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

FORM A - WITH SUPPORTING DOCUMENTS AS ENCLOSURES, ALSO IN DUPLICATE FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING 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 Counselling Centre/Genetic Laboratory/Genetic Clinic/any combination of these)

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

6.Type of ownership and Organisation (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 Counselling Centre only.

9.(a) Space available for the Counselling 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 Counselling 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 Counselling 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 Counselling 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 Counselling 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

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