Company : Sol Infotech Pvt. Ltd. Website : www.courtkutchehry.com ANDHRA PRADESH TRANSPLANTATION OF HUMAN ORGANS RULES, 1995 CONTENTS 1. Short title and commencement 2. Definitions 3. Authority for Removal of Human Organs 4. Duties of the Medical Practitioner 5. Preservation of Organs 6. Joint Application to the Competent Authority 7. Registration of Hospital 8. Renewal of Registration 9. Conditions for Grant of Certificate of Registration 10. Appeal ANDHRA PRADESH TRANSPLANTATION OF HUMAN ORGANS RULES, 1995 In exercise of the powers conferred by sub-section (1) of Section 24 of the Andhra Pradesh Transplantation of Human Organs Act, 1995 (Act 24 of 1995) the Government of Andhra Pradesh hereby makes the following rules: 1. Short title and commencement :- (1) These rules may be called the Andhra Pradesh Transplantation of Human Organs Rules, 1995. (2) They shall come into force on the date of their publication in the Official Gazette. 2. Definitions :- (1) In these rules unless the context otherwise requires; (i) "Act" means the Andhra Pradesh Transplantation of Human Organs Act, 1995 (Act 24 of 1995). (ii) "Form" means a form annexed to these rules; (iii) "Section" means a section of the Ordinance. (2) Words and expression used and not defined in these rules, but defined in the Ordinance, shall have the same meanings respectively assigned to them in the Ordinance. 3. Authority for Removal of Human Organs :- Any donor may authorise the removal, before his death, of any Human Organ of his body for therapeutic purposes in the manner and on such conditions as specified in Form-1. 4. Duties of the Medical Practitioner :- (1) A Registered Medical Practitioner shall, before removing a human organ from the body of a donor before his death satisfy himself (a) that the donor has given his authorisation in Form-1; (b) that the donor is in proper state of health and is fit to donate the organ, and shall sign a certificate specified in Form-2. (c) that the donor is a near relative of the recipient, and shall sign a certificate as specified in Form-3. after carrying out the following tests on the donor and the recipient, namely:- (i) tests for the antigenic products of the Human Major Histo- compatibility system HLA-A, HLA-B and HLA-DR using conventional serological techniques; (ii) tests to establsh HLA - DR deta and HLA - DQ deta generation fragment length polymorphism; (iii) where the tests referred to in sub-clause (i) and sub- clause (ii) do not establish a genetic relationship between the donor and the recipient, tests to establish DNA polymorphisms using atleast two multi-1 ocus gene probe; (iv) where the tests referred to in sub-clause (iii) do not establish a genetic relationship between the donor and the recipient further tests to establish DNA polymorphic probes. (d) in case recipient is a spouse of the donor, record the statement of the recipient and the donor to the effect that they are so related and shall sign a certificate in Form-4. (2) A Registered Medical Practitioner shall, before removing a human organ from the body of a person after his death satisfy himself; (a) that the donor had, in the presence of two or more witnesses (at least one of whom is a near relative of such person), unequivocally authorised as specified in Form-5, before his death the removal of the human organ of his body, after his death, for therapeutic purposes and there is no reason to believe that the donor had subsequently revoked the authority aforesaid; (b) that the person lawfully in possession of the dead body has signed a certificate as specified in Form-6 or Form-7. (3) A Registered Medical Practitioner shall, before removing a human organ from the body of a person in the event of his brain- stem death, satisfy himself; (a) that a certificate as specified in Form-8 has been signed by all the members of the Board of medical experts referred to in sub- section (6) of Section 3 of the Ordinance. (b) that in the case of brain-stem death of a person of less than eighteen years of age, a certificate specified in Form-8 has been signed by all the members of the Board of medical experts referred to in sub-section (6) of Section 3 of the Ordinance and an authority as specified in Form-9 has been signed by either of the parents of such person. 5. Preservation of Organs :- The organ removed shall be preserved according to current and accepted scientific methods in order to ensure viability for the purpose of transplantation. 6. Joint Application to the Competent Authority :- The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ to Authorisation Committees as specific in Form 10. 7. Registration of Hospital :- (1) An application for registration shall be made to the Appropriate Authority as specified in Form 11 by paying Rs. 1000 as fee for application form. The application shall be accompanied by a registration fee or Rs. 20,000/- payable to the Appropriate Authority by means of a bank draft. (2) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that applicant has complied with all the requirements, grant a certificate of registration as specified in Form 12 and shall be valid for a period of five years from the date of its issue and shall be renewable. 8. Renewal of Registration :- (1) An application for the renewal of a certificate of registration shall be made to the Appropriate Authority within a period of three months prior to the date of expiry of the original certificate of registration shall be accompanied by a fee or Rs. 20,000/- payable to the Appropriate Authority by means of a bank draft. (2) A renewal certificate of registration shall be as specified in Form 13 and shall be valid for a period of five years. (3) If, after an inquiry including inspection of the Hospital and scrutiny of its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applicant, since grant of certificate or registration under sub-rule (2) of Rule 7 has not complied with the requirements of this ordinance and the rules made thereunder and conditions subject to which the certificate of registration has been granted, shall, for reasons to be recorded in writing refuse to grant renewal of the certificate of registration. 9. Conditions for Grant of Certificate of Registration :- No Hospital shall be granted a certificate of registration under this Ordinance unless it fulfills the following requirements of manpower, equipment, specialised services and facilities as laid down below:- 10. Appeal :- (1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of Section 9, or by an order of the Appropriate Authority under sub-section (2) of Section 15 and sub- section (2) of Section 16 of the Ordinance may, within thirty days from the date of receipt of the order, prefer an appeal to the State Government. (2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against.