THE PRE-NATAL DIAGNOSTIC TECHNIQUES
(REGULATION AND PREVENTION OF MISUSE) RULES, 1996
1.Short title and commencement.- (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.
2.Definitions.- In these
rules, unless the context otherwise requires:-
(a)
Act means The
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994
(57 of 1994);
(b)
employee means a
person working in or employed by a Genetic Counselling Centre, a Genetic
Laboratory or a Genetic Clinic, and includes those working on part-time,
contractual, consultancy, honorary or on any other basis;
(c)
Form means a Form
appended to these rules;
(d)
Schedule means a
Schedule appended to these rules;
(e)
Section means a
section of the Act;
(f)
words and expressions
used herein and not defined in these rules but defined in the Act, shall have
the meanings, respectively, assigned to them in the Act.
3.Minimum requirements.-
(1) The minimum qualifications of the employees, the minimum equipment and
minimum place for a Genetic Counselling Centre, Genetic Laboratory and Genetic
Clinic shall be as specified in Schedules I, II and III.
(2)
Where an institute, hospital, nursing home, or any place, by whatever name
called, provides services jointly of Genetic Counselling Centre, Genetic
Laboratory and Genetic Clinic, or any combination of these, it shall conform to
the requirements as specified in Schedules I, II and III.
4.Registration of Genetic Counselling Centre, Genetic Laboratory and
Genetic Clinic.- (1) An
application for registration shall be made to the Appropriate Authority, in
duplicate, in Form A.
(2)
The Appropriate Authority, or any person in his office authorized in this
behalf, shall acknowledge receipt of the application for registration, in the
acknowledgement slip provided at the bottom of Form A, immediately if delivered
at the office of the Appropriate Authority, or not later than the next working
day if received by post.
5.Application Fee.- (1)
Every application for registration under rule 4 shall be accompanied by an
application fee of:-
(a)
Rs.2000.00 for Genetic
Counselling Centre;
(b)
Rs.3000.00 for Genetic
Laboratory;
(c)
Rs.3000.00 for Genetic
Clinic; and
(d)
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.
(2)
The application fee shall be paid by a demand draft drawn in favour of the
Appropriate Authority, on any scheduled bank located at the headquarters of the
Appropriate Authority.
6.Certificate of registration.- (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.
(5)
Grant of certificate of registration or rejection of application for
registration shall be communicated to the applicant as specified in Form B or
Form C, as the case may be, within a period of ninety days from the date of
receipt of application for registration.
(6)
The certificate of registration shall be non-transferable. In the event of
change of ownership or change of management or on ceasing to function as a
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, both copies,
of the certificate of registration shall be surrendered to the Appropriate
Authority.
(7)
In the event of change of ownership or change of management of the Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic, the new owner or
manager of such Centre, Laboratory or Clinic shall apply afresh for grant of
certificate of registration.
7.Validity of registration.-
Every certificate of registration shall be valid for a period of five years
from the date of its issue.
8.Renewal of registration.-
(1) An application for renewal of certificate of registration shall be made in
duplicate in Form A, to the Appropriate Authority thirty days before the date
of expiry of the certificate of registration. Acknowledgement of receipt of
such application shall be issued by the Appropriate Authority in the manner
specified in sub-rule (2) of rule 4.
(2)
The Appropriate Authority shall, after holding an enquiry and after satisfying
itself that the applicant has complied with all the requirements of the Act and
these rules and having regard to the advice of the Advisory Committee in this
behalf, renew the certificate of registration, as specified in Form B, for a
further period of five years from the date of expiry of the certificate of
registration earlier granted.
(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 reasons to be recorded
in writing, reject the application for renewal of certificate of registration
and communicate such rejection to the applicant as specified in Form C.
(4)
The fees payable for renewal of certificate of registration shall be one half
of the fees provided in sub-rule (1) of rule 5.
(5)
On receipt of the renewed certificate of registration in duplicate or on
receipt of communication of rejection of application for renewal, both copies
of the earlier certificate of registration shall be surrendered immediately to
the Appropriate Authority by the Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic.
(6)
In the event of failure of the Appropriate Authority to renew the certificate
of registration or to communicate rejection of application for renewal of
registration within a period of ninety days from the date of receipt of
application for renewal of registration, the certificate of registration shall
be deemed to have been renewed.
9.Maintenance and preservation of records.- (1) Every Genetic Counselling Centre, Genetic
Laboratory and Genetic Clinic shall maintain a register showing, in serial
order, the names and addresses of the women given genetic counseling, subjected
to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of
their husbands or fathers and the date on which they first reported for such
counseling, procedure or test.
(2)
The record to be maintained by every Genetic Counselling Centre, in respect of
each woman counseled shall be as specified in Form D.
(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.
(5)
The Appropriate Authority shall maintain a permanent record of applications for
grant or renewal of certificate of registration as specified in Form H. Letters
of intimation of every change of employee, place, address and equipment
installed shall also be preserved as permanent records.
(6)
All case related records, forms of consent, laboratory results, microscopic
pictures, sonographic plates or slides, recommendations and letters shall be
preserved by the Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic for a period of two years from the date of completion of counseling,
pre-natal diagnostic procedure or pre-natal diagnostic test, as the case may
be. In the event of any legal proceedings, the records shall be preserved till
the final disposal of legal proceedings, or till the expiry of the said period
of two years, whichever is later.
(7)
In case the Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic
maintains records on computer or other electronic equipment, a printed copy of
the record shall be taken and preserved after authentication by a person
responsible for such record.
10.Conditions for conducting pre-natal diagnostic procedures.- (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.
(2)
All the State Governments and Union Territories may issue translation of Form G
in languages used in the State or Union Territory and where no official
translation in a language understood by the pregnant woman is available, the
Genetic Clinic may translate Form G into a language she understands.
11.Facilities for inspection.- Every Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic
shall afford reasonable facilities for inspection of the place, equipment and
records to the Appropriate Authority or to any other person authorized by the
Appropriate Authority in this behalf.
12.Procedure for search and seizure.- (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.
(5)
In the case of non-completion of search and seizure operation, the Appropriate
Authority or the officer authorized in this behalf may make arrangement, by way
of mounting a guard or sealing of the premises of the Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic, for safe keeping, listing and
removal of documents, records, book or any other material object to be seized,
and to prevent any tampering with such documents, records, books or any other
material object.
13.Intimation of changes in employees, place or equipment. 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.
14.Conditions for analysis or test and pre-natal diagnostic procedures.- (1) No Genetic Laboratory shall accept for analysis
or test any sample, unless referred to it by a Genetic Clinic.
(2)
Every pre-natal diagnostic procedure shall invariably be immediately preceded
by locating the foetus and placenta through ultrasonography, and the pre-natal
diagnostic procedure shall be done under direct ultrasonographic monitoring so
as to prevent any damage to the foetus and placenta.
15.Meetings of the Advisory Committees.- The intervening period between any two meetings of
Advisory Committees constituted under sub-section (5) of Section 17 to advise
the Appropriate Authority shall not exceed sixty days.
16.Allowances to members of the Central Supervisory Board.- (1) The ex-officio members, and other Central and
State Government officers appointed to the Board will be entitled to Travelling
Allowance and Daily Allowance for attending the meetings of the Board as per
the Travelling Allowance rules applicable to them.
(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.
17.Public Information.- (1)
Every Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic shall
prominently display on its premises a notice in English and in the local
language or languages for the information of the public, to effect that
disclosure of the sex of the foetus is prohibited under law.
(2)
At least one copy each of the Act and these rules shall be available on the
premises of every Genetic Counselling Centre, Genetic Laboratory and Genetic
Clinic, and shall be made available to the clientele on demand for perusal.
(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.
[See Rule 3 (1)]
A room with an area of seven (7)
square meters.
Educational charts/models.
Any one of the following-
(1)
Medical Geneticist.
(2)
Gynaecologist with 6
months experience, in genetic counseling, or having completed 4 weeks
training in genetic counseling.
(3)
Paediatrician with 6
months experience in genetic counseling, or having completed 4 weeks training
in genetic counseling.
[See Rule 3(1)]
A room
with adequate space for carrying out tests.
These are categorized separately for each of the
under-mentioned studies.
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
(preferable electronic) with sensitivity of 0.1 milligram.
(14)
Double distillation
apparatus (glass).
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 betacounter) or
fluorometer for various biochemical test.
(12)
Vortex mixer.
(13)
Magnetic stirrer.
(14)
PH meter.
(15)
A sensitive balance
(preferable electronic) with sensitivity of 0.1 milligram.
(16)
Double distillation
apparatus (glass).
(17)
Liquid nitrogen tank.
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)
Vortex mixer.
(10) Magnetic stirrer.
(11) PH meter.
(12) A sensitive balance (preferable 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.
(1)
A Medical Geneticist.
(2)
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 years experience in conducting
appropriate pre-natal diagnostic tests.
[See Rule 3(1)]
A room with an area of twenty (20)
square metres with appropriate aseptic arrangements.
(1)
Equipment
and accessories necessary for carrying out clinical examination by an
obstetrician/gynaecologist.
(2)
Equipment, accessories
necessary for other facilities required for operations envisaged in the Act.
(a)
An ultra-sonography machine.*
(b)
Appropriate catheters
and equipment for carrying out chorionic villi aspirations per vagina or per
abdomen.*
(c)
Appropriate sterile
needles for amnicentesis or cordocentesis.*
(d)
A suitable foetoscope
with appropriate accessories for foetoscopy, foetal skin or organ biopsy or
foetal blood sampling shall be optional.
(*
These constitute the minimum requirement of equipment for conducting the
relevant procedure)
(3)
Equipment for dry and
wet sterilization.
(4)
Equipment for carrying
out emergency procedures such as evacuation of uterus or resuscitation in case
of need.
(1)
A gynaecologist with
adequate experience in pre-natal diagnostic procedures (should have performed
at least 20 procedures under supervision of a gynaecologist experienced in the
procedure which is going to be carried out, for example chorionic villi biopsy,
amniocentesis, cordocentesis and others indicated at B above).
(2)
A Radiologist or
Registered Medical Practitioner for carrying out ultrasonography. The required
experience shall be 100 cases under supervision of a similarly qualified person
experienced in these techniques.
[See rules 4(1) and 8(1)]
(To be submitted in Duplicate)
WITH SUPPORTING DOCUMENTS AS ENCLOSURES, ALSO IN DUPLICATE FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING CENTRE/GENETIC LABORATORY/GENETIC CLINIC
1.Name of the applicant
(specify
Sh./Smt./Kur./Dr.)
2.Address of the applicant
3.Capacity in which applying
(specify owner/partner/managing director/other-to be
stated)
4.Type of facility to be registered
(specify Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic/any combination of these)
5.Full name and address/addresses of Genetic
Counselling Centre/Genetic Laboratory/Genetic Clinic with Telephone/Telegraphic
Telex/Fax E-mail numbers.
6.Type of ownership and Organisation (specify
individual ownership/partnership/company/co-operative/any other). In case of
type of organization other than individual ownership, furnish copy of articles
of association and names and addresses of other persons responsible for
management, as enclosure.
7.Type of Institution (Govt. Hospital/Municipal
Hospital/Public Hospital/Private Hospital/Private Nursing Home/Private
Clinic/Private Laboratory/any other to be stated.) 8.Specific pre-natal
diagnostic procedures/tests for which approval is sought (for example
amniocentesis, chorionic villi aspiration/chromosomal/biochemical/molecular
studies etc.)
Leave blank if registration sought for Genetic
Counselling Centre only.
9.(a) Space available for the Counselling
Centre/Clinic/Laboratory give total work area excluding lobbies, waiting rooms,
stairs etc. and enclose plan)
10.Equipment available with the make and model of
each equipment. List to be attached on a separate sheet.
11. (a) Facilities
available in the Counselling Centre.
(b)Whether facilities are available in the
Laboratory/Clinic for the following tests:
(i)
Ultrasound
(ii)
Amniocentesis
(iii)
Chorionic villi
aspiration
(iv)
Foetoscopy
(v)
Foetal biopsy
(vi)
Cordocentesis
(b)
Whether facilities are
available in the Laboratory, Clinic for the following:
(i) Chromosomal studies
(ii)
Biochemical studies
(iii)Molecular
studies
12.Names, qualifications, experience and registration
number of employees may be furnished as an enclosure (Refer Schedules I, II or III).
13.State whether the Genetic Counselling
Centre/Genetic Laboratory/Genetic Clinic[1]
qualifies for registration in terms of minimum requirements laid down in
Schedule I, II and III and if not, reasons therefore.
14. For renewal applications only:
(a)
Registration No.
(b)
Date of issue and date
of expiry of existing certificate of registration.
15. List of Enclosures:
Please
attach a list of enclosures giving the supporting documents enclosed to this
application.
Date: (
..)
Place Name
and signature of applicant
I, Sh./Smt./Kum./Dr
son/daughter/wife of
aged
.. years resident of
.. 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, 1995,
2.I also undertake to explain the
said Act and Rules to all employees of the Genetic Counselling Centre/Genetic
Laboratory/Genetic Clinic in respect of which registration is sought and to
ensure that Act and Rules are fully complied with.
Date: (
..)
Place Name
and signature of applicant
[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:
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* named below for purposes of
carrying out Genetic Counselling/Pre-natal Diagnostic Procedures*/Pre-natal
Diagnostic Tests as defined in 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.
A. Name
and address of the Genetic Counselling Centre*/Genetic Laboratory*/Genetic
Clinic*.
B. Name
of Applicant for registration.
C. Pre-natal
diagnostic procedures approved for (Genetic Clinic).
(i)
Ultrasound
(ii)
Amniocentesis
(iii)
Chorionic villi biopsy
(iv)
Foetoscopy
(v)
Foetal skin or organ biopsy
(vi)
Cordocentesis
(vii)
Any other (specify)
D.
Pre-natal diagnostic
tests* approved (for Genetic Laboratory)
(i)
Chromosomal studies
(ii)
Biochemical studies
(iii)
Molecular studies
3.
Registration No.
allotted
4.
For renewed Certificate
of Registration only
Period of validity of earlier Certificate From
. To
. Or Registration.
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)]
REJECTION OF APPLICATION FOR REGISTRATION OR 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 Genetic Counselling Centre*/Genetic
Laboratory*/Genetic Clinic* named below for the reasons stated.
Name
and address of the Genetic Counselling Centre*/Genetic
Laboratory*/Genetic
Clinic*
Name
of Applicant who has applied for registration
Reasons
for rejection of application for registration
Signature, name and designation of
The
Appropriate Authority
Date:
SEAL
*Strike out whichever is not applicable or necessary.
FORM D
[See rule 9(2)]
NAME, ADDRESS AND REGISTRATION No. OF GENETIC COUNSELLING CENTRE RECORD TO BE MAINTAINED BY THE GENETIC COUNSELLING CENTRE
1. Patients name
2. Age
3. Husbands/Fathers 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:
(a) Clinical
(b) Bio-chemical
(c) Cytogenetic
(d)Other (e.g.radiological)
8.
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)
Any other (specify)
B.
Advanced maternal age (35 years)
C.
Mother/father/sibling has genetic disease (specify)
D.
Others (specify)
9.
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)
10.Laboratory
tests to be carried out
(i)
Chromosomal studies
(ii)
Biochemical studies
(iii)
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. Patients name
2. Age
3. Husbands/Fathers 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
(i) Chromosomal
disorders
(ii) Metabolic disorders
(iii) Malformation(s)
(iv)
Mental retardation
(v)
Hereditary haemolytic
anaemia
(vi)
Sex linked disorder
(vii)
Any other (specify)
B.Advanced
maternal age (-35 years)
C.Mother/father/sibling
has genetic disease (specify)
D.Other
(specify)
8.Laboratory
tests carried out (give details)
(viii)
Chromosomal studies
(ix)
Biochemical studies
(x)
Molecular studies
9.Result
of pre-natal diagnosis
If abnormal give details. Normal/Abnormal
10.
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
Date:
[See Rule 9(4)]
NAME,
ADDRESS AND REGISTRATION No. OF GENETIC CLINIC
RECORD TO BE MAINTAINED BY THE GENETIC CLINIC
1. Patients name
2. Age
3. Husbands/Fathers name
4. Full address with Tel. No., if any
5. Referred by (full name and address of Doctor(s)/Genetic
Counselling Centre (Referral 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:
(a) Clinical
(b) Bio-chemical
(c) Cytogenetic
(d)Other (e.g.radiological-specify)
8.
Indication for pre-natal diagnosis
A.Previous
child/children with:
(i) Chromosomal
disorders
(ii) Metabolic disorders
(viii)
Congenital anomaly
(ix)
Mental retardation
(x)
Haemoglobinopathy
(xi)
Sex linked disorders
(xii)
Any other (specify)
B.
Advanced maternal age (35 years)
C.
Mother/father/sibling has genetic disease (specify)
D.
Other (specify)
9.
Procedures carried out (with name and registration No. of
Gynaecologist/Radiologist/Registered Medical Practitioner) who performed it.
(i) Ultrasound
(ii)
Amniocentesis
(iii)
Chorionic Villi aspiration
(iv)
Foetal biopsy
(v)
Cordocentesis
(vi)Any other (specify)
10.Any
complication of procedure please specify
11.Laboratory
tests recommended[3]
(i) Chromosomal
studies
(ii) Biochemical
studies
(iii) Molecular
studies
12.
Result of pre-natal diagnostic procedure and specify Normal/Abnormal
abnormality detected, if any.
13.
Was MTP advised/conducted?
14.
Date(s) on which procedures carried out.
15.
Date on which MTP carried out.
16.
Date on which consent obtained.
17.
The result of pre-natal diagnostic procedure were conveyed to
.on
Name, Signature and Registration number of the
Gynaecologist/Radiologist/Registered
Medical
Practitioner
Date:
Place
FORM G
[See Rule 10]
FORM OF CONSENT
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 pre-natal diagnostic
procedures in my interest to find out the possibility of any abnormality (i.e.
deformity or disorder) in the child I am carrying.
I undertake not to terminate the
pregnancy if the pre-natal procedure and any pre-natal tests conducted show the
absence of deformity or disorders. 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).
Date Signature
Place
I have explained the contents of the
above consent to the patient and her companion (Name
.. Address
. Relationship
..) in a language she/they understand.
Name,
Signature and/Registration number
Of
Gynaecologist
Date
Name,
Address and Registration number of
Genetic
Clinic
FORM H
[See Rule 9(5)]
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.
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)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.
(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.