Transplant of Human Organs - Forms

As Published In The Gazette of India Extraordinary Part-II Section 3- Sub Section (i) Published by authority Issue No. 39- New Delhi Saturday, February 4, 1995 Magha 15, 1916
THE GAZETTE OF INDIA: EXTRAORDINARY (PART II Sec. 3-Sub-sec (ii)) MINISTRY OF HEALTH AND FAMILY WELFARE NOTIFICATION Published by Authority No.71, New Delhi Saturday February 4, 1995 / Magha 15, 1916
S.O.80(E) - In exercise of the powers conferred by sub-section (3) of section 1 of the Transplantation of Human Organs Act, 1994 (42 of 1994), the Central Government hereby appoints the Fourth day of February, 1995, as the date on which the said Act shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and all the Union Territories.
(No. S, 12011/2/94-MS)	O.P. NIGAM, Chief Controller of Accounts

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.

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.

6. The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ, to the Authorization Committee as specified in Form 10

7. REGISTRATION OF HOSPITAL

(1) An application for registration shall be made to the Appropriate Authority as specified in Form 11. The application shall be accompanied by a fee of rupees one thousand payable to the Appropriate Authority by means of a bank draft or postal order.
(2) The Appropriate Authority shall after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements, grant a certificate of registration as specified in Form 12 and shall be valid for period of 5 years from the date of its issue and shall be renewable.

8. RENEWAL OF REGISTRATION

(1) An application for the renewal of a certificate or registration shall be made to the Appropriate Authority within a period of three months prior to the date of expiry of the original certificate of registration and shall be accompanied by a fee of rupees five hundred payable to the Appropriate Authority by means of a bank draft or postal order.
(2) A renewal certificate of registration shall be as specified in Form 13 and shall be valid for a period of five years
(3) If, after an inquiry including inspection of the hospital and security of its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applicant, since grant of certificate of registration the under sub-rule (2) of Rule 7 has not complied with the requirements of this Act and the rules made there under and conditions subject to which the certificate of registration has been granted, shall, for reasons to be recorded in writing, refuse to grant renewal of the certificate of registration.

(9) CONDITIONS FOR GRANT OF CERTIFICATE OF REGISTRATION

No hospital shall be granted a certificate of registration under this Act unless it fulfills the following requirement of manpower, equipment, specialised services and facilities as laid down below -

GENERAL REQUIREMENT

1. Surgical Staff
2. Cardiology Staff
3. Nursing Staff
4. Communication System
5. Intensivist
6. Medical Social Worker
7. Perfusionist

VARIOUS DEPARTMENT

1. Microbiology
2. Mycology
3. Pathology
4. Virology
5. Nephrology
6. Neurology
7. Psychology
8. G.I. Surgery
9. Anaesthesiology
10. Imaging Facilities
11. Paediatrics
12. Physiotherapy
13. Immunology
14. Haematology
15. Blood Bank
16. Clinical Chemistry
17. Cardiology

NON-TRANSPLANTATION PROGRAMME TEAM

1. Neurologist
2. Neurosurgeon
3. Medical Superintendent
4. Any other hospital Staff

BASIC EQUIPMENT

Operating Room facilities for routine open heart surgery which includes heart-lung machine and accessories.

ADDITIONAL EQUIPMENT REQUIRED FOR TRANPLANTATION PROGRAMME

1. Cell Saver
2. Assist devices like IABP, Centrifugal Pump and various assist devices, both pneumatic and electric operated.
3. Mobile C-arm image intensifier for routine biopsies in the street operating room
4. Euct /Alert system for early detection of any infection
5. Radioimmunoassay for measuring Cyclosporin levels.
6. Routine Laboratory facilities for detection of HIV, Australia antigen, CMV, Toxoplasnosis and other Mycology Tests

EXPERTS
(A) Kidney Transplantation

M.S. (Gen.) Surgery or equivalent qualification which three years post M.S. training a recognized center in India or abroad and having attended to adequate number of renal transplantation as an active member of team

(B) Transplantation of Liver & Other Abdominal Organs

M.S. (Gen.) Surgery or equivalent qualification with adequate post M.S. training in an established center with reasonable experience of performing liver transplantation as an active member of team

(a) Cardiac, Pulmonary Cardio-Pulmonary Transplantation.
M.Ch Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad with at least 3 years experience as an active member of the team performing an adequate number of open heart operations per year and well-versed with coronary by-pass surgery and Heart valve Surgery.

10. APPEAL

(1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of section 9, or by an order of the Appropriate Authority under sub-section (2) of section 15 and Section 16 of the Act, may, within thirty days from the date of receipt of the order, prefer an appeal to the Central Government

(2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against