The Pre-Natal Diagnostic Techniques
(Regulation and Prevention of Misuse) Rules, 1996

1.Short title and commencement.- (1) These rules may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.
(2) They shall come into force on the date of their publication in the Official Gazette.

2.Definitions.- In these rules, unless the context otherwise requires:-
(a) "Act" means The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994);
(b) "employee" means a person working in or employed by a Genetic Counselling Centre, a Genetic Laboratory or a Genetic Clinic, and includes those working on part-time, contractual, consultancy, honorary or on any other basis;
(c) "Form" means a Form appended to these rules;
(d) "Schedule" means a Schedule appended to these rules;
(e) "Section" means a section of the Act;
(f) words and expressions used herein and not defined in these rules but defined in the Act, shall have the meanings, respectively, assigned to them in the Act.

3.Minimum requirements.- (1) The minimum qualifications of the employees, the minimum equipment and minimum place for a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic shall be as specified in Schedules I, II and III. (2) Where an institute, hospital, nursing home, or any place, by whatever name called, provides services jointly of Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, or any combination of these, it shall conform to the requirements as specified in Schedules I, II and III.

4.Registration of Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic.-
(1) An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A.
(2) The Appropriate Authority, or any person in his office authorized in this behalf, shall acknowledge receipt of the application for registration, in the acknowledgement slip provided at the bottom of Form A, immediately if delivered at the office of the Appropriate Authority, or not later than the next working day if received by post.

5.Application Fee.- (1) Every application for registration under rule 4 shall be accompanied by an application fee of:-
(a) Rs.2000.00 for Genetic Counselling Centre;
(b) Rs.3000.00 for Genetic Laboratory;
(c) Rs.3000.00 for Genetic Clinic; and
(d) Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the services of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic or any combination of such Centre, Laboratory or Clinic.

(2) The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank located at the headquarters of the Appropriate Authority.

6.Certificate of registration.- (1) The Appropriate Authority shall, after making such enquiry and after satisfying itself that the applicant has complied with all the requirements, place the application before the Advisory Committee for its advice.
(2) Having regard to the advice of the Advisory Committee the Appropriate Authority shall grant a certificate of registration, in duplicate, in Form B to the applicant. One copy of the certificate of registration shall be displayed by the registered Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic at a conspicuous place at its place of business: Provided that the Appropriate Authority may grant a certificate of registration to a Genetic Laboratory or a Genetic Clinic to conduct one or more specified pre-natal diagnostic tests or procedures, depending on the availability of place, equipment and qualified employees, and standards maintained by such laboratory or clinic.
(3) If, after enquiry 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 the Act and these rules, it shall, for the reasons to be recorded in writing, reject the application for registration and communicate such rejection to the applicant as specified in Form C.
(4) An enquiry under sub-rule(1), including inspection at the premises of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, shall, be carried out only after due notice is given to the applicant by the Appropriate Authority.
(5) Grant of certificate of registration or rejection of application for registration shall be communicated to the applicant as specified in Form B or Form C, as the case may be, within a period of ninety days from the date of receipt of application for registration.
(6) The certificate of registration shall be non-transferable. In the event of change of ownership or change of management or on ceasing to function as a Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, both copies, of the certificate of registration shall be surrendered to the Appropriate Authority.
(7) In the event of change of ownership or change of management of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, the new owner or manager of such Centre, Laboratory or Clinic shall apply afresh for grant of certificate of registration.

7.Validity of registration.- Every certificate of registration shall be valid for a period of five years from the date of its issue.

8.Renewal of registration.- (1) An application for renewal of certificate of registration shall be made in duplicate in Form A, to the Appropriate Authority thirty days before the date of expiry of the certificate of registration. Acknowledgement of receipt of such application shall be issued by the Appropriate Authority in the manner specified in sub-rule (2) of rule 4.
(2) The Appropriate Authority shall, after holding an enquiry and after satisfying itself that the applicant has complied with all the requirements of the Act and these rules and having regard to the advice of the Advisory Committee in this behalf, renew the certificate of registration, as specified in Form B, for a further period of five years from the date of expiry of the certificate of registration earlier granted.
(3) If, after enquiry 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 the Act and these rules, it shall, for reasons to be recorded in writing, reject the application for renewal of certificate of registration and communicate such rejection to the applicant as specified in Form C.
(4) The fees payable for renewal of certificate of registration shall be one half of the fees provided in sub-rule (1) of rule 5.
(5) On receipt of the renewed certificate of registration in duplicate or on receipt of communication of rejection of application for renewal, both copies of the earlier certificate of registration shall be surrendered immediately to the Appropriate Authority by the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic.
(6) In the event of failure of the Appropriate Authority to renew the certificate of registration or to communicate rejection of application for renewal of registration within a period of ninety days from the date of receipt of application for renewal of registration, the certificate of registration shall be deemed to have been renewed.

9.Maintenance and preservation of records.- (1) Every Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic shall maintain a register showing, in serial order, the names and addresses of the women given genetic counseling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their husbands or fathers and the date on which they first reported for such counseling, procedure or test.
(2) The record to be maintained by every Genetic Counselling Centre, in respect of each woman counseled shall be as specified in Form D.
(3) The record to be maintained by every Genetic Laboratory, in respect of each woman subjected to any pre-natal diagnostic test, shall be as specified in Form E.
(4) The record to be maintained by every Genetic Clinic, in respect of each woman subjected to any pre-natal diagnostic procedure, shall be as specified in Form F.
(5) The Appropriate Authority shall maintain a permanent record of applications for grant or renewal of certificate of registration as specified in Form H. Letters of intimation of every change of employee, place, address and equipment installed shall also be preserved as permanent records.
(6) All case related records, forms of consent, laboratory results, microscopic pictures, sonographic plates or slides, recommendations and letters shall be preserved by the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic for a period of two years from the date of completion of counseling, pre-natal diagnostic procedure or pre-natal diagnostic test, as the case may be. In the event of any legal proceedings, the records shall be preserved till the final disposal of legal proceedings, or till the expiry of the said period of two years, whichever is later.
(7) In case the Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic maintains records on computer or other electronic equipment, a printed copy of the record shall be taken and preserved after authentication by a person responsible for such record.

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