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;-
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short-term preservation;
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medium-term preservation;
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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
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There shall be one State Level Authorisation Committee.
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Additional authorization committees may be set up at various levels as per norms given below, namely;-
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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;
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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.
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Composition of Hospital Based Authorisation Committees: (To be
constituted by the State Government and in case of Union Territory by
the Central Government).
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the senior most person officiating as Medical Director or Medical
Superintendent of the Hospital;
- two senior medical practitioners from the same hospital who are not part of the transplant team;
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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
- Secretary (Health) or nominee and Director Health Services or nominee.
- 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).
-
a Medical Practitioner officiating as Chief Medical Officer or any other
equivalent post in the main/major Government Hospital of the District;
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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;
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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
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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 Respective 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:-
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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:-
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results of tissue typing and other basic tests;
- 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;
- 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;
- 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:
-
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.
- Test for Human Leukocyte Antigen-DR beta genes to be performed using
the Polymerase Chain reaction (PCR) based Deoxyribonucleic acid (DNA)
methods.
- 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).
- 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.
- 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.
- 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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