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The Pre-Natal Diagnostic Techniques - PNDT Act and Rules
Date 19/10/11/06/06  Author Infrosoft Health Content Team  Hits 1057  Language Global
Introduction

The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st January, 1996, in order to check female foeticide.  


Rules have also been framed under the Act.  The Act prohibits determination and disclosure of the sex of foetus .  It also prohibits any advertisements relating to pre-natal determination of sex and prescribes punishment for its contravention.  The person who contravenes the provisions of this Act is punishable with imprisonment and fine.

Recently, PNDT Act and Rules have been amended keeping in view the emerging technologies for selection of sex before and after conception and problems  faced in the working of implementation of the ACT and certain directions of Hon’ble Supreme Court after a PIL was filed in May, 2000 by CEHAT and Ors, an NGO on slow implementation of the Act.  These amendments have come into operation with effect from 14th February, 2003

  •  The PNDT (PRINCIPAL) ACT 1994              
  •  The PNDT (PRINCIPAL) RULES 1996
  •  The PNDT Advisory Committee Rules, 1996
  •  The PNDT Amendment Act, 2002
  •  The PNDT Amendment Rule, 2003

Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994

Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 

An Act to provide for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex linked disorders and for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female foeticide; and, for matters connected there with or incidental thereto.

BE it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows:--

CHAPTER I - DEFINITIONS

Short title, extent and commencement.-

(1) This Act may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) 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.

Definitions.- 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;

          (c)   "Genetic Counseling Centre" means an institute, hospital, nursing home or any place, by whatever name called, which provides for genetic Counseling 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;

          (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;

         (f)   "Gynecologist" means a person who possesses a post- graduate qualification in gynecology and obstetrics;

          (g)    "Medical geneticist" means a person who possesses a degree or diploma or certificate in medical genetics in the field of pre-natal diagnostic techniques or has experience of not less than two years in such field 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)   "Pediatrician" means a person who possesses a post- graduate qualification in pediatrics;

          (i)  "pre-natal diagnostic procedures" means all gynecological or obstetrical or medical procedures such as ultrasonography foetoscopy, taking or removing samples of amniotic fluid, chorionic villi, blood or any tissue of a pregnant woman for being sent to a Genetic Laboratory or Genetic Clinic for conducting pre-natal diagnostic test;

           (j)   "pre-natal diagnostic techniques" 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 of a pregnant woman 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.

CHAPTER II - REGULATION OF GENETIC COUNSELING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS

Regulation of Genetic Counseling Centres, Genetic Laboratories and Genetic Clinics.- On and from the commencement of this Act,--

 (1) no Genetic Counseling 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 Counseling Centre, Genetic Laboratory or Genetic Clinic shall  employ or  cause to  be employed any person who does not possess the prescribed qualifications;

 (3) no medical geneticist, gynecologist, pediatricians, 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.

CHAPTER III - REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES

          Regulation of pre-natal diagnostic techniques.- On and from the commencement of this Act,--

(1) no place including a registered Genetic Counseling 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 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 of 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 has a family history of mental retardation or physical deformities such as spasticity or any other genetic disease;

             (v) any other condition as may be specified by the Central Supervisory Board;

 (4) no person, being a relative or the husband of the pregnant woman shall seek or encourage the conduct of any pre-natal diagnostic techniques on her except for the purpose specified in clause (2).

 (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 conducting pre-natal diagnostic procedures shall communicate to the pregnant woman concerned or her relatives the sex of the foetus by words, signs or in any other manner.

 (6)  Determination of sex prohibited.- On and from the commencement of this Act,--

           (a)   no Genetic Counseling 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.

CHAPTER IV - CENTRAL SUPERVISORY BOARD

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)   two members to be appointed by the Central Government to represent the Ministries of Central Government in charge of Woman and Child Development and of Law and Justice, 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 gynaecologists and obstetricians;

                             (iii)    eminent paediatricians;

                             (iv)    eminent social scientists; and

                             (v)     representatives of women welfare Organizations;

          (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.

Term of office of members
.-

    (1) The term of office of a member, other than an ex officio member, shall be,--

            (a) in case of appointment under clause (e) or clause (f) of sub-section (2) of section 7, three years; and

              (b) in case of appointment under clause (g) of the said subsection, one year.

    (2) If a casual vacancy occurs in the office of any other members, whether by reason of his death, resignation or inability to discharge his functions owing to illness or other incapacity, such vacancy shall be filled by the Central Government by making a fresh appointment and the member so appointed shall hold office for the remainder of the term of office of the person in whose place he is so appointed.

    (3) The Vice-Chairman shall perform such functions as may be assigned to him by the Chairman from time to time.

    (4) The procedure to be followed by the members in the discharge of their functions shall be such as may be prescribed.

Meetings of the Board.-

(1) The Board shall meet at such time and place, and shall observe such rules of procedure in regard to the transaction of business at its meetings (including the quorum at such meetings) as may be provided by regulations:

Provided that the Board shall meet at least once in six months.

(2) The Chairman and in his absence the Vice-Chairman shall preside at the meetings of the Board.

(3) If for any reason the Chairman or the Vice-Chairman is unable to attend any meeting of the Board, any other member chosen by the members present at the meeting shall preside at the meeting.

(4) All questions which come up before any meeting of the Board shall be decided by a majority of the votes of the members present and voting, and in the event of an equality of votes, the Chairman, or in his absence, the person presiding, shall have and exercise a second or casting vote.

(5) Members other than ex officio members shall receive such allowances, if any, from the Board as may be prescribed.

Vacancies, etc., not to invalidate proceedings of the Board.- No act or proceeding of the Board shall be invalid merely by reason of—

       (a)     any vacancy in, or any defect in the constitution of, the Board; or

       (b)     any defect in the appointment of a person acting as a member of the Board; or

       (c)     any irregularity in the procedure of the Board not affecting the merits of the case.

 Temporary association of persons with the Board for particular purposes.

(1) The Board may associate with itself, in such manner and for such purposes as may be determined by regulations, any person whose assistance or advice it may desire in carrying out any of the provisions of this Act.

(2) A person associated with it by the Board under sub-section (1) for any purpose shall have a right to take part in the discussions relevant to that purpose, but shall not have a right to vote at a meeting of the Board and shall not be a member for any other purpose.

 Appointment or officers and other employees of the Board.-

(1) For the purpose of enabling it efficiently to discharge its functions under this Act, the Board may, subject to such regulations as may be made in this behalf, appoint (whether on deputation or otherwise) such number of officers and other employees as it may consider necessary:

 Provided that the appointment of such category of officers, as may be specified in such regulations, shall be subject to the approval of the Central Government.

(2) Every officer or other employee appointed by the Board shall be subject to such conditions of service and shall be entitled to such remuneration as may be specified in the regulations.

 Authentication of orders and other instruments of the Board.- All orders and decisions of the Board shall be authenticated by the signature of the Chairman or any other member authorized by the Board in this behalf, and all other instruments issued by the Board shall be authenticated by the signature of the Member-Secretary or any other officer of the Board authorized in like manner in this behalf.

 Disqualifications for appointment as member.- A person shall be disqualified for being appointed as a member if, he—

           (a)  has been convicted and sentenced to imprisonment for an offence which, in the opinion of the Central Government, involves moral turpitude; or

           (b)  is an undischarged insolvent; or

          (c)   is of unsound mind and stands so declared by a competent court; or

          (d)   has been removed or dismissed from the service of the Government or a Corporation owned or controlled by the Government; or

          (e)   has, in the opinion of the Central Government, such financial or other interest in the Board as is likely to affect prejudicially the discharge by him of his functions as a member; or

         (f)     has, in the opinion of the Central Government, been associated with the use or promotion of pre-natal diagnostic technique for determination of sex.

Eligibility of member for reappointment.- Subject to the other terms and conditions of service as may be prescribed, any person ceasing to be a member shall be eligible for reappointment as such member.

Functions of the Board. - The Board shall have the following functions, namely:--

          (i) to advise the  Government on policy matters relating to use of pre-natal diagnostic techniques;

           (ii) to review implementation of the Act and the rules made thereunder and recommend changes in the said Act and rules to the Central Government;

           (iii) to create public  awareness against  the practice  of pre-natal determination of sex and female foeticide;

           (iv) to  lay down  code of conduct to be observed by persons working at  Genetic Counseling Centres, Genetic Laboratories and Genetic Clinics;

           (v) any other functions as may be specified under the Act.

 

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