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
(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).
- 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:
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
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.