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The Pre-Natal Diagnostic Techniques - PNDT Act and Rules (2)
Date 19/10/11/06/11  Author Infrosoft Health Content Team  Hits 919  Language Global
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.

CHAPTER V - APPROPRIATE AUTHORITY AND ADVISORY COMMITTEE 

Appropriate Authority and Advisory Committee.-

(1) The Central Government shall appoint, by notification in the Official Gazette, one or more Appropriate Authorities for each of the Union territories for the purposes of this Act.

(2) The State Government shall appoint, by notification in the Official Gazette, one or more Appropriate Authorities for the whole or part of the State for the purposes of this Act having regard to the intensity of the problem of pre-natal sex determination leading to female foeticide.

(3) The officers appointed as Appropriate Authorities under sub- section (1) or sub-section (2) shall be,--

          (a)   when appointed for the whole of the State or the Union territory, of or above the rank of the Joint Director of Health and Family Welfare; and

         (b)    when appointed for any part of the State or the Union territory, of such other rank as the State Government or the Central Government, as the case may be, may deem fit.

 (4) The Appropriate Authority shall have the following functions, namely:--

            (a)  to grant, suspend or cancel registration of a Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic;

           (b)  to enforce standards prescribed for the Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic;

           (c)   to investigate complaints of breach of the provisions of this Act or the rules made thereunder and take immediate action; and

           (d)   to seek and consider the advice of the Advisory Committee, constituted under sub-section (5), on application for registration and on complaints for suspension or cancellation of registration.

 (5) The Central Government or the State Government, as the case may be, shall constitute an Advisory Committee for each Appropriate Authority to aid and advise the Appropriate Authority in the discharge of its functions, and shall appoint one of the members of the Advisory Committee to be its Chairman.

(6) The Advisory Committee shall consist of—

       (a)  three medical experts from amongst gynaecologists, obstericians, paediatricians and medical geneticists;

        (b)  one legal expert;

        (c)   one officer to represent the department dealing with information and publicity of the State Government or the Union territory, as the case may be;

        (d)   three eminent social workers of whom not less than one shall be from amongst representatives of women's Organizations.

 (7) No person who, in the opinion of the Central Government or the State Government, as the case may be, has been associated with the use or promotion of pre-natal diagnostic technique for determination of sex shall be appointed as a member of the Advisory Committee.

(8) The Advisory Committee may meet as and when it thinks fit or on the request of the Appropriate Authority for consideration of any application for registration or any complaint for suspension or cancellation of registration and to give advice thereon:

     Provided that the period intervening between any two meetings shall not exceed the prescribed period.

(9) The terms and conditions subject to which a person may be appointed to the Advisory Committee and the procedure to be followed by such Committee in the discharge of its functions shall be such as may be prescribed.

CHAPTER VI - REGISTRATION OF GENETIC COUNSELING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS

 Registration of Genetic Counseling Centres, Genetic Laboratories or Genetic Clinics.

(1) No person shall open any Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic after the commencement of this Act unless such Centre, Laboratory or Clinic is duly registered separately or jointly under this Act.

(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) Every Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic engaged, either partly or exclusively, in Counseling or conducting pre-natal diagnostic techniques for any of the purposes mentioned in section 4, immediately before the commencement of this Act, shall apply for registration within sixty days from the date of such commencement.

(4) Subject to the provisions of section 6, every Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic engaged in Counseling or conducting pre-natal diagnostic techniques shall cease to conduct any such Counseling or technique on the expiry of six months from the date of commencement of this Act unless such Centre, Laboratory or Clinic has applied for registration and is so registered separately or jointly or till such application is disposed of, whichever is earlier.

(5) No Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic shall be registered under this Act unless the Appropriate Authority is satisfied that such Centre, Laboratory or Clinic is in a position to provide such facilities, maintain such equipment and standards as may be prescribed. 

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 and having regard to the advice of the Advisory Committee in this behalf, grant a certificate of registration in the prescribed form jointly or separately to the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, as the case may be.

(2) If, after the inquiry and after giving an opportunity of being heard to the applicant and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that the applicant has not complied with the requirements of this Act or the rules, 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 after such period and on payment of such fees as may be prescribed.

(4) The certificate of registration shall be displayed by the registered Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic in a conspicuous place at its place of business.

 Cancellation or suspension of registration.-

(1) The Appropriate Authority may suo moto, or on complaint, issue a notice to the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic to show cause why its registration 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 Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that there has been a breach of the provisions of this Act or the rules, it may, without prejudice to any criminal action that it may take against such Centre, Laboratory or Clinic, suspend its registration for such period as it may think fit or cancel its registration, as the case may be.

(3) Notwithstanding anything contained in sub-sections (1) and (2), if 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 Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic without issuing any such notice referred to in sub-section (1).

 Appeal. The Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic may, within thirty days from the date of receipt of the order of suspension or cancellation of registration passed by the Appropriate Authority under section 20, prefer an appeal against such order to—

      (i) the Central Government, where the appeal is against the order of the Central Appropriate Authority; and

     (ii) the State Government, where the appeal is against the order of the State Appropriate Authority, in the prescribed manner. 

CHAPTER VII - OFFENCES AND PENALTIES

Prohibition of advertisement relating to pre-natal determination of sex and punishment for contravention.-

(1) No person, Organization, Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic shall issue or cause to be issued any advertisement in any manner regarding facilities of pre-natal determination of sex available at such Centre, Laboratory, Clinic or any other place.

(2) No person or Organization shall publish or distribute or cause to be published or distributed any advertisement in any manner regarding facilites of pre-natal determination of sex available at any Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic or any other place.

(3) Any person who contravenes the provisions of sub-section (1) or sub-section (2) shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to ten thousand rupees.

Explanation.--For the purposes of this section, "advertisement" includes any notice, circular, label wrapper or other document and also includes any visible representation made by means of any light, sound, smoke or gas.

 Offences and penalties.-

(1) Any medical geneticist, gynaecologist, registered medical practitioner or any person who owns a Genetic Counseling Centre, a Genetic Laboratory or a Genetic Clinic or is employed in such a Centre, Laboratory or Clinic and renders his professional or technical services to or at such a Centre, Laboratory or Clinic, whether on an honorary basis or otherwise, and who contravenes any of the provisions of this Act or rules made thereunder shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to ten thousand rupees and on any subsequent conviction, with imprisonment which may extend to five years and with fine which may extend to fifty thousand rupees.

(2) The name of the registered medical practitioner who has been convicted by the court under sub-section (1), 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 two years for the first offence and permanently for the subsequent offence.

(3) Any person who seeks the aid of a Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic or of a medical geneticist, gynaecologist or registered medical practitioner for conducting pre- natal diagnostic techniques on any pregnant woman (including such woman unless she was compelled to undergo such diagnostic techniques) for purposes other than those specified in clause (2) of section 4, shall, be punishable with imprisonment for a term which may extend to three years and with fine which may extend to ten thousand rupees and on any subsequent conviction with imprisonment which may extend to five years and with fine which may extend to fifty thousand rupees.

 Presumption in the case of conduct of pre-natal diagnostic techniques.- Notwithstanding anything in the Indian Evidence Act, 1872 (1 of 1872), the court shall presume unless the contrary is proved that the pregnant woman has been compelled by her husband or the relative to undergo pre-natal diagnostic technique and such person shall be liable for abetment of offence under sub-section (3) of section 23 and shall be punishable for the offence specified under that section.

 Penalty for contravention of the provisions of the Act or rules for which no specific punishment is provided.- Whoever contravenes any of the provisions of this Act or any rules made thereunder, for which no penalty has been elsewhere provided in this Act, shall be punishable with imprisonment for a term which may extend to three months or with fine, which may extend to one thousand rupees or with both and in the case of continuing contravention with an additional fine which may extend to five hundred rupees for every day during which such contravention continues after conviction for the first such contravention.

 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 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.

 Offence to be cognizable, non-bailable and non-compoundable.-Every offence  under this  Act shall  be cognizable,  non-bailable and non-compoundable.

 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 authorized in  this behalf  by the  Central Government  or  State Government, as the case may be, or the Appropriate Authority; or

        (b) a  person who  has given  notice of not less than thirty days in  the manner  prescribed, to the Appropriate Authority, of  the alleged  offence and  of his intention to make a complaint to the court.

 Explanation.--For the purpose of this clause, "person" includes a social Organization.

(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 subsection (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 VIII - MISCELLANEOUS

Maintenance of records

(1) All records, charts, forms, reports, consent letters and all other documents required to be maintained under this Act and the rules shall be preserved for a period of two years or for such period as may be prescribed:

 Provided that, if any criminal or other proceedings are instituted against any Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, the records and all other documents of such Centre, Laboratory or Clinic shall be preserved till the  final disposal of such proceedings.

(2) All such records shall, at all reasonable times, be made available for inspection to the Appropriate Authority or to any other person authorized by the Appropriate Authority in this behalf.

 Power to search and seize records,  - 

(1) If the Appropriate Authority has reason to believe that an offence under this Act has been or is being committed at any Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, such Authority or any officer authorized thereof in this behalf may, subject to such rules as may be prescribed, enter and search at all reasonable times with such assistance, if any, as such authority or officer considers necessary, such Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic and  examine   any  record,   register,  document,   book,   pamphlet, advertisement or any other material object found therein and seize the same if  such Authority  or officer  has reason to believe that it may furnish evidence  of the commission of an office punishable under this Act.

(2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) relating to searches and seizures shall, so far as may be, apply to every search or seizure made under this Act.

 Protection of action taken in good faith.-  No suit, prosecution or other legal proceeding shall lie against the Central or the State  Government or  the Appropriate  Authority  or  any  officer authorized by  the Central or State Government or by the Authority for anything which  is in  good faith  done or  intended  to  be  done  in pursuance of the provisions of this Act.

 Power to make rules.-

(1) The Central Government may make rules for carrying out the provisions of this Act.

(2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for--

 (i) the  minimum qualifications  for persons  employed at  a registered Genetic  Counseling  Centre,  Genetic  Laboratory  or Genetic Clinic under clause (1) of section 3;

(ii) the form in which consent of a pregnant woman has to be obtained under section 5;

(iii) the  procedure to  be followed  by the  members of the Central Supervisory  Board in the discharge  of their  functions under sub-section (4) of section 8;

(iv) allowances  for members  other than  ex officio members admissible under sub-section (5) of section  9;

(v) the  period intervening  between any two meetings of the Advisory Committee  under  the  proviso  to  sub-section  (8)  of section 17;

(vi) the  terms and conditions subject to which a person may be appointed  to the  Advisory Committee  and the procedure to be followed by such Committee under sub-section (9) of section 17;

(vii) the  form and  manner in which an application shall be made for  registration and  the fee  payable thereof  under  sub-section (2) of section 18;

(viii) the  facilities to  be provided,  equipment and other standards to  be maintained  by the  Genetic Counseling  Centre, Genetic Laboratory  or Genetic  Clinic under  sub-section (5)  of section 18;

(ix) the  form in  which a certificate of registration shall be issued under sub-section (1) of section 19;

(x) the  manner in  which  and  the  period  after  which  a certificate of  registration shall be renewed and the fee payable for such renewal under sub-section (3) of section 19;

(xi) the  manner in  which an  appeal may be preferred under section 21;

(xii) the period up to which records, charts, etc., shall be preserved under sub-section (1)   of section 29;

(xiii) the  manner  in  which  the  seizure  of  documents, records, objects,  etc., shall  be made  and the  manner in which seizure list  shall be  prepared and delivered to the person from whose custody  such documents,  records or  objects  were  seized under sub-section (1) of section 30;

(xiv) any  other matter  that is  required to be, or may be, prescribed.

 Power to make regulations.- The Board may, with the previous sanction of the Central  Government, by  notification in the Official Gazette, make regulations not inconsistent with the provisions of this Act and the rules made thereunder to provide for--

 (a) the  time and place of the meetings of the Board and the procedure to  be followed for the transaction of business at such meetings and  the number  of members  which shall form the quorum under sub-section (1) of section 9;

(b) the  manner  in  which  a  person  may  be  temporarily associated with the Board under sub-section (1) of section 11;

(c) the method of appointment, the conditions of service and the scales  of pay  and  allowances  of  the  officer  and  other employees of the Board appointed under section 12;

(d) generally  for the  efficient conduct  of the  affairs of the Board.

Rules and regulations to be laid before Parliament. –

Every rule and every regulation 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 regulation or both Houses agree that the rule or  regulation should  not be  made, the rule or regulation 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 or regulation.  

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