The Transplantation of Human Organ Rules 1995 Composition of Authorisation Committees

²[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.

(A) 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.

(B) 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;

1. 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;

2. 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.

1. 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.

3. 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.

4. Where the proposed transplant is between individuals who are not “near relatives”.

The authorization committee shall evaluate;-

(i) that there is no commercial transaction between the recipient and the donor.

That no payment of money or moneys worth as referred to in the sections of the Act, has been made to the donor or promised to be made to the donor or any other person. In this connection, the Authorisation Committee shall take into consideration:-

1. an explanation of the link between them and the circumstances which led to the offer being made;

2. documentary evidence of the link e.g. proof that they have lived together etc;

3. reasons why the donor wihses to donate; and

4. old photographs showing the donor and the recipient together.

(ii) that there is no middleman/tout involved;

(iii) that financial status of the donor and the recipient is probed by asking them

to give appropriate evidence of their vocation and income for the previous three inancial years. Any gross disparity between the status of the two, must be evaluated in the backdrop of the objective of preventing commercial dealing;

(iv) that the donor is not a drug addict or a known person with criminal record;

(v) that the next of kin of the proposed unrelated donor is interviewed regarding awareness about his\her intention to donate an organ, the authenticity of the

link between the donor and the recipient and the reasons for donation.

Any strong view of disagreement or objection of such kin may also be recorded and taken note of; and

(e) When the proposed donor or the recipient or both are foreigners:-

(i) a senior Embassy official of the country of origin has to certify the

relationship between the donor and the recipient.

(ii) Authorisation Committee shall examine the cases of Indian donors

consenting to donate organs to a foreign national (who is a near

relative), including a foreign national of India origin, with greater caution. Such cases should be considered rarely on case to case basis.

(f) In the course, of determining eligibility of the applicant to donate, the applicant

should be personally interview by the Authorisation Committee and minutes of the interview should be recorded. Such interviews with the donors should be videographed.

(g) In case where the donor is a woman greater precautions ought to be taken. Her identity and independent consent should be confirmed by a person other than the recipient. Any document with regard to the proof of the residence or domicile and particulars of parentage should be relatable to the photo identity of the applicant in order to ensure that the documents pertain to the same person, who is the proposed donor and in the event of any inadequate or doubtful information to this effect, the Authorisation committee may in its discretion seek such other information or evidence as may be expedient; and desirable in the peculiar facts of the case.

(h) The Authorisation Committee should state in writing its reason for rejecting / approving the application of the proposed donor and all approvals should be subject to the following conditions:-

(i) that the approved proposed donor would be subjected to all such medical test as required at the relevant stages to determine his biological capacity and compatibility to donate the organ in question.

(ii) futhter that the psychiatrist clearance would also be mandatory to certify his mental condition, awareness, absence of any overt or latent psychiatric disease and ability to give free consent.

(iii) all prescribed forms have been and would be filled up by all relevant persons involved in the process of transplantation.

(iv) all interviews to be video recorded.

(i) The authorization committee shall expedite its decision making process and use its

discretion judiciously and pragmatically in all such cases where, the patient requires immediate transplantation.

(j) Every authorized transplantation center must have its own website. The Authorization Committee is required to take final decision with in 24hours of holding the meeting for grant of permission of rejection for transplant. The decision of the Authorisation committee should be displayed on the notice board of the hospital or institution immediately and should reflect on the website of the hospital or institution within 24 hours of taking the decision. Apart from this, the website of the hospital or institution must update its website regularly in respect of the total number of the transplantations done in that hospital or institution along with the details of each transplantation. The same data should be accessible for compilation, analysis and further use by respective State Governments and Central Government.]