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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003 (2)
Date 19/10/11/06/50  Author Infrosoft Health Content Team  Hits 904  Language Global
G.S.R.109(E).-    In exercise of the powers conferred by section 32 of the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994), the Central Government hereby makes the following amendments to the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.

 (ix)   write his/her name and designation in full under his/her signature;

(x)    on no account conduct or allow/cause to be conducted female foeticide;

(xi)   not commit any other act of professional misconduct. 

 Appeals. – 

 (1) Anybody aggrieved by the decision of the Appropriate Authority at sub-district level may appeal to the Appropriate Authority at district level within 30 days of the order of the sub-district level Appropriate Authority.

(2) Anybody aggrieved by the decision of the Appropriate Authority at district level may appeal to the Appropriate Authority at State/UT level within 30 days of the order of the District level Appropriate Authority.

(3) Each appeal shall be disposed of by the District Appropriate Authority or by the State/Union Territory Appropriate Authority, as the case may be, within 60 days of its receipt.

(4) If an appeal is not made within the time as prescribed under sub-rule (1), (2) or (3), the Appropriate Authority under that sub-rule may condone the delay in case he/she is satisfied that appellant was prevented for sufficient cause from making such appeal.”.

      In the said rules, Schedule I, Schedule II and Schedule III shall be omitted.

      In the said rules, for the words “Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic”, the words “Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres” shall be substituted wherever they occur.

      In the said rules, for Form A, Form B, Form C, Form D, Form E, Form F, Form G, and Form H, the following forms shall be substituted respectively.

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 COUNSELING CENTRE/GENETIC LABORATORY/GENETIC CLINIC/ULTRASOUND CLINC/IMAGING CENTRE

1. Name of the applicant

(Indicate name of the organization 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 Counseling Centre/Genetic Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre or any combination of these)

4. Full name and address/addresses of Genetic Counseling 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 Organization (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 Counseling 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 Counseling 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 Counseling 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 sign on behalf of the Organization to be registered.

 

DECLARATION

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

[SEAL OF THE ORGANIZATION 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 Counseling 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

 

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

 CERTIFICATE OF REGISTRATION

(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*/Ultrasound Clinic*/Imaging Centre* named below for purposes of carrying out Genetic Counseling/Pre-natal Diagnostic Procedures*/Pre-natal Diagnostic Tests/ultrasonography  under 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 apart from prosecution.

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

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

Non-Invasive

            (i) Ultrasound

Invasive
            (ii) Amniocentesis

            (iii) Chorionic villi biopsy

            (iv) Foetoscopy

            (v) Foetal skin or organ biopsy

            (vi) Cordocentesis

            (vii) Any other (specify)

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

                  (i)   Chromosomal studies

                 (ii)    Biochemical studies

                (iii)     Molecular studies

     D.  Any other purpose (please specify)

 3.   Model and make of equipments being used (any change is to be intimated to the Appropriate Authority under rule 13).

 Registration No. allotted 

5.   Period of validity of earlier Certificate of Registration.                                            

(For renewed Certificate of Registration only)  From ………. To ……….

 

                                       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

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

 FORM FOR REJECTION OF APPLICATION FOR GRANT/RENEWAL OF REGISTRATION

             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 undermentioned Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic*/Ultrasound Clinic*/Imaging Centre*.

 (1) Name and address of the Genetic Counseling Centre*/Genetic Laboratory*/Genetic Clinic*/Ultrasound Clinic*/Imaging Centre*

(2) Reasons for rejection of application for grant/renewal of registration:

 

Signature, name and designation
of the Appropriate Authority with SEAL of Office

Date:

Place:

                                              
*Strike out whichever is not applicable or necessary.

 

 

FORM D

[See rule 9(2)]

 FORM FOR MAINTENANCE OF RECORDS BY THE GENETIC COUNSELING CENTRE

1. Name and address of Genetic Counseling centre.

2. Registration No.

3. Patient’s name

4. Age

5. Husband’s/Father’s name

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

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

8. Last menstrual period/weeks of pregnancy

9. History of genetic/medical disease in the family (specify)

Basis of diagnosis:

            (a) Clinical

            (b) Bio-chemical

            (c) Cytogenetic

            (d)Other (e.g.radiological, ulrasonography)

10. 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)   Single gene disorder

        (viii)  Any other (specify)

     B. Advanced maternal age (35 years or above)

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

     D. Others (specify)

11. Procedure advised

(i)  Ultrasound

(ii) Amniocentesis

(iii) Chorionic villi biopsy

(iv) Foetoscopy

(v) Foetal skin or organ biopsy

(vi) Cordocentesis

(vii) Any other (specify)

12. Laboratory tests to be carried out

(i)   Chromosomal studies

(ii)  Biochemical studies

(iii) Molecular studies

(iv)  Preimplantation genetic diagnosis

13. Result of diagnosis

    If abnormal give details.                          Normal/Abnormal

14. Was MTP advised?

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

16. Dates of commencement and completion of genetic counseling.

 

Name, Signature and Registration No.
of the Medical Geneticist/Gynaecologist/
Paediatrician administering Genetic Counseling.

 

Place:

Date:

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