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The Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003.

 

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.

1.         (1)        These may be called the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003.

            (2)        They shall come into force on the date of their publication in the official gazette.

2.         In the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996 (hereinafter referred to as the said rules) in rule 1, for sub-rule (1) the following sub-rule shall be substituted, namely:-

“(1)       These Rules may be called the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996.”

3.         In the said rules, in rule 2, clause (d) shall be omitted.

4.         In the said rules, for rule 3 the following rule shall be substituted, namely:-

“3. The qualifications of the employees, the requirement of equipment etc. for a Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre shall be as under:

(1)                 Any person being or employing

(i)                   a gynaecologist or a paediatrician having six months experience or four weeks training in genetic counseling or

(ii)                 a medical geneticists,

having adequate space and educational charts/models/equipments for carrying out genetic counselling may set up a genetic counselling center and get it registered as a genetic counselling center.

(2) (a)  Any person having adequate space and being or employing

(i)                   a Medical Geneticist and

(ii)                 a laboratory technician, having a B.Sc. degree in Biological Sciences or a degree or diploma in medical laboratory course with at least one year experience in conducting appropriate prenatal diagnostic techniques, tests or procedures may set up a genetic laboratory.

(b) Such laboratory should have or acquire such of the following equipments as may be necessary for carrying out chromosomal studies, bio-chemical studies and molecular studies:-

(i) Chromosomal studies:

(1)       Laminar flow hood with ultraviolet and fluorescent light or other suitable culture hood.

(2)       Photo-microscope with fluorescent source of light.

(3)       Inverted microscope.

(4)       Incubator and oven.

(5)       Carbon dioxide incubator or closed system with 5% CO2 atmosphere.

(6)       Autoclave.

(7)       Refrigerator.

(8)       Water bath.

(9)       Centrifuge.

(10)   Vortex mixer.

(11)   Magnetic stirrer.

(12)   pH Meter.

(13)   A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

(14)   Double distillation apparatus (glass).

(15)   Such other equipments as may be necessary.

(ii) Biochemical studies:

(requirements according to tests to be carried out)

(1)              Laminar flow hood with ultraviolet and fluorescent light or other suitable culture hood.

(2)              Inverted microscope.

(3)              Incubator and oven.

(4)              Carbon dioxide incubator or closed system with 5% CO2 atmosphere.

(5)              Autoclave.

(6)              Refrigerator.

(7)              Water bath.

(8)              Centrifuge.

(9)              Electrophoresis apparatus and power supply.

(10)          Chromatography chamber.

(11)          Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma beta-counter) or fluorometer for various biochemical tests.

(12)          Vortex mixer.

(13)          Magnetic stirrer.

(14)          pH meter.

(15)          A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

(16)          Double distillation apparatus (glass).

(17)          Liquid nitrogen tank.

(18)          Such other equipments as may be necessary.

 (iii) Molecular studies:

(1)              Inverted microscope.

(2)              Incubator.

(3)              Oven.

(4)              Autoclave.

(5)              Refrigerators (4 degree and minus 20 degree Centigrade).

(6)              Water bath.

(7)              Microcentrifuge.

(8)              Electrophoresis apparatus and power supply.

(9)              Vertex mixer.

(10)          Magnetic stirrer.

(11)          pH meter.

(12)          A sensitive balance (preferably electronic) with sensitivity of 0.1 milligram.

(13)          Double distillation apparatus (glass).

(14)          P.C.R. machine.

(15)          Refrigerated centrifuge.

(16)          U.V. Illuminator with photographic attachment or other documentation system.

(17)          Precision micropipettes.

(18)          Such other equipments as may be necessary.

(3) (1) Any person having adequate space and being or employing

(a)     Gynaecologist having experience of performing at least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis foetoscopy, foetal skin or organ biopsy or foetal blood sampling etc. under supervision of an experienced gynaecologist in these fields, or

(b)     a Sonologist, Imaging Specialist, Radiologist or Registered Medical Practitioner having Post Graduate degree or diploma or six months training or one year experience in sonography or image scanning, or.

(c)     A medical geneticist.

may set up a genetic clinic/ultrasound clinic/imaging centre.

 

(2) The Genetic Clinic/ultrasound clinic/imaging centre should have or acquire  such of the following equipments, as may be necessary for carrying out the tests or procedures  -

(a)                 Equipment and accessories necessary for carrying out clinical examination by an obstetrician or gynaecologist.

(b)                 An ultra-sonography machine including mobile ultrasound machine, imaging machine or any other equipment capable of conducting foetal ultrasonography.

(c)                 Appropriate catheters and equipment for carrying out chorionic villi aspirations per vagina or per abdomen.

(d)                 Appropriate sterile needles for amniocentesis or cordocentesis.

(e)                 A suitable foetoscope with appropriate accessories for foetoscopy, foetal skin or organ biopsy or foetal blood sampling shall be optional.

(f)                   Equipment for dry and wet sterilization.

(g)                 Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need.

(h)                 Genetic Works Station.”.

5.         In the said rules, after rule 3 a new rule 3A shall be inserted as follows, namely:-

“3A.      Sale of ultrasound machines/imaging machines:

(1)                 No organization including a commercial organization or a person, including manufacturer, importer, dealer or supplier of ultrasound machines/imaging machines or any other equipment, capable of detecting sex of foetus, shall sell distribute, supply, rent, allow or authorize the use of any such machine or equipment in any manner, whether on payment or otherwise, to any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre or any other body or person unless such Centre, Laboratory, Clinic, body or person is registered under the Act.

(2)                 The provider of such machine/equipment to any person/body registered under the Act shall send to the concerned State/UT Appropriate Authority and to the Central Government, once in three months a list of those to whom the machine/equipment has been provided.

(3)                 Any organization or person, including manufacturer, importer, dealer or supplier of ultrasound machines/imaging machines or any other equipment capable of detecting sex of foetus selling, distributing, supplying or authorizing, in any manner, the use of any such machine or equipment to any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre  or any other body or person   registered under the Act shall take an affidavit from the Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre or any other body or person purchasing or getting authorization for using such machine /equipment that the machine/equipment shall not be used for detection of sex of foetus or selection of sex before or after conception.”.

6.         In the said rules, in rule 4 for sub-rule (1) the following sub-rule shall be substituted, namely:-

“(1)       An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit containing–

(i)               an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Ultrasound Clinic/ Imaging Centre/ Combination thereof, as the case may be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of foetus  except for diseases specified in Section 4(2) nor shall the sex of  foetus be disclosed to any body; and

(ii)             an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Combination thereof, as the case may be, shall display prominently a notice that they do not conduct any technique, test or procedure etc. by whatever name called, for detection of sex of foetus or for selection of sex before or after conception.”.

 

7.         In the said rules, for rule 5, the following rule shall be substituted, namely:-

“5.        Application Fee – (1) Every application for registration under Rule 4 shall be accompanied by an application fee of :-

(a)     Rs.3000.00 for Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre.

(b)     Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or Imaging Centre or any combination thereof.

Provided that if an application for registration of any Genetic Clinic/ Laboratory/ Centre etc. has been rejected by the Appropriate Authority, no fee shall be required to be paid on re-submission of the application by the applicant for the same body within 90 days of rejection.  Provided further that any subsequent application shall be accompanied with the prescribed fee.  Application fee once paid will not be refunded.

(2)        The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank payable at the headquarters of the Appropriate Authority concerned. The fees collected by the Appropriate Authorities for registration of Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centre or any other body or person under sub-rule (1), shall be deposited by the Appropriate Authority concerned in a bank account opened in the name of the official designation of the Appropriate Authority concerned and shall be utilized by the Appropriate Authority in connection with the activities connected with implementation of the provisions of the Act and these rules.”.

8.         In the said rules, in rule 9, -

(a) for sub-rule (1), the following sub-rule shall be substituted, namely:-

“(1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test.”;

(b) for sub-rule (3), the following sub-rule shall be substituted, namely:-

“(3) The record to be maintained by every Genetic Laboratory, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form E.”; 

(c) for sub-rule (4), the following sub-rule shall be substituted, namely:-

“(4) The record to be maintained by every Genetic Clinic, in respect of each man or woman subjected to any pre-natal diagnostic procedure/technique/test, shall be as specified in Form F.”;

(d) after sub-rule (7), the following sub-rule shall be inserted, namely:-

“(8) Every Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall send a complete report in respect of all pre-conception or pregnancy related procedures/ techniques/tests conducted by them in respect of each month by 5th day of the following month to the concerned Appropriate Authority.”.

9.         In the said rules, in rule 10, -

(a) for sub-rule (1), the following sub-rule shall be substituted, namely:-

“(1) Before conducting preimplantation genetic diagnosis, or any pre-natal diagnostic technique/test/procedure such as amniocentesis, chorionic villi biopsy, foetoscopy, foetal skin or organ biopsy or cordocentesis, a written consent, as specified in Form G, in a language the person undergoing such procedure understands, shall be obtained from her/him.”;

(b) after sub-rule (1), the following new sub-rule (1A) shall be inserted, namely:-

“(1A) Any person conducting ultrasonography/image scanning on a pregnant woman shall give a declaration on each report on ultrasonography/image scanning that he/she has neither detected nor disclosed the sex of foetus of the pregnant woman to any body.  The pregnant woman shall before undergoing ultrasonography/image scanning declare that she does not want to know the sex of her foetus.”.

10.        In the said rules, for rule 11, the following rule shall be substituted, namely:-

“11. Facilities for inspection.- (1) Every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic, Imaging Centre, nursing home, hospital, institute or any other place where any of the machines or equipments capable of performing any procedure, technique or test capable of pre-natal determination of sex or selection of sex before or after conception is used, shall afford all reasonable facilities for inspection of the place, equipment and records to the Appropriate Authority or to any other person authorised by the Appropriate Authority in this behalf for registration of such institutions, by whatever name called, under the Act, or for detection of misuse of such facilities or advertisement therefore or for selection of sex before or after conception or for detection/disclosure of sex of foetus or for detection of cases of violation of the provisions of the Act in any other manner.

(2)    The Appropriate Authority or the officer authorized by it may seal and  seize any ultrasound machine, scanner or any other equipment, capable of detecting sex of foetus,  used by any organisation if the organisation has not got itself registered under the Act.  These machines of the organisations may be released if such organisation pays penalty equal to five times of the registration fee to the Appropriate Authority concerned and gives an undertaking that it shall not undertake detection of sex of foetus or selection of sex before or after conception.”.

11.        In the said rules, in rule 12 for sub-rule (1), the following sub-rule shall be substituted, namely:-

“12. Procedure for search and seizure. -  (1) The Appropriate Authority or any officer authorised in this behalf may enter and search at all reasonable times any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Imaging Centre or Ultrasound Clinic in the presence of two or more independent witnesses for the purposes of search and examination of any record, register, document, book, pamphlet, advertisement, or any other material object found therein and seal and seize the same if there is reason to believe that it may furnish evidence of commission of an offence punishable under the Act.

Explanation:- In these Rules –

(1)                 ‘Genetic Laboratory/Genetic Clinic/ Genetic Counselling Centre’ would include an ultrasound centre/imaging centre/ nursing home/hospital/institute or any other place, by whatever name called, where any of the machines or equipments capable of selection of sex before or after conception or performing any procedure, technique or test for pre-natal detection of sex of foetus, is used;

(2)                 ‘material object’ would include records, machines and equipments; and

(3)                 ‘seize’ and ‘seizure’ would include ‘seal’ and ‘sealing’ respectively.”.

12.        In the said rules, after rule 17, the following rules shall be inserted, namely:-

“18.       Code of Conduct to be observed by persons working at Genetic Counseling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics. Imaging Centres etc.

All persons including the owner, employee or any other persons associated with Genetic Counseling Centres, Genetic Laboratories, Genetic Clinics, Ultrasound Clinics, Imaging Centres registered under the Act/these Rules shall –

(i) not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus in any manner;

(ii)           not employ or cause to be employed any person not possessing qualifications necessary for carrying out pre-natal diagnostic techniques/ procedures, techniques and tests including ultrasonography;

(iii)          not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or procedure for selection of sex before or after conception or for detection of sex of foetus except for the purposes specified in sub-section (2) of section 4 of the Act;

(iv)          not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or test or procedure under the Act at a place other than a place registered under the Act/these Rules;

(v)            ensure that no provision of the Act and these Rules are violated in any manner;

(vi)          ensure that the person, conducting any techniques, test or procedure leading to detection of sex of foetus for purposes not covered under section 4(2) of the Act or selection of sex before or after conception, is informed that such procedures lead to violation of the Act and these Rules which are punishable offences;

(vii)         help the law enforcing agencies in bring to book the violators of the provisions of the Act and these Rules;

(viii)       display his/her name and designation prominently on the dress worn by him/her;

(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. 

19.        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.”. 

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

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

15.        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, namely:-

“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 

                                                                                    sign on behalf of the organisation 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 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


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*/Ultrasound Clinic*/Imaging Centre* named below for purposes of carrying out Genetic Counselling/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 Counselling 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).

 

  1. 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 Counselling Centre*/Genetic Laboratory*/Genetic Clinic*/Ultrasound Clinic*/Imaging Centre*.

 

(1)        Name and address of the Genetic Counselling 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 COUNSELLING CENTRE

 

1.         Name and address of Genetic Counselling 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 advise

(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 Counselling.

 

Place:

Date:


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 Counselling 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

(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 Counselling 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 Counselling 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 Counselling 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.”.

  

Joint Secretary to the Government of India.

 

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