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TRANSPLANTATION OF HUMAN ORGANS

1. Short title and commencement
2. Definitions
3. Authority for removal of human organ
4. Duties of the Medical Practitioner
5. Preservation of organs
6. Composition of Authorisation Committees
7. Registration of hospital
8. Renewal of registration
9. Conditions for grant of certificate of registration
10. Appeal

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;

PROVIDED that the eye-ball removed shall be preserved in the following three steps, namely;-
  1. short-term preservation;
  2. medium-term preservation;
  3. long-term preservation;
and suitable media shall be used for preservation.

6. The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ, to the concerned competent authority or Authorisation committee as specified in Form 10. The Authorisation Committee shall take a decision on such application in accordance with the guidelines in rule 6A.

6A. Composition of Authorisation Committees
  1. There shall be one State Level Authorisation Committee.
  2. Additional authorization committees may be set up at various levels as per norms given below, namely;-
    1. no member from transplant team of the institution should be a member of the respective Authorisation committee. All Foreign Nationals (related and unrelated) should go to “Authorisation Committee” as abundant precaution needs to be taken in such cases;
    2. Authorisation Committee should be Hospital based in Metro and big cities if the number of transplants exceeds 25 in a year at the respective transplantation centers. In small towns, there are State or District level Committees if transplants are less than 25 in a year in the respective districts.
      1. Composition of Hospital Based Authorisation Committees: (To be constituted by the State Government and in case of Union Territory by the Central Government).
        1. the senior most person officiating as Medical Director or Medical Superintendent of the Hospital;
        2. two senior medical practitioners from the same hospital who are not part of the transplant team;
        3. two members being persons of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants and doctors (of Indian Medical Association) etc.; and
        4. Secretary (Health) or nominee and Director Health Services or nominee.
      2. Composition of state or District Level Authorisation Committees: (To be constituted by the State Government and in case of Union territory by the Central Government).
        1. a Medical Practitioner officiating as Chief Medical Officer or any other equivalent post in the main/major Government Hospital of the District;
        2. two senior medical practitioners to be chosen from the pool of such medical practitioners who are residing in the concerned District and who are not part of any transplant team;
        3. two senior citizens, non-medical background (one lady) of high reputation and integrity to be chosen from the pool of such citizens residing in the same district, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants and doctors (of Indian Medical Association) etc; and
        4. Secreatry (Health) or nominee and Director Health Services or nominee.

    (Note: Effort should be made to have most of the members’ ex-officio so that the need to change the composition of committee is less frequent.)

    6B. The State level committees shall be formed for the purpose of providing approval or no objection certificate to the respective donor and recipient to establish the legal and residential status as a domicile state. It is mandatory that if donor, recipient and place of transplantation are from different states, then the approval or ”no objection certificate” from the respective domicile State Government should be necessary. The institution where the transplant is to be undertaken in such case the approval of Authorisation committee is mandatory.

    6C. The quorum of the Authorisation Committee should be minimum four. However, quorum ought not to be considered as complete without the participation of the chairman. The presence of Secretary (Health) or Nominee and Director of Health Services or nominee is mandatory.

    6D. The format of the Authorisation Committee approval should be uniform in all the institutions in a State. The format may be notified by Respecive State Government.

    6E. Secretariat of the Committee shall circulate copies of all applications received from the proposed donors to all members of the Committee. Such applications should be circulated along with all annexures, which may have been filed along with the applications. At the time of the meeting, the Authorisation committee should take note of all relevant contents and documents in the course of its decision making process and in the event any documents in the course of its decision making process and in the event any document or information is found to be inadequate or doubtful, explanation should be sought from the applicant and if it is considered necessary that any fact or information requires to be verified in order to confirm its veracity or correctness, the same be ascertained through the concerned officer(s) if the State/Union territory Government.

    6F. The Authorisation committee shall focus its attention on the following, namely:-
    1. Where the proposed transplant is between persons related genetically, Mother, Father, Brother, Sister, Son or Daughter Above the age of 18 years), the concerned competent authority shall evaluate:-
      1. results of tissue typing and other basic tests;
      2. documentary evidence of relationship e.g. relevant birth certificates and marriage certificate, certificate from Sub-divisional magis-rate/Metropolitan Magistrate/or Sarpanch of the Panchayat;
      3. documentary evidence of identity and residence of the proposed donor e.g. Ration Card or Voters identity Card or Passport or Driving License or PAN Card or Bank Account and family photograph depicting the proposed donor and the proposed recipient along with another near relative;
      4. if in its opinion, the relationship is not conclusively established after evaluating the above evidence, it may in its discretion direct further medical tests as prescribed as below:
        1. the test for Human Leukocyte Antigen (HLA), Human Leukocyte Antigen-B alleles to be performed by the serological and / or Polymerase chain reaction (PCR) based Deoxyribonucleic acid (DNA) methods.
        2. Test for Human Leukocyte Antigen-DR beta genes to be perfomed using the Polymerase Chain reaction (PCR) based Deoxyribonucleic acid (DNA) methods.
        3. The tests referred to in sub-rules (i) to (ii) shall be got done from a laboratory accredited with National Accreditation Board for Laboratories (NABL).
        4. Where the tests referred to in (i) to (iii) above do not establish a genetic relationship between the donor and the recipient, the same tests to be performed on both or at least one parent, preferably both parents. If parents are not available, same tests to be performed on such relatives of donor and recipient as are available and are willing to be tested failing which, genetic relationship between the donor and the recipient will be deemed to have not been established.
      5. The papers for approval of transplantation would be processed by the registered medical practitioner and administrative division of the Institution for transplantation, while the approval will be granted by the Authorisation Committee.
      6. Where the proposed transplant is between a married couple (except foreigners, whose cases should be dealt by Authorisation Committee): The concerned competent authority or authorization committee as the case may be must evaluate all available evidence to establish the factum and duration of marriage and ensure the documents such as marriage certificate, marriage photograph is placed before the committee along with the information on the number and age of children and a family photograph depicting the entire immediate family, birth certificate of children containing the particulars of parents.

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