REGD.No. D.L.-33004/99
The Gazette of India
EXTRAORDINARY
PART II- Section 3-Sub-section(i)
PUBLISHED BY AUTHORITY
No. 74] New Delhi, FRIDAY, FEBRUARY 14, 2003 /MAGHA 25, 1924
MINISTRY OF HEALTH AND
FAMILY WELFARE
(Department of Family
Welfare)
NOTIFICATION
New Delhi, the 14th
February, 2003
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.
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]
[See Rules 4(2) and 8(1)]
*The list of enclosures attached to the application in Form
A has been verified with the enclosures submitted and found to be correct.
*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:
ORIGINAL/DUPLICATE FOR DISPLAY
[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
(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).
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. Patients
name
4. Age
5.
Husbands/Fathers name
6. Full
address with Tel. No., if any
7. Referred by (Full name and address of
Doctor(s) with registration No.(s) (Referral note to be preserved carefully
with case papers)
8. Last
menstrual period/weeks of pregnancy
9.
History of
genetic/medical disease in the family (specify)
Basis of diagnosis:
(a)
Clinical
(b)
Bio-chemical
(c)
Cytogenetic
(d)Other (e.g.radiological,
ulrasonography)
10. Indication
for pre-natal diagnosis
A. Previous child/children with:
(i) Chromosomal disorders
(ii) Metabolic disorders
(iii)
Congenital anomaly
(iv)
Mental retardation
(v)
Haemoglobinopathy
(vi)
Sex linked disorders
(vii)
Single gene disorder
(viii) Any other (specify)
B. Advanced maternal age (35 years or
above)
C. Mother/father/sibling having genetic disease
(specify)
D. Others (specify)
11. Procedure
advised[2]
(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.
Patients name
4.
Age
5.
Husbands/Fathers 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:
[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. Patients
name and her age
4. Number
of children with sex of each child
5. Husbands/Fathers
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[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 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..
(Ms. K. Sujatha Rao)
Joint Secretary to the Government of India.
[No.N.24026/14/2002-PNDT Cell]
Footnote:- The Principal Notification was published in the Gazette of
India vide No.G.S.R. 1(E) dated 1st January, 1996. This is the first amendments to the
Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules,
1996.