1. These rules may be called the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996.
2. They shall come into force on the date of their publication in the Official Gazette.

An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A.

• Rs.2000.00 for Genetic Counselling Centre
• Rs.3000.00 for Genetic Laboratory
• Rs.3000.00 for Genetic Clinic
• Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the services of a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic or any combination of such Centre, Laboratory or Clinic.

(1) The Appropriate Authority shall, after making such enquiry and after satisfying itself that the applicant has complied with all the requirements, place the application before the Advisory Committee for its advice.

(2) Having regard to the advice of the Advisory Committee the Appropriate Authority shall grant a certificate of registration, in duplicate, in Form B to the applicant. One copy of the certificate of registration shall be displayed by the registered Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic at a conspicuous place at its place of business:
            Provided that the Appropriate Authority may grant a certificate of registration to a Genetic Laboratory or a Genetic Clinic to conduct one or more specified pre-natal diagnostic tests or procedures, depending on the availability of place, equipment and qualified employees, and standards maintained by such laboratory or clinic.

(3) If, after enquiry and after giving an opportunity of being heard to the applicant and having regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that the applicant has not complied with the requirements of the Act and these rules, it shall, for the reasons to be recorded in writing, reject the application for registration and communicate such rejection to the applicant as specified in Form C.

(4) An enquiry under sub-rule(1), including inspection at the premises of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, shall, be carried out only after due notice is given to the applicant by the Appropriate Authority.

(3) The record to be maintained by every Genetic Laboratory, in respect of each woman subjected to any pre-natal diagnostic test, shall be as specified in Form E.

(4) The record to be maintained by every Genetic Clinic, in respect of each woman subjected to any pre-natal diagnostic procedure, shall be as specified in Form F.

1) Before conducting any pre-natal diagnostic procedure, a written consent, as specified in Form G, in a language the pregnant woman understands, shall be taken from her:             Provided that where a Genetic Clinic has taken a sample of any body tissue or body fluid and sent it to a Genetic Laboratory for analysis or test, it shall not be necessary for the Genetic Laboratory to obtain a fresh consent in Form G

(1) The Appropriate Authority or any officer authorized in this behalf may enter and search at all reasonable times any Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, in the presence of two or more independent and respectable persons for the purposes of Section 30.

(2) A list of any document, record, register, book, pamphlet, advertisement or any other material object found in the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic and seized shall be prepared in duplicate at the place of effecting the seizure. Both copies of such list shall be signed on every page by the Appropriate Authority or the officer authorized in this behalf and by the witnesses to the seizure:
Provided that the list may be prepared, in the presence of the witnesses, at a place other than the place of seizure if, for reasons to be recorded in writing, it is not practicable to make the list at the place of effecting the seizure.

(3) One copy of the list referred to in sub-rule (2) shall be handed over, under acknowledgement, to the person from whose custody the document, record, register, book, pamphlet, advertisement or any other material object have been seized:
Provided that a copy of the list of such document, record, register, book, pamphlet, advertisement or other material object seized may be delivered under acknowledgement, or sent by registered post to the owner or manager of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, if no person acknowledging custody of the document, record, register, book, pamphlet, advertisement or other material object seized is available at the place of effecting the seizure.

(4) If any material object seized is perishable in nature, the Appropriate Authority, or the officer authorized in this behalf shall make arrangements promptly for sealing, identification and preservation of the material object and also convey it to a facility for analysis or test, if analysis or test be required:
Provided that the refrigerator or other equipment used by the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic for preserving such perishable material object may be sealed until such time as arrangements can be made for safe removal of such perishable material object and in such eventuality, mention of keeping the material object seized, on the premises of the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall be made in the list of seizure.

Every Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority within a period of thirty days of such change.

(2) The non-official members appointed to, and Members of Parliament elected to the Board will be entitled to Travelling Allowance and Daily Allowance for attending the meetings of the Board as admissible to non-official and Members of Parliament as the case may be, under the Travelling Allowances rules of the Central Government.

(3) The Appropriate Authority, the Central Government, the State Government, and the Government/Administration of the Union Territory may publish periodically lists of registered Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics and findings from the reports and other information in their possession, for the information of the public and for use by the experts in the field.

SCHEDULE I

A room with an area of seven (7) square meters.

B.EQUIPMENT

Educational charts/models.

C. EMPLOYEES

Any one of the following-

• Medical Geneticist.
• Gynaecologist with 6 months’ experience, in genetic counseling, or having completed 4 weeks’ training in genetic counseling.
• Paediatrician with 6 months’ experience in genetic counseling, or having completed 4 weeks’ training in genetic counseling.

SCHEDULE II

A. PLACE

A room with adequate space for carrying out tests.

B.EQUIPMENT

These are categorized separately for each of the under-mentioned studies.

Chromosomal studies:

• Laminar flow-hood with ultraviolet and fluorescent light or other suitable culture hood.
• Photo-microscope with fluorescent source of light.
• Inverted microscope.
• Incubator and oven.
• Carbon-dioxide incubator or closed system with 5% CO2 atmosphere.
• Autoclave.
• Refrigerator.
• Water bath.
• Centrifuge.
• Vortex mixer.
• Magnetic stirrer.
• PH meter.
• A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.
• Double distillation apparatus (glass)

• Laminar flow-hood with ultraviolet and fluorescent light or other suitable culture hood.
• Inverted microscope.
• Incubator and oven.
• Carbon-dioxide incubator or closed system with 5% CO2 atmosphere.
• Autoclave.
• Refrigerator.
• Water bath.
• Centrifuge.
• Electrophoresis apparatus and power supply.
• Chromatography chamber.
• Spectro-photometer and Elisa reader or Radio-immunoassay system (with gamma betacounter) or fluorometer for various biochemical test.
Vortex mixer.
• Magnetic stirrer.
• PH meter.
• A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.
• Double distillation apparatus (glass). Liquid nitrogen tank.

Molecular studies:

• Inverted microscope.
• Incubator.
• Oven.
• Autoclave.
• Refrigerators (4 degree and minus 20 degree Centigrade).
• Water bath.
• Microcentrifuge.
• Electrophoresis apparatus and power supply.
• Vortex mixer.
• Magnetic stirrer.
• PH meter.
• A sensitive balance (preferable electronic) with sensitivity of 0.1 milligram.
• Double distillation apparatus (glass).
• P.C.R. machine.
• Refrigerated centrifuge.
• U.V. Illuminator with photographic attachment or other documentation system.
• Precision micropipettes.

C.EMPLOYEES

• A Medical Geneticist.
• A laboratory technician having a B.Sc. degree in Biological Sciences or a degree or a diploma in medical laboratory course with at least one year’s experience in conducting appropriate pre-natal diagnostic tests.<

SCHEDULE III

B.EQUIPMENT

(* These constitute the minimum requirement of equipment for conducting the relevant procedure)

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

3.Capacity in which applying
(specify owner/partner/managing director/other-to be stated)

• Ultrasound
• Amniocentesis
• Chorionic villi aspiration
• Foetoscopy
• Foetal biopsy
• Cordocentesis

• Chromosomal studies
• Biochemical studies
• olecular studies

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

• Registration No.
• Date of issue and date of expiry of existing certificate of registration

15. List of Enclosures:

(…………………………………..)

Place Name and signature of applicant

DECLARATION

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:

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

• Ultrasound
• Amniocentesis
• Chorionic villi biopsy
• Foetoscopy
• Foetal skin or organ biopsy
• Cordocentesis
• Any other (specify)

• Chromosomal studies
• Biochemical studies
• Molecular studies

Signature, name and designation of
                                                                                    The Appropriate Authority
Date:

DISPLAY ONE COPY OF THIS CERTIFICATE AT A CONSPICUOUS PLACE AT THE PLACE OF BUSINESS

Name and address of the Genetic Counselling Centre*/Genetic
            Laboratory*/Genetic Clinic*

SEAL

FORM D
[See rule 9(2)]

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:

• Clinical
• Bio-chemical
• Cytogenetic
• Other (e.g.radiological

• Chromosomal disorders
• Metabolic disorders
• Congenital anomaly
• Mental retardation
• Haemoglobinopathy
• Sex linked disorders
• Any other (specify)

• Ultrasound
• Amniocentesis
• Chorionic villi biopsy
• Foetoscopy
• Foetal skin or organ biopsy
• Cordocentesis
                     
• Any other (specify)

Strike out whichever is not applicable or necessary.

• Chromosomal studies
• Biochemical studies
• 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

• Chromosomal disorders
• Metabolic disorders
• Malformation(s)
• Mental retardation
• Hereditary haemolytic anaemia
• Sex linked disorder
• Any other (specify)

• Chromosomal studies
• Biochemical studies
• Molecular studies

.Result of pre-natal diagnosis
            If abnormal give details.                               Normal/Abnormal

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

FORM F

NAME, ADDRESS AND REGISTRATION No. OF GENETIC CLINIC

• Clinical
• Bio-chemical
• Cytogenetic
• Other (e.g.radiological-specify)

• Chromosomal disorders
• Metabolic disorders
• Congenital anomaly
• Mental retardation
• Haemoglobinopathy
• Sex linked disorders
• Any other (specify)

B. Advanced maternal age (35 years)
C. Mother/father/sibling has genetic disease (specify)
D. Other (specify)

• Ultrasound
• Amniocentesis
• Chorionic Villi aspiration
• Foetal biopsy
• Cordocentesis
• Any other (specify)

• Chromosomal studies
• Biochemical studies
• Molecular studies

Name, Signature and Registration number of the
                                                Gynaecologist/Radiologist/Registered Medical
                                                            Practitioner
Date:
Place

FORM G
[See Rule 10]

Date                                                                                                                 Signature

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

FORM H

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.

Name, Designation and Signature of

Guidance for Appropriate Authority

• Form H is a permanent record to be maintained as a register, in the custody of the Appropriate Authority.
• * Means strike out whichever is not applicable.
• 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.
• 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

THE PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) AMENDMENT ACT, 2002