Section 24 in The Transplantation of Human Organs and Tissues Act, 1994

Title: Power to make rules

Description: (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. 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).

Title: Repeal and savings

Description: (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.

Title: Short title, extent and commencement

Description: (1) This Act may be called 1[the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection)] Act, 1994. (2) It shall extend to the whole of India 2***. (3) It shall come into force on such date3 as the Central Government may, by notification in the Official Gazette, appoint. 1 Subs. by s. 3, ibid., for "the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)" (w.e.f. 14-2-2003). 2. The words "except the State of Jammu and Kashmir" omitted by Act 34 of 2019, s. 95 and the Fifth Schedule (w.e.f. 31-10-2019). 3. 1st January, 1996, vide notification No. S.O. 990, dated 21st December, 1995, see Gazette of India, Extraordinary, Part II, sec. 3(ii).

Title: Definitions

Description: In this Act, unless the context otherwise requires, (a) "Appropriate Authority" means the Appropriate Authority appointed under section 17; (b) "Board" means the Central Supervisory Board constituted under section 7; 1[(ba) "conceptus" means any product of conception at any stage of development from fertilisation until birth including extra embryonic membranes as well as the embryo or foetus; (bb) "embryo" means a developing human organism after fertilisation till the end of eight weeks (fifty-six days); (bc) "foetus" means a human organism during the period of its development beginning on the fifty-seventh day following fertilisation or creation (excluding any time in which its development has been suspended) and ending at the birth;] (c) "Genetic Counselling Centre" means an institute, hospital, nursing home or any place, by whatever name called, which provides for genetic counselling to patients; (d) "Genetic Clinic" means a clinic, institute, hospital, nursing home or any place, by whatever name called, which is used for conducting pre-natal diagnostic procedures. 2[Explanation. - For the purposes of this clause, "Genetic Clinic" includes a vehicle, where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the foetus or a portable equipment which has the potential for detection of sex during pregnancy or selection of sex before conception, is used;] (e) "Genetic Laboratory" means a laboratory and includes a place where facilities are provided for conducting analysis or tests of samples received from Genetic Clinic for pre-natal diagnostic test. 2[Explanation. --For the purposes of this clause, "Genetic Laboratory" includes a place where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the foetus or a portable equipment which has the potential for detection of sex during pregnancy or selection of sex before conception, is used;] (f) "gynaecologist" means a person who possesses a post-graduate qualification in gynaecology and obstetrics; 3[(g) "medical geneticist" includes a person who possesses a degree or diploma in genetic science in the fields of sex selection and pre-natal diagnostic techniques or has experience of not less than two years in any of these fields after obtaining— (i) any one of the medical qualifications recognised under the Indian Medical Council Act, 1956 (102 of 1956); or (ii) a post-graduate degree in biological sciences;] (h) "paediatrician" means a person who possesses a post-graduate qualification in paediatrics; 4[(i) "pre-natal diagnostic procedures" means all gynaecological or obstetrical or medical procedures such as ultrasonography, foetoscopy, taking or removing samples of amniotic fluid, chorionic villi, embryo, blood or any other tissue or fluid of a man, or of a woman before or after conception, for being sent to a Genetic Laboratory or Genetic Clinic for conducting any type of analysis or pre-natal diagnostic tests for selection of sex before or after conception;] (j) "pre-natal diagnostic techniques" includes all pre-natal diagnostic procedures and pre-natal diagnostic tests; 5[(k) "pre-natal diagnostic test" means ultrasonography or any test or analysis of amniotic fluid, chorionic villi, blood or any tissue or fluid of a pregnant woman or conceptus conducted to detect genetic or metabolic disorders or chromosomal abnormalities or congenital anomalies or haemoglobinopathies or sex- linked diseases;] (l) "prescribed" means prescribed by rules made under this Act; (m) "registered medical practitione"r 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 (102 of 1956), and whose name has been entered in a State Medical Register; (n) "regulations" means regulations framed by the Board under this Act; 6[(o) "sex selection" includes any procedure, technique, test or administration or prescription or provision of anything for the purpose of ensuring or increasing the probability that an embryo will be of a particular sex; (p) "sonologist or imaging specialist" means a person who possesses any one of the medical qualifications recognised under the Indian Medical Council Act, 1956 (102 of 1956) or who possesses a post-graduate qualification in ultrasonography or imaging techniques or radiology; (q) "State Board" means a State Supervisory Board or a Union territory Supervisory Board constituted under section 16A; (r) "State Government" in relation to Union territory with Legislature means the Administrator of that Union territory appointed by the President under article 239 of the Constitution.] 1 Ins. by Act 14 of 2003, s. 4 (w.e.f. 14-2-2003). 2 Added by s. 4, ibid. (w.e.f. 14-2-2003). 3 Subs. by Act 14 of 2003, s. 4, for clause (g) (w.e.f. 14-2-2003). 4 Subs. by s. 4, ibid., for clause (i) (w.e.f. 14-2-2003). 5 Subs. by s. 4, ibid., for clause (k) (w.e.f. 14-2-2003). 6 Ins. by s. 4, ibid. (w.e.f. 14-2-2003).

Title: Regulation of Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics

Description: On and from the commencement of this Act,-- (1) no Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic unless registered under this Act, shall conduct or associate with, or help in, conducting activities relating to pre-natal diagnostic techniques; 1[(2) no Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall employ or cause to be employed or take services of any person, whether on honorary basis or on payment who does not possess the qualifications as may be prescribed;] (3) no medical geneticist, gynaecologist paediatrician registered 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 pre-natal diagnostic techniques at a place other than a place registered under this Act. 1 Subs. by Act 14 of 2003, s. 5, for clause (2) (w.e.f. 14-2-2003).

The Transplantation of Human Organs and Tissues Act, 1994