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PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) ACT, 1994
57 OF 1994
"An Act to provide for the prohibition of sex selection, before or after conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide and for matters connected therewith or incidental thereto." Be it enacted by Parliament in the Forth-fifty Year of the Republic of India as follows:-Prefatory Note- Statement of Objects and Reasons.-It is proposed to prohibit pre-natal diagnostic techniques for determination of sex of the foetus leading to female foeticide. Such abuse of techniques is discriminatory against the female sex and affects the dignity and status of women. A legislation is required to regulate the use of such techniques and to provide deterrent punishment to stop such inhuman act. 2. The Bill, inter alia, provides for:- (i) prohibition of the misuse of pre-natal diagnostic techniques for determination of sex of foetus, leading to female foeticide; (ii) prohibition of advertisement of pre-natal diagnostic techniques for detection or determination of sex; (iii) permission and regulation of the use of pre-natal diagnostic techniques for the purpose of detection of specific genetic abnormalities or disorders; (iv) permitting the use of such techniques only under certain conditions by the registered institutions; and (v) punishment for violation of the provisions of the proposed legislation. 3. The Bill seeks to achieve the aforesaid objectives.
CHAPTER 1 : PRELIMINARY
SECTION 1 : Short title, extent and commencement
(1) This Act may be called ["the Preconception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection)"] Act, 1994.
(2) It shall extend to the whole of India except the State of Jammu and Kashmir.
(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
SECTION 2 : Definitions
In this Act, unless the context otherwise requires,- (a) "Appropriate Authority" means the Appropriate Authority appointed under (section 17) ;
(b) "Board"meansthe Central Supervisory Boardconstituted under (Section 7) ;
(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;
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 tests;
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 whopossesses a post-graduate qualification in gynaecology and obstetrics;
(g) "medical geneticist" include 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 postgraduate degree in biological sciences;;
(h)[* * *]
(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 diagnostictechniques"includes all pre-natal diagnostic procedures and pre-natal diagnostic tests;
(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 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 (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.
(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 postgraduate 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 16-A;
(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.'.
CHAPTER 2 : REGULATION OF GENETIC COUNSELLING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS
SECTION 3 : Regulation of Genetic Counselling Centres, Genetic Laboratories & Genetic Clinics
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;
(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.
SECTION 3A : Prohibition of sex selection
No person, including a specialist or a team of specialists in the field of infertility, shall conduct or cause to be conducted or aid in conducting by himself or by any other person, sex selection on a woman or a man or on both or on any tissue, embryo, conceptus, fluid or gametes derived from either or both of them.
SECTION 3B : Prohibition on sale of ultrasound machine, etc., to persons, laboratories, clinics, etc., not registered under the Act.
No person shall sell any ultrasound machine or imaging machine or scanner or any other equipment capable of detecting sex of the foetus to any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic or any other person not registered under the Act.
CHAPTER 3 : REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES
SECTION 4 : Regulation of pre-natal diagnostic techniques
On and from the commencement of this Act,- (1) no place including a registered Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall be used or caused to be used by any person for conducting pre-natal diagnostic techniques except for the purposes specified in clause (2) and after satisfying any of the conditions specified in clause (3);
(2) no pre-natal diagnostic techniques shall be conducted except for the purposes of detection of any of the following abnormalities, namely:-
(i) chromosomal abnormalities;
(ii) genetic metabolic diseases:
(iii) haemoglobinopathies:
(iv) sex-linked genetic diseases;
(v) congenital anomalies;
(vi) any other abnormalities or diseases as may be specified by the Central Supervisory Board;
(3) No pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do so is satisfied for reasons to be recorded in writing that any of the following conditions are fulfilled, namely:
(i)age of the pregnant woman is above thirty-five years;
(ii)the pregnant woman has undergone two or more spontaneous abortions or foetal loss;
(iii)the pregnant woman had been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals;
(iv) the pregnant woman or her spouse has a family hisiory of mental retardation or physical deformities such as, spasticity or any other genetic disease;
(v)any other condition as may be specified by the Board :
Provided that the person conducting ultrasonography on a pregnant woman shall keep complete record thereof in the clinic in such manner, as may be prescribed, and any deficiency or inaccuracy found therein shall amount to contravention of the provisions of Section 5 or Section 6 unless contrary is proved by the person conducting such ultrasonography;
(4) No person including a relative or husband of the pregnant woman shall seek or encourage the conduct of any pre-natal diagnostic techniques on her except for the purposes specified in clause (2);
(5) No person including a relative or husband of a woman shall seek or encourage the conduct of any sex selection technique on her or him or both.
SECTION 5 : Written consent of pregnant woman and prohibition of communicating the sex of foetus
(1) No person referred to in clause (2) of (Section 3) shall conduct the pre- natal diagnostic procedures unless-
(a) he has explained all known side and after effects of such procedures to the pregnant woman concerned;
(b) he has obtained in the prescribed form her written consent to undergo such procedures in the language which she understands; and
(c) a copy of her written consent obtained under clause (b) is given to the pregnant woman.
(2) No person including the person conducting pre-natal diagnostic procedures shall communicate to the pregnant woman concerned or her relatives or any other person the sex of the foetus by words, signs, or in any other manner.
SECTION 6 : Determination of sex prohibited
On and from the commencement of this Act- (a) no Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall conduct or cause to be conducted in its Centre, Laboratory or Clinic, pre-natal diagnostic techniques including ultrasonography, for the purpose of determining the sex of a foetus;
(b) no person shall conduct or cause to be conducted any pre-natal diagnostic techniques including ultrasonography for the purpose of determining the sex of a foetus.
(c) no person shall, by whatever means, cause or allow to be caused selection of sex before or after conception.
CHAPTER 4 : CENTRAL SUPERVISORY BOARD
SECTION 7 : Constitution of Central Supervisory Board
(1) The Central Government shall constitute a Board to be known as the Central Supervisory Board to exercise the powers and perform the functions conferred on the Board under this Act.
(2) The Board shall consist of-
(a) the Minister in charge of the Ministry or Department of Family Welfare, who shall be the Chairman, ex officio-,
(b) the Secretary to the Government of India in charge of the Department of Family Welfare, who shall be the Vice-Chairman, ex officio',
(c) three members to be appointed by the Central Government to represent the Ministries of Central Government in charge of Women and Child Development, Department of Legal Affairs or Legislative Department in the Ministry of Law and Justice, and Indian System of Medicine and Homoeopathy, ex officio;
(d) the Director General of Health Services of the Central Government, ex officio',
(e) ten members to be appointed by the Central Government, two each from amongst-
(i) eminent medical geneticists:
(ii) eminent gynaecologist and obstetrician or expert of stri-roga or prasuti-tantra.
(iii) eminent paediatricians',
(iv) eminent social scientists: and
(v) representatives of women welfare organisations;
(f) three women Members of Parliament, of whom two shall be elected by the House of the People and one by the Council of States;
(g) four members to be appointed by the Central Government by rotation to represent the States and the Union territories, two in the alphabetical order and two in the reverse alphabetical order: Provided that no appointment under this clause shall be made except on the recommendation of the State Government or, as the case may be, the Union territory,
(h) an officer, not below the rank of a Joint Secretary or equivalent of the Central Government, in charge of Family Welfare, who shall be the Member-Secretary, ex officio.
SECTION 8 : Term of office of members
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