Laws Related to Organ Donation - Kidney Foundation Kerala

Acts, Rules, Bills & GOs

THE TRANSPLANTATION OF HUMAN ORGANS ACT - 1994

Bill No. LIX-F of 1992
The Transplantation of human organs bill, 1994

(As Passed by the Houses of Parliament Rajya Sabha on 5^th May, 1993)
Lok Sabha on 14^th June 1994 Amendments made by the Lok Sabha
Agreed to by the Rajya Sabha on 15^th June 1994)Assented to on 8-7-1994
Act No. 42 of 1994

Bill No. LIX-F of 1992

THE TRANSPLANTATION OF HUMAN ORGANS BILL, 1994
—————
ARRANGEMENT OF CLAUSES
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CHAPTER I
PRELIMINARY CLAUSES

short title, application and commencement
Definitions.

CHAPTER II
AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS

Authority for removal of human organs.
Removal of human organs not to be authorised in certain cases
Authority for removal of human organs in case of unclaimed bodies in hospital or prison.
Authority for removal of human organs from bodies sent for postmortem examination for medico-legal or pathological purposes.
Preservation of human organs
Savings
Restrictions on removal and transplantation of human organs

CHAPTER III
REGULATION OF HOSPITALS

Regulation of hospitals conducting the removal, storage or transplantation of human organs
Prohibition of removal or transplantation of human organs for any purpose other than therapeutic purposes.
Explaining effects, etc, to donor and recipient.

CHAPTER IV
APPROPRIATE AUTHORITY

Appropriate Authority

CHAPTER V

Registration of hospitals engaged in removal, storage or transplantation of human organs.
Certificate of registration.
Suspension or cancellation of registration
Appeals CHAPTER VI
OFFENCES AND PENALTIES
Punishment for removal of human organ without authority
Punishment for commercial dealings in human organs
Punishment for contravention of any other provision of this Act
Offences by Companies
Cognizance of offencesCHAPTER VII
MISCELLANEOUS
Protection of action taken in good faith
Power to make rules
Repeal and savings.

THE TRANSPLANTATION OF HUMAN ORGANS RULES, 2008

THE TRANSPLANTATION OF HUMAN ORGANS RULES, 1995

(GSR NO. 51(E), dr. 4-2-1995)

[As amended vide GSR 571(E), dt.31-7-2008]

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. Short title and commencement

These rules may be called the Transplantation of Human Organs Rules, 1995.
They shall come into force on the date1 of their publication in the Official Gazette.

2. Definitions

“Act” means the Transplantation of Human Organs Act, 1994 (42 of 1994);
“Form” means a form annexed to these Rules;
“Section” means a section of the Act;
²[“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;
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.]
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

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 Authorisation 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-

(a) 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.]

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-
1. 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.

4A. Authorisation committee

The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorisation committee constituted under the provision of clauses (a) and (b) of sub-section (4) of section9 of the Act.
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.
When the proposed donor or recipient or both are not Indian Nationals/citizens whether ‘near relatives’ or otherwise, Authorisation Committees shall consider all such requests.
When the proposed donor and the recipient are not “near relatives’, as defined under clause (i) of section 2 of the Act, the Authorisation Committee shall evaluate that,-
1. 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;
2. the following shall specifically be assessed by the Authorisation Committee:-
  1. an explanation of the link between them and the circumstances which led to the offer being made;
  2. reasons why the donor wished to donate;
  3. documentary evidence of the link, e.g. proof that the have lived together, etc;
  4. old photographs showing the donor and recipient together;
3. that there is no middleman or tout involved;
4. 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;
5. that the donor is not a drug addict or known person with criminal record;
6. 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;

PROVIDED that the eye-ball removed shall be preserved in the following three steps, namely;-

short-term preservation;
medium-term preservation;
long-term preservation;

and suitable media shall be used for preservation.

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 Authorisation committee as specified in Form 10. The Authorisation Committee shall take a decision on such application in accordance with the guidelines in rule 6A.

6A. Composition of Authorisation Committees

1. There shall be one State Level Authorisation Committee.
2. Additional authorization committees may be set up at various levels as per norms given below, namely;-
  1. no member from transplant team of the institution should be a member of the respective Authorisation committee. All Foreign Nationals (related and unrelated) should go to “Authorisation Committee” as abundant precaution needs to be taken in such cases;
  2. Authorisation 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.
    1. Composition of Hospital Based Authorisation 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.
    2. Composition of state or District Level Authorisation 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.

6B.

6C.

6D.

6E.

6F.

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:-
  1. results of tissue typing and other basic tests;
  2. 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;
  3. 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;
  4. 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 performed 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.
  5. 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 Authorisation Committee.
  6. Where the proposed transplant is between a married couple (except foreigners, whose cases should be dealt by Authorisation 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.

vii.

Where the proposed transplant is between individuals who are not “near relatives”. The authorization committee shall evaluate;-

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 Authorisation Committee shall take into consideration:-

	a	an explanation of the link between them and the circumstances which led to the offer being made;
	b	documentary evidence of the link e.g. proof that they have lived together etc;
	c	reasons why the donor wihses to donate; and
	d	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 financial 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; 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

viii

When the proposed donor or the recipient or both are foreigners:-
a senior Embassy official of the country of origin has to certify the relationship between the donor and the recipient. Authorisation 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.

In the course, of determining eligibility of the applicant to donate, the applicant should be personally interview by the Authorisation Committee and minutes of the interview should be recorded. Such interviews with the donors should be videographed.

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 Authorisation committee may in its discretion seek such other information or evidence as may be expedient; and desirable in the peculiar facts of the case.

The Authorisation 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.

xii

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.

xiii

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 Authorisation 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

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.
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.
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

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.
A renewal certificate of registration shall be as specified in Form 13 and shall be valid for a period of five years.
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.

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;-

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.

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.

Experts and their qualifications:

a	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.
b	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.
c	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 recognised hospital carrying out Corneal transplant operations.]

10.

Appeal

Any person aggrieved by an order of the Authorisation 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.

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

THO Amendment Bill 2011

THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL, 2011
A BILL to amend the Transplantation of Human Organs Act, 1994.
WHEREAS it is expedient to amend the said law enacted by Parliament relating to
regulation of removal, storage and transplantation of human organs for therapeutic purposes
and for prevention of commercial dealings in human organs;
AND WHEREAS Parliament has no power to make or amend laws for the States with
respect to any of the matters aforesaid except as provided in articles 249 and 250 of the
Constitution;
AND WHEREAS in pursuance of clause (1) of article 252 of the Constitution, resolutions
have been passed by all the Houses of the Legislatures of the States of Goa, Himachal
Pradesh and West-Bengal to the effect that the aforesaid Act should be amended by Parliament;
BE it enacted by Parliament in the Sixty-second Year of the Republic of India as
follows:—
1. (1) This Act may be called the Transplantation of Human Organs (Amendment)
Act, 2011.
(2) It applies, in the first instance, to the whole of the States of Goa, Himachal Pradesh
and West Bengal and to all the Union territories and it shall also apply to such other State
which adopts this Act by resolution passed in that behalf under clause (1) of article 252 of
the Constitution.
Bill No. 136-C of 2009
AS PASSED BY LOK SABHA ON 12 AUGUST, 2011

(3) It shall come into force in the State of Goa, Himachal Pradesh and West Bengal and
in all the Union territories on such date as the Central Government may, by notification,
appoint and in any other State which adopts this Act under clause (1) of article 252 of the
Constitution on the date of such adoption; and any reference in this Act to the commencment
of this Act shall, in relation to any State or Union terriotry, means the date on which this Act
comes into force in such State or Union territory.
2. In the Transplantation of Human Organs Act, 1994 (hereinafter referred to as the
principal Act), in the long title, for the words “human organs for therapeutic purposes and for
the prevention of commercial dealings in human organs”, the words “human organs and
tissues for therapeutic purposes and for the prevention of commercial dealings in human
organs and tissues” shall be substituted.
3. In section 1 of the principal Act, in sub-section (1), for the words “Human Organs”,
the words “Human Organs and Tissues” shall be substituted.
4. Throughout the principal Act [except clause (h) of section 2, sub-section (5) of
section 9, sub-section (1) of section 18 and section.], unless otherwise expressly provided,
for the words “human organ” and “human organs”, wherever they occur, the words “human
organ or tissue or both” and “human organs or tissues or both” shall respectively be
substituted with such consequential amendments as the rules of grammar may require.
5. In section 2 of the principal Act,—
(a) after clause (h), the following clauses shall be inserted, namely:—
(ha) “Human Organ Retrieval Centre” means a hospital,—
(i) which has adequate facilities for treating seriously ill patients
who can be potential donors of organs in the event of death; and
(ii) which is registered under sub-section (1) of section 14 for retrieval
of human organs;
(hb) “minor” means a person who has not completed the age of eighteen
years;
(b) for clause (i), the following clause shall be substituted, namely:—
‘(i) “near relative” means spouse, son, daughter, father, mother, brother,
sister, grandfather, grandmother, grandson or granddaughter;’;
(c) in clause (o), the word “and” shall be omitted;
(d) after clause (o), the following clauses shall be inserted, namely:—
‘(oa) “tissue” means a group of cells except blood performing a particular
function in the human body;
(ob) “Tissue Bank” means a facility registered under section 14A for
carrying out any activity relating to the recovery, screening, testing, processing,
storage and distribution of tissues, but does not include a Blood Bank;’
(e) after clause (p), the following clause shall be inserted namely:—
(pa) “transplant co-ordinator” means a person appointed by the hospital
for co-ordinating all matters relating to removal or transplantation of human
organs or tissues or both and for assisting the authority for removal of human
organs in accordance with the provisions of section 3.
6. In section 3 of the principal Act,—
(a) after sub-section (1), the following sub-sections shall be inserted, namely:—
(1A) For the purpose of removal, storage or transplantation of such human
organs or tissues or both, as may be prescribed, it shall be the duty of the registered
medical practitioner working in a hospital, in consultation with transplant co-ordinator,
if such transplant co-ordinator is available,—
(i) to ascertain from the person admitted to the Intensive Care Unit or from
his near relative that such person had authorised at any time before his death the
removal of any human organ or tissue or both of his body under sub-section (2),
then the hospital shall proceed to obtain the documentation for such authorisation
in such manner as may be prescribed;
(ii) where no such authority as referred to in sub-section (2) was made by
such person, to make aware in such manner as may be prescribed to that person
or near relative for option to authorise or decline for donation of human organs
or tissues or both;
(iii) to require the hospital to inform in writing to the Human Organ
Retrieval Centre for removal, storage or transplantation of human organs or
tissues or both, of the donor identified in clauses (i) and (ii) in such manner as
may be prescribed.
(1B) The duties mentioned under clauses (i) to (iii) of sub-section (1A) from such
date, as may prescribed, shall also apply in the case of registered medical practitioner
working in an Intensive Care Unit in a hospital which is not registered under this Act for the
purpose of removal, storage or transplantation of human organs or tissues or both.”;
(b) in sub-section (4), the following proviso shall be inserted, namely:—
“Provided that a technician possessing such qualifications and
experience, as may be prescribed, may enucleate a cornea.”;
(c) in sub-section (6), in clause (iii),—
(i) the word “and” shall be omitted; and
(ii) the following proviso shall be inserted, namely:—
“Provided that where a neurologist or a neurosurgeon is not
available, the registered medical practitioner may nominate an independent
registered medical practitioner, being a surgeon or a physician and an
anaesthetist or intensivist subject to the condition that they are not
members of the transplantation team for the concerned recipient and to
such conditions as may be prescribed;”.
7. In sectin 9 of the principal Act,—
(a) after sub-section (1), the following sub-section shall be inserted, namely:—
“(1A) Where the donor or the recepient being near relative is a foreign
national, prior approval of the Authorisation Committee shall be required before
removing or transplanting human organ or tissue or both:
Provided that the Authorisation Committee shall not approve such removal
or transplantation if the recipient is a foreign national and the donor is an Indian
national unless they are near relatives.
(1B) No human organs or tissues or both shall be removed from the body
of a minor before his death for the purpose of transplanation except in the
manner as may be prescribed.
(1C) No human organs or tissues or both shall be removed from the body
of a mentally challenged person before his death for the purpose of
tranplantation.
Explanation.— For the purpose of this sub-section,—
(i) the expression “mentally challenged person” includes a person with
mental illness or mental retardation, as the case may be;
(ii) the expression “mental illness” includes dementia, schizophrenia and
such other mental condition that makes a person intellectually disabled;
(iii) the expression “mental retardation” shall have the same meaning as
assigned to it in clause (r) of section 2 of the Persons With Disabilities (Equal
Opportunities, Protection of Rights and Full Participation) Act, 1995.”;
(b) after sub-section (3), the following sub-section shall be inserted, namely:—
“(3A) Notwithstanding anything contained in sub-section (3), where—
(a) any donor has agreed to make a donation of his human organ or
tissue or both before his death to a receipient, who is his near relative, but
such donor is not compatible biologically as a donor for the receipient;
and
(b) the second donor has agreed to make a donation of his human
organ or tissue or both before his death to such recipient, who is his near
relative, but such donor is not compatible biologically as a donor for
such recipient; then
(c) the first donor who is compatible biologically as a donor for the
second recipient and the second donor is compatible biologically as a
donor of a human organ or tissues or both for the first recipient and both
donors and both recipients in the aforesaid group of donor and recipient
have entered into a single agreement to donate and receive such human
organ or tissue or both according to such biological compatibility in the
group,
the removal and transplantation of the human organ or tissue or both, as
per the agreement referred to above, shall not be done without prior
approval of the Authorisation Committee.”;
(c) for sub-section (4), the following sub-section shall be substituted, namely:—
“(4)(a) The composition of the Authorisation Committees shall be such
as may be prescribed by the Central Government from time to time.
(b) The State Government and the Union territories shall constitute, by
notification, one or more Authorisation Committees consisting of such members
as may be nominated by the State Governments and the Union territories on
such terms and conditions as may be specified in the notification for the purposes
of this section.”.
8. In section 10 of the principal Act, in sub-section (1),—
(a) in clause (b), the word “and” occurring at the end shall be omitted;
(b) in clause (c), the word “and” shall be inserted at the end;
(c) after clause (c), the following clause shall be inserted, namely:—
(d) no Tissue Bank, unless registered under this Act, shall carry out any activity
relating to the recovery, screening, testing, processing, storage and distribution of
tissues.
9. In section 13 of the principal Act, in sub-section (3),—
(a) for clause (iii), the following clause shall be substituted, namely:—
“(iii) to enforce such standards, as may be prescribed,—
1 of 1996.
(A) for hospitals engaged in the removal, storage or transplantation
of any human organ;
(B) for Tissue Banks engaged in recovery, screening, testing,
processing, storage and distribution of tissues;”;
(b) after clause (iv), the following clause shall be inserted, namely:—
(iva) to inspect Tissue Banks periodically;’.
10. After section 13 of the principal Act, the following section be inserted, namely:—
“13A. (1) The Central Government and the State Governments, as the case may
be, by notification, shall constitute an Advisory Committee for a period of two years
to aid and advise the Appropriate Authority to discharge its functions.
(2) The Advisory Committee shall consist of—
(a) one administrative expert not below the rank of Secretary to the State
Government, to be nominated as Chairperson of the Advisory Committee;
(b) two medical experts have such qualifications as may be prescribed;
(c) one officer not below the rank of a Joint Director to represent the
Ministry or Department of Health and Family Welfare, to be designated as
Member-Secretary;
(d) two eminent social workers of high social standing and integrity, one
of whom shall be from amongst representatives of women’s organisation;
(e) one legal expert who has held the position of an Additional District
Judge or equivalent;
(f) one person to represent non-governmental organisations or
associations which are working in the field or organ or tissue donations or
human rights;
(g) one specialist in the field of human organ transplantation, provided
he is not a member of the transplantation team.
(3) The terms and conditions for appointment to the Advisory Committee shall be
such as may be prescribed by the Central Government.
13B. The Appropriate Authority shall for the purposes of this Act shall all the
powers of a civil court trying a suit under the Code of Civil Procedure, 1908 and, in
particular, in respect of the following matters, namely:—
(a) summoning of any person who is in possession of any information
relating to violation of the provisions of this Act or the rules made thereunder;
(b) discovery and production of any document or material object;
(c) issuing search warrant for any place suspected to be indulging in
unauthorised removal, procurement or transplantation of human organs or
tissues or both; and
(d) any other matter which may be prescribed.
13C. The Central Government may, by notification, establish a National Human
Organs and Tissues Removal and Storage Network at one or more places and Regional
Network in such manner and to perform such functions, as may be prescribed.

13D. The Central Government shall maintain a national registry of the donors
and recipients of human organs and tissues and such registry shall have such
information as may be prescribed to an ongoing evaluation of the scientific and
clinical status of human organs and tissues.”.
11. In section 14 of the principal Act,—
(a) in sub-section (1), for the words “No hospital”, the words “No hospital
(including Human Organ Retrieval Centre)” shall be substituted;
(b) after sub-section (3), the following sub-section shall be inserted, namely:—
“(4) No hospital shall be registered under this Act, unless the Appropriate
Authority is satisfied that such hospital has appointed a transplant coordinator having
such qualifications and experience as may be prescribed.
12. After section 14 of the principal Act, the following section shall be inserted,
namely:—
14A. (1) No Tissue Bank shall, after the commencement of the Transplantation
of Human Organs (Amendment) Act, 2011, commence any activity relating to the
recovery, screening, testing, processing, storage and distribution of tissues unless it
is duly registered under this Act:
Provided that any facility engaged, either partly or exclusively, in any activity
relating to the recovery, screening, testing, processing, storage and distribution of
tissues immediately before the commencement of the Transplantation of Human
Organs (Amendment) Act, 2011, shall apply for registration as Tissue Bank within
sixty days from the date of such commencement:
Provided further that such facility shall cease to engage in any such activity on
the expiry of three months from the date of commencement of the Transplantation of
Human Organs (Amendment) Act, 2011, unless such Tissue bank has applied for
registration and is so registered, or till such application is disposed of, whichever is
earlier.
(2) Every application for registration under sub-section (1) shall be made to the
Appropriate Authority in such form and in such manner and shall be accompanied by such
fees as may be prescribed.
(3) No Tissue Bank shall be registered under this Act unless the Appropriate authority
is satisfied that such Tissue Bank is in a position to provide such specialised services and
facilities, possess such skilled manpower and equipments and maintain such standards as
may be prescribed.”.
13. In section 15 of the principal Act, in sub-section (1), for the words “grant to the
hospital”, the words “grant to the hospital or to the Tissue Bank, as the case may be,” shall
be inserted.
14. In section 16 of the principal Act, for the work “hospital”, wherever it occurs, the
words “hospital or Tissue Bank, as the case may be,” shall be substituted,’ or
15. In section 17 of the principal Act, after the words, brackets and figure “under subsection
(6) of section 9, or any hospital”, the words “or Tissue Bank, as the case may be,”
shall be inserted.
16. In section 18 of the principal Act,—
(a) in sub-section (1), for the words “five years and with fine which may extend
to ten thousand rupees”, the words “ten years and with fine which may extend to
twenty lakh rupees” shall be substituted;
(b) in sub-section (2), for the words “two years”, the words “three years” shall
be substituted.
(c) after sub-section (2), the following sub-section shall be inserted, namely:—
(3) Any person who renders his services to or at any hospital and who
conducts, or associates with or helps in any manner in the removal of human
tissues without authority, shall be punishable with imprisonment for a term
which may extend to three years and with fine which may extend to five lakh
rupees.
17. In section 19 of the principal Act,—
(a) after clause (f), the following clause shall be inserted, namely:—
“(g) abets in the preparation or submission of false documents including
giving false affidavits to establish that the donor is making the donation of the
human organs, as a near relative or by reason of affection or attachment towards
the recipient.”;
(b) for the words “two years but which may extend to seven years and shall be
liable to fine which shall not be less than ten thousand rupees but may extend to
twenty thousand rupees”, the words “five years but which may extend to ten years
and shall be liable to fine which shall not be less than twenty lakh rupees but may
extend to one crore rupees” shall be substituted;
(c) the proviso shall be omitted.
18. After section 19 of the principal Act, the following section shall be inserted,
namely:—
“19A. Whoever—
(a) makes or receives any payment for the supply of, or for an offer to supply,
any human tissue; or
(b) seeks to find person willing to supply for payment and human tissue; or
(c) offers to supply any human tissue for payment; or
(d) initiates or negotiates any arrangement involving the making of any payment
for the supply of, or for an offer to supply, any human tissue; or
(e) takes part in the management or control of a body of persons, whether a
society, firm or company, whose activities consist of or include the initiation or
negotiation of any arrangement referred to in clause (d); or
(f) publishes or distributes or causes to be published or distributed any
advertisement—
(i) inviting persons to supply for payment of any human tissue; or
(ii) offering to supply any human tissue for payment; or
(iii) indicating that the advertiser is willing to initiate or negotiate any
arrangement referred to in clause (d); or
(g) abets in the preparation or submission of false documents including giving
false affidavits to establish that the donor is making the donation of the human
tissues as a near relative or by reason of affection or attachment towards the recipient,
shall be punishable with imprisonment for a term which shall not be less than one year but
which may extend to three years and shall be liable to fine which shall not be less than five
lakh rupees but which may extend to twenty-five lakh rupees.”.

19. In section 20 of the principal Act, for the words “three years or with fine which
may extend to five thousand rupees”, the words “five years or with fine which may extend
to twenty lakh rupees” shall be substituted.
20. In section 24 of the principal Act, in sub-section (2),—
(a) after clause (a), the following clauses shall be inserted, namely:—
(aa) the human organs or tissues or both in respect of which duty is cast
on registered medical practitioner, the manner of obtaining documentation for
authorisation under clause (i) of sub-section (1A) of section 3;
(ab) the manner of making the donor or his relative aware under clause (ii)
of sub-section (1A) of section 3;
(ac) the manner of informing the Human Organ Removal Centre under
clause (iii) of sub-section (1A) of section 3;
(ad) the date from which duties mentioned in sub-section (1A) are
applicable to registered medical practitioner working in a unregistered hospital
under sub-section (1B) of section 3;
(ae) the qualifications and experience of a technician under the proviso
to sub-section (4) of section 3;”;
(b) after clause (b), the following clause shall be inserted, namely:—
“(ba) the conditions for nomination of a surgeon or a physician and an
anaesthetist or intensivist to be included in the Board of medical experts under
the proviso to clause (iii) of sub-section (6) of section 3;”;
(c) after clause (e) the following clauses shall be inserted, namely:—
“(ea) the manner of removal of human organs or tissues or both from the
body of a minor before his death for transplantation under sub-section (1B) of
section 9;
(eb) the composition of the Authorisation Committees under sub-section
(4) of section 9;”;
(d) after clause (i), the following clauses shall be inserted, namely:—
“(ia) the qualifications of medical experts and the terms and conditions
for appointment to Advisory Committee under sub-sections (2) and (3) of section
13A;
(ib) the power of the Appropriate Authority in any other matter under
clause (d) of section 13B;
(ic) the manner of establishment of a National Human Organs and Tissues
Removal and Storage Network and Regional Network and functions to be
performed by them under section 13C;
(id) the information in the national registry of the donors and recipients
of human organs and tissues and all information under section 13D;”;
(e) after clause (k), the following clauses shall be inserted, namely:—
“(ka) the qualifications and experience of a transplant coordinator under
sub-section (4) of section 14;
(kb) the form and the manner in which an application for registration shall
be made, and the fee which shall be accompanied, under sub-section (2) of
section 14A;
(kc) the specialised services and the facilities to be provided skilled
manpower and the equipments to be possessed and the standards to be
maintained by a Tissue Bank, under sub-section (3) of section 14A;”;
(f) in clause (l), for the word “hospital”, the words “hospital or Tissue Bank”
shall be substituted.

THO Amendment Act 2011

Click to Download
THO Amendment Act 2011

THO Rules 2014

Click to Download
THO Rules 2014

Tamil Nadu GOs

Health and Family Welfare Department – Cadaver Organ transplantation – Participation of Private Hospitals in the State – Compulsory – Orders – Issued.
G.O.(Ms) No.87 Dated:26.02.2011
Health and Family Welfare Department – Cadaver Organ Transplantation – Post-mortem examination in medico legal cases – Procedure prescribed – Revised Orders Issued.
G.O.(Ms) No.86 Dated:26.02.2011
Health and Family Welfare Department – Cadaver Organ Transplant – Procedural formalities – Post-mortem examination – Orders – Issued.
G.O.(Ms) No.259 Dated:14.09.2010
Tamil Nadu Government Gazette – Supplement (THO Rules)
No.27A Dated:15.07.2009
Cadaver Transplant Program – Designation of Dr.J.Amalorpavanathan, Reader in Vascular Surgery, Madras Medical College and Vascular Surgeon, Government General Hospital, Chennai as Convenor, Cadaver Transplant Program, Tamil Nadu – Orders – Issued.
G.O.(Ms) No.296 Dated:16.09.2008
Health and Family Welfare Department – Non-Transplant centers – Criteria for non-transplant centers to retrieve organs from brain dead persons – Detailed instructions – Orders issued.
G.O.(Ms.) No. 289 Dated: 5.9.2008
Health and Family Welfare Department – Organ Transplant – Responsibilities of Transplant centers in hospitals – Detailed instructions – Orders issued.
G.O.(Ms.) No. 288 Dated: 5.9.2008
Health & Family Welfare Department – Organ Transplant – Cadaver Organ Transplant Program – Procedure to be adopted for cadaver transplant by the Government and Private Hospitals approved for organ transplant by the Appropriate Authority – orders issued.
G.O.(Ms.) No. 287 Dated: 5.9.2008
Health & Family Welfare Department – Organ Transplant – Authorization Committee Procedures – Additional responsibilities – Detailed instructions – orders issued.
G.O.(Ms.) No. 175 Dated: 6.6.2008
Brain death – Declaration of brain death made mandatory in Government Medical College Hospitals in Chennai – Procedure for declaration of brain death – orders issued.
Download G.O.(Ms.) No. 75 Dated: 3.3.2008
Brain death – Declaration of brain death made mandatory in Government Medical College Hospitals in Chennai – Orders Issued.
G.O.(Ms.) No. 6 Dated: 8.1.2008

Kerala GOs

GO on Declaration of brain death

GO on Cadaver Organ Transplantation Programme Procedure

GO on Criteria for Non Transplant Organ Retrieval Centers (NTORC)

GO on Duties and responsibilities of Transplant Centres

New GO on Declaration of Brain Death and Cadaver Organ Transplantation Programme Procedure

Letter for Ad hoc permission for –Organ retrieval

GUIDELINES-ALTRUSTIC AND SWAP DONATION 2018

53-2018-BRAIN DEATH-SOP

Brain Death Certification New Order

Brain Stem Death Certification Guidelines - Updated (January 2020)

Andhra Pradesh GOs

Implementation of Cadaveric Organ Donation Programme in Andhra Pradesh – Constitution of Cadaver Transplantation Advisory Committee (CTAC) – Nomination of Nizam Institute of Medical Sciences (NIMS) as Cadaver Transplantation Coordination Authority (CTCA) – Orders – Issued.
G.O.Rt.No. 1462 Dated:11.11.2009
HM&FW Dept. – The Andhra Pradesh Transplantation of Human Organs Act, 1995 and the Andhra Pradesh Transplantation of Human Organs Rules, 1995 – Cadaver Transplantation Advisory Committee – Report approved – Jeevandan Scheme Orders – Issued.
G.O.Ms.No.184 Dated: 16.08.2010

Maharashtra Government Resolutions

Government of Maharashtra - Public Health Departement - Govt Resolution - Procedure for the Declaration of Brain Death.

Government of Maharashtra - Public Health Departement - Govt Resolution - Human Organ Transplant Act 1994 Declaration of Brain Death.

Government of Maharashtra - Public Health Departement - Govt Resolution - Criteria for Non-Transplant Centers to Retrieve Organs from Brain Dead Persons.

Government of Maharashtra - Public Health Departement - Govt Resolution - Responsibilities of Hospitals registered under Human Organ Transplant Act, 1994.

Orders, Judgements & Forms

Inquest Order

Path Breaking Order for Inquest

Rc. No 21421/Crime (1)/2009

Office of the
Director General of Police
Chennai – 600 004

Dated: 13.07.2009

Circular Memorandum

Sub:-

Police – Tamil Nadu Third Police Commission – Recommendation No. (Para 434 (37.44) – Visit of the accident places by the investigation officers – instructions issued.

Ref:-

1) G.O.(MS) No 11 Home (Pol.XI) Department dated 6.1.2009

2) Chief Office U.C.Note in Rc.No 113949/RA (10/2006-2. dated: 13.4.2009)

It is brought to the notice of the Tamil Nadu Police Commission that when a person suffers a serious injury in an accident case and is referred to hospitals situated in Chennai or Madurai or Coimbatore a far off place from the jurisdiction Police Station, where better medical facilities are available and if the victim happens to die after a few days, the body is kept in the hospital till the arrival of the investigating officer from where the case was registered for conducting inquest.
This results in a delay of one or two days causing additional hardship to the relatives of the deceased who are already traumatized by the death.
Hence the inquest may be conducted by the local jurisdiction police and documents be transferred to the concerned Police Station for further investigation. Since the purpose of inquest is only to ascertain the apparent cause of death describing wounds, fractures, bruises and other marks of injury as may be found on the body and stating in what manner or by what weapon or instrument such marks appear to have been inflicted. This inquest should be conducted in the presence of 2 or more respectable inhabitants of the neighbourhood.
The Tamil Nadu Third Police Commission in its recommendation No. 434 para 37 44 in chapter 36 – has stated that. “The local jurisdiction police may be authorized to conduct inquest in accident cases without waiting for arrival of officers from far off places where cases were registered or the occurrence took place”.
The High powered committee has also agreed to this recommendation in respect of accident cases only. Government have also accepted the decision of the committee.
Therefore, all Commissioners of Police in Cities and Superintendents of Police in District are requested to instruct the Investigation Officers of the local jurisdiction police accordingly and they may be authorized to conduct the inquest in accident cases without waiting for the arrival of officers from far of places where cases are registered of the occurrence took place.
Receipt of the circular memo may be acknowledged.

Sd/-Seema Agrawal
For Director General of
Police

To

All Commissioners of Police in Cities
All Superintendents of Police in Districts
Copy to All Deputy Inspector Generals of Police in Ranges
Copy to All Inspector Generals of Police in Zones
Copy to A&R Section (For Printer Circular)
Copy to A&R Section (For Printer Circular)
Copy to RAI Section, Chief Office
Copy to All Superintendents in Crime Section, Chief Office
Copy to: Personal Assistant (Admin) Crime, Chief Office
Copy to Stock File
Copy to Spare

True Copy/Forwarded/By Order

Brain Stem Death Certification Guidelines - Kerala

Delhi High Court Judgement on Organ Transplant NOC State Government

Summary of Delhi High Court Judgement

Supreme Court Judgement on Euthanasia

Lok Sabha Discussion on Organ Donation

Lok Sabha Parliamentary Q & A on Organ Donation & Transplantation

GOVERNMENT OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE

LOK SABHA

UNSTARRED QUESTION NO 1563

ANSWERED ON 04.03.2016

Organ Donations

1563 . Prathap Simha

Shobha Karandlaje

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-

(a) whether a large number of people are dying prematurely due to heart, liver, lungs, kidneys and pancreas complications and that many lives can be saved by timely transplantation of organs donated by others, if so, the details thereof;

(b) whether the Government is aware that organ transplantation in the country faces red-tapism, social and cultural myths and if so, the details thereof;

(c) whether the Government proposes to create awareness programme on organ donation and importance of overcoming myths and fears surrounding organ donation among people across the country and if so, the details thereof; and

(d) the steps taken/being taken by the Government to support organ donation and transplantation less costly and without delay?

Answer

THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

(a): Exact data on the number of premature deaths due to heart, liver, lungs, kidneys and pancreas complications has not been compiled. However, there is a huge gap between the demand for and supply of human organs for transplantation. The present annual requirement and availability of commonly transplanted organs is assessed as below:

Requirement Availability
Kidney 2,00,000 6,000
Liver 30,000 1,500
Heart 50,000 15

(b): While no such complaints have been received by this Ministry, there are social and cultural issues that have a bearing on organ donation.

(c): The Government accords a very high priority for improving awareness on donation of cadaver organs to bridge the gap between the demand for and supply of organs and to save the lives of a large numbers of persons suffering from end stage organ failure. With this in view, the importance of organ donation has been highlighted by the Hon’ble Prime Minister in ‘Mann Ki Baat’ Programme in October and November 2015. Further steps have been taken to make organ donation easier including through provision of updated information to general public on NOTTO website, a 24×7 call centre with toll free helpline number (1800114770), launch of National Organ and Tissue Donation and Transplant Registry. Financial assistance has also been sanctioned for establishing four regional level organizations called Regional Organ and Tissue Transplant Organization (ROTTO) in the States of Tamil Nadu, Maharashtra, Assam and UT of Chandigarh and carrying out awareness and training of transplant coordinators. Hospitals have been advised to display boards outside the Intensive Care Units and at strategic locations in hospitals reminding that the law requires the doctor on duty/transplant coordinator/counsellor to make inquiry and request for organ donation from the family members of brain stem dead persons. Financial assistance is also being provided under the National Organ Transplant Programme for hiring transplant coordinators in Hospitals and Trauma Centres. The Government has also involved religious leaders and Non-Government Organisations, for generating awareness about organ donation.

(d) Government is implementing National Organ Transplant Programme to support organ donation and make transplantation less costly and without delay with following components:-
(a) Establishing National Networking including National Organ and Tissue Transplant Organisation at National level, Regional Organ and Tissue Transplant Organisation (ROTTO) at regional level and State Organ and Tissue Transplant Organisation (SOTTO) in States;

(b) Maintaining National Organ and Tissue Donation and Transplantation Registry;

(d) Provision of financial assistance to 100 needy and poor patients in Government hospitals every year for post transplant immunosuppressant therapy;

(e) Financial support for maintenance of body of deceased donor when the organ is allocated to a Government Hospital;

(f) Funding of two transplant coordinators @ Rs. 20000/- per coordinator per month and a computer set for each Government medical college and attached hospitals. Financial support for this component is also available for good performing private centres.

(g) Support for training of staff involved in transplantation such as Transplant Surgeons, Transplant Physicians, Nurses and Transplant Coordinators;

(h) Transplant facilities are provided at Government Hospitals at subsidized cost.
Financial Assistance is also provided to below poverty line patients under Rashtriya Arogya Nidhi for organ transplantation.

Requirements for Approval For Renal Transplantation

Procedure for getting approval for Renal Transplantation in Tamil Nadu

ORGAN TRANSPLANTATION: Procedure for getting approval for Renal Transplantation in Tamil Nadu

AUTHORISATION COMMITTEE FOR APPROVAL OF CASES FOR RENAL TRANSPLANTATION.

An Authorisation Committee was constituted by the Government in G.O.Ms.No.287, Health, dt.5.5.95 for the regulation of removal, storage, and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs consisting of the following members namely.
1. Director of Medical Education, Chennai-10 – Chennai
2. Director of Medical and Rural Health Services, Chennai-6 – Member
3. Dean, Madras Medical College, Chennai-3 – Member
To conduct a renal transplantation the hospital should be approved by the appropriate authority for organ transplantation namely the Director of Medical & Rural Health Services.
The approved Hospital propose the cases for Renal Transplant every week before the Authorization Committee for approval. It is the responsibility of the Hospitals approved for RENAL TRANSPLANTATION to verify the health condition of the Recipients/Donors and correctness of the address and identity of the recipients. They also give undertaking for each case that they have verified, the correctness of identity of recipients and donors and for the genuinity of all the documents they forward to the Authorization Committee. Based on the proposals from the approved Hospitals, the authorization committee verify the Identity / Nativity using Xerox copy of Ration cards / Election Identity cards or any other approved photo identity documents.
As per the orders of the Government, every Friday afternoon, the Authorization Committee meets to conduct the business of verifying the genuinity of Recipients and Donors and based on the satisfaction of all the Committee Members, approval is given to perform the Renal Transplantation. The decision of the Authorization Committee is then sent to the approved hospitals concerned by Fax, every Monday, followed by confirmation letters by post. The cases referred by the approved private hospitals are arranged for the presentation to the Authorization Committee in the order of the receipt of the documents from the private hospitals and according to the number assigned by the Tapal section. Every week representatives of the Chairman and Members of the Committee i.e., a Deputy Director of Medical Education, a Joint/ Deputy Director of Medical Rural Health Services and a Professor from the Madras Medical College will conduct the meeting by rotation, allowing no opporurnity for any individual to influence the Authorization Committee’s decision beforehand as the names of the Members are decided only on Friday mornings.As per the Transplantation of Human Organ Act / Government Order No. 341 Health and Family Welfare, dt.29.10.03, to process the Renal Transplantation cases the Nephrologist of the approval hospital should forward the following documents with reference to the recipient as well as donor of the organ.
1. Processing Fee (Demand Draft): for Rs.1000/- in favour of the Chairman, Authorisation Committee, Kilpauk, Chennai-10.
2. Form I, II and X Form III (If the Patient and Donor are related like Brother / Sister/ Mother / Father / Son / Daughter)
3. Patient and Donor: Identification Marks
Declaration: Consultant Nephrologist should explain the complications of the surgery.
Patient and Donor: Proof Nativity
1. The Patient and Donor should submit their Identity Card / Nativity using attested Xerox Copy of Ration Card/ Election Identity Card or any other approved photo identity document like, Passport or Pass Book with three years of transaction.
2. The Notary Public should attest Proof Nativity.
Other State / Other Countries
1. In the case of recipients who are natives of other States or Countries and non-resident in our State, any non-relative donors should normally be from their State/ Country only and should bring clearance from the Authorisation Committee governing their area.
2. Valid Passport, Visa, High Commission Embassy letters should be enclosed with the application from foreign national patients and donors; the applications are otherwise subject to rejection.
Consent Letter:
1. Original letter of consent from the spouse of the donor in the affidavit should be enclosed. Joint photographs should fixed in affidavit (Donor and Spouse)
2. Original letter of consent of the donor in the affidavit, duly signed in the presence of a Magistrate or Notary Public. Donor photograph should be affixed in the affidavit.
3. Original letter of consent of the patient in the affidavit, duly signed in the presence of a Magistrate or Notary Public. Joint photographs should be affixed in affidavit (Patient and Donor)
4. The affidavits produced by the Patient, Donor and Spouse of the Donor should be in English and also in the mother tongue of the donor.
5. Witness signatures should be affixed in the affidavit (at least one of whom is relative of such persons)
6. Joint photographs should affixed in the affidavit (Patient and Donor) and (Donor and Spouse)
HLA Test:
1. If the patient and donor are related, the tests for HLA matching should be done by an approved lab which is not attached or affiliated to the Hospital where the transplantation is to be performed.
Registration Copy:
A copy of Registration Letter issued to the approved institution by DM & RHS, Chennai should be enclosed along with the applications. Only when all the documents submitted are in order, the Patient will be called for counseling to the authorization committee and only after the approval from the committee the concerned hospital should perform the surgery.

Additional Authorization Committees for Organ Transplantation:

In order to avoid the difficulties faced by the patients undergoing transplantation in southern and western districts of Tamilnadu while traveling all the way to Chennai for approval, the Government has made provision for two more additional committees – one at Madurai and another at Coimbatore with the following persons as Members.

Dean of Madurai / Coimbatore Medical College
Joint Director of Medical Services of concerned District
DRO representing the District Collect of the concerned District

However, these subcommittees can deal cases only when the patient, donor and the referred hospitals are all situated in the following revenue districts, surrounding the respective committee.The Jurisdiction of Madurai and Coimbatore Committees :

These additional committees cannot deal cases when the patient/donor are from other parts of Tamilnadu / Other States / Other Countries

S.No.	Chennai	Madurai	Coimbatore
1.	Kancheepuram	Dindigul	Coimbatore
2.	Cuddalore	Kanniyakumari	Dharmapuri
3.	Nagapatinam	Madurai	Erode
4.	Thanjavore	Perambalur	Karur
5.	Tiruvallur	Pudukottai	Namakkal
6.	Tiruvarur	Ramanathapuram	The Nilgiris
7.	Tiruvannamali	Sivagangai	Salem
8.	Vellore	Theni at Periyakulam
9.	Villupuram	Tricy
10.	Chennai	Tirunelveli
11.		Tuticorin
12.		Virudhunagar

Law