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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996
Date 19/10/11/06/22  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.

SCHEDULE III - REQUIREMENTS FOR REGISTRATION OF A GENETIC CLINIC

[See Rule 3(1)]

  A.PLACE
             A room with an area of twenty (20) square metres with appropriate aseptic arrangements.

 B.EQUIPMENT
  
        (1)  Equipment and accessories necessary for carrying out clinical examination by an obstetrician/gynaecologist.

          (2)  Equipment, accessories necessary for other facilities required for operations envisaged in the Act.

                      (a)    An ultra-sonography machine.*

                      (b)    Appropriate catheters and equipment for carrying out chorionic villi aspirations per vagina or per abdomen.*

                      (c)     Appropriate sterile needles for amnicentesis or cordocentesis.*

                      (d)    A suitable foetoscope with appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling shall be optional.

              (* These constitute the minimum requirement of equipment for conducting the relevant procedure)

        (3)      Equipment for dry and wet sterilization.

        (4)      Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need.

 C.EMPLOYEES 

 (1)     A gynaecologist with adequate experience in pre-natal diagnostic procedures (should have performed at least 20 procedures under supervision of a gynaecologist experienced in the procedure which is going to be carried out, for example chorionic villi biopsy, amniocentesis, cordocentesis and others indicated at B above).

 (2)     A Radiologist or Registered Medical Practitioner for carrying out ultrasonography. The required experience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques.

FORM A - WITH SUPPORTING DOCUMENTS AS ENCLOSURES, ALSO IN DUPLICATE FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELING CENTRE/GENETIC LABORATORY/GENETIC CLINIC

[See rules 4(1) and 8(1)]

(To be submitted in Duplicate)

1.Name of the applicant

(specify Sh./Smt./Kur./Dr.)

2.Address of the applicant

3.Capacity in which applying

(specify owner/partner/managing director/other-to be stated)

4.Type of facility to be registered

(specify Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic/any combination of these)

5.Full name and address/addresses of Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic with Telephone/Telegraphic Telex/Fax E-mail numbers.

6.Type of ownership and Organization (specify individual ownership/partnership/company/co-operative/any other). In case of type of organization other than individual ownership, furnish copy of articles of association and names and addresses of other persons responsible for management, as enclosure.

7.Type of Institution (Govt. Hospital/Municipal Hospital/Public Hospital/Private Hospital/Private Nursing Home/Private Clinic/Private Laboratory/any other to be stated.) 8.Specific pre-natal diagnostic procedures/tests for which approval is sought (for example amniocentesis, chorionic villi aspiration/chromosomal/biochemical/molecular studies etc.)

Leave blank if registration sought for Genetic Counseling Centre only.

9.(a) Space available for the Counseling Centre/Clinic/Laboratory give total work area excluding lobbies, waiting rooms, stairs etc. and enclose plan)

10.Equipment available with the make and model of each equipment. List to be attached on a separate sheet.

11. (a) Facilities available in the Counseling Centre.

(b)Whether facilities are available in the Laboratory/Clinic for the following tests:

(i) Ultrasound

(ii) Amniocentesis

(iii) Chorionic villi aspiration

(iv) Foetoscopy

(v) Foetal biopsy

(vi) Cordocentesis

(c) Whether facilities are available in the Laboratory, Clinic for the following:

(i) Chromosomal studies

(ii) Biochemical studies

(iii)Molecular studies

12.Names, qualifications, experience and registration number of employees may be furnished as an enclosure (Refer Schedules I, II or III).

13.State whether the Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic[1] qualifies for registration in terms of minimum requirements laid down in Schedule I, II and III and if not, reasons therefore.

14. For renewal applications only:

(a) Registration No.

(b) Date of issue and date of expiry of existing certificate of registration.

15. List of Enclosures:

Please attach a list of enclosures giving the supporting documents enclosed to this application.

Date: (…………………………………..)

Place Name and signature of applicant

DECLARATION

I, Sh./Smt./Kum./Dr……………………  son/daughter/wife of ……………… aged  ……………….. years resident of  ………………………………… hereby declare that I have read and understood the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994) and the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1995,

2.I also undertake to explain the said Act and Rules to all employees of the Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic in respect of which registration is sought and to ensure that Act and Rules are fully complied with.

Date: (…………………………………..)

Place Name and signature of applicant

ACKNOWLEDGEMENT
[See Rules 4(2) and 8(1)]

The application in Form A in duplicate for grant*/renewal* of registration of Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic* by ………………………  (Name and address of applicant) has been received by the Appropriate Authority …………………. On (date).

*The list of enclosures attached to the application in Form A has been verified with the enclosures submitted and found to be correct.

OR
On verification it is found that the following documents mentioned in the list of enclosures are not actually enclosed.

This acknowledgement does not confer any rights on the applicant for grant or renewal of registration.

(…………………………………..)

Signature and Designation of Appropriate Authority, or

                                                 authorized person in the Office of the Appropriate Authority.

Date:

SEAL

ORIGINAL

DUPLICATE FOR DISPLAY

FORM B - CERTIFICATE OF REGISTRATION

[See Rules 6(2), 6(5) and 8(2)]

 (To be issued in duplicate)

 1.       In exercise of the powers conferred under Section 19 (1) of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994), the Appropriate Authority ………………….. hereby grants registration to the Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic* named below for purposes of carrying out Genetic Counseling/Pre-natal Diagnostic Procedures*/Pre-natal Diagnostic Tests as defined in the aforesaid Act for a period of five years ending on …………….

 2.       This registration is granted subject to the aforesaid Act and Rules thereunder and any contravention thereof shall result in suspension or cancellation of this Certificate of Registration before the expiry of the said period of five years.

 A.  Name and address of the Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic*.

 B.  Name of Applicant for registration.

C.   Pre-natal diagnostic procedures approved for (Genetic Clinic).

            (i) Ultrasound

            (ii) Amniocentesis

            (iii) Chorionic villi biopsy

            (iv) Foetoscopy

            (v) Foetal skin or organ biopsy

            (vi) Cordocentesis

            (vii) Any other (specify)

D.   Pre-natal diagnostic tests* approved (for Genetic Laboratory)

              (i)  Chromosomal studies

             (ii)  Biochemical studies

            (iii)  Molecular studies

 3.       Registration No. allotted

 4.       For renewed Certificate of Registration only

Period of validity of earlier Certificate From ……. To ……. Or Registration.

 

                                                                Signature, name and designation of  The Appropriate Authority

Date:

 

                                                                          SEAL

DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE PLACE OF BUSINESS.

 

FORM C - REJECTION OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION

[See Rules 6(3), 6(5) and 8(3)]

           In exercise of the powers conferred under Section 19(2) of the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, the Appropriate Authority ……………………………. Hereby rejects the application for grant*/renewal* of registration of the Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic* named below for the reasons stated.

Name and address of the Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic*

Name of Applicant who has applied for registration

Reasons for rejection of application for registration

Signature, name and designation of the Appropriate Authority

 Date:

                                                                           SEAL

 *Strike out whichever is not applicable or necessary.

 

FORM D - NAME, ADDRESS AND REGISTRATION No. OF GENETIC COUNSELING CENTRE RECORD TO BE MAINTAINED BY THE GENETIC COUNSELING CENTRE

[See rule 9(2)]

 1. Patient’s name

2. Age

3. Husband’s/Father’s name

4. Full address with Tel. No., if any

5. Referred by (Full name and address of Doctor(s) with registration No.(s) (Referred note to be preserved carefully with case papers)

6. Last menstrual period/weeks of pregnancy

7. History of genetic/medical disease in the family (specify) Basis of diagnosis:

            (a) Clinical

            (b) Bio-chemical

            (c) Cytogenetic

           (d)Other (e.g.radiological)

 8. Indication for pre-natal diagnosis

A.Previous child/children with:

            (i)   Chromosomal disorders

            (ii)  Metabolic disorders

            (iii)  Congenital anomaly

            (iv)  Mental retardation

            (v)   Haemoglobinopathy

            (vi)   Sex linked disorders

            (vii)  Any other (specify)

B. Advanced maternal age (35 years)

C. Mother/father/sibling has genetic disease (specify)

D. Others (specify)

9. Procedure advised

            (i)  Ultrasound

            (ii) Amniocentesis

            (iii) Chorionic villi biopsy

            (iv) Foetoscopy

            (v) Foetal skin or organ biopsy

            (vi) Cordocentesis

            (vii) Any other (specify)

10.Laboratory tests to be carried out

             (i)  Chromosomal studies

            (ii)   Biochemical studies

           (iii)   Molecular studies

11. Result of pre-natal diagnosis

            If abnormal give details.                          Normal/Abnormal

12. Was MTP advised?

13. Name and address of Genetic Clinic* to which patient referred.

14. Dates of commencement and completion of genetic counseling.

 

 

           Name, Signature and Registration No. of the 

Medical Geneticist/Gynaecologist/Paediatrician

Date: 

FORM E - NAME, ADDRESS AND REGISTRATION No. OF GENETIC LABORATORY RECORD TO BE MAINTAINED BY THE GENETIC LABORATORY

[See Rule 9(3)]

 1. Patient’s name

2. Age

3. Husband’s/Father’s name

4. Full address with Tel. No., if any

5. Referred by/sample sent by (full name and address of Genetic Clinic) (Referral note to be preserved carefully with case papers)

6. Type of sample: Maternal blood/Chorionic villus sample/amniotic fluid/Foetal blood or other foetal tissue (specify)

7. Specify indication for pre-natal diagnosis

A. Previous child/children with

      (i) Chromosomal disorders

     (ii) Metabolic disorders

     (iii) Malforma

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