The Transplantation of Human Organs and Tissues Act, 1994
Administered Ministry: Ministry of Health and Family Welfare / Department of Health and Family Welfare
Section
Section 16 Suspension or cancellation of registration.
(1) The Appropriate Authority may, suo motu or on complaint, issue a notice to any 1[hospital or Tissue Bank, as the case may be,] 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 1[hospital or Tissue Bank, as the case may be,] 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 1[hospital or Tissue Bank, as the case may be,] 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 2[hospital or Tissue Bank, as the case may be,] without issuing any notice.
(2) If, after giving a reasonable opportunity of being heard to the 1[hospital or Tissue Bank, as the case may be,] 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 1[hospital or Tissue Bank, as the case may be,] 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 2[hospital or Tissue Bank, as the case may be,] without issuing any notice.
1. Subs. by s. 14, ibid., for "hospital" (w.e.f. 10-1-2014).
2. Subs. by Act 16 of 2011, s. 14, for "hospital" (w.e.f. 10-1-2014).
2. Subs. by Act 16 of 2011, s. 14, for "hospital" (w.e.f. 10-1-2014).
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 1[or Tissue Bank, as the case may be,] 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--
(i) the Central Government where the appeal is against the order of the Authorisation Committee constituted under clause (a) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (1) of section 13; or
(ii) the State Government, where the appeal is against the order of the Authorisation Committee constituted under clause (b) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (2) of section 13.
(i) the Central Government where the appeal is against the order of the Authorisation Committee constituted under clause (a) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (1) of section 13; or
(ii) the State Government, where the appeal is against the order of the Authorisation Committee constituted under clause (b) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (2) of section 13.
1. Ins. by s. 15, ibid. (w.e.f. 10-1-2014).
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 1[ten years and with fine which may extend to twenty lakh 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 respective State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of 2[three years] for the first offence and permanently for the subsequent offence.
3[(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 tissue 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.]
(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 respective State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of 2[three years] for the first offence and permanently for the subsequent offence.
3[(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 tissue 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.]
1. Subs. by s. 16, ibid., for "five years and with fine which may extend to ten thousand rupees" (w.e.f. 10-1-2014).
2. Subs. by s. 16, ibid., for "two years" (w.e.f. 10-1-2014).
3. Ins. by s. 16, ibid. (w.e.f. 10-1-2014).
2. Subs. by s. 16, ibid., for "two years" (w.e.f. 10-1-2014).
3. Ins. by s. 16, ibid. (w.e.f. 10-1-2014).
Section 19 Punishment for commercial dealings in human organs.
Whoever--
(a) makes or receives any payment for the supply of, or for an offer to supply, any 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; 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 organ;
(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,--
(a) inviting persons to supply for payment of any human organ;
(b) offering to supply any human organ for payment; or
(c) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d);
1[(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,
shall be punishable with imprisonment for a term which shall not be less than 2[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].
3* * * * *
(a) makes or receives any payment for the supply of, or for an offer to supply, any 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; 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 organ;
(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,--
(a) inviting persons to supply for payment of any human organ;
(b) offering to supply any human organ for payment; or
(c) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d);
1[(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,
shall be punishable with imprisonment for a term which shall not be less than 2[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].
3* * * * *
1. Ins. by Act 16 of 2011, s. 17 (w.e.f. 10-1-2014).
2. Subs. by s. 17, ibid., for "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" (w.e.f. 10-1-2014).
3. The proviso omitted by s. 17, ibid. (w.e.f. 10-1-2014).
2. Subs. by s. 17, ibid., for "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" (w.e.f. 10-1-2014).
3. The proviso omitted by s. 17, ibid. (w.e.f. 10-1-2014).
Section 19A Punishment for illegal dealings in human tissues.
1[19A. Punishment for illegal dealings in human tissues.--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 a 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.
(a) makes or receives any payment for the supply of, or for an offer to supply, any human tissue; or
(b) seeks to find a 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.
1. Ins. by s. 18, ibid. (w.e.f. 10-1-2014).
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 1[five years or with fine which may extend to twenty lakh rupees].
1. Subs. by s. 19, ibid., for "three years or with fine which may extend to five thousand rupees" (w.e.f. 10-1-2014).
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 be 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 of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Explanation. -- For the purposes 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.
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 be 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 of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Explanation. -- For the purposes 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 Central Government or the State Government or, as the case may be, the Appropriate Authority; or;
(b) a person who has given notice of not less than sixty 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 that 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.
(a) the Appropriate Authority concerned, or any officer authorised in this behalf by the Central Government or the State Government or, as the case may be, the Appropriate Authority; or;
(b) a person who has given notice of not less than sixty 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 that 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.
Section 23 Protection of action taken in good faith.
(1) No suit, prosecution or other legal proceeding 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 proceeding shall lie against the Central Government or the State 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 provisions of this Act.
(2) No suit or other legal proceeding shall lie against the Central Government or the State 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 provisions of this Act.
Section 24 Power to make rules. 3 docs
(1) The Central Government may, by notification, make rules for carrying out 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 1[human organ or tissue or both] of his body under sub-section (1A) of section 3;
2[(aa) the human organ or tissues or both in respect of which duty is cast on registered medical pracitioner the manner of obtaining documentation of authoirsation under clause (i) of sub-section 3;
(ab) the manner of informing the Human Organ Retrieval Centre under clause (iii) of sub-section (1A) of section 3;
(ac) the date from which duties mentioned in sub-section (1A) are applicable to registered medical practitioner working a unregistered hospital under sub-section (1B) of section 3;
(ae) the qualification and experience of a technician under the proviso to sub-section (4) of section 3;]
(b) the form and the manner in which a brain-stem death is to be certified and the conditions and requirements which are to be satisfied for that purpose under sub-section (6) of section 3;
3[(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) 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 4[human organ or tissue or both] under sub-section (7) of section 3;
(d) the form in which authority for the removal of any 4[human organ or tissue or both] 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 4[human organ or tissue or both] removed from the body of any person, under section 7;
3[(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;]
(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 hospitals engaged in the removal, storage or transplantation of any 4[human organ or tissue or both] under clause (iii) of sub-section (3) of section 13;
(i) the other measures as the Appropriate Authority shall undertake in performing its functions under clause (vi) of sub-section (3) of section 13;
3[(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;]
(j) 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 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;
3[(ka) the qualifications and experience of a transplant co-ordinator 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 service and the facilities to be provided, skilled manpower and the equipment to be possessed and the standards to be maintained by a Tissue Bank, under sub-section (3) of section 14A;]
(l) the form in which, the period for which and the conditions subject to which certificate of registration is to be granted to a 5[hospital or Tissue Bank], under sub-section (1) of section 15;
(m) the manner in which and the fee on payment of which certificate of registration is to be renewed under sub-section (3) of 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 (1) of section 22; and
(p) any other matter which is required to be, or may be, prescribed.
(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, 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.
(a) the manner in which and the conditions subject to which any donor may authorise removal, before his death, of any 1[human organ or tissue or both] of his body under sub-section (1A) of section 3;
2[(aa) the human organ or tissues or both in respect of which duty is cast on registered medical pracitioner the manner of obtaining documentation of authoirsation under clause (i) of sub-section 3;
(ab) the manner of informing the Human Organ Retrieval Centre under clause (iii) of sub-section (1A) of section 3;
(ac) the date from which duties mentioned in sub-section (1A) are applicable to registered medical practitioner working a unregistered hospital under sub-section (1B) of section 3;
(ae) the qualification and experience of a technician under the proviso to sub-section (4) of section 3;]
(b) the form and the manner in which a brain-stem death is to be certified and the conditions and requirements which are to be satisfied for that purpose under sub-section (6) of section 3;
3[(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) 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 4[human organ or tissue or both] under sub-section (7) of section 3;
(d) the form in which authority for the removal of any 4[human organ or tissue or both] 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 4[human organ or tissue or both] removed from the body of any person, under section 7;
3[(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;]
(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 hospitals engaged in the removal, storage or transplantation of any 4[human organ or tissue or both] under clause (iii) of sub-section (3) of section 13;
(i) the other measures as the Appropriate Authority shall undertake in performing its functions under clause (vi) of sub-section (3) of section 13;
3[(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;]
(j) 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 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;
3[(ka) the qualifications and experience of a transplant co-ordinator 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 service and the facilities to be provided, skilled manpower and the equipment to be possessed and the standards to be maintained by a Tissue Bank, under sub-section (3) of section 14A;]
(l) the form in which, the period for which and the conditions subject to which certificate of registration is to be granted to a 5[hospital or Tissue Bank], under sub-section (1) of section 15;
(m) the manner in which and the fee on payment of which certificate of registration is to be renewed under sub-section (3) of 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 (1) of section 22; and
(p) any other matter which is required to be, or may be, prescribed.
(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, 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.
1. Subs. by Act of 16 of 2011, s. 4 for "human organ" (w.e.f. 10-1-2014).
2. Ins. by s. 20, ibid. (w.e.f. 10-1-2014).
3. Ins. by Act 16 of 2011, s. 20 (w.e.f. 10-1-2014).
4. Subs. by s. 4, ibid., for "human organ" (w.e.f. 10-1-2014).
5. Subs. by Act 16 of 2011, s. 20, for "hospital" (w.e.f. 10-1-2014).
2. Ins. by s. 20, ibid. (w.e.f. 10-1-2014).
3. Ins. by Act 16 of 2011, s. 20 (w.e.f. 10-1-2014).
4. Subs. by s. 4, ibid., for "human organ" (w.e.f. 10-1-2014).
5. Subs. by Act 16 of 2011, s. 20, for "hospital" (w.e.f. 10-1-2014).
Section 25 Repeal and savings.
(1) The Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1982 (28 of 1982) and the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 (29 of 1982) are hereby repealed.
(2) The repeal shall, however, not affect the previous operation of the Acts so repealed or anything duly done or suffered thereunder.
(2) The repeal shall, however, not affect the previous operation of the Acts so repealed or anything duly done or suffered thereunder.