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The Andhra Pradesh Transplantation of Human Organs Act, 1995.

Andhra Pradesh · state statute
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THE ANDHRA PRADESH TRANSPLANTATION OF HUMAN ORGANS
ACT, 1995
(ACT NO. 24 OF 1995)
ARRANGEMENT OF SECTIONS
Sections
CHAPTER - I
PRELIMINARY
1. Short title, extent and commencement
2. Definitions
CHAPTER – II
AUTHORITY FOR THE REMOVAL OF HUMAN
ORGANS
3. Authority for removal of human organs
4. Removal of human organs not to be authorised in certain cases
5. Authority for removal of human organs in case of unclaimed
bodies in hospital or prison
6. Authority for removal of human organs from bodies sent for
post-mortem examination for medico-legal or pathological
purposes
7. NIL
8. Savings
9. Restrictions on removal and transplantation of human organs
CHAPTER-III
REGULATION OF HOSPITALS
10. Regulation of hospitals conducting the removal, storage or
transplantation of human organs
11. Prohibition of removal or transplantation of human organs for
any purpose other than therapeutic purposes
12. Explaining effects etc., to donor and recipient.
CHAPTER – IV
APPROPRIATE AUTHORITY
13. Appropriate Authority
CHAPTER - V
REGISTRATION OF HOSPITALS
14. Registration of hospitals engaged in removal, storage or
transplantation of human organs
15. Certificate of registration
16. Suspension or cancellation of registration
17. Appeals
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CHAPTER - VI
OFFENCES AND PENALTIES
18. Punishment for removal of human organ without authority
19. Punishment for commercial dealings in human organs
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 of Act 22 of 1963 and Ordinance of 1995
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THE ANDHRA PRADESH TRANSPLANTATION OF HUMAN
ORGANS ACT, 1995
ACT No.24 OF 1995
[24th April, 1995]
AN ACT TO PROVIDE FOR THE REGULATION OF REMOVAL STORAGE
AND TRANSPLANTATION OF HUMAN ORGANS FOR THERAPEUTIC
PURPOSE AND FOR THE PREVENTION OF COMMERCIAL DEALINGS
IN HUMAN ORGANS AND FOR MATTERS CONNECTED THEREWITH
OR INCIDENTAL THERETO:
Be it enacted by the Legislative Assembly of the State of Andhra Pradesh
in the Forty sixth Year of the Republic of India as follows:-
CHAPTER - I
PRELIMINARY
1. Short title, extent and commencement - (1) This Act may be called the
Andhra Pradesh Transplantation of Human Organs Act, 1995.
(2) It extends to the whole of the State of Andhra Pradesh.
(3) It shall be deemed to have come in to force on the 9th March, 1995.
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 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;
(f) “donor”means any person, not less than eighteen years of age,
who voluntarily authorises in full consciousness after being explained
the full consequences of removing the organ by the Doctor who would
be removing the organ, the removal of any of his human organs for
therapeutic purposes under sub-section (1) or subsection (2) of
section 3;
(g)“Government”means the State Government;
(h) “hospital”includes a nursing home, clinic, medical Centre,
medical or teaching institution for therapeutic purposes and other
like institution;
(i) “human organ”means any part of a human body consisting or a
structured arrangement of tissues which, if wholly removed, cannot
be replicated by the body;
(j) “near relative”means spouse, son, daughter, father, mother,
brother or sister;
(k) “notification”means a notification published in the Andhra
Pradesh Gazette;
(l) “payment”means payment in money or money's worth but does
not include any payment for defraying or reimbursing,-
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(i) the cost of removing, transporting or preserving the human
organ 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;
(m)“prescribed”means prescribed by rules made under this Act;
(n)“recipient”means a person into whom any human organ is, or is
proposed to be, transplanted;
(o) “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
(Central Act 102 of 1956), and who is enrolled on a State Medical
Register as defined in clause (k) of that section;
(p) “therapeutic purposes”means systematic treatment of any
disease or the measures to improve health according to any
particular method or modality; and
(q)“transplantation”means the grafting of any human organ from
any living person or deceased person to some other living person for
therapeutic purposes.
CHAPTER - II
AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS
3. Authority for removal of human organs -(1) Any donor may, in such
manner and subject to such conditions as may be prescribed, authorise the
removal, in full consciousness and after being explained the full consequences
of removing the organ by the doctor who would be removing the organ in
presence of his spouse, if living, and in the presence of daughter or son or
sister or brother in the same order and in the presence of mother or father in
case of un-married persons before his death, of any human organ of his body
for therapeutic purposes.
(2) If any donor had, in writing and in presence of two or more witnesses
spouse if living, and in the presence of daughter or son or sister or brother in
that order and in the presence of mother or father or sister or brother in the
case of un-married persons 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 human organ from the dead body of the donor.
(3) Where no such authority as is referred to in subsection (2), was made
by any person before his death but no objection was also expressed by such
person to any of his human organs 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, human organs being used
for therapeutic purposes, authorise the removal of any human or an of the
deceased person for its use for therapeutic purposes.
(4) The authority given under sub-section (1) or subsection (2) or, as the
case may be, sub-section (3) shall be sufficient warrant for the removal, for the
therapeutic purposes, of the human organ; but no such removal shall be made
by any person other than the registered medical practitioner.
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(5) Where any human organ 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 human organ
is to be removed, that life is extinct in such body or where it appears to be case
of brainstem death that such death has been certified under sub-section (6).
(6) Where any human organ 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 unanimoulsy in such 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; and
(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 subsection (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 from the body of the deceased person.
4. Removal of human organs 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 subsection (3) of that section for the removal of
any human organ 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 time being in force.
(2) No authority for the removal of any human organ 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 internment cremation or other disposal.
5. Authority for removal of human organs in case of unclaimed bodies in
hospital or prison -(1) In the case of a dead body lying in hospital or person
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 from the dead body which so
remained unclaimed may be given, in the prescribed form by the person
incharge, 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 incharge of the management or control thereof.
(2) No authority shall be given under sub-section (1) if the person so
empowered to given such authority has reason to believe that any near relative
of the deceased person is likely to claim the dead body eventhough 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 human organs from bodies sent for post-
mortem examination for medico-legal or pathological purposes –
Where the body of a person has been sent for postmortem examination,-
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(a)  for medico-legal purposes by reason of the death of such person
having been caused by accident or any other un-natural cause; or
(b)  for pathological purposes, the person competent under this act to
give authority for the removal of any human organ from such dead
body may, if he has reason to believe that such human organ will not
be required for the purpose for which such body has been sent for
postmortem examination, authorise the removal, for therapeutic
purposes, of that human organ 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 human organs being used, for
therapeutic purposes after his death or, where he had granted an
authority for the use of any of his human organs for therapeutic
purposes after his death, such authority had not been revoked by
him before his death.
7. After the removal of any human organ from the body of any person, the
registered medical practitioner shall take such steps for the preservation of the
human organ 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 of authority for the removal of any
human organ from the body of a deceased person in accordance with the
provisions of this Act nor the removal of any human organ from the body of a
deceased person in pursuance of such authority shall be deemed to be an
offence punishable, under section 277 (Central Act 45 of 1860) of the Indian
Penal Code.
9. Restrictions on removal and transplantation of human organs –
(1) Save as otherwise provided in sub-section (3), no human organ
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.
(2) Where any donor authorises the removal of any of his human organs
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 from the body
of any deceased person authorises such removal, the human organ may be
removed and transplanted into the body of any recipient who may be in need of
such human organ.
(3) If any donor authorises the removal of any of his human organs
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 recipient or for any other special
reasons such human organ shall not be removed and transplanted without the
prior approval of the Authorisation Committee.
(4) The Government shall constitute by notification, one or more
Authorisation Committees consisting of such members as may be nominated
by the Government 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 on 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 the rules
made thereunder, grant to the applicants approval for the removal and
transplantation of the human organ.
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(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 human organs -(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 human organ;
(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 at a place other than a place registered under
this Act, and
(c) no place including a hospital registered under sub-section (1) of
section 15 shall be used or caused to be used by any person for the
removal storage of transplantation of any human organ except for
therapeutic purposes.
(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” include ear drums
and ear bones.
11. Prohibition of removal or transplantation of human organs for any
purpose other than therapeutic purposes -No donor and no person
empowered to give authority for the removal of any human organ shall
authorise the removal of any human organ 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 human
organ unless he had explain 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 Government shall appoint, by notification,
one or more officers as Appropriate Authorities for the purpose of this Act.
(2) 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 subsection (2) of
section 16;
(iii)to enforce such standards, as may be prescribed for
hospitals engaged in the removal, storage or transplantation of
any human organ;
(iv) to investigate any complaint or breach of any of the
provisions of this Act or any of the rules made thereunder and
take appropriate action;
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(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.
CHAPTER-V
REGISTRATION OF HOSPITALS
14. Registration of hospitals engaged in removal, storage or
transplantation of human organs -(1) No hospital shall commence any
activity relating to the removal, storage or transplantation of any human organ
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
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 human organ 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 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 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 man power and
equipments and maintain such standards as may be prescribed.
15. Certificate of registration -(1) The Appropriate Authority shall, after
holding anenquiry and after satisfying itself that the applicant has complied
with all the requirements of this Act and the rules made thereunder grant to
the hospital 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 requirements 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 hospital 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 hospital
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 hospital, suspend its
registration for such period as it may think fit or cancel its registration;
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 hospital without issuing
any notice.
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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 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 Government.
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 five years and with fine which
may extend to ten thousand rupees.
(2) Where any person convicted under sub-section (1) is registered
medical practitioner, his name shall be reported by the Appropriate Authority
to the State Medical Council for taking necessary action including the removal
of his name from the register of the Council for a period of two years for the
first offence and permanently for the subsequent offence.
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;
(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,-
 (i)  inviting persons to supply for payment of any human organ;
(ii)   offering to supply any human organ for payment; or
(iii)  indicating that the advertiser is willing to initiate or negotiate
any arrangement referred to in clause (d) shall be punishable with
imprisonment for a term which shall not be less than 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:
Provided that the court may, for any adequate and special
reason to be mentioned in the judgment, impose a sentence of
imprisonment for a term of less than two years and a fine less
than ten thousand 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 three years or with fine with may extend to five
thousand rupees.
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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 he had exercised all due deligence 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
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 ofoffences - (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 Government or, as the case may be, the
Appropriate Authority; or
(b)  a person who has given notice of not less than thirty 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 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 proceedings 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 proceedings shall lie against the 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 Government may, by notification, make
rules for carrying out all or any of 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,
human organ of his body under sub-section (1) of section 3;
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(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;
(c)  the form and the manner in which any of the parents may
give authority, in the case of brain-steam death of a minor, or
the removal of any human organ under subsection (7) of
section 3;
(d)  the form in which authority for the removal of any human
organ 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 human
organ removed from the body of any person, under section 7;
(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 human organ under clause (iii) of sub-
section (2) of section 13;
(i)   the other measures as the Appropriate Authority shall
undertake in performing its functions under clause (vi) of sub-
section (2) of section 13;
(j)   the form and the manner in which an application for
registration shall be made and the fees 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;
(l) the form in which, the period for which and the conditions
subject to which certificates of registration is to be granted to a
hospital, under sub-section (1) of section 15;
(m) the manner in which and the fees 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)  to provide for a registry to document all the organ
transplants to evaluate the performance of each transplants
centre and for matters connected therewith or incidental
thereto; and
(q)  any other matter which is required to be, or may be
prescribed.
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(3) Every rule made under this Act shall immediately after it is made, be
laid before the Legislative Assembly of the State, if it is in session and if it is
not in session, in the session immediately following for a total period of
fourteen days which may be comprised in one session or in two successive
sessions and if, before the expiration of the session in which it is so laid or the
session immediately following, the Legislative Assembly agrees in making any
modification in the rule or in the annulment of the rule, the rule shall, from the
date on which the modification or annulment is notified, have effect only in
such modified form or shall stand and annulled as the case may be, so
however, that any such modification, annulment shall be without prejudice to
the validity of anything previously done under that rule.
25. Repeal of Act 22 of 1963 and Ordinance of 1995 -The Andhra Pradesh
Corneal Grafting Act, 1963 and the Andhra Pradesh Transplantation of Human
Organs Ordnance 1995 are hereby repealed.
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