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The Transplantation of Human Organs Rules, 1995 (Amendment 2008) (2)
Date 19/10/11/03/49  Author Infrosoft Health Content Team  Hits 987  Language Global
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:-

 6F. The Authorization committee shall focus its attention on the following, namely:-

1.    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:-

                     i.        results of tissue typing and other basic tests;

                   ii.        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;

                     i.        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;

                   ii.        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:

1.    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.

2.    Test for Human Leukocyte Antigen-DR beta genes to be perfomed using the Polymerase Chain reaction (PCR) based Deoxyribonucleic acid (DNA) methods.

3.    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).

4.    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.

2.    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 Authorization Committee.

3.    Where the proposed transplant is between a married couple (except foreigners, whose cases should be dealt by Authorization 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.

4.    Where the proposed transplant is between individuals who are not “near relatives”.

The authorization committee shall evaluate;-

(i) that there is no commercial transaction between the recipient and the donor.

That no payment of money or moneys worth as referred to in the sections of the Act, has been made to the donor or promised to be made to the donor or any other person. In this connection, the Authorization Committee shall take into consideration:-

1.    an explanation of the link between them and the circumstances which led to the offer being made;

2.    documentary evidence of the link e.g. proof that they have lived together etc;

3.    reasons why the donor wihses to donate; and

4.    old photographs showing the donor and the recipient together.

(ii) that there is no middleman/tout involved;

(iii) 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 inancial years. Any gross disparity between the status of the two, must be evaluated in the backdrop of the objective of preventing commercial dealing;

(iv) that the donor is not a drug addict or a known person with criminal record;

(v) that the next of kin of the proposed unrelated donor is interviewed regarding awareness about his\her intention to donate an organ, the authenticity of the

link between the donor and the recipient and the reasons for donation.

Any strong view of disagreement or objection of such kin may also be recorded and taken note of; and

(e) When the proposed donor or the recipient or both are foreigners:-

(i) a senior Embassy official of the country of origin has to certify the

relationship between the donor and the recipient.

(ii) Authorization Committee shall examine the cases of Indian donors

consenting to donate organs to a foreign national (who is a near

relative), including a foreign national of India origin, with greater caution. Such cases should be considered rarely on case to case basis.

(f) In the course, of determining eligibility of the applicant to donate, the applicant

should be personally interview by the Authorization Committee and minutes of the interview should be recorded. Such interviews with the donors should be videographed.

(g) In case where the donor is a woman greater precautions ought to be taken. Her identity and independent consent should be confirmed by a person other than the recipient. Any document with regard to the proof of the residence or domicile and particulars of parentage should be relatable to the photo identity of the applicant in order to ensure that the documents pertain to the same person, who is the proposed donor and in the event of any inadequate or doubtful information to this effect, the Authorization committee may in its discretion seek such other information or evidence as may be expedient; and desirable in the peculiar facts of the case.

(h) The Authorization Committee should state in writing its reason for rejecting / approving the application of the proposed donor and all approvals should be subject to the following conditions:-

(i) that the approved proposed donor would be subjected to all such medical test as required at the relevant stages to determine his biological capacity and compatibility to donate the organ in question.

(ii) futhter that the psychiatrist clearance would also be mandatory to certify his mental condition, awareness, absence of any overt or latent psychiatric disease and ability to give free consent.

(iii) all prescribed forms have been and would be filled up by all relevant persons involved in the process of transplantation.

(iv) all interviews to be video recorded.

(i) The authorization committee shall expedite its decision making process and use its

discretion judiciously and pragmatically in all such cases where, the patient requires immediate transplantation.

(j) Every authorized transplantation center must have its own website. The Authorization Committee is required to take final decision with in 24hours of holding the meeting for grant of permission of rejection for transplant. The decision of the Authorization committee should be displayed on the notice board of the hospital or institution immediately and should reflect on the website of the hospital or institution within 24 hours of taking the decision. Apart from this, the website of the hospital or institution must update its website regularly in respect of the total number of the transplantations done in that hospital or institution along with the details of each transplantation. The same data should be accessible for compilation, analysis and further use by respective State Governments and Central Government.


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 or 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 a period of five years form the date of its issue and shall be renewable.

1[(3) Before a hospital is registered under the provisions of this rule, it shall be mandatory for the hospital to nominate a transplant co-ordinator.]


8. Renewal of registration

(1) An application for the renewal of a certificate of 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 scrutiny of its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the application, since grant of certificate of registration under sub-rule (2) of rule 7 has not complied with the requirements of this Act and the Rules made thereunder 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.

 
1[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, specialized services and facilities as laid down below;-

(A) General Manpower Requirement Specialised Services and Facilities:

1.    24 hours availability of medical and surgical, (senior and junior) staff.

2.    24 hours availability of nursing staff, (general and speciality trained).

3.    24 hours availability of Intensive Care Units with adequate equipments, staff and support system, including specialists in anaesthesiology, intensive care.

4.    24 hours availability of laboratory with multiple discipline testing facilities including but not limited to Microbiology, Bio-Chemistry, pathology and Hematology and Radiology departments with trained staff.

5.    24 hours availability of Operation Theatre facilities (OT facilities) for planned and emergency procedures with adequate staff, support system and equipments.

6.    24 hours availability of communication system, with power backup, including but not limited to multiple line telephones, public telephone system, fax, computers and paper photo-imaging machine.

7.    Experts, (other than the experts required for the relevant transplantation) of relevant and associated specialties including but not limited to and depending upon the requirements, the experts in internal medicine, diabetology, gastroenterology, nephrology, neurology, paediatrics, gynaecology, immunology and cardiology etc. should be available to the transplantation center.

(B) Equipments:

Equipments as per current and expected scientific requirements specific to organ or organs being transplanted. The transplant center should ensure the availability of the accessories, spare-parts and back-up/maintenance/service support system in relation to all relevant equipments.

(C) Experts and their qualifications:

1.    Kidney Transplantation

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

2.    Transplantation of liver and other abdominal organs

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

 

3.    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.

(d) Cornea Transplantation

M.D./M.S. ophthalmology or equivalent qualification with one year post M.D./M.S. training in a recoginsed hospital carrying out Corneal transplant operations.]


10. Appeal

(1) Any person aggrieved by an order of the Authorization Committee under sub-section (6) of section9, 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.

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