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

FORM A
[See rules 4(1) and 8(1)]
(To be submitted in Duplicate)

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 

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 

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 Counselling Centre*/Genetic Laboratory*/Genetic Clinic* named below for purposes of carrying out Genetic Counselling/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 Counselling 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 
[See Rules 6(3), 6(5) and 8(3)] 

REJECTION OF APPLICATION FOR REGISTRATION OR 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 Genetic Counselling Centre*/Genetic Laboratory*/Genetic Clinic* named below for the reasons stated. 

Name and address of the Genetic Counselling 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 
[See rule 9(2)] 
NAME, ADDRESS AND REGISTRATION No. OF GENETIC COUNSELLING CENTRE RECORD TO BE MAINTAINED BY THE GENETIC COUNSELLING CENTRE 

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[2] 
              (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
[See Rule 9(3)]

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

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) Malformation(s) 
       (iv) Mental retardation 
       (v) Hereditary haemolytic anaemia 
       (vi) Sex linked disorder 
       (vii) Any other (specify) 
B.Advanced maternal age (-35 years) 
C.Mother/father/sibling has genetic disease (specify) 
D.Other (specify) 

8.Laboratory tests carried out (give details) 
       (viii) Chromosomal studies 
       (ix) Biochemical studies 
       (x) Molecular studies 

9.Result of pre-natal diagnosis 
              If abnormal give details.                          Normal/Abnormal 
10. Date(s) on which tests carried out. 
          The results of the Pre-natal diagnostic tests were conveyed to ........................... on .........................

                                                                            Name, Signature and Registration No. of the 
                                                                                              Medical Geneticist 
Date: 

FORM F 
[See Rule 9(4)] 

NAME, ADDRESS AND REGISTRATION No. OF GENETIC CLINIC RECORD TO BE MAINTAINED BY THE GENETIC CLINIC 

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)/Genetic Counselling Centre (Referral 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-specify) 

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. Other (specify) 

9. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered Medical Practitioner) who performed it. 
        (i) Ultrasound 
        (ii) Amniocentesis 
        (iii) Chorionic Villi aspiration 
        (iv) Foetal biopsy 
        (v) Cordocentesis 
        (vi)Any other (specify) 

10.Any complication of procedure - please specify 

11.Laboratory tests recommended[3] 
        (i) Chromosomal studies 
        (ii) Biochemical studies 
        (iii) Molecular studies 

12. Result of pre-natal diagnostic procedure and specify Normal/Abnormal abnormality detected, if any. 

13. Was MTP advised/conducted? 

14. Date(s) on which procedures carried out. 

15. Date on which MTP carried out. 

16. Date on which consent obtained. 

17. The result of pre-natal diagnostic procedure were conveyed to ............................on ...........................
                                                                     Name, Signature and Registration number of the
                                                                     Gynaecologist/Radiologist/Registered Medical Practitioner 
Date: 
Place 

FORM G 
[See Rule 10] 

FORM OF CONSENT

 I, ..................................................... wife/daughter of ..............................................Age ...................... years residing at ..................................................... hereby state that I have been explained fully the probable side effects and after effects of the pre-natal diagnostic procedures. I wish to undergo the pre-natal diagnostic procedures in my interest to find out the possibility of any abnormality (i.e. deformity or disorder) in the child I am carrying. 

I undertake not to terminate the pregnancy if the pre-natal procedure and any pre-natal tests conducted show the absence of deformity or disorders. I understand that the sex of the foetus will not be disclosed to me. 

I understand that breach of this undertaking will make me liable to penalty as prescribed in the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (57 of 1994). 

Date                                                                                          Signature 
Place 

I have explained the contents of the above consent to the patient and her companion (Name ..................... Address ..................................................... Relationship ..............................................) in a language she/they understand. 

                                                     Name, Signature and/Registration number 
                                                                    Of Gynaecologist 
Date 
                                                  Name, Address and Registration number of 
                                                                     Genetic Clinic 

FORM H 
[See Rule 9(5)] 

PERMANENT RECORD OF APPLICATION FOR REGISTRATION, GRANT OF REGISTRATION REJECTION OF APPLICATION FOR REGISTRATION AND RENEWALS OF REGISTRATION

1.Sl. No. 
2.File number of Appropriate Authority. 
3.Date of receipt of application for grant of registration. 
4.Name, Address, Phone/Fax etc. of Applicant: 
5.Name and address(es) of Genetic Counselling Centre*/Genetic Laboratory*/Genetic Clinic*. 
6.Date on which case considered by Advisory Committee and recommendation of Advisory Committee, in summary. 
7.Outcome of application (state granted/rejected and date of issue of orders). 
8.Registration number allotted and date of expiry of registration. 
9.Renewals (date of renewal and renewed upto). 
10. File number in which renewals dealt. 
11. Additional information, if any. 

                                                                         Name, Designation and Signature of 
                                                                                       Appropriate Authority 

Guidance for Appropriate Authority 
(a)Form H is a permanent record to be maintained as a register, in the custody of the Appropriate Authority. 
(b)* Means strike out whichever is not applicable. 
(c)Against item 7, record date of issue of order in Form B or Form C. 
(d)On renewal, the Registration Number of the Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic will not change. A fresh registration Number will be allotted in the event of change of ownership or management. 
(e)No registration number shall be allotted twice. 
(f)Each Genetic Counselling Centre/Genetic Laboratory/Genetic Clinic may be allotted a folio consisting of two facing pages of the Register for recording Form H. 
(g)The space provided for 'additional information' may be used for recording suspension, cancellations, rejection of application for renewal, change of ownership/management, outcome of any legal proceedings, etc. 
(h)Every folio (i.e. 2 pages) of the Register shall be authenticated by signature of the Appropriate Authority with date, and every subsequent entry shall also be similarly authenticated.

------------------------- -------------------------------------------------------------------------------- 

[1] Strike out whichever is not applicable or not necessary. All enclosures are to be authenticated by signature of the applicant. 
[2] Strike out whichever is not applicable or necessary. 
[3] Strike out whichever is not applicable or not necessary.

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