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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996
Date 19/10/11/06/19  Author Infrosoft Health Content Team  Hits 969  Language Global
These rules may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.

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.

1. 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 Counseling 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.

2. Minimum requirements.-

(1) The minimum qualifications of the employees, the minimum equipment and minimum place for a Genetic Counseling 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 Counseling 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.

3. Registration of Genetic Counseling 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.

Application Fee.-

(1) Every application for registration under rule 4 shall be accompanied by an application fee of:-

         (a)    Rs.2000.00 for Genetic Counseling 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 Counseling 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.

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 Counseling 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 Counseling 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 Counseling 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 Counseling 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.

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

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 Counseling 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.

4. Maintenance and preservation of records.-

(1) Every Genetic Counseling 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 Counseling 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 Counseling 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 Counseling 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.

5. Conditions for conducting pre-natal diagnostic procedures.-

(1) Before conducting any pre-natal diagnostic procedure, a written consent, as specified in Form G, in a language the pregnant woman understands, shall be taken from her:

      Provided that where a Genetic Clinic has taken a sample of any body tissue or body fluid and sent it to a Genetic Laboratory for analysis or test, it shall not be necessary for the Genetic Laboratory to obtain a fresh consent in Form G.

(2) All the State Governments and Union Territories may issue translation of Form G in languages used in the State or Union Territory and where no official translation in a language understood by the pregnant woman is available, the Genetic Clinic may translate Form G into a language she understands.

6. Facilities for inspection.- Every Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic shall afford reasonable facilities for inspection of the place, equipment and records to the Appropriate Authority or to any other person authorized by the Appropriate Authority in this behalf.

7. Procedure for search and seizure.-

(1) The Appropriate Authority or any officer authorized in this behalf may enter and search at all reasonable times any Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, in the presence of two or more independent and respectable persons for the purposes of Section 30.

(2) A list of any document, record, register, book, pamphlet, advertisement or any other material object found in the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic and seized shall be prepared in duplicate at the place of effecting the seizure. Both copies of such list shall be signed on every page by the Appropriate Authority or the officer authorized in this behalf and by the witnesses to the seizure:

            Provided that the list may be prepared, in the presence of the witnesses, at a place other than the place of seizure if, for reasons to be recorded in writing, it is not practicable to make the list at the place of effecting the seizure.

(3) One copy of the list referred to in sub-rule (2) shall be handed over, under acknowledgement, to the person from whose custody the document, record, register, book, pamphlet, advertisement or any other material object have been seized:

            Provided that a copy of the list of such document, record, register, book, pamphlet, advertisement or other material object seized may be delivered under acknowledgement, or sent by registered post to the owner or manager of the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, if no person acknowledging custody of the document, record, register, book, pamphlet, advertisement or other material object seized is available at the place of effecting the seizure.

(4) If any material object seized is perishable in nature, the Appropriate Authority, or the officer authorized in this behalf shall make arrangements promptly for sealing, identification and preservation of the material object and also convey it to a facility for analysis or test, if analysis or test be required:

            Provided that the refrigerator or other equipment used by the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic for preserving such perishable material object may be sealed until such time as arrangements can be made for safe removal of such perishable material object and in such eventuality, mention of keeping the material object seized, on the premises of the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic shall be made in the list of seizure.

(5) In the case of non-completion of search and seizure operation, the Appropriate Authority or the officer authorized in this behalf may make arrangement, by way of mounting a guard or sealing of the premises of the Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic, for safe keeping, listing and removal of documents, records, book or any other material object to be seized, and to prevent any tampering with such documents, records, books or any other material object.

8. Intimation of changes in employees, place or equipment. – Every Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority within a period of thirty days of such change.

9.Conditions for analysis or test and pre-natal diagnostic procedures.-

(1) No Genetic Laboratory shall accept for analysis or test any sample, unless referred to it by a Genetic Clinic.

(2) Every pre-natal diagnostic procedure shall invariably be immediately preceded by locating the foetus and placenta through ultrasonography, and the pre-natal diagnostic procedure shall be done under direct ultrasonographic monitoring so as to prevent any damage to the foetus and placenta.

10. Meetings of the Advisory Committees.- The intervening period between any two meetings of Advisory Committees constituted under sub-section (5) of Section 17 to advise the Appropriate Authority shall not exceed sixty days.

11.Allowances to members of the Central Supervisory Board.-

(1) The ex-officio members, and other Central and State Government officers appointed to the Board will be entitled to Travelling Allowance and Daily Allowance for attending the meetings of the Board as per the Travelling Allowance rules applicable to them.

(2) The non-official members appointed to, and Members of Parliament elected to the Board will be entitled to Travelling Allowance and Daily Allowance for attending the meetings of the Board as admissible to non-official and Members of Parliament as the case may be, under the Travelling Allowances rules of the Central Government.

 12. Public Information.-

(1) Every Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic shall prominently display on its premises a notice in English and in the local language or languages for the information of the public, to effect that disclosure of the sex of the foetus is prohibited under law.

(2) At least one copy each of the Act and these rules shall be available on the premises of every Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic, and shall be made available to the clientele on demand for perusal.

(3) The Appropriate Authority, the Central Government, the State Government, and the Government/Administration of the Union Territory may publish periodically lists of registered Genetic Counseling Centres, Genetic Laboratories and Genetic Clinics and findings from the reports and other information in their possession, for the information of the public and for use by the experts in the field.

SCHEDULE I - REQUIREMENTS FOR REGISTRATION OF A GENETIC COUNSELING CENTRE

[See Rule 3 (1)]

  REQUIREMENTS FOR REGISTRATION OF A GENETIC COUNSELING CENTRE
 

A.PLACE
       A room with an area of seven (7) square meters.

B.EQUIPMENT
             Educational charts/models.

 C. EMPLOYEES
             Any one of the following-

 (1)     Medical Geneticist.

(2)     Gynaecologist with 6 months’ experience, in genetic counseling, or having completed 4 weeks’ training in genetic counseling.

(3)     Paediatrician with 6 months’ experience in genetic counseling, or having completed 4 weeks’ training in genetic counseling.

SCHEDULE II - REQUIREMENTS FOR REGISTRATION OF A GENETIC LABORATORY
[See Rule 3(1)]

 A. PLACE
            A room with adequate space for carrying out tests.

 B.EQUIPMENT
         These are categorized separately for each of the under-mentioned studies.

Chromosomal studies:

 (1)   Laminar flow-hood with ultraviolet and fluorescent light or other suitable culture hood.

(2)    Photo-microscope with fluorescent source of light.

(3)    Inverted microscope.

(4)    Incubator and oven.

(5)    Carbon-dioxide incubator or closed system with 5% CO2 atmosphere.

(6)    Autoclave.

(7)    Refrigerator.

(8)    Water bath.

(9)    Centrifuge.

(10)  Vortex mixer.

(11)  Magnetic stirrer.

(12)  PH meter.

(13)  A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.

(14)  Double distillation apparatus (glass).

Biochemical studies (requirements according to tests to be carried out)

 (1)   Laminar flow-hood with ultraviolet and fluorescent light or other suitable culture hood.

(2)    Inverted microscope.

(3)    Incubator and oven.

(4)    Carbon-dioxide incubator or closed system with 5% CO2 atmosphere.

(5)    Autoclave.

(6)    Refrigerator.

(7)    Water bath.

(8)    Centrifuge.

(9)    Electrophoresis apparatus and power supply.

(10)  Chromatography chamber.

(11)  Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma betacounter) or fluorometer for various biochemical test.

(12)  Vortex mixer.

(13)  Magnetic stirrer.

(14)  PH meter.

(15)  A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.

(16)  Double distillation apparatus (glass).

(17)  Liquid nitrogen tank.

Molecular studies:

 (1)  Inverted microscope.

(2)   Incubator.

(3)   Oven.

(4)   Autoclave.

(5)   Refrigerators (4 degree and minus 20 degree Centigrade).

(6)   Water bath.

(7)   Microcentrifuge.

(8)   Electrophoresis apparatus and power supply.

(9)   Vortex mixer.

(10) Magnetic stirrer.

(11) PH meter.

(12) A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.

(13) Double distillation apparatus (glass).

(14) P.C.R. machine.

(15) Refrigerated centrifuge.

(16) U.V. Illuminator with photographic attachment or other documentation system.

(17) Precision micropipettes.

C.EMPLOYEES 

(1)   A Medical Geneticist.

(2)   A laboratory technician having a B.Sc. degree in Biological Sciences or a degree or a diploma in medical laboratory course with at least one year’s experience in conducting appropriate pre-natal diagnostic tests.               

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