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THE PRE-NATAL DIAGNOSTIC
TECHNIQUES (PNDT) ACT, RULES & REGULATION
THE PRE-NATAL DIAGNOSTIC TECHNIQUES
(REGULATION AND PREVENTION OF MISUSE) ACT, 1994
ACT NO. 57 OF 1994
[20th
September, 1994]
An Act to provide for the regulation
of the use of pre-natal diagnostic techniques for the purpose of detecting
genetic or metabolic disorders or chromosomal abnormalities or certain
congenital malformations or sex linked disorders and for the prevention of
the misuse of such techniques for the purpose of pre-natal sex determination
leading to female foeticide; and, for matters connected there with or
incidental thereto.
BE it enacted by Parliament in the
Forty-fifth Year of the
CHAPTER I
PRELIMINARY
1.Short title, extent and commencement.-
(1) This Act may be called the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act,
1994.
(2) It shall extend to the whole of
(3) It shall come into force on such
date as the Central Government may, by notification in the Official Gazette,
appoint.
2. Definitions.- In
this Act, unless the context otherwise requires,-- (a) "Appropriate
Authority" means the Appropriate Authority appointed under section 17;
(b) "Board" means the Central
Supervisory Board constituted under section 7;
(c) "Genetic Counseling
Centre" means an institute, hospital, nursing home or any place, by whatever
name called, which provides for genetic counselling to patients;
(d) "Genetic Clinic" means
a clinic, institute, hospital, nursing home or any place, by whatever name called,
which is used for conducting pre-natal diagnostic procedures;
(e) "Genetic Laboratory"
means a laboratory and includes a place where facilities are provided for conducting
analysis or tests of samples received from Genetic Clinic for pre-natal
diagnostic test;
(f) "Gynecologist" means a
person who possesses a post- graduate qualification in gynecology and obstetrics;
(g) "Medical geneticist"
means a person who possesses a degree or diploma or certificate in medical genetics
in the field of pre-natal diagnostic techniques or has experience of not less
than two years in such field after obtaining--
(i) any one of the medical
qualifications recognised under the Indian Medical Council Act, 1956 (102 of
1956); or
(ii) a post-graduate degree in
biological sciences;
(h) "Pediatrician" means a
person who possesses a post- graduate qualification in pediatrics;
(i) "pre-natal diagnostic
procedures" means all gynecological or obstetrical or medical procedures
such as ultrasonography foetoscopy, taking or removing samples of amniotic
fluid, chorionic villi, blood or any tissue of a pregnant woman for being
sent to a Genetic Laboratory or Genetic Clinic for conducting pre-natal
diagnostic test;
(j) "pre-natal diagnostic
techniques" includes all pre-natal diagnostic procedures and pre-natal diagnostic
tests;
(k) "pre-natal diagnostic
test" means ultrasonography or any test or analysis of amniotic fluid, chorionic
villi, blood or any tissue of a pregnant woman conducted to detect genetic or
metabolic disorders or chromosomal abnormalities or congenital anomalies or
haemoglobinopathies or sexlinked diseases;
(l) "prescribed" means
prescribed by rules made under this Act;
(m) "registered medical
practitioner" means a medical practitioner who possesses any recognized medical
qualification as defined in clause (h) of section 2 of the Indian Medical
Council Act, 1956, (102 of 1956.) and whose name has been entered in a State
Medical Register;
(n) "regulations" means
regulations framed by the Board under this Act.
CHAPTER II
REGULATION OF GENETIC COUNSELLING
CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS
3. Regulation of Genetic
Counselling Centres, Genetic Laboratories and
Genetic Clinics.- On and from the commencement of this Act,--
(1) no Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic unless registered under this Act, shall
conduct or associate with, or help in, conducting activities relating to
pre-natal diagnostic techniques;
(2) no Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic shall employ or cause to be employed any
person who does not possess the prescribed qualifications;
(3) no medical geneticist,
gynaecologist, paediatrician, registered medical practitioner or any other
person shall conduct or cause to be conducted or aid in conducting by himself
or through any other person, any pre-natal diagnostic techniques at a place
other than a place registered under this Act.
CHAPTER III
REGULATION OF PRE-NATAL DIAGNOSTIC
TECHNIQUES
4. Regulation of pre-natal
diagnostic techniques.- On and from the commencement of this Act,-- (1)
no place including a registered Genetic Counselling Centre or Genetic
Laboratory or Genetic Clinic shall be used or caused to be used by any person
for conducting pre-natal diagnostic techniques except for the purposes
specified in clause (2) and after satisfying any of the conditions specified
in clause (3);
(2) no pre-natal diagnostic
techniques shall be conducted except for the purposes of detection of any of
the following abnormalities, namely:-- (i) chromosomal abnormalities;
(ii) genetic metabolic diseases;
(iii) haemoglobinopathies;
(iv) sex-linked genetic diseases;
(v) congenital anomalies;
(vi) any other abnormalities or
diseases as may be specified by the Central Supervisory Board;
(3) no pre-natal diagnostic
techniques shall be used or conducted unless the person qualified to do so is
satisfied that any of the following conditions are fulfilled, namely:--
(i) age of the pregnant woman is
above thirty-five years;
(ii) the pregnant woman has undergone
of two or more spontaneous abortions or foetal loss;
(iii) the pregnant woman had been
exposed to potentially teratogenic agents such as drugs, radiation, infection
or chemicals;
(iv) the pregnant woman has a family
history of mental retardation or physical deformities such as spasticity or
any other genetic disease;
(v) any other condition as may be
specified by the Central Supervisory Board;
(4) no person, being a relative or
the husband of the pregnant woman shall seek or encourage the conduct of any
pre-natal diagnostic techniques on her except for the purpose specified in
clause (2).
5. Written consent of pregnant
woman and prohibition of communicating the sex of foetus.
(1) No person referred to in clause
(2) of section 3 shall conduct the pre-natal diagnostic procedures unless— (a)
he has explained all known side and after effects of such procedures to the pregnant
woman concerned;
(b) he has obtained in the prescribed
form her written consent to undergo such procedures in the language which she
understands; and
(c) a copy of her written consent
obtained under clause (b) is given to the pregnant woman.
(2) No person conducting pre-natal
diagnostic procedures shall communicate to the pregnant woman concerned or
her relatives the sex of the foetus by words, signs or in any other manner.
6. Determination of sex
prohibited.- On and from the commencement of this Act,-- (a) no
Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic shall conduct
or cause to be conducted in its Centre, Laboratory or Clinic, pre-natal diagnostic
techniques including ultrasonography, for the purpose of determining the sex
of a foetus;
(b) no person shall conduct or cause
to be conducted any pre-natal diagnostic techniques including ultrasonography
for the purpose of determining the sex of a foetus.
CHAPTER IV
CENTRAL SUPERVISORY BOARD
7. Constitution of Central
Supervisory Board.- (1) The Central Government shall constitute a Board
to be known as the Central Supervisory Board to exercise the powers and
perform the functions conferred on the Board under this Act.
(2) The Board shall consist of— (a)
the Minister in charge of the Ministry or Department of Family Welfare, who shall
be the Chairman, ex officio;
(b) the Secretary to the Government
of India in charge of the Department of Family Welfare, who shall be the
Vice-Chairman, ex-officio;
(c) two members to be appointed by
the Central Government to represent the Ministries of Central Government in
charge of Woman and Child Development and of Law and Justice, ex-officio;
(d) the Director General of Health
Services of the Central Government, ex officio;
(e) ten members to be appointed by
the Central Government, two each from amongst—
(i) eminent medical geneticists;
(ii) eminent gynaecologists and
obstetricians;
(iii) eminent paediatricians;
(iv) eminent social scientists; and
(v) representatives of women welfare
organisations;
(f) three women Members of
Parliament, of whom two shall be elected by the House of the People and one
by the Council of States;
(g) four members to be appointed by
the Central Government by rotation to represent the States and the Union
territories, two in the alphabetical order and two in the reverse
alphabetical order:
Provided that no appointment under
this clause shall be made except on the recommendation of the State
Government or, as the case may be, the Union territory;
(h) an officer, not below the rank of
a Joint Secretary or equivalent of the Central Government, in charge of
Family Welfare, who shall be the Member-Secretary, ex officio.
8. Term of office of members.-
(1) The term of office of a member, other than an ex officio member, shall
be,-- (a) in case of appointment under clause (e) or clause (f) of sub-section
(2) of section 7, three years; and
(b) in case of appointment under
clause (g) of the said subsection, one year.
(2) If a casual vacancy occurs in the
office of any other members, whether by reason of his death, resignation or
inability to discharge his functions owing to illness or other incapacity,
such vacancy shall be filled by the Central Government by making a fresh
appointment and the member so appointed shall hold office for the remainder
of the term of office of the person in whose place he is so appointed.
(3) The Vice-Chairman shall perform
such functions as may be assigned to him by the Chairman from time to time.
(4) The procedure to be followed by
the members in the discharge of their functions shall be such as may be
prescribed.
9. Meetings of the Board.-
(1) The Board shall meet at such time and place, and shall observe such rules
of procedure in regard to the transaction of business at its meetings
(including the quorum at such meetings) as may be provided by regulations:
Provided that the Board shall meet at
least once in six months.
(2) The Chairman and in his absence
the Vice-Chairman shall preside at the meetings of the Board.
(3) If for any reason the Chairman or
the Vice-Chairman is unable to attend any meeting of the Board, any other
member chosen by the members present at the meeting shall preside at the
meeting.
(4) All questions which come up
before any meeting of the Board shall be decided by a majority of the votes
of the members present and voting, and in the event of an equality of votes,
the Chairman, or in his absence, the person presiding, shall have and
exercise a second or casting vote.
(5) Members other than ex officio
members shall receive such allowances, if any, from the Board as may be
prescribed.
10. Vacancies, etc., not to
invalidate proceedings of the Board.- No act or proceeding of the Board
shall be invalid merely by reason of— (a) any vacancy in, or any defect in
the constitution of, the Board; or
(b) any defect in the appointment of
a person acting as a member of the Board; or
(c) any irregularity in the procedure
of the Board not affecting the merits of the case.
11. Temporary association of
persons with the Board for particular purposes. (1) The Board may
associate with itself, in such manner and for such purposes as may be determined
by regulations, any person whose assistance or advice it may desire in
carrying out any of the provisions of this Act.
(2) A person associated with it by
the Board under sub-section (1) for any purpose shall have a right to take
part in the discussions relevant to that purpose, but shall not have a right
to vote at a meeting of the Board and shall not be a member for any other
purpose.
12. Appointment or officers and
other employees of the Board.- (1) For the purpose of enabling it efficiently
to discharge its functions under this Act, the Board may, subject to such
regulations as may be made in this behalf, appoint (whether on deputation or
otherwise) such number of officers and other employees as it may consider
necessary:
Provided that the appointment of such
category of officers, as may be specified in such regulations, shall be
subject to the approval of the Central Government.
(2) Every officer or other employee
appointed by the Board shall be subject to such conditions of service and
shall be entitled to such remuneration as may be specified in the
regulations.
13. Authentication of orders
and other instruments of the Board.- All orders and decisions of the Board
shall be authenticated by the signature of the Chairman or any other member
authorised by the Board in this behalf, and all other instruments issued by
the Board shall be authenticated by the signature of the Member-Secretary or
any other officer of the Board authorised in like manner in this behalf.
14. Disqualifications for
appointment as member.- A person shall be disqualified for being appointed
as a member if, he— (a) has been convicted and sentenced to imprisonment for
an offence which, in the opinion of the Central Government, involves moral
turpitude; or
(b) is an undischarged insolvent; or
(c) is of unsound mind and stands so
declared by a competent court; or
(d) has been removed or dismissed
from the service of the Government or a Corporation owned or controlled by
the Government; or
(e) has, in the opinion of the
Central Government, such financial or other interest in the Board as is
likely to affect prejudicially the discharge by him of his functions as a
member; or
(f) has, in the opinion of the
Central Government, been associated with the use or promotion of pre-natal
diagnostic technique for determination of sex.
15. Eligibility of member for
reappointment.- Subject to the other terms and conditions of service as
may be prescribed, any person ceasing to be a member shall be eligible for
reappointment as such member.
16. Functions of the Board.
- The Board shall have the following functions, namely:-- (i) to advise the
Government on policy matters relating to use of pre-natal diagnostic techniques;
(ii) to review implementation of the
Act and the rules made thereunder and recommend changes in the said Act and
rules to the Central Government;
(iii) to create public awareness
against the practice of pre-natal determination of sex and female foeticide;
(iv) to lay down code of conduct to
be observed by persons working at Genetic Counselling Centres, Genetic
Laboratories and Genetic Clinics;
(v) any other functions as may be
specified under the Act.
CHAPTER V
APPROPRIATE AUTHORITY AND ADVISORY
COMMITTEE
17. Appropriate Authority and
Advisory Committee.- (1) The Central Government shall appoint, by notification
in the Official Gazette, one or more Appropriate Authorities for each of the
Union territories for the purposes of this Act.
(2) The State Government shall
appoint, by notification in the Official Gazette, one or more Appropriate
Authorities for the whole or part of the State for the purposes of this Act
having regard to the intensity of the problem of pre-natal sex determination
leading to female foeticide.
(3) The officers appointed as
Appropriate Authorities under sub- section (1) or sub-section (2) shall be,--
(a) when appointed for the whole of the State or the Union territory, of or
above the rank of the Joint Director of Health and Family Welfare; and
(b) when appointed for any part of
the State or the Union territory, of such other rank as the State Government
or the Central Government, as the case may be, may deem fit.
(4) The Appropriate Authority shall
have the following functions, namely:-
(a) to grant, suspend or cancel
registration of a Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic;
(b) to enforce standards prescribed
for the Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic;
(c) to investigate complaints of
breach of the provisions of this Act or the rules made thereunder and take
immediate action; and
(d) to seek and consider the advice
of the Advisory Committee, constituted under sub-section (5), on application
for registration and on complaints for suspension or cancellation of
registration.
(5) The Central Government or the
State Government, as the case may be, shall constitute an Advisory Committee
for each Appropriate Authority to aid and advise the Appropriate Authority in
the discharge of its functions, and shall appoint one of the members of the
Advisory Committee to be its Chairman.
(6) The Advisory Committee shall
consist of— (a) three medical experts from amongst gynaecologists,
obstericians, paediatricians and medical geneticists;
(b) one legal expert;
(c) one officer to represent the
department dealing with information and publicity of the State Government or
the Union territory, as the case may be;
(d) three eminent social workers of
whom not less than one shall be from amongst representatives of women's
organisations.
(7) No person who, in the opinion of
the Central Government or the State Government, as the case may be, has been
associated with the use or promotion of pre-natal diagnostic technique for determination
of sex shall be appointed as a member of the Advisory Committee.
(8) The Advisory Committee may meet
as and when it thinks fit or on the request of the Appropriate
Authority for consideration of any
application for registration or any complaint for suspension or cancellation
of registration and to give advice thereon:
Provided that the period intervening
between any two meetings shall not exceed the prescribed period.
(9) The terms and conditions subject
to which a person may be appointed to the Advisory Committee and the
procedure to be followed by such Committee in the discharge of its functions
shall be such as may be prescribed.
CHAPTER VI
REGISTRATION OF GENETIC COUNSELLING
CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS
18. Registration of Genetic
Counselling Centres, Genetic Laboratories or Genetic Clinics. (1)
No person shall open any Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic after the commencement of this
Act unless such Centre, Laboratory or Clinic is duly registered separately or
jointly under this Act.
(2) Every application for
registration under sub-section (1), shall be made to the Appropriate
Authority in such form and in such manner and shall be accompanied by such
fees as may be prescribed.
(3) Every Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic engaged, either partly or exclusively,
in counselling or conducting pre-natal diagnostic techniques for any of the
purposes mentioned in section 4, immediately before the commencement of this
Act, shall apply for registration within sixty days from the date of such
commencement.
(4) Subject to the provisions of
section 6, every Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic engaged in counselling or conducting pre-natal diagnostic techniques
shall cease to conduct any such counselling or technique on the expiry of six
months from the date of commencement of this Act unless such Centre,
Laboratory or Clinic has applied for registration and is so registered
separately or jointly or till such application is disposed of, whichever is
earlier.
(5) No Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic shall be registered under this Act
unless the Appropriate Authority is satisfied that such Centre, Laboratory or
Clinic is in a position to provide such facilities, maintain such equipment
and standards as may be prescribed.
19. Certificate of registration.-
(1) The Appropriate Authority shall, after holding an inquiry and after satisfying
itself that the applicant has complied with all the requirements of this Act
and the rules made thereunder and having regard to the advice of the Advisory
Committee in this behalf, grant a certificate of registration in the
prescribed form jointly or separately to the Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic, as the case may be.
(2) If, after the inquiry 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 this Act or the
rules, it shall, for reasons to be recorded in writing, reject the
application for registration.
(3) Every certificate of registration
shall be renewed in such manner and after such period and on payment of such
fees as may be prescribed.
(4) The certificate of registration
shall be displayed by the registered Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic in a conspicuous place at its place of business.
20. Cancellation or suspension
of registration.- (1) The Appropriate Authority may suo moto,
or on complaint, issue a notice to the Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic to show cause why its registration should not be
suspended or cancelled for the reasons mentioned in the notice.
(2) If, after giving a reasonable
opportunity of being heard to the Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic and having regard to the advice of the Advisory Committee,
the Appropriate Authority is satisfied that there has been a breach of the
provisions of this Act or the rules, it may, without prejudice to any
criminal action that it may take against such Centre, Laboratory or Clinic,
suspend its registration for such period as it may think fit or cancel its
registration, as the case may be.
(3) Notwithstanding anything
contained in sub-sections (1) and (2), if the Appropriate Authority is, of the
opinion that it is necessary or expedient so to do in the public interest, it
may, for reasons to be recorded in writing, suspend the registration of any
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic without
issuing any such notice referred to in sub-section (1).
21. Appeal. The Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic may, within thirty days
from the date of receipt of the order of suspension or cancellation of registration
passed by the Appropriate Authority under section 20, prefer an appeal
against such order to— (i) the Central Government, where the appeal is
against the order of the Central Appropriate Authority; and
(ii) the State Government, where the
appeal is against the order of the State Appropriate Authority, in the
prescribed manner.
CHAPTER VII
OFFENCES AND PENALTIES
22. Prohibition of
advertisement relating to pre-natal determination of sex and punishment for contravention.-
(1) No person, organisation, Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic shall issue or cause to be issued
any advertisement in any manner regarding facilities of
pre-natal determination of sex available at such Centre, Laboratory, Clinic
or any other place.
(2) No person or organisation shall
publish or distribute or cause to be published or distributed any advertisement
in any manner regarding facilites of pre-natal determination of sex available
at any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic or any
other place.
(3) Any person who contravenes the
provisions of sub-section (1) or sub-section (2) shall be punishable with
imprisonment for a term which may extend to three years and with fine which
may extend to ten thousand rupees.
Explanation.--For the purposes of this section,
"advertisement" includes any notice, circular, label wrapper or
other document and also includes any visible representation made by means of
any light, sound, smoke or gas.
23. Offences and penalties.-
(1) Any medical geneticist, gynaecologist, registered medical practitioner or
any person who owns a Genetic Counselling Centre, a Genetic Laboratory or a
Genetic Clinic or is employed in such a Centre, Laboratory or Clinic and
renders his professional or technical services to or at such a Centre,
Laboratory or Clinic, whether on an honorary basis or otherwise, and who
contravenes any of the provisions of this Act or rules made thereunder shall
be punishable with imprisonment for a term which may extend to three years
and with fine which may extend to ten thousand rupees and on any subsequent
conviction, with imprisonment which may extend to five years and with fine
which may extend to fifty thousand rupees.
(2) The name of the registered
medical practitioner who has been convicted by the court under subsection
(1), shall be reported by the
Appropriate Authority to the respective State Medical Council for taking
necessary action including the removal of his name from the register of the
Council for a period of two years for the first offence and permanently for
the subsequent offence.
(3) Any person who seeks the aid of a
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic or of a
medical geneticist, gynaecologist or registered medical practitioner for
conducting prenatal diagnostic techniques on any pregnant woman (including
such woman unless she was compelled to undergo such diagnostic techniques)
for purposes other than those specified in clause
(2) of section 4, shall, be
punishable with imprisonment for a term which may extend to three years and
with fine which may extend to ten thousand rupees and on any subsequent
conviction with imprisonment which may extend to five years and with fine
which may extend to fifty thousand rupees.
24. Presumption in the case of conduct
of pre-natal diagnostic techniques.- Notwithstanding anything in the
Indian Evidence Act, 1872 (1 of 1872), the court shall presume unless the
contrary is proved that the pregnant woman has been compelled by her husband
or the relative to undergo prenatal diagnostic technique and such person
shall be liable for abetment of offence under sub-section (3) of section 23
and shall be punishable for the offence specified under that section.
25. Penalty for contravention
of the provisions of the Act or rules for which no specific punishment is
provided.- Whoever contravenes any of the provisions of this Act or
any rules made thereunder, for which no penalty has been
elsewhere provided in this Act, shall be punishable with imprisonment
for a term which may extend to three months or with fine, which may extend to
one thousand rupees or with both and in the case of continuing
contravention with an additional fine which may extend to five
hundred rupees for every day during which such contravention continues after
conviction for the first such contravention.
26. Offences by companies.-
(1) Where any offence, punishable under this Act has been committed by a
company, every person who, at the time the offence was committed was in charge
of, and was responsible to the company for the conduct of the business of the
company, as well as the company, shall be deemed to be guilty of the offence
and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in
this sub-section shall render any such person liable to any punishment, if he
proves that the offence was committed without his knowledge or that he had exercised
all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything
contained in sub-section (1), where any offence punishable under this Act has
been committed by a company and it is proved that the offence has been
committed with the consent or connivance of, or is attributable to any
neglect on the part of, any director, manager, secretary or other officer of
the company, such director, manager, secretary or other officer shall also be
deemed to be guilty of that offence and shall be liable to be proceeded
against and punished accordingly.
Explanation.--For the purposes of this section,-- (a) "company"
means any body corporate and includes a firm or other association of individuals,
and
(b)"director", in relation
to a firm, means a partner in the firm.
27. Offence to be cognizable,
non-bailable and non-compoundable.-Every offence under this Act shall
be cognizable, non-bailable and non-compoundable.
28. Cognizance of offences.
(1) No court shall take cognizance of an offence under this Act except on a
complaint made by-- (a) the Appropriate Authority concerned, or any officer
authorised in this behalf by the Central Government or State Government, as
the case may be, or the Appropriate Authority; or
(b) a person who has given notice of
not less than thirty days in the manner prescribed, to the Appropriate
Authority, of the alleged offence and of his intention to make a complaint to
the court.
Explanation.--For the purpose of this clause, "person"
includes a social organisation.
(2) No court other than that of a
Metropolitan Magistrate or a Judicial Magistrate of the first class shall try
any offence punishable under this Act.
(3) Where a complaint has been made
under clause (b) of subsection (1), the court may, on demand by such person,
direct the Appropriate Authority to make available copies of the relevant
records in its possession to such person.
CHAPTER VIII
MISCELLANEOUS
29. Maintenance of records.
(1) All records, charts, forms, reports, consent letters and all other documents
required to be maintained under this Act and the rules shall be preserved for
a period of two years or for such period as may be prescribed:
Provided that, if any criminal or
other proceedings are instituted against any Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, the records and all other documents of
such Centre, Laboratory or Clinic shall be preserved till the final disposal
of such proceedings.
(2) All such records shall, at all
reasonable times, be made available for inspection to the Appropriate
Authority or to any other person authorised by the Appropriate Authority in
this behalf.
30. Power to search and seize
records, etc. - (1) If the Appropriate Authority has reason to
believe that an offence under this Act has been or is being committed at any
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, such
Authority or any officer authorised thereof in this behalf may, subject to
such rules as may be prescribed, enter and search at all reasonable times
with such assistance, if any, as such authority or officer considers
necessary, such Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic and examine any record, register, document, book, pamphlet,
advertisement or any other material object found therein and seize the same
if such Authority or officer has reason to believe that it may furnish
evidence of the commission of an office punishable under this Act.
(2) The provisions of the Code of
Criminal Procedure, 1973 (2 of 1974) relating to searches and seizures shall,
so far as may be, apply to every search or seizure made under this Act.
31. Protection of action taken
in good faith.- No suit, prosecution or other legal proceeding shall lie
against the Central or the State Government or the Appropriate Authority or
any officer authorised by the Central or State Government or by the Authority
for anything which is in good faith done or intended to be done in pursuance
of the provisions of this Act.
32. Power to make rules.-
(1) The Central Government may make rules for carrying out the provisions of
this Act.
(2) In particular and without
prejudice to the generality of the foregoing power, such rules may provide for--
(i) the minimum qualifications for persons employed at a registered Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic under clause (1) of
section 3;
(ii) the form in which consent of a
pregnant woman has to be obtained under section 5;
(iii) the procedure to be followed by
the members of the Central Supervisory Board in the discharge of their
functions under sub-section (4) of section 8;
(iv) allowances for members other
than ex officio members admissible under sub-section (5) of section 9;
(v) the period intervening between
any two meetings of the Advisory Committee under the proviso to sub-section
(8) of section 17;
(vi) the terms and conditions subject
to which a person may be appointed to the Advisory Committee and the
procedure to be followed by such Committee under sub-section (9) of section
17;
(vii) the form and manner in which an
application shall be made for registration and the fee payable thereof under
sub-section (2) of section 18;
(viii) the facilities to be provided,
equipment and other standards to be maintained by the Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic under sub-section (5) of section
18;
(ix) the form in which a certificate
of registration shall be issued under sub-section (1) of section 19;
(x) the manner in which and the
period after which a certificate of registration shall be renewed and the fee
payable for such renewal under sub-section (3) of section 19;
(xi) the manner in which an appeal
may be preferred under section 21;
(xii) the period up to which records,
charts, etc., shall be preserved under sub-section (1) of section 29;
(xiii) the manner in which the
seizure of documents, records, objects, etc., shall be made and the manner in
which seizure list shall be prepared and delivered to the person from whose
custody such documents, records or objects were seized under sub-section (1)
of section 30;
(xiv) any other matter that is
required to be, or may be, prescribed.
33. Power to make regulations.-
The Board may, with the previous sanction of the Central Government, by
notification in the Official Gazette, make regulations not inconsistent with
the provisions of this Act and the rules made thereunder to provide for-- (a)
the time and place of the meetings of the Board and the procedure to be
followed for the transaction of business at such meetings and the number of
members which shall form the quorum under sub-section (1) of section 9;
(b) the manner in which a person may
be temporarily associated with the Board under sub-section (1) of section 11;
(c) the method of appointment, the
conditions of service and the scales of pay and allowances of the officer and
other employees of the Board appointed under section 12;
(d) generally for the efficient conduct
of the affairs of the Board.
34. Rules and regulations to be
laid before Parliament. – Every rule and every regulation made under
this Act shall be laid, as soon as may be after it is made, before each House
of Parliament, while it is in session, for a total period of thirty days
which may be comprised in one session or in two or more successive sessions,
and if, before the expiry of the session immediately following the session or
the successive sessions aforesaid, both Houses agree in making any modification
in the rule or regulation or both Houses agree that the rule or regulation
should not be made, the rule or regulation shall thereafter have effect only
in such modified form or be of no effect, as the case may be; so, however,
that any such modification or annulment shall be without prejudice to the validity
of anything previously done under that rule or regulation.
THE PRE-NATAL
DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) AMENDMENT ACT,
2002
No. 14 of 2003
[17th January, 2003]
An Act further to amend the Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.
Short
title and commencement
1.(1) This Act may be called the Pre-natal Diagnostic
Techniques (Regulation and Prevention of Misuse) Amendment Act, 2002.
(2) It shall come into force on such date as the Central Government
may, by notification in the Official Gazette, appoint.
Substitution
of long title.
2. In the Pre-natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act, 1994 (hereinafter referred to as the principal
Act), for the long title, the following long title shall be substituted,
namely:-
"An Act to provide for the prohibition of sex selection,
before or after conception, and for regulation of pre-natal diagnostic
techniques for the purposes of detecting genetic abnormalities or metabolic disorders
or chromosomal abnormalities or certain congenital malformations or
sex-linked disorders and for the prevention of their misuse for sex
determination leading to female foeticide and for matters connected therewith
or incidental thereto.”.
Amendment
of section 1.
3. 3. In section 1 of the principal Act, in sub-section (1),
for the words and brackets “the Pre-natal Diagnostic Techniques (Regulation
and Prevention of Misuse)”, the words and brackets “the Preconception and
Pre-natal Diagnostic Techniques (Prohibition of Sex Selection)” shall be
substituted.
Amendment
of section 2.
4. In section 2 of the principal Act, - (i) after clause
(b), the following clauses shall be inserted, namely:-
‘(ba) “conceptus” means any product of conception at any stage of
development from fertilisation until birth including extra embryonic
membranes as well as the embryo or foetus;
(bb) “embryo” means a developing human organism after fertilisation
till the end of eight weeks (fifty-six days);
(bc) “foetus” means a human organism during the period of its development
beginning on the fifty-seventh day following fertilization or creation
(excluding any time in which its development has been suspended) and ending
at the birth;’;
(ii) in clause(d), the following Explanation shall be added,
namely:-
‘Explanation – For the purpose of this clause, “Genetic
Clinic” includes a vehicle, where ultrasound machine or imaging machine or scanner
or other equipment capable of determining sex of the foetus or a portable
equipment which has the potential for detection of sex during pregnancy or
selection of sex before conception, is used;’;
(iii) in clause (e), the following Explanation shall be added,
namely:-
‘Explanation:- For the purposes of this clause “Genetic Laboratory”
includes a place where ultrasound machine or imaging machine or scanner or
other equipment capable of determining sex of the foetus or a portable
equipment which has the potential for detection of sex during pregnancy or
selection of sex before conception, is used;’;
(iv) for clause(g), the following clause shall be substituted,
namely:-
‘(g) “medical geneticist” includes a person who possesses a
degree or diploma in genetic science in the fields of sex selection and
prenatal diagnostic techniques or has experience of not less than two years
in any of these fields after obtaining – (i) any one of the medical
qualifications recognised under the Indian Medical Council Act, 1956; or
(ii) a post-graduate degree in biological sciences;’;
(v) for clause (i), the following clause shall be
substituted, namely:-
‘(i) “pre-natal diagnostic procedures” means all gynaecological or obstetrical
or medical procedures such as ultrasonography, foetoscopy, taking or removing
samples of amniotic fluid, chorionic villi, embryo, blood or any other tissue
or fluid of a man, or of a woman before or after conception, for being sent
to a Genetic Laboratory or Genetic Clinic for conducting any type of analysis
or pre-natal diagnostic tests for selection of sex before or after conception;’;
(vi) for clause (k), the following clause shall be
substituted, namely:-
‘(k) “pre-natal diagnostic test” means ultrasonography or
any test or analysis of amniotic fluid, chorionic villi, blood or any tissue
or fluid of a pregnant woman or conceptus conducted to detect genetic or metabolic
disorders or chromosomal abnormalities or congenital anomalies or
haemoglobinopathies or sex-linked diseases;’;
(vii) after clause (n), the following clauses shall be
inserted, namely:-
‘(o) “sex selection” includes any procedure, technique, test or administration
or prescription or provision of anything for the purpose of ensuring or
increasing the probability that an embryo will be of a particular sex;
(p) “sonologist or imaging specialist” means a person who possesses
any one of the medical qualifications recognised under the Indian Medical
Council Act, 1956 or who possesses a post-graduate qualification in
ultrasonography or imaging techniques or radiology ;
(q) “State Board” means a State Supervisory Board or a Union territory
Supervisory Board constituted under section 16 A;
(r) “State Government” in relation to Union territory with Legislature
means the Administrator of that Union territory appointed by the President
under article 239 of the Constitution.’.
Amendment
of section 3.
5. In section 3 of the principal Act, for clause (2), the
following clause shall be substituted, namely: -
“(2) no Genetic Counselling Center or Genetic Laboratory
or Genetic Clinic shall employ or cause to be employed or take services of
any person, whether on honorary basis or on payment who does not possess the
qualifications as may be prescribed.”.
Insertion
of new sections 3A and 3B.
Prohibition
of sex-selection.
6. After section 3 of the principal Act, the following sections
shall be inserted, namely:-
“3A. No person, including a specialist or a team of specialists
in the field of infertility, shall conduct or cause to be conducted or aid in
conducting by himself or by any other person, sex selection on a woman or a
man or on both or on any tissue, embryo, conceptus, fluid or gametes derived
from either or both of them.
Prohibition
on sale of ultrasound machine etc. to persons, laboratories, clinics etc. not
registered under the Act.
3B. No person shall sell any ultrasound machine or imaging machine
or scanner or any other equipment capable of detecting sex of foetus to any
Genetic Councelling Centre, Genetic Laboratory, Genetic Clinic or any other
person not registered under the Act.”.
Amendment
of section 4.
7. In section 4 of the principal Act, for clauses (3) and (4),
the following clauses shall be substituted, namely:-
“(3) no pre-natal diagnostic techniques shall be used or conducted
unless the person qualified to do so is satisfied for reasons to be recorded
in writing that any of the following conditions are fulfilled namely:-
( i) age of the pregnant woman is above thirty-five
years,
(ii) the pregnant woman has undergone two or more spontaneous
abortions or foetal loss;
(iii) the pregnant woman had been exposed to potentially teratogenic
agents such as, drugs, radiation, infection or chemicals;
(iv) the pregnant woman or her spouse has a family
history of mental retardation or physical deformities such as, spasticity mental
retardation or physical deformities such as, spasticity or any other genetic
disease;
(v) any other condition as may be specified by the Board:
Provided that the person conducting ultrasonography on a pregnant
woman shall keep complete record thereof in the clinic in such manner, as may
be prescribed, and any deficiency or inaccuracy found therein shall amount to
contravention of the provisions of section 5 or section 6 unless contrary is
proved by the person conducting such ultrasonography;
(4) no person including a relative or husband of the pregnant woman
shall seek or encourage the conduct of any pre-natal diagnostic techniques on
her except for the purposes specified in clause (2);
(5) no person including a relative or husband of a woman shall seek
or encourage the conduct of any sex-selection technique on her or him or
both.”.
Amendment
of section 5.
8. In section 5 of the principal Act, for sub-section (2), the
following subsection shall be substituted, namely:-
“(2) No person including the person conducting pre-natal diagnostic
procedures shall communicate to the pregnant woman concerned or her relatives
or any other person the sex of the foetus by words, signs, or in any other
manner.”.
Amendment
of section 6.
9. In section 6 of the principal Act, after clause (b), the
following clause shall be inserted, namely :-
“(c) no person shall, by whatever means, cause or allow to be caused
selection of sex before or after conception”.
Amendment
of Section 7
10. In section 7 of the principal Act,-
(i) in sub-section (2), for clause (c), the
following clause shall be substituted, namely:-
“(c) three members to be appointed by the Central Government
to represent the Ministeries of Central Government in charge of Women and
Child Development, Department of Legal Affairs or Legislative Department in
the Ministry of Law, Justice, and Indian System of Medicine and Homeopathy,
ex officio;”;
(ii) in clause (e), for sub-clause (ii),
the following sub-clause shall be substituted, namely:-
“(ii) eminent gynaecologist and obstetrician or expert of
striroga or prasuti-tantra.”.
Amendment
of section 14.
11. In section 14 of the principal Act, for clause (f),
the following clause shall be substituted, namely:-
“(f) has, in the opinion of the Central Government, been associated
with the use or promotion of pre-natal diagnostic technique for determination
of sex or with any sex selection technique.”.
Amendment
of section 15.
12. In section 15 of the principal Act, the following proviso
shall be inserted, namely: -
“Provided that no member other than an ex-officio member shall be
appointed for more than two consecutive terms.”.
Substitution
of new section for section 16.
Functions
of the Board.
13. For section 16 of the principal Act, the following section
shall be substituted, namely:-
“16. The Board shall have the following functions, namely:-
(i) to advise the Central Government on policy matters relating
to use of pre-natal diagnostic techniques, sex selection techniques and
against their misuse;
(ii) to review and monitor implementation of the Act and rules
made thereunder and recommend to the Central Government changes in the said
Act and rules.
(iii) to create public awareness against the practice of
preconception sex selection and pre-natal determination of sex of foetus
leading to female foeticide;
(iv) to lay down code of conduct to be observed by
persons working at Genetic Counselling Centres, Genetic Laboratories and Genetic
Clinics;
(v) to oversee the performance of various bodies
constituted under the Act and take appropriate steps to ensure its proper and
effective implementation;
(vi) any other functions as may be prescribed under the Act.”.
Insertion
of new section 16A.
14. After section 16 of the principal Act, the following section
shall be
inserted, namely: -
Constitution
of State Supervisory Board and
“16A (1) Each State and Union territory having
Legislature shall constitute a Board to be known as the State Supervisory Board
or the Union territory Supervisory Board, as the case may be, which shall
have the following functions: -
(i) to create public awareness against the practice of preconception
sex selection and pre-natal determination of sex of foetus leading to female
foeticide in the State;
(ii) to review the activities of the Appropriate Authorities
functioning in the State and recommend appropriate action against them;
(iii) to monitor the implementation of provisions of the Act and the
rules and make suitable recommendations relating thereto, to the Board;
(iv) to send such consolidated reports as may be prescribed in
respect of the various activities undertaken in the State under the Act to
the Board and the Central Government; and
(v) any other functions as may be prescribed under the Act.
(2) The State Board shall consist of: -
(a) the Minister in-charge of Health and Family Welfare in the
State, who shall be the Chairperson, ex officio;
(b) Secretary in-charge of the Department of Health and Family
Welfare who shall be the Vice-Chairperson, ex officio;
(c) Secretaries or Commissioners in charge of Departments of
Women and Child Development, Social Welfare, Law and Indian System of
Medicines and Homeopathy, ex officio, or their representatives;
(d) Director of Health and Family Welfare or Indian System of
Medicines and Homeopathy of the State Government, ex officio; Government, ex
officio;
(e) three women members of Legislative Assembly or Legislative
Council;
(f) ten members to be appointed by the State Government out of
which two each shall be from the following categories:-
(i) eminent social scientists and legal experts;
(ii) eminent women activists from nongovernmental organizations
or otherwise;
(iii) eminent gynaecologists and obstetricians or experts of
stri-roga or prasuti-tantra;
(iv) eminent pediatricians or medical geneticists;
(v) eminent radiologists or sonologists;
(g) an officer not below the rank of Joint Director in-charge
of Family Welfare, who shall be the Member Secretary, ex officio
(3) The State Board shall meet at least once in four
months.
(4) The term of office of a member, other than an ex
officio member, shall be three years.
(5) If a vacancy occurs in the office of any member other
than an ex officio member, it shall be filled by making fresh appointment.
(6) If a member of the Legislative Assembly or member of
the Legislative Council who is a member of the State Board, becomes Minister
or Speaker or Deputy Speaker of the Legislative Assembly or Chairperson or
Deputy Chairperson of the Legislative Council, she shall cease to be a member
of the State Board.
(7) One-third of the total number of members of the State
Board shall constitute the quorum.
(8) The State Board may co-opt a member as and when
required, provided that the number of co-opted members does not exceed one third
of the total strength of the State Board.
(9) The co-opted members shall have the same powers and functions
as other members, except the right to vote and shall abide by the rules and
regulations.
(10) In respect of matters not specified in this section,
the State Board shall follow procedures and conditions as are applicable to
the Board.”.
Amendment
of section 17.
15. In section 17 of the principal Act,- (i) in
sub-section (3), for clause (a), the following clause shall be substituted,
namely:-
“(a) when appointed for the whole of the State or the
Union territory, consisting of the following three members -
(i) an officer of or above the rank of the Joint Director
of Health and Family Welfare - Chairperson;
(ii) an eminent woman representing women’s organisation; and
(iii) an officer of Law Department of the State or the
Union territory concerned:
Provided that it shall be the duty of the State or the Union territory
concerned to constitute multi-member State or Union territory level
Appropriate Authority within three months of the coming into force of the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Amendment Act, 2002:
Provided further that any vacancy occurring therein shall be filled
within three months of the occurrence.”;
(ii) in sub-section (4), after clause (d),
the following clauses shall be inserted, namely:-
“(e) to take appropriate legal action against the use of any sex
selection technique by any person at any place, suo-motu or brought to its
notice and also to initiate independent investigations in such matter;
(f) to create public awareness against the practice of
sex selection or pre-natal determination of sex;
(g) to supervise the implementation of the provisions of the Act
and rules;
(h) to recommend to the Board and State Boards modifications
required in the rules in accordance with changes in technology or social
conditions;
(i) to take action on the recommendations of the Advisory
Committee made after investigation of complaint for suspension or cancellation
of registration.”;
(iii) for sub-section (7), the following
sub-section shall be substituted, namely:-
“(7) No person who has been associated with the use or promotion
of pre-natal diagnostic techniques for determination of sex or sex selection
shall be appointed as a member of the Advisory Committee.”.
Insertion
of new section 17A.
16. After section 17 of the principal Act, the following section
shall be inserted, namely :-
Powers
of Appropriate Authorities.
“17A. The Appropriate Authority shall have the powers in respect
of the following matters, namely :-
(a) summoning of any person who is in possession of any information
relating to violation of the provisions of this Act or the rules made
thereunder;
(b) production of any document or material object
relating to clause (a);
(c) issuing search warrant for any place suspected to be indulging
in sex selection techniques or pre-natal sex determination; and
(d) any other matter which may be prescribed.”.
Amendment
of section 18
17. In section 18 of the principal Act, for sub-section (1),
the following sub-section shall be substituted, namely :-
“(1) No person shall open any Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, including clinic, laboratory or centre
having ultrasound or imaging machine or scanner or any other technology
capable of undertaking determination of sex of foetus and sex selection, or
render services to any of them, after the commencement of the Pre-natal
Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Act,
2002 unless such centre, laboratory or clinic is duly registered under the
Act.”.
Substitution
of new section for section 22.
18. For section 22 of the principal Act, the following section
shall be
substituted, namely:-
Prohibition
of advertisement relating to preconception andpre-natal determination of sex
and punishment for contravention.
’22. (1) No person, organisation, Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic, including clinic, laboratory or
centre having ultrasound machine or imaging machine or scanner or centre
having ultrasound machine or imaging machine or scanner or any other
technology capable of undertaking determination of sex of the foetus or sex
selection shall issue, publish, distribute, communicate or cause to be
issued, published, distributed or communicated any advertisement, in any
form, including internet, regarding facilities of pre-natal determination of
sex or sex selection before conception available at such centre, laboratory,
clinic or at any other place.
(2) No person or organisation including Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic shall issue,
publish, distribute, communicate or cause to be issued, published,
distributed or communicated any advertisement in any manner regarding
pre-natal determination or pre-conception selection of sex by any means whatsoever,
scientific or otherwise.
(3) Any person who contravenes the provisions of
sub-section (1) or sub-section (2) shall be punishable with
imprisonment for a term which may extend to three years and with fine which
may extend to ten thousand rupees.
Explanation.- For the purposes of this section,
‘advertisement’ includes any notice, circular, label, wrapper or any other
document including advertisement through internet or any other media in electronic
or print form and also includes any visible representation made by means of
any hoarding, wall-painting, signal, light, sound, smoke or gas.”.
Amendment
of section 23.
19. In section 23 of the principal Act, for sub-sections (2)
and (3), the following sub-sections shall be substituted, namely:-
“(2) The name of the registered medical practitioner
shall be reported by the Appropriate Authority to the State Medical Council concerned
for taking necessary action including suspension of the registration if the
charges are framed by the court and till the case is disposed of and on
conviction for removal of his name from the register of the Council for a
period of five years for the first offence and permanently for the subsequent
offence.
(3) Any person who seeks the aid of any Genetic
Counselling Centre, Genetic Laboratory, Genetic Clinic or ultrasound clinic
or imaging clinic or of a medical geneticist, gynaecologist, sonologist or imaging
specialist or registered medical practitioner or any other person for sex
selection or for conducting pre-natal diagnostic techniques on any pregnant
women for the purposes other than those specified in sub-section (2) of
section 4, he shall, be punishable with imprisonment for a term which may
extend to three years and with fine which may extend to fifty thousand rupees
for the first offence and for any subsequent offence with imprisonment which
may extend to five years and with fine which may extend to one lakh rupees.
(4) For the removal of doubts, it is hereby provided,
that the provisions of sub-section (3) shall not apply to the woman who was compelled
to undergo such diagnostic techniques or such selection.”.
Substitution
of new section for section 24.
20. For section 24 of the principal Act, the following section shall
be
substituted, namely:-
Presumption
in the case of conduct of pre-natal diagnostic techniques.
“24 Notwithstanding anything contained in the Indian Evidence Act,
1872, the court shall presume unless the contrary is proved that the pregnant
woman was compelled by her husband or any other relative, as the case may be,
to undergo pre-natal diagnostic technique for the purposes other than those
specified in sub-section (2) of section 4 and such person shall be
liable for abetment of offence under sub-section (3) of section 23 and
shall be punishable for the offence specified under that section.”.
Amendment
of section 28.
21. In section 28 of the principal Act, in sub-section (1),
in clause (b), for the words “thirty days”, the words “fifteen days”
shall be substituted.
Amendment
of section 30.
22. In section 30 of the principal Act, for sub-section (1),
the following sub-section shall be substituted, namely:-
“(1) If the Appropriate Authority has reason to believe
that an offence under this Act has been or is being committed at any Genetic Counselling
Centre, Genetic Laboratory, Genetic Clinic or any other place, such Authority
or any officer authorised in this behalf may, subject to such rules as may be
prescribed, enter and search at all reasonable times with such assistance, if
any, as such Authority or officer considers necessary, such Genetic
Counselling Centre, Genetic Laboratory, Genetic Clinic or any other place and
examine any record, register, document, book, pamphlet, advertisement or any other
material object found therein and seize and seal the same if such Authority
or officer has reason to believe that it may furnish evidence of the
commission of an offence punishable under this Act.”.
Insertion
of new section 31 A.
23. After section 31 of the principal Act, the following section
shall be inserted, namely:-
Removal
of difficulties.
“31A. (1) If any difficulty arises in giving effect to
the provisions of the Pre-natal Diagnostic Techniques (Regulation and Prevention
of Misuse ) Amendment Act, 2002, the Central Government may, by order
published in the Official Gazette, make such provisions not inconsistent with
the provisions of the said Act as appear to it to be necessary or expedient
for removing the difficulty:
Provided that no order shall be made under this section after the
expiry of a period of three years from the date of commencement of the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Amendment Act, 2002.
(2) Every order made under this section shall be laid, as soon as
may be after it is made, before each House of Parliament.”.
Amendment
of section 32.
24. In section 32, in sub-section (2),- (i) for
clause (i), the following clauses shall be substituted, namely:-
“(i) the minimum qualifications for persons employed at a
registered Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic
under clause (2) of section 3;
(ia) the manner in which the person conducting ultrasonography
on a pregnant woman shall keep record thereof ultrasonography on a pregnant woman
shall keep record thereof in the Clinic under the proviso to sub-section (3)
of section 4;”;
(ii) after clause (iv), the following clauses
shall be inserted, namely:-
“(iva) code of conduct to be observed by persons working at
Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics to be
laid down by the Central Supervisory Board under clause (iv) of section 16;
(ivb) the manner in which reports shall be furnished by the
State and Union territory Supervisory Boards to the Board and the Central
Government in respect of various activities undertaken in the State under the
Act under clause (iv) of subsection (1) of section 16A;
(ivc) empowering the Appropriate Authority in any other matter
under clause (d) of section 17A;”.
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 prenatal 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
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.
REQUIREMENTS FOR REGISTRATION OF A
GENETIC COUNSELLING CENTRE
REQUIREMENTS FOR REGISTRATION OF A
GENETIC LABORATORY
REQUIREMENTS FOR REGISTRATION OF A
GENETIC CLINIC
FORM OF APPLICATION FOR REGISTRATION
OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING CENTRE/GENETIC
LABORATORY/GENETIC CLINIC
CERTIFICATE OF REGISTRATION
FORM C
REJECTION OF APPLICATION FOR
REGISTRATION OR RENEWAL OF REGISTRATION
(RECORD TO BE MAINTAINED BY THE GENETIC
COUNSELLING CENTRE)
(RECORD TO BE MAINTAINED BY THE GENETIC
LABORATORY)
(RECORD TO
BE MAINTAINED BY THE GENETIC CLINIC)
FORM OF CONSENT
PERMANENT RECORD OF APPLICATION FOR
REGISTRATION, GRANT OF REGISTRATION
REJECTION OF APPLICATION FOR
REGISTRATION AND RENEWALS OF REGISTRATION
THE PRE-NATAL
DIAGNOSTIC TECHNIQUES (REGULATION AND PREVENTION OF MISUSE) (ADVISORY
COMMITTEE) RULES, 1996
G.S.R. 540 (E), dated 26th November,
1996- In exercise of the powers conferred
by Sec.32 of thePre-natal Diagnostic Techniques (Regulation and Prevention of
Misuse) Act, 1994 (57 of 1994), the Central Government hereby makes the
following rules, namely:-
1.Short title and commencement.-
(1) These rules may be called the Pre-natal Diagnostic Techniques (Regulation
and Prevention of Misuse) (Advisory Committees) 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) “Advisory Committee” means an
Advisory Committee constituted under sub-section (5) of Section 17 of the
Act;
(c) “Chairman” means the Chairman of
the Advisory Committee appointed under sub-section (5) of Section 17;
(d) “Principle rules” means the
Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Rules, 1996;
(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 or in the
principal rules, as the case may be, shall have the meanings, respectively, assigned
to them in the Act or in the principle rules.
3.Terms and conditions of
appointment as a member of an Advisory Committee.- (1) No person shall
be appointed as a member of an Advisory Committee if he – (a) has been
convicted and sentenced to imprisonment for an offence which, in the opinion
of the Central Government or the State Government, as the case may be, involves
moral turpitude; or
(b) is an undischarged insolvent; or
(c) is of unsound mind and stands so
declared by a competent Court; or
(d) has been removed or dismissed
from the service of the Government or a Corporation owned or controlled by
the Government; or
(e) has, in the opinion of the
Central Government or the State Government, as the case may be, such
financial or other interest as is likely to affect prejudicially the discharge
by him of his functions as a member of the Advisory Committee; or
(f) has, in the opinion of the Central
Government or the State Government, as the case may be, been associated with
the sue or promotion of pre-natal diagnostic techniques for determination of
sex.
(2) Every member of an Advisory
Committee shall be a resident of the State or
(3)A member of an Advisory Committee
shall hold office during the pleasure of the Central Government or the State
Government, as the case may be.
(4)Subject to the provisions of
sub-rule (3), every such member shall hold office for a period not exceeding
three years:
Provided that any person holding
office as a member of an Advisory Committee immediately before the
commencement of these rules shall hold such office only for the term of three
years from the date of his appointment.
(5)A retiring member or a member
whose term of office has expired by efflux of time shall be eligible for
re-appointment.
(6)A casual vacancy in an Advisory
Committee caused by the resignation, death, transfer or removal of any member
or otherwise shall be filled by fresh appointment and the person so appointed
shall hold office for a period not exceeding the term of office of the member
in whose place he is appointed.
(7)The Central Government or the
State Government, as the case may be, may remove from office any member of an
Advisory Committee before the expiration of his term of office.
(8)Every member of an Advisory
Committee shall be entitled to draw traveling and daily allowances for journeys
performed by him for attending the meetings (including a meeting adjourned
for want of quorum), of the Advisory Committee or for the purpose of
discharging any other duties prescribed under the Act, or under the Principle
rules or under these rules, on the scale admissible to First Grade Officers
of the Government of the State or of the Union Territory, as the case may be.
4.Meetings of the Advisory
Committees.- The intervening period between any two meetings of an Advisory
Committee shall not exceed sixty days.
5.Notice of meetings.-
(1) At least seven clear days’ notice of all meetings of the Advisory Committee
shall be given to each member, but an urgent meeting may be called by the
Chairman at three clear days’ notice:
Provided that if the Chairman is not
available, and a meeting is required to be held within the time limit
prescribed in Rule 4, the Appropriate Authority may call a meeting with seven
clear days’ notice after consultation with not less than four of the members
of the Advisory Committee.
(2)The notice shall state the
business to be transacted at the meeting and no business other than that stated
shall be transacted at such meeting except with the consent of the Chairman
or on his motion.
6.Business ordinarily to be
transacted at meetings.- The business of the Advisory Committee shall
ordinarily be transacted at a meeting duly called in accordance with the
provisions of these rules:
Provided that the Chairman may, if he
thinks fit, circulate any urgent matter among the members of the Advisory
Committee for their opinion.
7.Quorum.- At every
meeting of the Advisory Committee, four members shall form a quorum.
8.Chairman of the meeting.-
Meetings of the Advisory Committee shall be presided over by the Chairman or
in his absence, or if no Chairman has been appointed, by a member elected by
the members present from among themselves.
9.Assistance to be rendered by
the Appropriate Authority to the Advisory Committee.- (1)
Every meeting of the Advisory
Committee shall be attended by the Appropriate Authority concerned.
(2)All secretarial and other
assistance to the Advisory Committee for the discharge of its functions shall
be provided by the Appropriate Authority.
(3)The Appropriate Authority shall
issue the notice of meeting, agenda, notes on agenda and the minutes of the
meeting, in consultation with the Chairman, subject to the provisions of
Rules 5,6, 7 and 12.
10.Decisions on questions
before the Advisory Committee.- (1) The advice tendered by the Advisory
Committee shall be adopted, and in the event of any difference of opinion
amongst the members, the matter shall be put to vote and decided by a simple
majority of the members present.
(2)The Appropriate Authority shall
not have a right to vote.
(3)In the event of tie in votes, the
Chairman or in his absence, the member presiding shall have a second or
casting vote.
(4)The fact of any question having
been decided by the process of voting instead of by adoption, shall be
recorded in the minutes of that meeting of the Advisory Committee.
11.Vacancies etc. not to
invalidate proceedings of the Advisory Committees.- No meeting or proceeding
of the Advisory Committee shall be invalid merely by reason of-
(a) any vacancy in, or any defect in
the constitution of the Advisory Committee; or
(b) any defect in the appointment of
a person to be a member of the Advisory Committee; or
(c) any irregularity in the procedure
adopted by the Advisory Committee not affecting the merits of the case.
12.Record of proceedings of the
Advisory Committee.- One set of the agenda, notes on agenda, supporting
documents and minutes of every meeting of the Advisory Committee shall be authenticated
by the signature of the Chairman or in his absence by the signature of the
member presiding, and preserved by the Appropriate Authority as permanent
records.
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 counseling 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 Radioimmunoassay 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.
(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/
Centreetc. 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
preconception 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 organization
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 anymanner;
(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 subdistrict 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 OF APPLICATION FOR REGISTRATION
OR RENEWAL OF REGISTRATION OF A GENETIC COUNSELLING CENTRE/GENETIC
LABORATORY/GENETIC CLINIC/ULTRASOUND CLINC/IMAGING CENTRE
CERTIFICATE OF REGISTRATION
FORM FOR REJECTION OF APPLICATION FOR
GRANT/RENEWAL OF REGISTRATION
FORM FOR MAINTENANCE OF RECORDS BY
THE GENETIC COUNSELLING CENTRE
FORM FOR MAINTENANCE OF RECORDS BY
GENETIC LABORATORY
FORM F
FORM FOR MAINTENANCE OF RECORD IN
RESPECT OF PREGNANT WOMAN BY GENETIC CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE
FORM OF CONSENT
(For invasive techniques)
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
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Sunday, 6 July 2014
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