ANDHRA PRADESH TRANSPLANTATION OF HUMAN ORGANS ACT, 1995
24 of 1995
STATEMENT OF OBJECTS AND REASONS Keeping in view the considerable advancement in Medical Sciences in recent times and the world wide practice of transplantation of human organs, the Government of India have enacted the Transplantation of Human Organs Act, 1994. On the same lines, in the State of Andhra Pradesh, Governor has promulgated the Andhra Pradesh Transplantation of Human Organs Ordinance, 1994 (Andhra Pradesh Ordinance 18 of 1994) on the 8th September, 1994. As certain provisions of the Ordinance were under examination, a Bill replacing the said Ordinance could not be introduced in the Legislative Assembly and as a result, the said Ordinance lapsed on the 21st February, 1995. As it was decided to have a law for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings on human organs immediately, Government have decided to promulgate an Ordinance for the purpose on the same lines with certain minor modifications. As the Legislative Assembly of the State was not then in session having been prorogued, the Andhra Pradesh Transplantation of Human Organs Ordinance, 1995 was promulgated by the Governor on the 9th March, 1995. This Bill seeks to replace the Ordinance. (Appended to L.A.Bill No. 18 of 1995 A.P. Gazette Part IVA (Ext.) dt. 25-3-1995). Received the assent of the Governor on the 22nd April, 1995 Published on the 24th April, 1995 in the Andhra Pradesh Gazette Part IV-B (Extraordinary).
An Act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purpose and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto. Be it enacted by the Legislative Assembly of the State of Andhra Pradesh in the Forty Sixth Year of the Republic of India as follows
CHAPTER 1 Preliminary
Section 1 Short title, extent and commencement
(1) This Act may be called the Andhra Pradesh Transplantation of Human Organs Act, 1995.
(2) It extends to the whole of the State of Andhra Pradesh.
(3) It shall be deemed to have come into force on the 9th March, 1995.
Section 2 Definitions
In this Act, unless the context otherwise requires,- (a) "advertisement" includes any form of advertising whether to the public generally or to any section of the public or individually to selected persons;
(b) "Appropriate Authority" means the Appropriate Authority appointed under Section 13;
(c) "Authorisation Committee" means the committee constituted under sub-section (4) of Section 9;
(d) " brain-stem death" means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of Section 3;
(e) "deceased person" means a person in whom permanent disappearance of all evidence of life occurs; by reasons of brain-stem death or in a cardio pulmonary sense, at any time after live birth has taken place;
(f) "donor" means any person, not less-than eighteen years of age, who voluntarily authorises in full consciousness after being explained the full consequences of removing the organ by the Doctor who would be removing the organ, the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of Section 3;
(g) "Government" means the State Government.
(h) "hospital" includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution;
(i) "human organ" means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body;
(j) "near relative" means spouse, son, daughter, father, mother, brother or sister;
(k) "notification" means a notification published in the Andhra Pradesh Gazette;
(l) "payment" means payment in money or money's worth but does not include any payment for defraying or reimbursing;
(i) the cost of removing, transporting or preserving the human organ to be supplied; or (ii) any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his supplying any human organ from his body;
(m) "prescribed" means prescribed by rules made under this Act;
(n) "recipient" means a person into whom any human organ is, or is proposed to be, transplanted;
(o) "registered medical practitioner" means a medical practitioner who possesses any recognised medical qualification as defined in Clause (h) of Section 2 of the Indian Medical Council Act 1956, and who is enrolled on a State Medical Register as defined in Clause (k) of that section;
(p) "therapeutic purposes" means systematic treatment of any disease or the measures to improve health according to any particular method or modality; and
(q) "transplantation" means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.
CHAPTER 2 Authority for the Removal of Human Organs
Section 3 Authority for removal of human organs
(1) Any donor may, in such manner and subject to such conditions as may be prescribed, authorise the removal, in full consciousness and after being explained the full consequences of removing the organ by the doctor who would be removing the organ in the presence of his spouse, if living, and in the presence of daughter or son or sister or brother in the same order and in the presence of mother or father in case of un-married persons before his death, of any human organ of his body for therapeutic purposes.
(2) If any donor had, in writing and in the presence of two or more witnesses, spouse if living, and in the presence of daughter or son or sister or brother in that order and in the presence of mother or father or sister or brother in the case of un-married persons unequivocally authorised at any time before his death, the removal of any human organ of his body, after his death, for therapeutic purposes, the person lawfully in possession of the dead body of the donor shall unless he has any reason to believe that the donor had subsequently revoked the authority aforesaid, grant to a Registered Medical Practitioner all reasonable facilities for the removal, for therapeutic purposes, of that human organ from the dead body of the donor.
(3) Where no such authority as is referred to in sub-section (2), was made by any person before his death but no objection was also expressed by such person to any of his human organs being used after his death for therapeutic purposes, the person lawfully in possession of the dead body of such person may, unless he has reason to believe that any near relative of the deceased person has objection to any of the deceased person's human organs being used for therapeutic purposes, authorise the removal of any human organ of the deceased person for its use for therapeutic purposes.
(4) The authority given under sub-section (1) or sub-section (2) or, as the case may be, sub-section (3) shall be sufficient warrant for the removal, for the therapeutic purposes, of the human organ; but no such removal shall be made by any person other than the Registered Medical Practitioner.
(5) Where any human organ is to be removed from the body of a deceased person, the Registered Medical Practitioner shall satisfy himself, before such removal, by a personal examination of the body from which any human organ is to be removed, that life is extinct in such body or where it appears to be a case of brain-stem death, that such death has been certified under sub-section (6).
(6) Where any human organ is to be removed from the body of a person in the event of his brain-stem death, no such removal shall be undertaken unless such death is certified unanimously in such form and in such manner and on satisfaction of such conditions and requirements as may be prescribed, by a Board of medical experts consisting of the following, namely:-
(i) the Registered Medical Practitioner in charge of the hospital in which brain-stem death has occurred; (ii) an independent Registered Medical Practitioner, being a specialist to be nomi- nated by the Registered Medical Practitioner specified in Clause (i) from the panel of names approved by the Appropriate Authority; (iii)a neurologist or a neurosurgeon to be nominated by the Registered Medical Practitioner specified in Clause (i), from the panel of names approved by the Appropriate Authority; and (iv)the Registered Medical Practitioner treating the person whose brain-stem death has occurred.
(7) Notwithstanding anything contained in sub-section (3), where brain-stem death of any person less than eighteen years of age, occurs and is certified under sub-section (6), any of the parents of the deceased person may give authority, in such form and in such manner as may be prescribed, for the removal of any human organ from the body of the deceased person.
Section 4 Removal of human organs not to be authorised in certain cases
(1) No facilities shall be granted under sub-section (2) of Section 3 and no authority shall be given under sub-section (3) of that section for the removal of any human organ from the body of a deceased person if the person required to grant such facilities, or empowered to give such authority, has reason to believe that an inquest may be required to be held in relation to such body in pursuance of the provisions of any law for time being in force.
(2) No authority for the removal of any human organ from the body of a deceased person shall be given by a person to whom such body has been entrusted solely for the purpose of internment, cremation or other disposal.
Section 5 Authority for removal of human organs in case of unclaimed bodies in hospital or prison
(1) In the case of dead body lying in hospital or prison and not claimed by any of the near relatives of the deceased person within forty-eight hours from the time of the death of the concerned person, the authority for the removal of any human organ from the dead body which so remained unclaimed may be given, in the prescribed form by the person incharge, for the time being, of the management or control of the hospital or prison, or by an employee of such hospital or prison authorised in this behalf by the person incharge of the management or control thereof.
(2) No authority shall be given under sub-section (1) if the person so empowered to give such authority has reason to believe that any near relative of the deceased person is likely to claim the dead body even though such near relative has not come forward to claim the body of the deceased person within the time specified in sub-section (1).
Section 6 Authority for removal of human organs from bodies sent for post-mortem examination for medico legal or pathological purposes
Where the body of a person has been sent for post-mortem examination. (a) for medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause; or
(b) for pathological purposes. the person competent under this Act to give authority for the removal of any human organ from such dead body may, if he has reason to believe that such human organ will not be required for the purpose for which such body has been sent for post-mortem examination, authorise the removal, for therapeutic purposes, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs for therapeutic purposes after his death, such authority had not been revoked by him before his death.
Section 7 Preservation of human organs
After the removal of any human organ from the body of any person, the Registered Medical Practitioner shall take such steps for the preservation of the human organ so removed as may be prescribed.
Section 8 Savings
(1) Nothing, in the foregoing provisions of this Act shall be construed as rendering unlawful any dealing with the body or with any part of the body of a deceased person, if such dealing would have been lawful if this Act had not been passed.
(2) Neither the grant of any facility or authority for the removal of any human organ from the body of deceased person in accordance with the provisions of this Act nor the removal of any human organ from the body of deceased person in pursuance of such authority shall be deemed to be an offence punishable under Section 297 of the Indian Penal Code.
Section 9 Restrictions on removal and transplantation of human organs
(1) Save as otherwise provided in sub-section (3), no human organ removed from the body of a donor before his death shall be transplanted into a recipient unless the donor is near relative of the recipient.
(2) Where any donor authorises the removal of any of his human organs after his death under sub-section (2) of Section 3 or any person competent or empowered to give authority for the removal of any human organ from the body of any deceased person authorises such removal, the human organ may be removed and transplanted into the body of any recipient who may be in need of such human organ.
(3) If any donor authorises the removal of any of his human organs before his death under Sub-section (1) of Section 3 for transplantation into the body of such recipient, not being a near relative, as is specified by the donor by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the Authorisation Committee.
(4) The Government shall constitute by notification, one or more Authorisation Committees consisting of such members as may be nominated by the Government on such terms and conditions as may be specified in the notification for the purposes of this section.
(5) On an application jointly made, in such form and in such manner as may be prescribed, by the donor and the recipient the Authorisation Committee shall after holding an inquiry and after satisfying itself that the applicants have complied with all the requirements of this Act and the rules made thereunder, grant to the applicants approval for the removal and transplantation of the human organ.
(6) If, after the inquiry and after giving an opportunity to the applicants of being heard, the Authorisation Committee is satisfied that the applicants have not complied with the requirements of this Act and the rules made thereunder, it shall, for reasons to be recorded in writing, reject the application for approval.
CHAPTER 3 Regulation of Hospitals
Section 10 Regulation of hospitals conducting the removal, storage or transplantation of human organs
(1) On and from the commencement of this Act.
(a) No hospital, unless registered under this Act shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ; (b) No medical practitioner or any other person shall conduct, or cause to be conducted, or aid in conducting by himself or through any other person, any activity relating to the removal, storage or transplantation of any human organ at a place other than a place registered under this Act; and (c) No place including a hospital registered under sub-section (1) of Section 15 shall be used or caused to be used by any person for the removal, storage or transplantation of any human organ except for therapeutic purposes.
(2) Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purposes, by a Registered Medical Practitioner.
Explanation:- For the purposes of this sub-section, "ears" include ear drums and ear bones.
Section 11 Prohibition of removal or transplantation of human organs for any purpose other than therapeutic purposes
No donor and no person empowered to give authority for the removal of any human organ shall authorise the removal of any human organ for any purpose other than the rapeutic purposes.
Section 12 Explaining effects, etc. to donor and recipient
No Registered Medical Practitioner shall undertake the removal or transplantation of any human organ unless he had explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.
CHAPTER 4 Appropriate Authority
Section 13 Appropriate Authority
(1) The Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purpose of this Act.
(2) The Appropriate Authority shall perform the following functions, namely:-
(i) to grant registration under sub-section (1) of Section 15 or renew registration under sub-section (3) of that section; (ii) to suspend or cancel registration under sub-section (2) of Section 16; (iii) to enforce such standards, as may be prescribed for hospitals engaged in the removal, storage or transplantation of any human organ; (iv) to investigate any complaint or breach of any of the provisions of the Act or any of the rules made thereunder and take appropriate action; (v) to inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed, and (vi) to undertake such other measures as may be prescribed.
CHAPTER 5 Registration of Hospitals
Section 14 Registration of hospitals engaged in removal, storage or transplantation of human organs
(1) No hospital shall commence any activity relating to the removal, storage or transplantation of any human organ for therapeutic purposes after commencement of this Act unless such hospital is duly registered under this Act:
Provided that every hospital engaged either partly or exclusively, in any activity relating to the removal, storage or transplantation of any human organ for therapeutic purposes immediately before the commencement of this Act, shall apply for registration within sixty days from the date of such commencement; Provided further that every hospital engaged in any activity relating to the removal, storage or transplantation of any human organ shall cease to engage in any such activity on the expiry of three months from the date of commencement of this Act unless such hospital 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 hospital shall be registered under this Act unless the Appropriate Authority is satisfied that such hospital is in a position to provide such specialized service and facilities, possesses such skilled man power and equipments and maintain such standards as may be prescribed.
Section 15 Certificate of registration
(1) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements of this Act and the rules made thereunder, grant to the hospital a certificate of registration in such form for such period and subject to such conditions as may be prescribed.
(2) If after the inquiry and after giving an opportunity to the applicant of being heard, the Appropriate Authority is satisfied that the applicant not complied with the requirements of this Act and the rules made thereunder, it shall, for reasons to be recorded in writing, reject the application for registration.
(3) Every certificate of registration shall be renewed in such manner and on payment of such fees as may be prescribed.
Section 16 Suspension or cancellation of registration
(1) The Appropriate Authority may, suo motu or on complaint, issue a notice to any hospital to show cause why its registration under this Act should not be suspended or cancelled for the reasons mentioned in the notice.
(2) If, after giving a reasonable opportunity of being heard to the hospital the Appropriate Authority is satisfied that there has been a breach of any of the provisions of this Act or the rules made thereunder, it may, without prejudice to any criminal action that it may take against such hospital, suspend its registration for such period as it may think fit or cancel its registration: Provided that where the Appropriate Authority is of the opinion that it is necessary or expedient so to do in the public interest, it may, for reasons to be recorded in writing, suspend the registration of any hospital without issuing any notice.
Section 17 Appeals
Any person aggrieved by an order of the Authorisation Committee rejecting an application for approval under sub-section (6) of Section 9, or any hospital aggrieved by an order of the Appropriate Authority rejecting an application for registration under sub-section (2) of Section 15 or an order of suspension or cancellation of registration under sub-section (2) of Section 16, may, within thirty days from the date of the receipt of the order, prefer an appeal, in such manner as may be prescribed, against such order to the Government.
CHAPTER 6 Offences and Penalties
Section 18 Punishment for removal of human organ without authority
(1) Any person who renders his services to or at any hospital and who, for purposes of transplantation, conducts associates with, or helps in any manner in, the removal of any human organ without authority, shall be punishable with imprisonment for a term which may extend to five years and with fine which may extend to ten thousand rupees.
(2) Where any person convicted under sub-section (1) is a Registered Medical Practitioner, his name shall be reported by the Appropriate Authority to the State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of two years for the first offence and permanently for the subsequent offence.
Section 19 Punishment for commercial dealings in human organs
(a) makes or receives any payment for the supply of, or for an offer to supply, human organ;
(b) seeks to find a person willing to supply for payment, any human organ;
(c) offers to supply any human organ for payment;
(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human organ;
(e) takes part in the management or control of a body or 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 organ; (ii) offering to supply any human organ for payment; or (iii) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d), shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to seven years and should be liable to fine which shall not be less than ten thousand rupees, but may extend to twenty thousand rupees: Provided that the court may, for any adequate and special reason to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and a fine less than ten thousand rupees.
Section 20 Punishment for contravention of any other provision of this Act
Whoever contravenes any provision of this Act or any rule made, or any condition of the registration granted, thereunder for which no punishment is separately provided in this Act shall be punishable with imprisonment for a term which may extend to three years or with fine which may extend to five thousand rupees.
Section 21 Offences by companies
(1) Where any offence, punishable under this Act, has been committed by a company, every person who, at the time the offence was committed was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment, if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where any offence punishable under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any Director, Manager, Secretary or other Officer or the company such Director, Manager, Secretary or other Officer shall also be deemed to be guilty of the Offence and shall be liable to be proceeded against and punished accordingly.
Explanation:- For the purpose of this section, (a) "company" means any body corporate and includes a firm or other association of individuals; and (b) "director" in relation to a firm, means a partner in the firm.
Section 22 Cognizance of offences
(1) No court shall take cognizance of an offence under this Act except on a complaint made by
(a) the Appropriate Authority concerned, or any officer authorised in this behalf by the Government or, as the case may be, the Appropriate Authority; or (b) a person who has given notice of not less than thirty days, in such manner as may be prescribed, to the Appropriate Authority concerned, of the alleged offence and of his intention to make a complaint to the court.
(2) No court other than of a Metropolitan Magistrate or a Judicial Magistrate of the First Class shall try any offence punishable under this Act.
(3) Where a complaint has been made under Clause (b) of sub-section (1), the court may, on demand by such person, direct the Appropriate Authority to make available copies of the relevant records in its possession to such person.
CHAPTER 7 Miscellaneous
Section 23 Protection of action taken in good faith
(1) No suit, prosecution or other legal proceedings shall lie against any person for anything which is in good faith done or intended to be done in pursuance of the provisions of this Act.
(2) No suit or other legal proceedings shall lie against the Government for any damage caused or likely to be caused for anything which is in good faith done or intended to be done in pursuance of the purposes of this Act.
Section 24 Power to make rules
(1) The Government may, by notification, make rules for carrying out all or any of the purposes of this Act.
(2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters namely:-
(a) the manner in which and the conditions subject to which any donor may authorise removal, before his death, of any human organ of his body under sub-section (1) of Section 3. (b) the form and the manner in which a brain-stem death is to be certified and the condition and requirements which are to be satisfied for the purpose under sub-section (6) or Section 3; (c) the form and the manner in which any of the parents may give authority, in the case of brain-stem death of a minor, for the removal of any human organ under sub-section (7) of Section 3; (d) the form in which authority for the removal of any human organ from an unclaimed dead body may be given by the person incharge of the management or control of the hospital or prison, under sub-section (1) of Section 5; (e) the steps to be taken for the preservation of the human organ removed from the body of any person, under Section 7; (f) the form and the manner in which an application may be jointly made by the donor and the recipient under sub-section (5) of Section 9; (g) the manner in which all possible effects, complications and hazards connected with the removal and transplantation is to be explained by the Registered Medical Practitioner to the donor and the recipient under Section 12; (h) the standards as are to be enforced by the appropriate authority for hospital engaged in the removal, storage or transplantation of any human organ under Clause (iii) of Sub- section (2) of Section 13; (i) the other measures as the Appropriate Authority shall undertake in performing its functions under Clause (vi) of sub-section (2) of Section 13; (j) the form and the manner in which an application for registration shall be made and the fees shall be accompanied, under sub-section (2) of Section 14; (k) 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 hospital for registration under sub-section (3) of Section 14; (l) the form in which, the period for which and the conditions subject to which certificates of registration is to be granted to a hospital, under sub-section (1) of Section 15. (m) the manner in which, and the fees on payment of which certificate of registration is to be renewed under sub-section (3) or Section 15; (n) the manner in which an appeal may be preferred under Section 17; (o) the manner in which a person is required to give notice to the Appropriate Authority of the alleged offence and of his intention to make a complaint to the court, under Clause (b) of sub-section (I) of Section 22; and (p) to provide for a registry to document all the organ transplants to evaluate the performance of each transplant to evaluate the performance of each transplant centre and for matters connected therewith or incidental thereto; and (p) any other matter which is required to be, or may be prescribed.
(3) Every rule made under this Act shall immediately after it is made, be laid before the Legislative Assembly of the State, if it is in session and if it is not in session, in the session immediately following for a total period of fourteen days which may be comprised in one session or in two successive, sessions and if, before the expiration of the session in which it is so laid or the session immediately following the Legislative Assembly agrees in making any modification in the rule or in the annulment of the rule, the rule shall, from the date on which the modification or annulment is notified, have effect only in such modified form or shall stand annulled as the case may be so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.
Section 25 Repeal of Act 22 of 1963 and Ordinance 7 of 1995
The Andhra Pradesh Corneal Grafting Act, 1963 and the Andhra Pradesh Transplantation of Human Organs Ordinance of 1995 are hereby repealed.
RULE
ANDHRA PRADESH TRANSPLANTATION OF HUMAN ORGANS RULES, 1995
In exercise of the powers conferred by sub-section (1) of Section 24 of the Andhra Pradesh Transplantation of Human Organs Act, 1995 (Act 24 of 1995) the Government of Andhra Pradesh hereby makes the following rules:
Rule 1 Short title and commencement
(1) These rules may be called the Andhra Pradesh Transplantation of Human Organs Rules, 1995.
(2) They shall come into force on the date of their publication in the Official Gazette.
Rule 2 Definitions
(1) In these rules unless the context otherwise requires;
(i) "Act" means the Andhra Pradesh Transplantation of Human Organs Act, 1995 (Act 24 of 1995). (ii) "Form" means a form annexed to these rules; (iii) "Section" means a section of the Ordinance.
(2) Words and expression used and not defined in these rules, but defined in the Ordinance, shall have the same meanings respectively assigned to them in the Ordinance.
Rule 3 Authority for Removal of Human Organs
Any donor may authorise the removal, before his death, of any Human Organ of his body for therapeutic purposes in the manner and on such conditions as specified in Form-1.
Rule 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 authorisation in Form-1; (b) that the donor is in proper state of health and is fit to donate the organ, and shall sign a certificate 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 establsh HLA - DR deta and HLA - DQ deta generation 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, tests to establish DNA polymorphisms using atleast two multi-1 ocus gene probe; (iv) where the tests referred to in sub-clause (iii) do not establish a genetic relationship between the donor and the recipient further tests to establish DNA polymorphic probes.
(d) in case recipient is a spouse of the donor, record the statement of the recipient and the donor to the effect that they are so related and shall sign a certificate in Form-4.
(2) A Registered 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 least one of whom is a near relative of such person), unequivocally authorised 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 a human organ from the body of a person in the event of his brain-stem 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 Ordinance. (b) that in the case of brain-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 Ordinance and an authority as specified in Form-9 has been signed by either of the parents of such person.
Rule 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.
Rule 6 Joint Application to the Competent Authority
The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ to Authorisation Committees as specific in Form 10.
Rule 7 Registration of Hospital
(1) An application for registration shall be made to the Appropriate Authority as specified in Form 11 by paying Rs. 1000 as fee for application form. The application shall be accompanied by a registration fee or Rs. 20,000/- payable to the Appropriate Authority by means of a bank draft.
(2) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that 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 from the date of its issue and shall be renewable.
Rule 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 shall be accompanied by a fee or Rs. 20,000/- payable to the Appropriate Authority by means of a bank draft.
(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 applicant, since grant of certificate or registration under sub-rule (2) of Rule 7 has not complied with the requirements of this ordinance 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.
Rule 9 Conditions for Grant of Certificate of Registration
No Hospital shall be granted a certificate of registration under this Ordinance unless it fulfills the following requirements of manpower, equipment, specialised services and facilities as laid down below:-
Rule 10 Appeal
(1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of Section 9, or by an order of the Appropriate Authority under sub-section (2) of Section 15 and sub-section (2) of Section 16 of the Ordinance may, within thirty days from the date of receipt of the order, prefer an appeal to the State Government.
(2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against.
APPENDIX 1 FORM 1
FORM - 1
(See Rule 3)
I ........................ aged. ............ S/o. D/o, W/o, Mr. ............... Resident of ........ hereby authorise to remove for therapeutic purpose/consent to donate my organ, namely ............. to
(i) Mr./Ms. .............. S/o. D/o. W/o, Mr. ................. aged
............ Resident of ................. who happens to be my near relative as defined in Clause (i) of Section 2 of the Ordinance.
OR
(ii) Mr./Mrs. ............. S/o. D/o. W/o Mr. ................ aged
.................... resident of .......... towards whom I possess special affection or attachment or for any special reason to be specified I certify that the above authority/consent has been given by me out of my own free will without any undue 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 before giving this authority or consent or both.
Signature of the Donor
APPENDIX 2 FORM 2
FORM - 2
[See Rule 4(1)(b)]
I, Dr. ................ possessing qualification of ........ registered as medical practitioner at Serial No ............. by the........... Medical Council certify that I have examined Sri/Smt/Kum............. S/o, D/o W/o .............. aged .......... whose free and informed consent about donation of the organ, namely ........... to Sri/Smt./Kum ..... S/o, D/o, W/o .......... who 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 ............
Date ..............
Signature
APPENDIX 3 FORM 3
FORM
FORM-3
[See Rule 4(1)(c)]
I, Dr. ................. possessing qualification of ......... registered as medical practitioner at Serial No ................ by the Medical Council certify that Mr./Mrs. ............ S/o. D/o. W/o ......... aged ........ the donor and 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 Hystocompatibility System, namely ...................... by the Authorisation Committee as per the information contained in their letter of approval No ............ Dated .........
Place:
Date:
Signature
APPENDIX 4 FORM 4
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................ aged
.............. resident of ......................................... are related to each other as spouse according to the statement given by them and their statement has been confirmed by means of following evidence before effecting the organ removal from the body of the said Shri/Smt/kum ...................................... (Applicable only in the cases where considered necessary).
OR
(ii) The Clinical condition of Sri/Smt. ...... mentioned above is such that recording of his/her statement is not practicable.
Place.......
Signature of Regd. Medl.
Dated ..........
Practitioner.
APPENDIX 5 FORM 5
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.
APPENDIX 6 FORM 6
FORM-6
[See Rule 4(2)(b)]
I ......................................... S/o, D/o, W/o
.................................................... aged ........... resident of............................................... having lawful possession of the dead body of Sri/Smt.Kum ...................
.................. S/o, D/o, W/o ................................
.......... Aged ...................................... resident of
................................................. having known that the deceased has not expressed any objection to his/her organ/organs being removed for therapeutic purposes after his/her death and also having reasons to believe that no near relative of the said deceased person has objection to any of his/her organs being used for therapeutic purposes authorise removal of his/her body organs namely ............................................
Dated ............
Signature
Place ............
Person in lawful
Address............
Possession of dead body
APPENDIX 7 FORM 7
FORM-7
[See Rule 4(2)(b)]
I, ........................................................ Mr/Mrs./Miss .................................................. having lawful possession of the dead body of Mr./Mrs./Miss ...................
....................................... S/o, D/o, W/o ..............
.................................... aged ............... resident
of ...................................... after having known that no objection was expressed by the deceased to any of his human organ being used after his death for therapeutic purposes and also having reason to believe that no near relative of the deceased person has objection to any of the deceased person's organ being used for therapeutic purposes, hereby authorise the removal of the deceased's organ, namely ...................... for therapeutic purposes.
Name ................
Address..............
Time and Date ............
Signature .................
APPENDIX 8 FORM 8
FORM - 8
[See Rule 4(3)(a)and (b)]
We the following members of the Board of Medical experts after careful personal examination hereby certify that Sri/Smt/kum ...............
............................ aged about ........................ S/o, W/o, D/o .................................. resident of ............
........................ is dead on account of permanent and
irreversible cessation of all functions of the brain-stem. The tests carried out by us and the findings therein are recorded in the brain-stem death Certificate annexed hereto.
Dated .......... Signature........
1. R.M.P., Incharge of the Hospital in which brain-stem death has occured 3. Neurologist/Neurosurgeon nominated from the panel of names approved by the Appropriate Authority
2. R.M.P., nominated from the panel of names approved by the ppropriate Authority 4. R.M.P., treating the aforesaid deceased person.
BRAIN-STEM DEATH CERTIFICATE
(A) Patient details :
1. Name of the Patient S/o, D/o, W/o Mr./Ms...........................
............................... Mr. ..................................
...............................
2.Home Address.........................................................
................ Sex ............................ Age ................
.............................................................................................................................................................
3. Hospital Number..................................................... ....................
4. Name and address of next of kin or person responsible for the patient (if none exists, this must be Specified)......................
....................................................................................................................................................................................................
5. Has the patient or next of kin agreed to any Transplant............
......................................................................................................................................
6. Is this a Police Case? Yes ............................ No..........
..............................................................................................
(B) Pre-condition......................................................
...................
1. Diagnosis: Did the patient suffer from any illness or accident that led
to irreversible brain damage Specify details ......... Date and Time of ........... accident/onset of illness ...... Date and consent of non-responsible coma .......
2. Findings of Board of Medical Experts:
(1) The following irreversible causes of Coma have been excluded
Intoxication (Alcohol): Depresent Drugs: Relevant (Neuromuscular blocking agent) Hypovolaemic shock Metabolic or endocrine disorders Tests for absence of brain-stem functions
(2) Coma
(3) Cessation of spontaneous breathing
(4) Pupillary size
(5) Pupillary light reflexes
(6) Poll's head eye movements
(7) Corneal reflexes (Both sizes)
(8) Moto response in any cranial nerve distribution, any responses to
stimulation of face, limb or trunk
(9) Gag reflex.
(10) Cough (Tracheal)
(11) Eye movements on coloric testing bilaterally
(12) Apnoea tests as specified
(13) Were any respiratory movements seen
Date and time of first testing: ...........
Date and time of Second Testing............
This is to certify that the patient has been carefully examined twice after an interval of about six hours and on the basis of findings recorded above Mr. M/s......... is declared brain-stem dead.
1. Medical Administrator Incharge of the hospital
2. Authorised Specialist
3. Neurologist Neuro-Surgeon
4. Medical Officer treating the patient
APPENDIX 9 FORM 9
FORM-9
[See Rule 4(3)(b)]
I, Mr./Ms ..................................................... S/o, D/o. W/o ......................................................... hereby authorise removal of the organ/organs, namely from the dead body of my son/daughter Mr./Ms. ...........................................
.................. aged ...................... whose brain- stem death has been duly certified in accordance with the law.
Place ....................
Signature ................
Date .....................
Name .....................
APPENDIX 10 FORM 10
FORM - 10
(See Rule 6)
APPLICATION FOR APPROVAL FOR TRANSPLANTATION LIVE DONOR OTHER THAN NEAR RELATIVE
Whereas I, ................................................... S/o. D/o, W/o, L/o ............................................ aged ...................... residing at ....................... have been informed by my doctor that I am suffering from ......................
.................. and may be benefitted by transplantation of ........
.... into my body. And whereas I ......................................
.............. S/o D/o, W/o, .........................................
........... aged .......... residing at ...............................
.............. by reason of affection and attachment because .......... (reason to be filled in) would like to donate my ......................
............. to ............................ we (donor) and Recipient) hereby apply to authorisation committee for permission for such transplantation to be carried out.
We solemnly affirm that the above decision has been taken without any undue pressure inducement, influence or allurement and that all possible consequences and options of organ transplantation have been explained to us ......................................
Signature and address of
Signature and address of
prospective donor
prospective recipient.
APPENDIX 11 FORM 11
FORM-11
[See Rule 7(1)]
APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN TRANSPLANTATION
To
The Appropriate Authority for organ transplantation, ..................
.............................................................................. We hereby apply to be recognised as an institution to carry out organ transplantation. The required data about the facilities available in the hospital are as follows:-
(A) Hospital
1. Name...............................................................
.........
2. Location............................................................
...........
3. Govt./Private.......................................................
................
4. Teaching/Non-teaching...............................................
.........................
5. Approached by.......................................................
.................
Road : Yes No
Rail : Yes No
Air : Yes No
6. Total bed strength
7. Name of the disciplines in Hospital
8. Annual budget
9. Patient turnover (1) year
(B) Surgical Team :
1. No. of beds.........................................................
.............
2. No. of permanent staff members with their designations .............
.........................................................
3. No. of temporary staff with their designations......................
................................................
4. No. of operations done per year.....................................
.................................
5. Trained persons available for transplantation.......................
...............................................
(Please specify organ for transplantation).............................
.........................................
(C) Medical team
1. No. of beds........................................................
..............
2. No. of permanent staff members with their designations.............
.........................................................
3. No. of temporary staff with their designations.....................
.................................................
4. Patient turnover per year...........................................
...........................
5. No. of Potential transplant candidates admitted per year............
.........................................................
(D) Anaesthesiology
1. No. of permanent staff members with their designations..............
........................................................
2. No. of Temporary staff members with their designations..............
........................................................
3. Name and No. of operations performed................................
......................................
4. Name and No. of equipments available................................
......................................
5. Total No. of operation theatres in the hospital.....................
.................................................
6. No. of emergency operation theatres in the hospital.................
.....................................................
7. No. of emergency operation plant operation theatre..................
...................................................
(E) I.C.U./H.D.U. Facilities :
1. ICU/HDU facilities present ................ Not present.............
.........................................................
2. No. of I.C.U. beds..................................................
....................
3. Trained.............................................................
......... Nurses Technicians
4. Name and number of equipments in I.C.U..............................
.........................................
(F) Other Supportive Facilities :
Data about facilities available in the hospital........................
..............................................
(G) Laboratory Facilities :
1. No. of permanent staff with their designations.....................
.................................................
2. No. of temporary staff with their designations.....................
.................................................
3. Names of the investigations carried out in the department..........
............................................................
4. Name and number of equipments available.............................
.........................................
(H) Imaging Services :
1. No. of permanent staff with their designations......................
................................................
2. No. of temporary staff with their designations......................
................................................
3. Names of the investigations carried out in the department...........
...........................................................
4. Name and number of equipments available.............................
.........................................
(I) Haematology Services :
1. No. of permanent staff with their designations......................
................................................
2. No. of temporary staff with their designations......................
...............................................
3. Names of the investigations carried out in the department...........
..........................................................
4. Name and number of equipments available.............................
.........................................
(J) Blood Bank Facilities
Yes ................................ No.........................
(K) Dialysis Facilities
Yes ................................ No.........................
(L) Other Personnel....................................................
...................
1. Nephrologist Yes/No
2. Neurologist Yes/No
3. Neuro-Surgeon Yes/No
4. Urologist Yes/No
5. G.I. Surgeon Yes/No
6. Paediatrician Yes/No
7. Physiotherapist Yes/No
8. Social Worker Yes/No
9. Immunologists Yes/No
10. Cardiologist Yes/No
The above said information is true to the best of my knowledge and I have no objection to any scrutiny of our facility by authorised personnel. A bank Draft/Cheque of Rs. 20,000/- is being enclosed.
(Sd/-)
Head of the Institution
APPENDIX 12 FORM 12
FORM - 12
[See Rule 7(2)]
This is to certify that ............................................ Hospital located at ............................ has been inspected by the Appropriate Authority and certificate of registration is granted for performing the organ transplantation of the following organs.
1. .............................................................
2. .............................................................
3. .............................................................
4. .............................................................
This certificate of registration is valid for period of five years from the date of issue.
Signature .......................
Signature .....................
APPENDIX 13 FORM 13
FORM - 13
(Renewal of Certificate of Registration)
OFFICE OF THE APPROPRIATE AUTHORITY
This is with reference to the application, dated .......... from......
.....(Name of the hospital) for renewal of certificate of registration for performing organ transplantation, under the Act. After having considered the facilities and standards of the above-said hospital, the Appropriate Authority hereby renews the certificate of registration of the said hospital for the purpose of performing organ transplantation for a period of five years.
Appropriate Authority .....................
Place .....................
Date ......................
Secretary to Government. |
