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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003 (3)
Date 19/10/11/06/53  Author Infrosoft Health Content Team  Hits 1025  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.

FORM E

[See Rule 9(3)]

FORM FOR MAINTENANCE OF RECORDS BY GENETIC LABORATORY

1. Name and address of Genetic Laboratory

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

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

9. 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)   Single gene disorder

   (viii)   Any other (specify)

B. Advanced maternal age (35 years or above)

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

D. Other (specify)

10. Laboratory tests carried out (give details)

(i)   Chromosomal studies

(ii)   Biochemical studies

(iii)  Molecular studies

(iv)  Preimplantation gentic diagnosis

11. Result of diagnosis

    If abnormal give details.                          Normal/Abnormal

12. 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/
Director of the Institute

 

Place:

Date:

 

FORM F
[See Proviso to Section 4(3), Rule 9(4) and Rule 10(1A)]

FORM FOR MAINTENANCE OF RECORD IN RESPECT OF PREGNANT WOMAN BY GENETIC CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE

 1. Name and address of the Genetic Clinic/Ultrasound Clinic/Imaging Centre.

2. Registration No.

3. Patient’s name and her age

4. Number of children with sex of each child

5. Husband’s/Father’s name

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

7. Referred by (full name and address of Doctor(s)/Genetic Counseling Centre (Referral note to be preserved carefully with case papers)/self referral

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, ultrasonography etc. specify)

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)

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

D. Other (specify)

11. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered Medical Practitioner) who performed it.

Non-Invasive

(i) Ultrasound  (specify purpose for which ultrasound is to done during pregnancy)

[List of indications for ultrasonography of pregnant women are given in the note below]

 Invasive                                                            

(ii)   Amniocentesis

(iii)  Chorionic Villi aspiration

(iv)  Foetal biopsy

(v)   Cordocentesis

(vi)  Any other (specify)

12. Any complication of procedure – please specify

13. Laboratory tests recommended[3]

(i)   Chromosomal studies

(ii)   Biochemical studies

(iii)  Molecular studies

(iv)  Preimplantation genetic diagnosis

14. Result of

     (a) pre-natal diagnostic procedure (give details)                             

     (b) Ultrasonography              Normal/Abnormal

         (specify abnormality detected, if any).

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

16. Date on which consent obtained. (In case of invasive)

17. The result of pre-natal diagnostic procedure were conveyed to ……….on ……………

18. Was MTP advised/conducted?

19. Date on which MTP carried out.

                                            
Date: 

                                                               
                           

                                       Name, Signature and Registration number of the Place Gynaecologist/Radiologist/Director of the Clinic

 
DECLARATION OF PREGNANT WOMAN

I, Ms. ________________ (name of the pregnant woman) declare that by undergoing ultrasonography /image scanning etc. I do not want to know the sex of my foetus.

 Signature/Thump impression of pregnant woman

___________________________________________________________________________________

3 Strike out whichever is not applicable or not necessary

DECLARATON OF DOCTOR/PERSON CONDUCTING ULTRASONOGRAPHY/IMAGE SCANNING

I, __________________ (name of the person conducting ultrasonography/image scanning) declare that while conducting ultrasonography/image scanning on Ms. ___________ (name of the pregnant woman), I have neither detected nor disclosed the sex of her foetus to any body in any manner.

Name and signature of the person conducting ultrasonography/image scanning/

Director or owner of genetic clinic/ultrasound clinic/imaging centre. 

Important Note:

(i) Ultrasound is not indicated/advised/performed to determine the sex of foetus except for diagnosis of sex-linked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B etc.

(ii) During pregnancy Ultrasonography should only be performed when indicated. The following is the representative list of indications for ultrasound during pregnancy.

(1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.

(2) Estimation of gestational age (dating).

(3) Detection of number of foetuses and their chorionicity.

(4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/MTP failure.

(5) Vaginal bleeding / leaking.

(6) Follow-up of cases of abortion.

(7) Assessment of cervical canal and diameter of internal os.

(8) Discrepancy between uterine size and period of amenorrhoea.

(9) Any suspected adenexal or uterine pathology / abnormality.

(10) Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and their follow-up.

(11) To evaluate foetal presentation and position.

(12) Assessment of liquor amnii.

(13) Preterm labour / preterm premature rupture of membranes.

(14) Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retroplacental haemorrhage, abnormal adherence etc.).

(15) Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of vessels and presence of true knot.

(16) Evaluation of previous Caesarean Section scars.

(17) Evaluation of foetal growth parameters, foetal weight and foetal well being.

(18) Colour flow mapping and duplex Doppler studies.

(19) Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up.

(20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnio-infusion, intrauterine infusion, placement of shunts etc.

(21) Observation of intra-partum events.

(22) Medical/surgical conditions complicating pregnancy.

(23) Research/scientific studies in recognised institutions.

 Person conducting ultrasonography on a pregnant women shall keep complete record thereof in the clinic/centre in Form – F and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 of the Act, unless contrary is proved by the person conducting such ultrasonography.

FORM G

[See Rule 10]

FORM OF CONSENT

(For invasive techniques)

             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 preimplantation/pre-natal diagnostic technique/test/procedures in my own interest to find out the possibility of any abnormality (i.e. disease/deformity/disorder) in the child I am carrying.

I undertake not to terminate the pregnancy if the pre-natal procedure/technique/test conducted show the absence of disease/deformity/disorder.

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) and rules framed thereunder.

Date                                           Signature of the pregnant woman.

Place

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

 
Name, Signature and/Registration number of
Gynaecologist/Medical Geneticist/Radiologist/Paediatrician/
Director of the Clinic/Centre/Laboratory

 

 Date                                                Name, Address and Registration number of 
                                                                                                  Genetic  Clinic/Institute

 

                                                                       

SEAL

 

 

FORM H

[See Rule 9(5)]

FORM FOR MAINTENANCE OF PERMANENT RECORD OF APPLICATIONS FOR GRANT/REJECTION OF REGISTRATION UNDER THE PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) ACT, 1994.

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

6. Date of consideration by Advisory Committee and recommendation of Advisory Committee, in summary.

7. Outcome of application (state granted/rejected and date of issue of orders - record date of issue of order in Form B or Form C).

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)  On renewal, the Registration Number of the Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre will not change. A fresh registration Number will be allotted in the event of change of ownership or management.

(e)  Registration number shall not be allotted twice.

(f)   Each Genetic Counseling Centre/Genetic Laboratory/Genetic Clinic/ Ultrasound Clinic/Imaging Centre may be allotted a folio consisting of two 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.”.

(Ms.K.Sujatha Rao)
Joint Secretary to the Government of India.
[No.N.24026/14/2002-PNDT Cell]

 

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