1. Short title and commencement
In exercise of the powers conferred by sub-section (1) if section 24 of the Transplantation of Human Organs Act, 1994 (42 of 1994), the Central Government hereby makes the following rules, namely:-
1. These rules may be called the Transplantation of Human Organs Rules, 1995.
2. They shall come into force on the date1 of their publication in the Official Gazette.
(a)”Act” means the Transplantation of Human Organs Act, 1994 (42 of 1994);
(b)”Form” means a form annexed to these Rules;
(c)”Section” means a section of the Act;
2[(d) “National Accreditation Board for Laboratories” (NABL) means a Board set up by the Quality Council of India (set up by the Government of India) for undertaking assessment and accreditation of testing and calibration of laboratories in accordance with the international standard ISO/IEC/17025 and ISO 15189;
(e) the Registered Medical Practitioner, as defined in clause (n) of section 2 of Transplantation of Human Organs Act, 1994 includes an allopathic doctor with MBBS or equivalent degree under the Medical Council of India Act.]
3[(f)] Words and expressions used and not defined in these Rules, but defined in the Act, shall have the same meanings respectively assigned to them in the Act.
3. Authority for removal of human organ
Any donor may authorise the removal, before his death, of any human organ of his body for therapeutic purposes in the manner and so such conditions as specified in 4[Forms 1(A), 1(B) and 1(C)].
4. Duties of the Medical Practitioner
5[(1) A registered medical practitioner shall, before removing a human organ from the body of a donor before his death, satisfy himself-
1. that the donor has given his authorization in Form 1(A) or 1(B) or 1(C).
2. that the donor is in proper state of health and is fit to donate the organ, and the registered medical practitioner shall sign a certificate as specified in Form 2.
3. That the donor is a near relative of the recipient as certified in Form 3, who has signed Form 1(A) or 1(B) as applicable to the donor and that the donor has submitted an application in Form 10 jointly with the recipient and that the proposed donation has been approved by the concerned competent authority and that the necessary documents as prescribed and medical tests, if required, to determine the factum of near relationship, have been examined to the satisfaction of the Registered Medical Practitioner i.e. Incharge of transplant center.
4. That in case the recipient is spouse of the donor, the donor has given a statement to the effect that they are so related by signing a certificate in Form 1(B) and has submitted an application in Form 10 jointly with the recipient and that the proposed donation has been approved by the concerned competent authority under provision of sub-rule (2) of rule 4A.
5. In case of a donar who is other than a near relative and has sined Form 1(C) and submitted an application in Form 10 jointly with the recipient, the permission from the Authorization Committee for the said donation has been obtained.]
(2) A registered medical practitioner shall, before removing a human organ form the body of a person after his death satisfy himself-
1. 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 authorized 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;
1[(b) that then person lawfully in possession of the dead body has signed a certificate as specified in Form 6.]
(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 Act;
2. that in the case of brian-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 Act and an authority as specified in Form 9 has been signed by either of the parents of such person.
2[4A. Authorization committee
1. The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorization committee constituted under the provision of clauses (a) and (b) of sub-section (4) of section9 of the Act.
(2) Where the proposed transplantation is between a married couple, the Registered Medical Practitioner i.e. Incharge of transplant center must evaluate the factum and duration of marriage and ensure that documents such as marriage certificate, marriage photograph etc. Are kept for records along with the information on the number of age of children and family photograph depicting the entire immediately family, birth certificate of children containing particulars of parents.
(3) When the proposed donor or recipient or both are not Indian Nationals/citizens whether ‘near relatives’ or otherwise, Authorization Committees shall consider all such requests.
(4) When the proposed donor and the recipient are not “near relatives’, as defined under clause (i) of section 2 of the Act, the Authorization Committee shall evaluate that,-
(i) there is no commercial transaction between the recipient and the donor and that no
payment or money or moneys worth as referred to the Act, has been made to the donor
or promised to be made to the donor or any other person;
(ii) the following shall specifically be assessed by the Authorization Committee:-
1. an explanation of the link between them and the circumstances which led to the offer being made;reasons why the donor wished to donate;
2. documentary evidence of the link, e.g. proof that the have lived together, etc;
3. old photographs showing the donor and recipient together;
(iii) that there is no middleman or tout involved;
(iv) 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;
(v) that the donor is not a drug addict or known person with criminal record;
(vi) that the next of the kin of the proposed unrelated donor is interviewed regarding
awareness about his or 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 such kin shall also be recorded and taken note of.]
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;
1[PROVIDED that the eye-ball removed shall be preserved in the following three steps, namely;-
i. short-term preservation;
ii. medium-term preservation;
iii. long-term preservation;
and suitable media shall be used for preservation.]
1[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 Authorization committee as specified in Form 10. The Authorization Committee shall take a decision on such application in accordance with the guidelines in rule 6A.]
2[6A. Composition of Authorization Committees
1. There shall be one State Level Authorization Committee.
2. Additional authorization committees may be set up at various levels as per norms given below, namely;-
i. no member from transplant team of the institution should be a member of the respective Authorization committee. All Foreign Nationals (related and unrelated) should go to “Authorization Committee” as abundant precaution needs to be taken in such cases;
ii. Authorization 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 Authorization 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 Authorization 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 Authorization committee is mandatory.
6C. The quorum of the Authorization 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 Authorization 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 Authorization 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.