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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003

Rule 4 - An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit

  In the said rules, in rule 4 for sub-rule (1) the following sub-rule shall be substituted, namely:-

 “(1) An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit containing–

         (i) an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Ultrasound Clinic/ Imaging Centre/ Combination thereof, as the case may be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of foetus  except for diseases specified in Section 4(2) nor shall the sex of  foetus be disclosed to any body; and

        (ii) an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Combination thereof, as the case may be, shall display prominently a notice that they do not conduct any technique, test or procedure etc. by whatever name called, for detection of sex of foetus or for selection of sex before or after conception.”.

Rule 5 - Application Fee

    In the said rules, for rule 5, the following rule shall be substituted, namely:-

 Application Fee – (1) Every application for registration under Rule 4 shall be accompanied by an application fee of :-

 (a) Rs.3000.00 for Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre.

(b) Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or Imaging Centre or any combination thereof.

Provided that if an application for registration of any Genetic Clinic/ Laboratory/ Centre etc. has been rejected by the Appropriate Authority, no fee shall be required to be paid on re-submission of the application by the applicant for the same body within 90 days of rejection.  Provided further that any subsequent application shall be accompanied with the prescribed fee.  Application fee once paid will not be refunded.

 (2) The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank payable at the headquarters of the Appropriate Authority concerned. The fees collected by the Appropriate Authorities for registration of Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre or any other body or person under sub-rule (1), shall be deposited by the Appropriate Authority concerned in a bank account opened in the name of the official designation of the Appropriate Authority concerned and shall be utilized by the Appropriate Authority in connection with the activities connected with implementation of the provisions of the Act and these rules.”.

 Rule 9 – With Reference to Rule 1, 3, 4, 7    

 In the said rules, in rule 9, -

 (a) for sub-rule (1), the following sub-rule shall be substituted, namely:-

        “(1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test.”; 

(b) for sub-rule (3), the following sub-rule shall be substituted, namely:-

      “(3) The record to be maintained by every Genetic Laboratory, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form E.”;

 (c) for sub-rule (4), the following sub-rule shall be substituted, namely:-

       “(4) The record to be maintained by every Genetic Clinic, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form F.”;

 (d) after sub-rule (7), the following sub-rule shall be inserted, namely:-

 “(8) Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall send a complete report in respect of all pre-conception or pregnancy related procedures/ techniques/tests conducted by them in respect of each month by 5th day of the following month to the concerned Appropriate Authority.”

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