(a) 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:-
(i) results of tissue typing and other basic tests;
(ii) documentary evidence of relationship e.g. relevant birth certificates and marriage certificate, certificate from Sub-divisional magistrate^ Metropolitan Magistrate/or Sarpanch of the Panchayat;
(iii) 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;
(iv) 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:
(a) the tests 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.
(b) test for Human Leukocyte Antigen-DR beta genes to be performed using the Polymerase chain reaction (PCR) based Deoxyribonucleic acid (DNA) methods.
(c) the tests referred to in sub-rules (i) and (ii) shall be got done from a laboratory accredited with National Accreditation Board for Laboratories (NABL).”
(d) 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.
[HPT II—3g^3(i)] HRTT ^1WT5I : SmiHKUI 23
(b) 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.
(c) Where the proposed transplant is between a married couple (except foreigners, whose cases should be dealt by Authorisation Committee):
The concerned competent authority or authorisation committee as the case may be must evaluate all available evidence to establish the factum and duration of marriage and ensure that 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.
(d) 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:-
(a) an explanation of the link between them and the circumstances which led to the offer being made;
(b) documentary evidence of the link e g. proof that they have lived together etc.;
(c) reasons why the donor wishes to donate; and
(d) 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 financial 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 views or disagreement or objection of such kin may also be recorded and taken note of; arid 24 THE GAZETTE OF INDIA: EXTRAORDINARY [PartII—SEC.3(i)1
(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 Indian 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 interviewed 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 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:- e
(i) that the approved proposed donor would be subjected to all such medical tests as required at the relevant stages to determine his biological capacity and compatibility to donate the organ in question.
(ii) further 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 authorisation committee shall expedite its decision making process and use its discretion judiciously and pragmatically in all such cases where, the patient requires immediate transplantation.
[WTII—lgTO3(i)] 25 0 Every authorised transplantation centre must have its own website. The Authorisation Committee is required to take final decision within 24 hours of holding the meeting for grant of permission or 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.