MINISTRY OF HEALTH & FAMILY WELFARE NOTIFICATION
New Delhi, the 4^th February 1993

G.S.R. 51 (E) - In exercise of the powers conferred by sub-section (1) of Section 24 of the Transplantation of Human Organs Act. 1994(42 of 1994), the Central Government hereby makes the following rules, namely -

1. SHORT TITLE AND COMMENCEMENT

(1)   These rules may be at the earliest be the transplantation of Human Organs Rules, 1995.
(2) They shall come into force on the date of their publication in the Official Gazette
       
2. DEFINITIONS

(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;
(d) 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 the death, of any human organ of his body for therapeutic purposes in the manner and as such conditions as specified in Form 1.

4. DUTIES OF THE MEDICAL PRACTITIONER

(1)   A registered medical practitioner shall, before removing a human organ, from the body of a donor before his death satisfy himself -

(a) that  the donor has given his authorization in the Form 1

(b) that the donor is in proper state of health and is fit to donate the organ, and shall sign a certificate a specified in Form 2.

(c) that the donor is a near relative of the recipient and shall sign a certificate as specified in Form 3 after carrying out the following tests on the donor and the recipient, namely:-

(i) tests for the antigenic products of the Human Major Histo-compatibility system HLA-A, HLA-B and HLA-DR using conventional serological techniques;
(ii) tests to establish HLA-DR beta and HLA-DQ beta gene restriction fragment length polymorphism;
(iii) Where the tests referred to in sub-clause(i) and sub-clause(ii) do  not establish a genetic relationship between the donor  and the recipient further tests to establish DNA polymorphism using at least two multi locus gene probe;
(iv) Where the tests referred to in sub-clause (iii) do not establish a genetic relationship between the donor and the recepient further tests do establish DNA polymorphisms using atleast 5 single locus polymorphic probes.

(d) in case recipient is a spouse of the donor, record the statements of the recipient and the donor to the effect that they are so related and shall sign a certificate in Form 4;

 (2)   A registration medical practitioner shall, before removing a human organ from the body of a person after his death satisfy himself -

(a) that the donor had in the presence of two or more witnesses (at last 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
(b)   that the person lawfully in possession of the dead body has signed a certificate as  specified in Form 6 or Form 7.

(3)   A registered medical practitioner shall before removing human organ from the body of a person in the event of his brainstem 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 
(b) that in the case of brain stem death of a person of in less than eighteen years of age, a certificate specified in Form 8 has been singed 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 the parent of such person.