LexThe Human organ transplantation act 1994
Madhya Pradesh · state statute
Open in Lexace · Ask the AI about this actF.N o. S. 1 2 0 1 1 / 0 7 / 2 0 16-M S
G o v e rn m e n t o f In d ia
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D e p a r tm e n t o f H e a lth a n d F a m ily W elfare
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T r a n s p la n ta tio n A ct, 1 9 9 4 (a s a m e n d e d in 2 0 1 1 )”. T h e re fo re , it h a s b e e n d e c id e d
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p re fe ra b ly by 2 5 th S e p te m b e r, 2 0 1 7 . T h e c o m m e n ts re c e iv e d a fte r th is p e rio d w ill
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G o v e rn m e n t o f In d ia
M in is try of H e a lth a n d F a m ily W elfare
D e p a r tm e n t o f H e a lth a n d F a m ily W elfare
M e d ic a l S e rv ic e s S e c tio n
S u b je c t:- E x p a n s io n o f d e fin itio n o f ‘ n e a r r e la tiv e s 1 u n d e r T r a n s p la n ta tio n of
H u m a n O r g a n s a n d T is s u e s A ct, 1 9 9 4 a n d th e ir a m e n d m e n t th e re o f-
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T r a n s p la n ta tio n o f H u m a n O rg a n s A ct w a s e n a c te d in 1 9 9 4 w ith th e
o b jec tiv e o f r e g u la tio n o f re m o v a l, s to ra g e a n d t r a n s p la n t a t i o n o f h u m a n
o r g a n s fo r th e r a p e u tic p u r p o s e s a n d for th e p r e v e n tio n o f c o m m e rc ia l
d e a lin g s in h u m a n o rg a n s . T h is A ct w a s s u b s e q u e n tly a m e n d e d by
T r a n s p la n ta tio n o f H u m a n O r g a n s (A m en d m e n t) A ct, 2 0 11 a n d th e title w a s
re v is e d a s T r a n s p la n ta tio n o f H u m a n O r g a n s a n d T is s u e s A ct, 1 9 9 4 .
2. T h e s a id a m e n d m e n t A ct in te r a lia a m e n d e d th e c la u s e (i) o f S e c tio n 2
of th e T r a n s p la n ta tio n of H u m a n O r g a n s a n d T is s u e s A ct, 1 9 9 4 w h ic h
p ro v id e s fo r th e d e fin itio n o f “n e a r re la tiv e ” a c c o r d in g to w h ic h “n e a r
re la tiv e ” m e a n t “spouse, son, daughter, father, mother, brother or sister.”
S u b s e q u e n tly , v id e th e a m e n d m e n t A ct, th e d e fin itio n of “n e a r re la tiv e ” w a s
e x p a n d e d “ grandfather, grandm other, grandson or granddaughter3 ’ w e re a lso
in c lu d e d in th e d e fin itio n o f “n e a r re la tiv e ”. T h u s , a s p e r c la u s e (i) o f th e
a m e n d m e n t A ct, 2 0 1 1 , n e a r re la tiv e m e a n s " s p o u s e , s o n , d a u g h te r , fa th e r,
m o th e r, b r o th e r , s is te r , g r a n d f a th e r , g r a n d m o th e r , g r a n d s o n , o r
g r a n d d a u g h te r .”
3. D u rin g th e c o u rs e o f tim e , it h a s b e e n o b s e rv e d t h a t th e e x p a n s io n o f
d e fin itio n o f n e a r r e la tiv e s ” h a s n o t led to a n y s ig n ific a n t in c r e a s e in
a v a ila b ility o f liv in g d o n o r s a s g r a n d p a r e n ts a re e ith e r too old to d o n a te o r
c a n ’t d o n a te d u e to s o m e a d v e rs e m e d ic a l c o n d itio n , a n d g r a n d c h ild re n a re
u s u a lly to o y o u n g to d o n a te o rg a n s . T h u s d e m a n d for o r g a n s o u tw e ig h s
th e ir s u p p ly . T h is M in is try h a s b e e n re c e iv in g a n u m b e r o f g rie v a n c e s
c o n c e r n in g to th e ‘ T r a n s p la n ta tio n o f H u m a n O r g a n s a n d T is s u e s A ct, 1 9 9 4 ’
oi w h ic h m a jo rity a r e r e q u e s ts fo r o r g a n s d u e to n o n -a v a ila b ility o f n e a r
re la tiv e d o n o r o r b lo o d g ro u p m is m a tc h w ith n e a r re la tiv e .
4. F u r th e r , in r e c e n t tim e s th e r e h a v e b e e n in c r e a s e d in c id e n ts o f o rg a n
tra d in g . T h is c a n a ls o b e a ttr ib u te d to m is m a tc h b e tw e e n s u p p ly a n d
d e m a n d o f o r g a n s . T h u s , it is felt t h a t th e d e fin itio n o f ‘ n e a r r e la tiv e s ’
r e q u ir e s to be e x p a n d e d f u r th e r so a s to in c r e a s e th e a v a ila b ility o f living
o rg a n d o n o rs .
5. In lig h t o f th e s a m e , th e G o v e rn m e n t o f In d ia is c o n s id e r in g to e x p a n d
th e d e fin itio n o f n e a r re la tiv e a n d a m e n d th e s e c tio n 2(1) b y in c lu d in g th e
follow ing:
(i) ste p fath er, ste p m other;
(ii) step brother, ste p siste r , step so n , ste p dau gh ter and th eir
sp ou ses;
(iii) sp o u se s o f s o n s and daughters o f recip ien t;
(iv) b roth ers and siste r s o f r e c ip ie n t’s sp ou se and th e ir sp ou ses;
(v) broth ers and siste r s o f r e c ip ie n t’s parents and th eir sp ou ses;
(vi) first c o u sin s [having com m on grandparent(s)] o f th e recip ien t and
th eir sp o u ses;
6. In view o f th e a b o v e , b e fo re r e a c h in g to a n y c o n c lu s io n , it h a s b e e n
d e c id e d to s o lic it p u b lic o p in io n /c o m m e n ts w ith r e g a r d to a m e n d m e n t in
th e s a id A ct. It is r e q u e s te d t h a t th e c o m m e n ts /s u g g e s tio n in th is r e g a r d
m a y b e s e n t to th e M in is try of H e a lth a n d F a m ily W elfare b y e m a il o n
amendmentthotaffl gm ail.com ,
7. A p a rt fro m s u g g e s tio n s /c o m m e n ts in r e s p e c t o f th e a b o v e a m e n d m e n t
s u g g e s tio n s /c o m m e n ts m a y a ls o b e s e n t for a m e n d m e n t in o th e r s e c tio n s o f
th e s a id A ct, if a n y , for m a k in g th e t r a n s p la n t p r o c e d u r e s im p le r a n d e a s ie r.
THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT, 1994
ARRANGEMENT OF SECTIONS
CHAPTER I
Preliminary
Sections
!. Short title, application and commencement.
2. Definitions.
CHAPTER II
AUTHORITY FO R T H E REM O VAL O F HUM AN O RG ANS O R TISSUES O R B O T H
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
Re g u l a t io n o f h o s p it a l s
10. Regulation of hospital conducting the removal, storage or transplantation of human organs or
tissue or both.
1 I. 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
A p p r o p r ia t e A u t h o r it y
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.
1 3D. National registry.
C H A PT E R V
Re g is t r a t io n o f h o s p it a l s
14. Registration of hospitals engaged in removal, storage or transplantation of human organs or
tissues or both.
14A. Registration of Tissue Bank.
15. Certificate of registration.
16. Suspension or cancellation of registration.
17. Appeals.
1
Offences and penalties
CHAPTER VI
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
M is c e l l a n e o u s
23. Protection of action taken in good faith.
24. Power to make rules.
25. Repeal and savings.
2
THE ERANSPLAN FATION OF 3[HUMAN ORGANS AND TISSUES] ACT. 1994
Act N o . 42 of 1994
An Act to provide for the regulation o f removal, storage and transplantation of
[human organs and tissues for therapeutic purposes and for the prevention o P f commercial
dealings in human organs and tissues] and for matters connected therewith or incidental
W HEREAS it is expedient to provide for the regulation of removal, storage and transplantation of
l£ V C X n s ^ tissu es or°both][ ,heraPei"i< : P“' P0SeS f° r ■ * « * " ° f ^
wi,h respm ,o - ny ° f ,ht
and whereas inpursuance of clause (I) of article 252 of the Constitution, resolutions have been
r l 1 2 3 ! a . ^ ° U S eS °f .tlie Legfslatures of the St^es of Goa, Himachal Pradesh and Maharashtra to
e 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 follow s:-
CHAPTERI
Preliminary
3n aPP,icati0« and commencement. (7) This Act may be called the Transplantation of
[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
riion territories on such date as the Central Government may, by notification, appoint and in any
other State which adopts this Act under clause (7) 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 o f 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-pulmonarv 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 “11100311 O rgans'" (w.e.f 10-1-2014).
4' sec ' S I T " ]" 5, vWeN°tir,Cati0n No' S-°- dated the 4th February, 1995. see Gazette of India, Extraordinary, Pari II.
3
(/) “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;
{/?) “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;
\(ha) “Human Organ Retrieval Centre” means a hospital,—
(/) which has adequate facilities for treating seriously ill patients who can be potential
dortours of organs in the event of death; and
( i i ) which is registered under sub-section (/) of section 14 for retrieval of human organs;
( l i b ) “minor” means a person who has not completed the age of eighteen years;]
2[(j) -‘near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather,
grandmother, grandson or granddaughter;]
(/') “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—
(/) the cost of removing, transporting or preserving (lie ’[human organ or tissue or both] to be
supplied; or
(//) 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;
(/) “prescribed” means prescribed by rules made under this Act;
(m ) “recipient” means a person into whom any ’[human organ or tissue or both] is, or is
proposed to be, transplanted;
(«) “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 (£) 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;
(o b ) “Tissue Bank” means a facility registered under section I4A 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[(c/) “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.] * 2 3 4 5
]. Ins. by Act !6of2011 , s. 5 (w.e.f. 10-1-2014).
2. Subs, by s. 5. ibid., for clause (r) (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).
4
AU THORII Y FOR THE REMOVAL OF '[HUMAN ORGANS OR TISSUES OR BOTH]
3. Authority for removal of '[human organs or tissues or both],--(/) Any donor mav in such
manner and subject to such conditions as may be prescribed, authorise the removal, before his death
0 a,y thuman or£an or tIssue 0!' both] of his body for therapeutic purposes. ’
[(1 A) For the purpose of removal, storage or transplantation of such human organs or tissues or both
as may be prescnbed, ,t shall be the duty of the registered medical practitioner worldng in a hosph^ .n
consultation with transplant co-ordinator, it such transplant co-ordinator is available,— ’
(0 to ascertain from the person admitted to the Intensive Care Unit or from his near relative that
hoh authonsed at any time before his death the removal of any human organ or tissue or
such m hurtatfon, " 'he h°Spi,alShal1 proceed 10 obain ,he -lolimenlalion for
aw i i ') m ' T , n0 S U C h aUlh0rily as referred ,0 in sub-seclion (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; 0i
<mi) 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 (/) anci (/"/) in such manner as may be prescribed
(IB ) The duties mentioned under clauses (/) to ( H i ) of sub-section (l A ) from such date, as mav 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.]
1 1 a,y donor bad, 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 ot 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 aU.reasonable facilities for the removal, for therapeutic purposes, of that -[human organ or
tissue or both] from the dead body of the donor.
(j ) 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 '[human organs or tissues or both]
being used after his death tor therapeutic purposes, the person lawfully in possession of the dead body
o such peison may, unless he has reason to believe that any near relative of the deceased person has
objection to any of the deceased person’s '[human organs or tissues or both] being used for
therapeutic purposes, authorise the removal of any '[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.
CHAPTER II
sub-section (3) shall be sufficient warrant for the removal, for therapeutic purposes, of the “ [human? V J I IIIL L J J U I I laii
oigan oi tissue or both]; but no such removal shall be made by any person other than the registered
medical practitioner: ’ &
[Provided that a technician possessing such qualifications and experience, as may be prescribed
may enucleate a cornea.]
( 5 ) W here any [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 ol the body from which any “ [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 "[human organ or tissue or both] is to be removed from the body o f a person in the
event of his brain-stem death, no such removal shall be undertaken unless such death is certified, in such 1 2 3
1 . Subs, by Act ol 1 6 ot 201 I. 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).
S
form and in such manner and on satisfaction of such conditions and requirements as maybe prescribed,
by a Board of medical experts consisting of the following, namely:—
(ii) the registered medical practitioner in charge of the hospital in which brain-stem death lias
occurred;
(//) 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;
( i i i ) 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; '***
^[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;]
(;v) 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 '[human organ or tissue or both] from the body of the deceased person.
4. Removal o f * 2 3 4|human organs or tissues or both] not to be authorised in certain eases. (7) No
facilities shall be granted under sub-section (2) of section 3 and no authority shall be given under
sub-section (2) of that section for the removal of any ’ [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 ’[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. —(7) 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 ’[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 (7) if the person empowered to give such authority
lias 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 (7).
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
(/?) for pathological purposes.
I The word “and" omitted by Acl 16 of 2011, s. 6 {w.e.f. 10-1-2014).
2. Ins. by s. 6, ibid, (w.e.f. 10-1-2014).
3. Suhs. 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
t a H f T “ T T ! u kn d Je f lhiS AM ,0 8ive aulh°ri* for ,he re"1° ''al of a"J '[human organ or ,issue or
will „ m T SLIChd“ dbod: v ma>'-lf he has reason to believe that such '[human organ o r te u e or both]
w not be required for the purpose for which such body I,as been sent for post-mortem examination
authorise the removal, for therapeutic purposes, of that '[human organ or hssue ™ bothT of me
deceased person provided that he i s satisfied that the deceased person had not expressed before his
eath any objection to any of his “[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 S n organs o
before his deaih. Pl'rp°SeS' after his death’ such aathoi% had not been revoked by him
7. Preservation of ’[human organs or tissues or both].— After the removal of any ‘[human orean
oi tissue o[ both] from the body of any person, the registered medical practitioner* shall take such
steps foi the preservation of the [human organ or tissue or both] so removed as may be prescribed.
i 8‘ Swings.—(7) Nothing in the foregoing provisions of this Act shall be construed as rendering
unlawful any dealing with the body or with any pan of the body of a deceased person if such dealing
would have been lawful if this Act had not been passed. S
nr h 2 h i^ eithTi th, e F anl of facility or authority for the removal of any '[human organ or tissue
T i , y ° f a deC6aSed PerS° n inaccordance with the provisions of this Act nor the removal oil any [human organ or tissue or both] from the body of a deceased person in pursuance of
(45 ofT860)^ Shai be deemed t0 bean offence punishable under section 297 of the Indian Penal Code
9. Restrictions on removal and transplantation of 2 3 [human organs or tissues or both] -(1 ) Save
as otherwise provided in sub-section (5), no [human organ or tissue or both] removed from the body of a
donor before Ins death shall be transplanted into a recipient unless the donor is a near relative of the r cci pient.
J (1 A ) Where the donor or the recipient being near relative is a foreign national, prior approval of the
botIr°nSatl0n C° mmittee S h a1 1 be reclu,red before removing or transplanting human organ or tissue or
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.
(ID ) No human organs or tissues or both shall be removed from the body of a minor before his death
toj the pin pose 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,—
(/) the expression “mentally challenged person” includes a person with mental illness or mental
retardation, as the ease may be:
(//) the expression “mental illness” includes dementia, schizophrenia and such oilier mental
condition that makes a person intellectually disables;
(/7 Y ) thc^ expression “mental retardation” shall have the same meaning as assigned to it in
c ausc {> ) of section 2 oi the Persons With Disabilities (Equal Opportunities. Protection of Right and
Full Participation) Act, 1995 (I of 1996).]
(2) Where any donor authorises the removal of any of his ■'[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 ] [human organ or tissue or both] from the body of any deceased person authorises
such removal, the [human organ or tissue or both] may be removed and transplanted into the body of
any recipient who may be in need of such '[human organ or tissue or both].
(J) It any donor authorises the removal of any of his 2[human organs or tissues or both] before his
death under sub-section (/) 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 Acl 16 ol 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 '[human organ or tissue or both] shall not be removed
and transplanted without the prior approval of the Authorisation Committee.
2 [ ( 3 A ) Notwithstanding anything contained in sub-section (i), where—
(a) any donor lias 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 tor 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) 0 ) The composition of the Authorisation Committee shall be such as may be prescribed by the
Central Government from time to time.
(/?) 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].— (/) 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 '[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 ’[human organ or tissue or both] at a place other than a place
registered under this A ct;5 *** 1 2 3 4 5
1. Subs, by Act 16 of 2011, s. 4, for “human organ” (w.e.f 1 0-1-201 4).
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 “anil” omitted by s. 8. ibid, (w.e.f. 1 0-1 -201 4)
8
(O no place including a hospital registered under sub-section ( 7)
or cause to be used by any person for the removal, storage
[human organ or tissue or both] except for therapeutic purposes; 2 [and]
of section 1 5 shall be used
or transplantation of any
' [ ( d ) no Tissues Bank, unless registered under this Act, shall carry out any activity relation to the
i ecovery, screening, testing, processing, storage and distribution of tissues.] S
(2) Notwithstanding anything contained in sub-section (7), the eyes or the ears may be removed at
ny 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’1 includes ear drums and ear bones.
11. Prohibition of removal or transplantation of '[human organs or tissues or bothl for -mv
theTemova! f '! ^ purposes— No donor and ™ person empowered to give authority fore removal of any human organ shall authorise the removal of any '[human organ or tissue or bothl for
any purpose other than therapeutic purposes.
12. Explaining effects,
shall undertake the removal
explained, in such manner
connected with the removal and
etc., to donor and recipient — No registered medical practitioner
or transplantation of any '[human organ or tissue or both] unless he has
as may be prescribed, all possible effects, complications and hazards
transplantation to the donor and the recipient respectively.
CHAPTER IV
a p p r o p r ia t e A u t h o r it y
13. Appropriate Authority.— (7) The Central Government shall appoint, by notification, one
° ct ° re offlcers as Appropriate Authorities for each of the Union territories for the purposes of this
(2) ' The State Government shall appoint, by notification,
Authorities for the purposes of this Act. one or more officers as Appropriate
(J) The Appropriate Authority shall perform the following functions, namely:—
(0 to grant registration under sub-section (7) of section 15 or renew registration under
sub-section (J) of that section;
(//) to suspend or cancel registration under sub-section (2) of section 16;
[0‘0 to enforce such standards, as may be prescribed,—
(.4) lor 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;
to inspect Tissue Banks periodically;]
(G 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
(w) to undertake such other measures as may be prescribed.
7[13A- Advisory Committees to advise Appropriate Authority.— (7) The Central Government and
and the State Governments, as the case may be, by notification, shall constitute an Advisory Committee
tor a period of two years to aid and advise the Appropriate Authority to discharge its functions.
1 . Subs, by Acl 16 ol 2011 , s. 4. lor “human organ" (w.e.f. 10-1-2014).
2. The word “and" ins by s. 8. ibid, (w.e.f. I0-f-20l4).
3. Ins. by s. 8, ibid, (w.e.f. 10-1-201 4).
4. Subs, by s. 4. ibid., for “human organs” (w.e.f. 10-1-20141,
5. Subs, by s. 9, ibid., % clause ( H i ) (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 leaal expert who has held the position of an Additional District Judge or equivalent;
( J ) 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.
(d) 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 ot Civil Procedure, 1908 (Sot 1908)
and, in particular, in respect of the following matters, namely:—
(o) summoning of any person who is in possession of any information relating to violation ot the
provisions of this Act or the rules made thereunder;
(ft) 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
'[human organs or tissues or both].—(7) 1 2 3 [No hospital (including Human Organ Retrieval Centre)] shall
commence any activity relating to the removal, storage or transplantation ot any [human oigan oi
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 ''[human organ or tissue or both] toi 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 oi
transplantation of any '[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 eailier.
1 . Subs, by Act of 16 oT2011. 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, bv s. 4, ibid, for “human organ” (w.e.f. 10-1-2014).
10
{ 2 ) Every application for registration under sub-section (J ) shall he made m a
Authority in such torn, ,„d in such ™ „„cr and shah he , £ £ £
such "hnsnit: !105Pita' Sha" be registered L 1[lder this Act unless the Appropriate Authority is satisfied that
mann! P , r 'n-a P° Slt'0n t0 pr°V ‘de such specialised services and facilities, possess) such skilled manpower and equipments and maintain such standards as may be prescribed.
[ ( 4 ) No hospital shall be registered under this Act, unless the Appropriate Authority is satisfied that
prescribed!] 3 tr3nSP'ant C 0 ° rdm at0r having such qualifications and expedience as may be
2 [14A. Registration of Tissue Bank.—{/) No Tissue Bank shall, after the commencement of the
t o T e P imcove,n v ™ ° rganS (Amendment> Act, 2011 (16 of 2011), commence any activity relating
! e g ^ X d « t h 1 s A c ^ nS' Pr0C6SSing’ St° rage and d" tnbmi0n of ^ it is duly
Provided that any facility engaged, either party or exlusiveiy, in any activity relating to the recovery
screening, testing, processing, storage and distribution of tissues immediately before the commencemern
the Transplantation ol Human Organs (Amendment) Act, 2011 (16 of 2011). shall apply for
registration as Tissues Bank within sixty days from the date of such commencement:
Ptovided further that such facility shall cease to engage in any such activity on the expiry of three
A ° ' S i l Z ot “ "’« > = " > of the Transplantation of Human Organs (Amendement)
f ; 7° . (\6 of 2° M)’ un ess such Tissae 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 ( J ) shall be made to the Appropriate
Aulhoi itv in such form and ,n such manner and shall be accompanied by such fees as may be prescribed.
t h a t c h ’ ° T ? S U rS S * Sha" bC regiStered UIlder this Act l,nfess the Appropriate Authority is satisfied hat such fissue Bank is m a position to provide such specialised service and facilities, possess such
skilled manpower and equipments and maintain such standards as may be prescribed.]
~ 15‘ C^rtlfici,te of registration.—(/) The Appropriate Authority shall, after holding an inquiry and
after satisfyingitself that the applicant has complied with all the requirements of this Act and the rules
made thereunder, [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
Appiopnate 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
regisiraiion.
( 3 ) Eveiy certificate ol registration shall be renewed in such manner and on payment of such fees as
may be prescribed.
16. Suspension or cancellation of registration.-*/) The Appropriate Authority may
S U 0 mo,\l °f on comPlaint> [SSue a llotlce to any '[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) Ifi after giving a reasonable opportunity of being heard to the '[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
ol this Act or the rules made thereunder, it may, without prejudice to any criminal action that it may
take against such [hospital or Tissue Bank, as the case may be,] suspend its registration for such period
as it may think tit or cancel its registration:
1 . Ins. by Act [6 of 20 It, s, 1 1 (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 lo the hospital" (w.e.f 10-1 -2014).
4. Subs, by s. 14. ibid., for “hospital” (w.e.f. 10-1-2014).
1 1
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 ot any
'[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—
(?) 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 (/) of section 13; or
( i i ) the State Government, where the appeal is against the order of the Authorisation Committee
constituted under clause ( b) of sub-section (-/) 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 ’[ten years and with fine which may extend to twenty lakh
rupees].
(2) Where any person convicted under sub-section (/) is a registered medical practitioner, his
name shall be reporteExcerpt shown. Open the full act in Lexace.