manufacturing  premises  shall  be  cleaned  and  maintained  in  an  orderly 
manner, so that it is free from accumulated waste, dust, debris and other similar material. A 
validt. cleaning procedure shall be maintained. 

9.2        The manufacturing areas shall not be used for storage of materials, except for 

the material being processed. It shall not be used as a general thoroughfare. 

9.3         A routine sanitation program shall be drawn up and observed, which shall be 

properly recorded and which shall indicate– 

(a)  specific areas to be cleaned and cleaning intervals; 
(b)  cleaning procedure to be followed, including equipment and materials to 

be used for cleaning; and 

(c)  personnel assigned to and responsible for the cleaning operation. 

9.4        The  adequacy  of  the  working  and  in-process  storage  space  shall  permit  the 
orderly and logical positioning of equipment and materials so as to minimize the risk of mix- 
up  between  different  pharmaceutical  products  or 
their  components  to  avoid  cross 
contamination,  and  to  minimise  the  risk  of  omission  or  wrong  application  of  any  of  the 
manufacturing or control steps. 

9.5        Production areas  shall  be  well  lit,  particularly where  visual  on-line  controls 

are carried out. 

10.        Raw Materials: 

10.1      The  licensee  shall  keep  an  inventory of  all  raw  materials  to  be  used  at  any 

stage of manufacture of drugs and maintain records as per Schedule U. 

10.2      All  incoming  materials  shall  be  quarantined  immediately  after  receipt  or 
processing.  All  materials  shall  be  stored  under  appropriate  conditions  and  in  an  orderly 
fashion to permit  batch segregation and stock rotation by  a  ‗first in/first expiry‘ –  ‗first-out‘ 
principle. All incoming materials shall be checked to ensure that the consignment corresponds 
to the order placed. 

10.3      All incoming materials shall be purchased from approved sources under valid 
purchase  vouchers. Wherever possible,  raw  materials  should  be  purchased directly  from  the 
producers. 

10.4      Authorized staff appointed by the licensee in this behalf, which may include 
personnel from  the  Quality  Control  Department, shall  examine each  consignment on  receipt 
and shall check each container for integrity of package and seal. Damaged containers shall be 
identified, recorded and segregated. 

1.  Subs. by G.S.R. 431(E), dt. 30.6.2005. 

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10.5      If  a  single  delivery  of  material  is  made  up  of  different  batches,  each  batch 

shall be considered as a separate batch for sampling, testing and release. 

10.6      Raw materials in the storage area shall be appropriately labelled. Labels shall 

be clearly marked with the following information: 

(a) 

designated  name  of  the  product  and  the  internal  code  reference,  where 
applicable, and analytical reference number; 

(b)     manufacturer‘s name, address and batch number; 

(c) 

the  status  of  the  contents  (e.g.  quarantine,  under  test,  released,  approved, 
rejected); and 

(d)     the manufacturing date, expiry date and re-test date. 

10.7      There shall be adequate separate areas for materials ―under test‖, ―approved‖ 
and ―rejected‖ with arrangements and equipment to allow dry, clean and orderly placement of 
stored   materials   and   products,  wherever  necessary,  under   controlled  temperature  and 
humidity. 

10.8      Containers from which samples have been drawn shall be identified. 

10.9      Only   raw   materials  which   have   been   released   by   the   Quality   Control 
Department and which are within their  shelf-life shall be  used. It  shall be  ensured that shelf 
life of formulation product shall not exceed with that of active raw materials used. 

10.10    It  shall be  ensured that all  the containers of raw  materials are  placed on  the 

raised platforms/racks and not placed directly on the floor. 

11.         Equipment: 

11.1      Equipment shall be located, designed, constructed, adapted and maintained to 
suit  the  operations  to  be  carried  out.  The  layout  and  design  of  the  equipment  shall  aim  to 
minimise the  risk  of  errors  and  permit  effective cleaning and  maintenance in  order to  avoid 
cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality 
of products. Each equipment shall be provided with a logbook, wherever necessary. 

11.2      Balances  and  other  measuring  equipment  of  an  appropriate range,  accuracy 
and precision shall be available in the raw material stores, production and in-process control 
operations and these shall be calibrated and checked on a scheduled basis in accordance with 
Standard Operating Procedures and records maintained. 

11.3      The  parts  of  the  production  equipment  that  come  into  contact  with  the 
product shall not be reactive, additive or adsorptive to an extent that would affect the quality 
of the product. 

11.4      To avoid accidental contamination, wherever possible, non-toxic/edible grade 
lubricants shall be used and the equipment shall be maintained in a way that lubricants do not 
contaminate the products being produced. 

11.5      Defective equipment shall be removed from production and Quality Control 

areas or appropriately labelled. 

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12.        Documentation  and  Records:–  Documentation  is  an  essential  part  of  the  Quality 
assurance system and, as such, shall be related to all aspects of Good Manufacturing Practices 
(GMP).  Its  aim  is  to  define  the  specifications for  all  materials,  method  of  manufacture and 
control,  to  ensure  that  all  personnel  concerned  with  manufacture  know  the  information 
necessary to decide whether or not to release a batch of a drug for sale and to provide an audit 
trail that shall permit investigation of the history of any suspected defective batch. 

12.1      Documents    designed,    prepared,    reviewed    and    controlled,    wherever 

applicable, shall comply with these rules. 

12.2      Documents shall  be  approved, signed  and  dt.  by  appropriate and  authorized 

persons. 

12.3      Documents shall specify the title, nature and purpose. They shall be laid out 
in an orderly fashion and be easy to check. Reproduced documents shall be clear and legible. 
Documents shall be regularly reviewed and kept up to date. Any alteration made in the entry 
of a document shall be signed and dt.. 

12.4      The records shall be made or completed at the time of each operation in such 
a way that all significant activities concerning the manufacture of pharmaceutical products are 
traceable. Records and associated Standard Operating Procedures (SOP) shall be retained for 
at least one year after the expiry date of the finished product. 

12.5      Data may be recorded by electronic data processing systems or other reliable 
means, but Master Formulae and  detailed operating procedures relating to  the  system in  use 
shall  also  be  available  in  a  hard  copy  to  facilitate  checking  of  the  accuracy  of  the  records. 
Wherever  documentation  is  handled  by  electronic  data  processing  methods,  authorized 
persons  shall  enter  or  modify  data  in  the  computer.  There  shall  be  record  of  changes  and 
deletions. Access shall be restricted by ‗passwords‘ or other means and the result of entry of 
critical  data  shall  be  independently  checked.  Batch  records  electronically  stored  shall  be 
protected  by  a  suitable  back-up.  During  the  period  of  retention,  all  relevant  data  shall  be 
readily available. 

13.  Labels and other Printed Materials:– Labels are absolutely necessary for identification 
of  the  drugs  and  their  use.  The  printing  shall  be  done  in  bright  colours  and  in  a  legible 
manner. The label shall carry all the prescribed details about the product. 

13.1      All  containers and  equipment shall  bear  appropriate labels.  Different colour 
coded  labels  shall  be  used  to  indicate  the  status  of  a  product  (for  example  under  test, 
approved, passed, rejected). 

13.2      To  avoid  chance  mix-up  of  printed  packaging  materials,  product  leaflets, 

relating to different products, shall be stored separately. 

13.3      Prior to release, all labels for containers, cartons and boxes and all circulars, 

inserts and leaflets shall be examined by the Quality Control Department of the licensee. 

13.4       Prior  to  packaging  and  labelling  of  a  given  batch  of  a  drug,  it  shall  be 
ensured by the licensee that samples are drawn from the bulk and duly tested, approved and 
released by the quality control personnel. 

13.5      Records   of   receipt   of   all   labelling   and   packaging   materials   shall   be 
maintained  for  each  shipment  received  indicating  receipt,  control  reference  numbers  and 
whether  accepted  or  rejected.  Unused  coded  and  damaged  labels  and  packaging  materials 
shall be destroyed and recorded. 

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13.6      The  label  or  accompanying  document  of  reference  standards  and  reference 
culture shall  indicate concentration, lot  number, potency, date  on  which  containers was  first 
opened and storage conditions, where appropriate. 

14.    Quality  Assurance:–This  is  a  wide-ranging  concept  concerning  all  matters  that 
individually  or  collectively  influence  the  quality  of  a  product.  It  is  the  totality  of  the 
arrangements  made  with  the  object  of  ensuring  that  products  are  of  the  quality  required for 
their intended use. 

14.1        The  system  of  quality  assurance  appropriate  to  the  manufacture  of 

pharmaceutical products shall ensure that: – 

(a) 

(b) 

(c) 

(d) 

(e) 

the pharmaceutical products are designed and developed in a way that takes 
account  of  the  requirements  of  Good  Manufacturing  Practices  (hereinafter 
referred  as  GMP)  and  other  associated  codes  such  as  those  of  Good 
Laboratory  Practices  (hereinafter  referred  as  GLP)  and  Good  Clinical 
Practices (hereinafter referred as GCP); 

adequate  arrangements  are  made  for  manufacture,  supply  and  use  of  the 
correct starting and packaging materials. 

adequate  controls  on  starting  materials,  intermediate  products  and  bulk 
products  and  other  in-process  controls,  calibrations,  and  validations  are 
carried out. 

the  finished  product  is  correctly  processed  and  checked  in  accordance  with 
established procedures; 

the  pharmaceutical  products  are  not  released  for  sale  or  supplied  before 
authorized  persons  have  certified  that  each  production  batch  has  been 
produced  and  controlled  in  accordance  with  the  requirements  of  the  label 
claim and any other provisions relevant to production, control and release of 
pharmaceutical products. 

15.  Self Inspection and Quality audit:– It may be useful to constitute a self-inspection 
team  supplemented with  a  quality  audit  procedure for  assessment of  all  or  part  of  a  system 
with the specific purpose of improving it. 

15.1      To  evaluate  the  manufacturer‘s  compliance  with  GMP  in  all  aspects  of 
production and quality control, concept of self-inspection shall be followed. The manufacturer 
shall constitute a  team of independent, experienced, qualified persons from within or outside 
the  company, who  can  audit  objectively the  implementation of  methodology and  procedures 
evolved.  The  procedure  for  self-inspection  shall  be  documented  indicating  self-inspection 
results, evaluation, conclusions and recommended corrective actions with effective follow up 
program. The recommendations for corrective action shall be adopted. 

15.2      The program shall be designed to detect shortcomings in the implementation 
of  Good  Manufacturing  Practice  and  to  recommend  the  necessary  corrective  actions.  Self- 
inspections shall be performed routinely and on specific occasions, like when product recalls 
or repeated rejections occur or when an inspection by the licensing authorities is announced. 
The  team  responsible  for  self-inspection  shall  consist  of  personnel  who  can  evaluate  the 
implementation  of  Good  Manufacturing  Practice  objectively;  all  recommendations  for 
corrective action shall be implemented. 

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15.3      Written instructions for self-inspection shall be drawn up which shall include 

the following: - 

(a)   Personnel. 
(b)   Premises including personnel facilities. 
(c)   Maintenance of buildings and equipment 
(d)   Storage of starting materials and finished products. 
(e)   Equipment. 
(f)    Production and in-process controls. 
(g)   Quality control. 
(h)   Documentation. 
(i)    Sanitation and hygiene. 
(j)    Validation and revalidation programmes. 
(k)   Calibration of instruments or measurement systems. 
(l)    Recall procedures. 
(m)  Complaints management. 
(n)   Labels control. 
(o)   Results of previous self-inspections and any corrective steps taken. 

            16.       Quality Control System. -  Quality control shall  be  concerned with  sampling, 
specifications, testing, documentation, release procedures which ensure that the necessary and 
relevant tests are actually carried and that the materials are not released for use, nor products 
released  for  sale  or  supply  until  their  quality  has  been  judged  to  be  satisfactory.  It  is  not 
confined to laboratory operations but shall be involved in all decisions concerning the quality 
of  the  product.  It  shall  be  ensured  that  all  quality  control  arrangements  are  effectively  and 
reliably  carried  out.The  department  as  a  whole  shall  have  other  duties  such  as  to  establish, 
evaluate, validate and implement all Quality Control Procedures and methods. 

16.1      Every  manufacturing  establishment  shall  establish  its  own  quality  control 

laboratory manned  by qualified and experienced staff. 

16.2      The  area  of  the  quality  control  laboratory  may  be  divided  into  Chemical, 

Instrumentation, Microbiological and Biological testing. 

16.3      Adequate  area  having  the  required  storage  conditions  shall  be  provided  for 
keeping reference samples. The quality control department shall evaluate, maintain and store 
reference samples. 

16.4      Standard operating procedures shall be available for sampling, inspecting and 
testing  of  raw  materials,  intermediate  bulk  finished  products  and  packing  materials  and, 
wherever necessary, for monitoring environmental conditions. 

16.5      There  shall  be  authorized  and  dt.  specifications  for  all  materials,  products, 
reagents  and  solvents  including  test  of  identity,  content,  purity  and  quality.  These  shall 
include specifications for water, solvents and reagents used in analysis. 

16.6      No batch of the product shall be released for sale or supply until it has been 
certified  by  the  authorized  person(s)  that  it  is  in  accordance  with  the  requirements  of  the 
standards laid down. 

16.7      Reference/retained  samples  from  each  batch  of  the  products  manufactured 
shall  be  maintained  in  quantity  which  is  at  least  twice  the  quantity  of  the  drug  required  to 
conduct all  the tests, except sterility and pyrogen/Bacterial Endotoxin Test performed on the 
active material  and the product manufactured. The retained product shall be  kept in its  final 
pack or simulated pack for a period of three months after the date of expiry. 

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16.8      Assessment  of  records  pertaining  to   finished  products  shall  include  all 
relevant  factors,  including  the  production  conditions,  the  results  of  in-process  testing,  the 
manufacturing  (including  packaging)  documentation,  compliance  with  the  specification  for 
the finished product, and an examination of the finished pack. Assessment records should be 
signed  by  the  in-charge  of  production  and  countersigned  by  the  authorised  quality  control 
personnel before a product is released for sale or distribution. 

16.9      Quality control personnel shall have access to production areas for sampling 

and investigation, as appropriate. 

16.10    The quality control department shall conduct stability studies of the products 
to ensure and assign their shell life at the prescribed conditions of storage. All records of such 
studies shall be maintained. 

16.11    The  in-charge of  Quality Assurance  shall  investigate all  product complaints 

and records thereof shall be maintained. 

16.12    All instruments shall be calibrated and testing procedures validt. before these 
are  adopted  for  routine  testing.  Periodical  calibration  of  instrument  and  validation  of 
procedures shall be carried out. 

16.13    Each   specification  for   raw   materials,  intermediates,  final   products,  and 
packing  materials  shall  be  approved  and  maintained  by  the  Quality  Control  Department. 
Periodic revisions of the specifications shall be carried out whenever changes are necessary. 

16.14    Pharmacopoeia,  reference  standards,  working  standards,  references,  spectra, 
other  reference  materials  and  technical  books,  as  required,  shall  be  available  in  the  Quality 
Control Laboratory of the licensee. 

17.        Specification 

17.1     For raw materials and packaging materials. -  They shall include- 

(a)  the designated name and internal code reference; 
(b)  reference, if any, to a pharmacopoeial monograph; 
(c)  qualitative and quantitative requirements with acceptance limits; 
(d)  name and address of manufacturer or supplier and original manufacturer of the 

material; 

(e)  specimen of printed material; 
(f)  directions for sampling and testing or reference to procedures; 
(g)  storage conditions; and 
(h) maximum period of storage before re-testing. 

17.2      For product containers and closures:– 

17.2.1  All  containers  and  closures  intended  for  use  shall  comply  with  the 
pharmacopoeial  requirements.  Suitable  validt.  test  methods,  sample  sizes,  specifications, 
cleaning procedure and sterilization procedure, wherever indicated, shall  be  strictly followed 
to  ensure  that  these  are  not  reactive,  additive,  absorptive,  or  leach  to  an  extent  that 
significantly affects the quality or purity of the drug. No second hand or used containers and 
closures shall be used. 

17.2.2   Whenever  bottles  are  being  used,  the  written  schedule  of  cleaning  shall  be 
laid down and followed. Where bottles are not dried after washing, they should be rinsed with 
de-ionised water or distilled water, as the case may be. 

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17.3.        For  in-process  and  bulk  products.  -  Specifications  for  in-process  material, 

intermediate and bulk products shall be available. The specifications should be authenticated. 

17.4      For  finished  products.  -    Appropriate  specifications  for  finished  products 

shall include: - 

the formula or a reference to the formula and the pharmacopoeial reference; 
 directions for sampling and testing or a reference to procedures; 

(a)     the designated name of the product and the code reference; 
(b) 
(c) 
(d)     a description of the dosage form and package details; 
(e) 

the  qualitative and  quantitative requirements, with the  acceptance limits  for 
release; 

(f)     the storage conditions and precautions, where applicable, and 
(g)     the shelf-life. 

17.5      For preparation of containers and closures. - The requirements mentioned in 
the Schedule do not include requirements of machinery, equipments and premises required for 
preparation of containers and closures for different dosage forms and categories of drugs. The 
suitability and adequacy of the machinery, equipment and premises shall be examined taking 
into consideration the requirements of each licensee in this respect. 

18.     Master Formula Records: 

There  shall  be  Master  Formula  records  relating  to  all  manufacturing procedures  for 
each product and batch size to be manufactured. These shall be prepared and endorsed by the 
competent  technical  staff  i.e.  head  of  production  and  quality  control.  The  Master  Formula 
shall include: - 

(a) 

(b) 

the   name   of   the   product  together  with   product  reference  code   relating  to   its 
specifications; 
the  patent  or  proprietary  name  of  the  product  along  with  the  generic  name,  a 
description of the dosage form, strength, composition of the product and batch size; 

(c)  name, quantity, and reference number of all the starting materials to be used. Mention 
shall be made of any substance that may ‗disappear‘ in the course of processing. 
(d)  a  statement  of  the  expected  final  yield  with  the  acceptable  limits,  and  of  relevant 

intermediate yields, where applicable. 

(e)     a statement of the processing location and the principal equipment to be used. 
(f) 

the  methods,  or  reference  to  the  methods,  to  be  used  for  preparing  the  critical 
equipments including cleaning, assembling, calibrating, sterilizing; 
(g)    detailed stepwise processing instructions and the time taken for each step; 
(h)    the instructions for in-process control with their limits; 
(i) 

the  requirements  for  storage  conditions  of  the  products,  including  the  container, 
labelling and special storage conditions where applicable; 

(j)     any special precautions to be observed; 
(k)    packing details and specimen labels. 

19.     Packing Records: 

There shall be authorised packaging instructions for each product, pack size and type. 

These shall include or have a reference to the following: - 

(a)     name of the product; 

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(b)    description of the dosage form, strength and composition; 
(c) 

the  pack  size  expressed  in  terms  of  the  number  of  doses,  weight  or  volume  of  the 
product in the final container; 

(d)  complete  list  of  all  the  packaging  materials  required  for  a  standard  batch  size, 
including quantities, sizes and types with the code or reference number relating to the 
specifications of each packaging material.; 
reproduction  of  the  relevant  printed  packaging  materials  and  specimens   indicating 
where batch number and expiry date of the product have been applied; 
special  precautions  to  be  observed,  including  a  careful  examination  of  the  area  and 
equipment in order to ascertain the line clearance before the operations begin. 

(e) 

(f) 

(g)  description   of   the   packaging   operation,   including   any   significant   subsidiary 

operations and equipment to be used; 

(h)    details of in-process controls with instructions for sampling and acceptance; and 
(i) 

upon  completion  of  the  packing  and  labelling  operation,  a  reconciliation  shall  be 
made  between  number  of  labelling  and  packaging  units  issued,  number  of  units 
labelled,  packed  and  excess  returned  or  destroyed.  Any  significant  or  unusual 
discrepancy  in  the  numbers  shall  be  carefully  investigated before  releasing  the  final 
batch. 

20.     Batch Packaging Records: 

20.1      A   batch   packaging  record   shall   be   kept   for   each   batch   or   part   batch 
processed.  It  shall  be  based  on  the  relevant  parts  of  the  packaging  instructions,  and  the 
method of preparation of such records shall be designed to avoid transcription errors. 

20.2      Before  any  packaging  operation  begins,  check  shall  be  made  and  recorded 
that  the  equipment  and  the  work  stations  are  clear  of  the  previous  products,  documents  or 
materials not required for the planned packaging operations, and that the  equipment is  clean 
and suitable for use. 

21.    Batch Processing Records 

21.1      There shall be Batch Processing Record for each product. It shall be based on 
the  relevant  parts  of  the  currently  approved  Master  Formula.  The  method  of  preparation  of 
such records included in the Master Formula shall be designed to avoid transcription errors. 

21.2      Before  any  processing  begins,  check  shall  be  performed  and  recorded  to 
ensure  that  the  equipment  and  work  station  are  clear  of  previous  products,  documents  or 
materials  not  required  for  the  planned  process  are  removed  and  the  equipment is  clean  and 
suitable for use. 

21.3      During  processing,  the  following  information  shall  be  recorded  at  the  time 
each action is  taken and the record shall be dt. and signed by  the person responsible for the 
processing operations: - 

(a)     the name of the product, 
(b)    the number of the batch being manufactured, 
(c)  dates   and   time   of   commencement,   of   significant   intermediate   stages   and   of 

(d) 

(e) 

completion of production, 
initials   of   the   operator  of   different   significant  steps   of   production  and   where 
appropriate, of the person who checked each of these operations, 
the  batch  number and/or  analytical  control  number  as  well  as  the  quantities of  each 
starting material actually weighed, 

(f)     any relevant processing operation or event and major equipment used, 
(g)  a record of the in-process controls and the initials of the person(s) carrying them out, 

and the results obtained, 

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(h)    the  amount  of  product  obtained  after  different  and  critical  stages  of  manufacture 

(i) 

(j) 

(yield), 
comments  or  explanations for  significant  deviations from  the  expected  yield  limits 
shall be given, 
notes  on  special  problems  including  details,  with  signed  authorization,  for  any 
deviation from the Master Formula, 

(k)  addition  of  any  recovered  or  reprocessed  material  with  reference  to  recovery  or 

reprocessing stages. 

22.      Standard Operating Procedures (SOPs) and Records, regarding: 

22.1        Receipt of materials: 

22.1.1     There  shall  be  written  Standard  Operating  Procedures  and  records  for  the 
receipt of each delivery of raw, primary and printed packaging material. 

22.1.2     The records of the receipts shall include; 

(a)     the name of the material on the delivery note and the number of containers; 
(b)     the date of receipt; 
(c)     the manufacturer‘s and/ or supplier‘s name; 
(d)     the manufacturer‘s batch or reference number; 
(e) 

the  total  quantity,  and  number  of  containers,  quantity  in  each  container 
received; 

(f)      the control reference number assigned after receipt; 
(g)     any other relevant comment or information. 

22.1.3 

22.1.4 

There  shall  be  written  standard  operating  procedures  for  the  internal  labelling, 
quarantine  and  storage  of  starting  materials,  packaging  materials  and  other 
materials, as appropriate. 

There shall be Standard Operating Procedures available for each instrument and 
equipment and these shall be placed in close proximity to the related instrument 
and equipment. 

22.2             Sampling: 

22.2.1 

There  shall  be   written  Standard  Operating  Procedures  for  sampling  which 
include the person(s) authorized to take the samples. 

22.2.2          The sampling instructions shall include: 

(a)     the method of sampling and the sampling plan, 
(b)     the equipment to be used, 
(c) 

any precautions to be observed to avoid contamination of the material or 
any deterioration in its quality, 
(d)     the quantity of samples to be taken, 
(e)     instructions for any required sub-division or pooling of the samples, 
(f)      the types of sample container to be used, 
(g) 

any specific precautions to be observed, especially in regard to sampling of 
sterile and hazardous materials. 

22.3.            Batch Numbering: 

22.3.1          There shall be Standard Operating Procedures describing the details of the batch 

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(lot)  numbering  set  up  with  the  objective  of  ensuring  that  each  batch  of 
intermediate, bulk or finished product is identified with a specific batch number. 

22.3.2 

Batch  numbering  Standard  Operating  Procedures  applied  to  a  processing  stage 
and to the respective packaging stage shall be same  or traceable to  demonstrate 
that they belong to one homogenous mix. 

22.3.3          Batch  number  allocation  shall  be  immediately  recorded  in  a  logbook  or  by 
electronic  data  processing  system.  The  record  shall  include  date  of  allocation, 
product identity and size of batch. 

22.4.        Testing: 

22.4.1 

There shall be  written procedures for testing materials and  products at  different 
stages  of  manufacture,  describing  the  methods  and  equipment  to  be  used.  The 
tests performed shall be recorded. 

22.5             Records of analysis: 

22.5.1          The records shall include the following data: 

(a)         name of the material or product and the dosage form, 
(b)        batch number and, where appropriate the manufacturer and/ or supplier, 
(c)         references  to the relevant specifications and testing procedures, 
(d) 

test   results,  including  observations  and   calculations,  and   reference  to   any 
specifications (limits), 

(e)         dates of testing, 
(f)         initials of the persons who performed the testing, 
(g)        initials of the persons who verified the testing and the detailed calculations, 
(h)        a statement of release or rejection, and 
(i)         signature and date of the designated responsible person. 

22.5.2 

There shall be written standard operating procedures and the associated records of 
actions taken for: 

(a)     equipment  assembly and validation 
(b)     analytical apparatus and calibration, 
(c)     maintenance, cleaning and sanitation; 
(d)     personnel matters including qualification, training, clothing, hygiene; 
(e)     environmental monitoring; 
(f)      pest control; 
(g)     complaints; 
(h)     recalls made; and 
(i)      returns received. 

23.     Reference Samples:- 

23.1 

Each lot of every active ingredient, in a quantity sufficient to carry out all the tests, 
except sterility and pyrogens/Bacterial  Endotoxin Test, shall be retained for a 
period of 3 months after the date of expiry of the last batch produced from that 
active ingredient. 

23.2. 

Samples  of   finished  formulations  shall  be   stored  in   the   same  or   simulated 
containers in which the drug has been actually marketed. 

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24.   Reprocessing and Recoveries: 

24.1.  Where    reprocessing  is    necessary,    written    procedures    shall    be  
established    and  approved  by  the  Quality  Assurance  Department  that 
the  conditions  and  limitations  of  repeating  chemical 
shall  specify 
reactions. Such reprocessing shall be validt.. 

24.2. 

If  the  product  batch  has  to  be  reprocessed,  the  procedure  shall  be 
authorized  and  recorded.  An  investigation  shall  be  carried  out  into  the 
causes  necessitating  re-  processing  and  appropriate  corrective  measures 
shall  be  taken  for  prevention  of  recurrence. Re-processed batch  shall  be 
subjected to stability evaluation. 

24.3. 

Recovery  of  the  product  residue  may  be  carried  out,  if  permitted,  in  the 
master  production  and  control  records  by  incorporating  it  in  subsequent 
batches of the product. 

25.        Distribution records: 

25.1. 

Prior to distribution or dispatch of given batch of a drug, it shall be ensured 
that the batch has  been duly  tested, approved and  released by  the  quality 
control  personnel.  Pre-dispatch  inspection  shall  be  performed  on  each 
consignment on a random basis to  ensure  that  only  the  correct  goods are 
dispatched.  Detailed  instructions  for  warehousing  and  stocking  of  Large 
Volume  Parenterals,  if  stocked,  shall  be  in  existence  and  shall  be 
complied  with  after  the  batch  is  released  for  distribution.  Periodic  audits 
of  warehousing practices followed  at  distribution centers  shall  be carried 
out  and  records  thereof  shall  be  maintained.  Standard  Operating 
Procedures shall be developed for warehousing of products. 

25.2. 

Records  for  distribution  shall  be  maintained  in  a  manner  1[so  as]  to 
facilitate prompt and complete recall of the batch, if and when necessary. 

26.       Validation  and process validation: 

26.1. 

26.2. 

26.3. 

26.4. 

26.5. 

Validation  studies  shall  be  an  essential  part  of  Good  Manufacturing 
Practices  and  shall  be  conducted  as  per  the  pre-defined  protocols. These 
shall include validation of processing, testing and cleaning procedures. 
A  written  report  summarizing  recorded  results  and  conclusions  shall  be 
prepared, documented and maintained. 

Processes  and  procedures  shall  be  established  on  the  basis  of  validation 
study and undergo periodic revalidation to ensure that they remain capable 
of achieving the intended 
validt.,    prospectively    or retrospectively. 

results.    Critical    processes    shall    be    

When any new Master Formula or method of preparation is adopted, steps 
shall  be  taken  to  demonstrate  its  suitability  for  routine  processing.  The 
defined process, using  the  materials  and  equipment  specified  shall  be  
demonstrated  to  yield  a product consistently of the required quality. 

Significant    changes    to    the    manufacturing    process,    including    any  
change    in  equipment or materials that may affect product quality and/or 
the reproducibility of the process, shall be validt.. 

1.  Subs. by G.S.R. 431(E), dt. 30.6.2005. for ― such that finished batch of a drug can be traced to the retail level‖.  

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27.        Product Recalls: 

27.1             A  prompt  and  effective  product  recall  system  of  defective  products  shall  be 
devised  for  timely  information  of  all  concerned  stockists,  wholesalers,  suppliers, 
upto the retail level within the shortest period. The licensee may make use of both 
print and electronic media in this regard. 

27.2. 

27.3 

27.4 

27.5 

27.6 

There shall be an established written procedure in the form of Standard Operating 
Procedure  for  effective  recall  of  products  distributed  by  the  licensee.  Recall 
operations shall be capable of being initiated promptly so as to effectively reach at 
the level of each distribution channel. 

The distribution records shall be readily made available to  the persons designated 
for recalls. 

The  designated  person  shall  record  a  final  report  issued,  including  reconciliation 
between the delivered and the recovered quantities of the products. 

The  effectiveness of  the  arrangements for  recalls  shall  be  evaluated  from  time  to 
time. 

The  recalled  products  shall  be  stored  separately  in  a  secured  segregated  area 
pending final decision on them. 

28.     Complaints and Adverse Reactions:. 

28.1 

28.2. 

28.3 

All complaints thereof concerning product quality shall be carefully reviewed and 
recorded  according    to     written    procedures.    Each    complaint    shall    be 
investigated/evaluated by the designated personnel of  the company and records of 
investigation and remedial action taken thereof shall be maintained. 

Reports of serious adverse drug reactions resulting from the use of a drug along 
with comments and documents shall be forthwith reported to the concerned 
licensing authority. 

There  shall  be  written  procedures  describing  the  action  to  be  taken,  recall  to  be 
made of the defective product. 

29. Site Master File. –The licensee shall prepare a succinct document in the form of 
‗Site  Master  File‘  containing  specific  and  factual  Good  Manufacturing  Practices  about  the 
production  and/or  control  of  pharmaceutical  manufacturing  preparations  carried  out  at  the 
licensed premises. It shall contain the following: - 

29.1        General information: 

(a)         brief information of the firm; 
(b)         pharmaceutical manufacturing activities as permitted by the licensing authority; 
(c)         other manufacturing activities, if any, carried out on the premises; 
(d) 

type of products licensed for manufacture with flow charts mentioning procedure 
and process flow; 
number  of  employees  engaged  in  the  production,  quality  control,  storage  and 
distribution; 
use  of  outside  scientific,  analytical  or  other  technical  assistance  in  relation  to 
manufacture and analysis; 

(e) 

(f) 

(g)         short description of the Quality Management System of the firm; and 

(h)         products details registered with foreign countries. 

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29.2             Personnel: 

(a) 

organisational  chart  showing  the  arrangement  for  quality  assurance  including 
production and quality control; 

(b)         qualification, experience and responsibilities of key personnel; 

(c) 

outline for arrangements for basic and in-service training and how the records are 
maintained; 

(d)         health requirements for personnel engaged in production; and 
(e)         personnel hygiene requirements, including clothing. 

29.3             Premises: 

(a)         simple plan or description of manufacturing areas drawn to scale; 
(b)         nature of construction and fixtures/fittings; 
(c) 

brief  description  of  ventilation  systems.  More  details  should  be  given  for  critical 
areas  with  potential  risk  of  airborne  contamination  (schematic     drawing  of 
systems). Classification of the rooms used for  the  manufacture of  sterile products 
should be mentioned; 
special  areas  for  the  handling  of  the  highly  toxic,  hazardous  and  sensitizing 
materials; 
brief  description  of  water  system  (schematic  drawings  of  systems),  including 
sanitation; 
description  of  planned  preventive  maintenance  programs  for  premises  and  of  the 
recording system. 

(d) 

(e) 

(f) 

29.4             Equipment: 

(a)          brief  description  of  major  equipment  used  in  production  and  Quality  Control 

(b) 

(c) 

29.5 

(a) 

Laboratories (a list of equipment required); 
description of planned preventive maintenance programs for equipment and of the 
recording system; and 
qualification and calibration including the recording systems and arrangements for 
computerized systems validation. 
Sanitation: 

availability  of  written  specifications  and  procedures  for  cleaning  manufacturing 
areas and equipment. 

29.6             Documentation. - 

(a)           arrangements for the preparation, revision and distribution of; 
(b)           necessary documentation for the manufacture; 
(c)           any other documentation related to product quality that is not mentioned elsewhere 

(e.g. microbiological controls about air and water). 

29.7             Production:. 

(a) 

brief  description  of  production  operations  using,  wherever  possible,  flow  sheets 
and charts specifying important parameters; 

(b)         arrangements for the handling of starting materials, packaging materials, bulk and 

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finished products, including sampling, quarantine, release and storage; 

(c)         arrangements for the handling of rejected materials and products; 
(d)         brief description of general policy for process validation. 

29.8             Quality Control: 

(a)         description of the quality control system and of the activities of the Quality Control 

Department. Procedures for the release of the finished products. 

29.9             Loan licence manufacture and licensee: 

(a) 

description of  the  way  in  which  compliance of  Good  Manufacturing Practices by 
the loan licensee shall be assessed. 

29.10           Distribution, complaints and product recall: 

(a)        arrangements and recording system for distribution; 
(b)        arrangements for the handling of complaints and product recalls. 

29.11           Self inspection. - 

(a) 

short  description  of  the  self-inspection  system  indicating  whether  an  outside, 
independent  and  experienced  external  expert  was  involved  in  evaluating  the 
manufacturer‘s  compliance  with  Good  manufacturing  Practices  in  all  aspects  of 
production. 

29.12           Export of drugs. - 

(a)         products exported to different countries; 
(b)         complaints and product recall, if any. 

PART  IA 

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, 
PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE 
VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS. 

Note. - The general requirements as given in Part 1 of this Schedule relating to Requirements 
of  Good  Manufacturing  Practices  for  Premises  and  Materials  for  pharmaceutical  products 
shall be  complied with, mutatis mutandis, for the manufacture of  sterile products, Parenteral 
preparations  (Small  Volume  Injectables  and  Large  Volume  Parenterals)  and  Sterile 
Ophthalmic  Preparations.  In  addition  to 
these  requirements,  the  following  specific 
requirements shall also be followed, namely: - 

1.          General : 

Sterile  products,  being  very  critical  and  sensitive  in  nature,  a  very  high  degree  of 
precautions, prevention and  preparations are  needed.  Dampness, dirt  and  darkness  are  to  be 
avoided  to  ensure  aseptic  conditions  in  all  areas.  There  shall  be  strict  compliance  in  the 
prescribed standards especially in the matter of supply of water, air, active materials and in 
the maintenance of hygienic environment. 

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2.          Buildings  and Civil Works: 

2.1        The buildings shall be built on proper foundation with standardized materials 

to avoid cracks in critical areas like aseptic solution preparation, filling and sealing rooms. 

2.2        Location  of  services  like  water,  steam,  gases  etc.  shall  be  such  that  their 
servicing or repair shall not  pose any  threat to  the integrity of  the facility. Water lines shall 
not pose any threat of leakage to aseptic area. 

2.3.       The  manufacturing  areas  shall  be  clearly  separated  into  support  areas  (e.g. 
washing  and  component  preparation  areas,  storage  areas  etc.),  preparation  areas  (e.g.  bulk 
manufacturing  area,   non-aseptic  blending  areas   etc.)   change   areas   and   aseptic   areas. 
Operations like  removal  of  outer  cardboard  wrappings  of  primary  packaging  materials  shall 
be  done  in  the  de-cartoning  areas  which  are  segregated  from  the  washing  areas.  Wooden 
pallets, fiber board drums, cardboard and other particle shedding materials shall not be taken 
inside the preparation areas. 

2.4.       In aseptic areas – 

(a)  walls, floors and ceiling should be impervious, non-shedding, non-flaking and 
non-cracking. Flooring should  be  unbroken and  provided  with  a  cove  both  at 
the junction between the wall and the floor as well as the wall and the ceiling. 

(b)  walls  shall  be  flat,  and  ledges  and  recesses  shall  be  avoided.  Wherever  other 
surfaces  join  the  wall  (e,g,  sterilizers,  electric  sockets,  gas  points  etc.)  these 
shall flush the walls. Walls shall be provided with a cove at the joint between 
the ceiling and the floor; 

(c) 

ceiling shall be solid and joints shall be sealed. Light-fittings and air-grills shall 
flush  with  the  walls  and  not  hanging  from  the  ceiling,  so  as  to  prevent 
contamination; 

(d)     there shall be no sinks and drains in Grade A and Grade B areas; 

(e) 

doors  shall  be  made  of  non-shedding material.  These  may  be  made  preferably 
of  Aluminium or  Steel  material. Wooden  doors  shall  not  be  used.  Doors  shall 
open towards the higher-pressure area so that they close automatically due to air 
pressure; 

(f)  Windows shall be made of similar material as the doors, preferably with double 
panel and shall be flush with the walls. If fire escapes are to be provided, these 
shall be suitably fastened to the walls without any gaps; 

(g)  The  furniture  used  shall  be  smooth,  washable  and  made  of  stainless  steel  or 

any other appropriate material other than wood. 

2.5.       The  manufacturing  and  support  areas  shall  have  the  same  quality  of  civil 
structure  described  above  for  aseptic  areas,  except  the  environmental  standards  which  may 
vary in the critical areas. 

2.6        Change rooms with entrance in the form of air-locks shall be provided before 
entry  into  the sterile product manufacturing areas and  then to  the  aseptic area.  Separate exit 
space from the aseptic areas is advisable. Change rooms to the aseptic areas shall be clearly 
demarcated  into  ‗black‘.  ‗grey‘,  and  ‗white  rooms‘  with  different  levels  of  activity  and  air 
cleanliness. The ‗black‘ change room shall be provided with a hand-washing sink. The sink 

448 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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and  its  drain  in  the  un-classified  (first)  change  rooms  may  be  kept  clean  all  the  time.  The  specially 
designed  drain  shall  be  periodically  monitored  to  avoid  presence  of  pathogenic  micro-organisms. 
Change  room  doors  shall  not  be  opened  simultaneously.  An  appropriate  inter-locking  system  and  a 
visual and/or audible warning system may be installed to prevent the opening of more than one door at a 
time. 

2.7.              For  communication  between  aseptic  areas  and  non-aseptic  areas,  intercom 

telephones or speak-phones shall be used. These shall be minimum in number. 

2.8        Material transfer between aseptic areas and outside shall be through suitable airlocks or 

pass-boxes. Doors of such airlocks and pass-boxes shall have suitable interlocking arrangements. 

2.9.       Personal welfare areas like  rest rooms, tea  room, canteen and  toilets shall be outside 

and separated from the sterile product manufacturing area. 

2.10      Animal houses shall be away from the sterile product manufacturing area and shall not 

share a common entrance or air handling system with the manufacturing area. 

3.          Air Handling System (Central Air-Conditioning): 

3.1                Air  Handling  Units  for  sterile  product  manufacturing  areas  shall  be  different  from  
those    for    other    areas.    Critical    areas,    such    as    the    aseptic    filling    area,    sterilized  components 
unloading area and change room conforming to Grades B, C and D respectively shall have separate air 
handling units. The filter configuration in the air handling system shall be  suitably  designed  to  achieve 
the  Grade  of  air  as  given  in  Table1.   Typical  operational activities for clean areas are highlighted in 
Table II and Table III. 

3.2        For products which are filled aseptically, the filling room shall meet Grade B conditions 
at  rest  unmanned.  This  condition  shall  also  be  obtained  within  a  period  of  about  30  minutes  of  the 
personnel leaving the room after completion of operations. 

3.3.              The  filling  operations  shall  take  place  under  Grade  A  conditions  which  shall  be 
demonstrated under working of simulated conditions which shall be achieved by providing laminar air 
flow work stations with suitable HEPA filters or isolator technology. 

3.4.       For  products,  which  are  terminally  sterilized,  the  filling  room  shall  meet Grade C 
conditions  at  rest.  This  condition  shall  be  obtainable  within  a  period  of  about  30  minutes  of  the 
personnel leaving the room after completion of operations. 

3.5.       Manufacturing   and   component   preparation   areas   shall   meet   Grade   C 

conditions. 

3.6.       After  completion  of  preparation,  washed  components  and  vessels  shall  be protected 

with 1[Grade D background and should be handled in such a way that they are not recontaminated]. 

3.7.       The  minimum  air  changes  for  Grade  B  and  Grade  C  areas  shall  not  be  less than 20 
air changes per hour in a  room with good air flow pattern and appropriate HEPA filters. For Grade A 
laminar air flow work stations, the air flow rate shall be 0.3 meter per second ± 20% (for vertical flows) 
and 0.45 meter per second  ± 20% (for horizontal flows). 

3.8.              Differential pressure  between  areas  of  different  environmental standards  shall  be  at 
least  15  Pascal  (0.06  inches  or  1.5  mm  water  gauge).  Suitable  manometers  or  gauges  shall  be 
installed to measure and verify pressure differential. 

1. Subs. by G.S.R. 431(E), dt. 30.6.2005 

449 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.9        The  final  change  room  shall  have  the  same  class  of  air  as  specified for  the 
aseptic area. The pressure differentials in  the change rooms shall be in the descending order 
from ‗white‘ to ‗black‘. 

Drugs and Cosmetics Rules 1945 

3.10      Unless there are  product specific requirements, temperature and  humidity in 
the  aseptic  areas  1[shall  be  27  ±  2  degree  centigrade  and  relative  humidity  55%    ±  5, 
respectively]. 

1[TABLE I 

AIR BORNE PARTICULATE CLASSIFICATION FOR MANUFACTURE 
OF STERILE PRODUCTS 

Grade 

Maximum number of permitted particles per cubic metre  equal t to or above 

A 
B (a) 
C (a) 
D (a) 

Notes : 

(a) 

At rest (b) 

In operation (a) 

0.5µm 
3500 
3500 
350,000 
35,00,000 

5µm 
0 
0 
2,000 
20,000 

0.5µm 
3500 
3,50,000 
35,00,000 
Not defined  (c) 

5µm 
0 
2,000 
20,000 

Not defined (c)] 

In  order  to  reach  the  B,  C  and  D  air  grades,  the  number  of  air  changes  shall  be 
related  to  the  size  of  the  room  and  the  equipment  and  personnel  present  in  the 
room.  The  air system shall be provided with the appropriate filters such as HEPA 
for Grades A, B and C. The maximum permitted number of particles in the ―at rest‖ 
condition shall approximately be as under: 

1[Grade A and B corresponds with class 100 or M 3.5 or class 5]; Grade C with Class 

10,000 or M 5.5 or ISO Class 7; Grade D with Class 1,00,000 or M 6.5 or ISO Class 8. 

(b)  The requirement and limit for the area shall depend on the nature of the operation carried 

out. 

(c)     Type of operations to be carried out in the various grades are given in Table II and Table 

III as under: 

TABLE  II 

TYPES OF OPERATIONS TO BE CARRIED OUT IN THE VARIOUS 
GRADES FOR ASEPTIC PREPARATIONS 

Grade 
A 
B 
C 
D 

Types of operations for aseptic preparations 
Aseptic preparation and filling 
Background room conditions for activities requiring Grade A 
Preparation of solution to be filtered 
Handling of components after washing 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005. 

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TABLE III 

TYPES OF OPERATIONS TO BE CARRIED OUT IN THE VARIOUS 
GRADES FOR TERMINALLY STERILIZED PRODUCTS 

Grade 
A 
C 

D 

Types of operations for terminally sterilized products. 
Filling of products, which are usually at risk. 
Placement of filling and sealing machines, preparation of solutions when 1[unusually at 
risk]. Filling of product when unusually at risk. 
Moulding, blowing (pre-forming) operations of plastic containers, preparations of 
solutions and components for subsequent filling. 

4.         Environmental Monitoring: 

4.1      All environmental parameters listed under para 3.1 to 3.10 shall be verified and 
established  at  the  time  of  installation  and  thereafter  monitored  at  periodic  intervals.  The 
recommended  frequencies of periodic monitoring shall be as follows :- 

(a)     Particulate monitoring in air – 6 Monthly. 
(b)     HEPA filter integrity testing (smoke testing) – Yearly 
(c)     Air change rates – 6 Monthly. 
(d)     Air pressure differentials – Daily. 
(e)     Temperature and humidity – Daily 
(f)  Microbiological  monitoring  by  settle  plates  and/or  swabs  in  aseptic  areas– 

Daily, and at decreased frequency in other areas. 

`Note:        The  above  frequencies  of  monitoring  shall  be  changed  as  per  the 

requirements and load in individual cases. 

4.2        There    shall    be    a    written    environmental    monitoring    program    and 
microbiological   results   shall   be   recorded.   Recommended   limits   for   microbiological 
monitoring of clean areas ―in operation‖ are as given in the table below: 

RECOMMENDED LIMITS FOR MICROBIOLOGICAL MONITORING OF CLEAN 
AREAS ― IN OPERATION‖ 

TABLE 

Grade 

Air sample 
Cfu/m2

Settle plates (dia. 90mm. 
Cfu/2 hrs. 

< 1 
10 
100 
500 

A 
B 
C 
D 

Notes: 

< 1 
5 
50 
100 

Contact plates 
(dia. 55mm) cfu per 
plate 
< 1 
5 
25 
50 

Glove points 
(five fingers) cfu 
per glove 
< 1 
5 
-- 
-- 

(a)     These are average values. 
(b) 

Individual settle plates may be exposed for not less than two hours in Grade B, 
C and D areas and for not less than thirty minutes in Grade A area. 

1. Subs. by G.S.R. 431(E), dt. 30.6.2005. 

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4.3        Appropriate action shall be taken immediately if the result of particulate and 
microbiological  monitoring  indicates  that  the  counts  exceed  the   limits.  The  Standard 
Operating Procedures shall contain corrective action. After major engineering modification to 
the  HVAC  system  of  any  area,  all  monitoring  shall  be  re-performed  before  production 
commences. 

5.         Garments. 

5.1        This section covers garments required for use by  personnel working only in 

aseptic area.  Outdoor clothing shall not be brought into the sterile areas. 

5,2        The  garments  shall  be  made  of  non-shedding  and  tight  weave  material. 
Cotton garments shall not be used. The garments shall shed virtually no fibres or particulate 
matter. 

5.3        The  clothing  and  its  quality  shall  be  adopted  to  the  process  and  the  work 
place and worn in such a way as to protect the product from contamination. Garments shall be 
single piece with fastenings at cuffs, neck and at legs to ensure close fit. Trouser legs shall be 
tucked inside the cover boots. Suitable design of garments shall either include a hood (head- 
cover) or a separate hood which can be tucked inside the over-all.   Pockets, pleats and belts 
shall  be  avoided  in  garments.  Zips  (if  any)  shall  be  of  plastic  material.  Garments  with 
damaged zips shall not be used. 

5.4.       Only  clean,  sterilized  and  protective  garments  shall  be  used  at  each  work 
session  where  aseptic  filtration and  filling  operations are  undertaken and  at  each  work  shift 
for  products intended to  be  sterilized, post-filling. The  mask  and  gloves  shall be  changed at 
every work session in both instances. 

5.5        Gloves shall be made of latex or other suitable plastic materials and shall be 
powder-free. These  shall  be  long  enough  to  cover  wrists  completely  and  allow  the  over-all 
cuff to be tucked in. 

5.6.       The footwear shall be of suitable plastic or rubber material and shall be daily 

cleaned with a bactericide. 

5.7.       Safety goggles or numbered glasses with side extension shall be used inside 

aseptic areas. These shall be sanitized by a suitable method. 

5.8.       Garment  changing procedures shall  be  documented and  operators trained  in 
this respect. A full size mirror shall be provided in the final change room for the operator to 
verify  that  he  is  appropriately  attired  in  the  garments.  Periodic  inspection  of  the  garments 
shall be done by responsible staff. 

6.          Sanitation: 

6.1.       There  shall  be  written  procedures  for  the  sanitation  of  sterile  processing 
facilities.  Employees carrying out  sanitation of  aseptic areas shall  be  trained specifically for 
this purpose. 

6.2.       Different sanitizing agent shall be used in rotation and the concentrations of 
the same shall be as per the recommendations of the manufacturer. Records of rotational use 
of sanitizing agents shall be maintained. 

6.3.       Distilled  water  freshly  collected  directly  from  the  distilled  water  plant  or 
water  maintained  above  70  degree  centigrade  from  the  re-circulation  loop  shall  be  used  for 
dilution of disinfectants. Alternatively, distilled  water sterilized by  autoclaving or membrane 
filtration shall be used. The dilution shall be carried out in the ‗white‘ change room. 

452 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

6.4.       1[Where alcohol or isopropyl alcohol is used for dilution of disinfectants for 
use as hand sprays, the preparation of the same shall be done in the bulk preparation area in 
grade C.] 

6.5.       Diluted    disinfectants    shall    bear    the    label    ‗use    before‘,    based    on 
microbiological establishment of the germicidal properties. The solutions shall be adequately 
labelled and documents maintained. 

6.6.       Formaldehyde  or  any  other  equally  effective  fumigant  is  recommended  for 
the  fumigation  of  aseptic  areas  or  after  major  civil  modifications.  There  shall  be  Standard 
Operating Procedures for this purpose. Its use for routine purpose shall be discouraged and an 
equally effective surface cleaning regime shall be followed. 

6.7.       Cleaning of  sterile  processing facilities  shall  be  undertaken with  air  suction 

devices or with non-linting sponges or clothes. 

6.8.       Air  particulate  quality  shall  be  evaluated  on  a  regular  basis  and  record 

maintained. 

7.          Equipment: 

7.1  The  special  equipment  required  for  manufacturing  sterile  products  includes 
component  washing  machines,  steam  sterilizers,  dry  heat  sterilizers,  membrane  filter 
assemblies, manufacturing vessels, blenders, liquid filling machines, powder filling machines, 
sealing  and  labelling machines, vacuum  testing chambers, inspection machines, lyophilisers, 
pressure  vessels  etc.  Suitable  and  fully  integrated  washing  sterilizing  filling  lines  may  be 
provided, depending upon the type and volume of activity. 

7.2.  Unit-sterilizers    shall    be    double-ended    with    suitable    inter-locking 
arrangements  between  the  doors.  The  effectiveness  of  the  sterilization  process  shall  be 
established  initially  by  biological  inactivation  studies  using  microbial  spore  indicators  and 
then  at  least  once  a  year  by  carrying  out  thermal  mapping  of  the  chamber.  Various 
sterilization  parameters  shall  be  established  based  on  these  studies  and  documented.  For 
membrane  filters  used  for  filtration,  appropriate  filter  integrity  tests  that  ensure  sterilization 
shall be carried out before and after filtration. 

7.3.  Filling  machines  shall  be  challenged  initially  and  then  at  periodic  intervals  by 
simulation  trials  including  sterile  media  fill.  Standard  Operating  Procedures  and  acceptance 
criteria for media fills shall be established, justified and documented. Special simulation trial 
procedures  shall  be  developed,  validt.  and  documented  for  special  products  like  ophthalmic 
ointments. 

7.4.  The  construction  material  used  for  the  parts  which  are  in  direct  contact  with 
products and  the  manufacturing vessels  may  be  stainless  steel  316  or  Boro-silicate  glass  (if 
glass containers) and the tubing shall be capable of being washed and autoclaved. 

7.5 On procurement, installation qualification of each of the equipment shall be done 
by  engineers with  the  support of  production and quality  assurance personnel. Equipment  for 
critical  processes  like  aseptic  filling  and  sterilizers  shall  be  suitably  validt.  according  to  a 
written program before putting them to use. 

7.6.  Standard  Operating  Procedures  shall  be  available  for  each  equipment  for  its 
calibration  and  operation  and  cleaning.  Gauges  and  other  measuring  devices  attached  to 
equipment  shall  be  calibrated  at  suitable  intervals  against  a  written  program.  Calibration 
status of equipment gauges shall be adequately documented and displayed. 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005. 

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8.          Water and Steam Systems: 

8.1.  Potable  water  meeting  microbiological  specification  of  not  more  than  500 
cfu/ml  and  indicating  absence  of  individual  pathogenic  micro-organisms.    Escherichia  coli, 
Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa per 100 ml sample shall be 
used for the preparation of purified water. 

8.2  Purified  water  prepared  by  de-mineralization  shall  meet  the  microbiological 
specification  of  not  more  than  100  cfu  per  ml  and  indicate  absence  of  pathogenic  micro- 
organisms  in  100  ml.  Purified  water  shall  also  meet  IP  specification  for  chemical  quality. 
Purified  water  shall  be  used  for  hand  washing  in  change  rooms.  Containers,  closures  and 
machine parts may be washed with potable water followed by suitably filtered purified water. 
Purified water shall be stored in stainless steel tanks or plastic tanks. 

8.3. Water for Injection (hereinafter as WFI) shall be prepared from potable water or 
purified water meeting the above specifications by distillation. Water for Injection shall meet 
microbiological  specification  of  not  more  than  10  cfu  per  100  ml.  WFI  shall  also  meet  IP 
specification for Water for  Injection and shall have an  endotoxin level of  not  more than 
0.25 EU/Ml. Bulk solutions of liquid parenterals shall be made in WFI. Final rinse of product 
containers and machine parts shall be done with WFI. Disinfectant solutions for use in aseptic 
areas shall be prepared in WFI. 

8.4.  Water  for  Injection  for  the  manufacture  of  liquid  injectables  shall  be  freshly 
collected from the distillation plant or from a storage or circulation loop where the water has 
been  kept  at  above  70  degree  centigrade.  At  the  point  of  collection,  water  may  be  cooled 
using suitable heat exchanger. 

8.5  Water  for  non-injectable  sterile  products  like  eye  drops  shall  meet  IP 
specifications for purified water. In addition, microbiologial specification of not more than 10 
cfu  per  100  ml  and  absence  of  Pseudomonas aeruginosa  and  Enterobacter coli   in  100  ml 
shall also be met. 

8.6.  Water  for  Injection  shall  be  stored  in  steam  jacketed  stainless  steel  tanks  of 
suitable size and the tanks shall have hydrophobic bacterial retention with 0.22 µ vent filters. 
The filters shall be suitably sterilized at periodic intervals. The distribution lines for purified 
water  and  distilled  water  shall  be  of  stainless  steel  316  construction  and  shall  not  shed 
particles. 

8.7.  There  shall  be  a  written  procedure  and  program  for  the  sanitation  of  different 
water systems including storage tanks, distribution lines, pumps and other related equipment. 
Records of sanitation shall be maintained. 

8.8. There shall be written microbiological monitoring program for different types of 
water.  The  results  shall  justify  the  frequency of  sampling and  testing.  Investigation shall  be 
carried out and corrective action taken in case of deviation from prescribed limits. 

1[8.9  Steam  coming  in  contact  with  the  product,  primary  containers  and  other 

product contact surfaces shall be sterile and pyrogen free.] 

9.          Manufacturing Process: 

9.1.       Manufacture  of  sterile  products  shall  be  carried  out  only  in  areas  under 

defined conditions. 

1. Omitted by  G.S.R. 431(E), dt. 30.6.2005. 

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Drugs and Cosmetics Rules 1945 

9.2.  Bulk    raw    materials    shall    be    monitored  for   bio-burden  periodically.    Bio- 
burden  of  bulk  solution  prior  to  membrane  filtration  shall  be  monitored  periodically  and  a 
limit of not more than 100 cfu per ml is recommended. 

9.3 The   time   between   the   start   of   the   preparation   of   the   solution   and   its 
sterilization or  filtration through a  micro-organism retaining filter shall be  minimized. There 
shall  be  a  set  maximum  permissible  time  for  each  product  that  takes  into  account  its 
composition and method of storage mentioned in the Master formula record. 

9.4. Gases coming in contact with the sterile product shall be filtered through two 

0.22 µ hydrophobic filters connected in-series. These filters shall be tested for integrity. Gas 
cylinders shall not be taken inside aseptic areas. 

9.5.  Washed  containers  shall  be  sterilized  immediately  before  use.  Sterilized 
containers,  if  not  used  within  an  established  time,  shall  be  rinsed  with  distilled  or  filtered 
purified water and re-sterilized. 

9.6.  Each  lot  of  finished  product  shall  be  filled  in  one  continuous  operation.  In 
each case, where one batch is filled in using more than one operation, each lot shall be tested 
separately for sterility and held separately till sterility test results are known. 

9.7. Special  care  shall  be  exercised  while  filling  products  in  powder  form  so  as not 

to contaminate the environment during transfer of powder to filling machine-hopper. 

10.        Form-Fill-Seal Technology or Blow, Fill-Seal Technology: 

10.1    Form-Fill-Seal units  are  specially  built  automated  machines  in  which  through 
one continuous operation, containers are formed from thermoplastic granules, filled and then 
sealed.  Blow,  fill-seal  units  are  machines  in  which  containers  are  moulded  /  blown  (pre- 
formed) in separate clean rooms, by non-continuous operations. 

Note: 
(i)     These shall be installed in at least Grade C environment. 
(ii)   These shall comply with the limits as recommended in Table at Item 4.2. 

10.2.  Form-Fill-Seal/Blow,   Fill-Seal   machines   used   for   the   manufacture   of 
products for terminal sterilization shall be  installed in  at  least  Grade C  environment and  the 
filling zone within the machine shall fulfil Grade A requirements. 

10.3. Terminally sterilized products.– 

10.3.1.  Preparation  of  primary  packaging  material  such  as  glass  bottles,  ampoules 
and  rubber  stoppers  shall  be  done  in  at  least  Grade D  environment. Where there  is  unusual 
risk to the product from microbial contamination, the above operation shall be done in Grade 
C environment. All the processes  used for component preparation shall be validt.. 

10.3.2.  Filling of products requiring terminal sterilization shall be done under Grade 

A environment with a Grade C background. 

10.4  Preparation of solutions, which are to be sterilized by filtration, shall be done in 
Grade C environment, and if not to be filtered, the preparation of materials and products shall 
be in a Grade A environment with Grade B in background. 

455 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

10.5      Filtration (Membrane).- 

(i) 

Solutions for Large Volume Parenterals shall be filtered through a non-fibre releasing, 
sterilizing grade cartridge/membrane filter of nominal pore size of 0.22 µ   for aseptic 
filling whereas 0.45 µ porosity shall be used for terminally sterilized products. 

(ii)  A  second  filtration  using  another  0.22  µ sterilizing grade  cartridge  /  membrane filter 
shall  be  performed  immediately  prior  to  filling.  Process  specifications  shall  indicate 
the  maximum  time  during  which  a  filtration  system  may  be  used  with  a  view  to 
precluding microbial build-up to  levels that  may  affect the  microbiological quality of 
the Large Volume Parenterals. 

(iii)  The integrity of the sterilized filter shall be  verified and confirmed immediately after 
use by an appropriate method such as Bubble Point, Diffusive Flow or Pressure Hold 
Test. 

10.6      Sterilization (Autoclaving).– 

10.6.1.  Before any sterilization process is adopted, its suitability for the product and 
its  efficacy  in  achieving  the  desired  sterilizing  conditions  in  all  parts  of  each  type  of  load 
pattern  to  be  processed, shall  be  demonstrated by  physical  measurements and  by  biological 
indicators, where appropriate. 

10.6.2   All the sterilization process shall be appropriately validt.. The validity of the 
process  shall  be  verified  at  regular  intervals,  but  at  least  annually.  Whenever  significant 
modifications  have  been  made  to  the  equipment  and  product,  records  shall  be  maintained 
thereof. 

10.6.3   The sterilizer shall be double ended to prevent mix-ups. 

10.6.4   Periodic bio-burden monitoring of products before terminal sterilization shall 

be carried out and controlled to limits specified for the product in the Master Formula. 

10.6.5   The use of biological indicators shall be considered as an additional method 
of monitoring the sterilization. These shall be stored and used according to the manufacturer‘s 
instructions. Their quality shall be checked by positive controls. If biological indicators used, 
strict precautions shall be taken to avoid transferring microbial contamination from them. 

10.6.6   There shall  be  clear  means  of  differentiating ‗  sterilized‘ and  ‗un-sterilized‘ 
products. Each basket, tray or other carrier of products or components shall be clearly labelled 
with  the  name  of  the  material,  its  batch  number,  and  sterilization status.  Indicators  shall  be 
used,  where  appropriate,  to  indicate  whether  a  batch  (or  sub-batch)  has  passed  through  the 
sterilization process. 

10.6.7   Sterilization records shall be available for each sterilization-run and may also 
include thermographs and sterilization monitoring strips. They shall be maintained as part of 
the batch release procedure. 

10.7.    Sterilization (By dry heat).– 

10.7.1      Each heat sterilization cycle shall be recorded on a  time/temperature chart 
of  a  suitable  size  by  appropriate  equipment  of  the  required  accuracy  and  precision.  The 
position  of  temperature  probes  used  for  controlling  and/or  recording  shall  be  determined 
during  the  validation  and,  where  applicable,  shall  also  be  checked  against  a  second 
independent temperature probe located in the same position. The chart shall form a part of the 

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batch  record.  Container  mapping  may  also  be  carried  out  in  the  case  of  Large  Volume 
Parenterals. 

10.7.2 Chemical or biological indicators may also be used, but shall not take the place 

of physical validation. 

10.7.3. Sufficient   time   shall   be   allowed   for   the   load   to   reach   the   required 
temperature  before  measurement  of   sterilization  time   commences.  This  time   shall  be 
separately determined for each type of load to be processed. 

10.7.4.  After  the  high  temperature  phase  of  a  heat  sterilization  cycle,  precautions 
shall  be  taken  against  contamination of  sterilized  load  during  cooling.  Any  cooling  fluid  or 
gas  in  contact  with  the  product  shall  be  sterilized  unless  it  can  be  shown  that  any  leaking 
container would not be approved for use. Air inlet and outlets shall be provided with bacterial 
retaining filters. 

10.7.5.  The  process  used  for  sterilization  by  dry  heat  shall  include  air-circulation 
within  the  chamber and  the  maintenance of  a  positive  pressure  to  prevent the  entry  of  non- 
sterile  air.  Air  inlets  and  outlets  should  be  provided  with  micro-organism  retaining  filters. 
Where this process of sterilization by dry heat is also intended to remove pyrogens, challenge 
tests using endotoxins would be required as part of the validation process. 

10.8.  Sterilization (By Moist Heat).- 
10.8.1    Both  the  temperature  and  pressure  shall  be  used  to  monitor  the  process. 
Control  instrumentation  shall  normally  be  independent  of  monitoring  instrumentation  and 
recording  charts.  Where  automated  control  and  monitoring  systems  are  used  for  these 
applications, these shall be validt. to ensure that critical process requirements are met. System 
and cycle faults shall be registered by the system and observed by the operator. The reading 
of the independent temperature indicator shall be routinely checked against the chart-recorder 
during the sterilization period. For sterilizers fitted with a drain at the bottom of the chamber, 
it may also be necessary to record the temperature at this position throughout the sterilization 
period. There shall be frequent leak tests done on the chamber during the vacuum phase of the 
cycle. 

10.8.2  The  items  to  be  sterilized,  other  than  products  in  sealed  containers,  shall  be 
wrapped  in  a  material  which  allows  removal  of  air  and  penetration  of  steam  but  which 
prevents re-contamination after sterilization. All parts of the load shall be in contact with the 
sterilizing agent at the required temperature for the required time. 

10.8.3.  No  Large  Volume  Parenteral  shall  be  subjected  to  steam  sterilization  cycle 

until it has been filled and sealed. 

10.8.4  Care  shall  be  taken  to  ensure  that  the  steam  used  for  sterilization  is  of  a 
suitable quality and does not contain additives at a level which could cause contamination of 
the product or equipment. 

10.9. Completion/finalisation of sterile products– 

10.9.1.  All  unit  operations and  processes in  the  manufacture of  a  batch shall have  a 
minimum time specified and the shortest validt. time shall be used from the start of a batch to 
its ultimate release for distribution. 

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10.9.2.  Containers  shall  be  closed  by  appropriately  validt.  methods.  Containers 
closed  by  fusion  e.g.  glass  or  plastic  ampoules shall  be  subjected to  100%  integrity  testing. 
Samples  of   other  containers  shall   be   checked  for   integrity  according  to   appropriate 
procedures. 

10.9.3  Containers  sealed  under  vacuum  shall  be  tested  for  required  vacuum 

conditions. 

10.9.4  Filled  containers  of  parenteral  products  shall  be  inspected  individually  for 
extraneous contamination or other defects. When inspection is done visually, it shall be done 
under  suitably  controlled  conditions  of  illumination  and  background.  Operators  doing  the 
inspection  shall  pass  regular  eye-sight  checks  with  spectacles,  if  worn,  and  be  allowed 
frequent rest from inspection. Where other methods of inspection are used, the process shall 
be validt. and the performance of the equipment checked at suitable intervals. Results shall be 
recorded. 

11.     Product Containers and Closures. – 

11.1  All  containers  and  closures 

intended  for  use  shall  comply  with 

the 
pharmacopoeial  and other specified requirements. Suitable samples sizes, specifications, test 
methods,  cleaning  procedures  and  sterilization  procedures,  shall  be  used  to  assure  that 
containers,  closures  and  other  component  parts  of  drug  packages  are  suitable  and  are  not 
reactive,  additive,  adsorptive  or  leachable  or  presents  the  risk  of  toxicity  to  an  extent  that 
significantly affects the quality or purity of the drug. No second hand or used containers and 
closures shall be used. 

11.2  Plastic  granules  shall  also  comply  with  the  pharmacopoeial  requirements 

including physio-chemical and biological tests. 

11.3. All  containers and closures shall be rinsed prior to  sterilization with Water for 

Injection according to written procedure. 

11.4.  The  design  of  closures,  containers  and  stoppers  shall  be  such  as  to  make 

cleaning, easy and also to make airtight seal when fitted to the bottles. 

11.5  It  shall  be  ensured  that  containers  and  closures  chosen  for  a  particular 
product  are  such  that  when  coming  into  contact  they  are  not  absorbed into  the  product  and 
they do not affect the product adversely. The closures and stoppers should be of such quality 
substances as not to affect the quality of the product and avoid the risk of toxicity. 

11.6. Whenever glass bottles are  used, the  written schedule of  cleaning shall be laid 
down  and  followed.  Where  bottles  are  not  dried  after  washing,  these  shall  be  finally 
rinsed  with  distilled  water  or  pyrogen  free  water,  as  the  case  may  be,  according  to  written 
procedure. 

11.7. Individual  containers  of  parenteral  preparations,  ophthalmic  preparations shall 
be  examined  against  black/white  background  fitted  with  diffused  light  after  filling  so  as  to 
ensure freedom from foreign matters. 

11.8  Glass Bottles. – 

11.8.1  Shape  and  design  of  the  glass  bottle  shall  be  rational  and  standardized. 
Glass  bottles  made  of  USP  Type-I  and  USP  Type-II  glass  shall  only  be  used.  Glass  bottles 
shall  not  be  reused.  Before  use,  USP  Type-II  bottles  shall  be  validt.  for  the  absence  of 
particulate  matter  generated  over  a  period  of  the  shelf  -life  of  the  product  and  shall  be 

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regularly monitored after the production, following statistical sampling methods. USP Type- 
III glass containers may be used for non-parenteral sterile products such as Otic Solutions. 

11.9. Plastic Containers. – 

11.9.1  Pre-formed  plastic  containers  intended  to  be  used  for  packing  of  Large 
Volume  Parenteral  shall  be  moulded  in-house  by  one-continuous  operation  through  an 
automatic machine. 

11.9.2.  Blowing,  filling  and  sealing  (plugging)  operation  shall  be  conducted  in 
room(s) conforming to requirements as mentioned in Table III of Item 3.10. Entry to the area 
where  such  operations  are  undertaken,  shall  be  through  a  series  of  airlocks.  Blowers  shall 
have  an  air  supply which is  filtered through 0.22µ filters. Removal of  runners and  plugging 
operations shall be conducted under a laminar airflow workstation. 

11.10 Rubber Stoppers. – 

11.10.1  The  rubber  stoppers  used  for  Large  Volume  Parenterals  shall  comply  with 

specifications prescribed in the current edition of the Indian Pharmacopoeia. 

12.        Documentation: 

12.1  The  manufacturing  records  relating  to  manufacture  of  sterile  products  shall 

indicate the following details:- 

(1)       Serial number of the Batch Manufacturing Record. 
(2)       Name of the product 
(3)       Reference to Master Formula Record. 
(4)       Batch/Lot number 
(5)       Batch/Lot size. 
(6)       Date of commencement of manufacture and date of completion of manufacture. 
(7)       Date of manufacture and assigned date of expiry. 
(8)       Date of each step in manufacturing. 
(9)       Names of all ingredients with the grade given by the quality control department. 
(10)     Quality of all ingredients. 
(11)     Control reference numbers for all ingredients. 
(12)     Time and duration of blending, mixing, etc. whenever applicable. 
(13)     pH  of solution whenever applicable. 
(14)     Filter integrity testing records 
(15)     Temperature and humidity records whenever applicable 
(16)     Records of plate-counts whenever applicable. 
(17)     Results of pyrogen and/or bacterial endotoxin  & toxicity. 
(18)     Records of weight or volume of drug filled in containers. 
(19)     Bulk sterility in case of aseptically filled products. 
(20)     Leak test records. 
(21)     Inspection records. 
(22)  Sterilization  records  including  autoclave  leakage  test  records,  load  details,  date, 

duration, temperature, pressure, etc. 

(23)     Container washing records. 
(24)     Total number of containers filled. 
(25)     Total numbers of containers rejected at each stage 
(26)     Theoretical yield, permissible yield, actual yield and variation thereof. 
(27)     Clarification for variation in yield beyond permissible yield. 
(28)     Reference numbers of relevant analytical reports. 
(29)     Details of reprocessing, if any. 

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(30)     Name of all operators carrying out different activities. 
(31)     Environmental monitoring records. 
(32)     Specimens of printed packaging materials. 
(33)     Records of destruction of rejected containers  and printed packaging materials. 
(34)     Signature of competent technical staff responsible for manufacture and testing. 

Note: 

(1)  Products shall be released only after complete filling and testing. 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

Result  of  the  tests  relating  to  sterility,  pyrogens,  and  Bacterial 
endotoxins shall be maintained in the analytical records. 

Validation details  and  simulation  trial  records  shall  be  maintained 
separately, 

Records  of  environmental  monitoring  like  temperature,  humidity, 
microbilogical  data,  etc.  shall  be  maintained.  Records  of  periodic 
servicing of HEPA filters, sterilizers and other periodic maintenance 
of facilities and equipment carried out also be maintained. 

Separate facilities shall be provided for filling-cum-sealing of Small 
Volume Injectables  and Large Volume Parenterals. 

It  is  advisable  to  provide  separate  facilities  for  manufacture  of 
Large  Volume  Parenterals  in  glass  containers  and  /  or  plastic 
containers. 

For manufacture of  Large Volume Parenterals in  plastic containers, 
it  is  advisable to  instal    automatic  (with  all  operations) Form–Fill- 
Seal machines having one continuous operation. 

PART  IB 

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE 
FORMS (TABLETS AND CAPSULES) 

Note:  -  The  General  Requirements  as  given  in  Part  1  of  this  Schedule  relating  to 
requirements  of  Good  Manufacturing  Practices 
for 
pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of oral 
Solid Dosage Forms (Tablets and Capsules). In addition to  these  requirements, the  following 
Specific Requirement shall also be followed, namely :- 

for  Premises  and  materials 

1.      General: 

1.1  The  processing  of  dry  materials  and  products  creates  problems  of  dust control 
and  cross-contamination.  Special  attention  is  therefore,  needed  in  the  design,  maintenance 
and  use  of  premises  and  equipment  in  order  to  overcome  these  problems. Wherever 
required, enclosed dust control manufacturing systems shall be employed. 

1.2.  Suitable    environmental    conditions    for    the    products    handled    shall    be 
maintained  by  installation  of  air-conditioning  wherever  necessary.  Effective  air-extraction 
systems,  with  discharge  points  situated  to  avoid  contamination  of  other  products  and 
processes shall be provided. Filters shall be installed to retain dust and protect the factory and 
local environment. 

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1.3.  Special  care  shall  be  taken  to  protect  against  subsequent  contamination  of the 
product  by  particles  of  metal  or  wood.  The  use  of  metal    detector  is  recommended. 
Wooden equipment should be  avoided. Screens, sieves, punches and  dies shall be  examined 
for wear and tear or for breakage before and after each use. 

1.4.    All  ingredients  for  a    dry  product  shall  be  sifted  before  use  unless  the 
quality  of  the  input  material  can  be  assured.  Such  sifting  shall  normally  be  carried  out  at 
dedicated areas. 

1.5.  1[Where    the    facilities    are    designed    to    provide    special    environmental 
conditions  of  pressure  differentials  between  rooms,  these  conditions  shall  be  regularly 
monitored and  any  deviation shall  be   brought to  the  immediate  attention of  the  production 
and quality assurance departments]. 

1.6.  Care  shall  be  taken  to  guard  against  any  material  lodging  and  remaining 

undetected in any processing or packaging equipment. Particular care shall be taken to ensure 
that any vacuum, compressed air or air-extraction nozzles are kept clean and that there is no 
evidence of  lubricants leaking into the product from any part of the equipments. 

2.          Sifting, Mixing and Granulation: 

2.1.  Unless  operated  as  a  closed  system,  mixing,  sifting  and  blending  equipments 

shall be fitted with dust extractors 1[or in a dedicated area for each operation]. 

2.2. Residues from sieving operations shall be examined periodically for evidence of 

the presence of unwanted materials. 

2.3. Critical   operating  parameters  like   time   and  temperature  for   each   mixing, 
blending  and  drying  operation  shall  be  specified  in  a  Master  Formula,  monitored  during 
processing, and recorded in the batch records. 

2.4.  Filter  bags  fitted  to  fluid-bed  dryer  shall  not  be  used  for  different  products, 
without being washed in-between use. With certain highly potent or sensitizing products, bags 
specific to one product only shall be used. Air entering the dryer shall be filtered. Steps shall 
be taken to prevent contamination of the site and local environment by dust in the air leaving 
the dryer due to close positioning of the air-inlets and exhaust. 

2.5.  Granulation  and  coating  solutions  shall  be  made,  stored  and  used  in  a  manner 

which minimizes the risk of contamination or microbial growth. 

3.     Compressions (Tablets): 

3.1.  Each  tablet  compressing  machine  shall  be  provided  with  effective  dust  control 
facilities  to  avoid  cross-contamination.  Unless  the  same  product  is  being  made  on  each 
machine,  or  unless  the  compression  machine  itself  provides  its  own  enclosed  air  controlled 
environment, the machine shall be installed in separate cubicles. 

3.2.  Suitable  physical,  procedural  and  labelling  arrangements  shall  be    made  to 

prevent mix up of materials, granules and tablets on compression machinery. 

3.3. Accurate  and  calibrated  weighing  equipment  shall  be  readily  available  and 
used for in-process monitoring of tablet weight variation. Procedures used shall be capable of 
detecting out-of-limits tablets. 

1. Ins. by  G.S.R. 431(E), dt. 30.6.2005. 

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3.4.  At  the  commencement  of  each  compression  run  and  in  case  of  multiple 
compression points in a compression machine, sufficient individual tablets shall be examined 
at  fixed  intervals  to  ensure  that  a  tablet  from  each  compression  station  or  from  each 
compression   point   has   been   inspected   for   suitable   pharmacopoeial   parameters   like 
‗appearance‘, ‗weight variation‘, ‗disintegration‘, ‗hardness‘, ‗friability‘ and ‗thickness‘. The 
results shall be recorded as part of the batch documentation. 

3.5. Tablets    shall   be   de-dusted,    preferably   by    automatic    device    and   shall    be 

monitored for the presence of foreign materials besides any other defects. 

3.6.  Tablets shall be collected into clean, labelled containers. 

3.7. Rejected  or  discarded  tablets  shall  be  isolated  in  identified  containers  and their 

quantity recorded in the Batch Manufacturing Record. 

3.8 In-process  control  shall  be  employed  to  ensure  that  the  products  remain within 
specification. During compression, samples of tablets shall be taken at regular intervals of not 
greater than 30 minutes to ensure that they are being produced in compliance with specified 
in-process  specification.  The  tablets  shall  also  be  periodically  checked  for  additional 
parameters  such  as  ‗appearance‘,  ‗weight  variation‘,  ‗disintegration‘,  ‗hardness‘,  ‗friability‘ 
and ‗thickness‘ and contamination by lubricating oil. 

4.          Coating (Tablets): 

4.1.    Air  supplied  to  coating  pans  for  drying  purposes  shall  be  filtered  air  and  of 
suitable quality. The  area shall  be  provided with suitable exhaust system and  environmental 
control (temperature, humidity) measures. 

4.2    Coating  solutions and  suspensions shall  be  made  afresh  and  used  in  a  manner, 
which  shall  minimize  the  risk  of  microbial  growth.  Their  preparation  and  use  shall  be 
documented and recorded. 

5.          Filling of Hard Gelatin Capsule: 

Empty capsules shells shall be regarded as ‗drug component‘ and treated accordingly. 
They  shall  be  stored  under  conditions  which  shall  ensure  their  safety  from  the  effects  of 
excessive heat and moisture. 

6.          Printing (Tablets and Capsules) 

6.1.  Special  care  shall  be  taken  to  avoid  product  mix-up  during  any  printing  of 
tablets and  capsules. Where different products, or  different batches of  the  same  product, are 
printed  simultaneously,  the  operations  shall  adequately  be  segregated.  Edible  grade  colours 
and suitable printing ink shall be used for such printing. 

6.2.  After  printing,  tablets  and  capsules  shall  be  approved  by  Quality  Control 

before release for packaging or sale. 

7.          Packaging (Strip and Blister): 

7.1. Care  shall be  taken when using automatic tablet  and capsule counting, strip and 
blister  packaging  equipment  to  ensure  that  all  ‗rogue‘  tablets,  capsules  or  foils  from 
packaging  operation  are  removed  before  a  new  packaging  operation  is  commenced.  There 
shall  be  an  independent  recorded  check  of  the  equipment  before  a  new  batch  of  tablets  or 
capsules is handled. 

7.2.  Uncoated tablets shall be packed on equipment designed to minimize the risk of 
cross-contamination.  Such  packaging  shall  be  carried  out  in  an  isolated  area  when  potent 
tablets or Beta-Iactum containing tablets are being packed. 

1. Ins. by  G.S.R. 431(E), dt. 30.6.2005. 

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7.3.    The  strips  coming  out  of  the  machine  shall  be  inspected  for  defects  such  as 

misprint, cuts on the foil, missing tablets and improper sealing. 

7.4.    Integrity  of  individual  packaging  strips  and  blisters  shall  be  subjected  to 
vacuum test periodically to ensure leak proofness of each pocket strip and blister and records 
maintained. 

PART IC 

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS 
(SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS) 

Note:  The  General  Requirements  as  given  in  Part  I  of  this  Schedule  relating  to 
Requirements  of  Good  Manufacturing  Practices 
for 
pharmaceutical  products  shall  be  complied  with,  mutatis  mutandis,  for  the  manufacture  of 
(Syrups, Elixirs, Emulsions and Suspensions). In addition to these requirements, the following 
Specific Requirements shall also be followed, namely:- 

for  Premises  and  Materials 

1.          Building and Equipment:. 

1.1.       The premises and equipment shall be designed, constructed and maintained to 
suit the manufacturing of Oral Liquids. The layout and design of the manufacturing area shall 
strive to minimize the risk of cross-contamination and mix-ups. 

1.2.       Manufacturing area  shall  have  entry  through  double  door  airlock  facility.  It 

shall be made fly proof by use of ‗fly catcher‘ and/or ‗air curtain‘. 

1.3.       Drainage  shall  be  of  adequate  size  and  have  adequate  traps,  without  open 
channels  and  the  design  shall  be  such  as  to  prevent  back  flow.  Drains  shall  be  shallow  to 
facilitate cleaning and disinfecting. 

1.4.       The  production  area  shall  be  cleaned  and  sanitized  at  the  end  of  every 

production process. 

1.5.       Tanks,  containers,  pipe  work  and  pumps  shall  be  designed  and  installed  so 
that  they  can  be  easily  cleaned and  sanitized. Equipment design  shall  be  such as  to  prevent 
accumulation of residual microbial growth or cross-contamination. 

1.6.       Stainless  steel  or  any  other  appropriate  material  shall  be  used  for  parts  of 
equipments  coming  in  direct  contact  with  the  products. The  use  of  glass  apparatus  shall  be 
minimum. 

1.7.       Arrangements for cleaning of containers, closures and droppers shall be made 
with  the  help  of  suitable  machines/devices  equipped  with  the  high  pressure  air,  water  and 
steam jets. 

1.8.       The furniture used shall be smooth, washable and made of stainless steel  1[or 

any other appropriate material which is scratch proof, washable and smooth]. 

2.          Purified Water. 

2.1.       The  chemical  and  microbiological  quality  of  purified  water  used  shall  be 
specified  and  monitored  routinely.  The  microbiological  evaluation  shall  include  testing  for 
absence of pathogens and shall not exceed 100 cfu/ml (as per Appendix 12.5 of IP 1996.) 

1. Added by  G.S.R. 431(E), dt. 30.6.2005. 

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2.2.       There  shall  be  a  written  procedure  for  operation  and  maintenance  of  the 
purified  water  system.  Care  shall  be  taken  to  avoid  the  risk  of  microbial  proliferation  with 
appropriate  methods  like  re-circulation,  use  of  UV  treatment,  treatment  with  heat  and 
sanitizing agent. After any chemical sanitisation of the water system, a flushing shall be done 
to ensure that the sanitizing agent has been effectively removed. 

3.          Manufacturing: 

3.1.       1[Manufacturing personnel shall wear wherever required, non-fiber shedding 

clothing to prevent contamination of the products]. 

3.2.       Materials likely to shed fibre like gunny bags, or wooden pallets shall not be 

carried into the area where products or cleaned-containers are exposed. 

3.3.       Care  shall  be  taken  to  maintain  the  homogenecity  of  emulsion  by  use  of 
appropriate emulsifier and suspensions by use of appropriate stirrer during filling. Mixing and 
filling processes shall be specified and monitored. Special care shall be taken at the beginning 
of the filling process, after stoppage due to any interruption and at the end of the process to 
ensure that the product is uniformly homogenous during the filling process. 

3.4.       The primary packaging area shall have an air supply which is filtered through 

5 micron filters. The temperature of the area shall not exceed 30 degrees centigrade. 

3.5.       When  the  bulk  product  is  not  immediately  packed,  the  maximum  period  of 
storage and storage conditions shall be specified in the Master Formula. The maximum period 
of storage time of a product in the bulk stage shall be validt.. 

PART ID 

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS , 
i.e.  EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, 
EMULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL 
PRODUCTS) 

Note:        The  General  Requirements  as  given  in  Part  I  of  this  Schedule  relating  to 
Requirements  of  Good  Manufacturing  Practices 
for 
pharmaceutical  products  shall  be  complied  with,  mutatis  mutandis,  for  the  manufacture  of 
Topical Products i.e. External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, 
Solutions,  Dusting  powders  and  identical  products  used  for  external  applications).    In 
addition to these requirements,   the   following Specific Requirements shall also be followed, 
namely: - 

for  Premises  and  Materials 

1.  The  entrance  to  the  area  where  topical  products  are  manufactured 
shall be through a suitable airlock. Outside the airlock, insectocutors shall be 
installed. 

2. The air to this manufacturing area shall be filtered through at least 20µ 

air filters and shall be air-conditioned. 2 [***]. 

3.  The  area shall be  fitted with an  exhaust system of  suitable capacity to 

effectively remove vapours, fumes, smoke, floating dust particles. 

4.  The  equipment  used  shall  be  designed  and  maintained  to  prevent  the 
product  from  being  accidentally  contaminated  with  any  foreign  matter  or 
lubricant. 

5. 3[Suitable cleaning equipment and material] shall be used in the process 

of cleaning or drying the process equipment or accessories used. 

1. Subs. by G.S.R. 431(E), dt. 30.6.2005. 
2. The words ―The air shall be ventilated.‖  omitted by G.S.R. 431(E), dt. 30.6.2005. 
3. Subs.  by G.S.R. 431(E), dt. 30.6.2005, for ― no rags or dusters‖. 

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6. Water used in compounding shall be Purified Water IP. 

7. Powders, wherever used, shall be suitably sieved before use. 

8. Heating vehicles and a base like petroleum jelly shall be done in separate 
mixing area in suitable stainless steel vessels, using steam, gas, electricity, solar 
energy, etc. 

9. A separate packing section may be provided for primary packaging of the 

products. 

PART 1E 

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF 
METERED-DOSE-INHALERS (MDI) 

Note:      The  General  Requirements  as  given  in  Part  I  of  this  Schedule  relating  to 
Requirements  of  Good  Manufacturing  Practices 
for 
pharmaceutical  products  shall  be  complied  with,  mutatis  mutandis,  for  the  manufacture  of 
Metered-Dose-Inhalers  (MDI).  In  addition  to  these  requirements,  the  following  Specific 
Requirements shall also be followed, namely: - 

for  Premises  and  Materials 

1.    General: 

Manufacture  of  Metered-Dose-Inhalers  shall  be  done  under  conditions  which  shall 
ensure  minimum  microbial  and  particulate  contamination.  Assurance  of  the  quality  of 
components  and  the  bulk  product  is  very  important.  Where  medicaments  are  in  suspended 
state, uniformity of suspension shall be established. 

2.   Building and Civil Works: 

2.1.       The building shall be located on a solid foundation to reduce risk of cracking 

walls and floor due to the movement of equipment and machinery. 

2.2        All   building   surfaces   shall   be   impervious,   smooth   and   non-shedding. 
Flooring shall be continuous and provided with a cove between the floor and the wall as well 
as  the  wall  to  the  ceiling.  Ceiling  shall  be  solid,  continuous  and  covered  to  walls.  Light 
fittings  and  air-grills shall  be  flush  with  the  ceiling. All  service  lines  requiring  maintenance 
shall be erected in such a manner that these are accessible from outside the production area. 

2.3.       The manufacturing area shall be segregated into change rooms for personnel, 
container preparation area, bulk preparation and filling area, quarantine area and spray testing 
and packing areas. 

2.4.       Secondary  change  rooms  shall  be  provided  for  operators  to  change  from 
factory clothing to special departmental clothing before entering the manufacturing and filling 
area. 

2.5.       Separate  area  shall  be  provided for  de-cartoning of  components before they 

are air washed. 

2.6.       The propellants used for manufacture shall be delivered to the manufacturing 
area  distribution  system  by  filtering  them  through  2µ  filters.  The  bulk  containers  of 
propellants shall be stored, suitably identified, away from the manufacturing facilities. 

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3.          Environmental Conditions: 

3.1.       Where products or clean components are exposed, the area shall be supplied 

with filtered air of Grade C. 

3.2.       The   requirements   of   temperature   and   humidity   in   the   manufacturing 
area  shall  be  decided  depending  on  the  type  of  product  and  propellants  handled  in  the 
facility. Other support areas shall have comfort levels of temperature and humidity. 

3.3.       There  shall  be  a  difference  in  room  pressure  between  the  manufacturing 
area and the support areas and the differential pressure shall be not less than 15 Pascals (0.06 
inches or 1.5 mm water gauge). 

3.4.       There  shall  be  a  written  schedule  for  the  monitoring  of  environmental 

conditions.  Temperature and humidity shall be monitored daily. 

4.    Garments: 

4.1.       Personnel in the manufacturing and filling section shall wear suitable single- 
piece-garment  made  out  of  non-shedding,  tight  weave  material.  Personnel  in  support  areas 
shall wear clean factory uniforms. 

4.2.       Gloves  made  of  suitable material having no  interaction with  the  propellants 
shall  be  used  by  the  operators in  the  manufacturing and  filling areas.  Preferably, disposable 
gloves shall be used. 

4.3.       Suitable  department-specific  personnel  protective  equipment  like  footwear 

and safety glasses shall be used wherever hazard exists. 

5.          Sanitation: 

5.1.       There   shall   be   written   procedures   for   the   sanitation   of   the   MDI 
manufacturing  facility.  Special  care  should  be  taken  to  handle  residues  and  rinses  of 
propellants. 

5.2.       Use  of  water  for  cleaning shall  be  restricted and  controlled. Routinely  used 
disinfectants  are  suitable  for  sanitizing  the  different  areas.  Records  of  sanitation  shall  be 
maintained. 

6.          Equipment: 

6.1.       Manufacturing equipment shall be of closed system. The vessels and supply 

lines shall be of stainless steel. 

6.2.       Suitable check weights, spray testing machines and labelling machines shall 

be provided in the department. 

6.3.       All  the  equipment  shall  be  suitably  calibrated  and  their  performance validt. 

on receipt and thereafter periodically. 

7.          Manufacture: 

7.1.       There shall be an approved Master Formula Records for the  manufacture of 
metered dose inhalers. All propellants, liquids and gases shall be filtered through 2µ filters to 
remove particles. 

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7.2.       The  primary packing material  shall  be  appropriately cleaned by  compressed 
air suitably filtered through 0.2µ filter. The humidity of compressed air shall be controlled as 
applicable. 

7.3.       The  valves  shall  be  carefully  handled and  after  de-cartoning, these  shall  be 

kept in clean, closed containers in the filling room. 

7.4.       For suspensions, the bulk shall be kept stirred continuously. 

7.5.          In-process  controls  shall  include  periodical  checking  of  weight  of  bulk 
formulation filled  in  the  containers.  In  a  two-shot-filling process  (liquid  filling  followed  by 
gaseous filling), it shall be ensured that 100% check on weight is carried out. 

7.6.       Filled containers shall be quarantined for a suitable period established by the 

manufacturer to detect leaking containers prior to testing, labelling and packing. 

8.       Documentation- 

8.1.   In  addition  to  the  routine  good  manufacturing  practices  documentation, 

manufacturing records shall show the following additional information:- 

(1) Temperature and humidity in the manufacturing area. 
(2) Periodic filled weights of the formulation. 
(3) Records of rejections during on-line check weighing. 
(4) Records of rejection during spray testing. 

PART 1F 

SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR 
MANUFACTURE OF ACTIVE PHARMACEUTIAL INGREDIENTS 
(BULK DRUGS) 

Note: The   General   Requirements   as   given   in   Part   I   of   this   Schedule   relating   to 
Requirements  of    Good    Manufacturing  Practices    for    premises    and    Materials    for 
pharmaceutical products  shall  be  complied  with,  mutatis  mutandis,  for  the manufacture  of 
active  pharmaceutical  ingredients  (Bulk  Drugs).  In  addition  to  these  requirements,  the 
following Specific Requirements shall also be followed, namely: - 

1.        Building and Civil Works: 

1.1.       Apart from the building requirements contained in Part I,  General   ante, the 
active  pharmaceutical  ingredients  facilities  for  manufacture  of  hazardous  reactions,  Beta- 
Lactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances shall be provided 
in confined areas to prevent contamination of the other drugs manufactured. 

1.2.       The  final  stage  of  preparation  of  a  drug,  like  isolation/filtration/drying/ 
milling / sieving and packing operations shall be provided with air filtration systems including 
pre-filters and finally with a 5 micron filter. Air handling systems with adequate number of air 
changes per hour or any other suitable system to control the air borne contamination shall be 

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provided.  Humidity  /  Temperature  shall  also  be  controlled  for  all  the  operations  wherever 
required. 

1.3.       Air filtration systems including pre-filters and particulate matter retention air 
filters  shall  be  used,  where  appropriate,  for  air  supplies  to  production  areas.  If  air  is  re- 
circulated  to  production  areas,  measures  shall  be  taken  to  control  re-circulation  of  floating 
dust  particles  from  production.  In  areas  where  air  contamination  occurs  during  production, 
there shall be adequate exhaust system to control contaminants. 

1.4.       Ancillary  area  shall  be  provided  for  Boiler-house.  Utility  areas  like  heat 

exchangers, chilling workshop, store and supply of gases shall also be provided. 

1.5.       For specified preparation like manufacture of sterile products and for certain 
antibiotics, sex  hormones, cytotoxic and oncology products, separate enclosed areas shall be 
designed.  The  requirements  for  the  sterile  active  pharmaceutical  ingredient  shall  be  in  line 
with the facilities required for formulation to be filled aseptically. 

2.         Sterile Products: 

Sterile  active  pharmaceutical  ingredient  filled  aseptically  shall  be  treated  as 
formulation from the stage wherever the process demands like crystallization, lyophilisation, 
filtration etc. All conditions applicable to formulations that are required to be filled aseptically 
shall apply mutatis mutandis for the manufacture of sterile active pharmaceutical ingredients 
involving stages like filtration, crystallization and lyophilisation. 

3.         Utilities / Services: 

Equipment  like  chilling  plant,  boiler,  heat  exchangers,  vacuum  and  gas  storage 
vessels shall be serviced, cleaned, sanitized and maintained at appropriate intervals to prevent 
mal-functions  or  contamination  that  may  interfere  with  safety,  identity,  strength,  quality  or 
purity of the drug product. 

4.        Equipment Design, Size and Location: 

4.1.       Equipment  used  in  the  manufacture,  processing,  packing  or  holding  of  an 
active  pharmaceutical  ingredient  shall  be  of  appropriate  design,  adequate  size  and  suitably 
located to facilitate operations for its intended use and for its cleaning and maintenance. 

4.2.       If  equipment  is  used  for  different  intermediates  and  active  pharmaceutical 
ingredients,  proper   cleaning   before   switching   from   one   product   to   another   becomes 
particularly important. If  cleaning of  a specific type of  equipment is  difficult, the equipment 
may need to be dedicated to a particular intermediate or active pharmaceutical ingredient. 

4.3.       The  choice  of  cleaning  methods,  detergents  and  levels  of  cleaning  shall  be 

defined and justified. Selection of cleaning agents (e.g. solvents) should depend on : 

(a)         the  suitability  of  the  cleaning  agent  to  remove  residues  of  raw  materials; 

intermediates, precursors, degradation products and isomers, as appropriate. 

(b)         whether the cleaning agent leaves a residue itself; 
(c) 

compatibility    with    equipment   construction   materials   like    centrifuge/ 
filtration,  dryer/fluid  bed  dryer,  rotocone  proton  dryer,  vacuum  dryer,  frit 
mill, multi-mill/jet mills/sewetters cut sizing; 

(d)         test  for  absence  of  intermediate or  active  pharmaceutical ingredient  in  the 

final rinse. 

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4.4.          Written  procedures  shall  be  established  and  followed  for  cleaning  and 
maintenance of  equipment, including  utensils  used  in  the  manufacture, processing, packing 
or  holding  of  active  pharmaceutical  ingredients. These  procedures shall  include  but  should 
not be limited to the following : 

(c) 

(a)        assignment of responsibility for cleaning and maintaining equipment; 
(b) 

maintenance  and  cleaning  program  schedules,  including  where  appropriate, 
sanitizing schedules; 
a  complete  description  of  the  methods  and  materials  used  to  clean  and 
maintain  equipment,  including  instructions  for  de-assembling  and  re- 
assembling  each  article  of  equipment  to  ensure  proper  cleaning  and 
maintenance.; 

(d)        removal or obliteration of previous batch identification; 
(e)         protection of clean equipment from contamination prior to use; 
(f)         inspection of equipment for cleanliness immediately before use; 
(g) 

establishing  the  maximum  time  that  may  elapse  between  completion  of 
processing  and  equipment  cleaning  as  well  as  between  cleaning  and 
equipment reuse. 

4.5.       Equipment   shall   be   cleaned   between   successive   batches   to   prevent 
contamination  and  carry-over  of  degraded  material  or  contaminants  unless  otherwise 
established by validation. 

4.6.       As processing approaches the final purified active pharmaceutical ingredient, 
it  is  important  to  ensure  that  incidental  carry  over  between  batches  does  not  have  adverse 
impact  on  the  established  impurity  profile.  However,  this  does  not  generally  hold  good  for 
any  biological,  active  pharmaceutical  ingredient  where  many  of  the  processing  steps  are 
accomplished aseptically and where it  is  necessary to clean and sterilize  equipment between 
batches. 

5.     In-Process Controls: 

5.1. 

In-process control for chemical reactions may include the following: 

 reaction time or reaction completion; 

(a) 
(b)        reaction mass appearance, clarity, completeness or pH solutions; 
(c)         reaction temperature; 
(d)        concentration of a reactant; 
(e)         assay or purity of the product; 
(f)         process completion check by TLC / any other means. 

5.2. 

In-process control for physical operations may include the following: 

 appearance and colour; 

(a) 
(b)       uniformity of the blend;  
(c)       temperature of a process; 
(d)       concentration of a solution; 
(e)       processing rate or time; 
(f)        particle size analysis; 
(g)       bulk/tap density; 
(h)       pH determination; 
(i)        moisture content. 

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6.          Product Containers and Closures: 

6.1.       All  containers  and  closures  shall  comply  with  the  pharmacopoeial  or  any 
other  requirement,  suitable  sampling  methods,  sample  sizes,  specifications,  test  methods, 
cleaning procedures and sterilization procedures, when indicated, shall be used to assure that 
containers,  closures  and  other  component  parts  of  drug  packages  are  suitable  and  are  not 
reactive, additive, adsorptive or leachable to an extent that significantly affects the quality or 
purity of the drug. 

6.2.       The drug product container shall be tested or re-examined as appropriate and 
approved  or  rejected  and  shall  be  identified  and  controlled  under  a  quarantine  system 
designed to  prevent their  use  in  manufacturing or  processing operations for  which  these  are 
unsuitable. 

6.3        Container    closure    system    shall    provide    adequate    protection    against 
foreseeable external factors in storage / transportation and use that may cause deterioration or 
contamination of the active pharmaceutical ingredient. 

6.4.       Bulk  containers  and  closures  shall  be  cleaned  and,  where  indicated  by  the 
nature  of  the  active  pharmaceutical ingredient, sterilized to  ensure  that  they  are  suitable  for 
their intended use. 

6.5.      The  container  shall  be  conspicuously marked  with  the  name  of  the  product 

and the following additional information concerning : 

(a)       quality and standards, if specified; 
(b) 

 manufacturing   licence    number/drug    master    file    number    (whichever 
applicable), batch number; 

(c)       date of manufacture and date of expiry; 
(d) 

 method   for   container   disposal   (label   shall   give   the   methodology,   if 
required); 
 storage conditions, if specified and name and address of the manufacturer, if 
available. 

(e) 

6.6.       Areas  for  different  operation  of  active  pharmaceutical  ingredients  (bulk 
drugs)  section  shall  have  appropriate  area  which  may  be  suitably  partitioned  for  different 
operations. 

PART II 

REQUIREMENTS OF PLANT AND EQUIPMENT 

1.          External Preparations: 

The  following  equipment  is  recommended  for  the  manufacture  of  ‗External 
preparations‘ i.e.  Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders 
and such identical products used for external applications, whichever is applicable, namely :- 

(1) 

1[Mixing and storage tanks preferably of stainless steel  or any other appropriate 
material]. 
2[Stainless steel container] (steam, gas or electrically heated).  
Mixer (electrically operated). 

(2) 
(3) 
(4)        Planetary mixer. 
(5)        A colloid mill or a suitable emulsifier. 
(6)        A triple roller mill or an ointment mill. 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005; for ―mixing and storage tanks (Stainless steel)‖. 
2.  Subs. by  G.S.R. 431(E), dt. 30.6.2005; for ―Jacketted Kettle‖. 

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(7)        Liquid filling equipment (electrically operated). 
(8)        Jar or tube filling equipment 1 [***] 

Area. - (1) A minmum area of thirty square meters for basic installation and ten 

square meters for Ancillary area is recommended. 

(2) Areas for formulations meant for external use and internal use shall be 

separately provided to avoid mix-up. 

2[Note:  The  requirement  for  ancillary  area   in  this  part  shall  not  apply  to  units  registered 
before 1st January, 2002.] 

2.     Oral Liquid Preparations: 

The following equipments are recommended for the manufacture of oral/internal use 
preparations  i.e.   Syrups,  Elixirs,  Emulsions  and  Suspensions,  whichever  is   applicable, 
namely: - 

(1) 

3[Mixing and storage tanks preferably of Stainless steel or any other 
appropriate material]. 

(2)        Jacketted Kettle / Stainless steel tank (steam, gas or electrically heated). 
(3)        Portable stirrer (electrically operated). 
(4)        A colloid mill or suitable emulsifier (electrically operated). 
(5)        Suitable filtration equipment (electrically operated). 
(6)        Semi-automatic/automatic bottle filling machine. 
(7)        Pilfer proof cap sealing machine. 
(8)        Water distillation unit or deionizer. 
(9)        Clarity testing inspection units. 

Area. -   A  minimum area of thirty square meters for basic installation and ten square 

meters for Ancillary area is recommended. 

2[Note:  The  requirement  for  ancillary  area   in  this  part  shall  not  apply  to  units  registered 
before 1st January, 2002.] 

3.       Tablets: 

The Tableting section shall  be  free from  dust  and  floating particles and  may  be  air- 
conditioned.  For  this  purpose,  each  4[tablet  compression  machine]  shall  be  isolated  into 
cubicles  and  connected  to  a  vacuum  dust  collector  or  an  exhaust  system.  For  effective 
operations, the  tablet  production  department  shall  be  divided  into  four  distinct  and  separate 
sections as follows: - 

(a)    Mixing, Granulation and Drying section. 
(b)    Tablet compression section. 
(c)    Packaging section (strip/blister machine wherever required). 
(d)    Coating section (wherever required). 

3.1.       The  following  electrically  operated  equipments  are  recommended  for  the 
manufacture  of  compressed  tablets  and  hypodermic  tablets,  in  each  of  the  above  sections, 
namely: - 

(a)  Granulation-cum-Drying section: 

(1)     Disintegrator and sifter. 
(2)     Powder mixer. 
(3)     Mass mixer/Planetary mixer/Rapid mixer granulator. 

1.  The word ‗electrically operated‘  Omitted by G.S.R. 431(E), dt. 30.6.2005. 
2. Ins by  G.S.R. 431(E), dt. 30.6.2005. 
3  Subs.  by  G.S.R. 431(E), dt. 30.6.2005, for ―mixing and storage tanks (Stainless steel)‖. 
4. Subs.  by  G.S.R. 431(E), dt. 30.6.2005, for ‗tablet machine‘. 

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(4)      1[Granulator wherever required]. 
(5)  Thermostatically controlled hot air oven with trays (preferably mounted on a 

trolley)/Fluid bed dryer. 

(6)     Weighing machines. 

(b)  Compression section: 

(1)     Tablet compression machine, single/multi punch/rotatory. 
(2)     Punch and dies storage cabinets. 
(3)     Tablet de-duster 
(4)     Tablet inspection unit/belt. 
(5)     1[Dissolution test apparatus  wherever required]. 
(6) 

In-process testing equipment like single pan electronic balance, hardness tester, 
friability and disintegration test apparatus. 

(7)     Air-conditioning and dehumidification arrangement (wherever necessary) 

(c)  Packaging section: 

(1)     Strip/blister packaging machine. 
(2)     Leak test apparatus (vacuum system). 
(3)     Tablet counters (wherever applicable). 
(4)     Air-conditioning and dehumidification arrangement (wherever applicable). 

Area.  –  A  minimum  area  of  sixty  square  meters  for  basic  installation  and  twenty 

square meters for Ancillary area is recommended for un-coated tablets. 

(d)  Coating section: 

(1) 

Jacketted kettle  2[stainless steel container or any other appropriate material] 
(steam, gas or electrically heated for preparing coating suspension). 

(2)     Coating pan (Stainless steel). 
(3)     Polishing pan (where applicable). 
(4)     Exhaust system (including vacuum dust collector). 
(5)     Air-conditioning and Dehumidification Arrangement. 
(6)     Weighing balance. 

2[Note:  The  requirement  for  ancillary  area  in  this  part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

3.2.       The  coating section shall be  made dust  free with suitable exhaust system to 
remove  excess  powder  and  fumes  resulting  from  solvent  evaporation.  It  shall  be  air- 
conditioned and dehumidified wherever considered necessary. 

Area. –   A  minimum additional area  of  thirty  square  meters for  coating section  for 

basic installation and ten square meters for Ancillary area is recommended. 

Separate  area  and  equipment  for  mixing,  granulation,  drying,  tablet  compression, 
coating  and  packing  shall  be  provided  for  Penicillin  group  of  drugs  on  the  lines  indicated 
above.  In  case  of  operations involving dust  and  floating particles, care  shall  be  exercised to 
avoid cross-contamination. 

2[Note:  The  requirement  for  ancillary  area  in  this  part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

3.3.       The  manufacture  of  Hypodermic  tablets  shall  be  conducted  under  aseptic 
conditions  in  a  separate  air-conditioned  room,  the  walls  of  which  shall  be  smooth  and 
washable. The granulation, tableting and packing shall be done in this room. 

1. Subs. by  G.S.R. 431(E), dt. 30.6.2005. 
2. Ins. by  G.S.R. 431(E), dt. 30.6.2005. 

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The manufacture of effervescent and soluble 1 [***] tablets shall be carried out in air- 

3.4. 
conditioned and dehumidified areas. 

4.  Powders: 

The following equipment is recommended for the manufacture of powders, namely:- 

(1)     Disintegrator. 
(2)     Mixer (electrically operated). 
(3)     Sifter. 
(4)     Stainless steel vessels and scoops of suitable sizes. 
(5)     Filling equipment 1[***]. 
(6)     Weighing balance. 

In  the  case of operation involving floating particles of  fine powder, suitable exhaust 

system shall be provided. Workers should be provided with suitable masks during operation. 

Area.  –  A  minimum  area  of  thirty  square  meters  is  recommended  to  allow  for  the 
basic  installations.  Where  the  actual  blending  is  to  be  done  on  the  premises,  an  additional 
room shall be provided for the purpose. 

2[Note: The requirement for additional room in this part shall not apply to units registered 

before 1st January, 2002.] 

5.    Capsules: 

For  the  manufacture of  capsules, separate enclosed area suitably air-conditioned and 
dehumidified  with  an  airlock  arrangement  shall  be  provided.  The  following  equipment  is 
recommended for filling Hard Gelatin Capsules, namely: - 

(1)     Mixing and blending equipment (electrically or power driven). 
(2)     Capsules filling units 1[***]. 
(3)     Capsules counters (wherever applicable). 
(4)     Weighing balance. 
(5)     Disintegration test apparatus. 
(6)     Capsule polishing equipment. 

Separate equipment and,  filling and  packaging areas   shall  be  provided in  penicillin 
and non-penicillin sections. In case of operations involving floating particles of fine powder, a 
suitable exhaust system shall be provided. Manufacture and filling shall be carried out in air- 
conditioned area. The room shall be dehumidified. 

Area.  –A  minimum  area  of  twenty-five  square  meters  for  basic  installation  and  ten 
square  meters  for  Ancillary  area  each  for  penicillin  and  non-penicillin  sections  is 
recommended. 
2[Note:  The  requirement  for  ancillary  area   in  this  part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

6.    Surgical Dressing: 

The following equipment is recommended for the manufacture of Surgical Dressings 

other than Absorbent Cotton Wool, namely:- 

(1)        Rolling machine. 

1. Omitted   by  G.S.R. 431(E), dt. 30.6.2005. 
2. Ins.  by  G.S.R. 431(E), dt. 30.6.2005. 

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(2)        Trimming machine. 
(3)        Cutting equipment. 
(4)        Folding and pressing machine for gauze. 
(5)        Mixing tanks for processing medicated dressing. 
(6)        Hot air dry oven. 
(7)        Steam sterilizer or dry heat sterilizer or other suitable equipment. 
(8)        Work tables/benches for different operations. 

Area.  –  A  minimum  area  of  thirty  square  meters  is  recommended  to  allow  for  the 
basic installations. In case medicated dressings are to be  manufactured, another room with a 
minimum area of thirty square meters shall be provided. 

7.     Ophthalmic Preparations:. 

For the manufacture of Ophthalmic preparations, separate enclosed areas with airlock 
arrangement shall be provided. The following equipment is recommended for the manufacture 
under  aseptic  conditions  of  Eye-Ointment,  Eye-Lotions  and  other  preparations  for  external 
use, namely:- 

(1)       Thermostatically controlled hot air ovens (preferably double ended). 
(2)       Jacketted kettle/stainless steel tanks (steam, gas or electrically heated). 
(3)       Mixing and storage tanks of stainless steel/Planetary mixer. 
(4)       Colloid mill or ointment mill. 
Tube filling and crimping equipment (semi-automatic or automatic filling machines). 
(5) 
(6) 
Tube cleaning equipment (air jet type). 
(7)       Tube washing and drying equipment, if required. 
(8)       Automatic vial washing machine. 
(9)       Vial drying oven. 
(10)      Rubber bung washing machine. 
(11) 

Sintered glass funnel, Seitz filter and filter candle (preferably cartridge and membrane 
filters). 

(12)      Liquid filling equipment (semi-automatic or automatic filling machines). 
(13)      Autoclave (preferably ventilator autoclave). 
(14)  Air conditioning and dehumidification arrangement (preferably centrally air- 

conditioned and dehumidification system). 

(15)      Laminar airflow units. 

Area. –  (1) A  minimum area of  twenty-five square meters for basic installation  and 
ten square meters for Ancillary area is recommended. Manufacture and filling shall be carried 
out in air-conditioned areas under aseptic conditions. The rooms shall be further dehumidified 
as considered necessary if preparations containing antibiotics are manufactured. 

(2) Areas for formulations meant for external use and internal use shall be separately 

provided to avoid mix up. 
1[Note:  The  requirement  for  ancillary  area   in  this  Part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

8.        Pessaries and Suppositories: 

(i)  The  following  equipment  is  recommended  for  manufacture  of  Pessaries  and 

Suppositories, namely: - 

(1) Mixing and pouring equipment 
(2) Moulding equipment. 
(3) Weighing devices. 

1.  Ins.  by  G.S.R. 431(E), dt. 30.6.2005. 

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Area. –  A  minimum area  of  twenty square meters  is  recommended to  allow for  the 

basic installation. 

(ii)  In  the  case  of  pessaries  manufactured  by  granulation  and  compression,  the 

requirements as indicated under ―Item 3 of Tablet‖, shall be provided. 

9.          Inhalers and Vitrallae: 

The  following equipment is  recommended for  manufacture of  inhalers and  vitrallae, 

namely: - 

(1)  Mixing equipment. 
(2)  Graduated delivery equipment for measurement of the medicament during filling. 
(3)  Sealing equipment. 

Area.  –  An  area  of  minimum  twenty  square  meters  is  recommended  for  the  basic 

installations. 

10.    Repacking of drugs and pharmaceutical chemicals: 

The    following   equipment   is    recommended   for    repacking   of    drugs   and 

pharmaceuticals chemicals, namely:- 

(1)  Powder disintegrator. 
(2)  Powder sifter (electrically operated). 
(3)  Stainless steel scoops and vessels of suitable sizes. 
(4)  Weighing and measuring equipment. 
(5)  Filling equipment (semi-automatic / automatic machines). 
(6)  Electric sealing machine. 

Area.  –     An  area  of  minimum  thirty  square  metres  is  recommended for  the  basic 
installation.  In  case  of  operations  involving  floating  particles  of  fine  powder,  a  suitable 
exhaust system shall be provided. 

11.         Parenteral Preparations 

The  whole  operation  of  manufacture  of  parenteral  preparations  (small  volume 
injectables and large volume parenterals) in glass and plastic containers may be divided into 
the following separate areas/rooms, namely: - 

11.1      Parenteral preparations in  glass containers: – 

(1)     Water management area: This includes water treatment and storage. 
(2)  Containers and closures preparation area: This includes washing and drying of 

ampoules, vials, bottles and closures. 

(3)     Solution preparation area: This includes preparation and filtration of solution. 
(4)  Filling, capping and sealing area: This includes filling and sealing of ampoules and/or 

filling, capping and sealing of vials and bottles. 

(5)     Sterilization area 
(6)     Quarantine area 
(7)     Visual inspection area. 
(8)     Packaging area 

475 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

The  following  equipment  is  recommended  for  different  above-mentioned  areas, 

namely: - 

(a)   Water management area: 

(1)     De-ionised water treatment unit. 
(2)     Distillation (multi-column with heat exchangers) unit. 
(3)     Thermostatically controlled water storage tank. 
(4)     Transfer pumps. 
(5)     Stainless steel service lines for carrying water into user areas. 

(b)    Containers and closures preparation area: 

(1)  Automatic rotary ampoule/vial/bottle washing machine having separate air, water 

distilled water jets. 

(2)     Automatic closures washing machine, 
(3)     Storage equipment for ampoules, vials, bottles and closures. 
(4)     Dryer/sterilizer (double ended) 
(5)     Dust proof storage cabinets. 
(6)     Stainless steel benches/stools. 

(c)    Solution preparation area: 

(1)     Solution preparation and mixing stainless steel tanks and other containers. 
(2)     Portable stirrer. 
(3)     Filtration equipment with cartridge and membrane filters/bacteriological filters. 
(4)     Transfer pumps. 
(5)     Stainless steel benches/stools 

(d) Filling, capping and sealing area: 

(1)  Automatic ampoule/vial/bottle filling, sealing and capping machine under laminar air 

flow workstation. 

(2)     Gas lines  (Nitrogen, Oxygen, Carbon dioxide) wherever required. 
(3)     Stainless steel benches / stools. 

(e)  Sterilization area: 

(1)  Steam sterilizer (preferably with computer control for sterilization cycle along with 

trolley sets for loading/unloading containers before and after sterilization). 

(2)     Hot air sterilizer (preferably double ended). 
(3)     Pressure leak test apparatus. 

(f) Quarantine area. – 

(1)     Storage cabinets. 
(2)     Raised platforms/steel racks. 

(g) Visual inspection area: 

(1)  Visual inspection units (preferably conveyor belt type and composite white and black 

assembly supported with illumination). 

(2)     Stainless steel benches/stools. 

(h) Packaging area. - 

(1)     Batch coding machine (preferably automatic). 

476 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(2)     Labelling unit (preferably conveyor belt type). 
(3)     Benches/stools. 

Area.  –  (1)  A  minimum  area  of  one  hundred  and  fifty  square  meters  for  the  basic 
installation and an Ancillary area of one hundred square meters for Small Volume Injectables 
is  recommended.  For  Large  Volume  Parenterals,  an  area  of  one  hundred  and  fifty  square 
meters  each  for  the  basic  installation  and  for  Ancillary  area  is  recommended.  These  areas 
shall be partitioned into suitable enclosures with airlock arrangements. 

(2) Areas for formulations meant for external use and internal use shall be separately 

provided to avoid mix up. 

(3)  Packaging  materials  for  large  volume  parenteral  shall  have  a  minimum  area  of 

100 square meters. 
1[Note: The  requirement for  ancillary  area   in  this   part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

11.2      Parenteral  preparations  in  plastic  containers  by  Form-Fill-Seal/Blow, Fill- 
Seal   Technology.-The   whole   operation   of   manufacture   of   large   volume   parenteral 
preparations in plastic containers including plastic pouches by automatic (all operations in one 
station)  Form-Fill-Seal  machine  or  by  semi-automatic  blow  moulding,  filling-cum-sealing 
machine may be divided into following separate areas/rooms, namely: - 

(1) Water management area. 
(2) Solution preparation area. 
(3) Containers moulding-cum-filling and sealing area. 
(4) Sterilization area. 
(5) Quarantine area . 
(6) Visual inspection area. 
(7) Packaging area. 

The  following  equipment  is  recommended  for  different  above  mentioned  areas 

namely: - 

(a)  Water management area: 

(1)     De-ionised water treatment unit. 
(2)     Distillation unit (multi column with heat exchangers). 
(3)     Thermostatically controlled water storage tank. 
(4)     Transfer pumps. 
(5)     Stainless steel service lines for carrying water into user areas. 

(b) Solution preparation area: 

(1)     Solution preparation and storage tanks. 
(2)     Transfer pumps. 
(3)     Cartridge and membrane filters. 

(c)  Container moulding-cum-filling and sealing area: 

(1)  Sterile Form-Fill-Seal machine (all operations in one station with built-in laminar air 
flow workstation having integrated container output conveyor belt through pass box). 

(2)  Arrangement for feeding plastic granules through feeding-cum-filling tank into the 

machine. 

1. Ins. by 431(E), dt. 30.6.2005. 

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Drugs and Cosmetics Rules 1945 

(d)  Sterilization  area:  Super  heated  steam  sterilizer  (with  computer  control  for 
sterilization  cycle  along  with  trolley  sets  for  loading/unloading  containers  for 
sterilization). 

(e) Quarantine area:- Adequate number of platforms/racks with storage system. 

(f) Visual inspection area. - Visual inspection unit (with conveyor belt and composite 

white and black assembly supported with illumination). 

(g) Packaging area: 

(1)      Pressure leak test apparatus (pressure belt or rotating disc type). 
(2)      Batch coding machine (preferably automatic). 
(3)      Labelling unit (preferably conveyor belt type). 

Area. –   (1)  A  minimum  area  of  two  hundred and  fifty  square meters for  the  basic 
installation  and  an  Ancillary  area  of  one  hundred  and  fifty  square  metres  for  large  volume 
parenteral  preparations  in  plastic  containers  by  Form-Fill-Seal  technology  is  recommended. 
These areas shall be partitioned into suitable enclosures with airlock arrangements. 

(2) Areas for formulations meant for external use and internal use shall be separately 

provided to avoid mix up. 

(3) Packaging   materials  for large volume parenteral shall have a  minimum area of 

100 square meters.] 

1[Note:  The  requirement  for  ancillary  area   in  this  part  shall  not  apply  to  units  registered 

before 1st January, 2002.] 

1[Note  I:   There  are  certain  categories of  drugs  such  as  chemicals  and  pharmaceutical  aids, 
gauzes  and  bandages,  medicinal  gases,  empty  gelatin  capsules,  non-  chemical/mechanical 
contraceptives,  diagnostic  kits  and  reagents,  medical  devices,  new  dosage  forms  and  their 
delivery  systems,  disinfectant  fluids,  antacids,  raw-materials  manufactured  from  sea  bittern, 
veterinary  biologicals  including  poultry  vaccines,  re-packing  of  drugs,  etc.  for  which  this 
Schedule does  not  prescribe specific requirements of  space and  equipments.   The  Licensing 
Authority, as  the  case  may  be,  in  respect of  such  categories of  drugs, have  the discretion to 
modify  the  requirements  of  this  Schedule,  if  he  is  of  the  opinion  that  having  regard  to  the 
nature off the products and extent of manufacturing operations and for reasons to be recorded 
in writing, it is necessary to relax or alter them in the circumstances of a particular case and 
direct  the  manufacturer to  carry  out  necessary  modifications in  them  and  the  modifications 
having been made, approve the manufacturer of such categories of the drugs. 

Note II:  In case of manufacturers licensed to manufacture drugs prior to the 11th December, 
2001,  the requirements of this Schedule shall also apply to them from 1st July, 2005.] 

1. Ins. by G.S.R. 431(E), dt. 30.6.2005. 

478 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [SCHEDUE M-I 
[See Rule 85E (2)] 

GOOD MANUFACTURING PRACTICES AND  REQUIREMENTS  OF PREMISES, 
PLANT AND EQUIPMENT  FOR HOMOEOPATHIC MEDICINES 

1.GENERAL REQUIREMENTS: 

1.1 Location and Surroundings: - The premises shall be situated at a clean place which 
shall  not  be  adjacent    to  open  drains,  public  lavatory  or  any  factory  producing 
pollution of any kind, garbage dump,  slaughter  house or any other source likely 
to  cause  contamination    from  the  external  environment.  The  premises  shall  be 
located away from railway lines so that the performance of sensitive electronic 
equipment is not affected by vibrations.  There shall be no open drains inside or 
outside  the  manufacturing  premises.  It  shall  be  so  designed  that  the  entry  of 
rodents is checked. The drains shall facilitate easy flow of the effluent and shall 
be cleared periodically. 

1.2 Building: - The premises shall not be used for any purpose other than manufacture 
of homoeopathic drugs and no part of the manufacturing  premises shall be used 
for any other purpose. Other facilities, if needed, could be provided in separate 
building(s)  in  the  same  campus.  Crude  raw  materials,  packing  materials,  etc. 
shall be stored and handled in places earmarked for them and shall not be taken 
inside  areas  where  critical  operations  of  manufacture    are  done  excepting 
processed  raw  material.  Heating,  washing,  drying,  packing  and  labelling  etc. 
wherever  needed,  shall    be  done  in  dedicated  ancillary  areas  adjacent    to  the 
manufacturing  sections  concerned.  The  walls  and  floorings  of  manufacturing 
areas  shall  be  smooth  and  free  from  chinks,  cracks  and  crevices  and  shall  be 
washable.    The  design  of  the  windows,  windowpanes  and  all  fittings  shall  be 
such  that  they  will  not  facilitate  accumulation  /  lodging  of  dust  and  other 
contaminants. 

1.  Subs. by G.S.R. No. 678(E) , dt. 31-10-2006, for Schedule MI. Earlier Schedule MI was inserted by G.S.R. 507 (E), dt: 

12.6.1987. Schedule M1, before substitution, stood as under.: 

1. Requirement of factory premises for manufacture of Homeopathic preparations- 

―
SCHEDUE M-I 
[See Rule 85E (2)] 

(a) 

(b) 

Location and surroundings. -    The factory shall be situated in a place which shall not be adjacent 
to  an  open  sewage  drain,  public  lavatory  or  any  factory  which  produces  a  disagreeable  or 
obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in 
a sanitary place, remove from filthy surroundings. 

Buildings.  -   The  part  of  the  building  used  for  manufacturing  shall  not  be  used  for  a sleeping 
place and no  sleeping place adjoining to  it  shall communicate therewith except through open air 
or  through an  intervening open  space. The  walls  of  the  room  in  which manufacturing operations 
are carried out shall, upto a height of six feet from the floor, be smooth, waterproof and  shall be 
capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as 
not to permit retention or accumulation of dust. There shall be no chinks or crevices in the walls or 
floor. 

(c) 

The  building used  for  the  factory  shall  be  constructed so  as  to  permit production under hygienic 
conditions laid down in the Factories Act, 1948 (63 of 1948). 

(d)  Water  Supply.  -    The  water  used  in  manufacture  shall  be  pure  and  drinkable  quality,  free  from 

pathogenic microorganisms. 

(e) 

Disposal of waste. -   There should be adequate arrangement for disposal of waste-water and other 
residues from the laboratory. 

479 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(f) 

(g) 

The    rooms    should    be    airy    and    clean    and    the    temperature    of    the    room    should    be 
moderately comfortable. 

Health,  Clothing  and  Sanitary  requirement  of  the  Staff.  -    All  workers  shall  be  free  from 
contagious  or  obnoxious  disease.  Their  clothing  shall  consist  of  a  white  or  coloured  uniform 
suitable  to  the  nature  of  the  work  and  the  climate,  and  shall  be  clean.  Adequate  facilities  for 
personal  cleanliness,  such  as  clean  towels,  soap  and  hand  scrubbing  brushes,  shall  be  provided 
separately for each sex. The workers shall be required to wash and change  into  clean  footwear  
before  entering  the  rooms  where  the  manufacturing operations are carried on. Workers shall be 
required  to  wear  either  a  clean  cap  or  a  suitable  headgear  so  as  to  avoid  any  possibility  of 
contamination by air or perspiration. 

(h)  Medical  services.  -   The  manufacturer shall  provide  adequate  facilities  for  First  Aid, Medical 
inspection of  workers  at  the  time  of  employment and  periodically  check-up thereafter at least 
once a year. 

(i) 

(j) 

Working  benches.  -   Working  benches  shall  be  provided  for  carrying  out  operations such  as  
filling,  labelling,  packing  etc.  Such  benches  shall  be  fitted  with  smooth, impervious tops 
capable of being washed. 

Container  management.  -    Where  operations  involving  use  of  containers  such  as bottles, 
phials  and  jars  are  conducted,  there  shall  be  adequate  arrangements  separated  from 
potentisation chamber for washing, cleaning and  drying   such   containers,   with 
suitable equipment for the purpose. Wherever these are  attended manually adequate precaution 
of perfection in respect of cleanliness and avoidance of pollutants shall be taken. 

2.    Requirements of Plant and Equipment: 

(a)    Mother tinctures. External tinctures and Mother solution section. -   The following plant and 

equipment shall be provided namely: - 

(i)      Disintegrator. 
(ii)     Sieved Separator. 
(iii)    Balances and fluid measures.  
(iv)    Chopping boards and knives.  
(v)     Macerators with lids. 
(vi)   Percolators with lids and regulated discharge. 
(vii) Moisture determination apparatus or other suitable arrangement.  
(viii)   Filtering arrangement. 
(ix)      Mixing vessels and suitable non-metallic storage containers.  
(x)       Portable stirrers. 
(xi)      Water still. 

Note:  (1) As far as possible metal contacts may be avoided once the drug is processed. (2) 

An area of 

55 sq. meters is recommended for basic installations. 

(3) 

(4) 

(5) 

Adequate  separate  storage  facility  should  be  provided  for  raw  material 
quarantine, storage and bonded room for alcohol where applicable. 

Separate  and  suitable  storage  facility  should  be  provided  for  fresh  herbs and 
odorous raw materials. 

Adequate laboratory facility shall be provided for testing of raw  materials and 
finished products, 

(b)     Potentisation Section.  -  (1)  The  following arrangements are  recommended for 

container for closure preparation section namely: 

(i)    Washing tanks with suitable brushing arrangement manual or mechanical.  
(ii)   Purified Water rinsing tank 
(iii)   Closure macerating or washing tanks.  
(iv)   Drying chambers. 

An area of 20 sq. meters is recommended for basic installations. 

480 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2)     The following arrangements are recommended for potency preparation section, namely: 

Drugs and Cosmetics Rules 1945 

– 

(i)    Working tables with washable top. 
(ii)   Facilities for separate storage of different grades of back potencies. 
(iii)   Suitable measuring devices for discharge of drug and diluent in potentisation vial, 
(iv)   Potentiser with counter or suitable manual arrangement. 

Note: - (1) Different droppers shall be used for different drugs potencies. 

(2) All measuring devices shall be of metric system and be made of glass and shall be free from 

metallic contents. 

(3)  It  is  desired  that  glass  droppers  etc.  intended  for  re-use  after  cleaning should be 

sterilized by autoclave or heating in a hot air oven. 

(4) Plastics, rubber tubes, bulks etc. coming in contact with tinctures or back potencies should 

not be re-used for other tincture and potencies. 

(5)  Method  of  potentisation  will  be  adopted  as  specified  in  Homoeopathic 

Pharmacopoeia of India Vol. I. 

3. Triturating, Tableting and Pill/Globules section - 

(3) 

 The following arrangements are recommended: (i)

 Triturating machine for suitable device. 

(ii)        Disintegrator. 

(iii)       Mass Mixer. (iv)       
Granulator. (v)        
Oven. 
(vi)       Tableting punches or machines. 
(vii)      Kettle (Steam/gas/electrically heated) for preparation solution. (viii)     Dryers. 
(ix)       Sieved separator, tablet counters and balances. 

Note: Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is 

recommended for basic installations. 

(4)       Ointments and lotion section: 

The following arrangements are recommended namely: - 

(i)         Mixing tank 
(ii)        Kettle (Steam, gas or electrically heated). (iii)       
Suitable powder mixer 
(iv)       Ointment mill 
(v)        Filling equipment or arrangement. 

An area of 20 sq. meters is recommended for basic installations. (5)       Syrups 

and tonics: 

The following arrangements are recommended namely:- (i)

Mixing and storage tank. 

(ii)        Potable mixer. 
(iii)       Filtering equipment. (iv)       
Water still / Deioniser. 

(v)        Filling and sealing equipment. 

481 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
An area of 20 sq. meters is recommended for basic installations. (6)     

Drugs and Cosmetics Rules 1945 

Ophthalmic Preparations: 

The  following  equipment  is  recommended  for  manufacture  under  aseptic  conditions  of  Eye-
Ointments, Eye-Drops, Eye-lotions and other preparations for external use, namely: - 

Hot air even electrically heated with thermostatic control. (ii)  Colloid 

Kettle (gas or electrically heated) with suitable mixing arrangement. (iv)  Tube 

(i) 
mill or ointment mill. 
(iii) 
filling equipment. 
(v)  Mixing  and  storage  tanks  of  stainless  steel  or  of  other  suitable material. 
(vi)      Sintered glass funnel, Seitz filter or filter candle. (vii)    
Liquid filling equipment. 
(viii)   Autoclaves. 

Adequate precaution should be taken to ensure that the finished product is sterile. An area of 20 sq. 

meters is recommended for basic installations. 

(7) 

Adequate arrangements for space and equipment should be made for labelling and packing.‖ 

2.  PLANT AND EQUIPMENT: 

2.1 General: - The design of the plant shall be suitable for the nature and quantum 
of  the  activities  involved.  Equipment  shall  be  installed  in  such  a  manner  as  to 
facilitate easy flow of materials and to check criss-cross movement of the personnel.   
The entry to all manufacturing sections shall be regulated and persons not associated 
with  the  activities  in  the  sections  shall  not  have  access  to  them.    There  shall  be 
arrangements for personal cleanliness of workers and toilets.  These shall be separate 
for men and women workers. There shall be suitable arrangement, separate for men 
and women, to change from their outside dress and footwear into the factory dress and 
footwear.      Uniforms  of  suitable  colours  and  fabric  which  facilitate  proper  washing 
and  which  do  not  shed  fibres  other  contaminants  shall  be  provided.    Suitable  head-
covers and gloves shall be provided to the workers. The manufacturing premises shall 
not be used for dining. There shall be separate area for the personnel to take food or 
rest.  Toilets  shall  be  located  in  or  adjacent  to  any  of  the  areas  concerned  with  any 
the 
manufacturing  activity.  Spitting,  smoking,  chewing, 
manufacturing or ancillary areas shall not be permitted.  Standard operating practices 
(SOPs)  for  cleaning  and  sanitation,  personal  hygiene  of  the  workers,  general  and 
specific  upkeep  of  the  plant,  equipment  and  premises  and  every  activity  associated 
testing  and 
with  manufacture  of  drugs 
warehousing of material shall be written and adopted.  No person with any contagious 
disease shall be involved in any of the manufacturing activities. There shall be proper 
arrangements  for  maintenance  of  the  equipment  and  systems.    The  performance  of 
every  equipment  and  system  shall  be  properly  validated  and  their  use  shall  be 
monitored. Dos and don‘ts in the matter of the use of the plant and equipment as may 
be applicable shall be written and displayed in all places. 

including  procurement,  quarantine, 

littering,  etc. 

in 

There shall be separate dedicated areas for each ancillary activity such as receipt, 
cleaning, warehousing and issue of raw materials, packaging materials, containers and 
closures,  finished  goods  etc.  Adequate  measures  shall  be  taken  to  prevent 
entry/presence  etc.  of  insects,  rodents,  birds,  lizards  and  other  animals  into  the  raw 
material  handling  areas.  Every  material  shall  have  proper  identification  and  control 
numbers and inventory tags and labels displaying status of the quality being used, etc.   
There shall  be proper arrangements and SOPs for preventing mix-up of materials at 
every  stage  of  handling.  There  shall  be  separate  arrangements  for  handling  and 
warehousing  of  materials  of  different  origins.  Materials  with  odour  shall  be  kept  in 
tightly  closed  containers  and  shall  be  well  protected  from  other  materials.  Fresh 
materials and odorous materials shall, preferably be stored in separate dedicated areas.  
Where  bonded  manufacturing  and  /  or  warehousing  facilities  are  required  as  per 

482 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Excise    laws,    the  facilities  required  shall  be  provided    without  compromise  on  the 
requirements specified above. 

A well equipped laboratory for quality control/quality assurance of raw materials 

and finished products and for carrying out in-process controls shall be provided. 

(a)  Rooms: - The rooms shall be airy, ventilated, and maintained at temperatures  
which are moderate and comfortable.  Sections which  are required to be sterile, air-
conditioned and provided with air handling system shall be designed accordingly. All 
sections  shall  be  free  from  insects,  birds, rodents,  worms  etc. and  suitable  measures 
shall be taken to prevent the same from finding ways to the sections and equipment. 

(b)  Water:  - The water used for manufacture of drugs shall be of the quality as 
prescribed  in the rules or in the Homoeopathic Pharmacopoeia concerned, as the case 
may be, and shall be prepared from pure drinking quality water, free from pathogenic 
organisms. 

(c)  Disposal of waste: - Effluents, organic and inorganic  wastes shall be disposed 
of in such a manner  as may be prescribed in the laws pertaining to pollution control 
and if no such law exists in the place of manufacture, they shall be rendered harmless 
and shall be disposed of in such a manner that they are not hazardous to health of the 
public or cattle or plants.      

(d) Factories Act: - The provisions of the Factories Act, 1948(Act 63 of 1948), as 

applicable shall be adhered to. 

(e)    Medical    Services:-  All  persons  concerned  with  any  activity  pertaining  to 
manufacture of drugs including handling of raw materials, packing materials, packing 
and  labelling  of  drugs,  etc.  shall  be  medically  examined  for  fitness  at  the  time  of 
employment  and  subsequently  at  periodic  intervals  and  records  thereof  shall  be 
maintained. 

(f)   Safety measures: - First-aid facilities shall be provided in such a manner that 
they are easily accessible and staff shall be imparted knowledge and training in first-
aid measures as may be needed. Fire control equipment in suitable numbers shall be 
provided    at  easily  accessible  places  near  all  sections  including    stores  and 
warehouses. 

(g)   Workbenches: - Workbenches suitable to the nature and quantum of the work 
involved shall be provided in all sections.  Such work benches  in general, shall have 
smooth,  washable  and  impervious  tops  and  the  parts  shall  not  be  rough  or  rusty  or 
damaged otherwise. 

(h)  Container  management:  -  Proper  arrangements  shall  be  made  for  receiving 
containers,  closures  and  packing  materials  in  secluded  areas  and  for  de-dusting  the 
same, removal of wastes, washing, cleaning and drying. Suitable equipment shall be 
provided as may be needed, considering  the nature of work involved.  Where soaps 
and  detergents  are  used  to  wash  containers  and  closures  used  for  primary  packing, 
suitable procedure shall be prescribed and adopted for total removal of such materials 
from the containers and closures. Plastic containers which are likely to absorb active 
principle or which are likely to contaminate the contents may not be used. 

Glass  containers  used  shall  be  made  of  neutral  glass.  The  closures  and  washers 
used  shall  be  of  inert  materials  which  shall  not  absorb  the  active  principles  or 
contaminate the contents or which may otherwise be likely to cause deterioration of 
quality. The containers, closures and packing materials shall protect the properties of 
the medicines, Tablets, if blister-packed, shall have secondary protective packaging to 
protect the medicines from moisture, odour etc. Neutral glass phials and epoxy-coated 
closure  shall  be  used  for  eye-drops.  Transparent  plastic  containers  may  be  used  for 
eye-drops  containing  only  aqueous  preparations.  Sterile  plastic  nozzles  may  be 
provided to eye-drops separately along with the medicine, whatever needed. 

2.2. Personnel.- Manufacture of drugs shall be under the control of approved technical staff 
that shall possess the qualifications prescribed in rule 85.  

483 

 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.  REQUIREMENT OF EQUIPMENT AND FACILITIES: 

3.1  Mother  tinctures  and  mother  solutions:-  The  following  equipment  and  facilities 

shall be provided:- 

(i)  Disintegrator; 
(ii) Sieved separator; 
(iii) Balances, weights and fluid measures, all in metric system;  
(iv) Chopping table/board and knives; 
(v) Macerators with lids (all made of stainless steel of grade 304 or neutral glass); 
(vi) Percolators (all made of stainless steel of grade 304);  
(vii) Moisture determination apparatus; 
(viii) Filter press/Sparkler filter (all metal parts shall be of stainless steel);   
(ix)  Mixing and storage vessels (Stainless steel of grade 304); 
(x) Portable stirrers (Rod, blades and screws shall be of stainless steel);  
(xi)  Water still/water purifier; 
(xii) Macerators and percolators for preparing mother solutions of materials of chemical 
origin.  These shall be  of material, which will not react with the chemicals, used and 
which  do not bleach; and 
(xiii) Filling and sealing machine. 

The area and facilities for manufacture of mother tinctures and mother solutions shall be 

separate and shall be 55 square meters for each for basic installations. 

3.2 

Potentisation  section :- The section shall have the following facilities:-  
(i) 
(ii)   Facilities for orderly storage of different potencies and back-potencies of various  

 Work benches with washable impervious tops; 

drugs; 

(iii) Suitable devices for measuring and dispensing of potencies/back-potencies into the 

potentisation phials; 
(iv)  Potentiser with counter. 

An area of 20 square meters shall be provided for basic installations.  

Note: - 

(a) 

The  requirement  of  potentiser  is  not  mandatory.    The  process  may  be  done 
manually  also  with  proper  SOPs.  Potentiser,  if  used,  shall  be  properly  validated  and  shall  be 
calibrated every time before commencement of work for proper performance. 

(b) 
The manufactur er sh all  use  back-poten cies  procur ed fr om Licen sed 
manufacturers  and  the  firm  shall  maintain  proper  records  of  purchase  or  shall  prepare 
own-back  potencies  .  Every  container  of  potencies  and  back-potencies  shall  be  kept  properly 
labelled and there shall not be mix-up of different medicines and different potencies. 

3.3 
Containers  and  Closures  Section:  -  Separate  area  for  preparation  of  containers  and 
closures  shall  be  provided  adjacent  to  the  potentisation  section.    This  area  shall  have  the 
following facilities:- 

(i) 
(ii) 
(iii) 
(iv) 

 Washing tanks with suitable mechanical or hand operated brushes;  
 Rinsing tanks. Purified water shall be used for rinsing; 
 Closures washing / macerating tanks;  
 Driers; 

Note: - 
(a)  Different  droppers  shall  be  used  only  for  each  different  medicine  and  different 

potency. 

(b)  All  measures  shall  be  in  metric  system.    Measures  used  shall  be  of  neutral  glass.  

Metal droppers and plastic droppers shall not be used. 

(c) Glass droppers shall be reused only after proper cleaning and sterilization. 

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(d)  Potentisation  shall  be  done  by  the  method(s)  prescribed  in  the  Homoeopathic 

Drugs and Cosmetics Rules 1945 

Pharmacopoeia of India. 

3.4  Trituration,    Tableting,  Pills  and  Globules  making    sections:-  The  following  basic 
equipment and facilities shall be provided:- 

 Triturating Machine;  

(i) 
(ii)   Disintegrator; 
(iii)  Mass Mixer;  
(iv)   Granulator; 
(v)  Electrical Oven; 
(vi)   Tablets punching Machine; 
(vii)  Kettle (steam or electrically heated ) for preparing solutions;  
(viii) Driers for drying granules and tablets; 
(ix)   Sieved separator (stainless steel);  
(x)  Tablet counter; 
(xi)   Balances; 
(xii)  Coating Pan with spray-gun;  
(xiii)  Multi-sifter 
(xiv)  Mill with perforations. 

An area of 55 square meters shall be provided  for basic installations. The area shall be 

suitably divided into cubicles to minimize cross contamination, mix-up etc. 

Note:  -  The  section  shall  be  free  from  insects,  worms,  rodents,  dust  and  other  floating 

particles and moisture. 

3.5 Syrups and other oral liquids section:- The following basic equipment and facilities shall 
be provided:- 

 Mixing and storage tanks (stainless steel of grade 304); 
  Portable stirrer (rod, blades and screws shall be of stainless steel);  
 Filter  press / Sparkler filter (all metal parts shall be of stainless steel);   
  Filling and sealing machine; 
pH meter. 

(i) 
(ii) 
(iii) 
(iv) 
(v) 
An area of 20 square meters shall be provided  for basic installations.   The section shall 
be  free  from  dust  and  other  floating  particles,  cobwebs,  flies,  ants  and  other  insects,  birds, 
lizards and rodents. 

(1)    Adequate number of workbenches shall be provided. 
(2)    Visual inspection table shall be provided. This shall comprise of a colour con trast 

backgr ound with  lamp  for providing  diffused  ligh t, mounted on a suitable table. 

3.6  Ointments and lotions section :- The following basic equipments and facilities shall be 

provided:- 
(i)    Mixing tanks (Stainless steel) 
(ii)    Kettle (steam or electrically heated) for preparing solutions 
(iii)    Suitable powder / planetary Mixer 
(iv)    Ointment mill / colloidal Mill / Emulsifier 
(v)    Filling and sealing machine / Crimping machine 
(vi)    Filtering equipment 
(vii)    Balance and weights 

A  minimum  area  of  20  square  meters  shall  be  provided  for  basic  installations.  An 
ancillary  area  for  washing  vessels  and  equipment    shall  be  provided.    An  ancillary  area  for 
heating purposes shall also be provided. 

3.7  Ophthalmic  preparations  section:-  The  following  basic  equipment  and  facilities  shall 

be provided:- 
(i)  Hot air oven, electrically heated, with thermostatic control;  

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(ii)  Laminar Air Flow bench; 
(iii) Air Handling Unit with HEPA filters to provide filtered air and positive pressure to 
the section and air-locks; 
(iv)    Ointment mill / colloidal mill; 
(v) Mixing and storage tanks (Stainless steel of grade 304);  
(vi) Pressure vessels, as may be needed; 
(vii) Sintered glass funnels, Seitz Filter / Filter candle;  
(viii) Vacuum pump; 
(ix)    Filling machines for liquids ointments etc.; 
(x)    Autoclaves with pressure and temperature gauges; and 
(xi)    Necessary workbenches, visual inspection bench, etc. 

Area: Minimum area of 20 square meters shall be provided for basic installations.   

Note: - 

1.   The section shall have a clean room facility of Class 100 specification. 
2.   The section shall be air-conditioned and humidity controlled. 
3.    Entry  to  the  sections  shall    be  regulated  through    air-locks  with  differential  air 
pressures  with  the  air-lock  adjacent  to  the  section  having  higher  pressure  and  the  first  one 
through which entry is made with the least pressure. 

4. Materials shall be passed to the sections through suitable hatches. 
5.      The  personnel  shall  wear  sterile  clothing  including  headgear,  which  shall  not  shed 

fibre. 

6.      Washing  of  phials  shall  be  done  in  separate  areas  with  proper  equipment.    Proper 

facilities shall be provided in the area for washing vessels. 

7. 

Separate area shall be provided  for packing and labelling. 

4. QUALITY CONTROL DIVISION: 

4.1  Functions:  -  A  separate  quality  control  division  shall  be  provided  in  the  premises. 
The  section  shall  be  under  the  control  of  an  approved  technical  officer,  independent  of  the 
manufacturing  division  and  directly  responsible  to  the  management.  The  section  shall  be 
responsible for ensuring the quality of all raw materials, packing materials and finished goods. 
The section shall also carry out in-process quality checks of the products. The section shall be 
responsible  for  the  stability  of  the  products  and  for  prescribing  their  shelf  life  wherever 
applicable. 

The functions of the division shall include:- 
(1)      To  test  the  identity,  quality  and  purity  of  the  raw  materials  and  to  recommend 
rejection  of the material  of poor quality and approve materials  of the prescribed 
quality only. 

(2)  To test the identity,  quality and purity of the finished products and to recommend 
rejection of the material of poor quality and to approve materials of the prescribed 
quality only. 

(3)  To prepare and validate  the methods of analysis, validate  the equipment,  

monitor their use, take steps for proper maintenance, etc. 

(4)  To approve or reject container s, closures  and  packaging  materials  in accordance 

with the prescribed norms. 

(5)  To exercise / carry out in-process control of products. 
(6)  To prescribe SOPs on all matters concerning quality of materials and products.   
(7)  To monitor the storage and handling  of raw materials, finished products, 

containers, closures and packaging materials. 

(8)  To investigate complaints on quantity of products and take / recommend appropriate 
measures and to examine returned goods and recommend their proper disposal. 

4.2  Personnel:  - The quality control staff shall be full-time personnel.  Analysis and tests of 
drugs,  raw  materials,  etc.  shall  be  done  by  qualified  and  approved  technical  staff.      The 
technical  staff shall  have the minimum  qualification  of degree in Homoeopathic Pharmacy 
or  Science  with  Chemistry  or  Botany  as  the  principal  subject  and  experience  of  not  less  than 

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two years in the test and analysis of medicines including handling of instruments. 

Drugs and Cosmetics Rules 1945 

4.3 Equipment: - The following equipment shall be provided:- 

 Microscope of suitable magnification and photographic device;  
(i) 
 Dissecting microscope; 
(ii) 
 TLC apparatus;  
(iii) 
 UV lamp viewer; 
(iv) 
Monopan Digital Electronic Balance;  
(v) 
 Hot air oven; 
(vi) 
 Distillation apparatus;  
(vii) 
(viii) 
 Water Bath; 
(ix)        Polarimeter; 
(x) 
(xi) 
(xii) 
(xiii) 
(xiv) 
(xv) 
(xvi) 
(xvii) 
(xviii) 
(xix) 

Refractometer; 
 Melting point apparatus;  
 pH meter; 
 Magnetic stirrer;  
 Table Centrifuge; 
 Muffle furnace / electric Bunsen;  
 Moisture determination apparatus;  
  U.V. Spectrophotometer; 
 Rotary microtome / Section cutting facilities;  
 Tablet Disintegration Machine. 

5. RAW MATERIALS: 
5.1 Raw materials of Plant Origin:- 
(a)  The raw materials of plant origin used for manufacture of drugs shal l be of the following 
specifications:- 

(i)      the  materials  shall  be  those  recently  collected  and  dried  and  shall  be  free  from 
moisture so as to eliminate the risk of deterioration and infestation with pests moulds, etc. The 
materials  shall  be  collected  when  the  atmospheric  temperature  is  suitable  where  its  active 
constituents are not changed / damaged / destroyed. 

(ii)  when fresh materials are to be used, the time lapse from the time of collection to  
use shall be minimized to the extent possible; 
(iii) the materials  should be taken from healthy plants and shall be free from parasites, 

moulds,  etc.; 

(iv) the materials shall be free of inorganic or organic foreign matter; 
(v)  when  dry  materials  are  procured,  they  shall  be  from  healthy  plants  and  shall  be  in  
unprocessed  form,  free  from  all  extraneous    matters    such  as  fungus,  insects,  moulds, 
pathogenic  organisms,  etc.  and  should  not  be  more  than  six  months  old.    Plant  materi  alsof 
Agaricaceae, which are perishable shall be used within one week of ollection. 

(b) To facilitate proper identification and purity of the material and to exercise proper quality 
control of the material, the following conditions must be satisfied:- 

(i)   a small twig of the plant with leaves shall be available if the part used is bark  of the 

plant; 

(ii) 

 an  entire  plant  or  part  or  aerial  twig  with  leaves  and  some  uncut  roots  / 

rhizomes / bulbs shall be available if the part used is a root /rhizome / bulb; 

(iii) 

 if plants with flowers are to be used, a few dry flowers shall also be ava ilable 

with the aerial twig; 

(iv) 

 if  the  material    used  is  a  mould  or  of  the  plant  families  Agaricaceae, 
Polyporaceae/  amanitacaea  /  Boletaceae  /  Russulaceae,  a  whole  specimen  plant  /  mould  shall 
be available in properly dried form; 

(v) 
(vi) 

the materials shall be free from insecticides, fungicides, etc; 
 the materials shall be in open mesh bags or in suitable material which permits 

the passage of air inside; 

(vii) 
supplier‘s  name;  name  of  the  plant  with  description  of  the  part  supplied.  The 

 each consignment of the material shall be accompanied by a statement of the 

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Drugs and Cosmetics Rules 1945 
pharmacopoeial    reference,    place  of  collection    /harvest,  date  and  time    of  collection  and 
packaging and weight. 

5.2    Raw  material  of  Chemical  origin:  -  They  shall  be  of  respective  pharmacopoeial 
standards and statements of their specification shall accompany the materials. 
5.3  Raw  materials  of  animal  origin:  -  The  materials  shall  be  those  collected  from  healthy 
animals and shall be of pharmacopoeial specifications. The materials shall be thos e collected, 
packed  and  transported  under  proper  hygienic  conditions  and  well  protected  from  all 
contamination.      The  materials  shall  be  accompanied    by  statements    as  in  para  ‗a‘  above.  In 
case  of  drugs  derived  from  a  whole  insect,  bulk  of  such  drugs  along  with  some  uncut  whole 
insect should be provided / maintained for records. 
5.4  Sarcodes:  -  The  materials  shall  be  those  collected  from  healthy  animals  and  shall  be  of 
pharmacopoeial  specification.    The  materials  shall be  those  collected,  packed  and  transp orted 
under  proper  hygienic    conditions    and  well  protected  from  all  contamination.  The  materials 
shall be accompanied by statements as in the Para ‗a‘ above.  The materials shall be tested to 
see that they are free from pathogenic organisms such as E. Coli, Salmonella, etc. 
5.5  Nosodes:  -  These  shall  be  of  pharmacopoeial  specifications.  As  these  are  derived  from 
diseased  animals  or  human  beings,  they  shall  be  autoclaved  immediately  after  collection  and 
preserved  and  transported  under  proper  hygienic    conditions  and  well  protected  from  all 
contamination.  Before use, these shall be sterilized by autoclaving and shall comply with the 
test for sterility as specified  in  the Homoeopathic Pharmacopoeia. 

6. PROCEDURES: 
6.1  Manufacture of Mother tinctures: - 

(a)  Every material shall be identified and checked for its purity. They shall be cleaned 
and  processed  by  cutting,    chopping,    etc.  for  use  in  macerators  /  percolators.  A  specimen  of 
the material shall be preserved till approval of the product for release f or sale. 

(b)  The design and procedures adopted shall ensure reproduction of the product of the 

same quality every time. 

(c)    Mother  tinctures  shall  be  preserved    in  tight  closed  neutral  containers  at 

temperatures preferably below 250 C, protected from light. 
6.2 Manufacture of Attenuations: - 

(a)    Attenuations  shall  be  prepared  in  a  clean  room  environment  with  filtered  air  and 

positive pressure inside suitable for the operations. 

(b)  The methods used shall be reproducible  and shall be validated. 
(c)  The containers,  tubings, etc. of the machines used  for manufacture of attenuations 
shall be thoroughly washed, cleaned and dried after attenuation of a drug. Regular  checks shall 
be carried out on the materials. 

(d)    The  parts  of  the  equipment  that  come  into  contact  with  the  attenuation  materials 

shall be of neutral quality and shall not cause any contamination to the material.  
(e)  Attenuations shall be preserved in properly labeled glass containers. 
(f)      Alcohol  and  other  vehicles  used  shall  be  of  Homoeopathic  pharmacopoeia 

specification and shall be free from impurities. 
6.3 Trituration:  - Trituration  technique is used to  manufacture drugs from  insoluble strains. 
The procedure / method specified in the Homoeopathic pharmacopoeia shall be adopted.  
6.4 Formulations:- Compound formulations shall preferably be in liquid and solid forms and 
the potency of the ingredients shall be in detectable quantity preferably be in 3x except in case 
of highly poisonous material and toxins which should not be below 6x.  Th e ingredients  shall  
be  compatible    to  each    other.    Complete  pharmacopoeial  name  of  each  ingredient  shall  be 
printed on the label along with composition. 
6.5  Medicated  Insert  Pellets:  -  (a)    Pellets  shall  be  manufactured  in  clean  rooms  free  from 
particulate  contaminants.  The  equipment  used  shall  enable  prevention  of  contamination  and 
cross- contamination. 

(b) The procedures shall be validated. 

7. LABORATORY CONTROLS: 

Tests  as  per  the  pharmacopoeia  and  requirements  shall  be  carried  out  on  products  and 
materials. The stability of the products shall be established by proper methods. Sterility tests, 

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wherever applicable, shall be carried out. Control samples shall be preserved for not less than 
three years after the last sales. 

8. PACKINGAND LABELLING: 
A minimum area of 50 square meters shall be provided  for packing and labeling section. 

9. EXPIRYDATE: 

Not exceeding sixty (60) months from the date of manufacture. 

10. STANDARD OPERATING PRACTICES: 

Standard  Operating  Practices  (SOPs)  shall  be  developed  for  various  activities  such  as 
receipt,  identification,  cleaning,  drying,  warehousing,  issue,  handling,  sampling  etc.  of  all 
materials.  Labels  and  packing  materials  shall  be  examined    for  correctness  and  compliance 
with rules. Records shall be maintained for their printing, use, destruction etc. 

11. RECORDSAND REGISTERS: 

Records  shall  be  maintained    for  all  the  activities.  These  shall  include  records  of 
production,    records  of  raw  materials,  records  of  testing,  records  of  sales  and  other  supplies, 
records of rejection, complaints and actions taken, SOPs and records in respect of compliance 
thereof, log books of equipment,  master formula records, records of medical examination and 
fitness  of  personnel  etc.  All  records  shall  be  maintained    for  a  period  of  one  yea r  after  the 
expiry of a batch or for three years whichever  is later. 

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1[SCHEDULE M-II 
[See Rule 139] 

REQUIREMENTS   OF  FACTORY  PREMISES FOR  MANUFACTURE 
OF  COSMETICS 

I.  GENERAL REQUIREMENTS 

(A)  Location  and  surroundings.–The  factory  shall  be  located  in  a  sanitary  place  and  hygienic 
conditions shall be maintained in the premises. Premises shall not be used for residence or be 
interconnected with residential area. It shall be well ventilated and clean. 

(B)  Buildings.– The buildings used for the factory shall be constructed so as to permit production 

under hygienic conditions and not to permit entry  of  insects,  rodents,  files,  etc. 

The walls of the room in which manufacturing operations are carried out, shall be up to a 
height of six feet from the floor, be smooth, waterproof and capable of being kept clean. 
The  flooring  shall  be  smooth,  even  and  washable  and  shall  be  such  as  not  to  permit 
retention or accumulation of dust. 

(C)     Water supply: - The water used in manufacture shall be of potable quality. 

(D)    Disposal of water. –- Suitable arrangements shall be made for disposal of waste-water. 

(E)  Health,  clothing  and  sanitary  requirements  of  the  staff.–  All  workers  shall  be  free  from 
contagious  or  infectious  diseases.  They  shall  be  provided  with  clean  uniforms,  masks, 
headgears, and gloves wherever required. Washing facilities shall also be provided. 

(F)     Medical Services. -  Adequate facilities for first aid shall be provided. 

(G)  Work  benches  shall  be  provided  for  carrying  out  operations  such  as  filling,  labelling, 
packing,  etc.  Such  benches  shall  be  fitted  with  smooth,  impervious  tops  capable  of  being 
washed. 

(H)  Adequate facilities shall be provided for washing and drying of glass containers if the same 

are to be used for packing the product. 

II.         REQUIREMENTS OF PLANT AND EQUIPMENT 

The  following  equipment,  area  and  other  requirements  are  recommended  for  the 

manufacture of: − 

A. Powders:−  Face powder, cake make-up, compacts, face packs, masks and 

rouges, etc. 

1.          Equipment: 

(a)      Powder mixer of suitable type provided with a dust collector. 
(b)     Perfume and colour blender. 
(c)     Sifter with sieves of suitable mesh size. 
(d)     Ball mill or suitable grinder. 

1. Ins.  by  G.S.R 723(E) , dt.  11-8-1992. 

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Drugs and Cosmetics Rules 1945 

(e)     Trays and scoops (stainless steel). 
(f)      Filling and sealing equipment provided with dust extractor. 
(g)     For compacts: - 

(i) a separate mixer, (ii) compact pressing machine. 

(h)     Weighing and measuring devices 
(i)      Storage tanks. 

An  area  of  15  square meters is  recommended. The  section is  to  be  provided with  adequate 
exhaust fans. 

B. 

Creams,   lotions,   emulsions,   pastes,   cleansing   milks,   shampoos,   pomade, 
brilliantine, shaving creams and hair-oils etc. 

 Mixing and storage tanks of suitable materials. 

(a) 
(b)  Heating kettle – steam, gas or electrically heated. 
(c)  Suitable agitator. 
(d)    Colloidal mill or homogeniser (wherever necessary). 
(e)     Triple roller mill (wherever necessary). 
(f)     Filling and sealing equipment. 
(g)    Weighing and measuring devices. 

An area of 25 square meters is recommended. 

C.         Nail Polishes and Nail lacquers. 

1.          Equipment: 

(a)     A suitable mixer. 
(b)    Storage tanks. 
(c)     Filling machine – hand operated or power driven. 
(d)    Weighing and Measuring devices. 

An area of 15 square meters is recommended. The section shall be provided with flameproof 
exhaust system. 

2.          Premises:–The   following   are   the   special   requirements   related   to   Nail 

Polishes and Nail Lacquers: - 

(a)     It shall be situated in an industrial area. 
(b) 

It shall be separate from other cosmetic-manufacturing areas by metal/brick partition 
up to ceiling. 

(c)     Floors, walls, ceiling and doors shall be fireproof. 
(d)  Smoking, cooking and dwelling shall not be permitted and no naked flame shall be 

brought in the premises. 

(e)  All  electrical  wiring  and  connections  shall  be  concealed  and  main  electric  switch 

shall be outside the manufacturing area. 

(f)     All equipment, furniture and light fittings in the section shall be flameproof. 
(g)  Fire  extinguisher  like  foam  and  dry  powder  and  sufficient  number  of  buckets 

containing sand shall be provided. 

(h)    All doors of the section shall open outwards. 

3.     Storage: 

All  explosive  solvents  and  ingredients  shall  be  stored  in  metal  cupboards  or  in  a 

separate enclosed area. 

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4.    Manufacture: 

(a) 

 Manufacture  of  lacquer  shall  not  be  undertaken  unless  the  above  conditions  are 
complied with. 

(b)    Workers shall be asked to wear shoes with rubber soles in the section. 

5.      Other requirements: 

No objection certificate from the local Fire Brigade Authorities shall be furnished. 

D.         Lipsticks and Lip-gloss, etc. 

1. Equipment 

(a)     Vertical mixer. 
(b)    Jacketted kettle – steam, gas or electrically heated. 
(c)     Mixing vessel (stainless steel). 
(d)    Triple roller mill/Ball mill. 
(e)     Moulds with refrigeration facility. 
(f)     Weighing and measuring devices. 
An area of 15 square meters is recommended. 

E.         Depilatories. 

1.  Equipment: 

(a)     Mixing tanks. 
(b)    Mixer 
(c)     Triple roller mill or homogeniser (where necessary). 
(d)    Filling and sealing equipment. 
(e)     Weighing and measuring devices. 
(f)     Moulds (where necessary). 

An area of 10 square meters is recommended. 

F. 

Preparations used for Eyes: -  Such preparations shall be manufactured under strict 
hygienic conditions to ensure that these are safe for use. 

1.  Eyebrows, Eyelashes, Eyeliners, etc. 

1  Equipment: 

(a)     Mixing tanks. 
(b)    A suitable mixer. 
(c)     Homogeniser (where necessary) 
(d)    Filling and sealing equipment. 
(e)     Weighing and measuring devices. 

An area of 10 square meters is recommended. 

2.  Kajal and Surma 

1.  Equipment: 

(a)     Base sterilizer. 
(b)    Powder sterilizer (dry heat oven). 
(c)     Stainless steel tanks. 
(d)    A suitable Mixer. 

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Drugs and Cosmetics Rules 1945 

(e)     Stainless steel sieves. 
(f)     Filling and sealing arrangements. 
(g)    Weighing and measuring devices. 
(h)    Homogeniser (where necessary). 
(i)     Pestle and Mortar (for Surma). 

An  area  of  10  square  meters  with  a  separate  area  of  5  square  meters  for  base 

sterilization is recommended. 

Other requirements for 1 and 2: 

(a)      False ceiling shall be provided wherever required. 
(b)  Manufacturing  area  shall  be  made  fly  proof.  An  airlock  or  an  aircurtain  shall  be 

provided. 

(c)  Base  used  for  Kajal  shall  be  sterilized  by  heating  the  base  at  150  degree  C  for 

required time in a separate enclosed area. 

(d)    The vegetable carbon black powder shall be sterilized in a drying oven at 120 degree 

C for required time. 

(e)  All utensils used for manufacture shall be of stainless steel and shall be washed with 

detergent water, antiseptic liquid and again with distilled water. 

(f)  Containers employed for ‗Kajal‘ shall be cleaned properly with bactericidal solution 

and dried. 

(g)    Workers shall put on clean overalls and use hand gloves wherever necessary. 

G.         Aerosol. 

1.  Equipment: - 

(a)      Air-compressor (wherever necessary). 
(b)    Mixing tanks. 
(c)     Suitable propellant filling and crimping equipments. 
(d)    Liquid filling unit. 
(e)     Leak testing equipment. 
(f)     Fire extinguisher (wherever necessary) 
(g)    Suitable filtration equipment. 
(h)    Weighing and measuring devices. 

An area of 15 square meters is recommended. 

2.    Other  requirements:  -  No  objection  certificate  from  the  Local  Fire  Brigade 

Authorities shall be furnished. 

H.         Alcoholic Fragrance Solutions. 

Equipment: - 

(a)      Mixing tanks with stirrer 
(b)    Filtering equipment. 
(c)     Filling and sealing equipment. 
(d)    Weighing and measuring devices. 

An area of 15 square meters is recommended. 

I.           Hair Dyes. 

Equipment: 

(a)     Stainless steel tanks. 
(b)    Mixer. 

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(c)     Filling Unit. 
(d)    Weighing and measuring devices. 
(e)     Masks, gloves and goggles. 

An area of 15 square meters with proper exhaust is recommended. 

J.          Tooth powders and toothpastes, etc.: 

1.  Tooth-powder in General. 

Equipment: 

(a)     Weighing and measuring devices. 
(b)    Dry mixer (powder blender). 
(c)     Stainless steel sieves. 
(d)    Powder filling and sealing equipments. 

An area of 15 square meters with proper exhaust is recommended. 

2.  Toothpastes. 

Equipment: 

(a)     Weighing and measuring devices. 
(b)    Kettle – steam, gas or electrically heated (where necessary). 
(c)     Planetary mixer with de-aerator system. 
(d)    Stainless steel tanks. 
(e)     Tube filling equipment. 
(f)     Crimping machine. 

An additional area of 15 square meters with proper exhaust is recommended. 

3.  Tooth-powder (Black) 

Equipment: 

(a)     Weighing and measuring devices. 
(b)    Dry mixer powder blender. 
(c)     Stainless steel sieves. 
(d)    Powder filling arrangements. 

An  area  of  15  square  meters  with  proper  exhaust  is  recommended.  Areas  for 

manufacturing ―Black‖ and ―White‖ tooth powders should be separate. 

K.         Toilet Soaps: 

Equipment: - 

(a)       Kettles/pans for saponification. 
(b)      Boiler or any other suitable heating arrangement. 
(c)      Suitable stirring arrangement. 
(d)      Storage tanks or trays. 
(e)      Driers. 
(f)      Amalgamator/chipping machine. 
(g)      Mixer. 
(h)      Triple roller mill. 
(i)       Granulator. 
(j)       Plodder. 
(k)      Cutter. 
(l)       Pressing, stamping and embossing machine. 
(m)     Weighing and measuring devices. 

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A  minimum  area  of  100  square  meters  is  recommended  for  the  small-scale 

manufacture of toilet soaps. 

The areas recommended above are for basic manufacturing of different categories of 
cosmetics.  In  addition  to  that  separate  adequate space  for  storage  of  raw  materials, finished 
products, packing materials shall be provided in factory premises.1[***] 

Note No. I−The above requirements of the Schedule are made subject to modification at 
the  discretion  of  the  Licensing  Authority,  if  he  is  of  the  opinion  that  having  regard  to  the 
nature and extent of the manufacturing operations it is necessary to relax or alter them in the 
circumstances of a particular case. 

Note  No.  II.−The  above  requirements  do  not  include  requirements  of  machinery, 
equipments  and  premises  required  for  preparation  of  containers  and  clousers  of  different 
categories  of  cosmetics.  The  Licensing  Authority  shall  have  the  discretion  to  examine  the 
suitability and adequacy of the machinery, equipments and premises for the purpose of taking 
into consideration of the requirements of the licensee. 

Note  No.  III.−Schedule  M-II  specifies  equipments  and  space  required  for  certain 
categories  of  cosmetics  only.  There  are  other  cosmetics  items,  viz.  Attars,  perfumes,  etc., 
which are not covered in the above categories. The Licensing Authority shall, in respect  of    
such  items  or categories of cosmetics have the discretion to examine the adequacy of factory 
premises,  space,  plant  and  machinery  and  other  requisites  having  regard  to  the  nature  and 
extent of the manufacturing operations involved and direct the licensee to carry on necessary 
modification in them. 

1. The words ―A testing laboratory shall also be provided‖ omitted by G.S.R.285 (E) , dt. 16.7.1996. 

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1

[SCHEDULE M-III 

[See rules 69, 69A, 75, 75A and 76] 

QUALITY  MANAGEMENT  SYSTEM  –FOR  NOTIFIED  MEDICAL  DEVICES  AND  IN-

VITRO DIAGNOSTICS 

1. General Requirements: 

1.1.  

This schedule specifies requirements for a quality management system that shall be used by 

the  manufacturer  for  the  design  and  development,  manufacture,  packaging,  labeling,  testing, 

installation and servicing of medical devices and in-vitro diagnostics. If the manufacturer does not 

carry  out  design  and  development  activity,  the  same  shall  be  recorded  in  the  quality  management 

system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.  

1.2. 

If any requirement in clause 7(product realisation) of this Schedule is not applicable due to 

the nature of the medical device and in-vitro diagnostics for which the quality management system is 

applied,  the  manufacturer  does  not  need  to  include  such  a  requirement  in  its  quality  management 

system. 

1.3.  

The processes required by this Schedule, which are applicable to the medical device and in-

vitro diagnostic devices, but which are not performed by the manufacturer are the responsibility of 

the manufacturer and are accounted for in the manufacturer‘s quality management system. 

1.4.  

If a manufacturer engages in only some operations subject to the requirements of this part, 

and  not  in  others,  that  manufacturer  need  only  to  comply  with  those  requirements  which  are 

applicable to the operations in which it is engaged. 

1.5.  

It is emphasised that the quality management system requirements specified in this Schedule 

are in addition to complementary to technical requirements for products. 

1.6.   Manufacturers  of  components  or  parts  of  finished  devices  and  in-vitro  diagnostics  are 

encouraged to use appropriate provisions of this regulation as guidance. 

2. Applicability: 

The  provisions  of  this  Schedule  shall  be  applicable  to  manufacturers  of  finished  devices,  In-Vitro 

Diagnostics,  mechanical  contraceptives  (condoms,  intrauterine  devices,  tubal  rings),  surgical 

dressings,  surgical  bandages,  surgical  staplers,  surgical  sutures  and  ligatures,  blood  and  blood 

components collection bags with or without anticoagulants intended for human or animal use.  

1. Subs.by G.S.R. 640 (E) , dt. 29.6.2016. Previously, Ins. by G.S.R. 109 (E) , dt. 22.2.1994. 

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3. Terms and definitions: 

3.1  

Active implantable medical device.- Active medical device which is intended to be totally 

or  partially  introduced,  surgically  or  medically,  into  the  human  or  animal  body  or  by  medical 

intervention into a natural orifice and which is intended to remain after the procedure. 

3.2  

Active medical device.- Medical device relying for its functioning on a source of electrical 

energy or any source of power other than that directly generated by the human or animal body or 

gravity. 

3.3  

Advisory notice.- Notice issued by the manufacturer, subsequent to delivery of the medical 

device  and  in-vitro  diagnostic  devices,  to  provide  supplementary  information  or  to  advise  what 

action should be taken in or both in:- 

a.  

b. 

c.  

the use of a medical device and in-vitro diagnostic devices; 

the modification of a medical device and in-vitro diagnostic devices; 

the  return  of  the  medical  device  and  in-vitro  diagnostic  devices  to  the  organization  that 

supplied it; or 

d.  

the destruction of a medical device and in-vitro diagnostic devices. 

3.4  

Customer  complaint.- Written,  electronic  or  oral  communication  that  alleges  deficiencies 

related  to  the  identity,  quality,  durability,  reliability,  safety,  effectiveness  or  performance  of  a 

medical device and in-vitro diagnostic devices that has been placed on the market. 

3.5  

Implantable medical device.- Medical device intended:- 

a.  

b.  

to be totally or partially introduced into the human or animal body or a natural orifice; or 

to replace an epithelial surface or the surface of the eye; 

by surgical intervention, and which is intended to remain after the procedure for at least 

thirty days, and which can only be removed by medical or surgical intervention. 

3.6  

Component means any raw material, substance, piece, part, software, firmware, labeling, or 

assembly which is intended to be included as part of the finished, packaged, and labeled device. 

3.7  

Design input means the physical and performance requirements of a device that are used as a 

basis for device design. 

3.8  

Design output means the results of a design effort at each design phase and at the end of the 

total  design  effort.  The  finished  design  output  is  the  basis  for  the  device  master  record.  The  total 

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finished  design  output  consists  of  the  device,  its  packaging  and  labeling,  and  the  device  master 

record. 

3.9  

Design review means a documented, comprehensive, systematic examination of a design to 

evaluate the adequacy  of  the  design  requirements,  to  evaluate the  capability  of the design  to  meet 

these requirements, and to identify problems. 

3.10   Finished  device  means  any  device  or  accessory  to  any  device  that  is  suitable  for  use  or 

capable of functioning, whether or not it is packaged, labeled or sterilized. 

3.11  

In-vitro  Diagnostic  means  in-vitro  diagnostics  referred  in  this  Schedule  including 

diagnostics  kits  and reagents that  fall  under sub-clause  (i)  of  clause (b)  of section  3  of  Drugs  and 

Cosmetics Act, 1940. 

3.12   Management with executive responsibility means those senior employees of a manufacturer 

who have the authority to establish or make changes to the manufacturer's quality policy and quality 

system. 

3.13   Medical device referred in this Schedule means devices that are notified under clause (iv) of 

sub-section (b) of section 3 of Drugs and Cosmetics Act, 1940. 

3.14   Quality  audit  means  a  systematic,  independent  examination  of  a  manufacturer's  quality 

system that is performed at defined intervals and at sufficient frequency to determine whether both 

quality  system  activities  and  the  results  of  such  activities  comply  with  quality  system  procedures, 

that these procedures are implemented effectively, and that these procedures are suitable to achieve 

quality system objectives. 

3.15   Quality policy means the overall intention and direction of an organization with respect to 

quality, as established by management with executive responsibility. 

3.16   Quality  system  means  the  organisational  structure,  responsibilities,  procedures,  processes, 

and resources for implementing quality management. 

3.17   Rework  means  action  taken  on  a  nonconforming  product  that  will  fulfill  the  specified 

Device Master File requirements before it is released for distribution. 

3.18   Specification  means  any  requirement  with  which  a  product,  process,  service,  or  other 

activity must conform. 

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3.19   Validation means confirmation by examination and provision of objective evidence that the 

particular requirement for a specific intended use can be consistently fulfilled; 

3.19.1   Process  validation  means  establishing  by  objective  evidence  that  a  process  consistently 

produces a result or product meeting its predetermined specifications. 

3.19.2   Design  validation  means  establishing  by  objective  evidence  that  device  specifications 

conform with user needs and intended use(s). 

3.20   Verification  means  confirmation  by  examination  and  provision  of  objective  evidence  that 

specified requirements have been fulfilled. 

4 Quality management system.- 

4.1 General: 

The manufacturer shall establish, document, implement and maintain a quality management system 

and maintain its effectiveness in accordance with the requirements of this schedule. 

The manufacturer shall;- 

(a) 

identify  the  processes  needed  for  the  quality  management  system  and  their  application 

throughout the organization; 

(b)   determine the sequence and interaction of these processes; 

(c)   determine criteria and methods needed to ensure that both the operation and control of these 

processes are effective; 

(d)  

ensure  the  availability  of  resources  and  information  necessary  to  support  the  operation  and 

monitoring of these processes; 

(e)   monitor, measure and analyse these processes; and 

(f)  

implement actions necessary to achieve planned results and maintain the effectiveness of these 

processes. 

These processes shall be managed by the manufacturer in accordance with the requirements of this 

Schedule. Where a manufacturer chooses to outsource any process that affects product conformity 

with  requirements,  the  manufacturer  shall  ensure  control  over  such  processes.  Control  of  such 

outsourced processes shall be identified within the quality management system. 

NOTE:  Processes  needed  for  the  quality  management  system  referred  to  above  shall  include 

processes for management activities, provision of resources, product realization and measurement. 

4.2 Documentation requirements.- 

4.2.1 General 

The quality management system documentation shall include;- 

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(a)  

documented statements of a quality policy and quality objectives; 

Drugs and Cosmetics Rules 1945 

(b) 

(c) 

a quality manual; 

documented procedures required by this schedule; 

(d)  

documents  needed  by  the  manufacturer  to  ensure  the  effective  planning,  operation  and 

control of its processes; 

(e)  

records required by this schedule, and  

where  this  schedule  specifies  that  a  requirement,  procedure,  activity  or  special  arrangement  be 

―documented‖, it shall, in addition, be implemented and maintained. 

For each type or model of medical device or  In-vitro Diagnostics, the manufacturer shall establish 

and  maintain  a  file  either containing  or  identifying  documents  defining  product  specifications  and 

quality  management  system 

requirements.  These  documents  shall  define 

the  complete 

manufacturing process and, if applicable, installation. 

The  manufacture  shall  prepare  documentation  for  device  or  in-vitro  diagnostics  in  a  form  of  a 

Device  Master File containing  specific  information  as  referred  to  in  Annexure-A  appended to this 

Schedule. 

Data may be recorded by electronic data processing systems or other reliable means, but documents 

and record relating to the system in use shall also be available in a hard copy to facilitate checking of 

the  accuracy  of  the  records.  Wherever  documentation  is  handled  by  electronic  data  processing 

methods,  authorized  persons  shall  enter  or  modify  data  in  the  computer.  There  shall  be  record  of 

changes  and  deletions.  Access  shall  be  restricted  by  ‗passwords‘  or  other  means  and  the  result  of 

entry  of  critical  data  shall  be  independently  checked.  Batch  records  electronically  stored  shall  be 

protected  by  a  suitable  back-up.  During  the  period  of  retention,  all  relevant  data  shall  be  readily 

available. 

4.2.2 Quality manual.- 

The manufacturer shall establish and maintain a quality manual that includes:- 

(a)  the  scope  of the quality  management  system,  including  details  of  and justification  for  any 

exclusion or non-application or both; 

(b)  

the documented procedures established for the quality management system, or reference to 

them; and 

(c) 

a description of the interaction between the processes of the quality management system. 

The  quality  manual  shall  outline  the  structure  of  the  documentation  used  in  the  quality 

management system. 

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The manufacturer shall prepare documentation in a form of a Plant Master File containing specific 

information about the facilities, personnel and other details as prescribed in Annexure B appended to 

this Schedule. 

4.2.3 Control of documents.- 

Documents  required  by  the  quality  management  system  shall  be  controlled.  Records  are  a  special 

type  of  document  and  shall  be  controlled  according  to  the  requirements  given  in  the  control  of 

records.  Documents  shall  be  approved,  signed  and  dated  by  the  appropriate  and  the  authorised 

person. 

A documented procedure shall be established to define the controls needed.- 

(a)  

(b) 

(c)  

(d) 

(e)  

(f)  

to review and approve documents for adequacy prior to issue; 

to review and update as necessary and re-approve documents; 

to ensure that changes and the current revision status of documents are identified; 

to ensure that relevant versions of applicable documents are available at points of use; 

to ensure that documents remain legible and readily identifiable; 

to ensure that documents of external origin are identified and their distribution controlled; 

and 

(g)  

to prevent the unintended use of obsolete documents, and to apply suitable identification to 

them if they are retained for any purpose. 

Changes  to  document  shall  be  reviewed  and  approved.  Change  records  shall  be  maintained  which 

will include a description of the change, identification of the affected documents, the signature of the 

approving individual, the approval date, and when the change becomes effective. 

The manufacturer shall ensure that changes to documents are reviewed and approved either by the 

original  approving  functionary  or  another  designated  functionary  which  has  access  to  pertinent 

background information upon which to base its decisions. 

The  manufacturer  shall  define  the  period  for  which  at  least  one  copy  of  obsolete  controlled 

documents shall be retained. This period shall ensure that documents to which medical devices or in-

vitro diagnostics have been manufactured and tested are retained for at least one year after the date 

of expiry of the medical device or in-vitro diagnostic as defined by the manufacturer. 

4.2.4 Control of records.- 

Records shall be established and maintained to provide evidence of conformity to the requirements 

and  of  the  effective  operation  of  the  quality  management  system.  Records  shall  remain  legible, 

readily  identifiable  and  retrievable.  A  documented  procedure  shall  be  established  to  define  the 

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controls needed for the identification, storage, protection, retrieval, retention time and disposition of 

records. 

The  manufacturer  shall  retain  the  records  for  a  period  of  time  at  least  one  year  after  the  date  of 

expiry of the medical device or in-vitro diagnostics as defined by the manufacturer, but not less than 

two years from the date of product release by the manufacturer. 

5 Management responsibility.- 

5.1 Management commitment: 

Top management of the manufacturer shall provide evidence of its commitment to the development 

and implementation of the quality management system and maintaining its effectiveness by:- 

(a)  

communicating to the employees the importance of meeting customer as well as statutory and 

regulatory requirements; 

(b)  

establishing the quality policy; 

(c)  

ensuring that quality objectives are established; 

(d)  

conducting management reviews; and 

(e)  

ensuring the availability of resources. 

5.2 Customer focus: 

Top  management  of the  manufacturer  shall  ensure  that  customer requirements  are  determined  and 

are met. 

5.3 Quality policy: 

Top management of the manufacturer shall ensure that the quality policy:- 

(a)  

is appropriate to the purpose of the manufacturing facility; 

(b)  

includes a commitment to comply with requirements and to maintain the effectiveness of the 

quality management system; 

(c) 

provides a framework for establishing and reviewing quality objectives; 

(d)  

is communicated and understood within the manufacturer‘s organization; and 

(e)  

is reviewed for continuing suitability. 

5.4 Planning.- 

5.4.1 Quality objectives: 

Top management of the manufacturer shall ensure that quality objectives, including those needed to 

meet  requirements  for  product,  are  established  at  relevant  functions  and  levels  within  the 

manufacturing  organization.  The  quality  objectives  shall  be  measurable  and  consistent  with  the 

quality policy. 

5.4.2 Quality management system planning: 

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Top management of the manufacturer shall ensure that.- 

Drugs and Cosmetics Rules 1945 

(a) 

 the planning of the quality management system is carried out in order to meet the specified 

requirements, as well as the quality objectives; and 

(b)  

the integrity of the quality  management system is  maintained when changes to the quality 

management system are planned and implemented. 

5.5 Responsibility, authority and communication.- 

5.5.1 Responsibility and authority: 

Top management of the manufacturer shall ensure that responsibilities and authorities are defined, 

documented and communicated within the manufacturing organisation. 

Top management of the manufacturer shall establish the interrelation of all personnel who manage, 

perform  and  verify  work  affecting  quality,  and  shall  ensure  the  independence  and  authority 

necessary to perform these tasks. 

5.5.2 Management representative: 

Top management shall appoint a member of management who, irrespective of other responsibilities, 

shall have responsibility and authority that includes:- 

(a)  

ensuring  that  processes  needed  for  the  quality  management  system  are  established, 

implemented and maintained; 

(b)  

reporting to top management on the performance of the quality management system and any 

need for improvement; and 

(c) 

ensuring  the  promotion  of  awareness  of  regulatory  and  customer  requirements  throughout 

the 

manufacturing organization. 

5.5.3 Internal communication: 

Top management shall ensure that appropriate communication processes are established within the 

Manufacturing organization and that communication takes place regarding the effectiveness of the 

quality management system. 

5.6 Management review.- 

5.6.1 General: 

Top management shall review the organization‘s quality management system, at planned intervals, 

to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing 

opportunities  for  improvement  and  the  need  for  changes  to  the  quality  management  system, 

including  the  quality  policy  and  quality  objectives.  Records  from  management  reviews  shall  be 

maintained. 

5.6.2 Review input: 

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The input to management review shall include information on:- 

(a)  

(b)  

(c)  

(d)  

(e) 

(f) 

(g)  

(h)  

results of audits, 

customer feedback, 

process performance and product conformity, 

status of preventive and corrective actions, 

follow-up actions from previous management reviews, 

changes that could affect the quality management system, 

recommendations for improvement, and 

new or revised regulatory requirements as and when issued. 

5.6.3 Review output: 

The output from the management review shall include any decisions and actions related to:- 

(a)  

improvements needed to maintain the effectiveness of the quality management system and 

its processes, 

(b)  

(c)  

improvement of product related to customer requirements, and 

resource needs. 

6 Resource management.- 

6.1 Provision of resources: 

The manufacturing organization shall determine and provide the resources needed 

(a)  

(b)  

to implement the quality management system and to maintain its effectiveness, and 

to meet regulatory and customer requirements. 

6.2 Human resources.- 

6.2.1 General: 

Personnel performing work affecting product quality shall be competent on the basis of appropriate 

education, training, skills and experience. Number of personnel employed shall be adequate and in 

direct  proportion  to  the  workload.  Prior  to  employment,  all  personnel,  shall  undergo  medical 

examination  including  eye  examination,  and  shall  be  free  from  communicable  or  contagious 

diseases. Thereafter, they should be medically examined periodically, at least once a year. Records 

shall be maintained thereof.  

6.2.2 Competence, awareness and training: 

The manufacturer shall:- 

(a)  

determine  the  necessary  competence  for  personnel  performing  work  affecting  product 

quality, 

(b) 

(c)  

provide training or take other actions to satisfy these needs, 

evaluate the effectiveness of the actions taken, 

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(d)  

ensure  that  its  personnel  are  aware  of  the  relevance and  importance  of their  activities  and 

Drugs and Cosmetics Rules 1945 

(e)  

(f)  

how they contribute to the achievement of the quality objectives, 

maintain appropriate records of education, training, skills and experience, and 

establish documented procedures for identifying training needs and ensure that all personnel 

are trained to adequately perform their assigned responsibilities. 

6.3 Infrastructure: 

The  organisation  shall  determine,  provide  and  maintain  the  infrastructure  needed  to  achieve 

conformity to product requirements. Infrastructure includes, as applicable:- 

(a)  

(b) 

(c)  

buildings, workspace and associated utilities. 

process equipment (both hardware and software), and 

supporting services (such as transport or communication). 

The  manufacturer  shall  establish  documented  requirements  for  maintenance  activities,  including 

their  frequency,  when  such  activities  or  lack  thereof  can  affect  product  quality.  Records  of  such 

maintenance shall be maintained. 

6.4 Work environment: 

The organisation shall determine and manage the work environment needed to achieve conformity to 

product requirements. The following requirements shall apply, namely:- 

(a) 

the manufacturer shall establish documented requirements for health, cleanliness and clothing 

of  personnel  if  contact  between  such  personnel  and  the  product  or  work  environment  could 

adversely affect the quality of the product; 

(b)  

if  work  environment  conditions  can  have  an  adverse  effect  on  product  quality,  the 

manufacturer  shall  establish  documented  requirements  as  per  Annexure-C  of  this  schedule 

for  the  work  environment  conditions  and  documented  procedures  or  work  instructions  to 

monitor and control these work environment condition; 

(c)  

the manufacturer shall ensure that all personnel who are required to work temporarily under 

special environmental conditions within the work environment are appropriately trained and 

supervised by a trained person; 

(d)  

if  appropriate,  special  arrangements  shall  be  established  and  documented  for  the  control  of 

contaminated or potentially contaminated product in order to prevent contamination of other 

product, the work environment or personnel. 

(e) 

all  personnel  shall  bear  clean  body  covering  appropriate  to  their  duties.  Smoking,  eating, 

drinking, chewing or keeping food and drink shall not be permitted in production, laboratory 

and storage areas. 

7 Product realisation.- 

7.1 Planning of product realization: 

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The manufacturer shall plan and develop the processes needed for product realization. Planning of 

product  realization  shall  be  consistent  with  the  requirements  of  the  other  processes  of  the  quality 

management system. 

In  planning  product  realisation,  the  manufacturer  shall  determine  the  following,  as 

appropriate:- 

(a)   quality objectives and requirements for the product; 

(b)  

the need to establish processes, documents, and provide resources specific to the product; 

(c)  

required  verification,  validation,  monitoring,  inspection  and  test  activities  specific  to  the 

product and the criteria for product acceptance; 

(d)  

records needed to provide evidence that the realisation processes and resulting product meet 

requirements. 

The output of this planning shall be in a form suitable for the manufacturer‘s method of operations. 

The manufacturer organisation shall establish documented requirements for risk management (as per 

the IS or ISO 14971) throughout product realisation. Records arising from risk management shall be 

maintained. 

7.2 Customer-related processes.- 

7.2.1 Determination of requirements related to the product: 

The manufacturer shall determine:- 

(a)  

requirements  specified  by  the  customer,  including  the  requirements  for  delivery  and  post-

delivery activities, 

(b)  

requirements  not  stated  by  the  customer  but  necessary  for  specified  or  intended  use,  where 

known; 

(c)  

statutory requirements related to the product, and 

(d)  

any additional requirements determined by the manufacturer. 

7.2.2 Review of requirements related to the product: 

The  manufacturer  shall  review  the  requirements  related  to  the  product.  This  review  shall  be 

conducted  prior  to  the  manufacturer's  commitment  to  supply  a  product  to  the  customer  and  shall 

ensure that:- 

(a)  

product requirements are defined and documented; 

(b) 

(c) 

contract or order requirements differing from those previously expressed are resolved; and 

the manufacturer has the ability to meet the defined requirements. 

Records of the results of the review and actions arising from the review shall be maintained. 

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Where the customer provides no documented statement of requirement, the customer requirements 

shall be confirmed by the manufacturer before acceptance. 

Where product requirements are changed, the manufacturer shall ensure that relevant documents are 

amended and that relevant personnel are made aware of the changed requirements. 

7.2.3 Customer communication: 

The  manufacturer  shall  determine  and  implement  effective  arrangements  for  communicating  with 

customers in relation to:- 

(a) 

(b)  

(c)  

(d)  

product information; 

enquiries, contracts or order handling, including amendments; 

customer feedback, including customer complaints; and 

advisory notices. 

7.3 Design and development.- 

7.3.1 Design and development planning: 

The  manufacturer  shall  establish  documented  procedures  for  design  and  development.  The 

manufacturer shall plan and control the design and development of product. During the design and 

development planning, the manufacturer shall determine :- 

(a)  

(b)  

the design and development stages; 

the review, verification, validation and design transfer activities that are appropriate at each 

design and development stage; and 

(c)  

the responsibilities and authorities for design and development. 

The  manufacturer  shall  manage  the  interfaces  between  different  groups  involved  in  design  and 

development to ensure effective communication and clear assignment of responsibility. 

Planning  output  shall  be  documented,  and  updated  as  appropriate,  as  the  design  and  development 

progresses. 

NOTE: Design transfer activities during the design and development process ensure that design and 

development  outputs  are  verified  as  suitable  for  manufacturing  before  becoming  final  production 

specifications. 

7.3.2 Design and development inputs: 

Inputs  relating  to  product  requirements  shall  be  determined  and  records  maintained.  The  design 

requirements  relating  to  a  device  are  appropriate  and  address  the  intended  use  of  the  device, 

including the needs of the user and patients. 

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These inputs shall include:- 

Drugs and Cosmetics Rules 1945 

(a) 

(b)  

(c)  

(d)  

(e)  

functional, performance and safety requirements, according to the intended use; 

applicable statutory and regulatory requirements; 

where applicable, information derived from previous similar designs; 

other requirements essential for design and development; and 

output(s) of risk management. 

These inputs shall be reviewed for adequacy and approved by designated individual. 

Requirements shall be complete, unambiguous and not in conflict with each other. 

7.3.3 Design and development outputs: 

The outputs of design and development shall be provided in a form that enables verification against 

the design and development input and shall be documented, reviewed, and approved prior to release. 

Design and development outputs shall:- 

(a)  

(b) 

(c)  

(d)  

meet the input requirements for design and development; 

provide appropriate information for purchasing, production and for service provision; 

contain or reference product acceptance criteria; and 

specify the characteristics of the product that are essential for its safe and proper use. 

Records of the design and development outputs shall be maintained. 

Records  of  design  and  development  outputs  can  include  specifications,  manufacturing  procedures, 

engineering drawings, and engineering or research logbooks. 

7.3.4 Design and development review: 

At suitable stages, systematic reviews of design and development shall be performed in accordance 

with planned arrangements:- 

(a)  

(b)  

to evaluate the ability of the results of design and development to meet requirements; and 

to identify any problems and propose necessary actions. 

Participants in such reviews shall include representatives of functions concerned with the design and 

development stage being reviewed, as well as other specialist personnel. 

Records of the results of the reviews and any necessary actions shall be maintained 

7.3.5 Design and development verification: 

Verification shall be performed in accordance with planned arrangements to ensure that the design 

and development outputs have met the design and development input requirements. Records of the 

results of the verification and any necessary actions shall be maintained. 

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7.3.6 Design and development validation: 

Design and development validation shall be performed in accordance with planned arrangements to 

ensure that the resulting product is capable of meeting the requirements for the specified application 

or intended use. 

Design validation shall be performed under defined operating conditions on initial production units, 

lots,  or  batches  or  their  equivalence.  Design  validation  shall  include  software  validation  and  risk 

analysis, where appropriate validation shall be completed prior to the delivery or implementation of 

the product. 

Records of the results of validation and any necessary actions shall be maintained. 

As  part  of  design  and  development  validation, the  manufacturer  shall perform  clinical  evaluations 

and/or evaluation of performance of the medical device or In-vitro Diagnostics. 

NOTE 1.- If a medical device or In-vitro Diagnostic can only be validated following assembly and 

installation  at  point  of  use,  delivery  is  not  considered  to  be  complete  until  the  product  has  been 

formally transferred to the customer. 

NOTE 2.- Provision of the medical device for purposes of clinical evaluations and/or evaluation of 

performance is not considered to be delivery. 

7.3.7 Control of design and development changes: 

Design and development changes shall be identified and records maintained. The changes shall be 

reviewed, verified and validated, as appropriate, and approved before implementation. The review of 

design and development changes shall include evaluation of the effect of the changes on constituent 

parts  and  product  already  delivered.  Records  of  the  results  of  the  review  of  changes  and  any 

necessary actions shall be maintained. 

Note.-Each manufacturer shall establish and maintain a Design History File for each type of device. 

The  Design  History  File  shall  contain  or  reference  the  records  necessary  to  demonstrate  that  the 

design was developed in accordance with the approved design plan and the requirements of design 

and development. 

7.4 Purchasing.- 

7.4.1 Purchasing process: 

The  manufacturer  organisation  shall  establish  documented  procedures  to  ensure  that  purchased 

product conforms to specified purchase requirements. The type and extent of control applied to the 

supplier and the purchased product shall be dependent upon the effect of the purchased product on 

subsequent product realisation or the final product. 

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The  manufacturer  shall  evaluate  and  select  suppliers  based  on  their  ability  to  supply  product  in 

accordance with the manufacturer‘s requirements. Criteria for selection, evaluation and re-evaluation 

shall be established. 

Records of the results of evaluations and any necessary actions arising from the evaluation shall be 

maintained. 

7.4.2 Purchasing information: 

Purchasing information shall describe the product to be purchased, including where appropriate:- 

(a)  

(b)  

(c)  

requirements for approval of product, procedures, processes and equipment; 

requirements for qualification of personnel; and 

quality management system requirements. 

The  manufacturer  shall  ensure  the  adequacy  of  specified  purchase  requirements  prior  to  their 

communication to the supplier. 

To  the  extent  required  for  traceability,  the  manufacturer  shall  maintain  documents  and  records  of 

relevant purchasing information. 

7.4.3 Verification of purchased product: 

The  manufacturer  shall  establish  and  implement  the  inspection  or  other  activities  necessary  for 

ensuring  that  purchased  product  meets  specified  purchase  requirements.  Where  the  manufacturer 

intends to perform verification at the supplier‘s premises, the manufacturer shall state the intended 

verification arrangements and method of product release in the purchasing information. Records of 

the verification shall be maintained. 

7.5 Production and service provision.- 

7.5.1 Control of production and service provision: 

7.5.1.1 General requirements: 

The  manufacturer  shall  plan  and  carry  out  production  and  service  provision  under  controlled 

conditions. Controlled conditions shall include, as applicable:- 

(a)  

the availability of information that describes the characteristics of the product, 

(b) 

the availability of documented procedures, documented requirements, work instructions; and 

reference materials and reference measurement procedures as necessary; 

(c)  

(d)  

(e)  

(f)  

the use of suitable equipment; 

the availability and use of monitoring and measuring devices; 

the implementation of monitoring and measurement; 

the implementation of release, delivery and post-delivery activities; and 

510 

 
 
 
 
 
 
 
 
 
(g)  

the implementation of defined operations for labeling and packaging. 

Drugs and Cosmetics Rules 1945 

The manufacturer shall establish and maintain a record for each batch of medical device or In-vitro 

Diagnostic  devices  that  provides  traceability  and  identifies  the  amount  manufactured  and  amount 

approved for distribution. The batch record shall be verified and approved. 

7.5.1.2 Control of production and service provision — Specific requirements 

7.5.1.2.1 Cleanliness of product and contamination control: 

The manufacturer shall establish documented requirements for cleanliness of product if:- 

(a)  

(b)  

(c)  

(d)  

product is cleaned by the manufacturer prior to sterilisation or its use; or 

product is supplied non-sterile to be subjected to a cleaning process prior to sterilisation or 

its use; or 

product is supplied to be used non-sterile and its cleanliness is of significance in use; or 

process agents are to be removed from product during manufacture. 

If the product is cleaned in accordance with (a) or (b) above, the requirements content in clause 6.4 

(a) and (b) do not apply prior to the cleaning process 

7.5.1.2.2 Installation activities: 

If appropriate, the manufacturer shall establish documented requirements which contain acceptance 

criteria  for  installing  and  verifying  the  installation  of  the  medical  device  or  In-vitro  Diagnostic 

device. 

If the agreed customer requirements allow installation to be performed other than by manufacturer or 

its  authorised  agent,  the  manufacturer  shall  provide  documented  requirements  for  installation  and 

verification. Records of installation and verification performed by the manufacturer or its authorized 

agent shall be maintained. 

7.5.1.3 Particular requirements for sterile medical devices: 

The manufacturer shall maintain records of the process parameters for the sterilisation process which 

was used for each sterilisation batch. Sterilisation records shall be traceable to each production batch 

of medical device. 

7.5.2 Validation of processes for production and service provision.- 

7.5.2.1 General: 

The  manufacturer  shall  validate  any  processes  for  production  and  service  provision  where  the 

resulting  output  cannot  be  verified  by  subsequent  monitoring  or  measurement.  This  includes  any 

processes  where  deficiencies  become  apparent  only  after  the  product  is  in  use.  Validation  shall 

demonstrate the ability of these processes to achieve planned results. 

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The manufacturer shall establish arrangements for these processes including, as applicable:- 

Drugs and Cosmetics Rules 1945 

(a)  

(b) 

(c)  

(d)  

(e)  

defined criteria for review and approval of the processes; 

approval of equipment and qualification of personnel 

use of specific methods and procedures,; 

requirements for records; and 

revalidation. 

The  manufacturer  shall  establish  documented  procedures  for  the  validation  of  the  application  of 

computer software (and its changes to such software or its application) for production and service 

provision  that  affect  the  ability  of  the  product  conform  to  specified  requirements.  Such  software 

applications shall be validated prior to initial use. 

Records of validation shall be maintained. 

7.5.2.2 Particular requirements for sterile medical devices: 

The manufacturer shall establish documented procedures for the validation of sterilization processes. 

Sterilisation  processes  shall  be  validated  prior  to  initial  use.  The  records  of  validation  of  each 

sterilisation process shall be maintained. 

7.5.3 Identification and traceability.- 

7.5.3.1 Identification: 

The  manufacturer  shall  identify  the  product  by  suitable  means throughout product realization,  and 

shall  establish  documented  procedures  for  such  product  identification.  The  manufacturer  shall 

establish documented procedures to ensure that medical devices and In-vitro Diagnostics returned to 

the manufacturer are identified and distinguished from conforming product. 

7.5.3.2 Traceability.- 

7.5.3.2.1 General: 

The  manufacturer  shall  establish  documented  procedures  for  traceability.  Such  procedures  shall 

define the extent of product traceability and the records required. 

Where  traceability  is  a  requirement,  the  manufacturer  shall  control  and  record  the  unique 

identification of the product. 

NOTE.-  Configuration  management  is  a  means  by  which  identification  and  traceability  can  be 

maintained. 

7.5.3.2.2  Particular  requirements  for  active  implantable  medical  devices  and  implantable 

medical devices: 

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Drugs and Cosmetics Rules 1945 
In  defining  the  records  required  for  traceability,  the  manufacturer  shall  include  records  of  all 

components, materials and work environment conditions, if these could cause the medical device not 

to satisfy its specified requirements. 

The manufacturer shall require that its agents or distributors maintain records of the distribution of 

active  implantable  medical  devices  and  implantable  medical  devices  to  allow  traceability  and  that 

such records are available for inspection. Records of the name and address of the shipping package 

consignee shall be maintained. 

7.5.3.3 Status identification: 

The  manufacturer  shall  identify  the  product  status  with  respect  to  monitoring  and  measurement 

requirements.  The  identification  of  product  status  shall  be  maintained  throughout  production, 

storage, implant, usage and installation of the product to ensure that only product that has passed the 

required  inspections  and  tests  (or  released  under  an  authorized  concession)  is  dispatched,  used  or 

installed. 

7.5.4 Customer property: 

The  manufacturer  shall  exercise  care  with  customer  property  while  it  is  under  the  manufacturer‘s 

control  or  being  used  by  the  manufacturer.  The  manufacturer  shall  identify,  verify,  protect  and 

safeguard  customer  property  provided  for  use  or  incorporation  into  the  product.  If  any  customer 

property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the 

customer and records maintained. 

NOTE.- Customer property can include intellectual property or confidential health information. 

7.5.5 Preservation of product: 

The  manufacturer  shall  establish  documented  procedures  or  documented  work  instructions  for 

preserving  the  conformity  of  product  during  internal  processing  and  delivery  to  the  intended 

destination.  This  preservation  shall  include  identification,  handling,  packaging,  storage  and 

protection. Preservation shall also apply to the constituent parts of a product. 

The  manufacturer  shall  establish  documented  procedures  or  documented  work  instructions  for  the 

control  of  product  with  a  limited  shelf-life  or  requiring  special  storage  conditions.  Such  special 

storage conditions shall be controlled and recorded. 

7.6 Control of monitoring and measuring devices: 

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The  manufacturer  shall  determine  the  monitoring  and  measurement  to  be  undertaken  and  the 

monitoring  and  measuring  devices  needed  to  provide  evidence  of  conformity  of  product  to 

determined requirements. 

The manufacturer shall establish documented procedures to ensure that monitoring and measurement 

can  be  carried  out  and  are  carried  out  in  a  manner  that  is  consistent  with  the  monitoring  and 

measurement requirements. 

Where necessary to ensure valid results, measuring equipment shall be:- 

(a)  

calibrated or verified at specified intervals, or prior to use, against measurement standards 

traceable to Bureau of Indian Standards wherever available ; where no such standards exist, 

the basis used for calibration or verification shall be recorded; 

adjusted or re-adjusted as necessary; 

identified to enable the calibration status to be determined; 

safeguarded from adjustments that would invalidate the measurement result; 

protected from damage and deterioration during handling, maintenance and storage. 

(b)  

(c) 

(d)  

(e)  

In addition, the manufacturer shall assess and record the validity of the previous measuring results 

when  the  equipment  is  found  not  to  conform  to  requirements.  The  manufacturer  shall  take 

appropriate action on the equipment and any product affected. Records of the results of calibration 

and verification shall be maintained. 

When  used  in the  monitoring  and  measurement  of  specified  requirements,  the  ability  of  computer 

software  to  satisfy  the  intended  application  shall  be  confirmed.  This  shall  be  undertaken  prior  to 

initial use and reconfirmed as necessary. 

8 Measurement, analysis and improvement.- 

8.1 General: 

The  manufacturer  shall  plan  and  implement  the  monitoring,  measurement,  analysis  and 

improvement processes needed:- 

(a) 

(b) 

(c) 

to demonstrate conformity of the product; 

to ensure conformity of the quality management system; and 

to maintain the effectiveness of the quality management system. 

This  shall  include  determination  of  applicable  methods,  including  statistical  techniques,  and  the 

extent of their use. 

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Note.- If relevant Indian standards are not available, International standards are applicable. In case 

no  Indian  or  International  standards  are  available,  validated  testing  process  of  the  manufacturer  is 

applicable. 

8.2 Monitoring and measurement.- 

8.2.1 Feedback: 

As  one  of  the  measurements  of  the  performance  of  the  quality  management  system,  the 

manufacturer  shall  monitor  information  relating  to  whether  the  manufacturer  has  met  customer  or 

regulatory requirements. The methods for obtaining and using this information shall be determined. 

The  manufacturer  shall  establish  a  documented  procedure  for  a  feedback  system  to  provide  early 

warning of quality problems and for input into the corrective and preventive action processes. 

8.2.2 Internal audit: 

The manufacturer shall conduct internal audits at planned intervals to determine whether the quality 

management system:- 

a) 

conforms  to  the  planned  arrangements,  to  the  requirements  of  this  schedule  and  to  the 

quality management system requirements established by the manufacturer, and 

b)  

is effectively implemented and maintained. 

An  audit  programme  shall  be  planned,  taking  into  consideration  the  status  and  importance  of  the 

processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, 

frequency  and  methods  shall  be  defined.  Selection  of  auditors  and  conduct  of  audits  shall  ensure 

objectivity and impartiality of the audit process. Auditors shall not audit their own work. 

The responsibilities and requirements for planning and conducting audits, and for reporting results 

and maintaining records shall be defined in a documented procedure. The management responsible 

for  the  area  being  audited  shall  ensure  that  actions  are  taken  without  undue  delay  to  eliminate 

detected nonconformities and their causes. Follow-up activities shall include the verification of the 

actions taken and the reporting of verification results. 

8.2.3 Monitoring and measurement of processes: 

The manufacturer shall apply suitable methods for monitoring and, where applicable, measurement 

of  the  quality  management  system  processes.  These  methods  shall  demonstrate  the  ability  of  the 

processes  to  achieve  planned  results.  When  planned  results  are  not  achieved,  correction  and 

corrective action shall be taken, as appropriate, to ensure conformity of the product. 

8.2.4 Monitoring and measurement of product.- 

8.2.4.1 General requirements: 

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The manufacturer shall monitor and measure the characteristics of the product to verify that product 

requirements have been met. This shall be carried out at appropriate stages of the product realisation 

process in accordance with the planned arrangements and documented procedures. 

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the 

person(s)  authorizing  release  of  product.  Product  release  shall  not  proceed  until  the  planned 

arrangements have been satisfactorily completed. 

8.2.4.2 Particular requirement for active implantable medical devices and implantable medical 

Devices wherever applicable: 

The manufacturer shall record the identity of personnel performing any inspection or testing. 

8.3 Control of nonconforming product 

The  manufacturer  shall  ensure  that  product  which  does  not  conform  to  product  requirements  is 

identified  and  controlled  to  prevent  its  unintended  use  or  delivery.  The  controls  and  related 

responsibilities  and  authorities  for  dealing  with  nonconforming  product  shall  be  defined  in  a 

documented procedure. 

The manufacturer shall deal with nonconforming product by one or more of the following ways: 

(a)  

(b)  

(c)  

by taking action to eliminate the detected nonconformity; 

by authorizing its use, release or acceptance under concession; 

by taking action to preclude its original intended use or application. 

The  manufacturer  shall  ensure  that  nonconforming  product  is  accepted  by  concession  only  if 

regulatory  requirements  are  met.  Records  of  the  identity  of  the  person  authorisng  the  concession 

shall be maintained. 

Records of the nature of  nonconformities and any subsequent actions taken, including concessions 

obtained, shall be maintained. 

When  nonconforming  product  is  corrected  it  shall  be  subject  to  re-verification  to  demonstrate 

conformity to the requirements. When nonconforming product is detected after delivery or use has 

started, the manufacturer shall take action appropriate to the effects, or potential effects, of the non-

conformity. 

If product needs to be reworked (one or more times), the manufacturer shall document the rework 

process in a work instruction that has undergone the same authorisation and approval procedure as 

the  original  work  instruction.  Prior  to  authorisation  and  approval  of  the  work  instruction,  a 

determination of any adverse effect of the rework upon product shall be made and documented. 

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8.4 Analysis of data: 

The  manufacturer  shall  establish  documented  procedures  to  determine,  collect  and  analyze 

appropriate data to demonstrate the suitability and effectiveness of the quality management system 

and to evaluate whether improvement of the effectiveness of the quality management system can be 

made. 

This shall include data generated as a result of monitoring and measurement and from other relevant 

sources. 

The analysis of data shall provide information relating to:- 

(a)  

(b)  

(c)  

feedback 

conformity to product requirements; 

characteristics  and  trends of  processes  and products including  opportunities for  preventive 

action; and 

(d)  

suppliers. 

Records of the results of the analysis of data shall be maintained. 

8.5 Improvement.- 

8.5.1 General: 

The  manufacturer  shall  identify  and  implement  any  changes  necessary  to  ensure  and  maintain  the 

continued  suitability  and  effectiveness  of  the  quality  management  system  through  the  use  of  the 

quality  policy,  quality  objectives,  audit  results,  analysis  of  data,  corrective  and  preventive  actions 

and management review. 

The  manufacturer  shall  establish  documented  procedures  for  the  issue  and  implementation  of 

advisory notices. These procedures shall be capable of being implemented at  any time. Records of 

all  customer  complaint  investigations  shall  be  maintained.  If  investigation  determine  that  the 

activities  outside  the  manufacturer‘s  organisation  contributed  to  the  customer  complaint,  relevant 

information shall be exchanged between the organisations involved. 

If  any  customer  complaint  is  not  followed  by  corrective  or  preventive  action,  the  reason  shall  be 

recorded and approved. Manufacturer shall notify the adverse event to the regulatory authority and 

establish documented procedures for the same. 

8.5.2 Corrective action: 

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The  manufacturer  shall  take  action  to  eliminate  the  cause  of  nonconformities  in  order  to  prevent 

recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. 

A documented procedure shall be established to define requirements for:- 

(a)  

(b)  

(c)  

(d)  

(e)  

(f)  

reviewing nonconformities (including customer complaints); 

determining the causes of nonconformities; 

evaluating the need for action to ensure that nonconformities do not recur 

determining  and 

implementing  action  needed, 

including, 

if  appropriate,  updating 

documentation; 

recording of the results of any investigation and of action taken; and 

reviewing the corrective action taken and its effectiveness. 

8.5.3 Preventive action: 

The  manufacturer  shall  determine  action  to  eliminate  the  causes  of  potential  nonconformities  in 

order  to  prevent  their  occurrence.  Preventive  actions  shall  be  appropriate  to  the  effects  of  the 

potential problems. A documented procedure shall be established to define requirements for 

(a)  

(b)  

(c)  

(d)  

(e) 

determining potential nonconformities and their causes, 

evaluating the need for action to prevent occurrence of nonconformities, 

determining and implementing action needed, 

recording of the results of any investigations and of action taken, and 

reviewing preventive action taken and its effectiveness. 

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Annexure ‗A‘ 

(refer para 4.2.1) 

The manufacturer shall prepare a succinct document in the form of Device Master File containing 

specific information about the device manufacturing in the premises. 

1.0  Executive Summary: 

An executive summary shall be provided by the manufacturer and shall contain: 

Introductory descriptive information on the medical device or In-vitro Diagnostics, the intended use 

and indication for use, Class of Device, novel features of the device (if any), shelf life of the device 

and  a  synopsis  on  the  content  of  the  dossier  information  regarding  sterilisation  of  the  device 

(whether it is sterile or non-sterile; if sterile, mode of sterilisation) 

2.0  Device Description And Product Specification, Including Variants And Accessories: 

2.1 

2.2  

2.3 

Device Description 

Product Specification 

Reference to predicate and/or previous generations of the device 

3.0  Labelling 

4.0   Design And Manufacturing Information: 

4.1  

Device Design 

4.2   Manufacturing Processes 

5.0   Essential Principles (EP) Checklist 

6.0   Risk Analysis And Control Summary 

7.0   Product Verification And Validation: 

7.1  

Biocompatibility 

7.2   Medicinal Substances 

7.3  

7.4 

7.5  

7.6  

7.7  

7.8  

7.9 

Biological Safety 

Sterilisation 

Software Verification and Validation 

Animal Studies 

Shelf Life/Stability Data 

Clinical Evidence 

Post Marketing Surveillance Data (Vigilance Reporting) 

8.   Additional information in case of the diagnostic kits: 

Product dossier showing the: 

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8.1  

The  details  of  source  antigen  or  antibody  as  the  case  may  be  and  characterization  of  the 

Drugs and Cosmetics Rules 1945 

same. 

Process  control  of  coating  of  antigen  or  antibody  on  the  base  material  like  Nitrocellulose 

paper, strips or cards or enzyme-linked immunosorbent assay (ELISA) wells etc. 

Detailed composition of the kit and manufacturing flow chart process of the kit showing the 

specific flow diagram of individual components or source of the individual components. 

8.2  

Test  protocol  of  the  kit  showing  the  specifications  and  method  of  testing.  In  house 

evaluation report of sensitivity, specificity and stability studies. 

The detailed test report of all the components used/packed in the finished kit. 

Pack size and labelling. 

Product inserts. 

8.3  

8.4  

8.5  

Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity 

of the kit. 

Specific processing like safe handling, material control, area control, process control, and stability 

studies,  storage  at  quarantine  stage  and  finished  stage,  packaging  should  be  highlighted  in  the 

product dossier. 

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Annexure `B` 

(refer para 4.2.2) 

The  manufacturer  shall  prepare  a  succinct  document  in  the  form  of  Plant  Master  File  containing 

specific information about the production and/or control of device manufacturing carried out at the 

premises. It shall contain the following information: 

1.  General Information: 

(i) 

(ii) 

(iii) 

(iv) 

brief information on the site (including name and address), relation to other sites; 

manufacturing activities; 

any other operations carried out on the site 

name and exact address of the site, including telephone, fax numbers, web site URL and 

e-mail address; 

(v) 

type  of  medical  devices handled  on  the  site  and information  about  specifically  toxic  or 

hazardous  substances  handled,  mentioning  the  way  they  are  handled  and  precautions 

taken; 

(vi) 

short  description  of  the  site  (size,  location  and  immediate  environment  and  other 

activities on the site); 

(vii) 

number  of  employees  engaged  in  Production,  Quality  Control,  warehousing,  and 

distribution; 

(viii)  use of outside scientific, analytical or other technical assistance in relation to the design, 

manufacture and testing; 

(ix) 

(x) 

short description of the quality management system of the company; 

devices details registered with foreign countries; 

2. Personnel: 

(i) 

(ii) 

organisation chart showing the arrangements for key personne;l 

qualifications, experience and responsibilities of key personnel; 

(iii) 

outline of arrangements for basic and in-service training and how records are maintained; 

(iv) 

health requirements for personnel engaged in production 

(v) 

personnel hygiene requirements, including clothing. 

3. Premises and Facilities: 

(i) 

layout of premises with indication of scale; 

(ii) 

nature of construction, finishes/fixtures and fittings; 

(iii)  brief  description  of  ventilation  systems.  More  details  should  be  given  for  critical  areas 

with  potential  risks  of  airborne  contamination  (including  schematic  drawings  of  the 

systems). Classification of the rooms used for the manufacture of sterile products should 

be mentioned; 

(iv) 

special areas for the handling of highly toxic, hazardous and sensitizing materials; 

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(v) 

brief  description  of  water  systems  (schematic  drawings  of  the  systems  are  desirable) 

Drugs and Cosmetics Rules 1945 

including sanitation; 

(vi)  maintenance  (description  of  planned  preventive  maintenance  programmes  for  premises 

and recording system); 

4. Equipment: 

(i) 

Brief description of major production and quality control laboratories equipment (a list of 

the equipment is required); 

(ii)  maintenance (description of planned preventive maintenance programmes and recording 

system); 

(iii)  qualification  and  calibration,  including  the  recording  system.  Arrangements  for 

computerized systems validation. 

5. Sanitation: 

Availability of written specifications and procedures for cleaning the manufacturing areas and 

equipments. 

6. Production: 

(i) 

Brief  description  of  production  operations  using,  wherever  possible,  flow  sheets  and 

charts specifying important parameters ; 

(ii) 

arrangements  for  the  handling  of  starting  materials,  packaging  materials,  bulk  and 

finished products, including sampling, quarantine, release and storage; 

(iii)  arrangements for reprocessing or rework; 

(iv)  arrangements for the handling of rejected materials and products; 

(v) 

brief description of general policy for process validation. 

7. Quality Assurance: 

Description of the Quality Assurance system and of the activities of the Quality Assurance 

Department. Procedures for the release of finished products. 

8. Storage: 

Policy on the storage of medical device. 

9. Documentation: 

Arrangements  for  the  preparation,  revision  and  distribution  of  necessary  documentation, 

including storage of master documents. 

10. Medical Device Complaints and Field Safety Corrective Action: 

(i)  Arrangements for the handling of complaints ; 

(ii)  Arrangements for the handling of field safety corrective action 

11. Internal Audit: 

Short Description of the internal audit system. 

12. Contract Activities: 

Description of the way in which the compliance of the contract acceptor is assessed. 

522 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
Annexure ‗C‘ 

Environmental requirement for Notified medical devices and in-vitro diagnostics 

Name of Device 

Type of Operation 

ISO Class (At rest) 

Cardiac stent/Drug Eluting 
Stent  

Heart Valves  

Intra Ocular Lenses 

Bone Cements 

Internal Prosthetic 
Replacement 

Orthopedic Implants 

Catheters /Ablation Device / I 
V Cannulae / Scalp Vein Set/ 
Hypodermic Syringes/ 
Hypodermic Needles / 
Perfusion Sets 
Condom 

Intra Uterine Devices 

Tubal ring 

Blood bags 

Suture 

Staplers 

Primary Packing and Crimping  

5  

7 

8 
9 

Washing, Ultrasonic cleaning &Drug 
coating 
Assembly, Wrapping & Packaging 
Laser cutting, Descaling,  Annealing & 
Electro polishing 
5 
Valve Packing 
Ultrasonic Cleaning & Visual Inspection  7 
7 
Frame & Disc Assembly 
5 
Packing & Sealing 
7 
Final Inspection 
8 
Power Checking& Final Cleaning 
9 
Tumble Polishing & Lathe Cutting 
5 
Final Product Filling 
7 
Sieving & Calcinations 
8 
Powder Preparation, Granulation 
&Drying 
Packing 
Product Preparation 
Component Preparation 
Polishing &Cleaning & packaging (to be 
sterilized in factory premises) 
Polishing , cleaning & packaging (Non 
Sterile- to be sterilized in Hospital) 
Cutting, lathing 
Assembly, Coating, Wrapping & 
Packing 

5 
7 
8 
7 

9 
7 

8 

Component Preparation & Cleaning 
Moulding 

8 
9 

Compounding 

Moulding 

Vulcanising 
Packing 
Moulding 

Assembling 
Packaging 
Extrusion 
Cutting and Assembly 
Packaging 
Moulding/Extrusion of components 
Assembly 
Filing 
Extrusion 
Assembly 
Packing 
Staple formation 
Staple assembly 

523 

Well  ventilated  area  with 
minimum 5 micron filter 
Well  ventilated  area  with 
minimum 5 micron filter 
Normal air 
Air conditioned 
Well  ventilated  area  with 
minimum 5 micron filter 
7 
7 
7 
7 
7 
8 
7 
5 
9 
8 
8 
9 
8 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Staple final pack 

8 

9 
8 
8 
9 
9 
9 
Well Lighted and 
Ventilated controlled 
temperature &  humidity as 
per process or product 
requirement 
Well Lighted and 
Ventilated controlled 
temperature and humidity   
as per process or product 
requirement. Provision of 
Laminar hood if required, 
Clean Room class 8 or class 
9 as per product/process 
requirement 
Well Lighted and 
Ventilated controlled 
temperature if required 
As per recommended 
storage condition of the 
product]. 

Ligatures 

Surgical dressings 

In-vitro diagnostics 
Kit/Reagents 

Extrusion 
Cutting and assembly 
Final Pack 
Weaving 
Assembly and Gauzing 
Final pack 
Dry, Liquid Reagent Preparation  
Coating of sheets etc.  
Assembly and primary packing  

Filling 

Secondary Packing 

Storage 

524 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE N 

[See Rule 64(1)] 

LIST OF MINIMUM EQUIPMENT FOR THE EFFICIENT RUNNING 
OF A PHARMACY 

1.   Entrance. -  The front of a pharmacy shall bear an inscription ―Pharmacy‖ in front. 

2.   Premises. -  The premises of a pharmacy shall be separated from rooms for private 
use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions 
to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible 
and appropriate manner. The areas of the section to be used as dispensing department shall be 
not  less  than  6  square  meters  for  one  pharmacist  working  therein  with  additional  2  square 
meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters. 

The floor of the pharmacy shall be smooth and washable. The walls shall be plastered 
or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, 
cracks and crevices. 

A pharmacy shall be provided with ample supply of good quality water. 

The dispensing department shall be separated by a barrier to prevent the admission of 

the public. 

3.    Furniture  and  apparatus.  -      The  furniture  and  apparatus  of  a  pharmacy  shall  be 
adopted to the uses for which they are intended and correspond to the size and requirements 
of the establishment. 

Drugs,  chemicals,  and  medicaments  shall  be  kept  in  a  room  appropriate  to  their 
properties and in such special containers as will prevent any deterioration of the contents or of 
contents of containers kept near them. Drawers, glasses and other containers used for keeping 
medicaments shall be of suitable size and capable of being closed tightly to prevent the entry 
of dust. 

Every container shall bear a  label of  appropriate size, easily readable with names of 

medicaments as given in the Pharmacopoeias. 

A  pharmacy  shall  be  provided  with  a  dispensing  bench,  the  top  of  which  shall  be 

covered with washable and impervious material like stainless steel, laminated or plastic, etc. 

A pharmacy shall be provided with a  cupboard with lock and key  for the storage of 
poisons  and  shall  be  clearly  marked  with  the  work  ‗POISON‘  in  red  letters  on  a  white 
background. 

Containers  of  all  concentrated  solution  shall  bear  special  label  or  marked  with  the 

words ―To be diluted‖. 

A  Pharmacy  shall  be  provided  with  the  following  minimum  apparatus  and  books 

necessary for making of official preparations and prescriptions:- 

1.Subs.  by  S.O.2139 , dt. 12.8.1972. 

525 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Apparatus: - 

Balance, dispensing, sensitivity 30 mg. 
Balance, counter, capacity 3 Kgm., sensitivity 1 gm. 
Beakers, lipped, assorted sizes. 
Bottles, prescription, ungraduated assorted sizes. 
Corks assorted sizes and tapers. 
Cork, extracter. 
Evaporating dishes, porcelain. 
Filter paper. 
Funnels, glass. 
Litmas paper, blue and red. 
Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml. 
Mortars and pestles, glass. 
Mortars and pestles, wedgwood. 
Ointment pots with bakelite or suitable caps. 
Ointment slab, porcelain 
Pipette  graduated, 2 ml, 5 ml and 10 ml. 
Ring, stand (retort) iron, complete with rings. 
Rubber stamps and pad 
Scissors 
Spatulas, rubber or vulcanite 
Spatulas, stainless steel. 
Spirit lamp 
Glass stirring rods. 
Thermometer, 0oC to 200oC. 
Tripod stand. 
Watch glasses. 
Water bath. 
Water distillation still in case Eye drops and Eye lotions are prepared. 
Weights, Metric, 1 mg. to 100 gm. 
Wire Gauze. 
*Pill finisher, boxwood. 
* Pill Machine. 
* Pill Boxes. 
* Suppository mould. 

Books : 

The Indian Pharmacopoeia (Current Edition). 
National Formulary of Indian (Current Edition). 
The Drugs and Cosmetics Act, 1940. 
The Drugs and Cosmetics Rules, 1945. 
The Pharmacy Act, 1948. 
The Dangerous Drugs Act, 1930. 

526 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

4.          General provisions. -   A pharmacy shall be conducted under the continuous 
personal   supervision   of   a   Registered   Pharmacist   whose   name   shall   be   displayed 
conspicuously in the premises. 

The Pharmacist shall always put on clean white overalls. 

The premises and fittings of the pharmacy shall be properly kept and everything shall 

be in good order and clean. 

All records and registers shall be maintained in accordance with the laws in force. 

Any container taken from the poison cupboard shall be replaced therein immediately 
after  use  and  the  cupboard  locked.  The  keys  of  the  poison  cupboard  shall  be  kept  in  the 
personal custody of the responsible person. 

Medicaments when supplied shall have labels conforming to the provisions of laws in 

force. 

Note:  -  The  above  requirements are  subject to  modifications at  the  discretion of  the 
licensing  authority,  if  he  is  of  opinion  that  having  regard  to  the  nature  of  drugs  dispensed, 
compounded or prepared by the licensee. It is necessary to relax the above requirements or to 
impose additional requirements in the circumstances of a particular case. The decision of the 
licensing authority in that regard shall be final. 

*  These  items  are  to  be  provided  only  by  those  who  intend  to  dispense  pills  or 

suppositories, as the case may be.] 

527 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE  O 
[See  Rule 126] 

STANDARD FOR DISINFECTANT FLUIDS 

2[PART I 

PROVISION APPLICABLE TO BLACK FLUIDS AND WHITE FLUIDS 

The standards for disinfectants shall  conform to the Indian  Standards specification  (IS 
1061:1997) laid down from time to time by the Bureau of Indian Standards.] 

1.  Subs.  by  G.S.R.  1243,  dared  19-09-1979,  for  Schedule  O  (w.e.f.  6-10-979).  EARLIER  Schedule  O  was  added    y 
Notification No. F.1-20/60-D, dated 24-01-1964. 
2. Subs. by G.S.R. 735(E), dated 21-12-2005, for 

―PART I 

Provision applicable to Black Fluids and White Fluids 

1.Classification - The disinfectants shall be classified as follows: -  

(a) Black fluids 

(b) White fluids 

(A) Black  fluids.–  These  shall  be  homogeneous  dark  brown  solution  of  coal  tar acid  or 
similar  acids  derived  from  petroleum  with  or  without  hydrocarbon,  and/or  other 
phenolic compounds, and their derivatives and a suitable emulsifier. 

(B)  White  fluids.–  These  shall  be  finely  dispersed  homogeneous  white  to  off-  white 
emulsion consisting of coal tar acids or similar acids derived from petroleum, with or 
without hydrocarbons, and/or other phenolic compounds, and their derivatives. 

2.Gradation –  Each of  the  above classes of  disinfectant fluids shall be  graded on the basis of the 
minimum requirements in respect of: 

Rideal Walker (RW) Coefficient as follows: - 

Grade               Rideal Walker (RW)  

Coefficient (Minimum) 

1.                                  18 

2.                                  10 

3.                                   5 

3.Type -  Each of the above grades of disinfectant fluids shall be stable in the range of temperature 
indicated against each type. - 

Type                                                             Stable in the range of 

(I)  Normal                                                              15o C to 45o C. 
(II) Winter                                                                5 o C to 30 o C 

4.Requirements -   All  classes  and  grades  of  disinfectant  fluids  shall  comply with the following 
requirements, namely: - 

 (1)  Stability  after  dilution  -  When  tested  by  the  method  described  hereinafter  the 
disinfectant fluid shall be miscible with artificial hard water (for Black fluids) or with artificial  sea 
water  (for  White  fluids)  in  all  proportion  from  1  per  cent  to  5  per  cent  by volume, to  give 

528 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
emulsion which shall not break or show more than traces of separation of either top or bottom oil 
when  kept  for  6  hours  at  15o  C  to  45o  C  for  Type  (I)  (Normal)  and  5o  C  to  30o  C  for  Type  (II) 
(Winter). 

(2) Germicidal  Value.–  Rideal  Walker  Coefficient  –  Black  fluids  and  White fluids  shall 
be    tested  for  determination  of  Rideal  Walker  Coefficient  (R.W.Coefficient)  by  the  method 
described hereinafter. 

(3) Storage.– Disinfectant fluids of all classes shall be stored in mild steel, tinned mild steel or 

other suitable containers. These shall not be stored in containers made of galvanized iron. 

(4) Labelling. -Subject to  the  other  provisions in  these  rules,  the  label  on  the container shall 

state- 

(i)        the name of the product, 

(ii)        the name and full address of the manufacturer, 

(iii)       grade, type, R.W. Coefficient of product, 

(iv)       date of manufacture, 

(v)         quantity present in the container, 

(vi)       indications and mode of use, and 

(vii)      date up to which the product can be used. 

5.Method of testing -  (1)  Preparation  of  sample  -     The  sample  of  disinfectant  fluid  to  be  tested 
should  be  mixed  thoroughly  taking  care  that  no  air  is  beaten  into  the  fluid  immediately  before 
withdrawing any  portion  for  testing.  The  rest  portion  should  be withdrawn from the middle of the 
sample. 

(2)  Method of resting stability after dilution. - (a)  Preparation of  Artificial  Hard Water: 40 
ml  of  I  N  Hydrochloric  Acid  (Analytical  Reagent  Quality)  is  neutralized  with  a  slight  excess  of 
Calcium  Carbonate  and  filtered.  The  filtrate  is  diluted  to  1000  ml  with distilled water, 10 parts 
of this solution is further diluted to 100 parts with distilled water. 

(b)  Preparation  of  Artificial  Sea  Water:  27G  of  Sodium  Chloride  (Analytical  Reagent 
Quality)  and  5  G  of  Magnesium  Sulphate  (Analytical  Reagent Quality) are  dissolved in  distilled 
water and diluted to 1000 ml. The solution is filtered before use. 

(c) Procedure: Take 1 ml and 5 ml portions of the sample in duplicate in 100 ml stoppered 
measuring cylinder  (IS:  878  –  1956)  by  means  of  pipettes.  Dilute  the  sample  with  artificial  Hard 
water or Artificial Sea water (as the case may be) upto 10 ml mark. Mix thoroughly by inverting the 
cylinders 5 times. Keep the cylinders containing the diluted fluids for 6 hours at the extremes of the 
temperature range specified for the particular type. The sample complies with the test if the solution 
shows not more than a trace of separation at its top and bottom. 

(3)  Method of determination of Rideal Walker Coefficient (R.W.C)-  

Apparatus – A loop, 4 mm in internal diameter is made at the end of 28 swg (0.376 mm) 
wire of platinum or platinum iridium alloy, 38 mm long from the loop to the holder. The loop is bent 
at such an angle to the length of the wire as will facilitate in  removal  vertically  from  the  surface  of 
the  liquid  while  keeping  the  place  of  the loop horizontal. 
Incubator – Set and maintained at 37o C ± 1o C 
Pipettes – Standard graduated pipettes of capacity 10 ml; 5 ml and 1 ml 
Dropping Pipette – Made of delivery 0.2 ml 
Medication   tubes   –   5   sterile   plugged   rimless   test   tubes   125   mm   x   22   mm 

(5 inch x ¾ inch) made of hard neutral glass. 

Both tubes – About 2 dozens of the same description as medication tubes. 

529 

 
 
 
 
 
 
 
 
Standard   measuring   cylinders   stopped   and   graduated—500   ml   graduated   in 
10  ml–;one  100  ml  graduated  1  ml–  five.      All  apparatus  must  be  scrupulously  clean  and 
sterile; immediately before use. 

Drugs and Cosmetics Rules 1945 

Reagents– (a) Broth.– Prepare a mixture of the following ingredients: 

Meat  extract  (Microbiological  grade)  20  g  Peptone  (Micro  biological  grade)  20g.  Sodium 
Chloride (Regent Quality) 10 g Distilled Water- 1000 ml. 

Dissolve  the  solids  in  distilled  water.  Add  sufficient  sodium  hydroxide  to  neutralize  the 
solution;  then  boil  it  to  bring  down  phosphates  and  filter  while  hot.  The  broth  thus prepared 
is  then  adjusted  to  pH  7.6  with  normal  Hydrochloric  acid.  The  broth  is  then sterilized by 
autoclaving at  15  lbs  pressure  for  20  minutes.  It  is  then  filtered  and  placed  in  5 ml  quantities in 
sterilized  broth  tubes.  The  tubes  of  media  thus  prepared  are  sterilized  by  autoclaving  at  15  lbs 
pressure  for  10  minutes.  The  final  pH  of  the  medium  should  lie  between  7.3  and  7.5.    Further 
resterilization in bulk or in tubes is not permissible. 

(b)  Test  Organism- Test  organism used  is  Salmonella typhi   (NCTC  786)  of  which suitable 
culture  shall  be  obtained  from  the  Director,  Central  Drugs  Laboratory,  Calcutta.  This  culture  is 
maintained by weekly sub-culture on a  nutrient agar slope (made by  dissolving 2.5 per  cent  Agar 
Agar (Bacteriological grade) in  broth prepared as  above), incubating the  sub- culture for 24 hours 
at 37O C and then storing in refrigerator at a temperature below 22o C. For the purpose of the test a 
little of the growth from the most recent sub-culture in nutrient agar slope is placed in tube of R.W. 
broth and incubated for 23 hours at 38o C.  A standard loopful is then transferred to a second tube 
and incubated as before. This is done at least three times before a test is carried out. Sub-culturing 
in broth is limited to 14 days. 

(c)  Standard  phenol:  5  per  cent  W/V  solution  in  sterile  distilled  water  of  chemically  pure 
phenol having a crystallizing point of not less than 40.5oC is prepared. Test dilutions are prepared 
from this stock solution containing 1 g of phenol in each 95, 100, 105, 115 ml of the solution made. 
These dilutions shall be used within a week of preparation. 

(d)  Test  dilutions  of  Disinfectant  (sample)-  The  sample  is  prepared  as  described  under 
―Preparation of samples‖. A test portion of 5 ml is withdrawn and discharged into about 480 ml of 
sterile  distilled  water  in  a  500  ml  glass  stoppered  sterile  measuring  cylinder  and  the  pipette  is 
rinsed  three  times  or  more  in  the  clear  liquid.  The  whole  is  then  made  up  to  500  ml  with  sterile 
distilled  water,  the  cylinder  is  stoppered  and  the  contents  thoroughly  mixed  by  inverting  the 
cylinder  several  times.  Suitable  test  dilutions  in  sterile  distilled  water  are  then  immediately 
prepared from this stock solution. 

Procedure:  5  ml  of  4  chosen  dilutions  of  the  disinfectant  are  placed  in  4  medication  tubes 
which  are  then  placed  in  a  rack  provided  with  water  bath  maintained  at  a  constant  temperature 
between  17o    C  and  19o    C,  with  the  strongest  dilution  on  the  left.  The  fifth  medication tube 
containing 5  ml  of  the  particular phenol dilution is  placed on  the  right. When the  content  on  the 
medication tubes and broth culture of the  test organism have reached the temperature of the water 
bath, starting at Zero time, 0.2 ml of the culture is added to the left hand medication tube and the 
tube  is  shaken  gently.  After  30  seconds  the  next  tube  is  inoculated  similarly  and  the  process  is 
repeated  with  each  successive  tube  at  intervals  of  30  seconds  until  the  phenol  control  has  been 
inoculated. Thirty seconds after this last  addition (that  is  2-1/2  minutes  from  zero)  a  loopful  of 
the  well-shaken  content  of  the  tube  at  the  extreme  left  is  withdrawn  and  placed  in  tube 
containing 5 ml of the broth medium. Thirty seconds  after  this  similar  operation  is  performed  
on  the  second  medication  tube.  The procedure  is  repeated  at  an  interval  of  30  seconds  with 
each  of  the  5  medication  tubes working from left to right until 4 sets of cultures have been made 
i.e. at 2-1/2, 5, 7-1/2 and 10 minutes  respectively  after  exposure.  In  each  withdrawal  care  should 
530 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
be  taken  to  ensure  that the loop is removed vertically from the surface of the liquid with its plane 
horizontally and without touching the side of the test tubes. The loop shall be sterilized by flaming 
between each  operation,  care  being  taken  that  the  loop  is  cooled  before  being  again  used.  
The inoculated broth tubes are incubated for not less than 48 hours and not more than 72 hours at 
37o C when the tubes showing growth of the test organisms will be recognized by turbidity of the 
broth. 

Calculation    of    Coefficient  –    The    R.W.    Coefficient    is    obtained    by    dividing    that 
dilution  of  the  disinfectant  which  shows  life  of  test  organism  in  2-1/2  and  5  minutes  but  no life 
thereafter by  that  dilution of the phenol which gives the same response.A typical set of sample is 
given below: 

Sample disinfectant           Time of exposures in minutes 
Dilutions                            2½        5          7½        10 

1:1000 
1:1100 
1:1200 
1:1300 
1:100 Pheno control 

− 
+ 
+ 
+ 
+ 

− 
− 
+ 
+ 
+ 

− 
− 
− 
+ 
− 

− 
− 
. − 
− 
− 

R.W. Coefficient 
= 1200    =  12 

100 

(+ = growth   − = No growth) 

Provisions applicable to other disinfectant fluids: 

PART  II 

Disinfectant  fluids  which  are  made  with  chemicals  other  than  those  specified  under Part I of this 
Schedule shall conform to the formula or list of ingredients shown on the label. 

Labelling :  Subject to the provisions of rules on labelling, the label of container shall state:  

  (i)        the name of the product; 
(ii)        the name and full address of the manufacturer; 
(iii)       the full formula or list of ingredients of the preparation;  
(iv)       date of manufacture; 
(v)        date up to which the product can be used;  
(vi)       quantity present in the container; and 
(vii)      indications and mode of use. 

Cautionary note: 

Mercury compounds shall be strictly excluded from all grades.] 

531 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
1[SCHEDULE P 

[See Rule 96] 

LIFE PERIOD OF DRUGS 

Sl. 
No. 

Name of the drug                                         Period   in   months   (unless 
specified) 
 date           of 

otherwise 
between 
manufacture and date of 
expiry which the labelled 
potency period of the drug 
shall not exceed under the 
conditions 
specified in Column No.4 

of       storage 

Condition of storage 

1                         2                                                                   3                                                4 

30 
36 
24 
24 
24 
36 
30 
36 
24 
18 
18 
12 
12 
24 

24 

24 
60 
48 
48 
36 
24 
48 
36 
60 
60 
24 
24 
36 
36 

In a cool place 
In a cool place 

In a cool place 
In a cool place 
In a cool place 

In a cool place 

At temperature not   
Exceeding 5°C 
At temperature not   
Exceeding 5°C 
In a cool place 
In a cool place 

In a cool palace 
In a cool place 
In a cool place 

In a cool place 
In a cool place 

ANTIBIOTICS 

1.  Adramycin 
2.  Ampicillin 
3.  Ampicillin Capsules 
4.  Ampicillin Dry Syrup 
5.  Ampicillin Injection 
6.  Ampicillin Sodium 
7.  Ampicillin Trihydrate 
8.  Amoxycillin Trihydrate 
9  Amoxycillin Trihydrate Capsules 
10.  Amoxycillin Trihydrate Dry Syrup 
11.  Bacitracin 
12.  Bacitracin or Zinc Bacitracin Tablets 
13.  Bacitracin Lozenges 
14.  Carbenicillin Sodium Injection 

15.  Carbenicillin Sodium Powder 

16.  Cephalexin 
17.  Chloramphenicol 
18.  Chloramphenicol Capsules & Tablets 
19.  Chloramphenicol Palmitate 
20.  Chloramphenicol Palmitate Oral Suspension 
21.  Chloramphenicol Eye drops 
22.  Chloramphenicol Sodium Succinate Powder 
23.  Chloramphenicol Sodium Succinate Injection 
24  Chlortetracycline Hydrochloride 
25.  Chlortetracycline Hydrochloride Capsules 
26.  Chlortetracycline Hydrochloride Tablets 
27.  Chlortetracycline Hydrochloride Ointment 
28.  Cloxacillin (Oral) 
29.  Cloxacillin Sodium (Injection Grade) 

1.  Subs.  by  G.S.R. 17(E) , dt. 7.1.1986 ( w.e.f. 7.1.1986 ). 

532 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Protected  from light 
In a cool place 

1                                       2                                                                         3                           4 
30.  Colistin Sulphate 
31.  D-Cycloserine 
32.  Dimethyl Chlortetracycline Hydrochloride 
33.  Dimethyl Chlortetracycline Hydrochloride Capsules 
34.  Daunoblastin Injection. 
35.  Doxycycline Hydrochloride 
36.  Doxcycline Monohydrate 
37.  Doxycyline Monohydrate for Oral Suspension. 
38.  Doxycycline Monohydrate Capsules. 
39.  Erythromycin Estolate 
40.  Erythromycin Ethylsuccinate 
41.  Erythromycin Oral Suspension 
42.  Erythromycin Estolate for Oral Suspension 
43.  Erythromycin Ethyl Succinate Tablet 
44.  Erythromycin Estolate Tablets 
45.  Erythromycin Stearate 
46. 

60 
48 
48 
36 
36 
48 
36 
24 
36 
36 
60 
36 
36 
24 
24 
36 
48 

Framycetin Sulphate 

In a cool place 
In a cool place 

In a cool place 
In a cool place 

In a cool place 
In a well closed container 
with temperature not 
exceeding 30°C 
In a  well closed container 
with temperature not 
exceeding 30°C 

In a  well closed container 
with temperature not 
exceeding 30°C 

In a cool place. 

In a cool place 
In a cool place 

In a cool place 
In a cool place 
In a cool place 
At temperature not exceeding 
5°C 
In a cool place 
In a cool place 
In a cool place 

In a cool place 
In a cool place 

In a cool place 

47. 

Framycetin Sulphate Eye drops 

48. 

Framycetin Sulphate Ointment 

49.  Gentamycin Sulphate 
50.  Gentamycin Sulphate Injection 
51.  Gramicidin 
52.  Griseofulvin 

53.  Griseofulvin Tablets 

54.  Kanamycin Sulphate Injection. 
55.  Kanamycin Acid Sulphate Powder 
56.  Mitomycin C 
57.  Neomycin Sulphate. 
58.  Nystatin 

59.  Oleandomycin Phosphate sterile 
60.  Oleandomycin Phosphate non sterile 
61.  Oxytetracline Hydrochloride 
62.  Oxytetracycline Hydrochloride Capsules. 
63.  Oxytetracycline Hydrochloride Tablets 
64.  Oxytetracycline Hydrochloride Injection 
65.  Oxytetracycline Hydrochloride Ointment 
66. 
67. 

Penicillin Crystalline 
Penicillin Tablets 

68.     Procaine Penicillin G 

533 

24 

24 

60 
36 
60 
48 

36 

24 
48 
48 
48 
36 

24 
36 
36 
36 
24 
24 
36 
36 
18 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                        2                                                                      3                                  4 

Benzathin Penicillin G 
69. 
Potassium Phenoxy Methyl Penicillin 
70. 
Potassium Phenoxy Methyl PenicillinTablets 
71. 
Polymixin B Sulphate 
72. 
Polymixin B Sulphate Ointment or Powder 
73. 
74. 
Rifampicin 
1[75  Rifampicin Capsules 
76. 
77. 
78. 
79. 
80. 
81. 
82. 
83. 
84. 
85. 

Spramycin Base 
Strepromycin Injection. 
Streptomycin Ointment 
Streptomycin Tablets 
Streptomycin Sulphate 
Tetracycline Base 
Tetracycline Hydrochloride 
Tetracycline Hydrochloride Capsules 
Tetracycline Tablets 
Tyrothricin 

VITAMINS 
1.  Vitamin A Injection 
2.  Vitamin B1 Injection 
3. 

Thiamine Mononitrate Tablets 

4. 

Thiamine Hydrochloride 

5. 

Thiamine Mononitrate 

6.  Riboflavin 

7.  Riboflavin-5-Phosphate 

8.  Riboflavin Tablets 
9.  Vitamin B2 Injection 
10.  Vitamin B6 

11.  Vitamin B6 tablets 
12.  Cyanacobalamin 

13.  Hydroxycobalamin 

14.  Vitamin B12 Injection 
15.  Calcium Pantothenate 

16.  Vitamin C Injection 
17.  Calcium Pantothenate Tablets 
218.  Vitamin C 

1. Subs. by G.S.R. 250(E), dt. 4.4.2002 
2. Subs. by G.S.R. 626(E), dt. 14.10.1991 

534 

48 
48 
24 
48 
24 
36 
36] 
24 
36 
24 
24 
48 
24 
36 
36 
24 
60 

24 

24 
36 

48 

48 

60 

24 

36 
24 
60 

36 
48 

48 

36 
36 

24 
36 
48 

In a cool place 

In a cool place 

In a cool place 
In a cool place 
In a cool place 

In a cool place 

At temperature not exceeding 20oC 
In a cool place 
In a cool place 

In a cool place. 

In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 
In a well closed container, protected 
from light, in a cool place. 
In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 

In a well closed container, protected 
from light, in a cool place. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                       2                                                                 3                                        4 

19.  Vitamin D2   D3 

20.  Vitamin E or E-Acetate 

21.  Folic Acid 

22.  Folic Acid Tablets 
23.  Vitamin K 

24.  Vitamin K Injection 
25.  Niacinamide 

26.  Niacinamide Tablets 
27.  D-Panthenol 

INSULIN PREPARATIONS 

1.  Globuline Zinc Insulin Injection 

2. 

Insulin Injection 

3. 

Insulin Zinc Suspension 

4. 

Isophane Insulin Injection. 

1[5.  Human Insulin Injection 

NORMAL HUMAN PLASMA 

1.  Anti-Haemophillic Human Globulin 
2.  Dried Plasma 

3.  Dried Normal Human Serum Albumin 

4.  Frozen Plasma 
5.  Liquid Plasma 
6.  Liquid Normal Human Serum Albumin. 
2[7.  Whole Human Blood- 

36 

60 

60 

36 
60 

36 
60 

36 
60 

24 

24 

24 

24 

30 

12 
60 

60 

60 
24 
60 

In a well closed container, protected from 
light, in a cool place. 

In a well closed container, protected from 
light, in a cool place. 
In a well closed container, protected from 
light, in a cool place. 

In a well closed container, protected from 
light, in a cool place. 

In a well closed container, protected from 
light, in a cool place. 

In a well closed container, protected from 
light, in a cool place. 

At temperature between 2oC and 8oC, 
must not be allowed to freeze. 
At temperature between 2oC and 8oC, 
must not be allowed to freeze. 
At temperature between 2oC and 8oC, 
must not be allowed to freeze. 
At temperature between 2oC and 8oC, 
must not be allowed to freeze. 
At temperature between 2oC and 8oC, 
must not be allowed to freeze. 

In a cool place 
At a temperature not exceeding 
25oC 
At a temperature not exceeding 
25oC 

In deep freeze 
In cold place 
In cold place. 

(a) Collected in ACD solution 

(b) Collection in CPDA solution. 

21days 

35days 

At temperature between 4oC and 
6oC 
At temperature between 4oC and 
6oC] 

1. Subs.  by   G.S.R. 626(E) , dt. 14.10.1991. 
2. Subs.  by   G.S.R. 626(E) , dt. 14.10.1991. 

535 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

SERA TOXIN AND TOXOID 

1.        Alum Precipitated Diphtheria Toxoid                  24                   In cold place. 
2. 

Alum Precipitated Diphtheria and  
Tetanus toxoid and Pertusis vaccine combined    18                      In cold place 

3. 
4. 

5. 

Alum Precipitated Tetanus Toxoid 
Aluminium Hydroxide 
Absorbed Diphtheria Toxoid 
Aluminium          Hydroxide 
Absorbed 
Diphtheria  Tetanus  Toxoid  and   Pertussis 
Vaccine combined. 

24 
24 

18 

In a cold place 
In a cold place. 

In a cold place 

6.       Aluminium  Phosphate  Absorbed  Diphtheria 

24                     In a cold place. 

Toxoid. 

7.       Aluminium Phosphate absorbed 
Diphtheria and Tetanus Toxoid 

8.       Aluminium phosphate absorbed diphtheria 

Toxoid Tetanus Toxoid and 
Pertussis vaccine combined. 

24                     In a cold place. 

18                     In cold place 

9.       Diagnostic Diphtheira Toxin (Schick Test)           12                      In cold place 
10.  Cobra venom in solution                                          3           Between 2oC and 5oC protected 

11. 
12. 
13. 

14. 
15. 
16 
17. 
18. 
19. 

1[

Diphtheria Toxoid 
Inactivted Diagnostic Diphtheria Toxin. 
Liquid serum 

Lyophilised anti-snake venom serum 
Lyophilised Schick test Toxin and control 
Old Tuberculin 
Thrombin (Bovine origin) 
Tetanus Toxoid 
uberculin PPD 

24 
12 
12 

60 
60 
60 
36 
36 
60 

from light. 

In cold place 
In cold place 
Between 2oC and 10 
at the lower limit. 

oC preferable 

In cold place 
In cold place. 
In cold place] 
In cold place 

536 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                         
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

OTHER VACCINES 

1.  Alum precipitatd pertussis Vaccine. 
2[2.  BCG Vaccine 
3.  Cholera Vaccine 

4.  DHL Vaccine (for dog) 

5.  Measles Vaccine 

6. 

7. 

Plague Vaccine 

Polio Vaccine 

8.  Rabies vaccine 

9. 

Typhoid vaccine 

10.  Typhoid and Para Typhoid Vaccine. 

11.  Typhoid Para Typhoid A and B vaccine. 

1. Subs.  by   G.S.R. 26(E) , dt. 19.01.2006. 
2. Subs.  by   G.S.R. 174(E) , dt. 16.03.2005. 

18 
24 
18 

12 

24 

36 

24 

6 

3 

6 

18 

18 

18 

In cold place 
In cold place] 
In cold place 

In cold place 

In cold place 

In cold place 
When stored at minus 20oC 
When stored at Zero oC 
When stored at 4 oC 

In cold place 

In cold place 

In cold place 

In cold place 

537 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                            2                                                               3                                   4 

12. 
13. 

14. 

Typhoid Para Typhoid A,B & C Vaccine 
Typhoid Para Typhoid  A, B & C and 
Tetanus Vaccine. 
Typhus vaccine 

15.  Yellow Fever Vaccine 

18 
18 

12 

12 

In cold place 
In cold place 

In cold place 

In cold place 

1 [16.         Anti-Rabies Vaccine (Cell Culture)                      24                         In cold place.] 

ANTITOXIN 

(For serum extracted preparations) 
20% Excess potency 
30% Excess potency 
40% Excess potency 
50% Excess potency (for enzyme preparations) 
5% Excess potency 
10% Excess potency 

15% Excess potency 

20% Excess Potency 

MISCELLANEOUS  DRUGS 

2[1.  Andrenaline for Injection 
2.  Chorionic Gonadotrophin for 
Injection (Lyophilised) 

3.  Corticotrophin 
4.  Corticotrophin Lyophilised 
5.  Heparin Injection 
6.  Liquid Extract of Ergot 
7.  Liver Extract Crude Injection 
8.  Oxytocin Injection 
9.  Paraldehyde Injection 
10.  Pituitary Injection 
11.  Vasopressin Injection 

   12 
24 
36 
48 
12 
24 

36 

48 

In cold place 
In cold place 
In cold place 
In cold place 
In cold place 
In cold place 

In cold place 

In cold place 

12 

36 

24 
36 
36 
12 
24 
24 
6 
24 
24 

[As prescribed in Indian Pharmacopoeia] 
. 
At temperature not exceeding 20oC 

In cold place 
In cold place 
In a cool place. 
In cold place 
In a cool place 
In cold place 
In cool place protected from light. 
In cold place. 
In cold place. 

Note :   (1) The term ―cool place‖ means place having a temperature between 10oC and 25oC. 

(2) The term ―cold place‖ means a place having a temperature not exceeding 8 oC. 

 (3) Capsules should be kept in a well-closed container at temperature not exceeding 30 o C. 

(4) Wherever condition of storage is not specified in Column 4, it may be stored   under normal room 

temperature.] 

1. Ins.  by  G.S.R. 215(E) , dt.  19. 3. 1999. 
2. Subs.  by  G.S.R. 174(E) , dt.  16. 3.2005. 

538 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE  P1 
[See Rule 109] 
PACK SIZES OF DRUGS 

Name of the Drug                                             Dosage form                            Pack size 

1                                                              2                                                    3 

Albendazole                                                      Suspension 

Atenolol 

Tablets 

Anti-Haemmorhoidal Topicals 

Rectal Capsules 

Aspirin (Low-dose) 

Cholecalciferol or Ergocalciferol 

Tablets 

Granules 

10ml 

14 

20 

14 

1 gm. Sachet 

30 gms. 

15 ml 

14 

25 

25 

200 ml 

10 ml 

Pouches to be reconstituted 
to one litre in one pack or 
in 5 unit dose sachets in 
one pack. 

5 gm. 

30 ml 

8 ml or 10 ml 

60 ml and 200 ml. 

21  or  22  with  or  without 
placebo. 

7 

Vaginal Cream 

Ophthalmic drops 

Tablets 

Spansules (Long Acting) 

Spansules (Long Acting) 

Syrup 

Syrup 

Powder 

Granules 

Syrup 

Syrup 

Syrup 

Tablets 

Tablets 

Drops 

Suspension 

Oral Solution 

14 

7.5 ml.] 

50 ml. 

15 ml. 

Oral Liquid Concentrate 

15 ml.] 

Ciclopiroxolamine 

Catalin 

Famotidine 

Glyceryl Trinitrate 

Isosorbide Dinitrate 

Isoniazide 

Ipecacuanha 

Oral Rehydration Salt (ORS) 

Piperazine 

Pyrantel Pamoate 

Potassium Chloride. 

Progestogen Qestrogen 
(Combinations for Oral Contraception) 

Roxatidine Acetate Hydrochloride 

Vitamin A Oral Drops 
2[Co-trimoxazole 

Haloperidol 

Loxapine 

1.  Ins.   by   G.S.R. 796(E) , dt. 1.10.1992 (w. e. f. 1.1.1993). 
2.   Ins.   by  G.S.R. 753(E), dt.  4.11.1999. 

539 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1 [SCHEDULE  Q 

(See rules 134 and 144) 
2[PART I] 
3[LIST OF DYES, COLOURS AND PIGMENTS PERMITTED TO BE USED IN COSMETICS AND 
SOAPS AS GIVEN UNDER IS : 4707  

(PART I)-1988  
(AS AMENDED BY THE BUREAU OF INDIAN STANDARDS) 

Common name of the 
colour 

Colour 
Index 
Number 

Chemical name of the colour 

1                                    2                                                                 3 

Guinea Green B                      42085          Monosodium      salt       of       4-(N-ethyl-p-sulfobenzylamino)– 
2,5- 

diphenylmethylone-(1-(N-ethyl-N-p-sulfoniumbenzyl)∆ 
cyclohexadienimine). 

Light Green SF Yellowish 

42095 

Disodium salt  of  4-[4-(N-ethyl-p-sulfobenzylamine)-phenyl)-4- 
sulphoniumphenyl)   methylene]-2(-(N-ethyl-N-sulfobenzyl)   ∆ 
2,5-Cyclohexadienimine. 

Tartrazine 

Sunset yellow FCF 

Ponceau 3R 

Amarnath. 

19140 

15985 

16155 

Trisodium   salt   of   3-carboxy-5-hydroxy-1-p-sulfophenyl-4-p- 
sulfophenylazo-pyrazole. 

Disodium   salt   of   1-p-sulfophenylazo-2-   naphthol-6-sulfonic 
acid. 
Disodium salts of a mixture of 1-alkyl- phenylazo-2-napthol 3, 
6-disulfonic acids. 

16185 

Trisodium  salt  of  1-(4-sulfo-1-  napthylazo)  2-naphthol  3,  6- 
disulfonic acid. 

Erythrosine. 

45430  Disodium   salt   of   9-0-carboxyphenyl-6-   hydroxy   2,4,5,   7- 

tetraiodo-3- isoxanthone. 

Ponceau SX. 

14700  Disodium   salt   of   2-(5   sulfo-2,   4-xylyl-   azo)-1-naphthol-4- 

sulfonic acid. 

Brilliant Blue FCF 

42090  Disodium  salt  of  4-(9-4-(N-ethyl-p-sulfobenzylamino)-phenyl)- 
2-sulfonium  phenyl)-  methylene)-(1-(N-ethyl-N-p-sulfobenzyl)- 
∆ 2, 5-cyclohexadienimine). 

Indigocarmine. 

73015  Disodium  salt of 5,5‘-indigotindisulfonic  acid. 

Wool Violet 5 BN 
(Acid- violet 6B) 

Light Green SF  
Yellowish 

42640  Monosodium salt  of  4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(4- 
(N-ethyl-p-(sulfonium-benzylamine)-phenyl)  methylene)-(N,  N- 
dimethyl-∆ 2,5-cyclohexadienimine) 

42095  Calcium  salt  of  4-(4-(N-ethyl-p-sulfobenzyl) (minophenyl) 

(4- sulfonium-phenyl)methylene),  (1-(N-ethyl-N-p-sulfobenzyl)-  
∆2,5-cyclohexadienimine). 

1. Inserted by Notification F.-1-36/64 D, dated 17.8.1964. 
2. Renumbered as Part I by G.S.R. 11(E) , dated 7.1.1991. 
3. Substituted  by G.S.R. 811(E) , dated 14.11.1994. 

540 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                                       2                                              3 

Alizarin Cyanine Green F 

61570 

Disodium salt of 1,4-bis (O-sulfo-p-toluino) anthraquinone 

Quinazarine Green SS 

61565 

1,4-bis-(p-Toluino)-anthraquinone 

Fast Green FCF 

42053  Disodium  salt   of   4-(4-(ethyl-p-sulfobenzylamino)-phenyl)  (4- 
hydroxy-2      sulphoniumphenyl)      methylene)-(1-N-ethyl-N-p- 
sulfobenzyl) ∆  2, 5, cyclohexadienimine). 

Acid Fast Green                         42100     Monosodium salt  of  4-(4-N-ethyl-p-sulfobenzylomino) phenyl)- 
(o-chlorophenyl)-methylene)-       1-(N-ethyl-N-       p-sulfonium- 
benzyl- ∆ 2,5, cyclohexadienimine). 

Pyranine Concentrated 
Quinoline Yellow WS 

Trisodium  salt of 

59040 
47005  Disodium   salt   of   disulfonic   acid   of   2-(2-Quinolyl)-1,   3- 

acid. 

Quinoline Yellow SS 

47000 

indandione. 
2-(2-quinolyl)-1, 3 indandiene. 

Poneceau 2 R 

16150  Disodium salt of 1-xylylazo-2-naphthol-3, 6-disulfonic acid. 

Lithol Rubin B. 

15850 

Monosodium salt of 4-(o-sulfo-p-tolylazo)3 hydroxy-2-naphthoic 
acid. 

Lithol Rubin BCA 

15850  Calcium   salt   of   4-(o-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic 

acid 

Lake Red D. 

15500 

Monosodium salt of 1-0-carboxyphenylazo-2-naphthol. 

Lake Red DBA 

15500  Barium salt of 1-o-carboxyphenylazo-2-naphthol. 

Lake Red DCA. 

15500  Calcium salt of 1-o-carboxyphenylazo-2-naphthol. 

Toney Red. 

Oil Red OS. 

26100 

I-p-phenylazophenylazo-2-naphthol. 

26125 

I-Xylylazoxylylazo-2-napththol 

Tetrabromofluorescein 

45380 

2,4,5,7-Tetrabromo-3, 6-flurandiol. 

Eosin TS 

Eosin YSK.       . 

45380 

45380 

Disodium  salt  of  2,4,5,7-tetrabromo-9-0  carboxyphenyl-6- 
hyroxy-3-isoxanthone. 
Dipotassium salt  of  2,4,5,7-tetrabromo-9-0 carboxyphenyl- 
6-hyroxy-3-isoxanthone 

Tetrachlorofluorescein NA 

45366 

2,4,5,7- tetrachloro-S, 6-Fluorandiol 

Tetrachlorofluorescein K. 

45366  Disodium  salt  of  9-0-carboxyphenyl-2,4,5,7-tetrachloro-6- 

hydroxy-3-isoxanthone. 

Tetrachloro Tetrabromo 
fluorescein 

45410 

2,4,5,7-Tetrabromo-12,13,14,15-tetrachloro-3, 
6-fluorandiol. 

Phloxine B 

45410  Disodium salt of 2,4,5,7-tetrabromo-9 (3,4,5,6-tetra chloro- 

o-carboxyphenyl)-6-hydroxy-3-isoxanthone 

Bluish Orange T.R. 

45457 

1,4,5,8, 15-Pentabromo-2, 7-dicarboxy-3, 6-fluoran diol. 

Helindone Pink CN. 

73360 

5, 5-Dichloro-3, 3‘ dimethyl-thioindigo 

541 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                                            2                               3 

Deep Maroon (Fanchon Maroon) 

15880 

Toluidine Red.  . 

12120 

Calcium   salt   of   4-(I-sulfo-2-naphthylazo  3-   hydroxy-2- 
naphthoic acid. 
1-(o-Nitro-p-tolylazo)-2-naphthol. 

Flaming Red. 

12085 

I- (o-Chloro-p-nitrophenylazo)-2-naphthol 

Deep Red  (Maroon). 

Alba Red. 

Orange G. 

Orange II 

12350 

13058 

3-Hydroxy-N-        (m-nitrophenyl)-4-(o-nitro-p-tolylazo)-2- 
naphthamide. 
o-(p,β,β-Dihydroxy-diethylamino)-        phenylazo)-benzoic 
acid. 

16230 

15510 

Disodium     salt   of  1-phenylazo-2-naphthol-6-8-disulfonic 
acid. 
Monosodium salt of 1-p-sulfophenylazo-2-naphthol. 

Dichlorofluorescein 

45365 

4,5-Dichloro-3, 6-fluorandiol. 

Dichlorofluorescein. NA 

45365  Disodium   salt   of   9-o-carboxyphenyl-1-4,5-   dichloro-6- 

Diiodofluorescein. 

45425 

hydroxy-3-isoxanthone 
4,5 –Diiodo-3, 6-fluorandiol 

Erythrosine Yellowish NA. 

45425  Disodium   salt   of   9-o-carboxyphenyl-6-   hydroxy-4,   5- 

diiodo-3-isoxanthone. 

Erythrosine Yellowish K. 

45425  Dipotassium   salt   of   9-o-carboxyphenyl-6-hydroxy-4,  5- 

diiodo-3-isoxanthone. 

Erythrosine Yellowish NH 

45425  Dipotassium  salt  of      9-o-carboxyphenyl-6-hydroxy-4, 5- 

diiodo-3-isoxanthone 

Orange TR 

Alizarin. 

45456 

4,5, 15-Tribromo 2, 7-dicarboxy-3, 6- fluorandiol. 

58000 

1,2- Anthraquinonediol. 

Dibromodiiodofluorescein. 

45371 

4 ,5- Dibromo-2, 7-diiodo-3, 6-fluorandiol. 

1[***] 

Alphazurine FG. 

42090  Diammonium  salt  of  4-(N-ethyl-p-  sulfobenzyl  amino)- 
phenyl)-(2-sulfoniumphenyl)-Methytlene)-(-(1  (N-ethyl-N- 
p-sulfobenzyl) ∆ 2 ,5-cyclohexadienimine). 

Allarin Astrol B. 

61530  Monosodium  salt  of  1-methylamino-4-(o-sulfo-p-toluino)- 

Indigo. 

73000 

Indigotin. 

anthroquinone. 

Patent Blue NA.             . 

42052  Monosodium salt of 4-(4- (N-ethyl- benzyl-amino)-phenyl – 
(5-hydroxy-4-sulfo-2-sulfoniumphenyl-methylene)(N-ethyl- 
Benzyl- ∆  2, 5-cyclohexadienimine). 

Patent Blue CA. 

42052 

Calcium  salt  of  4-(4-  (N-ethyl-  benzyl-amino)-phenyl)-(5 
hydroxy-4-sulfo-2-sulfoniumphenyl,  methylene)-  (N-ethyl- 
N-benzyl- ∆  2- 5-cyclohexadienimine). 

  Carbrantherene Blue                        69825      3, 3- Dichloroindanthrene. 

1. Omitted by G.S.R. 203(E), dated 18-03-2015. 

542 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1                                             2                              3 

Napthol Blue 
Black 

20470 

Disodium  salt  of  8-amino-7-p-  nitrophenylazo  3-
phenylazo-1-  naphthol-3, 6-disulfonic acid 

Alizurol purple SS 

60725 

I-hydroxy-4-p-toluino-anthraquinone. 

Acid Red 89 

Acid Red 97 
Acid Blue 1 
Food Blue 3 

Natural Orange 

Solvent Blues 4 
Solvent Yellow 18 

Food Yellow 12. 
1[***] 

Solvent Yellow 32. 

Fanchon Yellow 
(Hansa Yellow G). 

23910 

22890 
42045 
42045 

75480 

44045 
12740 

12740 

48045 

11680 

---- 

---- 
---- 
---- 

---- 

---- 
---- 

---- 

---- 

---- 

(α) -(O-Nitro-p-tolylazo) 
accetoacetanilide 

2[Part II  
LIST OF COLOURS PERMITTED TO BE USED IN SOAPS. 

  Common  name of the                            Colour Index        Chemical name of the colour 
  Colour                                                     No. 

Phthalocyanine Blue                        74160        (phthalocyninate (2--)  copper. 
Iragalite Red CVPB  
Paste or Pigment  
Orange 5 
Citrus Red No.2.                              12156        1-2(2,5-dimethoxy phenylazo) 2-naphthol. 
Rhodamine B 500                            45170        3-ethochloride of 9-0 carboxy-ethenyl-6-diethylamino- 

12075        1-(2,4-dinithro phenylazo)-2-Naphthalenol. 

Aqueous Green Paste                       74260        Polychloro copper Phthalocyanine. 
Pigment Yellow 3                            11710        2-(4-Chloro-2-nitrophenyl)-azo-N-(-2-Chloro-

3-ethylamine-3-isoxanthene.  

Irgalite Carmine F-P Powder 
or Pigments Red 5. 

Monolite Red 4R HV Paste 
or Pigment Red 7. 

Oil Red No.1 or Solvent  
Red 24 or Oil Red 3R. 

phenyl)-3- Oxobutamide. 

12490        N-(5-Chloro-2, 4-dimethoxy-phenyl)-4-(CS- 

                        diathylamine) Sulfonyl-2-methoxyphenyl)azo-

3-hydroxy-2-naphthalene carboxamide. 
12420        N-(4-Chloro-2-methylphenyl-4-(-4-Chloro-2-methylphenyl) 
                 Azo 3-hydroxy-2-naphthalenol Carboxamide. 
26105        4-0-Tolylazo-Toluidine azo 2-naphthalenol.] 

*This list of colour for use in soaps is in addition to those colours already given in Schedule Q  and are used 
for soaps.] 

1.  Omitted by G.S.R. 203(E) dated 18-03-2015 
2.  Ins. by  G.S.R. 11(E) , dt. 7.1.1991. 

543 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE  R 

[See Rule 125] 

STANDARDS FOR CONDOMS MADE OF RUBBER LATEX INTENDED FOR SINGLE USE 
AND OTHER MECHANICAL CONTRACEPTIVES 

I-Condoms 

1. Description - Condoms consist of cylindrical rubber sheaths with one end open. The 
open  end  shall  terminate  with  an  integral  rim.  The  closed  end  may  have  a  receptacle.  They 
may be supplied rolled and shall be free from tackiness and shall be capable of being unrolled 
readily. 

2. Materials - (1) Condoms shall be manufactured from good quality rubber latex and 
shall be free from embedded grit and shall be opaque or translucent prior to the application of 
dusting materials or lubricants. 

(2) The rubber latex, colours used and any dusting materials or lubricants applied to the 
condoms shall neither contain nor liberate substances which are known to  have toxic or other 
harmful  effects  under  normal  conditions  of  use.  Any  dusting  material  or  lubricant  or  colour 
used shall not have deleterious effect on the condoms or be harmful to the users. 

3.  Procedure  for  sampling  during  production − (1) Specimens  constituting  the  test 
samples  shall  be taken at random successively from each quantum of production that is, from 
the  quantity produced from the same  finished  rubber  latex  and  under  the  same  processing 
and  finishing  conditions  of  manufacture  and  samples  from  each  quantum  shall  be  tested 
separately  to  ascertain  conformity  of  quantum  with  the  specified  requirements in  accordance 
with the tests described in this Schedule. 

(2) (a) The number of samples drawn from each quantum shall be not less than 0.5 per 

cent of the number. 

(b)  The  number  of  samples  drawn  from  each  quantum  shall  be  tested  for  Burst 
Volume and Pressure Test and Water Leakage Test in accordance with the method prescribed 
in paras 9 and 10 of this Schedule. 75 per cent of the samples drawn will be tested for Water 
Leakage Test and 25 per cent will be tested for Burst Volume and Pressure Test. 

(c)  The  number  of  test  samples  ‗N‘  and  the  number  of  rejected  samples  ‗R‘  from  a 
sequence  of  production  quanta  shall  be  recorded  in  a  register.    The  cumulative  total  of  test 
samples  ‗N‘  and  the  cumulative  total  of  rejects  ‗R‘  from  the  test  shall  be  recorded  and  the 
condoms  shall  be  deemed  to  comply  with  the  requirements  if  the  cumulative  total  of  rejects 
‗R‘  is  not  more  than  2[0.0025N+3  x  √0.0025N]  for  Water  Leakage Test, and 2[0.015N+3 x 
√0.015N] for Burst Volume and Pressure Test. 

(3) Each unit of 100 test samples shall be distributed for the various tests as follows: - 

25 for Burst Volume Pressure Test, and; 
75 for Water Leakage Test. 

1  Subs.  by G.S.R. 495(E) , dt. 9.6.1995. 
2. Subs. by G.S.R. 353(E),  dt. 26.4.2000. 

544 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

  (4)  Where  the  number  of  test  samples  is  a  multiple  of  100  the  distribution  scale 

mentioned above shall be prorated. 

(5)  If  the  cumulative  total  sample  rejected  exceeds  the  number  of  allowables  at  any 
point in the sequence of quanta, the quantum at which this occurs shall be liable to rejection. 
The assessment of quality of further  production quanta shall  include all  previous test  results 
starting  from  quantum  number  1  and  approval  of  production  shall  be  in  suspense  until  the 
condition required by the scheme is again fulfilled. 

(6) At  least  one  sample  shall  be  taken  at  random  from  each  production  quantum  not 
exceeding  10,000  condoms  and  shall  satisfy  all  requirements  regarding  dimensions  as 
specified in paragraph 8  of this Schedule. 

4.    Procedure for sampling and testing of finished products by a manufacturer – 

A. Water Leakage Test.-  (1)  Statistical  sampling for  quality  control assessment of  the finished 
product in respect of Water Leakage Test shall be done in accordance with the plan set out in 
Annexure 1 to this Schedule. 

(2)  A  test  sample  failing  in  the  above  test  is  to  be  considered  as  defective.  If  the 
cumulative total of rejects ‗R‘ is found to be equal to or greater than the number shown against 
‗R‘ in Annexure-I, the batch or lot shall be declared as not of standard quality. 

B.  Bursting  Volume    and    Pressure  Test.-        (1)    Sample    condoms  shall    be    tested    for 
Bursting  Volume  and  Pressure  Test.  Statistical  sampling  for  this  test  shall  be  done  in 
accordance with the plan set out in Annexure III to this Schedule. 

Condoms  shall  not  leak  or  burst  at  a  volume  of  less  than  that  specified  or  at  a 
pressure less than 1.0 kpa (gauge), when tested as per paragraph 9, both before and after oven 
conditioning  as  specified  in  Annexure  V.  Bursting  Volume  minimum  limit  in  litres  shall  be 
equal to   [mean condom width (mm)2]   rounded to the nearest 0.5 litre. 

151.8 

(2)  A  test  sample  failing  in  the  above  test  is  to  be  considered  defective.  If  the 
cumulative total of rejects ‗R‘ is found to be equal or  greater than the number shown against 
‗R‘ in Annexure III, the batch or lot shall be declared as not of standard quality. 

C. Dimensions. -  At least 2 samples drawn from the lot or batch shall satisfy the requirements 
regarding dimensions as specified in paragraph 8 of this Schedule. 

5. Procedure for sampling and testing of condoms by a purchaser - 

A. Water Leakage Test-  (1)  Statistical sampling of condoms by a purchaser for Water Leakage 
Test shall be done in accordance with the plan set out in Annexure II to this Schedule; 

(2)  A  test  sample  failing  in  the  above  test  is  to  be  considered  as  defective.  If  the 
cumulative  total  of  rejects  ‗R‘  is  found  to  be  equal  to  or  greater  than  the  number  shown 
against ‗R‘ in the Annexure-II, the batch or lot shall be declared as not of standard quality. 

B. Bursting  Volume  and  Pressure  Test -  Sample  condoms  shall  be  tested  for Bursting 
Volume and  Pressure Test.  Statistical  sampling for  this  test  shall  be  done in accordance with 
the plan set out in Annexure III to this Schedule. If the cumulative total of rejects ‗R‘ is found 

545 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 
to  be  equal  to  or  greater  that  the  number shown against ‗R‘  in  Annexure  III, the batch or lot 
shall be declared as not of standard quality. 

Condom shall not  leak  or  burst at  a  volume of  less than that  specified or  at  a  pressure 
less  than 1.0  kpa  (gauge), when  tested as  specified in  paragraph 9,  both before and  after oven 
conditioning as per specified in Annexure V. Bursting volume minimum limit in litres shall be 
equal to   

[mean condom   width (mm)2] rounded to the nearest 0.5 litre. 

                            151.8 

C. Dimensions.  -   At  least  two  samples  from  the  lot  or  batch  shall  satisfy  the  requirements 
regarding dimensions as specified in paragraph 8 of this Schedule. 

6. Sampling plan for a Drugs Inspector - (1) Where an Inspector under the Act desires 
to take test samples from the premises of manufacturer or a distribution depot; twenty containers 
from each batch of production may be selected by him on a random basis and from each of the 
containers, five samples shall be taken. The hundred samples so selected shall be distributed for 
various tests as specified in paragraph 7 of this Schedule. In case the number of container is less 
than  twenty,  the  number  of  samples  to  be  taken  from  each  container  shall  be  proportionately 
increased. 

(2) Where an Inspector under the Act desires to take samples from a sales premises, he 
shall take hundred samples from each batch of production in accordance with the procedure as 
specified in sub- paragraph (1). 

7. Sampled condoms drawn under sub-paragraph.- (1) shall be distributed for various tests 

as follows: -   Two samples for thickness, length and width; 

Forty-five samples for Water Leakage Test; 
Forty-five samples for Bursting Volume and Pressure Test; and 
Eight samples as reserve. 

The  samples  shall  be  declared  as  not  of  standard  quality,  if,  -  (i)  the  number  of 
condoms found defective in  the  Water Leakage Test exceeds one; (ii)  the  number of  condoms 
found  defective  in  Bursting  Volume  and  Pressure  Test  exceeds  two;  (iii)  samples  fail  to 
conform to the requirements of dimensions as specified in paragraph 8 of this Schedule. 

8. Dimensions -  (1) The length when unrolled (excluding test) shall be not less than - 

(i)     170 mm. 
(ii)    180 mm. 

(2) The  width   of  a  condom  which  laid  flat  and  measured  at  any  point  within  85  mm 

from the open end shall be,– 

(i) 
(ii) 

49 ± 2 mm for 170 mm length.  
53 ± 2 mm for 180 mm length. 

(3) The single-wall thickness of a condom when measured at three points, one at 30 ± 
2mm from the open end, 30 ± 5mm from the close end excluding the reservoir tip and at the 
mid distance between these two point shall be from 0.045 mm to 0.075 mm. 

NOTE 1. - The single-wall thickness shall be  determined with a  suitable  micrometer 

dial gauge graduated in intervals of 0.01 mm. 

NOTE  2.  -  Condoms  shall,  prior  to  the  measurement of  thickness,  have  the  dusting 

powder or the lubricant or both removed by means of water or Isopropanol. 

546 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

9.  Bursting  Volume  and  Pressure  Test  -  Determination  of  Bursting  Volume  and 

Pressure Test shall be done as specified in Annexure IV. 

10. Water  Leakage  Test -  Unroll  the  condom  and  fit  the  open  end  on  a  suitable 
mount,  the condom thus being suspended open end upwards. Fill it with 300 ml water at room 
temperature and inspect it after a period of at least 1 minute for leakage up to 25.mm from the 
open end. If, because of distension of the condom the water does not extend to 25 mm from the 
open  end,  raise  the  closed  end  until  the  water  level  reaches  this  distance.    After  at  least  1 
minute, inspect the newly-wetted part of the condom for leakage. The condom shall be deemed 
to  be defective if  it  bursts during test  or shows any evidence of leakage or  seepage of micro-
droplets or does not hold 300 ml water. 

11.  Quantity of  Lubricant -  (1) The condoms shall be dressed with  silicone  lubricant. 
The  quantity  required  on  each  individual  condom  should  not  be  less  than  200  mg  and 
minimum viscosity shall be 200 centistokes. 

(2)  Lubricated condoms in  individual foil packages shall be weighed on an Analytical 
Balance.  Each  condom  shall  be  removed  from  its  foil  package  and  both  condom  and  its  foil 
package  shall  be  washed  in  denatured  ethanol  or  isopropanol,  dried  and  then  weighed  again. 
All  weights  shall  be  recorded  to  the  nearest  milligram  (mg.).  Compliance  with 
the 
requirement  shall  be  determined  by  subtracting  the  weight  of  the washed and dried condom 
and its foil package from the weight of sample condom in individual foil package prior  to  the 
removal  of  lubricant.  Washing  and  drying  may  be  required  upto  a  total  of  four  times  if 
the lubricant quantity is less than the required minimum. 

(3) At least thirteen samples shall be drawn from the lot or batch and the samples shall 

satisfy the requirements regarding the quantity of lubricant. 

12. Colour Fastness -   Not less than ten samples taken at  random from each batch of 

coloured condoms shall pass the following test for colour fastness, namely :- 

Thoroughly  wet  inside  and  outside  of  the  condom  with  distilled  water.  Make  no 
attempt  to  remove any dusting material or lubricant. Wrap the wet condom in white absorbent 
paper so that the largest possible surface area  of  the  condom is  in  contact with  the  paper  and 
seal  the  whole  in  a  suitable  container to  prevent loss of moisture. Allow the container and its 
contents to stand for 16  hours to  24 hours at  room temperature. After removing the absorbent 
paper  from  the  container,  examine  it  visually  in  the  natural  daylight  for  any  indication  of 
staining. No part of the absorbent paper shall be stained. If there is any indication of staining of 
the  absorbent  paper  by  any  colouring  agent  present  in  any  of  the  condoms  or  any  dusting 
material or lubricant, the entire batch shall be declared to be not of standard quality. 

13. Labelling, packing and  storage  - (1) The  condoms shall be individually wrapped 
and  sealed  in  laminates  containing  at  least  eight  microns  of  aluminium  foil.  The  individual 
condom shall  be  packed  in  square  (non-squeeze  condition)  /  rectangular  aluminium foil.  The 
packing shall protect the condoms from contamination and mechanical damage.   The smallest 
packing  offered  to  the  consumer  shall  bear  a  clear  permanent  marking  with  the  following 
particulars, namely: - 

547 

 
 
 
 
 
 
 
 
(i) Manufacturer‘s name and address and the trade name of the condoms, if any;  

Drugs and Cosmetics Rules 1945 

(ii) Batch number; 

(iii) Date of manufacture (Month and year only); 

(iv) Date of expiry (Month and year only) which shall not be more than thirty-six 

months from the date of manufacture; 

(v)  The words ―For single use only‖ 

(2) The condoms shall be stored in a cool dry place away from heat and direct sunlight. 

14. Integrity  of  individual  package  seals  - Sample  condoms  in  individual  packages  shall  be 
placed in a sealed, transparent container (such as a laboratory Bell jar) and subjected to vacuum 
of 50± 10 kpa (gauge) for a period of one minute. 

Condom packages that do not inflate or remain inflated for the period of the test shall be 
deemed non- compliers. In doubtful cases, the test  may be repeated, and  both the inflation and 
deflation of packages may be observed on  application and removal of  vacuum. An  AQL of 2.5 
per cent will be applied in assessing the results of this test. Thirty-two samples of condoms for a 
batch size less than 5 lakhs and fifty samples of condoms for batch size more than 5 lakhs shall 
be  tested  for  integrity  test  of  individual  package  seals  and  compliance  limit  or  acceptance 
number shall be not more than two or three condoms respectively. 

II- Other Mechanical Contraceptive 

15.  Standards  for  other  mechanical  contraceptive  -  Standards  for  ‗Copper  T‘  and  ‗Tubal 
Ring‘shall be as laid down in Annexure VI. 

1

[ANNEXURE  I 

[See Paragraph 4-A] 

SAMPLING PLAN FOR QUALITY CONTROL OF CONDOMS AT MANUFACTURER’S 
LEVEL. 

 Single Sampling Plan 

BATCH SIZE: 35,001 TO 1.5 LAKH 

 Sample Size 200:                                                                                     AQL      -    0.25 

                                                                                                                R          -     2  

 AC        -    1 

1. Subs.  by. G.S.R. 353(E) , for  ― Annexures I to III‖  dt. 26-4-2000. 

548 

 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Single Sampling Plan 

BATCH SIZE:  150001 TO 5 LAKHS 

Sample Size 315 :                                                                                  AQL     -    0.25 

       AC       -    2 
                                                                                                                 R          -    3  

BATCH SIZE: OVER 5 LAKHS 

Single Sampling Plan. 
Sample Size 500:                                                                                    AQL   -     0.25 

                                                                                            AC       -     3 

                                                                                                                  R         -      4  
Note :  AQL denotes Acceptance Quality Level; 

AC  denotes  Acceptance  Number  i.e.  the  maximum  allowable 
number of defectives for acceptance of the Batch; and 
R  denotes  Rejection  Number  i.e.,  the  minimum  number  of 
defectives for rejection of the Batch. 

ANNEDURE  II 

[See Paragraph 5A] 

SAMPLING PLAN FOR QUALITY CONTROL OF CONDOMS AT PURCHASER‘S 
LEVEL. 

Single Sampling Plan 
Sample Size 200: 

BATCH SIZE: 35,001 TO 1.5 LAKHS 

AQL 
AC 

-     0.25 
-     1 

                                                               R                                        -     2  

BATCH SIZE : 15,001 TO 5 LAKHS 

Single Sampling Plan. 
Sample Size 315: 

AQL 
AC 

 -     0.25 
 -      2 

                                                                 R                                     -      3  

BATCH SIZE : OVER 5 LAKHS 

Single Sampling Plan 
Sample Size 500: 

AQL 
AC 

-      0.25 
-      3 

                                                                 R                                      -      4  

Note:      AQL denotes Acceptance Quality Level; 
AC  denotes  Acceptance  Number  i.e.  the  maximum  allowable  number  of      defectives  for 
acceptance of the Batch; and 
R  denotes Rejection Number i.e., the minimum number of defectives for rejection   of the 
Batch. 

549 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

ANNEXURE  III 

[See Paragraph 4-B and 5-B] 

SAMPLING PLAN FOR BURSTING VOLUME AND PRESSURE TEST. 

Single Sampling Plan. 

BATCH SIZE: 35,001  TO 1.5 LAKH. 

Sample Size 200:                                                                                   AQL     -     1.5 

BATCH SIZE:  150001 LAKHS TO 5 LAKHS 

          AC        -     7 
          R          -     8 

Single Sampling Plan. 

Sample Size 315:                                                                                      AQL    -      1.5 
AC     -        10 
R     -           11 

BATCH SIZE: OVER 5 LAKHS 

Single Sampling Plan. 

Sample Size 500:                                                                                    AQL      -   1.5 
            AC       -   14 

                                                                                                                   R          -    15  

Note :   AQL denotes Acceptance Quality Level; 

AC      denotes  Acceptance  Number  i.e.  the  maximum  allowable  number  of  defectives 
for acceptance of the Batch; and 

R     denotes Rejection Number i.e., the minimum number of defectives for rejection   of the 
Batch.] 

ANNEXURE  IV 

(See Paragraph 9) 
DETERMINATION OF BURSTING VOLUME AND PRESSURE 

1. Principle  -    Inflation  of  constant  length  of  the  condom  with  air  and  recording 

the  volume  and pressure at the moment of bursting. 

2. Apparatus  -  (1)  Apparatus  suitable  for  inflating  the  condom  with  clean  air  at  a 

specified rate  and provided with equipment for measuring volume and pressure. 
(2)  Suitable mount for fitting the condoms to the apparatus as shown in the figure annexed. 
(3)   Rod,  140  mm  in  length  having  a  smooth  sphere  20  mm  in  diameter  at  its  top  (see 
the  figure) for hanging the unrolled condom when fixed to the apparatus. 

3.  Procedure  -  (1)  Unroll  the  condom,  hang  it  on  the  rod  (2.3),  affix  to  the  mount 

(2.2) and inflate with air at a rate of 0.4 to 0.5 litre/sec. (24 to 30 litres/min.) 

(2)        Measure  and  note  the  bursting  volume,  in  litres  rounded  to  the  nearest  0.5 

litre  and  the  bursting pressure, in kilopascals rounded to the nearest 0.1 kpa. 
4. Test report -  The test report shall include the following particulars: 

(a)  the identification of the sample;  
(b)  the bursting volume and bursting pressure of each tested condom; 
(c)  the date of testing. 

550 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

ANNEXURE  V 

[See Paragraphs 4(B) and 5 (B) 

OVEN CONDITIONING 

1. Principle  of  the  Method - The  test  consists  in  subjecting  test  samples  to  controlled 
deterioration by air at  an elevated temperature and at atmospheric pressure after which burst 
volume and pressure limits are measured. 

2.  Apparatus  -    The  air  oven  shall  be  of  such  a  size  that  the  total  volume  of  the  test 
samples  does  not  exceed  10  per  cent  of  the  free  air  space  of  the  oven.  Provision  shall  be 
made for slow circulation of air in the oven of not less than three changes and not more than 
ten changes per hour. The temperature of the oven shall be thermostatically controlled so that 
the test samples are kept within ± 2o C of the specified ageing temperature. A  thermometer 
shall  be  placed  near  the  centre  of  the  ageing  test  samples  to  record  the  actual  ageing 
temperature. 
Note: - Copper or copper alloys shall not be used for the material of construction of the oven 
prescribed. 

3.  Test  sample  -    The  foil  laminations  of  individual  packages  should  remain  intact 
throughout all laboratory handling including over conditioning. 

4. Temperature of the oven – Maintain the oven at 70 ± 2o C. 

5. Duration of test -  96 hours. 

6. Procedure  -  Condition the requisite number of unopened packages of rubber condoms in 
the oven at 70 ± 2o C for 96 hours. After heating, keep the packages at 23  ± 5o C for at least 
12 hours but not more than 96 hours. Open the packages and examine conditioned condoms 
for tackiness, brittleness, or other signs of deterioration. Within 96 hours but not sooner than 
12  hours  after  conditioning,  do  the  bursting  volume  and  pressure Test  as  described in  this 
Schedule. 

ANNEXURE  VI 

(See Paragraph 15) 

1.  Standards  for  Copper  T  (200B)  (IS-12418)  (part  4)-1991-UDC  615.477.87)  - 
Contraceptive  Device  Copper  T  (200  B)  shall  conform  to  the  Indian  Standards  laid  down 
from time to time by the Bureau of Indian Standards. 

2.  Standards  for    Contraceptive  Tubal  Ring    (IS    13009  :    1990-UDC  615.472.6  :  
611.656)  -  Contraceptive  Device  Tubal  Ring  shall  conform  to  the  Indian  Standards  laid 
down from time to time by the Bureau of Indian Standards.] 

551 

 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE  R1 
(See Rules 109A, 109, 109C and 125A) 

The  medical  devices  shall  conform  to  the  Indian  Standards  laid  down  from time to 
time  by  the  Bureau of  Indian Standards.  If  there  are  no  Bureau  of  Indian  Standards  then  it 
shall  conform 
for 
Standardisation,  or  other  International  Pharmacopeia  Standards  and  such  other  standards  as 
may be specified for this purpose. In case national or international standards are not available, 
the device shall conform to the manufacturer‘s validated standards.] 

International  Organisation 

International  Standards, 

like 

the 

to 

2[SCHEDULE  S 
[See Rule 150-A] 

STANDARDS FOR COSMETICS 

Standards for cosmetics in finished form − The  following cosmetics in finished form 
shall  conform  to  the  Indian  Standards  specifications  laid  down  from  time  to  time  by  the 
3

[Bureau of Indian Standards (BIS)]. 

1.       Skin Powders. 
2.       Skin Powder for infants. 
3.       Tooth Powder. 
4.       Toothpaste. 
5.       Skin Creams. 
6.       Hair Oils. 
7.       Shampoo, Soap-based. 
8.       Shampoo, Synthetic-Detergent based. 
9.       Hair Creams. 
10.      Oxidation hair dyes, Liquid. 
11.      Cologne.] 

        4

[12.     Nail Polish (Nail Enamel). 

13.      After Shave Lotion. 
14.      Pomades and Brilliantines. 
15.      Depliatories Chemical. 
16       Shaving Creams. 
17.      Cosmetic Pencils. 
18.      Lipstick.] 

        5

[19.      Toilet Soap. 

20.     Liquid Toilet Soap. 
21.     Baby Toilet Soap. 
22.     Shaving Soap. 
23.     Transparent Toilet Soap.] 

1.  Subs. by  G.S.R. 690(E), dt. 25.9.2014. 
2.  Ins.  by  G.S.R. 510(E) , dt. 26.07.1982. 
3. Subs. by G.S.R. 673(E), dt. 27.10.1993. 
4. Ins. By G.S.R. 731(E) dated 23-08-1990 
5.  Ins. By G.S.R. 673(E) dated 27-10-1993 

552 

 
 
 
 
 
 
 
 
          
 
Drugs and Cosmetics Rules 1945 

            1[24.     Lipsalve IS:10284. 

25.     Powder Hair Dye IS: 10350. 
26.     Bindi (Liquid) IS: 10998. 
27.     Kum Kum Powder IS: 10999. 
28.     Henna Powder IS: 11142.] 

         2[29. 
         3[30. 
         4[31. 
         4[32. 
         4[33. 
         4[34. 
         4[35. 
         4[36. 

Bathing Bars IS: 13498: 1997 
Sindoor IS: 14649: 1999 
Liquid Foundation makeup IS 14318 
Cold Wax Hair remover IS 15152 
Face pack IS 15153 
Kajal IS 15154 
Oxidation Hair Dyes (Emulson Type) IS 15205 
Cream Bleach IS 15608 

1.  Ins. by  G.S.R. 553(E), dt. 20.7.1995. 
2.  Ins. by  G.S.R. 592(E), dt.13.8.2008. 
3.  Ins. by  G.S.R. 724(E), dt. 07.11.2013. 
4.  Ins. by  G.S.R. 203(E), dt.18.03.2015. 

5[SCHEDULE  T 

(See rule 157) 

GOOD  MANUFACTURING  PRACTICES  FOR  AYURVEDIC, SIDDHA AND UNANI 
MEDICINES 

The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and    Part II 
to ensure that: 

(i)  Raw materials used in the manufacture of drugs are authentic, of prescribed   
      quality and are free from contamination. 

(ii) The manufacturing process is as has been prescribed to maintain the standards. 
(iii) Adequate quality control measures are adopted. 
(iv) The manufactured drug which is released for sale is of acceptable quality. 
(v) To achieve the objectives listed above, each licensee shall evolve methodology 
and  procedures  for  following  the  prescribed  process  of  manufacture  of  drugs 
which  should  be  documented  as  a  manual    and  kept  for  reference  and 
inspection.   However, under  IMCC  Act  1970 registered Vaidyas, Siddhas and 
Hakeems who prepare medicines on their own to dispense to their patients and 
not selling such drugs in the market are exempted from the purview of  G.M.P. 

5. Subs. by  G.S.R. 560(E), dt. 07.3.2003. 

553 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

PART  I 
GOOD MANUFACTURING PRACTICES 

1.1 Factory Premises: 

The manufacturing plant should have adequate space for: -  

(i)Receiving and storing raw material. 
(ii)Manufacturing process areas.  
(iii)Quality control section. 
(iv)Finished goods store.  
(v)Office. 
(vi)Rejected goods/drugs store. 

1.1  General Requirements: 

1.1(A)  Location  and  surroundings  -    The  factory  building  for  manufacture  of 
Ayurveda,  Siddha  and  Unani  medicines  shall  be  so  situated  and  shall  have  such 
construction as to avoid contamination from open sewerage, drain, public lavatory for any 
factory  which produces  disagreeable or obnoxious odour or fumes or excessive soot, dust 
and smoke. 

1.1(B)  Buildings  -      The  buildings  used  for  factory  shall  be  such  as  to  permit 
production  of  drugs  under  hygienic  conditions  and  should  be  free  from  cobwebs  and 
insects/rodents.  It  should  have adequate provision of  light  and  ventilation. The  floor  and 
the walls should not be damp or moist. The premises used for manufacturing, processing, 
packaging  and  labelling  will  be  in  conformity  with  the  provisions of the Factory Act.  It 
shall be located so as to be: 

(I)  Compatible  with  other  manufacturing  operations  that  may  be  carried  out  in 

the same or adjacent premises. 

(II)  Adequately  provided  with  working  space  to  allow  orderly  and  logical 
placement  of  equipment  and  materials  to  avoid  the  risk  of  mix-up  between 
different  drugs  or  components  thereof  and  control  the  possibility  of  cross 
contamination by  other  drugs  or substances and avoid the risk of omission of 
any manufacturing or control step. 

(III) Designed, constructed and maintained to prevent entry of insects and rodents.    

Interior  surface  (walls,  floors  and  ceilings)  shall  be  smooth  and  free  from 
cracks  and  permit  easy  cleaning  and  disinfection.  The  walls  of  the  room  in 
which the manufacturing operations are carried out shall be impervious to and 
be  capable  of  being  kept  clean.  The  flooring  shall  be  smooth  and  even  and 
shall  be  such  as  not  to  permit  retention  or  accumulation  of  dust  or  waste 
products. 

(IV)  Provided  with  proper  drainage  system  in  the  processing  area.  The  sanitary 
fittings  and  electrical  fixtures  in  the  manufacturing  area  shall  be  proper  and 
safe. 

(V)  Furnace/Bhatti  section  could  be    covered  with    tin    roof    and  proper 

ventilation,  but sufficient care should be taken to prevent flies and dust. 

554 

 
 
 
 
 
 
 
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(VI) There should be fire safety measures and proper exits should be there. 
(VII) Drying  Space:  -There  should  be  separate  space  for  drying  of  raw  material, 
in  process  medicine  or  medicines  which  require  drying  before  packing.  This 
space  will  be  protected from  flies/  insects/dust etc.,  by  proper  flooring, wire-
mash window, glass panels or other material. 

1.1(C) Water Supply -   The water used in manufacture shall be pure and of potable 

quality. Adequate provision of water for washing the premises shall be made. 

1.1(D)  Disposable  of  Waste  -      From  the  manufacturing  section  and  laboratories 
the waste water and the residues which might be prejudicial to the workers or public health 
shall be disposed off. 

1.1(E) Container‘s Cleaning -   In  factories where operations involving the  use  of 
containers  such  as  glass  bottles,  vials  and  jars  are  conducted,  there  shall  be  adequate 
arrangements  separated  from  the  manufacturing  operations  for  washing,  cleaning  and 
drying of such containers. 

1.1(F)  Stores  -    Storage  should  have  proper  ventilation  and  shall  be  free  from 
dampness.  It should  provide  independent   adequate  space  for  storage  of  different  types 
of  material,  such as  raw material, packaging material and finished products. 

1.1. (F)(A) Raw Materials -  All raw materials procured for manufacturing will  be 
stored  in  the  raw  materials  store.  The  manufacture  based  on  the  experience  and  the 
characteristics of  the  particular raw material used in Ayurveda, Siddha and Unani system 
shall  decide  the  use  of  appropriate  containers  which  would  protect  the  quality  of  raw 
materials  as  well  as  prevent  it  from  damage  due  to  dampness,  microbiological 
contamination  or  rodent  and  insect  infestation,  etc.  If  certain  raw  materials  require  such 
controlled  environmental   conditions,  the   raw   materials   stores   may   be   sub-divided  
with    proper  enclosures  to    provide    such    conditions  by    suitable  cabinization.  While  
designing  such    containers,  cupboard  or  areas  in  the  raw  materials  store,  care  may  be 
taken to handle the following different categories of raw materials:- 

1.     Raw material of metallic origin. 
2.     Raw material of mineral origin. 
3.     Raw material from animal source. 
4.     Fresh herbs. 
5.     Dry herbs or plant parts 
6.      Excipients etc. 

7.      Volatile oils/perfumes and flavours 

8.      Plant  concentrates/ extracts and exudates/resins. 

555 

 
 
 
 
 
 
 
 
 
 
 
 
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Each container used for  raw material  storage shall  be  properly identified with the 
label which indicates name of the raw material, source of supply and will also clearly state 
the status of raw material such  as  ‗UNDER  TEST‘  or  ‗APPROVED‘  or   ‗REJECTED‘.   
The  labels  shall  further  indicate  the identity of the particular supply in the form of Batch 
No. or Lot No. and the date of receipt of the consignment. 

All  the  raw  materials  shall  be  sampled  and  got  tested  either  by  the  in-house 
Ayurvedic, Siddha and   Unani  experts  (Quality  control  technical   person)  or   by   the  
laboratories    approved    by    the  Government  and  shall  be  used  only  on  approval  after 
verifying. The rejected raw material should be removed from other raw material store and 
should be kept in separate room. Procedure of ‗First in first out‘ should be adopted for raw 
materials wherever necessary. Records of the receipt, testing and approval or rejection and 
use of raw material shall be maintained. 

1.1.  (F)(B)  Packaging  Materials. -   All  packaging materials  such  as  bottles,  jars, 
capsules  etc. shall  be  stored  properly.  All  containers  and  closure  shall  be  adequately 
cleaned  and  dried  before packing the products. 

1.1.  (F)(C)  Finished  Goods  Stores.  -    The  finished  goods  transferred  from  the 
production area after proper packaging shall be stored in the finished goods stores within 
an  area  marked  ―Quarantine‖.  After  the  quality  control  laboratory  and  the  experts  have 
checked the correctness of finished goods with reference to its packing/labelling as well as 
the  finished  product  quality  as  prescribed,  then  it  will  be moved to  ―Approved Finished 
Goods  Stock‖  area.  Only  approved  finished  goods  shall  be  dispatched  as  per  marketing 
requirements. Distribution records shall be maintained as required. 

If any Ayurvedic, Siddha and Unani drug needs special storage conditions, finished 

goods store shall provide necessary environmental requirements. 

1.1(G)  Working  space.  -  The  manufacturing  area  shall  provide  adequate  space 
(manufacture and quality control) for orderly placement of equipment and material used in 
any  of  the  operations for which these employed so as to facilitate  easy  and safe working 
and to minimize or to eliminate any risk of mix-up between different drugs, raw materials 
and  to  prevent  the  possibility  of  cross  contamination of one drug by another drug that is 
manufactured, stored or handled in the same premises. 

1.1(H)      Health  Clothing,  Sanitation  and  Hygiene  of  Workers.-  All  workers 
employed  in  the  Factory  shall  be  free  from  contagious  diseases.  The  clothing  of  the 
workers shall consist of proper uniform suitable to the nature of work and the climate and 
shall be clean. The  uniform shall  also include  cloth  or  synthetic  covering  for  hands,  feet 
and  head  wherever  required.  Adequate  facilities  for  personal  cleanliness  such  as  clean 
towels, soap and scrubbing brushes shall be provided. Separate provision shall be made for 
lavatories  to  be  used  by  men  and  women,  and  such  lavatories  shall  be  located  at  places 
separated from the processing rooms. Workers will also be provided facilities for changing 
their clothes and to keep their personal belongings. 

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1.1. (I) Medical Services: The manufacturer shall also provide:-  
(a)  adequate facilities for first aid; 
(b)  medical  examination  of  workers  at  the  time  of  employment  and  periodical 
check  up  thereafter    by    a    physician    once    a    year,    with    particular    attention    being  
devoted  to freedom from infections. Records thereof shall be maintained. 

1.1(J) Machinery and Equipments -   For carrying out manufacturing depending on 
the  size  of  operation  and  the  nature  of  product  manufactured,  suitable  equipment  either 
manually  operated  or  operated  semi-automatically  (Electrical  or  steam  based)  or  fully 
automatic machinery shall be made available.  These  may  include  machines  for  use  in  
the   process  of    manufacture  such   as    crushing, grinding, powdering, boiling, mashing, 
burning,  roasting,  filtering,  drying,  filling,  labelling  and  packing  etc.  to  ensure  ease  in 
movement  of  workers  and  orderliness  in  operations  a  suitably  adequate  space  will  be 
ensured between two machines or rows of machines. These equipments have to be properly 
installed  and  maintained  with  proper  cleaning.  List  of  equipments  and  machinery 
recommended is indicated in Part II-A. 

Proper  Standard  Operational  Procedures  (SOPs)  for  cleaning,  maintaining  and 

performance of every machine should be laid down. 

1.1(K)  Batch  Manufacturing  Records  -  The  licensee  shall  maintain  batch 
manufacturing record of each   batch of Ayurvedic, Siddha and Unani drugs manufactured 
irrespective  of  the  type  of  product  manufactured  (classical  preparation  or  patent  and 
proprietary  medicines).  Manufacturing  records  are  required  to  provide  an  account  of  the 
list  of  raw  materials  and  their  quantities  obtained  from  the  store,  tests  conducted  during 
the various stages of  manufacture like  taste,  colour, physical characteristics and chemical 
tests  as  may  be  necessary  or  indicated  in  the  approved  books  of  Ayurveda,  Siddha  and 
Unani  mentioned  in  the  First  Schedule  of  the  Drugs  and  Cosmetics  Act,  1940  (23  of 
1940).  These  tests  may  include  any  in-house  or  pharmacopoeial  test  adopted  by  the 
manufacturer  in  the  raw  material  or  in  the  process  material  and  in  the  finished  product. 
These  records  shall  be  duly  signed  by  Production  and  Quality  Control  Personnel 
respectively.      Details  of  transfer  of  manufactured  drug  to  the  finished  products  store 
including  dates  and  quantity  of  drugs  transferred  along  with  record  of  testing  of  the 
finished  product,  if  any,  and  packaging,  records  shall  be  maintained.  Only  after  the 
manufactured drugs have been verified and accepted quality shall be allowed to be cleared 
for sale. 

It  should  be  essential  to  maintain  the  record  of  date,  manpower,  machine  and 
equipments used and to keep in process record of various shodhana, bhavana, burning and 
fire and specific grindings in terms of internal use. 

557 

 
 
 
 
 
 
 
 
 
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1.1(L)   Distribution Records -   Records  of  sale  and  distribution of  each  batch  of 
Ayurveda, Siddha and  Unani Drugs shall be  maintained in  order  to  facilitate  prompt and 
complete  recall  of  the  batch,  if  necessary.The  duration  of  record  keeping  should  be  the 
date  of  expiry  of  the  batch.  Certain category of  Ayurvedic, Siddha and  Unani  medicines 
like  Bhasma,  Rasa,  Kupi-pakva,  Parpati,  Sindura,  Karpu/Uppu/Puram,  Kushta,  Asava-
arishta  etc.    do    not    have  expiry  date  in    contrast  their  efficacy  increases  with  the 
passage of  time.  Hence,  records  need be  maintained upto  five  years  of  the  exhausting  of 
stock. 

1.1(M) Record of Market Complaints -    Manufacturers shall maintain a register to 
record all reports of market complaints received regarding the products sold in the market. 
The manufacturer shall enter  all  data  received  on  such  market  complaints,  investigations 
carried out  by  the  manufacturers regarding the complaint as well as any  corrective action 
initiated to prevent recurrence of such market complaints shall also be recorded. Once in a 
period  of  six  months  the  manufacturer shall  submit  the record  of  such  complaints  to  the 
licensing  authority.  The  Register  shall  also  be  available  for  inspection  during  any 
inspection of the premises. 

Reports  of  any  adverse  reaction  resulting  from  the  use  of  Ayurvedic, Siddha  and 
Unani  drugs  shall  also  be  maintained  in  a  separate  register  by  each  manufacturer.  The 
manufacturer shall investigate any of the adverse reaction to find if the same is due to any 
defect in the product, and whether such reactions are already reported in the literature or it 
is a new observation. 

1.1(N)      Quality  Control.  -        Every  licensee  is  required  to  provide  facility  for 
quality  control  section  in  his  own  premises  or  through  Government  approved  testing 
laboratory.  The  test  shall  be  as  per  the  Auurveda,  Siddha  and  Unani  pharmacopoeial 
standard. Where the  tests  are  not  available,  the  test should be performed according to the 
manufacturers‘  specification  or  other  information  available.  The  quality  control  section 
shall verify all the raw materials, monitor in-process quality checks and control the quality 
of finished product being  released to  finished goods store/warehouse. Preferably for such 
quality  control  there  will  be  a  separate  expert. The  quality  control  section shall  have  the 
following facilities:– 

(1) There should be 150 sq. feet area for quality control section. 
(2) For  identification  of  raw  drugs,  reference  books  and  reference  samples 
should  be maintained. 
(3) Manufacturing record should be maintained for the various processes. 
(4) To  verify the  finished products, controlled samples of  finished products of 
each batch will be kept till the expiry date of product for 3 years. 
(5)  To  supervise  and  monitor  adequacy  of  conditions  under  which  raw 
materials,  semi- finished products and finished products are stored. 
(6) Keep record in establishing shelf life and storage requirements for the drugs. 

558 

 
 
 
 
 
 
 
 
 
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 (7)  Manufacturers  who  are  manufacturing  patent  and  proprietary  Ayurveda, 
Siddha,  and Unani medicines shall provide their own specification and control 
references  in respect of such formulated drugs. 
(8)  The  record  of  specific  method  and  procedure  of  preparation, that  is,  
―Bhavana‖, ―Mardana‖ and ―Puta‖ and the record of every process carried out 
by the manufacturer shall be maintained. 
(9)  The  standards  for  identity,  purity  and  strength  as  given  in  respective 
pharmacopoeias  of  Ayurveda,  Siddha  and  Unani  systems  of  medicines 
published by Government of India shall be complied with. 
(10)  All  raw  materials  will  be  monitored  for  fungal,  bacterial  contamination 
with a view to minimize such contamination. 
(11)      Quality control section will have a minimum of: – 
1[(i)  (a)  Expert  in  Ayurveda  or  Sidha  or  Unani  medicine  who  possesses    a 
degree  qualification  recognized  under  Schedule  II  of  Indian  Medicine  Central 
Council Act 1970; 
(b)  Chemist,  who  shall  possess  at  least  Bachelor  Degree  in  Science  or 
Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and 
(c)  Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in 
Science      (Medical)  or  Pharmacy  or  Pharmacy  (Ayurveda)    awarded  by  a 
recognized University.] 
(ii)  The  manufacturing  unit  shall  have  a  quality  control  section  as  explained  
under Section 35 (ii). Alternatively, these quality control provisions will be met 
by getting testing etc., from a recognised  laboratory for Ayurveda, Siddha and 
Unani  drugs;  under  Rule  160-A  of  the  Drugs  and  Cosmetics  Act.  The 
manufacturing  company  will  maintain  all  the  record  of  various  tests  got  done 
from outside recognised laboratory. 
(iii) 

 List of equipments recommended is indicated in Part II C. 

1.2.    Requirement for Sterile Product: 

(A)   Manufacturing Areas: –  For the manufacture of sterile Ayurvedic, Unani and 
Siddha  drugs,  separate  enclosed  areas  specifically  designed  for  the  purpose  shall  be 
provided.  These  areas  shall  be  provided  with  air  locks  for  entry  and  shall  be  essentially 
dust free and ventilated with an air supply. For all areas where aseptic manufacture has to 
be carried out, air supply shall be filtered through bacteria retaining filters (HEPA Filters) 
and shall be at a pressure higher than in the adjacent areas. The filters shall be checked for 
performance  on  installation  and  periodically  thereafter  the  record  of  checks  shall  be 
maintained. All the surfaces in sterile manufacturing areas shall  be  designed  to  facilitate  
cleaning    and   disinfection.    For   sterile   manufacturing    routine microbial  counts  of  all 
Ayurvedic,  Siddha  and  Unani  drug  manufacturing  areas  shall  be  carried  out    during 
operations.  Results  of    such    count  shall    be    checked  against  established  in-house 
standards and record maintained. 

1. Subs. by G.S.R. 463(E) dated 08-07-2005. 

559 

 
 
 
 
 
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Access  to  manufacturing  areas  shall  be  restricted  to  minimum  number  of 
authorized  personnel.  Special  procedure  to  be  followed  for  entering  and  leaving  the 
manufacturing areas shall be written down and displayed. 

For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilized 
in  their  final  containers,  the  design  of  the  areas  shall      preclude  the  possibility  of  the 
products  intended  for  sterilization  being  mixed  with  or  taken  to  be  products  already 
sterilized. In  case  of terminally sterilized  products, the  design of  the  areas  shall  preclude 
the possibility of mix-up between non-sterile products. 

(B) Precautions against contamination and mix: 

(a) Carrying out  manufacturing operations in  a  separate  block  of  adequately 
isolated building or operating in an isolated enclosure within the building, 
(b) Using appropriate pressure differential in the process area.  
(c) Providing a suitable exhaust system. 
(d) Designing laminar flow sterile air system for sterile products. 
(e)  The  germicidal  efficiency  of  UV  lamps  shall  be  checked  and  recorded 
indicating the burning hours or checked using intensity. 
(f)  Individual    containers    of    liquids    and   ophthalmic   solutions    shall   be  
examined  against  black-white  background  fitted  with  diffused  light  after 
filling to ensure freedom from contamination with foreign suspended matter. 
(g) Expert    technical    staff   approved    by    the    Licensing    Authority    shall  
check    and  compare  actual  yield  against  theoretical    yield  before  final 
distribution of the batch. 

All  process  controls  as  required  under  master  formula 

including  room 
temperature,  relative  humidity,  volume  filled,  leakage  and  clarity  shall  be  checked  and 
recorded. 

PART  II 

A.   LIST OF RECOMMENDED MACHINERY, EQUIPMENT AND MINIMUM 
MANUFACTURING PREMISES REQUIRED FOR THE    MANUFACTURE OF 
VARIOUS CATEGORIES OF AYURVEDIC, SIDDHA SYSTEM OF MEDICINES 

One machine indicated for one category of medicine could be used for the manufacturing 
of  other  category  of  medicine  also.      Similarly  some  of  the  manufacturing  areas  like 
powdering, furnace, packing  of liquids and Avaleha, Paks, could also be shared for these 
items. 

560 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Sl.No.       Category of Medicine          Minimum manufacturing 

space required 

Machinery/equipment 
recommended 

(1)                           (2)                                        (3)                                                      (4) 

  Square 
area 
cabins 
for 
If 

feet 
1200 
with 
covered 
or 
separate 
each 
partitions 
Unani 
activity. 
are 
medicines 
in  same 
manufactured 
premises  an  additional 
area  of  400  sq.  feet  will 
be required. 

1.              Anjana/Pisti                         100 sq. feet.                         Karel/mechanized/motorized, karel. 
End                         runner/Ball-Mill 
Sieves/Shifter. 

2. 

Churna / Nasya/ 
Manjan/Lepa/ 
Kwath Churn 

3.              Pills/Vati /Gutika 
Matirai and tablets 

Kupi pakava/Ksara/ 
Parpati/LavanaBhasm 
a Satva/Sindura 
Karpu/ Uppu / Param 

200 sq feet                           Grinder/disintegrator/Pulveriser/ 

Powder mixer/sieves/shifter. 

100 sq. feet                          Ball   Mill,      Mass   mixer/powder 
tablet 
mixer,  Granulator,  drier, 
compressing  machine, 
pill/vati 
cutting  machine,  stainless  steel 
trays/container 
for    storage    and 
sugar coating, polishing pan in case 
of  sugar-coated  tablets,mechanised 
chattoo (for mixing guggulu) where 
required. 

150 sq. feet                   Bhatti,       Karahi/Stainless       steel 
Vessels/Patila 
Flask,  Multani 
Matti/Plaster  of  Paris,  Copper  Rod, 
Earthern  container,  Gaj  Put  Bhatti, 
Mufflefurnace(Electrically 
operated) End/EdgeRunner, Exhaust 
Fan, Wooden/S.S.Spatula. 

Kajal                                           100 sq. feet                   Earthern   lamps   for   collection   of 
Kajal,  Triple  Roller  Mill,  End 
Runner,  Sieves,  S.S.Patila,  Filling/ 
packing  and  manufacturing  room 
should be provided with exhaust fan 
and ultra violet lamps. 

Capsules                                     100 sq. feet                   Air     Conditioner,     De-humidifier, 
hygrometer,  thermometer,  Capsule 
filling  machine 
chemical 
balance. 

and 

7.             Ointment/Marham 

Pasai 

100sq. feet                    Tube    filling    machine,    Crimping 
Machine/Ointment      Mixer,      End 
Runner/ Mill (Where required) S.S. 
Storage Container S.S.Patila. 

561 

4. 

5. 

6. 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Sl.No.       Category of Medicine          Minimum manufacturing 

space required 

Machinery/equipment 
recommended 

(1)                           (2)                                        (3)                                                      (4) 

8.             Pak/Avaleh/Khand/ 

Modak/Lakayam                        

100 sq. feet

9. 

Panak, Syrup / Pravahi 
Kwath Manapaku 

150 sq, feet 

10. 

Asava / Arishta 

200 sq. ft 

11. 

Sura 

100 sq. ft 

12. 

Ark  Tinir 

100 sq. ft 

  fitted 

  section 

Bhatti 
  with  
exhaust  fan  and  should  be  fly 
proof, Iron Kadahi/S.S. Patila and 
S.S. Storage container. 

Tincture    press,    exhaust    fan  
fitted and fly proof, Bhatti section, 
Bottle washing     machine,     filter   
press      /  Gravity          filter,  liquid     
filling  machine  P.P.  Capping 
Machine 

Same 
above. 
as  mentioned 
Fermentation  tanks,  containers  and 
distillation  plant  where  necessary, 
Filter Press. 

Same  as  mentioned  above  plus 
Distillation  plant  and  Transfer 
pump. 
Maceration tank, Distillation plant, 
Liquid   filling   tank   with   tap   / 
Gravity 
p ress, 
inspection box. 

filter/Filter  
Visual 

13. 

14. 

15. 

Tail/Ghrit Ney                            100 sq. ft                       Bhatti,         Kadahi/S.S.         Patila 
S.S.Storage  Containers,  Filtration 
equipment, 
tank  with 
filling 
tap/Liquid filling machine. 

Aschyotan / Netra Malham 
Panir/Karn Bindu/Nasa- 
bindu 

100  sq.  ft                                            Hot    air    oven    electrically  
heated  with    thermostatic    control,  
kettle  gas  or  electrically  heated 
with suitable mixing arrangements, 
collation  mill,  or  ointment  mill, 
tube filling equipment, mixing and 
storage  tanks  of  stainless  steel  or 
of  other      suitable      material   
sintered glass funnel, seitz filter or 
filling 
filter 
equipment, autoclave. 

candle, 

liquid 

200 sq. ft 

Each  manufacturing  unit  will 
have  a  separate  area  for 
Bhatti,  furnace  boilers,  puta, 
etc.  This  will  have  proper 
ventilation, 
  of 
smoke,  prevention  of  flies, 
insets,  dust  etc.  The  furnace 

  removal 

                   section could have tin roof.  

562 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

B. LIST  OF  MACHINERY, EQUIPMENT AND  MINIMUM MANUFACTURING 
PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS 
CATEGORIES OF UNANI SYSTEM OF MEDICINES 

One  machine indicated for  one  category of  medicine could be  used for  the  manufacturing 
of  other  category  of  medicine  also.      Similarly  some  of  the  manufacturing  areas  like 
powdering, furnace, packing  of liquids  could also be shared for these items. 

Sl.No.  Category of 

Medicine 

Minimum manufacturing space 
required 

Machinery/equipment recommended 

(1) 

       (2) 

(3) 

(4) 

1200 square feet covered area 
cabins, 
separate 
with 
partitions  for  each  activity. If    
Ayurveda        /        Siddha 
also 
medicines 
manufactured 
same 
premises an additional area of 
400 
feet  will  be 
required. 

are 
in 

square 

1. 

Itrifal 
Tirya/majoon/ 
Laooq/Jawarish 
Khamiras 

100 sq. feet 

Grinder/  Pulveriser,  Sieves,  powder 
mixer  (if  required),  S.S.  Patilas, 
Bhatti  and  other  accessories,  plant 
mixer for Khamiras. 

2.  Arq. 

100 sq. feet 

Plant        (garembic)    

Distillation 
S.S.  storage  tank,  Boiling  Vessel, 
Gravity filter, Bottle filling machine, 
Bottle  washing  machine,  Bottle 
drier. 

3.  Habb  (Pills)  and 

100 sq. feet 

tablets. 

563 

Ball  Mill,  Mass  Mixer/Powder 
tablet 
mixer,  Granulator  drier, 
pill/vati 
compressing  machine, 
cutting  machine, 
steal 
trays/  container  for  storage    and  
sugar    coating,    polishing  pan      in 
case 
tablets, 
sugar-coated 
mechanized        chattoo,        (for    
mixing guggul) where required. 

stainless 

of 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

4.  Sufoof (Powder)                 

200 sq. feet                              

Grinder  /  pulveriser,  Sieves,  Trays, 
Scoops, 
Powder 
(where required). 

  mixer     

5.  Raughan  (oils)  (Crushing 

100 sq. feet 

and boiling) 

Oil  Expeller,  S.S.  Patilas  Oil  filter 
bottle,  Filling  machine,  Bottle  drier, 
Bhatti. 

6.  Shiyaf, Surma, Kajal 

100 sq. feet 

End runner, mixing S.S. Vessel.. 

7.        Marham, Zimad 

100 sq. feet 

(Ointment) 

8.          Qurs (Tab.) 

100 sq. feet 

Kharal,  Bhatti,  End  runner,  Grinder, 
Pulveriser,    Triple    Roller    Mill    (if 
required). 

Grinder/Pulveriser,  Sieves,  Powder 
mixer 
(where  needed),  Granulator, 
Drier,  Tablet  Compressing  Machine, 
Die    punches  Trays,  O.T.  Apparatus, 
Balance  with  weights,  Scoops,  Sugar 
Coating Pan, polishing pan, Heater. 

9.           Kushta                               100 sq. feet                     Bhatti, Kharal, Sil Batta, Earthen pots. 

10.          Murabba                            100 sq. feet.                     Aluminium      Vessels      50-100kgs.                 
                                                                                                  Capacity, Gendna, Bhatti. 

11. 

Capsule                         100 sq. feet                       Pulveriser,       Powder      mixer     

capsule 

needed), 

filling 
(where 
machine,  Air 
conditioner,  De-
humidifier,  Balance  with  weights, 
storage containers, glass. 

12. 

13. 

14. 

Sharbat and Joshanda        100 sq. feet                   Tinctum  Press,  exhaust  fan  fitted, 
Bhatti 
section,  Bottle  washing 
machine,  Filter  Press  Gravity  filter, 
Liquid  filling  tank  with  tap/liquid 
filling  machine,      hot  air  oven 
electrically heated with thermostatic 
control, kettle. 

Chashm 

Qutoor-e- 
and 
drops, eye ointment) 

Marham(Eye   

100 sq. feet 

Hot   air   oven   electrically   heated  
with thermostatic control, kettle 

Each  manufacturing 
  will  have  a 
unit 
separate 
for 
area 
furnaces, 
Bhatti, 
boilers, 
putta,etc. 
This will have proper 
ventilation,removal 
of  smoke,  prevention 
of  flies,  insects,  dust, 
etc. 

200 sq. feet 

564 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

C.   LIST  OF  EQUIPMENT  RECOMMENDED  FOR  IN-HOUSE  QUALITY  CONTROL 
SECTION 

(Alternatively,  unit can get testing done  from the Government approved laboratory). 

 (A)    CHEMISTRY SECTION                      (B)      PHARMACOGNOSY SECTION 

1. 
2. 
3. 
4. 
5. 
6. 
7. 

8. 

Microscope Binoculor. 
 Dissecting Microscope.  
 Microtome. 
Physical Balance.  
Aluminium Slide Trays.  
Stage Micrometer. 
Camera  Lucida  (Prism  and  
Mirror Type). 
Chemicals, Glassware etc. 

1. 

2. 

3. 

4. 

5. 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. 
14. 
15. 
16. 
17 
18 
19. 

20 

21. 

22 
23. 
24 
25. 

Alcohol   Determination   Apparatus  
(complete set) 
Volatile Oil Determination 
Apparatus.  
Boiling Point Determination 
Apparatus. 
Melting Point Determination 
Apparatus.  
Refractometer. 
 Polarimeter.  
Viscometer. 
Tablet Disintegration Apparatus.  
Moisture Meter. 
Muffle Furnace.  
Electronic Balance.  
Magnetic Stirrer. 
Hot Air Oven.  
Refrigerator. 
Glass/Steel Distillation Apparatus. 
LPG Gas Cylinders with Burners. 
Water Bath (Temperature controlled.) 
Heating Mantles/ Hot Plates. 
TLC Apparatus with all accessories 
(Manual)  
Paper Chromatography apparatus 
with accessories. 
  Sieve size 10 to120 with Sieve     
  shaker.  
Centrifuge Machine. 
Dehumidifier.  
pH Meter. 
Limit Test Apparatus. 

565 

 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[D. SUPPLEMENTARY GUIDELINES FOR MANUFACTURING OF 
RASAUSHADHIES OR RASAMARUNTHUKAL AND KUSHTAJAT (HERBO-
MINERAL-METALLIC COMPOUNDS)  OF AYURVEDA, SIDDHA AND UNANI 
MEDICINES 

These guidelines are intended to complement those provided above and should be 
read  in  conjunction  with  the  parent  guidelines.  The  supplementary  guidelines  are  to 
provide general and minimum technical  requirements for quality assurance and control in  
manufacturing  Rasaushadhis  or  Rasamarunthukal  and  Kushtajat  (Herbo-mineral-metallic 
formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, 
Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali  Rasa, Satwa (of Metals  and Minerals 
origin)  Druti  Parpam,  Karpu,  and  Kushta  etc.  used  in  Ayurvedic,    Siddha  and  Unani 
Systems of medicine. 

The  supplementary  GMP  guidelines  for  Rasaushadhi  or  Rasamarunthukal  and 
Kushtajat  are  needed  to  establish  the  authenticity  of  raw  drug,  minerals  and  metals,  in-
process  validation  and  quality  control  parameters  to  ensure  that  these  formulations  are 
processed and prepared in accordance with classical  texts and for which  safety measures 
are complied.  Only those manufacturing units which have Good Manufacturing Practices 
for  ASU  drugs  and  supplementary  certificate  for  Rasaushadhi  or  Rasamarunthukal  and 
Kushtajat formulations shall be allowed to manufacture  th e same.  Supplementary  Good 
Manufactur  ing    Pr  actices    Certificate    for  Rasaushadhies  shall  be  issued  by  the  State 
Licensing  Authority  only  after  thorough  inspection  by  an  expert  team  including 
Rasashastra experts nominated  by the Department of AYUSH. 

2. Manufacturing Process Areas :- 

For  the  manufacture  of  Bhasma  and  Kupipakawa  and  Rasaushadhi  preparations 
made  from  metals  and  minerals  the  following  specific  areas  shall  be  provided,  which 
should  be  completely  segregated  from  the  production  area  used  for  preparation  of  plants 
and  animal  by  product  based  formulation    to  avoid  cross  contamination.    The  following  
exclusive  areas the required  for Rasaushadhies or Rasamarunthukal and Kushtajat:- 

2.2 

(a)  Bhatti or Heating Device Section for Bhasma and Rasaushadhies :- 100 sq. 
feet  for  heating,  burning,  putta  and  any  heat  related  work  with  proper 
ventilation, exhaust and chimney. This could be tin shed also. 

 1. Ins. By G.S.R. 157(E), dated 04-03-2009 

566 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(b)  Grinding, Drying and Processing Section for Bhasma and Rasaushadhies:- 

100 Sq. feet (Manual or Mechanical,  oven etc.). Drying  1[Shall be] done in 
a  space  which  is  covered  by  glass  or  other  transparent  material  to  allow 
entry of sunrays on the material to keep for the purpose. If drying is being 
done  in    oven  the  temperature  of  the  same  may  be  selected  specific 
temperature. 

(c)  Rashaushadi Related Store :-100 Sq. feet. 

The  size  and  dimensions  of  each  Bhatti  Section  would  be  so  designed  to  suit  the 
batch size or quantity of materials to be processed, keeping in mind the processing is done 
as  per  the  conditions  of  Drug  and  Cosmetics  Act  mentioned  under  Schedule  I  official 
books. 

In  addition  to  the  fuels  prescribed  in  the  schedule  books  namely  coal,  fire  wood, 
cow dung cakes  etc., use of other heating devices  e.g. electrical   heating, oil or gas  fired 
furnaces and others Shall be] employed  so as to provide  the required temperature as per 
the  nature  of  material  and  object  of  heating.  Depending  on  the  formulation  being 
manufactured, manufacturers may adopt aerobic or anaerobic process. Properly baked and 
clean  earthen  pots  of  other  crucibles  and  glass  containers  of  appropriate  design  shall  be 
used. 

The  manufacturing  area  should  be  designed  with  special  attention  to  process  the 
products that generate toxic fumes like SO2, arsenic and mercury vapor, etc. When heating 
and  boiling  of  the  materials  is  necessary,  suitable  ventilation  and  air  exhaust  flow 
mechanism should be provided to prevent accumulation of unintended fumes and vapors.  
Such areas may be provided with properly designed chimneys or ducts fitted with exhaust 
system  and  suitable  scrubbing  system  to  remove  fumes  and  smoke,  so  that  safety  of 
personnel and environment is taken care of. 

Since processing of Rasaushadhis  may introduce  heavy metal  contamination  and 
cross  contamination  etc.,  therefore,  cleaning  of  equipment  is  particularly  important  after 
every process by using appropriate cleaning agent which should not react with material of 
equipment and must be free from unwanted properties e.g. corrosiveness. 

2.3  Records  shall  be  maintained  specially  for  temperatures  attained  during  the  entire 
process of Bhasmikaran, while employing different kinds of classical puta, furnaces using 
oil, gas or electricity. Appropriate temperature measuring instrument should be employed 
such  as  pyrometer    and,  pyrograph    for  manual  reading  or  recording  by  heat  sensors, 
connected to computer  as the case may be. 

In order to handle large quantities, appropriate technology like use of hand operated 
extruders  for  making  chakrikas  or  pellets  may  be  adopeted.  However,    such  equipments  
made of aluminium or its alloys should not be used. 

1. Subs. by G.S.R.Subs. by G.S.R.338(E), dated 15-04-2010. 

567 

 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Access to manufacturing areas shall be restricted to minimum number of authorized 

personnel only. 

3. Quality Control :- 
A. Inprocess Quality Control :- 
The registers  as indicated below should exclusively be maintained for ready reference :- 

(a) Shodhan Register with following details :- 

1. 
2. 
3. 
4. 
5. 
6. 
7. 

Sl No. 
Batch No. and Size 
Date, time and duration 
Name of the Raw-material with Quality reference and quantity 
Quantity of Shodhana Dravya 
Book Reference followed 
Methodology 

(b) Bhavana and Putta Register with following details :- 

1. 
2. 
3. 
4. 
5. 
6. 
7. 

Sl No. 
Batch No. 
Date, time 
Name of the material and quantity of starting materials 
Quantity of Nirvapya Dravya 
Quantity of Bhavana Dravya 
Date  and  time  of  Starting  and  completion  of  Bhavana  or  Mardana  and 
duration 
Type and Number of Puttas 
8. 
9. 
Time and Date of completion of Puttas 
10.   Color and texture of the product or standards 
11.  
12.  

Inprocess tests followed (Bhasma Pariksha and any other tests) 
In case heating at a particular temperature is required, record of attainment 
of that temperature. 

 (c) Grinding Record Register:- (Finished Product / Intermediate procedure) 

1. 
2. 
3. 
4. 
5. 
6. 
7. 

Sl. No. 
Batch No. 
Date and time 
Name of the material and quantity 
Name of the equipment (SS/granite) 
Duration of grinding 
Repeat the grinding if required (Number of repetition) 

(d) Packing details:- 

1. 
2. 
3. 

Name of Rasaushadhi 
Type of Dosage Form (eg. Powder, pill, tablet etc) 
Weight of Rasaushadhi in each unit 

568 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

B. Product Quality Control:- 

The  specifications  for  finished  Rasaushadhi  are  primarily  intended  to  define  the 
quality  rather  than  to  establish  full  characterization,  and  should  focus  on  those 
characteristics  found  to  be  useful  in  ensuring  the  quality.  Consistent  quality  for 
Rasaushadhi  can  only  be  assured  if  the  starting  material-metals  and  minerals  are  used  of 
pharmacopoeial  standards.  In  some  cases  more  detailed  information  may  be  needed  on 
aspects of their process. The manufacturer will ensure in-house standards for the uniform 
quality of product. 

Quality testing will be carried out as per official Pharmaceutica or Schedule books 
for  texts  namely,  color,  taste,  varitaratwa,  Rekhapurnatwa,  Laghutva,  Nirdhumatwa, 
Dntagre Kachakacha, Niruttha,  Apunarbhava and Nischandratwa. 

The Particle size of the product should be tested by adopting microscope fitted with 
micrometer or particle size analyzer or any appropriate other techniques.  Required physio-
chemical  characterization  of  the  product  should  be  undertaken  by  appropriate  analytical 
equipment.  The Standard Manufacturing  Process of the product should be evolved/follow 
up.  The disintegration time of pills-vati and tablets should also be recorded. 

4.  Product  recalls:-  Literature  inserted  inside  the  product  package  should  indicate  the 
name,  address  of  the  manufacturing  unit  1[and]  telephone  number  for  reporting  of  any 
adverse drug reaction by physicians or patients. On receipt of such Adverse Drug Reaction 
report, it will be the responsibility of the manufacturer  to ensure the recall of the product 
from the market. 

Standard  Operating  Procedures  (SOP)  should  be  included  for  storage  of  recalled 
Rasaushadhies in a secure segregated area, complying with the requirements specified for 
storage till their final disposal. 

5. Medical examination of the Employees:- Employees engaged in manufacturing should 
be medially examined periodically at least once a  year for any adverse effect of the drug 
during  manufacturing  process  for  which    necessary  investigations  1[Shall  be]  carried  out 
for ensuring that there is no effect of material on the vital organs of the employees.  Annual 
examination  reports  of  the  employees    shall    be  made  available    to  statutory  inspectors  
during  Good Manufacturing  Practices inspections. 

6. Self-Inspection:-   The release of Rasaushadhis should be under the control of a person 
who  has  been  trained  in  the  specific  features  of  the  processing  and  quality  assurance  of 
Rasaushadhis.  Personnel  dealing  with 
the  production  and  quality  assurance  of 
Rasaushadhis  manufacturing  section  should  have  an  adequate  training  in  the  specific 
subject of Rasaushadhis manufacturing. He will be at least a degree holder in Ayurvedic, 
Siddha  /  Unani  medicines  or  B.Pharma  degree  holder  in  Ayurvedic  /  Siddha  /  Unani 
medicines. 

1. Subs. by G.S.R. 338(E) dated 15-04-2010. 

569 

 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

7.  Dosage  form  of  Rasaushadhis:-    The  Rasaushadhis  may  be  made  into  an  acceptable 
dosage  forms  such  as  churna,  vati,  guti,  tablet  or  capsules  etc.  after  adding  suitable 
permissible fillers or binding  agents  as permissible under the Ayurvedic  Pharmacopoeia  
of India  or Indian pharmacopoeia as updated  from time to time. In such cases the label 
must indicate the quantity of Ayurveda, Siddha and Unani medicines in one Tablet or Pill 
or Capsule in addition to the filler. The crystalline product may be grinded before packing 
in  the  individual    dispensing  size.  All  the  Rasaushadhis  or  Rasamaruthukal  or  Kushtajat 
shall be packed in a dosage form which is ready for use for the consumer.  Grinding  and 
weighing  of  individual  dose  of  potentially  poisonous  products  will  not  be  permissible  in 
patient  consumer  pack.  This  arrangement  may  reduce  the  Adverse  Drug  Reaction  of 
Rasaushadhi which takes place due to dose variation.  However, for hospital bulk pack, it 
will not be applicable and label will clearly indicate the ―Hospital pack.‖ 

8. Area Specifications/ requirement for an applicant companies only to have GMP of 
(Herbomineral/metallic 
Rasaushadhis  or  Rasamarunthukal  and  Kushtajat 
compounds) of Ayurveda, Siddha and Unani medicines:- 

1. Subs. by G.S.R. 338(E) dated 15-04-2010 

570 

 
 
 
 
 
 
 
 
Machinery equipme recommended 

Kharal/mechanized/motorized Kharal, 
End runner / Ball-Mill Sieves / Sifter.  
Grinder  /  Distintegrator  /Pulverisor  /  Powder 
mixer / Sieves / Sifter 

Ball  Mills,  Mass  Mixer/Powder  mixer, 
Granulator,  drier,  tablet  compressing  machine, 
pill/ vati cutting machine, stainless steel trays / 
for  storage  and  sugar  coating, 
container 
polishing  pan  in  case  of  sugar  coated  tablets, 
mechanized chatoo, (for mixing 
of guggulu) where required. 

Bhatti, Karahi / stainless steel vessels 
/patila flask, Multani Matti / Plaster 
of  Paris,  Copper  Rod,  Earthen  container,  Gaj 
Put  Bhatti,  Muffle 
(electrically 
operated)  End  /  Edge  Runner,  Exhaust  Fan, 
Wooden, S.S. Spatula. 

furnace 

Drugs and Cosmetics Rules 1945 

Sr. No. 

Category of Medicine / 
Manufacturing area 

Pisti / grinding area for 
Bhasma, Pishti, Kushtajat 
Powdering area for raw drugs 
of plant origin giving in 
Rasaushadhis (Herbo-metalic 
formulations) 
Pills / Vati/ Gutika Matrica 
and tablets / Habb making area 

Minimum 
Manufacturing 
space required 
(1500 sq. ft.) 

100 sq. ft. 

200 sq. ft. 

100 sq. ft. 

Kupi pakva / Ksara / Parpati / 
Lavana Bhasma Satva / 
Sindura Kapu / Uppa / Param / 
Qushta / Jawhar 

150 sq. ft. 

Receiving and storing raw 
material 
Quality Control Section 
Quarantine / observation 
Finished goods store  
Rejected goods store  
Bhatti-putta area 
Area for water and washing 
etc. 
Office 
TOTAL 

200 sq. ft. 

150 sq. ft. 
50 sq. ft. 
150 sq. ft. 
50 sq. ft. 
200 sq. ft. 
50 sq. ft. 

100 sq. ft. 
1500 sq. ft 

1. 

2. 

3. 

4. 

5. 

6. 
7. 
8. 
9. 
10. 
11. 

12. 

Note : The above requirements of machinery,  equipments,  space are made subject to 
the modification at the discretion of the Licensing Authority; if he is of the opinion that having 
regard to the nature and extent of the manufacturing operations it is necessary to relax or alter 
them  in  the  circumstances  in  a  particular    case,  1[he  may  do  so  after  recording  reasons  in  
writing]]. 

1. Added by G.S.R.463(E), dated 08-07-2005 

571 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[Schedule TA  
(See rule 157 A) 
FORM FOR RECORD OF UTILIZATION OF RAW MATERIAL BY AYURVEDA OR 
SIDDHA OR UNANI LICENSED MANUFACTURING UNITS DURING THE 
FINANCIAL YEAR 

Identification  Particulars: 

Manufacturing  License No ................................... 
Issued by.................................................................. 

  Pin Code: ...................................................................  

Name: ............................................  
Address: ........................................ 
State: .............................................  
Telephone:......................................    Fax: .........................................................................  
Email: .................................. 
1.  Quantity  of  Medicinal  Plants/Extracts/Essential  Oils/Metals/Animal  By-Products 
Minerals Used During  1st April, to 31st March of the preceeding year (For Productions at 
the identified facility) 
(a) Herbs Used 
Plant’s 
Common Name 
Botanical 
as in AFI/API* 
Name 

Sources of Supply 
Cultivators 

Part Used 

Imported 

Others 

Total 

Root 

Leaf 

Traders/ 
Manufacturers 

Forest 
Collectors 

Whole 
plans 

Quantity 
Used/per 
annum (in 
Kgs.) 

*Ayurvedic Formulary of India/Ayurvedic Pharmacopoeia of India 

(b) Extracts Used 

Name of Extracts 

Common Name as in 
AFI/API* 

Botanical Name 

Quantity Used/per 
annum (in Kgs.) 

In-House 

Export Suppliers 

Imported 

Total 

Sources of Supply 

* Ayurvedic Formulary of India/Ayurvedic Pharmacopoeia of India 

(c) Metals/Minerals Used 

Name of Mineral 

Common Name  

Chemical Name 

Quantity Used/per 
annum (in Kgs.) 

Manufacturers Traders 
 (Domestic) 

Sources of Supply 

Importers 

Total 

1. Ins. By G.S.R. 512 (E), dated 09-07-2008 

572 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(d) Animal By-Products Used 

Name of By-Product 

Common Name  

Biological/Chemical 
Name (if any) 

Quantity Used/per 
annum (in Kgs.) 

Manufacturers Traders 
 (Domestic) 

Sources of Supply 

Importers 

Total 

2. Shortage of raw material(s)/inputs during the preceeding year. 

Y 

N 

If  yes, please indicate  name(s) of such raw material(s) by level  of importance 
starting from most important to least important, reason for shortage [availability, quality 
or any other (please specify)] 

Name of Raw Materials 

Appro. Qty of shortage (in 
Kgs.) 

Reason 

Name  of  the  drug  and  part 
used as mentioned in official 
formulary / Pharmacopoeial/ 
Schedue I books 

Biological/  Chemical  Name  (if 
any) 

1[SCHEDULE  U 
(See  rules 74, 74A, 74B, 78 and 78A) 

I.    PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS 

A.   SUBSTANCES, OTHER THAN PARENTERAL PREPARATIONS IN GENERAL. 

1.  Serial number 
2.  Name of the product 
3.  Reference of Master Formula Records. 
4.  Lot/Batch Size. 
5.  Lot/Batch Number. 
6.   Date  of  commencement of  manufacture and  date  of  completion  of  manufacture and  assigned 

date of expiry. 

7.  Name of all ingredients, specifications quantities required for the lot/Batch size and quantities 
actually  used.  All  weighings  and  measurements  shall  be  carried  out  by  a  responsible  person  and 
initialled by him and shall be counter-checked and signed by the competent technical staff under whose 
personal supervision the ingredients are used for manufacture. 

8. Control Numbers of raw materials used in the formulation. 
9. Date, time and duration of mixing. 
10. Details of environmental controls like room temperature, relative humidity. 
11.Date of granulation, wherever applicable. 
12. Theoretical weight and actual weight of granules/powder blend. 
13. Records of in-processes controls (Periodically whenever necessary):  

(a)  Uniformity of mixing. 
(b)  Moisture content of granules/powder in case of Tablet/Capsules.  
(c)  pH of solution in case of liquid. 
(d)  Weight variation.  
(e)  Disintegration time.  

1. Subs. by G.S.R. 735(E) dated 24-06-1988 

573 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(f)  Hardness 
(g)  Friability test 
(h)  Leak test in case of strip packing.  
(i)  Filled volume of liquids. 
(j)  Quantity of tablets/capsules in the final container.  
(k)  Content of ointment in the filled containers. 

14. Date of compression in case of Tablets/date of filling in case of capsules. 
15. Date of sealing/coating /polishing in case of capsules/tablets wherever applicable. 
16. Reference to analytical Report number stating the result of test and analysis. 
17. Separate records of the disposal of the rejected batches and of batches withdrawn from the 
market. 
18.The theoretical yield and actual productions yield and packing particulars indicating the size and 

quantity of finished packings. 

19.  Specimen  of  label/strip,  carton  with  batch  coding  information  like  Batch  Number,  date  of 
manufacture, date of expiry, retail price as applicable stamped thereon and inserts used in the finished 
packings. 

20. Signature with date of competent technical staff responsible for the manufacture. 
21. Counter-signature of the head of the testing units or other approved person-in-charge of testing 
for  having  verified  the  batch  records  and  for  having  released  and  batch  for  sale  and  distribution,  the 
quantity released and date of release. 

22. Date of release of finished packings and quantity released for sale and distribution. 
23. Quantity transferred to warehouse. 
24.  For  Hypodermic  tablets  and  ophthalmic  preparations,  which  are  required  to  be  manufactured 
under aseptic conditions, records shall be maintained indicating the precautions taken during the process 
of manufacture to ensure that aseptic conditions are maintained. 

B.  PARENTERAL PREPARATIONS. 

1.    Serial number. 
2.    Name of the product. 
3.    Reference of the master formula record. 
4.    Batch /Lot size. 
5.    Batch No. and/or Lot No. 
6.    Date of commencement of manufacture and date of completion. 
7.      Names  of  all  ingredients,  specifications  and  quantity  required  for  the  Lot/Batch  size 
and  quantity  actually  used.  All  weighings  and  measurements  shall  be  carried  out  by  a 
responsible person and initialled by him and shall be countersigned by the technical staff under 
whose personal supervision the stock are issued and by another competent technical staff under 
whose supervision the ingredients are used for manufacture. 

8.    Control numbers of raw materials used in the formulation. 
9.    Date, time and duration of mixing. 
10.  Details  of  environmental  controls  like  temperature,  humidity,  microbial  count  in  the 

sterile working areas. 

11.  pH of the solution, wherever applicable. 
12.  Date and method of filtration. 
13. Sterility test, reference on bulk batch wherever applicable. 
14. Record of check on volume filled. 
15. Date of filling. 
16. Records of tests employed: - 

574 

 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(a) To ensure that sealed ampoules are leak proof 
(b) To check the presence of foreign particles.  
(c) Pyrogen test, wherever applicable 
(d) Toxicity test,  wherever applicable. 

17. Records of checking of instruments and apparatus of sterilization (indicators). 
18.  Records of cleaning and sterilization of containers and closures, if necessary. 
19.  Records  of  sterilization  in  case  of  parenteral  preparations  which  are  heat  sterilized 
including  particulars  of  time,  temperature  and  pressure  employed.  Such  records  should  be 
marked to relate to the batch sterilized. 

20.  Number and size of containers filled and quantity rejected. 
21. The theoretical yield and actual yield and the percentage yield thereof. 
22. Reference to Analytical report numbers stating whether of standard quality or otherwise. 
23. Specimen of labels, cartons, etc. with Batch coding information like batch number, date 
of manufacture, date of expiry, as applicable, stamped thereon, and inserts used in the finished 
packings. 

24. Signature with date of the component technical staff responsible for manufacture. 
25. Particulars regarding the precautions taken during the manufacture to ensure that aseptic 

conditions are maintained. 

26.  Countersignature  of  head  of  the  testing  unit  or  person  in  charge  of  testing  for  having 
verified  the  documents  and  for  having  released  the  product  for  sale  and  distribution,  the 
quantity released and date of release. 

27. Records for having transferred to warehouse giving packings and quantities. 
28.  Separate  records  of  the  disposal  of  the  rejected  batches  and  of  all  batches  withdrawn 

from the market. 

29. Records of reprocessing if any and particulars of reprocessing. 

II.  RECORDS OF RAW MATERIALS 

Records  in  respect  of  each  raw  material  shall  be  maintained  indicating  the  date  of  receipt, 
invoice number, name and address of the manufacturer/supplier, batch number, quantity received, pack 
size,  date  of  manufacture,  date  of  expiry,  if  any,  date  of  analysis  and  release/rejection  by  quality 
control,  analytical  report  number  with  special  remarks,  if  any,  quantity  issued,  date  of  issue  and  the 
particulars  of  the  name  and  batch  numbers  of  products  for  the  manufacture  of  which  issued  and  the 
proper disposal of the stocks. 

III. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS 

A.  TABLETS AND CAPSULES. 

1.       Analytical report number. 
2.       Name of the sample. 
3.       Date of receipt of sample. 
4.       Batch/Lot number. 
5.       Protocols of tests applied.  

(a) Description. 
(b) Identification. 
(c) Uniformity of weight. 
(d) Uniformity of diameter (if applicable).  
(e) Disintegration test (time in minutes).  
(f) Any other tests. 
(g) Results of Assay. 

575 

 
 
 
 
 
 
 
 
 
 
Note:  Records regarding various tests applied (including readings and calculations) should be 
maintained and necessary reference to these records should be entered in Col. 5 above whenever 
necessary. 

Drugs and Cosmetics Rules 1945 

6.   Signature of the Analyst. 
7.   Opinion and signature of the approved Analyst. 

B.  PARENTERAL PREPARATIONS. 

1.  Analytical report number. 
2.  Name of the sample. 
3.  Batch number. 
4.  Date of receipt of samples. 
5.  Number of containers filled. 
6.  Number of containers received. 
7.   Protocols of tests applied.  

(a)  Clarity. 
(b)  pH wherever applicable.  
(c)  Identification. 
(d)  Volume in container. 
(e)  Sterility –  

(i) Bulk sample wherever applicable  
(ii) container sample.  
(f)   Pyrogen test, wherever applicable. 
(g)  Toxicity test, wherever applicable.  
(h)  Any other tests. 
(i)   Results of Assay. 

Note: Records  regarding  various  tests  applied  (including  readings  and  calculations)  should  be 
maintained and necessary reference to these records should be entered in Col. 7 above, wherever 
necessary. 

8.   Signature of the Analyst. 
9.   Opinion and signature of the approved Analyst. 

PYROGEN TEST: 

1. Test Report Number. 
2. Name of the sample. 
3. Batch Number. 
4. Number of rabbits used. 
5. Weight of each rabbit. 
6. Normal temperature of each rabbit. 
7. Mean initial temperature of each rabbit. 
8. Dose and volume of solution injected into each rabbit and time of injection. 
9. Temperature of each rabbit noted at suitable intervals. 
10. Maximum temperature. 
11. Response. 
12.  Summed response. 
13. Signature of the Analyst. 
14.Opinion and signature of the approved Analyst. 

TOXICITY TEST 

1.   Test Report Number. 
2.   Name of the sample. 

576 

 
 
 
 
 
  
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

3.   Batch Number. 
4.   Number of mice used and weight of each mouse. 
5.   Strength and volume of the drugs injected. 
6.   Date of injection. 
7.   Results and remarks. 
8.   Signature of Analyst. 
9.   Opinion and signature of the approved Analyst. 

C.  FOR OTHER DRUGS 

1.   Analytical report number. 
2.   Name of the sample. 
3.   Batch/Lot number. 
4.   Date of receipt of sample. 
5.   Protocol of tests applied.  

(a)  Description. 
(b)  Identification.  
(c)  Any other tests.  
(d)  Results of Assay. 

Note:Particulars regarding various tests applied (including readings and calculations) shall be maintained 
and necessary reference to these records shall be entered in Column 5 above, wherever necessary. 

6.   Signature of Analyst. 

7.   Opinion and signature of the approved Analyst.  

D. RAW MATERIALS 

1.    Serial number. 
2.    Name of the materials. 
3.    Name of the manufacturer/supplier. 
4.    Quantity received. 
5.   Invoice/Challan number and date. 
6.   Protocols of tests applied. 

Note:  Particulars  regarding  various  tests  applied  (including  readings  and  calculations)  shall  be 
maintained  and  necessary  reference  to  these  records  shall  be  entered  in  Column  6  above,  wherever 
necessary. 

E.  CONTAINER, PACKING MATERIALS ETC. 

1.   Serial number. 
2.   Name of the item. 
3.   Name of the manufacturer/supplier. 
4.   Quantity received. 
5.   Invoice/Challan number and date 
6.   Results of tests applied. 

Note:   Particulars regarding various tests applied shall be maintained and necessary reference to these 
records shall be entered in Column 6 above, wherever necessary 

7.   Remarks. 
8.  Signature of the examiner. 

Notes: 1. The  foregoing provisions represent the  minimum requirements to  be  complied  with  by 
the licensee. The Licensing Authority may, however, direct the nature of records to be maintained by the 
licensee for such products as are not covered by the categories described above. 

2. The  Licensing  Authority  may  permit  the  licensee  to  maintain  records  in  such  manner  as  

are considered satisfactory, provided the basic requirements laid down above are complied with. 

3. The Licensing Authority may  at  its  discretion direct the licensee  to  maintain records for such 

additional particulars as it may consider necessary in the circumstances of a particular case.] 

577 

 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1

[SCHEDULE  U(I) 
(See rules 142 and 142B) 

I. PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS: 

1. Serial number. 
2. Name of the product. 
3. Lot/Batch size. 
4. Lot/Batch number. 
5. Date of commencement of manufacture and date when manufacture was completed. 
6. Names of all ingredients, quantities required for the lot/batch size, quantities actually used. 
7. Control reference numbers in respect of raw materials used in formulation. 
8. Reference to analytical report numbers. 
9.  Actual    production    and    packing    particulars    indicating    the    size    and    quantity    of 
finished packings. 
10. Date of release of finished packing for distribution or sale. 
11. Signature of the expert staff responsible for the manufacture. 

II. RECORDS OF RAW MATERIALS: 

Records in respect of each raw material  shall be  maintained indicating the quantity received, 
control reference number, the quantity issued from time to time, the names and batch numbers of the 
products for  the manufacture  of  which  the  said  quantity  of  raw  material  has  been  issued  and  the 
particulars relating  to  the proper disposal of the stocks. 

Notes:        (1)  The  Licensing  Authority  may  permit  the  licensee  to  maintain  records  in  such 
manner  as  is  considered satisfactory, provided the  basic requirements laid  down  above  are  complied 
with. 

(2)  The    Licensing    Authority    may    direct    the    licensee    to    maintain    records    for    such  

additional particulars, as it may consider necessary in the circumstances of a particular case.] 

2[SCHEDULE  V 
( See rule 124B) 

STANDARDS FOR PATENT OR PROPRIETARY MEDICINES 

3 [***] 
4[2.   Standards for patent or proprietary medicines, containing vitamins: Patent  or  proprietary  
medicines    containing    vitamins    for    prophylactic,    therapeutic    or  paediatric  use  shall  contain  the 
vitamins in quantities not less than and not more than those specified below in single or in two divided 
daily doses, namely: - [see table below]. 

3 [***] 
5[4.  General Standards for Different Categories of Patent or Proprietary Medicines. - In the 

case of pharmaceutical products containing several active ingredients, the selection shall be such that 
the ingredients do not interact with one another and do not affect the safety and therapeutic efficacy of 
the product. The combination shall not also lead to analytical difficulties for the purpose of assaying 
the content of such ingredient separately. The substances added as additives shall be innocuous, shall 
not affect the safety or therapeutic efficacy of the active ingredients, and shall not affect the assays and 
identity tests in the amount present.] 

1. Added by G.S.R. 1594, dt. 28-10-1976. 
2. Added by G.S.R. 665, dt. 06-05-1977. 
3. Omitted. G.S.R. 56(E) ,dt. 22.1.1992.  
4. Added by G.S.R. No. 930 ,dt. 13-7-1978. 
5. Ins. by. G.S.R. 792(E) ,dt. 17.9.1987. 

578 

 
 
 
 
 
 
 
Subject to  the provisions of  these rules, patent or proprietary medicines shall comply with the 

Drugs and Cosmetics Rules 1945 

following standards, namely: - 

1.  Patent  or  proprietary  medicines  shall  comply  with  the  general  requirements  of  the  dosage 
form under which it falls as given in the Indian Pharmacopoeia.  If the dosage form is not included in 
the Indian Pharmacopoeia, but is included in any other pharmacopoeia, prescribed  for  the  purpose  of 
the  Second  Schedule  to  the  Act,  it  shall  comply  with  the  general  requirements  of  the  dosage  of 
such  pharmacopoeia.  Without  prejudice  to  the  generality  of  the  foregoing  requirements,  general 
requirements  shall  include  compliance  with  colour  consistency,  clarity,  stability,  freedom  from 
contamination  with  foreign  matter  or  fungal  growth,  defects  like  chipping  and  capping  of  tablets, 
cracking  of  the  coating,  mottled  appearance  and  other  characteristic  defects  that  can  be  perceived  by 
visual inspection. 

2.  Without  prejudice  to  the  generality  of  the  following  paras,  dosage  forms  of  patent  or 

proprietary medicines shall comply with the following requirements, namely:- 

(a) Tablets:   Medicines shall comply with requirements for tablets  as  laid  down in the  Indian  
Pharmacopoeia.  The  nature  of  coating  shall  be  indicated  on  the  label. Permitted colours 
may,  however, be  added  and  declared  on  the  label.  Nature  of  tablets, such as uncoated, sugar 
coated or film coated, shall be declared on the label. 

1[***] 

(b)  Capsules  :    Medicines  shall  comply  with  the  requirements  for  capsules  laid  down  in  the 
Indian  Pharmacopoeia.  However,  the  capsules  shall  be  free  from  distortion  or  shape,  dis-
colouration and other physical defects like leakage of powder from joints, pinholes or cracks in 
the capsules; 
(c) Liquid  oral dosage forms:  Emulsions and suspensions shall disperse uniformly on  shaking. 
Homogeneous solutions shall contain no  sediments. The volume of  the product (net content) in 
the  container  shall  be  not  less  than  the  labelled  volume.  The  limit  for  ethanol  content  of 
pharmaceutical products shall be not less than 90 per cent and not more than 110 per cent of the 
labelled contents. 
(d) Injections: Medicines shall comply with the requirements for injections as laid down in the 
Indian Pharmacopoeia. 
(e) Ointments: Medicines shall comply with the requirements for injections as laid down in the 
Indian Pharmacopoeia. 

3. The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or 
proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled 
content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry 
formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in 
case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents. 

Fiducial limits  for  error for  microbiological assay of  antibiotics may  be  estimated depending 
upon  the  design  of  assay  procedure. Methods,  used  for  assaying  active  ingredients shall  employ the 
same  basic  principles  and  shall  use  same  organisms  as  given  in  the  latest  edition  of  the  Indian 
Pharmacopoeia  or  shall  follow  any  other  methods  as  approved  by  the  authority  competent  to  grant 
licence to manufacture. 

1. Omitted. by G.S.R. 59(E) ,dt. 22.1.1992. 

579 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

4.   All patent or  proprietary medicines containing aspirin shall be subjected to ―Free Salicylic 
Acid Test‖  and the limit  of such acid shall be 0.75 per cent. Except in case of soluble type aspirin in 
which case the limit of such acid shall be 3 per cent. 

5. Patent or proprietary medicine to be tested under the provisions of rule 121-A for pyrogen 
shall be  tested by  injecting into rabbits not less than the human dose of  the  medicine based on body 
weight of a  60 kg. human being.   Methodology and limits  shall be based on the  method recorded  in 
the  Indian  Pharmacopoeia. Dose  selected  shall  be  indicated  in  the  protocol  but  the dose shall be not 
greater than 5 times the human dose based on body weight of 60 kg for man. 

6.   In  injectable  patent or  proprietary medicines, the test for freedom from  toxicity, shall be 
performed as described in the Indian Pharmacopoeia. Dose selected shall be indicated in the protocol 
but the dose shall not be less than five times the human dose based on body weight of 60 kg. human 
being.] 

580 

 
 
 
Drugs and Cosmetics Rules 1945 

Drugs and Cosmetics Rules, 1945 

Vitamin 

Unit 

Patent or proprietary 
Medicines containing 
Vitamins for prophylactic 
Use. 

Patent or proprietary 
medicines containing 
vitamins for therapeutic 

Patent or proprietary medicines containing 
vitamins for paediatric use. 

(in single dose or in two divided doses) per   daily  dose 

1 

2 

3 

4 

5                                                6 

For adults 

For infants less than          For children above one 
one year.                               year  up to adults 

Vitamin A. 

I.U 

Not less than 1600 and not 
more than 2,500 

Not less than 5000 and not more 
than 10,000 

Not less than 750 and not           Not less than 1500 and more 
more than 3,000                          than 5,000 

Vitamin D. 

I.U 

Not less than 100 and not more 
than 200. 

Not  less  than  400  and  not  more 
than 1,000 

Not less than 200 and not           Not less than 100 and more than 
more than 400                             400 

Vitamin B1 

mg. 

Not less than 1 and not more 
than 2 

Not less than 4.5 and not more 
than 10 

Not  less  than  0.5  and  more    Not less than 1 and  not more 
than 1                                          than 4.5 

Vitamin B2 

mg 

Not less than 1 and not more 
than 3 

Not less than 5 and not more 
than 10 

Not   less   than   0.5   and   not    Not less than 1 and not more 
more than 1.5                              than 5. 

Vitamin B6 

mg 

Not less than 0.5 and not more 
than 1.5 

Not less than 1.5 and not more 
than 3 

Not   less   than   0.5   and   not    Not less than 1 and not more 
more than 1.5                              than 3 

Niacinamide 

mg 

Not less than 15 and not more 
than 26 

Not less than 45 and not more 
than 100 

Not less than 5 and not more    Not less than 10 and not more 
than 15                                        than 40. 

d-Pantothenic  mg 
acid or its salts   
and panthenol. 

Not less than 1 and not more 
than 5 

Not less than 5 and not more 
than 50 

Not less than 1 and not more  Not less than 2.5 and not more 
than 3 

than 10 

Folic acid 

mg. 

Not less than 50 and not more 
than 300 

Not less than 1000 and not more  Not   less   than   25   and   not  Not less than 100 and not more 
than 1500 

more than 100 

than 500 

581 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                         Drugs and Cosmetics Rules, 1945 

Drugs and Cosmetics Rules 1945 

1                           2                                         3                           4                                                        5                                                                      6 

Vitamin B12 

mcg 

Not less than 0.5 and not more 
than 1 

Not less than 5 and not more 
than 15 

Not less than 1 and not more 
than 3 

Not less than 1 and not more 
than 5 

Vitamin C            mg        Not less than 25 and not more 

than 50 

Not less than 75 and not more 
than 150 

Not   less   than   20   and   not 
more than 40 

Not less than 30 and not more 
than 80 

Vitamin E            I.U        Not less than 5 and not more 

than 10 

Not  less  than  15  and  not  more 
than 25 

Not   less   than   2.5   and   not 
more than 10 

Not less than 5 and not more 
than 20. 

Notes: 

(1) Patent or proprietary medicines containing vitamins intended for prophylactic, therapeutic or paediatric use shall bear on the label the words ―For 
Prophylactic Use‖ ― For Therapeutic Use,‖ or ―For Paediatric Use‖ as the case may be. In the case of paediatric preparations the age of the infant or 
the child for whose use it is intended, shall be given in addition to the particulars required to be given under these rules. 
(2)The above standards shall not apply to any preparation containing a single vitamin only and also to any preparation containing vitamins intended 
for parenteral use. 
Provided,  however,  that  in  the  case  of  patent  or  proprietary  medicines  containing  vitamins  which  are  intended  for  the  treatment  of  certain  specific 
conditions or diseases, the Licensing Authority specified in clause (b) of rule 21, may permit the addition of vitamins therein in relaxation of the limits 
specified above, if satisfactory evidence is produced in justification of such relaxation. 

1. Subs. by G.S.R. dated 22-12-2009 

582 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[***] 

2[SCHEDULE  X 
[See Rules 23, 61, 75, 97 and 105A] 

Amobarbital                                                    
Glutethimide 
Pentobarbital      
3[Ketamine hydrochloride] 
Amphetamine 
Meprobamate                                                                                        
Phencyclidine 
Barbital   
Methamphetamine 
Phenometrazine 
Cyclobarbital 
4[***] 
5[***] 
Dexamphetamine   
Methylphenidate 
Secobarbital 
Ethclorvynol     
Methylphenobarbital                                                                                                                                

Note: 1. Any stereoisometric form of the substance specified in this Schedule, any salt of the 
substance and preparation containing such substances are also covered by this Schedule. 

2.  Preparations containing the above substances  are also covered by this Schedule.  

Provided,  however,  preparations  containing  Meprobamate 

[***]  in  combination 
with other  drugs  may  be  exempted by  the  Licensing Authority specified in  clause (b)  of  rule 
21,  from  the  provisions  of  this  Schedule,  if  satisfactory  evidence  is  adduced  that  these 
preparations are not liable to be misused.] 

5

1.Omitted by. G.S.R. 94(E) ,dt.   8.5. 2000 
2 Ins. by G.S.R. 462(E) ,dt. 22.6.1982 
3. Ins. by G.S.R. 724(E) ,dt. 07.11.2013 
4. Omitted by G.S.R. 647(E) ,dt. 28.10.1998. 
5.Omitted by. G.S.R. 673(E) ,dt. 27.10.1993. 

583 

 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

1[SCHEDULE Y 
(See rules 122A, 122B, 122D, 122DA, 122DAA and 122E) 

REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR 
MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL 
TRIALS 

1. Application  for  permission.-  (1)  Application  for  permission  to  import  or manufacture 
new  drugs  for  sale  or  to  undertake  clinical  trials  shall  be  made  in  Form  44  accompanied with 
following data in accordance with the appendices, namely:- 

(i)  chemical  and  pharmaceutical  information  as  prescribed  in  item  2  of  Appendix  I;  
(ii) animal pharmacology data as prescribed in item 3 of Appendix I and Appendix IV; 

(a)  specific  pharmacological  actions  as  prescribed  in  item  3.2  of  Appendix  I,  and 

demonstrating,  therapeutic  potential  for  humans   shall  be  described  according  to   
the animal models and species used. Wherever possible, dose-response relationships 
and  ED50s    shall  be  submitted.  Special  studies  conducted  to  elucidate  mode  of 
action  shall also be described (Appendix IV); 

(b)  general  pharmacological  actions  as  prescribed  in  item  3.3  of  Appendix  I  and item 

1.2 of Appendix IV; 

(c)  pharmacokinetic  data    related    to    the    absorption,  distribution,  metabolism  and 
excretion of  the test  substance as prescribed in item 3.5 of Appendix I.   Wherever 
possible, the drug effects shall be corelated to the plasma drug concentrations; 

(iii) animal toxicology data as prescribed in item 4 of Appendix I and Appendix III; 
(iv) human Clinical Pharmacology Data as prescribed in items 5, 6 and 7 of Appendix I 

and as stated below:- 

(a)   for new drug substances discovered in India, clinical trials are required to be carried 
out in India right from Phase I and data should be submitted as required under items 
1, 2, 3, 4, 5 (data, if any, from other countries), and 9 of Appendix I; 

(b)    for  new  drug  substances  discovered  in  countries  other  than  India,  Phase  I  data  as 
required under items  1,  2,  3,  4,  5  (data  from other  countries) and  9  of  Appendix I 
should  be  submitted  along  with  the  application.        After  submission  of      Phase  I 
data generated outside India to the  Licensing Authority, permission may be granted 
to repeat Phase I  trials  and/or to conduct Phase II trials  and subsequently Phase III 
trials concurrently with other global trials for that drug.   Phase III trials are required 
to be conducted in India before permission to market the drug in India is granted; 
(c)    the  data  required  will  depend  upon  the  purpose  of  the  new  drug  application .  The 
number  of  study  subjects  and  sites  to  be  involved  in  the  conduct  of    clinical  trial 
will depend upon the nature and objective of the study. Permission to carry out these 
trials  shall generally be given in stages, considering the data emerging from earlier 
Phase(s); 

(d)  application  for  permission  to  initiate  specific  phase  of  clinical  trial  should  also 
accompany  Investigator‘s  brochure,  proposed  protocol  (Appendix  X),  case  record 
form,  study  subject‘s  informed  consent  document(s) (Appendix  V),    investigator‘s 
undertaking (Appendix VII) and ethics committee clearance, if available (Appendix 
VIII); 

1.  Subs. G.S.R. 32(E), dt. 20.1.2005. 

584 

 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

(e)  reports  of  clinical  studies  submitted  under  items  5-8  of  Appendix  I  should  be  in 
consonance  with  the  format  prescribed  in  Appendix  II  of  this  Schedule.    The  study 
report  shall  be  certified  by  the  Principal  Investigator  or,  if  no  Principal  Investigator  is 
designated, then by each of the Investigators participating in the study.  The  certification  
should  acknowledge  the  contents  of  the  report,  the accurate  presentation  of  the  study 
as  undertaken,  and  express  agreement  with  the  conclusions.  Each  page  should  be 
numbered; 

(v) regulatory  status  in  other  countries  as  prescribed  in  item  9.2  of  Appendix  I, including 
Information in respect of restrictions imposed, if any,  on the use of the drug in  other countries, 
e.g.  dosage  limits,  exclusion  of  certain  age  groups,  warning  about  adverse  drug  reactions,.etc. 
(item  9.2  of  Appendix  I).    Likewise,  if  the  drug  has  been  withdrawn  in  any  country  by  the 
manufacturer or by regulatory authorities, such information  should  also  be  furnished  along  with 
the  reasons  and  their  relevance,  if any, to India. This information must continue to be submitted 
by the sponsor to the Licensing Authority during the course of marketing of the drug in India; 

(vi)  the  full  prescribing  information  should  be  submitted  as  part  of  the  new  drug 
application  for  marketing  as  prescribed  in  item  10  of  Appendix  I.  The  prescribing  information 
(package  insert)  shall  comprise  the  following  sections:  generic  name;  composition;  dosage 
form/s,  indications;  dose  and  method  of  administration;  use  in  special  populations  (such  as 
pregnant women, lactating women, paediatric patients, geriatric patients etc.); contra-indications; 
warnings;  precautions;  drug  interactions;  undesirable  effects;  overdose;  pharmacodynamic  and 
pharmacokinetic      properties;  incompatibilities;  shelf-life;  packaging  information;  storage  and 
handling  instructions.  All  package inserts,  promotional literature  and  patient  education material 
subsequently  produced  are  required  to  be  consistent  with  the  contents  of  the  approved  full 
prescribing information. The  drafts  of  label  and  carton  texts  should  comply  with provisions  of  
rules  96  and  97.  After  submission  and  approval  by  the  Licensing Authority, no changes in 
the  package  insert  shall  be  effected  without  such  changes  being  approved  by  the  Licensing 
Authority; and 

(vii) complete   testing   protocol/s   for   quality   control   testing   together   with   a complete 
impurity profile and release specifications for the product as prescribed in item 11 of Appendix I 
should be submitted as part of new drug application for marketing.  Samples  of  the  pure  drug  
substance  and  finished  product  are  to  be submitted when desired by the regulatory authority. 

(2)   If the study drug is intended to be imported for the purposes of examination,   test or 
analysis,  the application for import of small quantities of drugs for such purpose should also be 
made in Form 12. 

(3)   For drugs indicated in life threatening / serious diseases or diseases of special relevance 
to  the  Indian  health  scenario,  the  toxicological  and  clinical  data  requirements  may  be 
abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority. 

2.  Clinical Trial: 
(1)  Approval for clinical trial 

(i) Clinical trial on a new drug shall be initiated only after the permission has been granted 
by  the      Licensing  Authority  under  rule  21  (b),  and  the  approval  obtained  from  the  respective 
ethics committee (s). The Licensing Authority as defined shall be informed of the approval of the 
respective institutional ethics committee(s) as prescribed in Appendix VIII, and  the  trial  initiated 
at  each  respective  site  only  after  obtaining  such  an  approval  for  that site.     The   trial   site(s)  
may  accept  the approval  granted  to  the  protocol  by  the  ethics committee  of  another  trial 
site  or  the  approval  granted  by  an  independent  ethics  committee (constituted as  per  Appendix 
VIII), provided  
that the approving ethics committee(s) is/are willing to accept their responsibilities for the study 
at  such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the 
protocol version is same at all trial sites. 

(ii)  All  trial  Investigator(s)  should  possess  appropriate  qualifications,  training  and 
experience and should have access to such investigational and treatment facilities as are relevant 

585 

 
 
 
 
 
Drugs and Cosmetics Rules 1945 

to the proposed trial protocol.    A qualified physician (or dentist, when appropriate)  who  is  an  
investigator  or   a   sub-investigator  for   the   trial,   should   be responsible  for  all  trial-related  
medical  (or  dental)  decisions.    Laboratories  used  for generating data for clinical trials should 
be  compliant  with  Good  Laboratory  Practices. If services of  a  laboratory or  a  facilities  outside 
the country are to be availed, its/their name(s), address(s) and specific services to be used should 
be  stated in  the  protocol to avail  Licensing Authority‘s permission to  send  clinical  trial  related 
samples  to  such  laboratory(ies)  and/or    facility(ies).        In    all    cases,    information    about  
laboratory(ies)  / facilities to be used for the trial, if other than those at the investigation site(s), 
should be furnished to the Licensing Authority prior to initiation of trial at such site(s). 

(iii) Protocol  amendments    if  become  necessary  before  initiation  or  during  the course 
of a clinical trial,   all such amendments should be notified to the Licensing Authority in writing 
along with the approval by  the ethics committee which has granted the  approval  for  the  study.   
No  deviations  from  or  changes  to  the  protocol  should  be  implemented  without  prior  written 
approval of the ethics committee and the Licensing Authority  except  when  it  is  necessary  to  
eliminate    immediate    hazards    to    the    trial  Subject(s)  or  when  change(s)  involve(s)  only 
logistic  or  administrative  aspects  of  the trial.  All such exceptions must be immediately notified 
to  the  ethics  committee  as  well  as  to  the  Licensing  Authority.  Administrative  and/or  logistic 
changes in the protocol should be notified to the Licensing Authority within 30 days. 
(2) Responsibilities of Sponsor: 

(i)    The  clinical    trial    Sponsor  is  responsible  for  implementing  and  maintaining 
quality  assurance  systems  to  ensure  that  the  clinical  trial  is  conducted  and  data  generated, 
documented  and  reported  in  compliance  with  the  protocol  and  Good  Clinical  Practice  (GCP)  
Guidelines    issued    by      the      Central    Drugs    Standard    Control    Organization,  Directorate  
General  of  Health  Services,  Government  of  India  as  well  as  with  all applicable statutory 
provisions.    Standard  operating  procedures  should  be  documented  to  ensure  compliance  with 
GCP and applicable regulations. 

(ii)  Sponsors are required to submit a status report on the clinical trial to the Licensing 

Authority at the prescribed periodicity. 

(iii)    In  case  of  studies  prematurely  discontinued  for  any  reason  including  lack  of 
commercial interest in pursuing the new drug application, a summary report should be submitted  
within 3 months.  The summary report should provide a brief description of the study, the number 
of  patients  exposed  to  the  drug,  dose  and  duration  of  exposure,  details      of      adverse      drug   
reactions   (Appendix  XI),   if   any,   and   the   reason   for discontinuation of the study or non-
pursuit of the new drug application; 

1[(iv) Any report of the serious adverse event, after due analysis shall be forwarded by the 
sponsor  to  the  Licensing  Authority  as  referred  to  in  clause  (b)  of  rule  21,  the  Chairman  of  the 
Ethics  Committee  and  the  head  of  the  institution  where  the  trial  has  been  conducted,  within 
fourteen days of the occurrence of the serious adverse event.] 

2[(v) in case of injury or death occurring to the clinical trial subject, the Sponsor (whether 
a  pharmaceutical    company  or  an  Institution)  or  his  representative,  whosoever,  had  obtained 
permission from the Licensing Authority for conduct of the clinical trial, shall make payment for 
medical management of the subject and also provide financial compensation for the clinical trial 
related injury or death in the manner as prescribed  in Appendix XII; 

2[(vi)  the  Sponsor  (whether  a  pharmaceutical    company  or  an  Institution)    or  his 
representative, whosoever had obtained permission from the Licensing Authority for conduct of 
the  clinical  trial,  shall  submit  details  of  compensation  provided  or  paid  for  clinical  trial  related 
injury  or  death,  to  the  Licensing  Authority  within  thirty  days  of  the  receipt  of  the  order  of  the 
Licensing Authority.] 

1. Subs. by G.S.R. 889(E) dated 12-12-2014 
2. Ins. By G.S.R. 53(E) dated 30-1-2013 

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1[(3)(i)] Responsibilities of the Investigator(s): 

Drugs and Cosmetics Rules 1945 

The  Investigator(s)  shall  be  responsible  for  the  conduct  of  the  trial  according  to  the 
protocol  and  the  GCP  Guidelines  and  also  for  compliance  as  per  the  undertaking  given  in 
Appendix  VII.      Standard  operating  procedures  are  required  to  be  documented  by  the 
investigators for the tasks performed by them. During and following a subject‘s participation  in  
a    trial,    the    investigator  should  ensure  that    adequate  medical    care  is  provided  to  the 
participant for any adverse events. Investigator(s) shall report all serious and unexpected adverse 
events  to  the  2[Licensing  Authority  defined  under  clause  (b)  of  rule  21,  the  Sponsor  or  his 
repeesentative, whosoever had obtained permission from the Licensing Authority for conduct of 
the clinical trial, and the Ethics Committee that accorded approval to the study protocol, within 
twenty four hours of their occurance. 3[In case, the Investigator fails to report any serious adverse 
event  within  the  stipulated  period,  he  shall  have  to  furnish  the  reason  for  the  delay  to  the 
satisfaction  of  the  Licensing  Authority  along  with  the  report  of  the  serious  adverse  event.  The 
report of the serious adverse event, after due analysis, shall be forwarded by the Investigator to 
the  Licensing  Authority  as  referred  to  in  clause  (b)  of  rule  21,  the  Chairman  of  the  Ethics 
Committee  and  the  Head  of  the  institution  where  the  trial  has  been  conducted  within  fourteen 
days of the occurrence of the serious adverse event.]]. 
4[(ii)The  Investigator    shall  provide  information  to  the  clinical  trial  subject  through  informed 
consent process as provided in Appendix V about the essential elements of the clinical trial and 
the  subject‘s  right  to  claim  compensation  in  case  of  trial  related  injury  or  death.  He  shall  also 
inform  the  subject  or  his/her  nominees(s)  of  their  rights  to  contact  the  Sponsor  or  his 
representative  whosoever  had  obtained permission from  the  Licensing  Authority  for  conduct  of 
the clinical trial for the purpose of making claims in the case of trial related injury or death.] 

(4) Informed Consent: 

(i)  In  all  trials,  a  freely  given,  informed,  written  consent  is  required  to  be  obtained 
from  each  study  subject. The  Investigator  must  provide  information  about  the  study verbally 
as  well  as  using  a  patient  information  sheet,  in  a  language  that  is  non-technical  and 
understandable by  the  study  subject.   The  Subject‘s consent  must  be  obtained in writing using 
an  ‗Informed  Consent  Form‘.    Both  the  patient  information  sheet  as  well  as  the  Informed 
Consent Form should have been approved by the ethics committee and furnished to the Licensing 
Authority.    Any  changes  in  the  informed  consent  documents  should  be  approved  by  the  ethics 
committee and submitted to the Licensing Authority before such changes are implemented. 

(ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a 
minor  or  those  suffering  from severe  mental  illness  or  disability),  the same   may   be    obtained  
from  a  legally  acceptable  representative  (a  legally acceptable  representative  is  a  person  who 
is able to give consent for or authorize an intervention in the patient as provided by the law(s) of 
India).    If  the  Subject  or  his/her  legally  acceptable  representative  is  unable  to  read/write  –  an 
impartial witness should be present during the entire informed consent process who must append 
his/her signatures to the consent form. 

(iii)  A  checklist  of  essential  elements  to  be  included  in  the  study  subject‘s  informed 
consent document as well as a format for the Informed Consent Form for study Subjects is given 
in Appendix V. 
1. Sub-para (3) renumbered as sub-para, (3)(i) thereof by G.S.R 53(E), dated 30-01-2013. 
2. Subs. by G.S.R. 53(E), dated 30-01-2013. 
3. Subs. by G.S.R. 889(E), dated 12-12-2014. 
4. Ins. by G.S.R. 53(E), dated 30-01-2013. 

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Drugs and Cosmetics Rules 1945 

(5) Responsibilities of the Ethics Committee: 

(i) It is the responsibility of the ethics committee that reviews and accords its approval to 
a  trial  protocol  to  safeguard  the  rights,  safety  and  well  being  of  all  trial  subjects.    The  ethics 
committee  should  exercise  particular  care  to  protect  the  rights,  safety  and  well being  of  all 
vulnerable  subjects  participating  in  the  study,  e.g.,  members  of  a  group  with  hierarchical  
structure  (e.g.  prisoners,  armed  forces  personnel,  staff  and  students  of medical, nursing and 
pharmacy academic  institutions), patients with incurable diseases, umemployed or impoverished 
persons,  patients  in  emergency  situation,  ethnic  minority  groups,  homeless  persons,  nomads, 
refugees,  minors  or  others  incapable  of  personally giving consent. Ethics committee(s) should 
get document ‗standard operating procedures‘ and should maintain a record of its proceedings. 

(ii) Ethics Committee(s) should make, at appropriate intervals, an ongoing review of the 
trials  for  which  they  review  the  protocol(s).      Such  a  review  may  be  based  on  the  periodic 
study progress reports furnished by the investigators and/or monitoring and internal audit reports 
furnished by the Sponsor and/or by visiting the study sites. 

(iii) In case an ethics committee revokes its approval accorded to a trial protocol, it must 
record the  reasons for doing so  and at  once communicate such a  decision to  the Investigator as 
well as to the Licensing Authority. 

1[(iv)  In  case  of  serious  adverse  event  occurring  to  the  clinical  trial  subject,  the  Ethics 
Committee shall forward its report on the serious adverse event, after due analysis, along with its 
opinion  on  the  financial  compensation,  if  any,  to  be  paid  by  the  Sponsor  or  his  representative, 
whosoever had obtained permission from the Licensing Authority as referred to in clause (b) of 
rule  21  for  conducting  the  clinical  trial,  to  the  Licensing  Authority  within  thirty  days  of  the 
occurrence of the serious adverse event. 
2[5(A).  Serious Adverse Events: 

(1) A serious adverse event is an untoward medical occurrence during clinical trial that is 
associated with death, in patient hospitalization (in case the study was being conducted  on out- 
patient),  prolongation  of  hospitalization (in  case the study  was  being  conducted    on in-patient), 
persistent  or  significant  disability  or  incapacity,  a  congenital  anomaly  or  birth  defect  or  is 
otherwise life threatening. 

(2)  The  Investigator  shall  report  all  serious  3[***]  adverse  events  to  the  Licensing 
Authority  as  defined under  clause  (b)  of  Rule 21, the  Sponsor  or  his  representative,  whosoever 
had  obtained  permission  from  the  Licensing  Authority  for  conduct  of  the  clinical  trial  and  the 
Ethics Committee that accorded approval to the study protocol, within twenty four hours of their 
occurrence  as  per  Appendix  XI  and  the  said  Licensing  Authority  shall  determine  the  cause  of 
injury or death as per the procedure prescribed under Appendix XII and pass orders as deemed 
necessary. 4[In case, the Investigator fails to report any serious adverse event within the stipulated 
period,  he  shall  have  to  furnish  the  reason  for  the  delay  to  the  satisfaction  of  the  Licensing 
Authority along with the report of the serious adverse event. 

1. Subs. by G.S.R. 889(E) dated 12-12-2014. 
2. Ins. by G.S.R. 53(E) dated 30-01-2013. 
3. The words ―and unexpected‖omitted by G.S.R. 889(E) dated 12-12-2014. 
4. Ins. by G.S.R. 889 (E) dated 12-12-2014. 

588 

 
 
 
 
 
 
 
(6) Human Pharmacology (Phase I): 

Drugs and Cosmetics Rules 1945 

(i) The objective of studies in this Phase is the estimation of safety and tolerability with 
the initial administration of an investigational new drug into human(s).   Studies in this Phase of 
development usually have non-therapeutic objectives and may be conducted in healthy volunteers 
subjects or certain types of patients. Drugs with significant potential toxicity e.g. cytotoxic drugs 
are usually  studied in  patients.    Phase I  trials  should preferably be carried out by  Investigators 
trained  in  clinical  pharmacology  with  access  to  the  necessary  facilities  to  closely  observe  and 
monitor the Subjects. 

(ii)  Studies  conducted  in  Phase  I,  usually  intended  to  involve  one  or  a  combination of 

the following objectives:- 

(a) Maximum tolerated dose:   To  determine the  tolerability  of  the  dose  range expected 
to  be  needed  for  later  clinical  studies  and  to  determine  the  nature  of adverse  reactions  that  
can  be  expected.  These  studies  include  both  single  and multiple dose administration. 

(b)  Pharmacokinetics,  i.e.,  characterization  of  a  drug's  absorption,  distribution, 
metabolism  and  excretion.  Although  these  studies  continue  throughout  the  development  plan, 
they   should  be  performed  to  support  formulation  development and determine pharmacokinetic 
parameters in different age groups to support dosing recommendations. 

(c)  Pharmacodynamics:  Depending    on    the    drug    and    the    endpoints    studied, 
pharmacodynamic  studies  and  studies  relating 
levels  (pharmacokinetic/ 
pharmacodynamic  studies)  may  be  conducted  in  healthy  volunteer  Subjects  or  in  patients with 
the target disease. If there are appropriate validated indicators of activity and  potential  efficacy, 
pharmacodynamic  data  obtained  from  patients  may  guide  the  dosage  and  dose  regimen  to  be 
applied in later studies. 

to  drug  blood 

(d) Early  Measurement  of  Drug  Activity:  Preliminary  studies  of  activity  or potential 
therapeutic  benefit  may  be  conducted  in  Phase  I  as  a  secondary  objective.  Such  studies  are 
generally  performed  in  later  Phases  but  may  be  appropriate  when  drug  activity  is  readily 
measurable with a short duration of drug exposure in patients at this early stage. 

(7) Therapeutic exploratory trials (Phase II): 

(i) The primary objective of Phase II trials  is to evaluate the effectiveness of a drug for a 
particular indication or indications in patients with the condition under study and to determine the 
common short-term side-effects and risks associated with the drug. Studies in Phase II should be 
conducted  in  a  group  of  patients  who  are  selected  by  relatively  narrow  criteria  leading  to  a 
relatively homogeneous population. These studies   should be closely  monitored.    An  important 
goal  for  this  Phase  is  to  determine  the  dose(s)  and regimen for Phase III trials.  Doses used in 
Phase II are usually (but not always) less than the highest doses used in Phase I. 

(ii) Additional  objectives  of  Phase  II  studies  can  include  evaluation  of  potential study 
endpoints, therapeutic regimens (including concomitant medications) and target populations (e.g. 
mild versus severe disease) for further studies in Phase II or III. These objectives may be served 
by exploratory analyses, examining subsets of data and by including multiple endpoints in trials. 

(iii)  If the application is for conduct of clinical  trials as a  part of multi-national clinical 
development  of  the  drug,  the  number  of  sites  and  the  patients  as  well  as  the  justification  for 
undertaking such trials in India shall   be provided to the Licensing Authority. 

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 (8) Therapeutic confirmatory trials (Phase III): 

Drugs and Cosmetics Rules 1945 

(i)  Phase  III  studies  have  primary  objective  of  demonstration  or  confirmation  of 
therapeutic  benefit(s).      Studies  in  Phase  III  are  designed  to  confirm  the  preliminary  evidence 
accumulated in  Phase II  that  a  drug  is  safe and  effective for  use in  the intended indication and 
recipient  population.  These  studies  should  be      intended  to  provide  an  adequate  basis  for 
marketing approval. Studies in Phase III may also further explore the dose-response relationships 
(relationships among dose, drug concentration in blood and clinical response),  use of the drug in 
wider  populations,  in  different  stages  of  disease,  or  the  safety  and  efficacy  of  the  drug  in 
combination with other drug(s). 

(ii)    For  drugs  intended  to  be  administered  for  long  periods,  trials  involving  extended 
exposure  to  the  drug  are  ordinarily  conducted  in  Phase  III,  although  they  may  be  initiated  in 
Phase  II.  These  studies  carried  out  in  Phase  III  complete  the  information  needed  to  support 
adequate instructions for use of the drug (prescribing information). 

(iii)    For  new  drugs  approved  outside  India,  Phase  III  studies  need  to  be  carried  out 
primarily to generate evidence of efficacy and safety of the drug in Indian patients when used  as 
recommended  in  the  prescribing  information.    Prior  to  conduct  of  Phase  III studies in Indian 
subjects, Licensing Authority may require pharmacokinetic studies to be undertaken to verify that 
the data generated in Indian population is in conformity with the data already generated abroad. 

(iv)    If  the  application  is  for  the  conduct  of  clinical  trials  as  a  part  of  multi-national 
clinical development of the drug, the number of sites and patients as well as the justification for 
undertaking  such  trials  in  India  should  be  provided  to  the  Licensing  Authority  along  with  the 
application. 

(9)  Post Marketing Trials  (Phase IV): 

Post  Marketing  trials  are  studies  (other  than  routine  surveillance)  performed  after  drug 
approval  and  related  to  the  approved  indication(s).    These  trials  go  beyond  the  prior 
demonstration  of  the  drug‘s  safety,  efficacy  and  dose  definition.    These  trials  may  not  be 
considered  necessary  at  the  time  of  new  drug  approval  but  may  be  required  by  the  Licensing 
Authority  for  optimizing  the  drug's  use.  They  may  be  of  any  type  but  should  have      valid   
scientific    objectives.   Phase   IV   trials   include   additional   drug-drug interaction(s), dose-
response or safety studies and trials designed to support use under the approved indication(s), e.g. 
mortality/morbidity studies, epidemiological studies etc. 

3.  Studies in special populations: 

Information supporting the use of the drug in children, pregnant women, nursing women, 
elderly  patients,  patients  with  renal  or  other  organ  systems  failure,  and  those  on  specific 
concomitant  medication  is  required  to  be  submitted  if  relevant  to  the  clinical  profile  of  the 
drug and its anticipated usage pattern. Any claim sought to be made for the drug product that is 
not  based  on  data  submitted  under  preceding  items  of  this  Schedule  should  be  supported  by 
studies included under this item of the Schedule  (Appendix I, item 8.3). 
(1) Geriatrics: 

Geriatric patients should be included in Phase III clinical trials (and in Phase II trials, at 

the Sponsor's option) in meaningful numbers, if- 

(a) the disease intended to be treated is characteristically a disease of aging; or 
(b) the  population  to  be  treated  is  known  to  include  substantial  numbers  of geriatric 

patients; or 

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(c) when  there  is  specific  reason  to  expect  that  conditions  common  in  the elderly are 

likely to be encountered; or 

(d) when  the  new  drug  is  likely  to  alter  the  geriatric  patient's  response  (with regard to 

safety or efficacy) compared with that of the non-geriatric patient. 

(2) Paediatrics: 

(i) The timing of paediatric studies in the new drug development program will depend on 
the  medicinal  product, the type of disease being treated, safety considerations, and  the  efficacy 
and  safety  of  available  treatments.   For  a  drug  expected  to  be  used  in children,  evaluations 
should be made in the appropriate age group. When clinical development is to include studies in 
children,  it  is  usually  appropriate  to  begin  with  older  children  before  extending  the  trial  to 
younger children and then infants. 

(ii)  If  the  new  drug  is  for  diseases  predominantly  or  exclusively  affecting  paediatric 
patients,  clinical  trial  data  should  be  generated  in  the  paediatric  population  except  for  initial 
safety  and  tolerability  data,  which  will  usually  be  obtained  in  adults  unless  such  initial  safety 
studies in adults would yield little useful information or expose them to inappropriate risk. 

(iii)    If    the    new    drug    is    intended    to    treat    serious    or    life-threatening  diseases, 
occurring  in  both  adults  and  paediatric  patients,  for  which  there  are  currently  no  or limited 
therapeutic options, paediatric population should be included in the clinical trials early, following 
assessment of  initial  safety  data  and  reasonable evidence  of  potential benefit.  In  circumstances 
where this is not possible, lack of data should be justified in detail. 

(iv)  If  the  new  drug  has  a  potential  for  use  in  paediatric  patients  –  Paediatric  studies 
should  be  conducted.    These  studies  may  be  initiated  at  various  phases  of  clinical 
development  or after  post  marketing survelliance in  adults  if  a  safety  concern exists.    In  cases 
where  there  is  limited  paediatric  data  at  the  time  of  submission  of  application  –  more  data  in 
paediatric patients would be expected after marketing authorisation for use in children is granted. 

(v) The paediatric studies should include –  

(a)   clinical trials, 
(b)    relative  bioequivalence comparisons of  the  paediatric formulation with  the 

adult formulation performed in adults, and 

(c)  definitive pharmacokinetic studies for dose selection across the age ranges of 
paediatric  patients  in  whom  the  drug  is  likely  to  be  used.      These  studies 
should  be  conducted  in  the  paediatric  patient  population  with  the  disease 
under study. 

(vi)  If  the  new  drug  is  a  major  therapeutic advance  for  the  paediatric  population  –  the 
studies should begin early  in the drug development , and this data should be submitted with the 
new drug application. 

(vii) Paediatric Subjects are legally unable to provide written informed consent, and   are 
dependent  on  their  parent(s)/  legal  guardian  to  assume  responsibility  for  their  participation  in 
clinical  studies.  Written  informed  consent  should  be  obtained  from  the  parent/  legal  guardian. 
However,  all  paediatric  participants should  be  informed  to  the  fullest  extent  possible  about  the 
study  in  a  language  and  in  terms  that  they  are  able  to  understand.  Where  appropriate, 
paediatric  participants  should  additionally  assent  to  enrol  in  the  study.  Mature  minors  and 
adolescents    should  personally  sign  and  date  a  separately  designed  written  assent  form. 
Although  a  participant‘s  wish  to  withdraw  from  a  study  must  be  respected,  there  may  be 
circumstances  in  therapeutic  studies  for  serious  or  life-threatening  diseases  in  which,  in  the 
opinion of the Investigator and parent(s)/ legal guardian, the welfare of a pediatric patient would 

591 

 
 
 
 
Drugs and Cosmetics Rules 1945 

be  jeopardized  by  his  or  her  failing  to  participate  in  the  study.  In  this  situation, continued 
parental/ legal guardian consent should be sufficient to allow participation in the study. 

(viii)  For  clinical  trials  conducted  in  the  paediatric  population,  the  reviewing  ethics 
committee should include members who are knowledgeable about pediatric, ethical, clinical and 
psychosocial issues. 
(3) Pregnant or nursing women: 

(i) Pregnant or nursing women should be included in clinical trials only when the drug is 
intended  for  use  by  pregnant/nursing  women  or  foetuses/nursing  infants  and  where  the  data 
generated from women who are not pregnant or nursing, is not suitable. 

(ii)  For  new  drugs  intended  for  use  during  pregnancy,  follow-up  data  (pertaining  to  a 

period  appropriate  for    that    drug)  on    the    pregnancy,  foetus  and    child    will    be    required.    
Where applicable, excretion of the drug or its  metabolites into human milk should be examined 
and the infant should be monitored for predicted pharmacological effects of the drug. 
1[(4)   Post Marketing Surveillance: 

(i)  The  applicant  shall  have  a  pharmacovigilance  system  in  place  for  collecting, 
processing  and  forwarding  the  report  to  the  licensing  authority  for  information  on 
adverse drug reactions emerging from the use of the drug manufactured or marketed by 
the applicant in the country.  

(ia) The system shall be managed by qualified and trained personnel and the officer in-
charge of collection and processing of data shall be a medical officer or a pharmacist 
trained in collection and analysis of adverse drug reaction reports.  

(ib)  Subsequent to approval  of  the  product,  new  drug  shall  be  closely  monitored  for  its 

clinical safety once it is marketed.  

(ic) The applicant shall furnish Periodic Safety Update Reports (PSURs) in order to- 
(a)  report all the relevant new information from appropriate sources;  
(b)  relate these data to patient exposure ; 
(c)  summarize  the   market  authorization  status  in  different  countries  and  
any significant variations related to safety; and 
(d)  indicate  whether changes should be made to product information in order to 
optimize the use of the product. 

(ii)   Ordinarily  all  dosage  forms  and  formulations as  well  as  indications for  new  drugs 
should  be  covered  in  one  PSUR.  Within  the  single  PSUR  separate  presentations  of  data  for 
different dosage forms, indications or separate population need to be given. 

(iii)   All relevant clinical and non-clinical safety data should cover only the period of the 
report (interval data). The PSURs shall be submitted every six months for the first two years after 
approval of the drug is granted to the applicant.  For subsequent two years – the PSURs need  to  
be  submitted  annually.  Licensing  authority  may  extend  the  total  duration  of submission of 
PSURs if it is considered necessary in the interest of public health.  PSURs due for a period must 
be submitted within 30 calendar days of the last day of the reporting period.  
However,  all  cases  involving  serious  unexpected  adverse  reactions  must  be  reported  to  the 
licensing  authority  within  15  days  of  initial  receipt  of  the  information  by  the  applicant.    If 
marketing of  the new  drug is  delayed by  the  applicant  after  obtaining approval to  market, such 
data  will  have  to  be  provided  on  the  deferred  basis  beginning  from  the  time  the  new  drug  is 
marketed. 

(iv)   New studies specifically planned or conducted to examine a safety issue should be 

described in the PSURs. 
1. Subs. by G.S.R. 287(E) dated 08-03-2016. 

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(v)  A PSUR should be structured as follows: 

Drugs and Cosmetics Rules 1945 

(a) A title page stating: Periodic safety update report for the product, applicant‘s 
name,  period  covered  by  the  report,  date  of  approval  of  new  drug,  date  of 
marketing of new drug and  date of reporting; 
(b) Introduction, 
(c) Current worldwide market authorization status,  
(d) Update of actions taken for safety reasons, 
(e)  Changes to reference safety information,  
(f)  Estimated patient exposure, 
(g) Presentation of individual case histories,  
(h) Studies, 
(i)  Other information, 
(j)  Overall safety evaluation,  
(k)  Conclusion, 
(l)    Appendix  providing  material  relating  to  indications,  dosing,  pharmacology 
and other related information. 

(5)  Special studies: Bioavailability / Bioequivalence Studies: 

(i) For drugs approved elsewhere in the world and absorbed systemically, bioequivalence 
with the reference formulation should be carried out wherever applicable.   These studies should 
be  conducted  under  the  labelled  conditions  of  administration.  Data  on  the  extent  of  systemic 
absorption may be required for formulations other than those designed for systemic absorption. 

(ii) Evaluation of the effect of food on absorption following oral administration should be 
carried  out.    Data  from  dissolution  studies  should  also  be  submitted  for  all  solid  oral  dosage 
forms. 

(iii)  Dissolution  and  bioavailability  data  submitted  with  the  new  drug  application  must 
provide  information  that    assures  bioequivalence  or    establishes  bioavailability  and  dosage 
correlations between the  formulation(s) sought to  be  marketed and those  used  for  clinical  trials 
during clinical development of the product.  (See items 8.1, 8.2 and 8.3 of Appendix  I). 

(iv) All bioavailability and bioequivalence studies should be conducted according to the 

Guidelines for Bioavailability and Bioequivalence studies as prescribed. 

Note.-    The    data    requirements  stated    in    this    Schedule  are    expected  to    provide 
adequate information to  evaluate the  efficacy, safety  and  therapeutic rationale of  new  drugs  (as 
defined under  rule  122-E)  prior  to  the  permission for  sale.   Depending upon  the  nature  of  new 
drugs and  disease(s), additional information may  be  required by  the  Licensing Authority.   The 
applicant  shall  certify  the  authencity  of  the  data  and  documents  submitted  in  support  of  an 
application for  new  drug.    The  Licensing Authority reserves the  right to  reject  any  data  or  any 
document(s) if such data or contents of such documents are found to be of doubtful integrity. 

APPENDIX I 

DATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO CONDUCT 
CLINICAL TRIALS/IMPORT/MANUFACTURE OF NEW DRUGS FOR MARKETING IN 
THE COUNTRY 

1.  Introduction 

A brief description of the drug and the therapeutic class to which it belongs. 

2.  Chemical and pharmaceutical information 

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2.1. Information on active ingredients 

Drug information (Generic Name, Chemical Name or  INN) 

Drugs and Cosmetics Rules 1945 

2.2. Physicochemical Data 

(a)  Chemical name and Structure 

Empirical formula 
Molecular weight 

(b)  Physical properties  
Description  
Solubility 
Rotation 
Partition coefficient 
Dissociation constant 

2.3. Analytical Data  

Elemental analysis  

  Mass spectrum  

NMR spectra 
IR spectra 
UV spectra 
Polymorphic identification 

2.4. Complete monograph specification including 

Identification 
Identity/quantification of impurities 
Enantiomeric purity 
Assay 
2.5. Validations 

Assay method 
Impurity estimation method 
Residual solvent/other volatile impurities (OVI) estimation method 

2.6.  Stability Studies (for details refer Appendix IX)  

Final release specification 
Reference standard characterization 

  Material safety data sheet 
2.7. Data on Formulation  

Dosage form  
Composition 
Master manufacturing formula 
Details of the formulation (including inactive ingredients)  
In process quality control check  
Finished product specification  
Excipient compatibility study  
Validation of the analytical method 
Comparative  evaluation  with  international  brand(s)  or  approved  Indian  brands, 
if applicable 

Pack presentation 
Dissolution  
Assay  
Impurities 

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Content uniformity  
pH 

Force degradation study 
Stability evaluation in market intended pack at proposed storage conditions 
Packing specifications 
Process validation 

When  the  application  is  for  clinical  trials  only,  the  international  non-proprietary  name 
(INN)  or  generic  name,  drug  category,  dosage  form  and  data  supporting  stability    in  the 
intended  container-closure system  for  the  duration  of  the  clinical  trial  (information  covered  in 
item nos. 2.1, 2.3, 2.6, 2.7) are required. 
3. Animal Pharmacology (for details refer Appendix IV) 

3.1. Summary 
3.2. Specific pharmacological actions 
3.3. General pharmacological actions 
3.4. Follow-up and Supplemental Safety Pharmacology Studies 
3.5. Pharmacokinetics: absorption, distribution; metabolism; excretion 

4. Animal Toxicology (for details refer Appendix III) 

4.1. General Aspects 
4.2. Systemic Toxicity Studies 
4.3. Male Fertility Study 
4.4. Female Reproduction and Developmental Toxicity Studies 
4.5. Local toxicity 
4.6. Allergenicity/Hypersensitivity 
4.7. Genotoxicity 
4.8. Carcinogenicity 

1[Note.-  Where  the  data  on  animal  toxicity  as  per  the  specifications  of  Appendix  III  has  been 
submitted and the same has been considered by the regulatory authority of the country which had 
earlier approved the drug, the animal toxicity studies shall not be required to be conducted in India 
except in cases where there are specific concerns recorded in writing.] 

5.  Human / Clinical pharmacology (Phase I) 

5.1. Summary 
5.2. Specific Pharmacological effects 
5.3. General Pharmacological effects 
5.4. Pharmacokinetics, absorption, distribution, metabolism, excretion 
5.5. Pharmacodynamics / early measurement of drug activity 

6. Therapeutic exploratory trials (Phase II) 

6.1. Summary 
6.2. Study report(s) as given in Appendix II 

7.  Therapeutic confirmatory trials (Phase III) 

7.1. Summary 
7.2. Individual study reports with listing of sites and Investigators. 

8.  Special studies 

8.1. Summary 
8.2. Bio-availability / Bio-equivalence. 
8.3. Other studies e.g. geriatrics, paediatrics, pregnant or nursing women 

1. Subs. by G.S.R. 313(E) dated 16-03-2016. 

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9.  Regulatory status in other countries 

9.1. Countries where the drug is  
a. Marketed 
b. Approved 
c. Approved as IND 
d. Withdrawn, if any, with reasons 

9.2. Restrictions on use, if any, in countries where marketed /approved 
9.3. Free sale certificate or certificate of analysis, as appropriate. 

10.  Prescribing information 

10.1. Proposed full prescribing information 

11.  Samples and Testing Protocol/s 

11.1.  Samples  of  pure  drug  substance  and  finished  product  (an  equivalent  of  50  clinical 
doses,  or  more  number  of  clinical  doses  if  prescribed  by  the  Licensing  Authority),  with 
testing protocol/s, full impurity profile and release specifications. 

1[12. New Chemical Entity and Global Clinical Trial: 

12.1 Assessment of risk versus benefit to the patients 
12.2 Innovation vis-à-vis existing therapeutic option 
12.3 Unmet medical need in the country.] 

NOTES: 

(1)  All items may not be applicable to all drugs. For explanation, refer text of Schedule Y. 
(2)   For  requirements of data to be submitted with application for clinical trials refer text 

of   this Schedule. 

APPENDIX IA 

DATA REQUIRED TO BE SUBMITTED BY AN APPLICANT FOR GRANT OF 
PERMISSION TO IMPORT AND / OR MANUFACTURE A  NEW DRUG ALREADY 
APPROVED IN THE COUNTRY 

1. Introduction 

A brief description of the drug and the therapeutic class 

2. Chemical and pharmaceutical information 

2.1. Chemical  name,  code  name  or  number,  if  any;  non-proprietary  or  generic  name,  if 
any, structure; physico-chemical properties 
2.2. Dosage form and its composition 
2.3. Test specifications  

(a) active ingredients  
(b) inactive ingredients 

2.4  Tests for identification of the active ingredients and method of its assay 
2.5  Outline of the method of manufacture of active ingredients 
2.6  Stability data 

1. Ins. by G.S.R. 826 (E), dt. 30-10-2015. 

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3. Marketing information 
3.1 Proposed package insert / promotional literature 
3.2  Draft specimen of the label and carton 

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4. Special studies conducted with approval of Licensing Authority 
4.1 Bioavailability / Bioequivalence and comparative dissolution studies for oral dosage forms 
4.2 Sub-acute animal toxicity studies for intravenous infusions and injectables. 

1[APPENDIX I B 

DATA TO BE SUBMITTED ALONG WITH APPLICATION TO CONDUCT CLINICAL 
TRIAL OR IMPORT OR MANUFACTURE OF A PHYTOPHARMACEUTICAL DRUG IN 
THE COUNTRY 

1. Data to be submitted by the applicant:  

PART - I 

1.1. A brief description or summary of the phytopharmaceutical drug giving the botanical name of 
the  plant  (including  vernacular  or  scriptural  name,  wherever  applicable),  formulation  and  route  of 
administration, dosages, therapeutic class for which it is indicated and the claims to be made for the 
phytopharmaceutical product.  

1.2. Published literature including information on plant or product or phytopharmaceutical drug, as a 
traditional medicine or as an ethno medicine and provide reference to books and other documents, 
regarding  composition,  process  prescribed,  dose  or  method  of  usage,  proportion  of  the  active 
ingredients in such traditional preparations per dose or per day‘s consumption and uses.  

1.3.  Information  on  any  contraindications,  side  effects  mentioned  in  traditional  medicine  or  ethno 
medicine literature or reports on current usage of the formulation.  

1.4.  Published  scientific  reports  in  respect  of  safety  and  pharmacological  studies  relevant  for  the 
phytopharmaceutical drug intended to be marketed,-  

(a) where the process and usages are similar or same to the product known in traditional medicine or 
ethno medicine; and  

(b) where process or usage is different from that known in traditional medicine or ethno medicine.  

1.5. Information on any contraindications, side effects mentioned or reported in any of the studies, 
information  on  side  effects  and  adverse  reactions  reported  during  current  usage  of  the 
phytopharmaceutical in the last three years, wherever applicable.  

1.6. Present usage of the phytopharmaceutical drug, – to establish history of usages, provide details 
of the product, manufacturer, quantum sold, extent of exposure on human population and number of 
years for which the product is being sold.  

2. Human or clinical pharmacology information:  

2.1.  Published  scientific  reports  in  respect  of  pharmacological  studies  including  human  studies  or 
clinical studies or epidemiological studies, relevant for the phytopharmaceutical drug intended to be 
marketed,-  

(a) where the process and usages are similar or same to the product known in traditional medicine or 
ethno medicine; and  

(b) where process or usage is different from that known in traditional medicine or ethno medicine.  

2.2. Pharmacodynamic information (if available).  

2.3.  Monographs,  if  any,  published  on  the  plant  or  product  or  extract  or  phytopharmaceutical. 
(Copies of all publications, along with english translation to be attached.)  

1. Ins. by G.S.R. 918 (E), dt. 30-11-2015. 

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PART – II 

Data generated by applicant 

3. Identification, authentication and source of plant used for extraction and fractionation:  

3.1.  Taxonomical  identity  of  the  plant  used  as  a  source  of  the  phytopharmaceutical  drug  giving 
botanical name of genus, species and family, followed by the authority citation (taxonomist‘s name 
who named the species), the variety or the cultivar (if any) needs to be mentioned. 

3.2  Morphological  and  anatomical  description  giving  diagnostic  features  and  a  photograph  of  the 
plant  or  plant  part  for  further  confirmation  of  identity  and  authenticity.  (Furnish  certificate  of 
confirmation of botanical identity by a qualified taxonomist).  

3.3 Natural habitat and geographical distribution of the plant and also mention whether the part of 
the plant used is renewable or destructive and the source whether cultivated or wild.  

3.4 Season or time of collection.  

3.5 Source of the plant including its geographical location and season or time of collection.  

3.6 A statement indicating whether the species is any of the following, namely:-  

(a) determined to be endangered or threatened under the Endangered Species Act or the Convention 
on International Trade in Endangered species (CITES) of wild Fauna and Flora;  

(b)  entitled  to  special  protection  under  the  Biological  Diversity  Act,  2002  (18  of  2003);  (c)  any 
known genotypic, chemotypic and ecotypic variability of species.  

3.7. A list of grower or supplier (including names and addresses) and information on the following 
items for each grower or supplier, if available or identified already, including information of primary 
processing, namely:-  

(a) harvest location;  

(b) growth conditions;  

(c) stage of plant growth at harvest;  

(d) harvesting time;  

(e) collection, washing, drying and storage conditions;  

(f) handling, garbling and transportation;  

(g) grinding, pulverising of the plant material; and  

(h) sieving for getting uniform particle size of powdered plant material.  

3.8. Quality specifications, namely:-  

(a) foreign matter;  

(b) total ash;  

(c) acid insoluble ash;  

(d) pesticide residue;  

(e) heavy metal contamination;  

(f) microbial load;  

(g) chromatographic finger print profile with phytochemical reference marker;  

(h) assay for bio-active or phytochemical compounds; and  

(i)  chromatographic  fingerprint  of  a  sample  as  per  test  method  given  under  quality  control  of  the 
phytopharmaceutical drug (photo documentation).  

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3.9  .  An  undertaking  to  supply  specimen  sample  of  plant  duly  labeled  and  photocopy  of  the 
certificate  of  identity  confirmation  issued  by  a  qualified  taxonomist  along  with  drawings  or 
photographs of the diagnostic morphological and histological features of the botanical raw material 
used for the confirmation of authenticity.  

Drugs and Cosmetics Rules 1945 

4. Process for extraction and subsequent fractionation and purification:  

4.1. Quality specifications and test methods for starting material.  

4.2. Steps involved in processing.  

(a) details of solvent used, extractive values, solvent residue tests or limits, physico-chemical tests, 
microbial loads, heavy metal contaminants, chromatographic finger print profile with phytochemical 
reference  markers,  assay  for  active  constituents  or  characteristic  markers,  if  active  constituents  are 
not known;  

(b) characterisation of final purified fraction;  

(c) data on bio-active constituent of final purified fraction;  

(d) information on any excipients or diluents or stabiliser or preservative used, if any.  

4.3.  Details  of  packaging  of  the  purified  and  characterised  final  product,  storage  conditions  and 
labeling. 

5. Formulation of phytopharmaceutical drug applied for:  

5.1.  Details  of  the  composition,  proportion  of  the  final  purified  fraction  with  defined  markers  of 
phytopharmaceutical drug per unit dose, name and proportions of all excipients, stabilisers and any 
other agent used and packaging materials.  

5.2. Test for identification for the phytopharmaceutical drug.  

5.3. Quality specifications for active and inactive phytopharmaceutical chromatographic finger print 
profile  with  phytochemical  reference  marker  and  assay  of  active  constituent  or  characteristic 
chemical marker.  

6. Manufacturing process of formulation:  

6.1.  The  outline  of  the  method  of  manufacture  of  the  dosage  form,  along  with  environmental 
controls, in-process quality control tests and limits for acceptance.  

6.2. Details of all packaging materials used, packing steps and description of the final packs.  

6.3.  Finished  product‘s  quality  specifications,  including  tests  specific  for  the  dosage  form,  quality 
and chromatographic finger print profile with phytochemical reference marker and assay for active 
constituent or characteristic marker, if active constituents are not known.  

7. Stability data:  

7.1. Stability data of the phytopharmaceutical drug described at 4 above, stored at room temperature 
at 40 +/- 2 deg. C and humidity at 75%RH +/- 5%RH for 0, 1, 2, 3 and 6 months.  

7.2  Stability  data  of  the  phytopharmaceutical  drug  in  dosage  form  or  formulation  stored  at  room 
temperature at 40 +/- 2 deg. C and humidity at 75%RH +/- 5%RH for 0, 1, 2, 3 and 6 months, in the 
pack intended for marketing.  

8. Safety and pharmacological information:  

8.1. Data on safety and pharmacological studies to be provided.  

8.2. Animal toxicity and safety data:  

(a) 28 to 90 days repeat dose oral toxicity on two species of animals;  

(b) In-vitro genotoxicity data (Ame‘s test and Chromosomal aberration test as per Schedule Y);  

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(c) dermal toxicity tests for topical use products;  

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(d) teratogenicity study (only if phytopharmaceutical drug is intended for use during pregnancy).  

9. Human studies:  

9.1.  Clinical  trials  for  phytopharmaceutical  drugs  to  be  conducted  as  per  applicable  rules  and 
guidelines for new drugs.  

9.2. For all phytopharmaceutical drugs data from phase I (to determine maximum tolerated dose and 
associated toxicities) and the protocols shall be submitted prior to performing the studies.  

9.3. Data of results of dose finding studies performed and the protocols shall be submitted prior to 
performing the studies: Provided that in the case of phytopharmaceutical drug already marketed for 
more  than  five  years  or  where  there  is  adequate  published  evidence  regarding  the  safety  of  the 
phytopharmaceutical drug, the studies may be abbreviated, modified or relaxed.  

10. Confirmatory clinical trials:  

10.1.  Submit  protocols  for  approval  for  any  specific or  special  safety  and  efficacy  study  proposed 
specific to the phytopharmaceutical drug.  

10.2.  Submit  proposed  protocol  for  approval  for  human  clinical  studies  appropriate  to  generate  or 
validate  safety  and  efficacy  data  for  the  phytopharmaceutical  dosage  form  or  product  as  per 
applicable rules and guidelines.  

10.3.  Submit  information  on  how  the  quality  of  the  formulation  would  be  maintained  during  the 
above studies.  

11. Regulatory status:  

11.1.  Status  of  the  phytopharmaceutical  drug  marketed  in  any  country  under  any  category  like 
functional food or dietary supplement or as traditional medicine or as an approved drug.  

12. Marketing information:  

12.1.  Details  of  package  insert  or  patient  information  sheet  of  the  phytopharmaceutical  drug  to  be 
marketed.  

12.2. Draft of the text for label and carton.  

13. Post marketing surveillance (PMS):  

13.1.  The  applicant  shall  furnish  periodic  safety  update  reports  every  six  months  for  the  first  two 
years after approval the drug is granted.  

13.2. For subsequent two years the periodic safety update reports need to be submitted annually.  

14. Any other relevant information:  

Any other relevant information which the applicant considers that it will help in scientific evaluation 
of the application.] 

APPENDIX II 

STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL STUDY REPORTS 

1.   Title Page: 

This page should contain information about the title of the study, the protocol code, name of the 
investigational product tested, development Phase, indication studied, a brief description of  the trial 
design,  the start and end date of patient accrual and the names of the Sponsor and the participating 
Institutes (Investigators). 

2. Study Synopsis (1 to 2 pages): 

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A brief overview of the study from the protocol development to the trial closure should be given 

here. This section will only summarize the important conclusions derived from the study. 

Drugs and Cosmetics Rules 1945 

3. Statement of compliance with the ‗Guidelines for Clinical Trials on Pharmaceutical 

Products in India : 
GCP  Guidelines‘ issued by the Central Drugs Standard Control Organization, Ministry of 

Health, Government of India. 

4. List of Abbreviations and Definitions 

5. Table of contents 

6. Ethics Committee: 

This  section  should  document  that  the  study  was  conducted  in  accordance  with  the  ethical 
principles  of  Declaration  of  Helsinki.  A  detailed  description  of  the  Ethics  Committee  constitution 
and  date(s)  of  approvals  of  trial  documents  for  each  of  the  participating  sites  should  be 
provided.    A  declaration  should  state  that  EC  notifications  as  per    Good  Clinical  Practice  
Guidelines  issued  by  Central  Drugs  Standard  Control  Organization  and  Ethical Guidelines for 
Biomedical Research on Human Subjects, issued by Indian Council of Medical Research have been 
followed. 

7.  Study Team: 

Briefly describe the administrative structure of the study (Investigators, site staff, Sponsor/ 

designates, Central laboratory etc). 

8.   Introduction: 

A brief description of the product development rationale should be given here. 

9. Study Objective: 

A  statement  describing  the  overall  purpose  of  the  study  and  the  primary  and  secondary 

objectives to be achieved should be mentioned here. 

10. Investigational Plan: 

This section should describe the overall trial  design, the Subject selection criteria, the treatment 
procedures, blinding /  randomization techniques if any, allowed/ disallowed concomitant treatment, 
the  efficacy  and  safety  criteria  assessed,  the  data  quality  assurance  procedures  and  the  statistical 
methods planned for the analysis of the data obtained. 

11. Trial Subjects: 

A clear accounting of all trial Subjects who entered the study will be given here. Mention should 
also  be  made  of  all  cases  that  were  dropouts  or  protocol  deviations.    Enumerate  the  patients 
screened, randomised, and prematurely discontinued. State reasons for premature discontinuation of 
therapy in each applicable case. 

12. Efficacy evaluation 

The  results  of  evaluation  of  all  the  efficacy  variables  will  be  described  in  this  section  with 
appropriate  tabular  and    graphical  representation.  A    brief    description  of    the    demographic 
characteristics  of  the  trial  patients  should  also  be  provided  along  with  a  listing  of  patients  and 
observations excluded from efficacy analysis. 

13. Safety Evaluation: 

 This section should include the complete list 

13.1 All serious adverse events, whether expected or unexpected and 
13.2 unexpected advese events whether serious or not (compiled from data received as per Appendix 
XI). 

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The  comparison  of  adverse  events  across  study  groups  may  be  presented  in  a  tabular  or 
graphical  form.  This  section  should  also  give  a  brief  narrative  of  all  important  events  considered 
related to the investigational product. 

Drugs and Cosmetics Rules 1945 

14.  Discussion and overall Conclusion: 

Discussion  of  the  important  conclusions  derived  from  the  trial    and  scope  for  further 

development. 

15. List of References: 

16. Appendices: 

List of Appendices to the Clinical Trial Report 

(a)  Protocol and amendments 
(b)  Specimen of Case Record Form 
(c)  Investigators‘ name(s) with contact addresses, phone, e-mail etc. (d)   Patient data listings 
(e)   List of trial participants treated with investigational product 
(f)   Discontinued participants 
(g)  Protocol deviations 
(h)  CRFs of cases involving death and life threatening adverse event cases 
(i)   Publications from the trial 
(j)   Important publications referenced in the study 
(k)  Audit certificate, if available 
(l)  Investigator‘s  certificate  that  he/she  has  read  the  report  and  that  the  report accurately 

describes the conduct and the results of the study. 

APPENDIX III 

ANIMAL TOXICOLOGY (NON-CLINICAL TOXICITY STUDIES) 

1.  General Principles: 
     Toxicity  studies  should  comply  with  the  norms  of  Good  Laboratory  Practice  (GLP).    Briefly, 
these  studies  should  be  performed  by  suitably  trained  and  qualified  staff  employing  properly 
calibrated and standardized equipment of adequate size and capacity.   Studies should be done as per 
written  protocols  with  modifications  (if  any)  verifiable  retrospectively.    Standard  operating 
procedures  (SOPs)  should  be  followed  for  all  managerial  and  laboratory  tasks  related  to  these 
studies.   Test  substances  and test  systems  (in-vitro  or  in-vivo)  should  be  properly  characterized 
and  standardized. All  documents  belonging  to  each  study,  including  its  approved  protocol,  raw 
data, draft report, final report, and histology slides and paraffin tissue blocks should be preserved for 
a minimum of 5 years after marketing of the drug. 
Toxicokinetic  studies  (generation  of  pharmacokinetic  data  either  as  an  integral  component  of  the 
conduct  of  non-clinical  toxicity  studies  or  in  specially  designed  studies)  should  be  conducted  to 
assess  the  systemic  exposure  achieved  in  animals  and  its  relationship  to  dose level  and  the  time 
course  of  the  toxicity  study.  Other  objectives  of  toxicokinetic  studies include obtaining data to 
relate  the  exposure  achieved  in  toxicity  studies  to  toxicological  findings  and  contribute  to  the 
assessment of the relevance of these findings to clinical safety, to support the choice of species and  
treatment  regimen  in  nonclinical toxicity  studies  and  to provide information which, in  conjunction 
with the toxicity findings, contributes to the design of subsequent non-clinical toxicity studies. 

1.1  Systemic Toxicity Studies 

1.1.1  Single-dose Toxicity Studies:  These studies (see Appendix I item 4.2) should be carried out in 
2  rodent  species  (mice  and  rats)  using  the  same  route  as  intended  for  humans.  In  addition, 
unless the  intended route of  administration in  humans is  only intravenous, at  least  one more 

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route should be  used in  one  of  the  species to  ensure systemic absorption  of  the  drug.   This 
route  should  depend  on  the  nature  of  the  drug.      A  limit  of 2g/kg (or 10 times the normal 
dose  that  is  intended  in  humans,  whichever  is  higher)  is  recommended  for  oral  dosing.   
Animals  should  be  observed  for  14  days  after  the  drug  administration,  and  minimum  lethal  
dose  (MLD)  and    maximum  tolerated  dose  (MTD)  should  be  established.    If  possible,  the 
target organ of toxicity should also be determined. Mortality should be observed for up to 7 
days  after  parenteral  administration  and  up  to  14  days  after  oral  administration.  Symptoms, 
signs  and  mode  of  death  should  be  reported,  with  appropriate  macroscopic  and  microscopic 
findings  where  necessary.  LD10    and  LD50    should  be  reported  preferably  with  95  percent 
confidence limits.  If LD50s cannot be determined, reasons for the same should be stated. 

The  dose  causing  severe  toxic  manifestations  or  death  should  be  defined  in  the  case of 
cytotoxic anticancer agents, and the post-dosing observation period should be up to 14 days. 
Mice should first be used for determination of MTD.  Findings should then be confirmed in rat 
for  establishing  linear  relationship  between  toxicity  and  body  surface  area.    In  case  of 
nonlinearity,  data  of  the  more  sensitive  species  should  be  used  to  determine  the  Phase  I 
starting  dose.      Where  rodents  are  known  to  be  poor  predictors  of  human  toxicity  (e.g., 
antifolates), or where the cytotoxic drug acts by a novel mechanism of action, MTD should be 
established in non-rodent species. 

1.1.2 Repeated-dose Systemic Toxicity Studies: These studies (see Appendix I, item 4.2) should be 
carried  out  in  at  least  two mammalian  species,  of  which  one  should  be  a  non-  rodent.  Dose 
ranging studies should precede the 14-, 28-, 90- or 180- day toxicity studies. Duration of the 
final systematic toxicity study will depend on the duration, therapeutic indication and scale of 
the proposed clinical trial (see item 1.8).  If a species is known to metabolize the drug in the 
same way as humans, it should be preferred for toxicity studies. 

In  repeated-dose toxicity  studies the  drug should be  administered 7  days a  week by  the 
route  intended  for  clinical  use.  The  number  of  animals  required  for  these  studies,  i.e.  the 
minimum number of animals on which data should be available, is shown in Item 1.9. 

Wherever  applicable,  a  control  group  of  animals  given  the  vehicle  alone  should  be 
included, and three other groups should be given graded doses of the drug. The highest dose 
should produce observable toxicity; the lowest dose should not cause observable toxicity, but 
should be comparable to the intended therapeutic dose in humans or a multiple of it .  To make 
allowance  for  the  sensitivity  of  the  species  the  intermediate  dose  should  cause  some 
symptoms, but not gross toxicity or death, and should be placed logarithmically between the 
other two doses. 

The parameters to be monitored and recorded in long-term toxicity studies should include 
behavioral,  physiological,  biochemical  and  microscopic  observations.    In  case  of  parenteral 
drug  administration,  the  sites  of  injection  should  be  subjected  to  gross  and  microscopic 
examination.  Initial and final electrocardiogram and fundus examination should be carried out 
in the non-rodent species. 

In  the  case  of  cytotoxic  anticancer  agents  dosing  and  study  design  should  be  in 
accordance  with  the  proposed clinical  schedule  in  terms  of  days  of  exposure and  number  of 
cycles. Two rodent species  may be tested for initiating Phase  I trials.  A non-rodent species 
should be added if the drug has a novel mechanism of action, or if permission for Phase II, III 
or marketing is being sought. 

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For  most  compounds,  it  is  expected  that  single  dose  tissue  distribution  studies  with 
sufficient    sensitivity    and    specificity    will    provide    an    adequate    assessment    of    tissue 
distribution  and    the    potential  for    accumulation.  Thus,    repeated  dose    tissue    distribution 
studies  should  not  be  required  uniformly  for  all  compounds  and  should  only  be  conducted 
when  appropriate  data  cannot  be  derived  from  other  sources.  Repeated  dose  studies  may  be 
appropriate    under    certain    circumstances    based    on    the    data    from    single    dose    tissue 
distribution  studies,  toxicity  and  toxicokinetic  studies.  The  studies  may  be  most  appropriate 
for  compounds  which  have  an  apparently  long  half  life,  incomplete  elimination  or 
unanticipated organ toxicity. 

Notes: 

(i) Single Dose Toxicity Study:   Each group should contain at least 5 animals of either sex.  At 
least four graded doses should be given.  Animals should be exposed to the test substance in a single 
bolus or by continuous infusion or several doses within 24 hours. Animals should be observed for 14 
days.   Signs of intoxication, effect on body weight, gross pathological changes should be  reported.  
It is desirable to include histo-pathology of grossly affected organs, if any. 

(ii) Dose-ranging Study:  Objectives of this study include the identification of target organ of 

toxicity and establishment of MTD for subsequent studies. 

(a)  Rodents:    Study  should  be  performed  in  one  rodent  species  (preferably  rat)  by  the 
proposed  clinical  route  of  administration.  At  least  four  graded  doses  including  control 
should be given, and each dose group as well as the vehicle control should consist  of  a 
minimum  of  5  animals  of  each  sex.   Animals  should  be  exposed  to  the test  substance 
daily  for  10  consecutive days.   Highest  dose  should be  the  maximum tolerated dose  of 
single-dose study.   Animals  should  be  observed daily  for  signs  of intoxication (general 
appearance,  activity  and  behaviour  etc),  and  periodically  for  the  body  weight  and 
laboratory  parameters.      Gross  examination  of  viscera  and  microscopic examination of 
affected organs should be done. 

(b) Non-rodents:  One male and one female are to be taken for ascending Phase MTD study.  
Dosing  should  start  after  initial  recording  of  cage-side  and  laboratory  parameters. 
Starting dose may be 3 to 5 times the extrapolated effective dose or MTD (whichever  is 
less),  and  dose  escalation  in  suitable  steps  should  be  done  every  third  day  after 
drawing  the  samples  for  laboratory  parameters.   Dose  should  be  lowered appropriately 
when  clinical  or  laboratory  evidence  of  toxicity  are  observed.  Administration  of  test 
substance  should  then  continue  for  10  days  at  the  well-tolerated  dose  level  following 
which,  samples  for  laboratory  parameters  should  be  taken.  Sacrifice,    autopsy    and  
microscopic    examination  of    affected    tissues    should   be performed as  in the case of 
rodents. 

(iii)  14-28  Day  repeated-dose  toxicity  studies:    One  rodent  (6-10/sex/group)  and  one  non-
rodent  (2-3/sex/group)  species  are  needed.    Daily  dosing  by  proposed  clinical  route  at 
three dose levels should be done with highest dose having observable toxicity, mid- dose 
between high and low dose, and low dose. The doses should preferably be multiples of 
the  effective  dose  and  free  from  toxicity.  Observation  parameters  should  include  cage- 
side  observations,  body  weight  changes,  food/water  intake,  blood  biochemistry, 
haematology, and gross and microscopic studies of all viscera and tissues. 

(iv)  90-Day  repeated-dose  toxicity  studies:  One  rodent  (15-30/sex/group)  and  one  non- 
rodent  (4-6/sex/group)  species  are  needed.   Daily  dosing  by  proposed  clinical  route  at 
three graded dose levels should be done.  In addition to the control a ―high-dose-reversal‖ 

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group and its control group should be also included.  Parameters should include signs of 
intoxication (general appearance, activity  and  behaviour etc),  body  weight, food  intake, 
blood  biochemical  parameters,  haematological  values,  urine  analysis,  organ  weights, 
gross and microscopic study of viscera and tissues.  Half the animals in ―reversal‖ groups 
(treated  and  control) should  be  sacrificed after  14  days  of  stopping the  treatment.   The 
remaining animals should be sacrificed after 28 days of stopping the treatment or after the 
recovery  of  signs  and/or  clinical  pathological  changes  –  whichever  comes  later,  and 
evaluated for the parameters used for the main study. 

(v) 180-Day  repeated-dose  toxicity  studies:   One  rodent  (15-30/sex/group)  and  one non-
rodent (4-6/sex/group) species are needed.   At  least  4  groups, including control, should 
be taken.   Daily dosing by proposed clinical route at three graded dose levels should be 
done.   Parameters should include signs of  intoxication, body weight, food intake, blood 
biochemistry,  hematology,  urine  analysis,  organ  weights,  gross  and  microscopic 
examination of organs and tissues. 

1.2   Male Fertility Study 

One rodent species (preferably rat) should be used.  Dose selection should be done from the 
results of the previous 14 or 28-day toxicity study in rat.  Three dose groups, the highest one 
showing  minimal  toxicity  in  systemic  studies,  and  a  control  group  should  be  taken.    Each 
group  should  consist  of  6  adult  male  animals.    Animals  should  be  treated  with  the  test 
substance by the intended route of clinical use for minimum 28 days and maximum 70 days 
before they are paired with female animals of proven fertility in a ratio of 1:2 for mating. 
Drug  treatment  of  the  male  animals  should  continue  during  pairing.  Pairing  should  be 
continued till the detection of vaginal plug or 10 days, whichever is earlier.  Females getting  
thus  pregnant  should  be  examined  for  their  fertility  index  after  day  13  of gestation.  
All the male animals should be sacrificed at the end of the study.  Weights of each testis and 
epididymis should be separately recorded.  Sperms from one epididymis should be examined 
for their motility and morphology.  The other epididymis and both testes should be examined 
for their histology. 

1.3     Female Reproduction and Developmental Toxicity Studies 

These studies (see Appendix I, item 4.4) need to be carried out for all drugs proposed to be 
studied or used in women of child bearing age.   Segment I, II and III studies (see below) are 
to  be  performed in  albino mice  or  rats, and  segment II  study  should include albino rabbits 
also as a second test species. 
On the occasion, when the test article is not compatible with the rabbit (e.g. antibiotics which 
are effective against gram positive, anaerobic organisms and protozoas) the Segment II data 
in the mouse may be substituted. 

1.3.1    Female  Fertility  Study  (Segment  I):   The  study  should  be  done  in  one  rodent species (rat 
preferred).  The  drug  should  be  administered  to  both  males  and  females,  beginning  a 
sufficient number of days (28 days in males and 14 days in females) before mating.   Drug 
treatment  should  continue  during  mating  and,  subsequently,  during  the  gestation  period.  
Three  graded  doses  should  be  used,  the  highest  dose  (usually  the  MTD  obtained  from 
previous systemic toxicity studies) should not affect general health of the parent animals. At 
least  15  males  and  15  females  should  be  used  per  dose  group.  Control  and  the 
treated groups should be of similar size.  The route of administration should be the 
same as intended for therapeutic use 

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Dams should be allowed to litter and their medication should be continued till the 
weaning  of  pups.     Observations  on  body  weight,  food  intake,  clinical  signs  
of  intoxication,  mating  behaviour,  progress  of  gestation/  parturition  periods, 
length  of  gestation,  parturition,  post-partum  health  and  gross  pathology  (and 
histopathology  of  affected  organs)  of  dams  should  be  recorded.    The  pups  from  both 
treated  and  control  groups  should  be  observed  for  general  signs  of  intoxication,  sex-wise 
distribution  in  different  treatment  groups,  body  weight,  growth  parameters,  survival,  gross 
examination, and autopsy.  Histopathology of affected organs should be done. 

1.3.2  Teratogenicity Study (Segment II): 

One  rodent  (preferably  rat)  and  one  non-rodent    (rabbit)  species  are  to  be  used.  The  drug 
should  be  administered throughout the  period  of  organogenesis, using  three  dose levels  as 
described  for  segment  I.   The  highest  dose  should  cause  minimum  maternal toxicity  and 
the lowest one should be proportional to the proposed dose for clinical use in humans or 
a  multiple  of  it.    The  route  of  administration  should  be  the  same  as  intended  for 
human therapeutic use. 
The  control  and  the  treated  groups  should  consist  of  at  least  20  pregnant  rats  (or 
mice) and  12  rabbits,  on  each  dose  level.     All  foetuses  should     be  subjected  to  
gross  examination,  one  of  the  foetuses  should  be  examined  for  skeletal  abnormalities  and 
the other half for visceral abnormalities.      Observation parameters should include: (Dams) 
signs  of  intoxication,  effect  on  body  weight,  effect  on  food  intake,  examination  of  uterus, 
ovaries  and  uterine  contents,  number  of  corpora  lutea,  implantation  sites,  resorptions  (if 
any); and for the foetuses, the total number, gender, body length, weight and gross/ visceral/ 
skeletal abnormalities, if any. 

1.3.3   Perinatal Study (Segment III): 

This  study  is  specially  recommended  if  the  drug  is  to  be  given  to  pregnant  or  nursing 
mothers for long periods or where there are indications of possible adverse effects on foetal 
development.   One rodent species (preferably rat) is needed.   Dosing at levels comparable 
to multiples of human dose should be done by the intended clinical route.  At least 4 groups 
(including  control),  each  consisting  of  15  dams  should  be  used.    The  drug  should 
be    administered  throughout  the  last    trimester  of    pregnancy  (from  day    15    of 
gestation)  and  then  the  dose  that  causes  low  foetal  lo ss  should  be  continued 
throughout lactation and weaning.     Dams should then be sacrificed and examined 
as described below. 
One  male  and  one  female  from  each  litter  of  F1    generation  (total  15  males  and  15 
females  in  each  group)  should  be  selected  at  weaning  and  treated  with  vehicle  or  test 
substance  (at  the  dose  levels  described  above)  throughout  their  periods  of  growth  to 
sexual  maturity,  pairing,  gestation,  parturition  and  lactation.      Mating  performance  and 
fertility of F1  generation should thus be evaluated to obtain the F2  generation whose growth 
parameters should be monitored till weaning.  The criteria of evaluation should be the same 
as described earlier (3.4.1). 

Animals should be sacrificed at the end of the study and the observation parameters should 
include  (Dams)  body  weight,  food  intake,  general  signs  of  intoxication,  progress  of 
gestation/ parturition periods and  gross  pathology (if any); and  for  pups, the  clinical signs,  

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sex-wise    distribution  in    dose    groups,    body    weight,    growth    parameters,    gross 
examination, survival and autopsy (if needed) and where necessary, histopathology. 

Drugs and Cosmetics Rules 1945 

1.4      Local toxicity 

These studies (see Appendix I, item 4.5) are required when the new drug is proposed to be 
used  by  some  special route  (other  than  oral)  in  humans. The  drug  should be  applied to  an 
appropriate  site  (e.g.,  skin  or  vaginal  mucous  membrane)  to  determine  local  effects  in  a 
suitable  species.   Typical  study  designs for  these  studies  should  include  three  dose levels 
and untreated and/ or vehicle control, preferably use of 2 species, and increasing group size 
with  increase  in  duration  of  treatment.      Where  dosing  is  restricted  due  to  anatomical  or 
humane reasons, or the drug concentration cannot be increased beyond a certain level due to 
the problems of solubility, pH or tonicity, a clear statement to this effect should be given.   If 
the  drug  is  absorbed from the  site  of  application, appropriate systemic toxicity studies will 
also be required. 

Notes:  

Dermal  toxicity  study:  The  study  should  be  done  in  rabbit  and  rat.  Daily  topical  
(i)  
(dermal)  application  of  test  substance  in  its  clinical  dosage  form  should  be  done.   Test 
material  should  be  applied  on  shaved  skin  covering  not  less  than  10%  of  the  total  body 
surface  area.      Porous  gauze  dressing  should  be  used  to  hold  liquid  material  in  place. 
Formulations  with  different  concentrations  (at  least    3)  of  test  substance,  several  fold 
higher than the clinical dosage form should be used.  Period of application may vary from 7 
to 90 days depending on the clinical duration of use.  Where skin irritation is grossly visible 
in  the initial  studies, a  recovery group should be included in  the subsequent repeated-dose 
study.      Local  signs  (erythema,  oedema  and  eschar  formation)  as  well  as  histological 
examination of sites of application should be used for evaluation of results. 
Photo-allergy or dermal photo-toxicity: It should be tested by Armstrong/ Harber 
(ii)  
Test in guinea pig. This test should be done if the drug or a metabolite is related to an agent 
causing photosensitivity or the nature of action suggests such a potential (e.g., drugs to  be  
used    in    treatment    of    leucoderma).          Pretest    in    8    animals    should    screen    4 
concentrations (patch application for 2 hours ±15 min.) with and without UV exposure (10 
J/cm2).      Observations  recorded  at  24  and  48  hours  should  be  used  to  ascertain  highest 
nonirritant  dose.      Main  test  should  be  performed  with  10  test  animals  and  5  controls. 
Induction with the dose selected from pretest should use 0.3 ml/patch  for 2 hour ±15 min. 
followed by 10 J/cm2 of UV exposure.  This should be repeated on day 0, 2,4,7,9 and 11 of 
the  test.      Animals  should  be  challenged  with  the  same  concentration  of  test  substance 
between day 20 to 24 of the test with a similar 2-hour application followed by exposure to 10 
J/cm2  of  UV  light.    Examination  and  grading  of  erythema  and  oedema  formation  at  the 
challenge sites should be done 24 and 48 hours after the challenge.  A positive control like 
musk ambrett or psoralin should be used. 

Vaginal Toxicity Test:  Study is to be done in rabbit or dog.  Test substance should 
(iii)  
be  applied  topically  (vaginal  mucosa)  in  the  form  of  pessary,  cream  or  ointment.   Six  to 
ten  animals  per  dose  group  should  be  taken.      Higher  concentrations  or  several  daily 
applications  of  test  substance  should  be  done  to  achieve  multiples  of  daily  human  dose. 
The  minimum  duration  of  drug  treatment  is  7  days  (more  according  to  clinical  use), 
subject to a maximum of 30 days.   Observation parameters should include swelling, closure 
of introitus and histopathology of vaginal wall. 

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(iv)  
Rectal  Tolerance  Test:      For  all  preparations  meant  for  rectal  administration  this 
test may be performed in rabbits or dogs.  Six to ten animals per dose group should be taken.   
Formulation  in  volume  comparable  to  human  dose  (or  the  maximum  possible  volume) 
should  be  applied  once  or  several  times  daily,  per  rectally,  to  achieve  administration  of 
multiples  of  daily  human  dose.    The  minimum  duration  of  application  is  7  days  (more 
according to clinical use), subject to a maximum of 30 days.   Size of suppositories may be 
smaller, but the drug content should be several fold higher than the proposed human dose.  
Observation  parameters  should  include  clinical  signs  (sliding  on  backside),  signs  of  pain, 
blood  and/or  mucus  in  faeces,  condition  of  anal  region/sphincter,  gross  and  (if  required) 
histological examination of rectal mucosa. 
(v)        Parenteral  Drugs:      For  products  meant  for  intravenous  or  intramuscular  or 
subcutaneous  or  intradermal  injection  the  sites  of  injection  in  systemic  toxicity  studies 
should  be  specially  examined  grossly  and  microscopically.      If  needed,  reversibility  of 
adverse effects may be determined on a case to case basis. 
(vi)  
Ocular toxicity studies (for products meant for ocular instillation):   These studies 
should be carried out in two species, one of which should be the albino rabbit which has a 
sufficiently  large  conjunctival  sac.      Direct  delivery  of  drug  onto  the  cornea  in  case  of 
animals having small  conjunctival sacs should be  ensured.  Liquids, ointments, gels or soft 
contact lenses (saturated with drug) should be used.  Initial single dose application should be 
done  to  decide  the  exposure  concentrations  for  repeated-dose  studies  and  the  need  to 
include a recovery group.  Duration of the final study will depend on the proposed length of  
human    exposure    subject    to    a    maximum    of    90    days.  At    least    two    different 
concentrations exceeding  the  human  dose  should  be  used  for  demonstrating the  margin  of 
safety.  In acute studies, one eye should be used for drug administration and the other kept as 
control. A separate control group should be included in repeated-dose studies. 

Slit-lamp  examination  should  be  done  to  detect  the  changes  in  cornea,  iris  and  aqueous 
humor.  Fluorescent dyes (sodium fluorescein, 0.25 to 1.0%) should be used for detecting the 
defects  in  surface  epithelium  of  cornea  and  conjunctiva.      Changes  in  intra-ocular  tension 
should be monitored by a tonometer.  Histological examination of eyes should be done at the 
end of the study after fixation in Davidson‘s or Zenker‘s fluid. 
(vii)  
Inhalation toxicity studies:  The studies are to be undertaken in one rodent and one 
non-rodent species  using the formulation that is to be eventually proposed to  be marketed.  
Acute, subacute and chronic toxicity studies should be performed according to the  intended 
duration of  human exposure.   Standard systemic toxicity  study designs (described above) 
should  be  used.      Gases  and  vapours  should  be  given  in  whole  body  exposure  chambers; 
aerosols  are  to  be  given  by  nose-only  method.    Exposure  time  and  concentrations  of    test  
substance    (limit    dose    of    5mg/l)    should    be    adjusted    to    ensure  exposure  at  levels 
comparable  to  multiples  of  intended  human  exposure.      Three  dose  groups  and  a  control 
(plus  vehicle control, if  needed) are  required.   Duration of  exposure may vary subject to a 
maximum of 6 hours per day and five days a  week.  Food and water should be withdrawn 
during the period of exposure to test substance. 

Temperature, humidity and flow rate of exposure chamber should be recorded and reported. 
Evidence  of  exposure  with  test  substance  of  particle  size  of  4  micron  (especially  for 
aerosols)  with  not  less  that  25%  being  1  micron  should  be  provided.      Effects  on 
respiratory rate,  findings of  bronchial lavage fluid examination, histological examination of 

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respiratory passages and lung tissue should be included along with the regular parameters of 
systemic toxicity studies or assessment of margin of safety. 

Drugs and Cosmetics Rules 1945 

1.5     Allergenicity/ Hypersensitivity: 

Standard  tests  include  guinea  pig  maximization  test  (GPMT)  and  local  lymph  node  assay 
(LLNA) in mouse.  Any one of the two may be done. 

Notes: 

(i)  Guinea  Pig  Maximization  Test:  The  test  is  to  be  performed  in  two  steps;  first, 
determination  of  maximum  nonirritant  and  minimum  irritant  doses,  and  second,  the  main 
test.      The  initial  study  will  also  have  two  components.      To  determine  the  intradermal 
induction dose, 4 dose levels should be tested by the same route in a batch of 4 male and 4 
female  animals (2  of  each  sex  should be  given  Freund‘s adjuvant).    The  minimum  irritant 
dose  should  be  used  for  induction.    Similarly,  a  topical  minimum  irritant  dose  should  be 
determined  for  challenge.      This  should  be  established  in  2  males  and  2  females.         A 
minimum  of  6  male  and  6  female  animals  per  group  should  be  used  in  the  main  study. 
One test  and one control group should be used.   It  is  preferable to  have one  more positive 
control  group.      Intradermal  induction  (day  1)  coupled  with  topical  challenge  (day  21) 
should  be  done.    If  there  is  no  response,  re-challenge  should  be  done  7-30  days  after  the 
primary  challenge.      Erythema  and  oedema  (individual  animal  scores  as  well  as 
maximization grading) should be used as evaluation criteria. 

(ii)  Local Lymph Node Assay:  Mice used in this test should be of the same sex, either only 
males  or  only  females.   Drug  treatment  is  to  be  given  on  ear  skin.   Three  graded doses, 
the  highest  being  maximum  nonirritant  dose  plus  vehicle  control  should  be  used.    A 
minimum of 6 mice per group should be used.  Test material should be applied on ear skin on 
three consecutive days and on day 5, the draining auricular lymph nodes should be dissected 
out  5  hours  after  i.v.  H-thymidine  or  bromo-deoxy-uridine  (BrdU).    Increase  in  H-
thymidine  or  BrdU  incorporation  should  be  used  as  the  criterion  for  evaluation  of 
results. 
1.6     Genotoxicity 

Genotoxic compounds, in the absence of  other data, shall be presumed to  be  trans- species  
carcinogens,  implying  a  hazard  to  humans.  Such  compounds  need  not  be subjected to 
long-term  carcinogenicity  studies.  However,  if  such  a  drug  is  intended  to  be  administered 
for chronic illnesses or otherwise over a long period of time - a chronic toxicity study (up to 
one year) may be necessary to detect early tumorigenic effects. 

Genotoxicity tests are in vitro and in vivo tests conducted to detect compounds which induce 
genetic damage directly or indirectly. These tests should enable a hazard identification with 
respect to damage to DNA and its fixation. 

The following standard test battery is generally expected to be conducted:  

(i)  A test for gene mutation in bacteria. 
(ii)  An  in  vitro  test  with cytogenetic evaluation  of  chromosomal damage with mammalian 
cells or an in vitro mouse lymphoma tic assay. 
(iii)  An  in  vivo  test  for  chromosomal  damage  using  rodent  haematopoietic  cells.  Other  
genotoxicity tests  e.g.  tests  for  measurement of  DNA  adducts, DNA  strand 
breaks, DNA repair or recombination serve as options in addition to the standard battery 
for  further  investigation  of  genotoxicity  test  results  obtained  in  the  standard  battery.  Only 
under extreme conditions in which one or more tests comprising the standard battery cannot 

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be  employed  for  technical  reasons,  alternative  validated  tests  can  serve  as  substitutes 
provided sufficient scientific justification should be provided to support the argument that a 
given standard battery test is not appropriate. 
Both  in-vitro  and  in-vivo  studies  should  be  done.   In-vitro  studies  should  include Ames‘ 
Salmonella  assay  and  chromosomal  aberrations  (CA)  in  cultured  cells.      In-vivo  studies 
should include micronucleus assay (MNA) or CA in rodent bone marrow.   Data analysis of 
CA should include analysis of ‗gaps.‘ 
Cytotoxic anticancer agents:   Genotoxicity data are not required before Phase I and 
II trials.  But these studies should be completed before applying for Phase III trials. 

Notes: 

Ames‘  Test  (Reverse  mutation  assay  in  Salmonella):      S.  typhimurium  tester  strains 
such  as  TA98,  TA100,  TA102,  TA1535,  TA97  or  Escherichia  coli  WP2  uvrA  or 
Escherichia coli WP2 uvrA (pKM101) should be used. 
(i)  In-vitro  exposure (with  and  without  metabolic  activation,  S9  mix)  should  be  done at  a 
minimum  of  5  log  dose  levels.   ―Solvent‖  and  ―positive‖ control  should  be  used. Positive 
control  may  include  9-amino-acridine,  2-nitrofluorine,  sodium  azide  and  mitomycin  C, 
respectively, in the tester strains mentioned above.  Each set should consist of  at least  three 
replicates.      A  2.5  fold  (or  more)  increase  in  number  of  revertants  in  comparison  to 
spontaneous revertants would be considered positive. 
(ii)   In-vitro cytogenetic assay :   The desired level  of toxicity for in vitro cytogenetic tests 
using cell lines should be greater than 50% reduction in cell number or culture confluency. 
For  lymphocyte cultures, an  inhibition of  mitotic  index  by  greater  than  50%  is  considered 
sufficient. It should be performed in CHO cells or on human lymphocyte in culture.  In-vitro 
exposure (with and without metabolic activation, S9 mix) should be done using a minimum 
of 3 log doses.  ―Solvent‖ and ―positive‖ control should be included.  A positive control like 
Cyclophosphamide  with  metabolic  activation  and  Mitomycin  C  for  without  metabolic 
activation should  be  used  to  give  a  reproducible and  detectable  increase  clastogenic  effect 
over the background which demonstrates the sensitivity of the test system.   Each set should 
consist  of  at  least  three  replicates.      Increased  number  of  aberrations  in  metaphase 
chromosomes should be used as the criteria for evaluation. 
(iii)  In-vivo  micronucleus assay:   One  rodent  species  (preferably  mouse)  is  needed. Route 
of administration of test substance should be the same as intended for humans.  Five animals 
per  sex  per  dose  groups  should  be  used.    At  least  three  dose  levels,  plus  ―solvent‖  and 
―positive‖  control  should  be 
like  mitomycin  C  or 
cyclophosphamide  should  be  used.      Dosing  should  be  done  on  day  1  and  2  of  study 
followed by sacrifice of animals 6 hours after the last injection.  Bone marrow from both the 
femora  should  be  taken  out,  flushed  with  fetal  bovine  serum  (20  min.),  pelletted  and 
smeared  on  glass  slides.    Giemsa-MayGruenwald  staining  should  be  done  and  increased 
number  of  micronuclei  in  polychromatic  erythrocytes  (minimum  1000)  should  be  used  as 
the evaluation criteria. 
(iv) In-vivo cytogenetic assay:  One rodent species (preferably rat) is to be used.  Route of 
administration  of  test  substance  should  be  the  same  as  intended  for  humans.      Five 
animals/sex/dose  groups  should  be  used.    At  least  three  dose  levels,  plus  ―solvent‖  and 
―positive‖  control  should  be  tested.      Positive  control  may  include  cyclophosphamide. 
Dosing should be done on day 1 followed by intra-peritoneal colchicine administration at 
22  hours.      Animals  should  be  sacrificed  2  hours  after  colchicine  administration.    Bone 
marrow from both the femora should be taken out, flushed with hypotonic saline (20 min.), 

tested.  A  positive  control 

610 

 
 
Drugs and Cosmetics Rules 1945 

pelletted  and resuspended in  Carnoy‘s fluid.   Once again the cells  should be pelletted and 
dropped  on  clean  glass slides  with a  Pasteur pipette.    Giemsa  staining  should be  done  and 
increased number of aberrations in metaphase chromosomes (minimum 100) should be used 
as the evaluation criteria. 

1.7     Carcinogenicity (see Appendix I, item 4.8) 

Carcinogenicity  studies  should  be    performed  for    all    drugs  that    are    expected  to    be 
clinically used for more than 6 months as well as for drugs used frequently in an intermittent 
manner in the treatment of chronic or recurrent conditions.  Carcinogenicity studies are also 
to  be  performed for  drugs  if  there  is  concern  about  their  carcinogenic potential  emanating 
from previous demonstration of carcinogenic potential in the product class that is considered 
relevant  to  humans  or  where  structure-activity  relationship  suggests  carcinogenic  risk  or 
when  there  is  evidence  of  preneoplastic  lesions  in  repeated  dose  toxicity  studies  or  when 
long-term  tissue  retention  of  parent  compound  or  metabolite(s)  results  in  local  tissue 
reactions  or  other  pathophysiological  responses.  For  pharmaceuticals  developed  to  treat 
certain  serious  diseases,  Licensing  Authority  may  allow  carcinogenicity  testing  to  be 
conducted after marketing permission has been granted. 

In instances where the life-expectancy in the indicated population is short (i.e., less than 
2-3  years)-  no  long-term  carcinogenicity  studies  may  be  required.  In  cases  where  the 
therapeutic  agent  for  cancer  is  generally  successful  and  life  is  significantly  prolonged 
there  may    be    later    concerns    regarding    secondary    cancers.    When    such    drugs    are  
intended    for  adjuvant  therapy  in  tumour  free  patients  or  for  prolonged  use  in  non-cancer 
indications, carcinogenicity studies may be / are needed.  Completed rodent carcinogenicity 
studies are not needed in advance of the conduct of large scale clinical trials, unless there is 
special concern for the patient population. 

Carcinogenicity studies should be done in a rodent species (preferably rat).  Mouse may be 
employed only with proper scientific justification.  The selected strain of animals should not 
have a very high or very low incidence of spontaneous tumors. 

At  least  three  dose  levels  should  be  used.    The  highest  dose  should  be  sub-lethal,  and  it 
should  not  reduce  the  life  span  of  animals  by  more  than  10%  of  expected  normal.    The 
lowest dose should be comparable to the intended human therapeutic dose or a multiple of it, 
e.g. 
2.5x;  to  make  allowance  for  the  sensitivity  of  the  species.    The  intermediate  dose  to  be 
placed logarithmically between the other two doses. An untreated control and (if indicated) a 
vehicle control group should be included. The drug should be administered 7 days a week for 
a fraction of the life span comparable to the fraction of human life span over which the drug 
is likely to be used therapeutically. Generally, the period of dosing should be 24 months for 
rats and 18 months for mice. 

Observations  should  include  macroscopic  changes  observed  at    autopsy  and  detailed 
histopathology  of  organs  and  tissues.      Additional  tests  for  carcinogenicity  (short-term 
bioassays,  neonatal  mouse  assay  or  tests  employing  transgenic  animals)  may  also  be  done 
depending on their applicability on a case to case basis. 

Note: 

Each  dose  group and  concurrent control group  not  intended to  be  sacrificed early  should contain 
atleast 50 animals of each sex.  A high dose sattelite group for evaluation of pathology other than 
neoplasia should contain 20 animals of each sex while the sattelite control group should contain 10 
animals of each sex.   Observation parameters should include signs of intoxication, effect on body 
weight,  food  intake,  clinical  chemistry  parameters,  hematology  parameters,  urine  analysis,  organ 
weights, gross pathology and detailed histopathology. Comprehensive  descriptions  of  benign  and  

611 

 
 
 
 
 
 
malignant  tumour  development,  time  of  their detection, site, dimensions, histological typing etc. 
should be given. 

Drugs and Cosmetics Rules 1945 

   1.8     Animal toxicity requirements for clinical trials and marketing of a new drug.  

Systemic Toxicity Studies 

Route of administration 

 1[Oral or Parenteral or 
Transdermal 

Duration of 
proposed human 
administration 

Single dose or 
several  doses   in one 
day, Upto 1wk 
> 1 wk but upto 2wks 
Upto 2 wks 

Human Phase(s) 
for which study is  
proposed to be   
conducted 
I,II,III 

Long term toxicity 
requirements 

2sp,2wks 

I,II,III 
Marketing permission 

2sp;4wks 
2sp;4wks 

> 2 wk but upto 4wks 

I,II,III 

2 sp; equal to duration of human 
exposure 

Marketing permission 

2 sp; 12 wks 

> 4 wks but upto 12 wks  I,II,III 

> 12 wks but upto 24 
wks 

Marketing permission 
I,II,III 

Marketing permission 

> 24 wks 

I,II,III 

Marketing permission 

2 sp; equal to duration of human 
exposure 
2sp;24wks 
2 sp; equal to duration of human 
exposure 

2 sp; Rodent 24 wks, non-rodent 
36 wks 
2 sp; Rodent 24 wks, non-rodent 
36 wks 

2 sp; Rodent 24 wks, non-rodent 
36 wks] 

Inhalation (general 
anaesthetics, aerosols) 

Upto 2 wk 

Upto 4wk 

I,II,III 

I,II,III 

> 1 4wk 

I,II,III 

Local Toxicity Studies 
Dermal 

Upto 2 wk 

Ocular or Otic or 
Nasal 

Vaginal or Rectal 

> 2 wk 
Upto 2 wk 

> 2 wk 
Upto 2 wk 

> 2 wk 

1. Subs. by G.S.R. 287(E), dt. 08.3.2016. 

I,II, 

III 
I,II,III 
I,II 

III 
I,II,III 
I,II 
 III 
I,II,III 

612 

2sp;1mo; 
(Exposure  time 3h/d, 
5d/wk) 
2sp;12wk,  
(Exposure time 
6h/d, 5d/wk) 
2sp;24wk,  
(Exposure time 
6h/d, 5d/wk) 
1sp;4wk 

2sp;4wk 
2sp;12wk 
1sp;4wk 

2sp;4wk 
2sp;12wk 
1sp;4wk 
     2sp;4wk 
2sp;12wk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Special Toxicity Studies 
Male Fertility Study: 

1[ Phase III in male volunteers/patients] 

 
Female Reproduction and Developmental Toxicity Studies: 

Drugs and Cosmetics Rules 1945 

  Segment  II  studies  in  2  species;  Phase  II,  III  involving  female  patients  of  child- bearing 

age. 

  Segment I study; Phase III involving female patients of child-bearing age. 
  Segment III study; Phase III for drugs to be given to pregnant or nursing mothers for  long 
periods  or  where  there  are  indications  of  possible  adverse  effects  on  foetal development. 

Allergenicity/Hypersensitivity: Phase I, II, III - when there is a cause of concern or for parenteral 

drugs (including derrmal application).   

Photo-allergy or dermal photo-toxicity: 

  Phase  I,  II,  III  -  if  the  drug  or  a  metabolite  is  related  to  an  agent  causing 

photosensitivity or the nature of action suggests such a potential.  

Genotoxicity: 

  In-vitro studies - Phase I 

  Both in-vitro and in-vivo - Phase II, III  

Arcinogenicity: 

  Phase III - when there is a cause for concern, or when the drug is to be used for more than 6   
     months.  

Abbreviations: sp-species; mo-month; wk-week; d -day; h-hour; I, II, III - Phases of clinical trial; 

Note: 
1.  Animal  toxicity  data  generated  in  other  countries  may  be  accepted  and  may  not  be  asked  to  be 
repeated/duplicated in India on a case to case basis depending upon the quality of data and the 
credentials of the laboratory(ies) where such data has been generated. 

2. Requirements for fixed dose combinations are given in Appendix VI. 

1.9     Number of animals required for repeated-dose toxicity studies 

14-28 days                                               84-182 days 

Group                    Rodent (Rat)            Non-rodent 

Rodent (Rat)            Non-rodent 

                                   Monkey)                                                  Monkey)  

(Dog            or 

(Dog             or 

                                M             F              M             F              M              F             M             F  

Control               6-10 

6-10         2-3           2-3       15-30 

15-30 

4-6            4-6 

Low dose           6-10 

6-10         2-3           2-3       15-30 

15-30 

4-6            4-6 

Intermediate     6-10 
  dose                                                                                     

6-10         2-3           2-3       15-30 

15-30 

4-6            4-6 

High dose        6-10 

6-10         2-3           2-3       15-30 

15-30 

4-6            4-6 

1. Subs. by G.S.R. 287(E),  dt. 08.3.2016. 

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Drugs and Cosmetics Rules 1945 

2.0         Laboratory parameters to be included in toxicity studies. 

Haematological parameters 

• 

Haemoglobin               •        Total     RBC 

•    Haematocrit          •   Reticulocyte Count 

Count 

•  Total WBC Count           •  Differential WBC 

Count 

•   Platelet 
Count 

•    Terminal Bone  
            Marrow Examination  

•      ESR (Non- 
rodents  only) 

•  General Blood Picture:        A special mention of abnormal and immature 

cells should be made. 

•   Coagulation Parameters (Non-rodents only):  Bleeding Time, Coagulation Time, Prothrombin Time, 

                                                                                 Activated Partial Thromboplastin Time  

Urinalysis Parameters: 

•    Colour                      •    Appearance                •      Specific 

• 24-hour urinary 

                                                                                             Gravity                 output  

  •   Reaction (pH)             •  Albumin                    •Sugar                           • Acetone  

Bile pigments                   Urobilinogen                •    Occult 
                                                                                           Blood  

 •   Microscopic examination of urinary sediment.  

614 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood Biochemical Parameters 

Drugs and Cosmetics Rules 1945 

•  Glucose                         •    Cholesterol                       •   Triglycerides 

•  HDL 

Cholesterol 
(Non- 
rodents 

                                                                                                                                       only)  
• SGOT 
(AST) 

•    Bilirubin                           •  SGPT (ALT) 

• LDL Cholesterol 
(Non-rodents 

     only)  

• Alkaline 

•   GGT                                  •  Blood        Urea 

• Ceatinine 

Phosphatase                    (Non-rodents only) 
(ALP) 

•   Total Proteins                •    Albumin 

Nitrogen 

•     Globulin                • 

(Calculated               Sodium 

                                                                                                     values)  

•                               •                                    • 

     Potassium                          Phosphorus                             Calcium  

Gross and Microscopic Pathology 

• Brain*: 
Cerebrum, 
cerebellum, 

  Midbrain  

• (Spinal Cord)                •   Eye                            • (Middle   Ear) 

 •   Thyroid                     •   Parathyroid)               •   Spleen                      •  Thymus  

 •   Adrenal*                    •    (Pancreas)                 •  (Trachea)                  •  Lung*  

 •    Heart*                       •     Aorta                        • Oesophagus              • Stomach  

•    Duodenum                •     Jejunum                   • 

Terminal 

• Colon 

                                                                                       ileum  

 •   (Rectum)                   •   Liver*                        • Kidney*                    •   Urinary bladder  

 • Epididymis                   •     Testis*                      • Ovary                       •  Uterus*  

•    Skin                          • 

Mesenteric 
                                                 gland                             lymph node  

Mammary                  • 

•   Skeletal muscle 

* Organs marked with an asterisk should be weighed. 

()  Organs listed  in parenthesis should be examined if  indicated by  the nature of the drug or 
observed effects. 

Non-clinical toxicity testing and safety evaluation data of an IND needed for the conduct of 
different phases of clinical trials. 

615 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

Note:  Refer Appendix III (Points 1.1 through 1.7 and tables 1.8 and 1.9) for essential 
features of study designs of the non-clinical toxicity studies listed below. 

For Phase I Clinical Trials 
Systemic Toxicity studies 

(i) Single dose toxicity studies 

(ii) Dose Ranging Studies 
(iii)  Repeat-dose  systemic  toxicity  studies  of  appropriate  duration  to  support  the 
duration of proposed human exposure. 

Male fertility study 

In-vitro genotoxicity tests 
Relevant local  toxicity studies with  proposed route of  clinical  application (duration 

depending on proposed length of clinical exposure) 

Allergenicity/Hypersensitivity  tests  (when  there  is  a  cause  for  concern  or  for 

parenteral drugs, including dermal application) 

Photo-allergy or dermal photo-toxicity test  (if  the drug or a  metabolite is related  to 

an agent causing photosensitivity or the nature of action suggests such a potential) 

For Phase II Clinical Trials 

Provide a summary of all the non-clinical safety data (listed above) already submitted 

while obtaining the permissions for Phase I trial, with appropriate references. 

In case of an application for directly starting a Phase II trial - complete details of the 
non- clinical  safety  data  needed  for  obtaining  the  permission  for  Phase  I  trial,  as  per 
the  list provided above must be submitted. 

Repeat-dose systemic toxicity studies of appropriate duration to support the duration 

of proposed human exposure 

In-vivo genotoxicity tests- 
Segment  II  reproductive/developmental  toxicity  study  (if  female  patients  of  child 

bearing age are going to be involved) 

For Phase III Clinical Trials 

Provide  a  summary  of  all  the  non-clinical  safety  data  (listed  above)  already 
submitted  while  obtaining  the  permissions  for  Phase  I  and  II  trials,  with  appropriate 
references. 

In  case  of  an  application  for  directly  initiating  a  Phase  III  trial  -  complete  details 
of  the  non-clinical  safety  data  needed  for  obtaining  the  permissions  for  Phase  I  and  II 
trials, as per the list provided above must be provided. 

Repeat-dose systemic toxicity studies of appropriate duration to support the duration 

of proposed human exposure 

Reproductive/developmental toxicity studies 

Segment I (if female patients of child bearing age are going to be involved), and 

Segment  III  (for  drugs  to  be  given  to  pregnant  or  nursing  mothers  or  where  there  are 
indications of possible adverse effects on foetal development). 

Carcinogenicity studies (when there is a cause for concern or when the drug is to be 

used for more than 6 months). 

616 

 
 
 
 
 
For Phase IV Clinical Trials 

Drugs and Cosmetics Rules 1945 

Provide  a  summary  of  all  the  non-clinical  safety  data  (listed  above)  already 
submitted  while  obtaining  the  permissions  for  Phase  I,  II  and  III  trials,  with  appropriate 
references. 

In case an application is made for initiating the Phase IV trial, complete details of the 
non-clinical safety data needed for obtaining the permissions for Phase I, II and III trials, as 
per the list provided above must be submitted. 

Application Of Good Laboratory Practices (GLP) 

The  animal  studies  be  conducted  in  an  accredited  laboratory.    Where  the  safety 
pharmacology studies are part of toxicology studies, these studies should also be conducted 
in an accredited laboratory. 

APPENDIX  IV 
ANIMAL PHARMACOLOGY 

1. General Principles 

Specific and general pharmacological studies should be conducted to support use of 
therapeutics  in  humans.  In  the  early  stages  of  drug  development  enough  information  may 
not  be  available  to  rationally  select  study  design  for  safety  assessment.  In  such  a 
situation,  a  general  approach  to  safety  pharmacology  studies  can  be  applied.  Safety 
pharmacology  studies  are  studies  that  investigate  potential  undesirable  pharmacodynamic 
effects  of  a  substance  on  physiological  functions  in  relation  to  exposure  within  the 
therapeutic range or above. 

1.1 Specific Pharmacological Actions 

Specific pharmacological actions are those which demonstrate the therapeutic potential 

for humans. 

The specific studies that should be conducted and their design will be different based on 
the  individual properties and  intended uses  of  investigational drug.  Scientifically validated 
methods  should  be  used.  The  use  of  new  technologies  and  methodologies  in  accordance 
with sound scientific principles should be preferred. 

1.2 General Pharmacological Actions 

1.2.1  Essential Safety Pharmacology 

Safety  pharmacology  studies  need  to  be  conducted  to  investigate  the  potential 
undesirable pharmacodynamic effects of  a  substance on  physiological  functions in relation 
to  exposure  within  the  therapeutic range  and  above.    These  studies  should  be designed  to 
identify  undesirable  pharmacodynamic  properties  of  a  substance  that  may  have  relevance 
to  its    human  safety;  to  evaluate  adverse  pharmacodynamic  and/or  pathophysiological 
effects observed in  toxicology and/or clinical  studies;  and  to investigate the  mechanism of 
the adverse pharmacodynamic effects observed and/or suspected. 

The  aim  of  the  essential  safety  pharmacology is  to  study  the  effects  of  the  test  drug on 
vital functions. Vital  organ systems such as  cardiovascular, respiratory and central nervous 
systems  should  be  studied.  Essential  safety  pharmacology  studies  may  be  excluded  or 
supplemented based on scientific rationale.  Also, the exclusion of certain 

617 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

test(s)  or  exploration(s)  of  certain  organs,  systems  or  functions  should  be  scientifically 
justified. 

1.2.1.1 Cardiovascular System 

Effects of  the  investigational drug should be  studied on  blood pressure, heart rate,  and 
the  electrocardiogram.  If  possible  in  vitro,  in  vivo  and/or  ex  vivo  methods  including 
electrophysiology should also be considered. 

1.2.1.2 Central Nervous System 

Effects  of  the  investigational  drug  should  be  studied  on  motor  activity,  behavioral 

changes, coordination, sensory and motor reflex responses and body temperature. 

1.2.1.3 Respiratory System 

Effects  of  the  investigational  drug  on  respiratory  rate  and  other  functions  such  as tidal 

volume and hemoglobin oxygen saturation should be studied. 

1.3  Follow-up and Supplemental Safety Pharmacology Studies 

In addition to the essential safety pharmacological studies, additional supplemental and 
follow-up  safety  pharmacology  studies  may  need  to  be  conducted  as  appropriate.  These 
depend  on  the  pharmacological  properties  or  chemical  class  of  the  test  substance,  and  the 
data  generated  from  safety  pharmacology  studies,  clinical  trials,  pharmacovigilance, 
experimental in vitro or in vivo studies, or from literature reports. 

1.3.1  Follow-up Studies  For Essential Safety Pharmacology 

Follow-up  studies      provide  additional  information  or  a  better  understanding  than 

that provided by the essential safety pharmacology. 

1.3.1.1 Cardiovascular System 

These  include  ventricular contractility,  vascular resistance and   the  effects of chemical 

mediators, their agonists and antagonists on the cardiovascular system. 

1.3.1.2 Central Nervous System 

These  include  behavioral  studies  ,  learning  and  memory,  electrophysiology studies , 

neurochemistry and  ligand binding studies. 

1.3.1.3 Respiratory System 

These  include  airway  resistance,  compliance,    pulmonary  arterial  pressure,  blood  gases 

and blood pH. 

1.3.2 Supplemental Safety Pharmacology Studies 

These studies are required to investigate the possible adverse pharmacological effects 
that  are  not  assessed  in  the  essential  safety  pharmacological  studies  and    are    a cause for 
concern. 

618 

 
 
 
 
 
 
 
 
 
 
 
 
 
1.3.2.1 Urinary System 

Drugs and Cosmetics Rules 1945 

These  include  urine  volume,  specific  gravity,  osmolality,  pH,  proteins,  cytology  and 

blood urea nitrogen, creatinine and plasma proteins estimation. 

1.3.2.2 Autonomic Nervous System 

These  include  binding  to  receptors  relevant  for  the  autonomic  nervous  system,  and 
functional response to agonist or antagonist responses in vivo or in vitro, and effects of direct 
stimulation of autonomic nerves and their effects on cardiovascular responses. 

1.3.2.3   Gastrointestinal System 

These  include  studies  on  gastric  secretion,  gastric  pH  measurement,  gastric  mucosal 
examination,  bile  secretion,  gastric  emptying  time      in  vivo  and  ileocaecal  contraction in 
vitro. 

1.3.2.4 Other Organ Systems 

Effects   of   the   investigational  drug   on   organ   systems  not   investigated elsewhere 
should  be  assessed  when  there  is  a  cause  for  concern.  For  example  dependency  potential, 
skeletal muscle, immune and endocrine functions may be investigated. 

1.4 Conditions Under Which Safety Pharmacology Studies Are Not Necessary 

Safety  pharmacology  studies  are  usually  not  required  for  locally  applied  agents  e.g. 
dermal or ocular, in cases when the pharmacology of the investigational drug is well known, 
and/or  when  systemic  absorption  from  the  site  of  application  is  low.  Safety  pharmacology 
testing is also not necessary, in the case of a new derivative having similar pharmacokinetics 
and pharmacodynamics. 

1.5 Timing Of Safety Pharmacology Studies In Relation To Clinical Development 

1.5.1 Prior To First Administration In Humans 

The effects of an investigational drug on the vital functions listed in the essential safety 
pharmacology  should  be  studied  prior  to  first  administration  in  humans. Any  follow-up or 
supplemental  studies  identified,  should  be  conducted  if  necessary,  based  on  a  cause  for 
concern. 

1.5.2 During Clinical Development 

Additional    investigations    may    be    warranted    to    clarify    observed    or  suspected 

adverse effects in animals and humans during clinical development 

1.5.3 Before applying for marketing Approval 

Follow-up  and  supplemental    safety  pharmacology  studies  should  be  assessed  prior  to  
justified.  Available 
toxicology  studies  addressing  safety  pharmacology  endpoints  or 

approval  unless  not  required, 
information  from 
information from clinical studies can replace such studies. 

in    which  case 

this  should  be 

1.6 Application Of Good Laboratory Practices (GLP) 

The  animal  studies  be  conducted  in  an  accredited  laboratory.      Where  the  safety 
pharmacology studies are part of toxicology studies, these studies should also be conducted 
in an accredited laboratory. 

619 

 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules 1945 

APPENDIX  V 

INFORMED CONSENT 

1. Checklist for study Subject‘s informed consent documents 

1.1 Essential Elements: 

1.  Statement that the study involves research and explanation of the purpose of the research 
2.  Expected duration of the Subject's participation. 
3.  Description  of  the  procedures  to  be  followed,  including  all  invasive  procedures and 
4.  Description of any reasonably foreseeable risks or discomforts to the Subject 
5.  Description of any benefits to the Subject or others reasonably expected from research. If no 

benefit is expected Subject should be made aware of this. 

6.  Disclosure  of  specific  appropriate  alternative  procedures  or  therapies  available  to  the 

Subject. 

7.  Statement  describing  the  extent to  which  confidentiality  of  records  identifying  the  Subject 

will be maintained and who will have access to Subject‘s medical records 

8.  Trial treatment schedule(s) and the probability for random assignment to each treatment (for 

randomized trials) 

9.  1[Statement describing the financial compensation and medical management as under: 

2[(a)  In  case  of  any  injury  occurring  to  the  subject  during  the  clinical  trial,  free  medical 
management  shall  be  given  as  long  as  required  or  till  such  time  it  is  established  that  the 
injury is not related to the clinical trial, whichever is earlier.] 
(b)  In  the  event  of  a  trial  related  injury  or  death,  the  Sponsor  or  his  representative, 
whosoever has obtained permission from the Licensing Authority for conduct of the clinical 
trial, shall provide financial compensation for the injury or death]. 

10.  An explanation about whom to contact for trial related queries, rights of Subjects and in the 

event of any injury 

11.  The anticipated prorated payment, if any, to the Subject for participating in the trial 
12.  Subject's responsibilities on participation in the trial 
13.  Statement that participation is voluntary, that the subject can withdraw from the study at any 
time and that refusal to participate will not involve any penalty or loss of benefits to which 
the Subject is otherwise entitled. 

3[14.  Statement  that  there  is  a  possibility  of  failure  of  investigational  product  to  provide 

intended therapeutic effect. 

15.  Statement  that  in  the  case  of  placebo  controlled  trial,  the  placebo  administered  to  the 

subjects shall not have any therapeutic effect. 

16.Any other pertinent information.] 

1.2 Additional elements, which may be required 

(a) Statement of foreseeable circumstances under which the Subject's  participation may be  

terminated by the Investigator without the Subject's consent. 

(b)  Additional costs to the Subject that may result from participation in the study. 
(c) The consequences of a Subject‘s decision to withdraw from the research and  

procedures for  orderly termination of participation by Subject. 

(d) Statement that the Subject or Subject's representative will be notified in a timely manner 

if  significant new findings develop during the course of the research which may affect the Subject's 
willingness to continue   participation will be provided. 

(e) A statement that the particular treatment or procedure may involve risks to the Subject (or 

to the embryo or fetus, if the Subject is or may become pregnant), which are currently  
unforeseeable 

(f)   Approximate number of Subjects enrolled in the study. 

1. Subs. by G.S.R. 53(E), dt. 30-01-2013.                                          3. G.S.R. 611(E), dt. 31-7-2015. 
2. Subs. by G.S.R. 889(E), dt. 12-12-2014. 

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2. Format of informed consent form for Subjects participating in a clinical trial 
Informed Consent form to participate in a clinical trial 
Study Title:  
Study Number: 
Subject‘s Initials:  _________ 
Date of Birth / Age:  _______ 
1[Address of the Subject______________ 
Qualification ______________________ 
Occupation: Student/Self-Employed/ Service/Housewife/Others (Please tick as appropriate) 
Annual Income of the subject __________________ 
Name and address of the nominee(s) and his relation to the subject ________ (for the purpose of 
compensation in case of trial related death).] 

                                   Subject‘s Name: ______________ 

Please initial box 

       (Subject) 

(i)             I confirm that I have read and understood the information sheet dated                [         ] 

for the above study and have had the opportunity to ask questions. 

(ii)           I understand that my participation in the study is voluntary and that I am         [         ] 

(iii) 

free  to  withdraw  at  any  time,  without  giving  any  reason,  without  my 
medical care or legal rights being affected. 
I understand that the Sponsor of the clinical trial, others working on the         [         ] 
Sponsor‘s  behalf,  the  Ethics  Committee  and  the  regulatory  authorities 
will not need my permission to look at my health records both in respect 
of  the  current  study  and  any  further  research  that  may  be  conducted  in 
relation  to  it,  even  if  I  withdraw  from  the  trial.   I  agree  to  this  access. 
However,  I  understand  that  my  identity  will  not  be  revealed  in  any 
information released to third parties or published. 

(iv)           I  agree  not  to  restrict the  use  of  any  data or  results that  arise  from this         [        ] 

study provided such a use is only for scientific purpose(s) 

(v)            I agree to take part in the above study.                                                                   [         ] 

Signature       (or       Thumb       impression)       of       the       Subject/Legally       Acceptable 
Representative:  _________________________________________________________________ 

Date:          /        _/  

Signatory‘s Name:  

Signature of the Investigator:  _______________________________________________ 
Date:Study Investigator‘s Name:   
Signature of the Witness   
Date:          /          /  
Name of the Witness:                                                                 

1[Copy  of  the  Patient  Information  Sheet  and  duly  filled  Informed  Consent  Form  shall  be 
handled over to the subject or his/her attendant.] 

1. Ins. by G.S.R 53(E), dt. 30-01-2013 

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APPENDIX VI 

FIXED DOSE COMBINATIONS (FDCs) 

Fixed  Dose  Combinations  refer  to  products  containing  one  or  more  active  ingredients  used  for  a 
particular indication(s). FDCs  can  be  divided  into  the  following groups  and  data required for approval 
for marketing is described below: 

(a)   The first group of FDCs includes those in which one or more of the active ingredients is a 
new  drug.   For  such  FDCs  to  be  approved  for  marketing  data  to  be submitted will be similar to data 
required for any new drug (including clinical trials) [see rule 122E, item (a)]. 

(b)(i)  The  second  group  FDCs 

ingredients  already 
approved/marketed  individually  are  combined  for  the  first  time,  for  a  particular  claim  and  where  the 
ingredients  are  likely  to  have  significant  interaction  of  a  pharmacodynamic or pharmacokinetic nature 
[see rule 122E, item (c)].   If clinical trials have been carried out with the FDC in other countries, reports 
of  such  trials  should  be  submitted.    If  the  FDC  is  marketed  abroad,  the  regulatory  status  in  other 
countries should be stated. (see Appendix I, item 9). 

in  which  active 

includes 

those 

(ii)  For  marketing permission, appropriate chemical and  pharmaceutical data  will be submitted. 
In case such a combination is not marketed anywhere in the world but these drugs  are  already  in  use 
concomitantly  (not  as  an  FDC  but  individually)  for  the  said  claim,  marketing  permission  may  be 
granted based on  chemical and  pharmaceutical data. Data showing the stability of the proposed dosage 
form will also have to be submitted. 

(iii)     For  any  other  such  FDCs,  clinical  trials  may  be  required.    For  obtaining permission to 
carry  out  clinical  trials  with  such  FDCs  a  summary  of  available  pharmacological,  toxicological  and 
clinical  data  on   the  individual ingredients should be submitted, along with the rationale for combining 
them in the proposed ratio.  In addition, acute toxicity data (LD 50) and pharmacological data should be 
submitted on the individual ingredients as well as their combination in the proposed ratio. 

(c)     The  third  group  of  FDCs  includes  those  which  are  already  marketed,  but  in  which  it  is 
proposed either to change the ratio of active ingredients or to make a new therapeutic claim.   For  such 
FDCs,  the  appropriate  rationale  including  published  reports  (if  any)  should  be  submitted  to  obtain 
marketing  permission.    Permission  will  be  granted  depending  upon  the  nature  of  the  claim  and  data 
submitted. 

(d)   The fourth group of FDC includes those whose individual active ingredients (or drugs from 
the  same  class)  have  been  widely  used  in  a  particular  indication(s) for  years, their  concomitant use  is 
often  necessary  and  no  claim  is  proposed  to  be  made  other  than  convenience.  It  will  have  to  be 
demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant 
interaction of a pharmacodynamic or pharmacokinetic nature. 

No additional animal or human data are generally required for these FDCs, and marketing permission may 
be granted if the FDC has an acceptable rationale. 

APPENDIX VII  

UNDERTAKING BY THE INVESTIGATOR 

1.      Full  name,  address  and  title  of  the  Principal  Investigator  (or  Investigator(s)  when  there  is  no 
Principal Investigator) 

2.    Name and address of the medical  college, hospital or other facility  where the clinical trial  will  be 
conducted:   Education, training  &  experience  that  qualify  the  Investigator for  the clinical  trial  (Attach 
details including Medical Council registration number, and / or any other statement(s) of qualification(s)) 

3.     Name and address of all clinical laboratory facilities to be used in the study. 

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4.      Name  and  address  of  the  Ethics  Committee  that  is  responsible  for  approval  and continuing 
review of the study. 

5.      Names  of  the  other  members of  the  research team  (Co-  or  sub-Investigators) who will be 
assisting the Investigator in the conduct of the investigation (s). 

6.      Protocol Title and Study number (if any) of the clinical trial to be conducted by the 
Investigator. 

7.      Commitments: 

(i) 
I  have  reviewed  the  clinical  protocol  and  agree  that  it  contains  all  the  necessary 
information        to  conduct  the  study.    I  will  not  begin  the  study  until  all  necessary  Ethics 
Committee and regulatory approvals have been obtained. 
(ii) 
I  agree  to  conduct  the  study  in  accordance  with  the  current  protocol.    I  will  not 
implement  any  deviation  from  or  changes  of  the  protocol  without  agreement  by  the Sponsor 
and prior review and documented approval / favorable opinion from the Ethics Committee  of  the  
amendment,    except    where    necessary    to    eliminate    an    immediate  hazard(s)  to    the  trial  
Subjects  or  when  the  change(s)  involved  are  only  logistical  or administrative in nature. 
(iii) 
I agree to personally conduct and/or supervise the clinical trial at my site. 
(iv) 
I agree to inform all Subjects, that the drugs are being used for investigational purposes 
and  I  will  ensure  that  the  requirements  relating  to  obtaining  informed  consent  and  ethics 
committee review and approval specified in the GCP guidelines are met. 
(v) 
investigation(s) in accordance with the regulatory and GCP guidelines. 

I  agree to  report to the  Sponsor all  adverse experiences that  occur in  the course of the 

(vi) 
potential risks and side effects of the drug. 

I have read and understood the information in the Investigator's brochure, including the 

(vii) 
I  agree to  ensure that  all  associates, colleagues and  employees assisting in  the conduct 
of  the  study  are  suitably  qualified  and  experienced  and  they  have  been  informed  about  their 
obligations in meeting their commitments in the trial. 

(viii) 
I  agree  to  maintain adequate and  accurate  records and  to  make  those  records available 
for  audit  /  inspection by  the  Sponsor, Ethics  Committee, Licensing Authority or their authorized 
representatives, in  accordance with regulatory and GCP provisions.  I  will fully   cooperate   with  
any  study  related  audit  conducted  by  regulatory  officials  or authorized representatives of the 
Sponsor. 
(ix) 
activities and all unanticipated problems involving risks to human Subjects or others. 

I  agree  to  promptly  report  to  the  Ethics  Committee  all  changes  in  the  clinical  trial 

(x) 
Ethics Committee within seven days of their occurence. 

I  agree  to  inform  all  unexpected  serious  adverse  events  to  the  Sponsor  as  well  as the 

(xi) 
assure security and  confidentiality of study data. 

I will maintain confidentiality of the identification of all participating study patients and 

(xii) 
applicable to clinical Investigators participating in clinical trials 

I  agree  to  comply  with  all  other  requirements,  guidelines  and  statutory  obligations  as 

8.   Signature of Investigator with Date 

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Drugs and Cosmetics Rules, 1945 
APPENDIX VIII  

ETHICS COMMITTEE 

1[I. Requirements and guidelines for registration  of Ethics Committee 
1. Scope: 
           Ethics  Committee  shall  review  every  clinical  trial  proposal  and  evaluate  the  possible 
risks  to  the  subjects,  expected  benefits  and  adequacy  of  documentation  for  ensuring  privacy, 
confidentiality and justice.  In the case of any serious adverse event occurring to the clinical trial 
subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion  as 
per procedures specified in APPENDIX XII of Schedule Y. 

2.  Composition of Ethics Committee: 

(a)  Ethics  Committee  shall    consist  of  not  less  than  seven  members  and  one  among  its 
members, who is from outside the institute, shall be appointed as Chairman; one member as a 
Member Secretary and rest of the members shall be from Medical, Scientific, Non-medical  and 
Non-scientific fields including lay public. 

(b)  The  committee  shall  include  at  least  one  member    whose  primary  area  of  interest  or 
specialization is Non-scientific and at least one member who is independent of the institution. 
Besides, there should be appropriate gender representation on the Ethics Committee. 

(c) The Ethics Committee can  have as its members, individuals from other 
Institutions or Communities, if required. 
(d) Members should be conversant with the provisions of clinical trials under this Schedule, 
Good Clinical Practice Guidelines for clinical trials in India and other regulatory requirements 
to safeguard the rights, safety and well- being of the trial subjects. 

(e)    For  review  of  each  protocol  the  quorum  of  Ethics  Committee  shall  be  at  least  five 

members with the following representations: 

(i) Basic medical scientist (preferably one pharmacologist) 
(ii) Clinician;  
(iii) Legal expert; 
(iv)  Social  scientist  or  representative  of  non-governmental  voluntary  agency  or 

philosopher or ethicist or theologian or a similar person; 

(v)  Lay person from community. 
(f)  The members representing medical scientists and clinicians should have post graduate 
qualification  and  adequate  experience  in  their  respective  fields  and  aware  of  their 
role and responsibilities as committee members. 

(g) As far as possible,  based on the requirement of research area such as HIV, Genetic 
disorder  etc.,  specific  patient  group  may  also  be  represented  in  the  Ethics 
Committee. 

(h)  There  should  be no conflict  of interest.   The members shall  voluntarily withdraw 
from  the  Ethics  Committee  meeting  while  making    a  decision  on  an  application 
which  evokes    a  conflict  of  interest  which  may  be  indicated  in  writing  to  the 
Chairman prior to the review and be recorded so in the minutes. All members shall 
sign a declaration  on conflict of interest. 

(i)    Subject experts or other experts may be invited  to the meetings for their advice. But 

no such expert shall have voting rights. 

Information  required to be submitted by the applicant for registration of Ethics 

3. 
Committee: 

(a) Name of the Ethics Committee 
(b)  Authority  under  which  the  Ethics    Committee  has  been  constituted,    membership 
requirements,    the  term  of  reference,  conditions    of  appointment    and  the  quorum 
required. 

1. Subs. by G.S.R. 72(E), dt. 8-2-2013. 

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(c) The procedure for resignation, replacement or removal of members.  
(d) Address of the office of the Ethics Committee. 
(e)    Name,  address,  qualification,  organizational  title,  telephone  number,  fax  number, 

email, mailing address and brief profile of the Chairman. 

(f)   Names, qualifications, organizational title, telephone number, fax number, e-mail and 
mailing address of the members of the Ethics Committee.  The information shall also 
in  clude  member  ‘s specialty  (pr  imary,    scientific   or  non  -scientific),    member  ‘s 
affiliation with institutions and patient group representation, if any. 

(g) Details of the supporting staff. 
(h) In the case of Ethics Committees existing before the publication of the Drugs and 
Cosmetics (Third Amendment) Rules, 2013,- 

(i)    Type  of  clinical  research  reviewed  by  the  committee  (e.g.  pharmaceuticals, 

devices, epidemiological,  retrospective, herbals, etc.) 

(ii) Documents reviewed for every clinical trial  protocol including Informed 

Consent documents. 

(iii)  In  for  mation    in    respect  of  number  of  meetings    of  the  committee    and 
documentation  of  the  minutes  of  meetings  of  these  committees  concerning 
clinical trials. 

(iv)  Information  regarding  review  of  serious  adverse  events  reported  during  the 

conduct of the trial. 

(i)  The Standard Operating Procedures to be followed by the committee in general. 
(j)    Standard  Operating    Procedures  to  be  followed    by  the  committee  for  vulnerable 

population. 

(k)  Policy  regarding  training  for  new  and  existing  committee  members  along  with 

Standard Operating Procedures. 

(l)  Policy to monitor or prevent the conflict of interest along with Standard Operating 

Procedures. 

(m) If the committee has been audited or inspected before, give details. 

4.   Maintenance of record: 

All  documentation and communication of an Ethics Committee are to be dated, filed and 
preserved according to the Standard Operating  Procedures.   Strict confidentiality shall 
be maintained during access and retrieval  procedures.   Records should  be maintained  
for the following, namely:- 

(a) The constitution and composition of the Ethics Committee; (b) The curriculum vitae 

of all the committee members; 

(c)  Standard  Operating  Procedures  followed  by  the  committee;  (d)  National  and 

international guidelines; 

(e)  Copies of the protocol,  data collection formats, Case Report  Forms,  Investigator‘s 

brochures, etc, submitted for review; 

(f)  All  correspondence  with  committee  members  and  Investigators  regarding 

application, decision and follow up; 

(g) Agenda of all Ethics Committee meetings; 
(h)  Minutes  of  all  Ethics  Committee  meetings  with  signature  of  the  Chairman;  (i)  

Copies of decisions communicated to the applicants; 

(j)  Record  of  all  notification  issued  for  premature  termination  of  a  study  with  a 

summary of the reasons; 

(k)  Final report of the study including  microfilms, compact disks or video-recordings. 
All  records  shall  be  safely  maintained  after  the  completion  or  termination  of  the 
study for not less than five years from the date of completion or termination of the 
trial (Both in hard and soft copies). 

5.  The Ethics Committee shall be open to inspection by the officers authorized by the Central 
Drugs Standard Control Organization, who may include an officer of the State Drug Control 
Authority concerned, to verify compliance to the requirements of Schedule Y, Good Clinical 
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well-being of the trial subjects.] 

Drugs and Cosmetics Rules, 1945 

III. Format for According Approval to clinical trial protocol by the Ethics Committee.]  

To 

Dr. 

Dear Dr.   

The  Institutional  Ethics  Committee  /  Independent  Ethics  Committee  (state  name  of  the 
committee,  as  appropriate)  reviewed  and  discussed  your  application  to  conduct  the  clinical  trial 
entitled ―……‖ on …….(date). 

The following documents were reviewed: 

(a) Trial Protocol (including protocol amendments), dated                         Version no (s).    
(b) Patient  Information  Sheet  and  Informed  Consent  Form  (including  updates  if any) in English and/or 
vernacular language. 
(c) Investigator‘s Brochure, dated                  , Version no.  
(d) Proposed   methods   for   patient   accrual   including   advertisement   (s)   etc. proposed to be used for 
the purpose. 
(e) Principal Investigator‘s current CV. 
(f) Insurance  Policy  /  Compensation  for  participation  and  for  serious  adverse events occurring during 
the study participation. 

(g) Investigator‘s Agreement with the Sponsor.  

(h) Investigator‘s Undertaking  (Appendix VII). 

The  following  members  of  the  ethics  committee  were  present  at  the  meeting  held  on  (date,  time, 
place). 
                     Chairman of the Ethics Committee 

                     Member secretary of the Ethics Committee 

                     Name of each member with designation 

We approve the trial to be conducted in its presented form. 

The  Institutional  Ethics  Committee  /  Independent  Ethics  Committee  expects  to  be  informed  about  the 
progress of  the  study,  any  SAE  occurring in  the  course  of  the  study,  any changes  in  the  protocol  and 
patient information/informed consent and asks to be provided a copy of the final report. 

Yours sincerely, 

Member Secretary, Ethics Committee. 

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Drugs and Cosmetics Rules, 1945 

APPENDIX IX 

STABILITY TESTING OF NEW DRUGS 

Stability testing is to be performed to provide evidence on how the quality of a drug substance or 
formulation varies with time  under the  influence of various environmental factors such  as  temperature, 
humidity and light, and to establish shelf life for the formulation and recommended storage conditions. 

Stability studies should include testing of those attributes of the drug substance that are susceptible 
to  change  during  storage  and  are  likely  to  influence  quality,  safety,  and/or  efficacy.  In    case  of  
formulations  the    testing  should  cover,  as    appropriate,  the    physical,  chemical,  biological,  and 
microbiological  attributes,  preservative  content  (e.g.,  antioxidant,  antimicrobial  preservative),  and 
functionality tests (e.g., for a dose delivery system). 

Validated  stability-indicating  analytical  procedures  should  be  applied.      For  long  term  studies, 

frequency of testing should be sufficient to establish the stability profile of the drug substance. 

In  general,  a  drug  substance  should  be  evaluated  under  storage  conditions  that  test  its  thermal 
stability  and,  if  applicable, its  sensitivity  to  moisture.  The  storage  conditions and  the length of studies 
chosen should be sufficient to cover storage, shipment and subsequent use. 

Stress testing of the drug substance should be conducted to identify the likely degradation products, 
which  in  turn  establish  the  degradation  pathways,  evaluate  the  intrinsic  stability  of  the  molecule  and 
validate the stability indicating power of the analytical procedures used. The nature of the stress testing 
will depend on the individual drug substance and the type of formulation involved. 

Stress  testing  may  generally  be  carried  out  on  a  single  batch  of  the  drug  substance.  It  should  
include  the  effect  of  temperatures  ),  humidity  where  appropriate,  oxidation,  and photolysis on the 
drug substance. 

Data should be provided for (a) Photostability on at least one primary batch of the drug substance 
as  well  as  the  formulation,  as  the  case  may  be  and  (b)  the  susceptibility  of  the  drug  substance  to 
hydrolysis across a wide range of pH values when in solution or suspension. 

Long-term  testing  should  cover  a  minimum  of  12  months‘  duration  on  at  least  three  primary 
batches of the drug substance or the formulation at the time of submission and should be  continued  for  a 
period  of  time  sufficient  to  cover  the  proposed  shelf  life.  Accelerated  testing  should  cover  a 
minimum of 6 months duration at the time of submission. 

In  case of  drug substances, the batches should be  manufactured to  a  minimum of  pilot scale  by  the 
same synthetic route and using a method of manufacture that simulates the final process to  be  used for 
production batches.  In case of formulations, two of the three batches should be at  least  pilot scale  and 
the  third  one  may  be  smaller.  The  manufacturing process(es) used  for primary batches should simulate 
that to be applied to production batches and should provide products of the same quality and meeting the 
same specifications as that intended for marketing. 

The stability  studies for drug substances should be conducted either in the same container - closure 
system  as  proposed  for  storage  and  distribution  or  in  a  container  -  closure  system  that  simulates  the 
proposed final packaging.  In case of formulations, the stability studies should be conducted in the final 
container - closure system proposed for marketing. 

Stability Testing of new drug substances and formulations: 

(i)  Study  conditions  for  drug  substances  and  formulations  intended  to  be  stored under 

general conditions 

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Study 

Long term 

Accelerated 

Study conditions 

30°C ± 2°C/65% RH ± 5% RH 

40°C ± 2°C/75% RH ± 5% RH 

Duration of study 

12 months 

6 months 

If at any time during 6 months‘ testing under the accelerated storage condition, such changes occur that 
cause  the  product  to  fail  in  complying  with  the  prescribed  standards,  additional  testing    under    an  
intermediate  storage  condition  should  be  conducted  and evaluated against significant change criteria. 

(ii)  Study conditions for drug substances and formulations intended to be stored in a refrigerator 

Study 

Long term 

Accelerated 

Study conditions 

5°C ± 3°C 

25°C ± 2°C/60% RH ± 5% RH 

Duration of study 

12 months 

6 months 

(iii) Study conditions for drug substances and formulations intended to be  stored in a freezer 

Study                      Study conditions                                    Duration of study____________________ 

Long term               - 20°C ± 5°C                                          12 months 

(iv)      Drug substances intended for storage below -20°C shall be treated on a case-by-

case basis. 

(v)   Stability  testing  of  the  formulation  after  constitution  or  dilution,  if  applicable, 
should  be  conducted  to  provide  information  for  the  labelling  on  the  preparation,  storage 
condition,  and  in-use  period  of  the  constituted  or  diluted  product.  This  testing  should  be 
performed on the constituted or diluted product through the proposed in-use period. 

CONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL 
TRIALS 

APPENDIX X 

1. Title Page 

(a)  Full title of the clinical study, 

(b) Protocol / Study number, and protocol version number with date 

(c)  The IND name/number of the investigational drug 
(d) Complete name and address of the Sponsor and contract research organization if any 
(e)   List   of   the   Investigators   who   are   conducting   the   study,   their   respective institutional 

affiliations and site locations 

(f) Name(s)   of   clinical   laboratories   and   other   departments   and/or   facilities participating in 

the study. 

2.  Table of Contents 

A complete Table of Contents including a list of all Appendices. 

1.   Background and Introduction 

(a)   Preclinical experience.  

(b)   Clinical experience. 

Previous  clinical  work  with  the  new  drug  should  be  reviewed  here  and  a  description  of  how  the 
current protocol extends existing data should be provided. If this is an entirely new indication, how this 
drug  was  considered  for  this  should  be  discussed.  Relevant  information  regarding  pharmacological, 
toxicological  and  other  biological  properties  of the drug/biologic/medical device, and previous efficacy 
and safety experience should be described. 

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2.  Study Rationale 

Drugs and Cosmetics Rules, 1945 

This  section  should  describe  a  brief  summary  of  the  background  information  relevant  to  the  study 
design  and  protocol  methodology.    The  reasons  for  performing  this  study  in  the  particular population 
included by the protocol should be provided. 

3.   Study Objective(s) (primary as well as secondray) and their logical relation to the study design. 

4.   Study Design 

(a)  Overview  of  the  Study  Design:  Including  a  description of  the  type  of  study  (i.e., double-blind, 
multicentre,  placebo  controlled,  etc.),  a  detail  of  the  specific  treatment  groups and  number  of  study  
Subjects  in   each  group  and  investigative  site,   Subject  number assignment, and the type, sequence 
and duration of study periods. 

(b) Flow chart of the study 

(c) A brief description of the methods and procedures to be used during the study. 

(d)  Discussion of  Study  Design:  This  discussion  details  the  rationale  for  the  design  chosen for this 

study. 

5. Study Population: the number of Subjects required to be enrolled in the study at the investigative site 
and  by  all  sites  along  with  a  brief  description  of  the  nature  of  the  Subject population required is also 
mentioned. 

6.  Subject Eligibility 

(a)   Inclusion Criteria 

(b)  Exclusion Criteria 

7.  Study Assessments – plan, procedures and methods to be described in detail 
8.  Study  Conduct  stating  the  types  of  study  activities  that  would  be  included  in  this  section 
would  be:  medical  history,  type  of  physical  examination,  blood  or  urine  testing,  electrocardiogram 
(ECG),  diagnostic  testing  such  as  pulmonary  function  tests,  symptom  measurement,  dispensation  and 
retrieval of medication, Subject cohort assignment, adverse event review, etc. 
Each visit should be described separately as Visit 1, Visit 2, etc. 

Discontinued  Subjects:  Describes  the  circumstances  for  Subject  withdrawal,  dropouts,  or  other 
reasons for  discontinuation of  Subjects  .   State  how  dropouts would be  managed and  if  they would be 
replaced, describe the method of handling of protocol waivers, if any.   The person(s) who approves all 
such waivers should be identified and the criteria used for specific waivers should be provided. 

Describes  how  protocol  violations  will  be  treated,  including  conditions  where  the  study  will  be 

terminated for non-compliance with the protocol. 

9. Study Treatment 

(a)  Dosing  schedule  (dose,  frequency,  and  duration  of  the  experimental  treatment) Describe the 
administration  of  placebos  and/or  dummy  medications  if  they  are  part  of  the  treatment  plan.  If 
applicable, concomitant drug(s), their doses, frequency, and duration of concomitant treatment should be 
stated. 

(b)  Study  drug  supplies  and  administration:  A  statement  about  who  is  going  to  provide the  study 
medication  and  that  the  investigational  drug  formulation  has  been  manufactured  following    all  
regulations       Details    of    the    product    stability,    storage    requirements   and  dispensing requirements 
should be provided. 

(c) Dose modification for study drug toxicity: Rules for changing the dose or stopping the study drug 

should be provided. 

(d)   Possible drug interactions. 
(e)  Concomitant  therapy:  The  drugs  that  are  permitted  during  the  study  and  the  conditions  under 
which they may be used are detailed here. Describe the drugs that a Subject is not allowed to use during 

629 

 
 
 
 
 
 
 
parts  of  or  the  entire  study.    If  any  washout  periods  for  prohibited  medications  are  needed  prior  to 
enrolment, these should be described here. 

(f) Blinding procedures: A detailed description of the blinding procedure if the study employs a blind 

Drugs and Cosmetics Rules, 1945 

on the Investigator and/or the Subject. 

(g)  Unblinding  procedures:  If  the  study  is  blinded,  the  circumstances in  which  unblinding  may  be 

done and the mechanism to be used for unblinding should be given. 

10.  Adverse  Events  (See  Appendix  XI):  Description  of  expected  adverse  events  should  be given. 

Procedures used to evaluate an adverse event should be described. 

11.  Ethical Considerations:  Give the summary of: 

(a) Risk/benefit assessment: 

(b) Ethics Committee review and communications.  

(c)     Informed consent process. 
(d) Statement   of   Subject   confidentiality   including   ownership   of   data   and   coding procedures. 

12. Study  Monitoring  and  Supervision:   A  description  of  study  monitoring  policies  and procedures 
should be provided along with the proposed frequency of site monitoring visits, and who is expected to 
perform monitoring. 

Case Record Form (CRF)   completion requirements, including who gets which copies of the forms   
and  any  specifics  required  in  filling  out  the  forms  CRF  correction  requirements,  including  who  is 
authorized  to  make  corrections  on  the  CRF  and  how  queries  about  study  data  are  handled  and  how 
errors, if any, are to be corrected should be stated. 

Investigator  study  files,  including  what  needs  to  be  stored  following  study  completion  should  be 

described. 

13. Investigational Product Management 

(a)  Give  Investigational  product  description  and  packaging  (stating  all  Ingredients  and  the 

formulation of the investigational drug and any placebos used in the study) 

(b) The precise dosing required during the study. 
(c) Method of packaging, labelling, and blinding of study substances. 
(d)  Method  of  assigning  treatments  to  Subjects  and  the  Subject  identification  code numbering 

system. 

(e) Storage conditions for study substances. 
(f) Investigational product accountability: Describe instructions for the receipt, storage, dispensation, 
and  return  of  the  investigational  products  to  ensure  a  complete  accounting  of  all  investigational 
products received, dispensed, and returned/destroyed. 

(g.) Describe policy and procedure for handling unused investigational products. 

14. Data Analysis: 

Provide  details  of  the  statistical  approach  to  be  followed  including  sample  size,  how  the 
sample  size  was  determined,  including  assumptions  made  in  making  this  determination,  efficacy 
endpoints (primary as well as secondary) and safety endpoints. 

Statistical analysis: Give complete details of how the results will be analyzed and reported along 
with  the  description  of  statistical  tests  to  be  used  to  analyze  the  primary  and  secondary  endpoints 
defined above.   Describe the level of significance, statistical tests to be used, and the methods used for 
missing  data;    method  of  evaluation  of  the  data  for  treatment  failures,  non-compliance,  and  Subject 
withdrawals; rationale and conditions for any interim analysis if planned. 
Describe statistical considerations for Pharmacokinetic (PK) analysis, if applicable. 

15.   Undertaking by the Investigator (see Appendix VII). 

630 

 
 
 
 
 
 
16.  Appendices:  Provide  a  study  synopsis,  copies  of  the  informed  consent  documents  (patient 
information  sheet,  informed  consent  form  etc.);  CRF  and  other  data  collection  forms;  a  summary  of 
relevant pre-clinical safety information and any other documents referenced in the clinical protocol. 

Drugs and Cosmetics Rules, 1945 

Data Elements for reporting serious adverse events occuring in a clinical trial 

APPENDIX XI 

1. 

Patient Details 

Initials & other relevant identifier (hospital/OPD record number etc.)* Gender 
Age and/or date of birth 

Weight 

2. 

Height 
Suspected Drug(s) 
Generic name of the drug*. 

Indication(s) for which suspect drug was prescribed or tested. Dosage form and strength. 
Daily dose and regimen (specify units - e.g., mg, ml, mg/kg).  
Route of administration. 
Starting date and time of day. 
Stopping date and time, or duration of treatment 

3.  Other Treatment(s) 

4. 

Provide  the  same  information  for  concomitant  drugs  (including  non  prescription/OTC 
drugs) and non-drug therapies, as for the suspected drug(s). 
Details of Suspected Adverse Drug Reaction(s) 
Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) 
for  regarding  the  report  as  serious.  In  addition  to  a  description  of  the  reported  signs  and 
symptoms, whenever possible, describe a specific diagnosis for the reaction.* 

Start date (and time) of onset of reaction.  

Stop date (and time) or duration of reaction.  

Dechallenge and rechallenge information. 
Setting (e.g., hospital, out-patient clinic, home, nursing home). 

5.  Outcome 

Information  on  recovery  and  any  sequelae;  results  of  specific  tests  and/or  treatment  that may 
have been conducted. 
For a  fatal outcome, cause of death and a comment on its  possible relationship to the suspected 
reaction; any post-mortem findings. 
Other information: anything relevant to facilitate assessment of the case, such as medical history 
including allergy, drug or alcohol abuse; family history; findings from special investigations etc. 
Details about the Investigator* 
Name 

6. 

Address 

Telephone number 

Profession (speciality) 
Date of reporting the event to Licensing Authority: 

Date of reporting the event to Ethics Committee overseeing the site:  
Signature of the Investigator 

Note: Information marked * must be provided.‖] 
631 

 
 
 
 
 
 
 
Drugs and Cosmetics Rules, 1945 

Compensation in case of injury or death during clinical trial 

1[APPENDIX XII 

2[(1) In case of an injury occurring to the subject during the clinical trial, free medical 
management shall be given as long as required or till such time it is established that 
the injury is not related to the clinical trial, whichever is earlier.] 

(2)  In case the injury occurring to the trial subject is related to the clinical trial, such 
subject  shall  also  be  entitled  for  financial  compensation  as  per  order  of  the 
Licensing  Authority  defined  under  clause  (b)  of  Rule  21  and  the  financial 
compensation  will  be  over  and  above  any  expenses  incurred    on  the  medical 
management of the subject.  3[In case, there is no permanent injury, the quantum of 
compensation  shall  be commensurate  with the  nature  of the  non-permanent  injury 
and loss of wages.] 

(3)  In the case of clinical trial related death of the subject, his/her nominee(s) would be 
entitled  for  financial  compensation  as  per  the  order  of  the  Licensing  Authority 
defined  under  clause  (b)  of  Rule  21,  and  the  financial  compensation  will  be  over 
and above any expenses incurred  on the medical management of the subject. 

(4) The financial compensation for clinical trial related injury or death could be in the 

form of:- 
(a)  Payment for medical management; 
(b)  Financial compensation for trail related injury; 
(c)  Financial compensation to nominee(s) of the trial subject in case of death; 
(d)  Financial  compensation  for  the  child  injured  in–utero  because  of  the 

participation of parent in clinical trial. 

(5)  The  Sponsor  or  his  representative,  whosoever  had  obtained  permission  from  the 
Licensing  Authority  for  conduct  of  the  clinical  trial  shall  provide  financial 
compensation, if the injury or death has occurred because of any or the following 
reasons, namely:- 

(a)  Adverse effect of investigational product(s); 
(b)  Any clinical trial procedures involved in the study; 
(c)  Violation  of  the  approved  protocol,  scientific    misconduct  or  negligence  by  the 

Sponsor or his representative or the Investigator; 

(d)  Failure  of  investigational  product  to  provide  intended  therapeutic  effect;  where, 
the  standard  care,  though  available,  was  not  provided  to  the  subject  as  per  the 
clinical trial protocol. 
 Use  of  placebo  in  a  placebo-controlled  trial,  where,  the  standard  care,    though 
available, was not provided to the subject as per the clinical trial protocol; 

(e) 

1. Ins. by  G.S.R. 53(E), dt. 30.1.2013. 
2. Subs. by  G.S.R. 889(E), dt. 12.12.2014. 
3. Ins. by  G.S.R. 889(E), dt. 12.12.2014. 

632 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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(f) 

 Adverse  effects  due  to  concomitant  medication  excluding  standard  care, 
necessitated as part of approved protocol; 

(g)  Injury to the child in-utero because of the participation of parent in clinical trial.  

(6)  Procedure for payment of financial compensation. 

(a)  The  Investigator  shall  report  all  serious  1[***]  adverse  events  to  the  Licensing 
Authority as defined under clause (b) of Rule 21, the Sponsor or his representative 
whosoever had obtained permission from the Licensing Authority for conduct of 
the  clinical  trial  and  the  Ethics  Committee  that  accorded  approval  to  the  study 
protocol,  within  twenty  four  hours  of  their  occurrence  as  per  Appendix  XI.  2[In 
case, the Investigator fails to report any serious adverse event within the stipulated 
period, he shall have to furnish the reason for the delay to the satisfaction of the 
Licensing Authority along with the report of the serious adverse event.] 

(b) (i) The cases of serious adverse events of death shall be examined as under: 

(A)  An  independent  Expert  Committee  shall  be  constituted  by  the  Licensing 
Authority as defined under Rule 21(b) to examine the cases and recommend to 
the  Licensing  Authority  for  the  purpose  of  arriving  at  the  cause  of  death  and 
quantum of compensation in case of clinical trial related death. 

(B)The Sponsor or his representative, whosoever had obtained permission from 
the  Licensing  Authority  for  conducting  the  clinical  trial  and  the  Investigator 
shall forward their reports on serious adverse event of death after due analysis 
to  3[***] the Licensing Authority as defined under Rule 21(b) and the head of 
the  Institution  where  the  trial  has  been  conducted  within  4[fourteen  days]  of 
occurrence of the serious adverse event of death. 

(C)  The  Ethics  Committee  shall  forward  its  report  on  serious  adverse  event  of 
death after due analysis along with its opinion on the financial compensation, if 
any,  to  be  paid  by  the  Sponsor or  his representative, whosoever  had  obtained 
permission  from  the  Licensing  Authority  as  defined  under  Rule  21(b)  for 
conducting  the  clinical  trial,  5[***]  to  the  Licensing  Authority  within  6[thirty 
days] of the occurrence of the serious adverse event of death. 

2[(CA)  The  Licensing  Authority  shall  forward  the  report  of  the  Investigator, 
Sponsor  or  his  representative  whosoever  had  obtained  permission  from  the 
Licensing  Authority  for  conducting  clinical trial  and the  Ethics  Committee  to 
the Chairman of the Expert Committee.] 

1. The word ―and unexpected‖ omitted by  G.S.R. 889(E), dt. 12.12.2014. 
2. Ins. by  G.S.R. 889(E), dt. 12.12.2014. 
3. The word ―Chairman of the Expert Committee with a copy of the report to‖ omitted by 

G.S.R. 889(E), dt. 12.12.2014. 

4. Subs. by  G.S.R. 889(E), dt. 12.12.2014. 
5. The word ―to the Chairman of the Expert Committee with a copy of the report‖ omitted by 

G.S.R. 889(E), dt. 12.12.2014. 

6. Subs. by  G.S.R. 889(E), dt. 12.12.2014. 

633 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules, 1945 

(D) The Expert Committee shall examine the report of serious adverse event of 
death  and  give  its  recommendations  to  the  Licensing  Authority  for  the 
purpose of arriving at the cause of the adverse event with in  1[one hundred 
and  five  days  of  the  occurrence  of  the  adverse  event,]  and  the  expert 
committee  while  examining  the  event,  may  take  into  consideration,  the 
reports  of  the  Investigator,  Sponsor  or  his  representative  whosoever  had 
obtained  permission  from  the  Licensing  Authority  for  conducting  the 
clinical trial and the Ethics Committee. 

(E) In the case of clinical trial related death, the Expert Committee shall also 
recommend the quantum of compensation to be paid by the Sponsor or his 
representative,  whosoever  had  obtained  permission  from  the  Licensing 
Authority as defined under Rule 21(b) for conducting the clinical trial. 

(F) The Licensing Authority shall consider the recommendations of the Expert 
Committee  and  shall  determine  the  cause  of  death  and  pass  orders  as 
deemed necessary. 

(G)  In  case  of  clinical  trial  related  death,  the  Licensing  Authority,  after 
considering  the  recommendations  of  the  Expert  Committee,  shall  decide 
the  quantum  of  compensation  to  be  paid  by  the  Sponsor  or  his 
representative,  whosoever  had  obtained  permission  from  the  Licensing 
Authority for conducting the clinical trial and shall pass  orders as deemed 
necessary  within  1[one  hundred  and  fifty  days  of  the  occurrence  of  the 
adverse event]. 

(ii) Cases of serious adverse events, other than deaths, shall be examined as under: 

(A) The Sponsor or his representative, whosoever had obtained permission 
from  the  Licensing  Authority  for  conducting  the  clinical  trial,  and  the 
Investigator  shall  forward  their  reports  on  serious  adverse  event,  after 
due  analysis,  to  the  Licensing  Authority  as  defined  under  Rule  21(b), 
Chairman of the Ethics Committee and the head of the Institution where 
the trial has been conducted within 1[fourteen days] of occurrence of the 
serious adverse event. 

(B) The  Ethics  Committee  shall  forward  its  report  on  the  serious  adverse 
event,  after  due  analysis  along  with  its  opinion  regarding  the  financial 
compensation,  if  any,  to  be  paid  by  the  Sponsor  or  his  representative, 
whosoever  had  obtained  permission  from  the  Licensing  Authority  as 
defined  under  Rule  21(b)  for  conducting  the  clinical  trial,  to  the 
Licensing  Authority  within  1[thirty  days]  of  occurrence  of  the  serious 
adverse event. 

(C) The  Licensing  Authority  shall  determine  the  cause  of  injury  and  pass 
order  as  deemed  necessary.  The  Licensing  Authority  shall  have  the 
option  to  constitute  an  independent  Expert  Committee,  wherever 
considered necessary, to examine such serious adverse events of injury, 
which will recommend to the Licensing Authority for arriving at the  

1. Subs. by  G.S.R. 889(E), dt. 12.12.2014. 

634 

 
 
 
 
 
 
 
 
 
 
 
 
 
Drugs and Cosmetics Rules, 1945 

      cause  considered  necessary,  to  examine  such  serious  adverse  events  of 
injury, which will recommend to the Licensing Authority for arriving at the 
cause of the injury and also the quantum of compensation in case of clinical 
trial  related  injury,  to  be  paid  by  the  Sponsor  or  his  representative 
whosoever  had  obtained  permission  from  the  Licensing  Authority  as 
defined under Rule 21(b) for conducting the clinical trial. 

(D) In case of clinical trial related injury, the Licensing Authority, shall decide 
the  quantum  of  compensation  to  be  paid  by  the  Sponsor  or  his 
representative  whosoever    had  obtained    permission    from  the  Licensing 
Authority for conducting the clinical trial and shall pass orders as deemed 
necessary  within  1[one  hundred  and  fifty  days  of  the  occurrence  of  the 
adverse event]. 

(c) The sponsor or his representative, whosoever had obtained permission  from the 
Licensing Authority for conducting the clinical trial shall pay the compensation 
in case of clinical trial related injury or death as per the order of the Licensing 
Authority as defined under Rule 21(b) within thirty days of the receipt of such 
order.] 

1. Subs. by  G.S.R. 889(E), dt. 12.12.2014. 

635 

 
 
 
 
 
 
