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THE
TRANSPLANTATION OF HUMAN ORGANS ACT,1994
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,--
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no hospital, unless registered under this Act, shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ;
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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
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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.
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 explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.
Chapter IV
Appropriate Authority
13. Appropriate
Authority.-- (1) The Central Government shall appoint, by notification, one or more officers as Appropriate Authorities for each of the Union territories for the purposes of this Act.
(2) The State Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purposes of this Act.
(3) The Appropriate Authority shall perform the following functions, namely :-
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to grant registration under sub-section (1) of Section 15 or renew registration under sub-section (3) of that section;
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to suspend or cancel registration under suh-section (2) of Section 16;
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to enforce such standards, as may be prescribed, for hospitals engaged in the removal, storage or transplantation of any human organ;
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to investigate any com(plaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action;
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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
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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 manpower and equipments and maintain such standards as may be prescribed.
15. Certificate of registration. -- (1) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements of this Act and the rules made thereunder, 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 moto 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.
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--
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the Central Government where the appeal is against the order of the Authorisation Committee constituted under clause (a) of sub- section (4) of Section 9 or against the order of the Appropriate Authority appointed under sub-section (1) of Section 13; or
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the State Government, where the appeal is against the order of the Authorisation Committee constituted under clause (b) of sub- section (4) of Section 9 or against the order of the Appropriate Authority appointed under sub-section (2) of Section 13.
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