THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT, 1994 

_______ 

ARRANGEMENT OF SECTIONS 
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CHAPTER I 

PRELIMINARY 

SECTIONS 

1.  Short title, application and commencement. 
2.  Definitions. 

CHAPTER II 

AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS OR TISSUES OR BOTH 

3.  Authority for removal of human organs or tissues or both. 
4.  Removal of human organs or tissues or both not to be authorised in certain cases. 
5.  Authority for removal of human organs or tissues or both in case of unclaimed bodies in hospital 

or prison. 

6.  Authority  for  removal  of  human  organs  or  tissues  or  both  from  bodies  sent  for  post-mortem 

examination for medico-legal or pathological purposes. 

7.  Preservation of human organs or tissue or both. 
8.  Savings. 
9.  Restrictions on removal and transplantation of human organs or tissues or both. 

CHAPTER III 

REGULATION OF HOSPITALS 

10.  Regulation  of  hospital  conducting  the  removal,  storage  or  transplantation  of  human  organs  or 

tissue or both. 

11.  Prohibition  of  removal  or  transplantation  of  human  organs  or  tissues  or  both  for  any  purpose 

other than therapeutic purpose. 

12.  Explaining effects, etc., to donor and recipient. 

CHAPTER IV 

APPROPRIATE AUTHORITY 

13.  Appropriate Authority. 
13A. Advisory Committees to advise Appropriate Authority. 
13B. Powers of Appropriate Authority. 
13C. National Human Organs or tissues or both and Tissues Removal and Storage Network. 
13D. National registry. 

14.  Registration  of  hospitals  engaged  in  removal,  storage  or  transplantation  of  human  organs  or 

CHAPTER V 

REGISTRATION OF HOSPITALS 

tissues or both. 

14A. Registration of Tissue Bank. 
15.  Certificate of registration. 
16.  Suspension or cancellation of registration. 
17.  Appeals. 

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CHAPTER VI 

OFFENCES AND PENALTIES 

SECTIONS 

18.  Punishment for removal of human organ without authority. 
19.  Punishment for commercial dealings in human organs. 
19A. Punishment for illegal dealings in human tissues. 
20.  Punishment for contravention of any other provision of this Act. 
21.  Offences by companies. 
22.  Cognizance of offences. 

CHAPTER VII 

MISCELLANEOUS 

23.  Protection of action taken in good faith. 
24.  Power to make rules. 
25.  Repeal and savings. 

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THE TRANSPLANTATION OF 3[HUMAN ORGANS AND TISSUES] ACT, 1994 

ACT NO. 42 OF 1994 

[8th July, 1994.] 

An  Act 

to  provide  for 

the  regulation  of  removal,  storage  and 

transplantation  of                                   

1[human  organs  and  tissues  for  therapeutic  purposes  and  for  the  prevention  of  commercial 
dealings  in  human  organs  and  tissues]  and  for  matters  connected  therewith  or  incidental 
thereto. 

WHEREAS  it  is  expedient  to  provide  for  the  regulation  of  removal,  storage  and  transplantation  of 
2[human organs or tissues or both] for therapeutic purposes and for the prevention of commercial dealings 
in 2[human organs or tissues or both]; 

AND  WHEREAS  in  Parliament has no power to make  laws  for  the States with respect to any of the 

matters aforesaid except as provided in articles 249 and 250 of the Constitution; 

AND  WHEREAS  in pursuance of clause (1) of article  252  of  the Constitution,  resolutions have been 
passed by all the Houses  of  the Legislatures of the States of Goa, Himachal Pradesh and Maharashtra to 
the  effect  that the matters aforesaid should be regulated  in  those  States by Parliament by law; 

BE it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows:— 

CHAPTER I 

PRELIMINARY 

1. Short title, application and commencement.—(1) This Act may be called the Transplantation of 

3[Human Organs and Tissues] Act, 1994. 

(2)  It  applies,  in  the first instance, to  the  whole  of  the States  of Goa, Himachal Pradesh and 
Maharashtra and to all the  Union territories  and it shall also apply to such other State which  adopts this  
Act  by  resolution passed in that behalf under  clause  (1)  of article 252 of the Constitution. 

(3)  It  shall  come into force in the States  of  Goa,  Himachal Pradesh and Maharashtra and in all the 
Union territories on such  date4 as  the  Central Government may, by notification, appoint and  in  any 
other  State which adopts this Act under clause (1) of article 252  of the Constitution, on the date of such 
adoption; and any  reference  in this  Act  to the commencement of this Act shall, in relation  to  any State 
or Union territory, means the date on which this Act comes into force in such State or Union territory. 

2. Definitions.—In  this  Act,  unless  the   context   otherwise requires,— 

(a)  “advertisement”  includes  any  form  of   advertising whether  to  the public generally or to 

any  section  of  the public or, individually to selected persons; 

(b)  “Appropriate Authority” means the Appropriate Authority appointed under section 13; 

(c)  “Authorisation Committee” means the committee constituted under clause (a) or clause (b) of                   

sub-section (4) of section 9; 

(d)    “brain-stem    death”    means    the    stage    at    which      all  functions  of  the  brain-stem  have 

permanently and irreversibly ceased  and is so certified under sub-section (6) of  section 3; 

(e)  “deceased person” means a person in whom permanent disappearance  of  all  evidence of life 
occurs,  by  reason  of  brain-stem  death or in a cardio-pulmonary sense, at any  time after live birth 
has taken place; 

1. Subs. by Act 16 of 2011, s. 2, for “human organs for therapeutic purposes and for the prevention of commercial dealings in 

human organs” (w.e.f. 10-1-2014).  

2. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014).  
3. Subs. by s. 3, ibid., for “Human Organs” (w.e.f. 10-1-2014). 
4. 4th February, 1995, vide Notification No. S.O. 80(E), dated the 4th February, 1995, see Gazette of India, Extraordinary, Part II, 

sec. 3(ii). 

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(f)  “donor” means any person, not less than eighteen  years of age, who voluntarily authorises the 

removal  of  any  of  his  human    organs  for  therapeutic  purposes  under  sub-section  (1)  or                      
sub-section (2) of section 3; 

(g)  “hospital” includes  a nursing home,  clinic,  medical centre,  medical  or  teaching  institution  

for  therapeutic purposes and other like institution; 

(h)  “human organ” means any part of a human body consisting of  a structured arrangement of 

tissues which, if wholly,  removed, cannot be replicated by the body; 
 1[(ha) “Human Organ Retrieval Centre” means a hospital,— 

 (i)  which  has  adequate  facilities  for  treating  seriously  ill  patients  who  can  be  potential 

donours of organs in the event of death; and  

(ii) which is registered under sub-section (1) of section 14 for retrieval of human organs; 

(hb) “minor” means a person who has not completed the age of eighteen years;] 

            2[(i)  “near  relative”  means  spouse,  son,  daughter,  father,  mother,  brother,  sister,  grandfather, 

grandmother, grandson or granddaughter;] 

 (j)  “notification”  means a notification  published  in  the Official Gazette; 

(k)   “payment”  means payment in money or money’s worth  but does not include any payment 

for defraying or reimbursing— 

(i) the cost of removing, transporting or  preserving the 3[human organ or tissue or both] to be 

supplied; or 

(ii)  any  expenses  or loss of earnings incurred by a person so far as reasonably and directly  

attributable to his supplying any human organ from his body; 

(l)  “prescribed” means prescribed by rules made under  this  Act; 
(m)  “recipient”    means  a  person  into  whom  any    3[human    organ  or  tissue  or  both]  is,  or  is 

proposed to be, transplanted; 

(n)   “registered  medical  practitioner”  means  a   medical practitioner    who   possesses   any   
recognised    medical  qualification    as  defined  in  clause  (h)  of  section  2    of    the  Indian    Medical 
Council Act, 1956 (102 of 1956), and who is enrolled  on  a State  Medical  Register  as defined in 
clause  (k)  of  that section; 

(o)  “therapeutic  purposes”  means  systematic    treatment    of  any    disease  or  the  measures  to 

improve health  according  to any particular method or modality; 4*** 

5[(oa)  “tissue”  means  a  group  of  cells,  except  blood,  performing  a  particular  function  in  the 

human body; 

(ob)  “Tissue  Bank”  means  a  facility  registered  under  section  14A  for  carrying  out  any  activity 
relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not 
to include a Blood Bank;] 

 (p)  “transplantation”  means  the  grafting  of  any  human  organ  from    any    living    person  or 

deceased person  to  some  other living person for therapeutic purposes; 

 5[(q)  “transplant  co-ordinator”  means  a  person  appointed  by  the  hospital  for  co-ordinating  all 
matters relating to removal or transplantation of human organs or tissues or both and for assisting the 
authority for removal of human organs  in accordance with the provisions of sections 3.] 

1. Ins. by Act 16 of 2011, s. 5 (w.e.f. 10-1-2014). 
2. Subs. by s. 5, ibid., for clause (i) (w.e.f. 10-1-2014). 
3. Subs. by s. 4, ibid., for “human organ” (w.e.f. 10-1-2014). 
4. The word “and” omitted by s. 5, ibid. (w.e.f. 10-1-2014). 
5. Ins. by s. 5, ibid. (w.e.f. 10-1-2014). 

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CHAPTER II 
AUTHORITY FOR THE REMOVAL OF 1[HUMAN ORGANS OR TISSUES OR BOTH] 

3.  Authority    for  removal  of  1[human  organs  or  tissues  or  both].—(1)  Any  donor  may,  in  such  
manner  and  subject to such conditions as  may  be  prescribed, authorise  the  removal, before his death, 
of any 2[human organ or tissue or both]  of  his body for therapeutic purposes. 

 3[(1A) For the purpose of removal, storage or transplantation of such human organs or tissues or both, 
as may be prescribed, it shall be the duty of the registered medical practitioner working  in a hospital, in 
consultation with transplant co-ordinator, if such transplant co-ordinator is available,— 

(i) to ascertain from the person admitted to the Intensive Care Unit or from his near relative that 
such person had authorised at any time before his death the removal of any human organ or tissue or 
both of his body under sub-section (2), then the hospital shall proceed to obtain the documentation for 
such authorisation; 

(ii) where no such authority as referred to in sub-section (2) was made by such person, to make 

aware  to  that  person  or  near  relative  for  option  to  authorise  or  decline  for  donation  of                           
human organs or tissues or both; 

(iii) to require the hospital to inform in writing to the Human Organ Removal Centre for removal, 

storage  or  transplantation  of  human  organs  or  tissues  or  both  of  the  donor  identified  in                 
clauses (i) and (ii) in such manner as may be prescribed 
(1B)  The  duties  mentioned  under  clauses  (i)  to  (iii)  of  sub-section  (1A)  from  such  date,  as  may  be 
prescribed, shall also apply in the case of a registered medical practitioner working in an Intensive Care 
Unit  in  a  hospital  which  is  not  registered  under  this  Act  for  the  purpose  of  removal,  storage  or 
transplantation of human organs or tissues or both.] 

(2)    If    any  donor  had,  in  writing  and  in  the  presence  of  two    or  more    witnesses                                             

(at  least one of whom is a  near  relative  of  such person),  unequivocally authorised at any time before 
his  death,  the  removal  of  any  human  organ  of his  body,  after  his  death,  for therapeutic  purposes, 
the person lawfully in possession of  the  dead body of the donor shall, unless he has any reason to believe 
that    the  donor    had    subsequently  revoked  the  authority  aforesaid,  grant    to    a  registered    medical  
practitioner all reasonable  facilities  for  the removal,  for therapeutic purposes, of that 2[human organ or 
tissue or both] from the  dead body of the donor. 

(3)  Where  no  such authority as is referred to  in  sub-section (2), was made by any person before his 
death but no objection was also expressed  by such person to any of his 1[human organs or tissues or both]  
being used  after his death for therapeutic purposes, the person lawfully in  possession of  the dead body 
of such person may, unless he has reason to  believe that any near relative of the  deceased person has 
objection  to  any  of  the    deceased    person’s    1[human    organs  or  tissues  or  both]  being    used    for   
therapeutic  purposes,  authorise  the  removal  of  any  2[human  organ  or  tissue  or  both]  of  the  deceased 
person for its use for  therapeutic purposes. 

(4)    The  authority  given  under  sub-section  (1)  or  sub-section  (2)  or,    as  the  case  may  be,                          

sub-section  (3)  shall  be    sufficient    warrant  for  the  removal,  for  therapeutic  purposes,  of  the  2[human 
organ or tissue or both]; but  no such  removal  shall be made by any person other than  the  registered 
medical practitioner: 

 3[Provided  that  a  technician  possessing  such  qualifications  and  experience,  as  may  be  prescribed, 

may enucleate a cornea.] 

(5)    Where    any  2[human  organ  or  tissue  or  both]  is  to  be  removed  from  the  body    of    a  deceased  
person,    the  registered  medical  practitioner    shall    satisfy  himself,    before  such  removal,  by  a  personal 
examination of  the  body from  which any 2[human organ or tissue or both] is to be removed, that life is 
extinct    in  such  body  or,  where  it  appears  to  be  a  case  of  brain-stem  death,    that  such  death  has  been 
certified under  sub-section (6). 

(6)  Where  any 2[human organ or tissue or both] is to be removed from the body  of  a  person in the 
event of his brain-stem death, no such removal shall  be undertaken  unless such death is certified, in such 

1. Subs. by Act of 16 of 2011, s. 4, for “human organs” (w.e.f. 10-1-2014). 
2. Subs. by s. 4, ibid., for “human organ” (w.e.f. 10-1-2014). 
3. Ins. by s. 6, ibid. (w.e.f. 10-1-2014). 

5 

 
                                                           
form and  in  such manner and on satisfaction of such conditions and requirements as  may be  prescribed,  
by  a  Board of medical  experts  consisting  of  the following, namely:— 

(i)  the registered medical practitioner in charge  of  the hospital in which brain-stem death has 

occurred; 

(ii) an independent registered medical practitioner, being a specialist,  to  be  nominated  by  the  
registered      medical  practitioner  specified  in  clause  (i),  from  the  panel  of  names  approved  by  the 
Appropriate Authority; 

(iii)    a    neurologist  or  a  neurosurgeon  to  be    nominated    by  the  registered  medical  practitioner 

specified in clause  (i), from   the  panel  of  names  approved  by  the   Appropriate  Authority: 1*** 

 2[Provided  that  where  a  neurologist  or  a  neurosurgeon  is  not  available,  the  registered  medical 
practitioner  may  nominate  an  independent  registered  medical  practitioner,  being  a  surgeon  or  a 
physician and an anaesthetist or intensivist subject to the condition that they are not members of the 
transplantation team for the concerned recipient and to such conditions as may be prescribed;] 

(iv)  the registered medical practitioner treating the person whose brain-stem death has occurred. 

(7)  Notwithstanding anything contained in sub-section (3), where  brain-stem  death  of  any person, 
less than eighteen  years  of  age, occurs  and is certified under sub-section (6), any of the parents  of the  
deceased  person  may give authority, in such form  and  in  such manner  as may be prescribed, for the 
removal of any 3[human organ or tissue or both]  from the body of the deceased person. 

4. Removal of 4[human organs or tissues or both] not to be authorised in certain cases.—(1) No 

facilities  shall  be  granted  under  sub-section  (2)  of  section  3  and  no  authority  shall  be  given  under                  
sub-section (3) of that  section for the removal of any 3[human organ or tissue or both] from the body of a 
deceased person, if the person required to grant such facilities, or empowered to  give such authority, has 
reason to believe that an inquest may be  required to be held in relation to such body in pursuance of the 
provisions  of any law for the time being in force. 

(2) No authority for the removal of any 3[human organ or tissue or both] from the body of a deceased 
person  shall  be  given  by  a  person  to  whom  such  body  has  been  entrusted  solely  for  the  purpose  of 
interment, cremation or other disposal. 

5. Authority for  removal of 4[human organs or tissues or both] in  case  of  unclaimed bodies in 
hospital or  prison.—(1) In the case of a dead body lying in a  hospital or prison and not claimed by any 
of the near relatives  of the  deceased  person within forty-eight hours from the  time  of  the death  of the 
concerned person, the authority for the removal  of  any 3[human  organ or tissue or both] from  the dead 
body which so remains  unclaimed  may  be given,  in the prescribed form, by the person in charge, for 
the    time  being,    of  the  management  or  control  of  the  hospital  or  prison,  or    by  an    employee  of  such 
hospital or prison authorised in this  behalf  by the person in charge of the management or control thereof. 

(2)  No authority shall be given under sub-section (1) if the person empowered to give such authority 
has reason to believe that any near relative of the deceased person is likely to claim the dead body even 
though such near relative has not come forward to claim the body of the deceased person within the time 
specified in sub-section (1). 

6.  Authority  for  removal  of  4[human  organs  or  tissues  or  both]  from  bodies  sent  for                     

post-mortem  examination  for  medico-legal  or  pathological  purposes.—Where  the  body  of  a  person 
has been sent for post-mortem examination— 

(a) for medico-legal purposes by reason of the death of  such person having been caused by accident 

or any other  unnatural cause; or 

 (b) for pathological purposes,  

1. The word “and” omitted by Act 16 of 2011, s. 6 (w.e.f. 10-1-2014). 
2. Ins. by s. 6, ibid. (w.e.f. 10-1-2014). 
3. Subs. by s. 4, ibid., for “human organ” (w.e.f. 10-1-2014). 
4. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014). 

6 

 
                                                           
 
the person competent under this Act to give authority for the  removal of  any  1[human  organ or tissue or 
both] from such dead body may, if  he  has  reason  to believe that such 1[human organ or tissue or both] 
will not be required for the purpose for which  such body has been sent for post-mortem  examination,  
authorise  the    removal,    for  therapeutic  purposes,  of  that  1[human    organ  or  tissue  or  both]    of    the 
deceased  person  provided  that  he  is  satisfied  that  the  deceased  person  had    not  expressed,    before  his 
death, any objection to any  of  his 2[human organs or tissues or both] being used, for therapeutic purposes 
after  his  death    or,  where    he    had  granted  an  authority  for the  use  of  any    of   his    2[human  organs  or 
tissues  or  both]  for  therapeutic  purposes,  after  his  death,  such  authority    had  not  been  revoked  by  him 
before his death. 

7. Preservation  of 2[human organs or tissues or both].—After the removal of  any 1[human organ 
or tissue or both] from  the  body  of  any  person,  the   registered   medical practitioner  shall take such 
steps for the preservation of the  1[human organ or tissue or both] so removed as may be prescribed. 

8.  Savings.—(1)  Nothing  in  the  foregoing  provisions  of      this  Act  shall  be  construed  as  rendering 
unlawful any dealing with the body or with   any part of the body of a deceased person if such dealing 
would have been lawful if this Act had not been passed. 

(2)  Neither  the  grant  of any facility or  authority  for  the removal  of  any  1[human organ or tissue 
or  both]  from  the  body  of a    deceased    person   in  accordance    with   the provisions  of this  Act  nor the 
removal  oil  any 1[human  organ or tissue or both] from the body of a deceased person in pursuance  of  
such authority  shall be deemed to be an offence punishable  under  section  297 of the Indian  Penal Code 
(45 of 1860). 

9. Restrictions on removal and transplantation of 2[human organs or tissues or both].—(1) Save 
as otherwise provided in sub-section (3), no 1[human organ or tissue or both] removed from the body of a 
donor  before  his  death  shall  be  transplanted  into  a  recipient  unless  the  donor  is  a  near  relative  of  the 
recipient. 

 3[(1A) Where the donor or the recipient being near relative is a foreign national, prior approval of the 
Authorisation  Committee  shall  be  required  before  removing  or  transplanting  human  organ  or  tissue  or 
both: 

Provided that the Authorisation Committee shall not approve such removal or transplantation if the 

recipient is a foreign national and the donor is an Indian national unless they are near relatives. 

(1B) No human organs or tissues or both shall be removed from the body of a minor before his death 

for the purpose of transplantation except in the manner as may be prescribed. 

(1C)  No  human  organs  or  tissues  or  both  shall  be  removed  from  the  body  of  a  mentally  challenge 

person before his death for the purpose of transplantation. 
Explanation.—For the purpose of this sub-section,— 

(i) the expression “mentally challenged person” includes a person with mental illness or mental 

retardation, as the case may be; 

(ii)  the  expression  “mental  illness”  includes  dementia,  schizophrenia  and  such  other  mental 

condition that makes a person intellectually disables; 

(iii)  the  expression  “mental  retardation”  shall  have  the  same  meaning  as  assigned  to  it  in               

clause (r) of section 2 of the Persons With Disabilities (Equal Opportunities, Protection of Right  and 
Full Participation) Act, 1995 (1 of 1996).] 
(2)  Where  any donor authorises the removal of any of his  2[human organs or tissues or both]   after  
his  death under sub-section (2) of section 3 or  any person competent or empowered to give authority for 
the removal of any   1[human organ or tissue or both]  from the body  of any deceased person authorises  
such  removal, the   1[human organ or tissue or both] may be removed and transplanted into the body of  
any recipient who may be in need of such 1[human organ or tissue or both]. 

(3)  If  any  donor authorises the removal of any  of  his  2[human organs or tissues or both] before  his  
death  under  sub-section (1)  of  section  3  for transplantation  into  the body of such recipient, not  being  
a    near  relative,    as    is    specified  by  the  donor  by  reason    of    affection    or  attachment    towards    the 

1. Subs. by Act 16 of 2011, s. 4 for “human organ” (w.e.f. 10-1-2014). 
2. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014). 
3. Ins. by s. 7, ibid. (w.e.f. 10-1-2014). 

7 

 
                                                           
 
recipient or for any other  special  reasons, such  1[human  organ or tissue or both] shall not be removed 
and transplanted  without  the prior approval of the Authorisation Committee.  
2[(3A) Notwithstanding anything contained in sub-section (3), where— 

(a) any donor has agreed to make a donation of his human organ or tissue or both before his death 
to a recipient, who is his near relative, but such donor is not compatible biologically as a donor for the 
recipient; and  

(b) the second donor has agreed to make a donation of his human organ or tissue or both before 
his death to such recipient, who is his near relative, but such donor is not compatible biologically as a 
donor for such recipient; then 

(c)  the  first  donor  who  is  compatible  biologically  as  a  donor  for  the  second  recipient  and  the 
second donor is compatible biologically as a donor of a human organ or tissue or both for the first 
recipient  and  both  donors  and  both  recipients  in  the  aforesaid  group  of  donor  and  recipient  have 
entered into a single agreement to donate and receive such human organ or tissue or both according to 
such biological compatibility in the group,  

the  removal  and  transplantation  of  the  human  organ  or  tissue  or  both,  as  per  the  agreement  referred  to 
above, shall not be done without prior approval of the Authorisation Committee.] 

3[(4) (a)   The composition of the Authorisation Committee shall be such as may be prescribed by the 

Central Government from time to time. 

 (b)  The  State  Government  and  the  Union  territories  shall  constitute,  by  notification,  one  or  more 
Authorisation Committee consisting of such members as may be nominated by the State Government and 
the Union territories on such terms and conditions as may be specified in the notification for the purposes 
of this section.] 

(5)  On  an  application jointly made, in such form and  in  such manner  as  may  be prescribed, by 
the donor and  the  recipient,  the Authorisation  Committee  shall, after holding an  inquiry  and  after 
satisfying  itself  that  the applicants have complied  with  all  the requirements of this Act and tile rules 
made  thereunder,  grant  to    the  applicants    approval  for  the  removal  and  transplantation  of  the  human 
organ. 

(6)    If,  after  the  inquiry  and  after  giving  an  opportunity  to  the  applicants    of  being  heard,  the 
Authorisation Committee  is  satisfied that  the applicants have not complied with the requirements  of  
this  Act    and   the    rules   made  thereunder, it  shall,   for    reasons   to    be  recorded  in  writing,  reject the 
application for approval. 

CHAPTER III 

REGULATION OF HOSPITALS 

10.  Regulation  of  hospitals  conducting  the  removal,  storage  or  transplantation  of                    

4[human organs or tissues or both].—(1) On and from the commencement of this Act,—  

(a)  no hospital, unless registered under this  Act,  shall conduct, or associate with, or help in, the 

removal,  storage or transplantation of any 1[human organ or tissue or both;] 

(b)   no  medical  practitioner  or any  other  person  shall conduct,  or cause to be conducted, or 
aid  in    conducting    by  himself  or  through  any  other  person,  any  activity  relating  to  the  removal, 
storage  or  transplantation  of  any  1[human  organ  or  tissue  or  both]  at  a  place  other  than  a  place 
registered under this Act; 5*** 

1. Subs. by Act 16 of 2011, s. 4, for “human organ” (w.e.f. 10-1-2014). 
2. Ins. by s. 7, ibid. (w.e.f. 10-1-2014). 
3. Subs. by s. 7, ibid., for sub-section (4) (w.e.f. 10-1-2014). 
4. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014). 
5. The word “and” omitted by s. 8, ibid. (w.e.f. 10-1-2014) 

8 

 
                                                           
 
 
 
(c)   no  place  including a hospital registered  under  sub-section (1)   of  section 15 shall be used 
or cause  to  be used   by   any   person  for   the   removal,   storage   or transplantation  of  any 
1[human organ or tissue or both] except  for  therapeutic purposes; 2[and] 

 3[(d) no Tissues Bank, unless registered under this Act, shall carry out any activity relating to the 

recovery, screening, testing, processing, storage and distribution of tissues.] 

(2)  Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at 
any place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner. 

Explanation.—For the purposes of   this sub-section, “ears” includes ear drums and ear bones. 
11.  Prohibition  of  removal  or  transplantation  of  4[human  organs  or  tissues  or  both]  for  any  
purpose other than the rapeatic purposes.— No donor and no  person empowered  to give authority for 
the removal of any human organ  shall authorise  the removal of any 1[human organ or tissue or both] for 
any purpose  other  than therapeutic purposes. 

12. Explaining   effects,   etc.,  to  donor  and   recipient.— No registered  medical  practitioner  
shall  undertake  the  removal   or transplantation  of any  1[human organ or tissue or both] unless he has 
explained,    in    such  manner    as  may  be  prescribed,  all  possible  effects,  complications    and  hazards  
connected with the removal and transplantation to  the  donor and the recipient respectively.  

CHAPTER IV 

APPROPRIATE AUTHORITY 

13. Appropriate  Authority.—(1)  The  Central  Government   shall appoint,  by  notification,  one  
or  more  officers  as   Appropriate  Authorities for each of the Union territories for the purposes of this  
Act. 

(2)    The  State  Government  shall  appoint,  by  notification,  one  or  more  officers  as  Appropriate 

Authorities for the purposes of this Act. 

(3)  The Appropriate Authority shall perform the following functions, namely:— 

(i)  to  grant  registration  under  sub-section  (1)  of    section  15    or    renew    registration  under               

sub-section  (3)  of  that section; 

(ii) to suspend or cancel registration under sub-section (2) of section 16; 
 5[(iii) to enforce such standards, as may be prescribed,— 

(A) for hospitals engaged in the removal, storage or transplantation of any human organ: 
(B)  for  Tissue  Banks  engaged  in  recovery,  screening,  testing,  processing,  storage  and 

distribution of tissues;] 
(iv) to  investigate any complaint of breach of any  of  the provisions  of this Act or any of the 

rules  made  thereunder and take appropriate action; 
 6[(iva) to inspect Tissue Banks periodically;] 
(v)  to  inspect hospitals periodically for  examination  of the quality of transplantation and the   
follow-up  medical care to  persons  who have undergone transplantation  and  persons from whom 
organs are removed; and 

(vi) to undertake such other measures as may be prescribed. 

 7[13A. Advisory Committees to advise Appropriate Authority.—(1) The Central Government and 
and the State Governments, as the case may be, by notification, shall constitute an Advisory Committee 
for a period of two years to aid and advise the Appropriate Authority to discharge its functions. 

1. Subs. by Act 16 of 2011, s. 4, for “human organ” (w.e.f. 10-1-2014). 
2. The word “and” ins by s. 8, ibid. (w.e.f. 10-1-2014). 
3. Ins. by s. 8, ibid. (w.e.f. 10-1-2014). 
4. Subs. by s. 4, ibid., for “human organs” (w.e.f. 10-1-2014). 
5. Subs. by s. 9, ibid., for clause (iii) (w.e.f. 10-1-2014). 
6. Ins. by s. 9, ibid. (w.e.f. 10-1-2014). 
7. Ins. by s. 10, ibid. (w.e.f. 10-1-2014). 

9 

 
                                                           
(2) The Advisory Committee shall consist of— 

(a) one administrative expert not below the rank of Secretary to the State Government, to be 

nominated as Chairperson of the Advisory Committee; 

(b) two medical experts having such qualifications as may be prescribed; 
(c) one officer not below the rank of a Joint Director to represent the Ministry or Department 

of Health and Family Welfare, to be designated as Member-Secretary; 

(d) two eminent social workers of high social standing and integrity, one of whom shall be 

from amongst representatives of women’s organisation; 

(e) one legal expert who has held the position of an Additional District Judge or equivalent; 
(f) one person to represent non-governmental organisations or associations which are working 

in the field of organ or tissue donations or human rights; 

(g) one specialist in the field of human organ transplantation, provided he is not a member of 

the transplantation team. 

(3)  The  terms  and  conditions  for  appointment  to  the  Advisory  Committee  shall  be  such  as  may  be 

prescribed by the Central Government. 

13B. Powers of Appropriate Authority.—The Appropriate Authority shall for the purposes of this 
Act have all the powers of a civil court trying a suit under the Code of Civil Procedure, 1908 (5 of 1908) 
and, in particular, in respect of the following matters, namely:— 

(a) summoning of any person who is in possession of any information relating to violation of the 

provisions of this Act or the rules made thereunder; 

(b) discovery and production of any document or material object; 

(c)  issuing  search  warrant  for  any  place  suspected  to  be  indulging  in  unauthorised  removal, 

procurement or transplantation of human organs or tissues or both; and 

(d) any other matter which may be prescribed. 

13C.  National  Human  Organs  and  Tissues  Removal  and  Storage  Network.—The  Central 
Government may, by notification, establish a National Human Organs and Tissues Removal and Storage 
Network at one or more places and Regional Network in such manner and to perform such functions, as 
may be prescribed. 

13D.  National  registry.—The  Central  Government  shall  maintain  a  national  registry  of  the  donors 
and  recipients  of  human  organs  and  tissues  and  such  registry  shall  have  such  information  as  may  be 
prescribed to an ongoing evaluation of the scientific and clinical status of human organs and tissue.] 

CHAPTER V 

REGISTRATION OF HOSPITALS 

14.  Registration    of    hospitals    engaged    in    removal,    storage    or  transplantation  of                       

1[human organs or tissues or both].—(1) 2[No hospital (including Human Organ Retrieval Centre)] shall  
commence    any  activity    relating  to  the removal,  storage  or  transplantation   of   any  3[human    organ  or 
tissue or both] for therapeutic purposes after the commencement  of  this Act unless such hospital is duly 
registered under this Act: 

Provided   that   every  hospital  engaged,  either   partly   or exclusively,  in  any  activity relating to 
the  removal,  storage  or transplantation   of   any  3[human  organ or tissue or both]  for   therapeutic   
purposes  immediately    before    the    commencement  of  this  Act,    shall    apply    for  registration  within           
sixty days from the date of such commencement:  

Provided    further    that  every  hospital engaged    in    any    activity  relating  to the  removal,  storage  or 
transplantation of any 3[human organ or tissue or both] shall  cease  to engage in any such activity on the  
expiry  of  three months from the date of commencement of this Act unless such  hospital  has  applied  
for registration  and is go  registered  or  till  such application is disposed of, whichever is earlier. 

1. Subs. by Act of 16 of 2011, s. 4, for “human organs” (w.e.f. 10-1-2014). 
2. Subs. by s. 11, ibid., for “No hospital” (w.e.f. 10-1-2014). 
3. Subs. by s. 4,  ibid., for “human organ” (w.e.f. 10-1-2014). 

10 

 
                                                           
(2)    Every  application  for  registration  under  sub-section  (1)  shall  be  made  to  the  Appropriate 

Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed. 

(3)  No  hospital shall be registered under this Act  unless  the  Appropriate Authority is satisfied that 
such  hospital  is  in  a  position  to    provide    such  specialised  services  and  facilities,  possess)  such  skilled 
manpower and equipments and maintain such standards as may  be prescribed. 

 1[(4) No hospital shall be registered under this Act, unless the Appropriate Authority is satisfied that 
such hospital has appointed a transplant coordinator having such qualifications and experience as may be 
prescribed.] 

 2[14A.  Registration  of  Tissue  Bank.—(1)  No  Tissue  Bank  shall,  after  the  commencement  of  the 
Transplantation of Human Organs (Amendment) Act, 2011 (16 of 2011), commence any activity relating 
to  the  recovery,  screening,  testing,  processing,  storage  and  distribution  of  tissues  unless  it  is  duly 
registered under this Act: 

Provided that any facility engaged, either party or exlusively, in any activity relating to the recovery, 
screening, testing, processing, storage and distribution of tissues immediately before the commencement 
of  the  Transplantation  of  Human  Organs  (Amendment)  Act,  2011  (16  of  2011),  shall  apply  for 
registration as Tissues Bank within sixty days from the date of such commencement: 

Provided further  that  such facility  shall  cease to  engage  in  any  such activity  on the  expiry  of  three 

months  from  the  date  of  commencement  of  the  Transplantation  of  Human  Organs  (Amendement)               
Act, 2011 (16 of 2011), unless such Tissue Bank has applied for registration and is so registered, or till 
such application is disposed of, whichever is earlier. 

(2)  Every  application  for  registration  under  sub-section  (1)  shall  be  made  to  the  Appropriate 

Authority in such form and in such manner and shall be accompanied by such fees as may be prescribed. 

(3)  No Tissue  Bank  shall be  registered  under this  Act  unless  the  Appropriate Authority  is  satisfied 
that  such  Tissue  Bank  is  in  a  position  to  provide  such  specialised  service  and  facilities,  possess  such 
skilled manpower and equipments and maintain such standards as may be prescribed.] 

15. Certificate of  registration.—(1) The  Appropriate  Authority shall,  after holding an inquiry and 
after satisfying itself that  the applicant  has complied with all the requirements of this Act and  the  rules  
made    thereunder,  3[grant  to  the  hospital  or  to  the  tissue  Bank,  as  the  case  may  be,]    a    certificate    of 
registration  in  such  form,  for such period  and  subject  to  such conditions as may be prescribed. 

(2)    If,  after  the  inquiry  and  after  giving  an  opportunity  to  the  applicant  of  being  heard,  the 
Appropriate  Authority  is  satisfied  that  the  applicant  has  not  complied  with  the  requirement  of  this  Act  
and the  rules  made thereunder, it shall, for reasons to be  recorded  in writing, reject the application for 
registration.  

(3)  Every certificate of registration shall be renewed in such manner and on payment of such fees as 

may be prescribed. 

16.  Suspension      or      cancellation      of      registration.—(1)      The    Appropriate  Authority  may,                

suo motu or on complaint, issue a notice to any  4[hospital or Tissue Bank, as the case may be,] to show 
cause why its registration under this Act  should not be suspended or cancelled for the reasons mentioned 
in the notice. 

(2)  If, after giving a reasonable opportunity of being heard  to the  4[hospital or Tissue Bank, as the 
case may be,] the Appropriate Authority is satisfied that  there  has been  a breach of any of the provisions 
of this Act or the rules  made thereunder,  it may, without prejudice to any criminal action that  it may  
take  against such 4[hospital or Tissue Bank, as the case may be,] suspend its registration  for  such period 
as it may think fit or cancel its registration: 

1. Ins. by Act 16 of 2011, s. 11 (w.e.f. 10-1-2014). 
2. Ins. by s. 12, ibid. (w.e.f. 10-1-2014). 
3. Subs. by s. 13, ibid., for “grant to the hospital” (w.e.f. 10-1-2014). 
4. Subs. by s. 14, ibid., for “hospital” (w.e.f. 10-1-2014). 

11 

 
                                                           
Provided that where the Appropriate Authority is of the opinion that it is necessary or expedient so to 
do in the public interest, it may,  for reasons to be recorded in writing, suspend the  registration of any 
1[hospital or Tissue Bank, as the case may be,] without issuing any notice.  

17.  Appeals.—Any  person  aggrieved  by  an  order  of  the  Authorisation    Committee  rejecting  an 
application for approval under sub-section (6) of section 9, or any hospital  2[or Tissue Bank, as the case 
may  be,]  aggrieved  by  an  order  of  the  Appropriate    Authority  rejecting  an  application  for  registration 
under  sub-section  (2)  of  section  15  or an order of  suspension  or  cancellation  of registration  under 
sub-section (2) of section 16, may, within  thirty days  from the date of the receipt of the order, prefer an 
appeal,  in such manner as may be prescribed, against such order to— 

(i)  the Central Government where the appeal is against  the order of the Authorisation Committee 
constituted under clause  (a)  of sub-section (4) of section 9 or against the order  of the Appropriate 
Authority appointed under sub-section (1)  of section 13; or 

 (ii) the State Government, where the appeal is against  the order of the Authorisation Committee 
constituted under clause (b)  of sub-section (4) of section 9 or against the order  of the Appropriate 
Authority appointed under sub-section (2)  of section 13. 

CHAPTER VI 

OFFENCES AND PENALTIES 

18. Punishment for removal of human organ without authority.—(1) Any person who renders his 
services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or  helps  
in  any  manner  in,  the  removal  of  any  human  organ  without  authority,  shall  be    punishable  with 
imprisonment for a term which may extend  to 3[ten years and with fine which may extend to twenty lakh 
rupees]. 

(2)  Where  any  person  convicted under  sub-section  (1)  is  a registered  medical  practitioner, his 
name  shall  be reported    by    the  Appropriate    Authority    to  the  respective  State   Medical    Council    for 
taking    necessary    action  including  the removal  of  his  name    from    the  register    of    the    Council for a 
period of 4[three years] for  the  first offence and permanently for the subsequent offence. 

 5[(3) Any person who renders his services to or at any hospital and who conducts, or associates with 
or  helps  in  any  manner  in  the  removal  of  human  tissue  without  authority,  shall  be  punishable  with 
imprisonment for a term which may extend to three years and with fine which may extend to five lakh 
rupees.] 

19. Punishment for commercial dealings in human organs.—Whoever— 

(a)  makes or receives any payment for the supply of, or for an offer to supply, any human organ; 

(b)  seeks  to find a person willing to supply  for  payment any human organ; 

(c) offers to supply any human organ for payment; or 

(d)   initiates or negotiates any arrangement involving  the making  of any payment for the supply 

of, or for an offer  to supply, any human organ; 

(e)  takes  part  in the management or control of a body  of persons, whether a society, firm or 
company, whose activities consist of   or  include  the  initiation  or  negotiation  of   any arrangement 
referred to in clause (d); or 

(f)  publishes or distributes or causes to be  published  or distributed any advertisement,—            

(a)  inviting  persons  to supply for payment of  any  human organ; 

(b)  offering to supply any human organ for payment; or 

1. Subs. by Act 16 of 2011, s. 14, for “hospital” (w.e.f. 10-1-2014). 
2. Ins. by s. 15, ibid. (w.e.f. 10-1-2014). 
3. Subs. by s. 16, ibid., for “five years and with fine which may extend to ten thousand rupees” (w.e.f. 10-1-2014). 
4. Subs. by s. 16, ibid., for “two years” (w.e.f. 10-1-2014). 
5. Ins. by s. 16, ibid. (w.e.f. 10-1-2014). 

12 

 
                                                           
(c)  indicating that the advertiser is willing to  initiate or negotiate any arrangement referred 

to in clause (d); 
1[(g) abets in the preparation or submission of false documents including giving false affidavits to 
establish that the donor is making the donation of the human organs, as a near relative or by reason of 
affection or attachment towards the recipient, 

shall  be punishable with imprisonment for a term which shall  not  be less  than 2[five  years but which 
may extend to ten years and shall  be liable  to fine which shall not be less than twenty lakh rupees  but 
may extend to one crore rupees]. 

3* 
4[19A. Punishment for illegal dealings in human tissues.—Whoever— 

* 

* 

* 

* 

(a) makes or receives any payment for the supply of, or for an offer to supply, any human tissue; 

or 

(b) seeks to find a person willing to supply for payment and human tissue; or 
(c) offers to supply any human tissue for payment; or 
(d) initiates or negotiates any arrangement involving the making of any payment for the supply 

of, or for an offer to supply, any human tissue; or 

(e)  takes  part  in  the  management  or  control  of  a  body  of  persons,  whether  a  society,  firm  or 
company,  whose  activities  consist  of  or  include  the  initiation  or  negotiation  of  any  arrangement 
referred to in clause (d); or  

(f) publishes or distributes or causes to be published or distributed any advertisement— 

 (i) inviting persons to supply for payment of any human tissue; or 

(ii) offering to supply any human tissue for payment; or  

(iii) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to 

in clause (d); or 
(g) abets in the preparation or submission of false documents including giving false affidavits to 
establish that the donor is making the donation of the human tissues as a near relative or by reason of 
affection or attachment towards the recipient, 

shall be punishable with imprisonment for a term which shall not be less than  one year but which may 
extend to three years and shall be liable to fine which shall not be less than  five lakh rupees but which 
may extend to twenty-five lakh rupees.] 

20. Punishment  for contravention of any other provision  of  this  Act.—Whoever contravenes 
any provision of this Act or any rule made, or any condition of the registration granted, thereunder for 
which  no punishment  is  separately provided in this Act, shall  be  punishable with  imprisonment for a 
term which may extend to 5[five years or  with fine which may extend to twenty lakh rupees]. 

21.  Offences  by  companies.—-(1)  Where  any  offence  punishable  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,  if    he    proves    that    the  offence    was  committed  without  his  knowledge  or  that  be  had  
exercised all due diligence to prevent the commission of such offence. 

(2)  Notwithstanding anything contained in sub-section (1), where any offence punishable 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 

1. Ins. by Act 16 of 2011, s. 17 (w.e.f. 10-1-2014). 
2. Subs. by s. 17, ibid., for “two years but which may extend to seven years and shall be liable to fine which shall not be less than 

ten thousand rupees but may extend to twenty thousand rupees” (w.e.f. 10-1-2014). 

3. The proviso omitted by s. 17, ibid. (w.e.f. 10-1-2014). 
4. Ins. by s. 18, ibid. (w.e.f. 10-1-2014). 
5. Subs. by s. 19, ibid., for “three years or with fine which may extend to five thousand rupees” (w.e.f. 10-1-2014). 

13 

 
 
 
 
 
 
 
 
 
                                                           
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. 

Explanation.—For the purposes of this section,— 

(a)    “company”  means  any  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. 

 22. Cognizance of offences.—(1) No court shall take cognizance of an offence under this Act except 

on a complaint made by— 

 (a)    the    Appropriate    Authority  concerned,  or    any    officer  authorised    in  this  behalf  by  the 
Central Government  or  the State  Government  or, as the case may  be,  the  Appropriate  Authority; 
or; 

(b)    a    person  who  has  given  notice  of  not  less  than    sixty  days,  in  such  manner  as  may  be 
prescribed, to the Appropriate Authority  concerned,  of  the alleged  offence  and  of  his intention to 
make a complaint to the court. 

(2)  No court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the    first  class  

shall  try  any   offence punishable under this Act. 

(3)  Where  a  complaint has been made under clause (b)  of  sub-section  (1),  the  court may, on 
demand by such  person,  direct  the Appropriate  Authority  to  make available  copies  of  the  relevant 
records in its possession to such person. 

CHAPTER VII 

MISCELLANEOUS 

 23.  Protection    of    action    taken    in    good    faith.—(1)    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  in pursuance of the provisions of this Act. 

(2)    No    suit    or  other  legal  proceeding  shall    lie    against    the  Central    Government  or  the  State 
Government for any damage  caused  or likely  to  be  caused for anything which is in  good  faith  done  
or intended to be done in pursuance of the provisions of this Act. 

      24. Power to make rules.—(1) The Central Government may, by notification, make rules for carrying   
out the purposes of this Act. 

(2)    In  particular,  and  without  prejudice  to  the  generality  of  the  foregoing  power,  such  rules  may 

provide for all or any of the following matters, namely:— 

 (a)  the manner in which and the conditions subject to which any  donor  may authorise removal, 
before  his  death,    of    any  1[human  organ  or  tissue  or  both]  of    his  body  under  sub-section  (1A)  of 
section 3; 

2[(aa) the human organ or tissues or both in respect of which duty is cast on registered medical 
pracitioner the manner of obtaining documentation of authoirsation under clause (i) of sub-section 3; 

(ab)  the  manner  of  informing  the  Human  Organ  Retrieval  Centre  under  clause  (iii)  of                  

sub-section (1A) of section 3; 

(ac)  the  date  from  which  duties  mentioned  in  sub-section  (1A)  are  applicable  to  registered 

medical practitioner working  a unregistered hospital under sub-section (1B) of section 3; 

(ae)  the  qualification  and  experience  of  a  technician  under  the  proviso  to  sub-section  (4)  of 

section 3;]                                         

1. Subs. by Act of 16 of 2011, s. 4 for “human organ” (w.e.f. 10-1-2014). 
2. Ins. by s. 20, ibid. (w.e.f. 10-1-2014). 

14 

 
                                                           
(b)  the form and the manner in which a brain-stem death  is to be certified and the conditions and 

requirements which are to  be  satisfied for that purpose under sub-section  (6)  of section 3; 

1[(ba) the conditions for nomination of a surgeon or a physician and an anaesthetist or intensivist 

to be included in the Board of medical experts under the proviso to clause (iii) of sub-section (6) of 
section 3;] 

(c)    the  form  and  the  manner  in  which  any  of  the  parents  may  give    authority,  in  the  case  of    

brain-stem  death  of  a    minor,  for    the  removal  of  any  2[human  organ  or  tissue  or  both]  under                     
sub-section (7)  of section 3; 

(d)  the form  in which authority for the  removal  of  any 2[human organ or tissue or both] from 
an, unclaimed dead body may be given by  the person incharge of the management or control of the  
hospital or prison under sub-section (1) of section 5; 

(e)   the steps to  be taken  for  the  preservation  of the  2[human  organ  or  tissue  or  both]  removed 

from the body of any person, under section 7; 

 1[(ea) the manner of removal of human organs or tissues or both from the body of a minor before 

his death for transplantation under sub-section (1B) of section 9; 

(eb) the composition of the Authorisation Committees under sub-section (4) of section 9;] 

(f)  the form and the manner in which an application may  be jointly made by the donor and the 

recipient under sub-section (5) of section 9; 

(g)    the  manner  in  which  all  possible  effects,  complications  and  hazards  connected  with  the 
removal and transplantation is to be explained by the registered medical practitioner to the donor and 
the recipient under section 12; 

 (h)  the standards as are to be enforced by the  Appropriate Authority  for hospitals engaged in 
the removal,  storage  or transplantation of any 2[human organ or tissue or both] under clause (iii) of 
sub-section (3) of section 13; 

(i)  the other measures as the Appropriate Authority  shall undertake  in performing its functions 

under clause  (vi)  of sub-section (3) of section 13; 

 1[(ia) the qualifications of medical experts and the terms and conditions for appointment to 

Advisory committee under sub-sections (2) and (3) of section 13A; 

(ib) the power of the Appropriate Authority in any other matter under clause (d) of section 13B; 

(ic) the manner of establishment of a National Human Organs and Tissues Removal and Storage 

Network and Regional Network and functions to be performed by them under section 13C; 

(id) the information in the national registry of the donors and recipients of human organs and 

tissues and all information under section 13D;] 

(j)  the  form  and the manner in which an  application  for registration  shall  be  made  and the  

fee  which  shall  be accompanied, under sub-section (2)  of section 14; 

(k)    the    specialised    services    and  the    facilities    to    be  provided,  skilled  manpower  and  the 
equipments to be possessed and  the  standards  to  be  maintained  by  a  hospital  for registration, 
under sub-section (3) of section 14; 

 1[(ka)  the  qualifications  and  experience  of  a  transplant  co-ordinator  under  sub-section  (4)  of 

section 14; 

(kb) the form and the manner in which an application for registration shall be made and the fee 

which shall be accompanied, under sub-section (2) of section 14A; 

1. Ins. by Act 16 of 2011, s. 20 (w.e.f. 10-1-2014). 
2. Subs. by s. 4, ibid., for “human organ” (w.e.f. 10-1-2014). 

15 

 
                                                           
(kc) the specialised service and the facilities to be provided, skilled manpower and the equipment 

to  be  possessed  and  the  standards  to  be  maintained  by  a  Tissue  Bank,  under  sub-section  (3)  of            
section 14A;] 

(l)   the  form  in  which,  the period  for  which  and  the conditions subject to which certificate of 

registration is to be  granted to a 1[hospital or Tissue Bank], under sub-section (1)  of  section 15; 

(m)  the  manner  in which and the fee on payment  of  which certificate  of  registration  is to be  

renewed  under  sub-section (3) of section 15; 

(n)  the   manner in which an appeal may be  preferred  under section 17; 

(o)  the manner in which a person is required to give notice to  the Appropriate Authority of the 

alleged  offence    and    of  his  intention  to  make  a  complaint  to  the  court,  under    clause  (b)  of                      
sub-section (1) of section 22; and 

(p)  any other matter which is required to be, or  may  be, prescribed. 

(3)    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, 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 form  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. 

25.  Repeal  and  savings.—(1)  The  Ear  Drums  and  Ear  Bones  (Authority  for  Use  for  Therapeutic 
Purposes) Act, 1982 (28 of 1982) and the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 
(29 of 1982) are hereby repealed. 

(2)  The repeal shall, however, not affect the previous operation of the Acts so repealed or anything 

duly done or suffered thereunder. 

1. Subs. by Act 16 of 2011, s. 20, for “hospital” (w.e.f. 10-1-2014). 

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