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TRANSPLANTATION OF HUMAN ORGANS ACT, 1994
42 of 1994
8th July, 1994
An Act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto Whereas it is expedient to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs: And whereas 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 01: PRELIMINARY
SECTION 01: SHORT TITLE, APPLICATION AND COMMENCEMENT
(1) This Act may be called the Transplantation of Human Organs 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 date 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.
SECTION 02: 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',
(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:
(i) "near relative" means spouse, son, daughter, father, mother, brother or sister;
(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 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:
(l) "prescribed" means prescribed by rules made under this Act:
(m) "recipient" means a person into whom any human organ 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; and
(p) "transplantation" means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.
CHAPTER 02: AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS
SECTION 03: 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, before his death, of any human organ of his body for therapeutic purposes.
(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 human organ 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 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's human organs being used for therapeutic purposes, authorise the removal of any human organ 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 human organ; but no such removal shall be made by any person other than the registered medical practitioner.
(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 a case of brain-stem 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, 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 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 from the body of the deceased person.
SECTION 04: 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 sub-section (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 the 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 interment, cremation or other disposal.
SECTION 05: 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 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 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).
SECTION 06: 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 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, 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 post-mortem 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.
SECTION 07: PRESERVATION OF HUMAN ORGANS
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.
SECTION 08: 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 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 297 of the Indian Penal Code (45 of 1860)-.
SECTION 09: 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) or 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)(a) The Central Government shall constitute, by notification, one or more Authorisation Committees consisting of such members as may be nominated by the Central Government on such terms and conditions as may be specified in the notification for each of the Union territories for the purposes of this section.
(b) The State Government shall constitute, by notification, one or more Authorisation Committees consisting of such members as may be nominated by the State 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 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.
(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 03: REGULATION OF HOSPITALS
SECTION 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 cause to be used by any person for the removal, storage or 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" includes ear drums and ear bones.
SECTION 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.
SECTION 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 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 04: APPROPRIATE AUTHORITY
SECTION 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 -;
(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 of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action;
(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 05: RHGISTRATION OF HOSPITALS
SECTION 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 skil
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