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The Transplantation of Human Organs Rules, 1995
Date 19/10/11/03/15  Author Infrosoft Health Content Team  Hits 1105  Language Global
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 Authorization  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

No. S. 12011/2/94-MS
O.P. Nigam Chief Controller of Account


FORM - 1

(See rule 3)

I, ........................................................, aged ....................................... S/o, D/o, W/o, Mr. ..................................... resident of .............................................................................. hereby authorise to remove for therapeutic purposes / consent to donate my organ, namely ................................................................. ......…………………………

(1) Mr. / Mrs. ..............................................
S/o, D/o, W/o, Mr. .............................……….
aged ...................... resident of ........................................................ .................. happens to be my near relative as defined in clause (2) of section 2 of the Act.

(Or)

(2) Mr./Mrs. ......................................................
S/o, D/o, W/o, Mr. ................................…
aged ................................. resident of ..................................................................towards when I possess special affection, attachments, or for any special reason (to be specified).

I certify that the above authority/consent has been given by me out my own free will without pressure, inducement, influence or allurement and that the purposes of the above authority/donation and of all possible complications, side-effects, consequences and options have been explained to me giving this authority or consent or both.

Signature of the Donor



FORM - 2

[(See rule 4(1) (b)] 

I, Dr.…………………………………………........, possessing the qualification of  ........…………… registered as medical practitioner at serial No. ................. by the ....................................... Medical as Medical Council, certify that I have examined Shri / Smt / Kum. ............................. S/o, D/o, W/o ......................................................... aged ................................ who is free and is near relative of the donor and that the said donor is in proper state of health and is ........................... medically fit to be subjected to the procedure of organ removal. 

Place: ..........................      

                                                                                   Signature
Date:  ......................…



FORM -3

[(See rule 4(1) (c)] 

I,Dr...............................................possessing the qualification of .....................     …………………………………… registered as med. practitioner at Serial No. .............................. by the .......................... ..................... Medical council, certify that Mr./Mrs. …………………………… .S/o, D/o, W/o ............................……………aged ...............the donor, an Mr./Mrs. …………… ……… ……… S/o, D/o, W/o ………………………………… aged ........................., the recipient of the organ donated by the said donor are related to each other as brother/sister/mother/father/son/daughter as per their statement and the fact of this relationship has been established by the results of the tests for Antigenic Products of the Human Major Hysto-compability System, namely .......................................... by the Authorization Committee as per the information contained in their letter of approval No. .................................................. dated .......................


Place..........................                                                                                                    Signature

Date..........................

 

FORM -4
[(See rule 4(1) (d)] 

  I, Dr. .......................................................................... possessing qualification of ..........................……………………………………… registered as medical practitioner at Serial No. ...................................... by the .............................................., Medical council, certify that :- 

(i)       Mr. …………………………………………………………………….. S/o ………………………………………………….. aged ………………. resident of …………………………………………………….. and Mrs. ……………………………… D/o, W/o …….………………………………………………………… ………………….. ............................................. resident .............................. ................. are related to each other as spouse a according to the statement given by them and their statement has been confirmed by means of following evidence before effecting the organ removal from body of the said Shri / Smt / Km......................................……….………………  ………………… ……………………

(Applicable only in the cases where considered necessary).

(Or) 

(ii) The Clinical condition of Shri/Smt............................................. .................  mentioned above is such that recording of his/her statement is not practicable           

                                                   Signature of Regd. medical practitioner

Place.........................

Date........................... 

 

FORM -5
[(See rule 4(2) (a)] 

I .................................................................. S/o, D/o, W/o ...................... ............. ............ aged ...................................... resident of ................. in the presence of persons mentioned below hereby unequivocally authorise the removal of my organ/organs, namely, ................................ from my body after my death for therapeutic purposes.


Dated:                                             Signature of the Donor

(Signature)

1.      Shri/Smt./Km............................................................................

S/o, D/o, W/o .......................................................................... aged  .................... resident of .............................. .................. ......................…... …………  ……………………… ……… ……………………………… 

      (Signature)

2.      Shri/Smt./Km................................................................of ....................aged .............................……………….. resident of ............................................… is a near relative to the donor as................................................................

Dated............................

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