Pre-Natal Diagnostic Techniques Amendment Rules, 2003 - Form A

FORM A

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

(To be submitted in Duplicate with supporting documents as enclosures)

FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING CENTRE/GENETIC LABORATORY/GENETIC CLINIC/ULTRASOUND CLINC/IMAGING CENTRE

1. Name of the applicant

(Indicate name of the organisation sought to be registered)

2. Address of the applicant

3. Type of facility to be registered

(Please specify whether the application is for registration of a Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre or any combination of these)

4. Full name and address/addresses of Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic/ Ultrasound Clinic/Imaging Centre with Telephone/Fax number(s)/Telegraphic/Telex/E-mail address (s).

5. Type of ownership of Organisation (individual ownership/partnership/company/co-operative/any other to be specified). In case type of organization is other than individual ownership, furnish copy of articles of association and names and addresses of other persons responsible for management, as enclosure.

6. Type of Institution (Govt. Hospital/Municipal Hospital/Public Hospital/Private Hospital/Private Nursing Home/Private Clinic/Private Laboratory/any other to be stated.)

7. Specific pre-natal diagnostic procedures/tests for which approval is sought

(a) Invasive (i) amniocentesis/ chorionic villi aspiration/chromosomal/biochemical/molecular studies

(b) Non-Invasive Ultrasonography

Leave blank if registration is sought for Genetic Counselling Centre only.

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

9. (a) Facilities available in the Counselling Centre.

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

(i) Ultrasound

(ii) Amniocentesis

(iii) Chorionic villi aspiration

(iv) Foetoscopy

(v) Foetal biopsy

(vi) Cordocentesis

Whether facilities are available in the Laboratory/ Clinic for the following:

(i) Chromosomal studies

(ii) Biochemical studies

(iii) Molecular studies

(iv) Preimplantation genetic diagnosis

10. Names, qualifications, experience and registration number of employees (may be furnished as an enclosure).

11. State whether the Genetic Counselling Centre/ Genetic Laboratory/ Genetic Clinic/ultrasound clinic/imaging centre [1] qualifies for registration in terms of requirements laid down in Rule 3 ]

12. For renewal applications only:

(a) Registration No.

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

13. List of Enclosures:

(Please attach a list of enclosures / supporting documents attached to this application.)

Date: (…………………………………..)

Place

Name, designation and signature of the person authorized

to

DECLARATION

I, Sh./Smt./Kum./Dr……………………… son/daughter/wife of ………………… aged ……………….. years resident of  …………………………………  working as (indicate designation) ………………………………… in (indicate name of the organisation to be registered) ……………..…………………..  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, 1996,

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

Date: (…………………………………..)

Place

Name, designation and signature of the person authorized to

sign on behalf of the organisation to be registered

[SEAL OF THE ORGANISATION SOUGHT TO BE REGISTERED]

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*/Ultrasound Clinic*/Imaging Centre* 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:

Place:

SEAL