GOVERNMENT
OF INDIA
MINISTRY
OF HEALTH AND FAMILY WELFARE
DEPARTMENT
OF FAMILY WELFARE
Proposed Amendments in PNDT Act 1994
Existing
Title:
The
Pre-natal Diagnostic Techniques (Regulation and prevention of Misuse) Act, 1994.
Suggested Title:
“The Pre-Conception and Pre-Natal Sex
Selection/Determination (Prohibition and Regulation) Act, 2001”
2. LONG TITLE (PREAMBLE)
Existing Long Title :
An
Act to provide for regulation of the use of pre-natal diagnostic techniques for
the purpose of detecting genetic or metabolic disorders, chromosomal
abnormalities or certain congenital malformations or sex-linked disorders and
for the prevention of misuse of such techniques for the purpose of prenatal sex
determination leading female foeticide and for matters connected therewith or
incidental thereto.
Suggested Long Title:
An
Act to provide for prohibition of sex selection/determination, before or after
conception, and for regulation of prenatal diagnostic technique 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 and for
matters connected therewith or incidental thereto.
3. Add
the following explanation below sub-section (d) of Section 2:-
“Explanation
– Any place, including a mobile vehicle, where ultrasound machine (capable of
determining sex of foetus) or any other
equipment for selection of sex before conception is used shall fall within the above definition of Genetic
Clinic.”
4. Substitute
Sub Section (g) of Section 2 with the following: -
“medical
geneticist” includes a person who possesses a degree or diploma or
certificate in genetic science in the field of pre-conception
techniques/ pre-natal 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 recognized under the Indian Medical council Act, 1956; or
(ii) a
post graduate degree in biological sciences”;
6. Add the
following definition
(o)
“Sonologist/Imaging Specialist” means a person who possesses any one of the
medical qualifications recognised under the Indian Medical Council Act 1956,
and/or a post graduate qualification in ultrasonography/imaging
technique/radiology and who is certified for performing sonography;
7.
Add
the following definition
(p)
“pre-conception sex selection technique” includes all medical or other
scientific techniques such as sperm separation, which are used or claimed to be
used for selecting the sex of the offspring before conception;
REGULATION
OF GENETIC COUNSELING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS.
8.
Amendment of section 3:
Existing
sub-section (1)
(1)
no genetic counseling centre, genetic laboratory or genetic clinic unless
registered under the Act shall conduct or associate with, or help in,
conducting activities relating to diagnostic techniques.
Suggested
sub-section (1)
(1) no genetic counseling centre, genetic
laboratory or genetic clinic, including clinic or laboratory or centre
having ultrasound machine/ imaging machine, unless registered under the Act
shall conduct or associate with, or help in, conducting activities relating to
diagnostic techniques
Justification:
need to register ultra sound machines for use in prenatal diagnostic
techniques.
9. Existing sub-section (2)
(2) no
genetic counseling center, genetic laboratory or genetic clinic shall employ or
cause to be employed any person who does not possess the prescribed
qualifications
Suggested
sub-section (2)
(2) no genetic counseling center, 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 prescribed qualifications:
Justification:
unqualified person may not be employed by the centre/ clinic/ laboratory.
10. Add:
3(4) no person, including a specialist in the field of infertility shall
conduct or cause to be conducted or aid
in conducting by himself or any other person, a pre-conception sex selection technique on a woman or a man or on
both or on any tissue, conceptus, fluid
or gametes derived from either or both of them.
Justification:
Include prohibition of pre-conception
sex selection
Ref:
SC order, ref to emerging technologies.
11. Amendment
of Section 4:
Existing
Sub-Section (3)
(3) (3)
no prenatal 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 women is above 35 years,
(ii) (ii)
the pregnant women has undergone of two or more spontaneous
abortions or foetal loss;
(iii) (iii)
the pregnant woman had been exposed to potentially
teratogenic agents such as drugs, radiation, infection or che4micals;
(iv) (iv)
the pregnant woman has a family history of mental retardation
or physical deformities such as spasticity or any other genetic disease;
(v) (v)
any other condition as may be specified by the Central
Supervisory Board.
Suggested Sub-Section (3)
(3) (3)
no prenatal 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 women is above 35 years,
(ii) the
pregnant women has undergone of two or more spontaneous abortions or foetal loss;
(iii) (iii)
the pregnant woman had been exposed to potentially
teratogenic agents such as drugs,
radiation, infection or che4micals;
(iv) (iv)
the pregnant woman has a family history of mental
retardation or physical deformities such as spasticity or any other genetic
disease;
(v) (v)
any other condition as may be specified by the Central
Supervisory Board.
12. Existing Sub Section (4)
(4) no person being 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
purpose specified in the clause (2).
Suggested Sub Section (4)
(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 purpose specified in the
clause (2).
Justification:
to include people other than husband or relative
13. Add:
4(5) no person, including a relative or the husband of a woman shall
seek or encourage the conduct of any
pre-conception sex selection technique on her or him or both.
Justification:
Including pre-conception sex selection
14. Amendment of Section 5
Prohibition
of communicating the sex of foetus:
Existing
Sub Section (2)
(2) No person conducting prenatal 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.
Suggested Sub Section (2)
(2) No person including the person conducting
prenatal 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.
Justification:
Violation of law often takes place through the agent of gynecologist/
sonologist, rather than the specialist himself / herself.
15. Add Section
5(3):
“5(3) Any person conducting ultra-sound
scan/test/procedure on any pregnant woman shall keep complete record of such
scan/test/procedure indicating her complete name, address, husband’s name as
well as name and address of the referring medical practitioner/doctor, the reasons
requiring such scan/test/procedure, etc.”
Justification: Due
to non-maintenance of adequate records by the Clinics it is difficult to
identify the purpose for which an ultra-sound test has been conducted. The absence of such records affects enquiry.
16. Amendment of Section 6
Add
clause (c)
“(c) No
person shall, by whatever means, cause or allow to be caused selection of sex
before conception”
Justification:
To include pre-conception sex selection.
CHAPTER IV
CENTRAL
SUPERVISORY BOARD
DISQUALIFICATION
FOR APPOINTMENT AS MEMBERS:
17. Amendment
of Section 14 (f)
Existing clause (f)
(a) (a)
Has, in the opinion of the Central Government, been
associated with the use or promotion of pre-natal diagnostic technique for
determination of sex.
Suggested Clause (f)
(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 of
any pre-conception sex selection
technique.
Justification:
Inclusion of pre-conception sex selection technique.
18. Amendment of Section 16
Existing Clause
16(i)
To advise the government on policy matters relating to use of prenatal diagnostic techniques,
Suggested
Clause
16(i)
To advise the government on policy matters relating to use of prenatal diagnostic techniques, pre-conception sex
selection techniques and their misuse.
19.
Existing clause
16(ii) to review implementation of
the Act and rules made thereunder and
recommend changes in the said Act and rules to the Central Government.
Suggested
Clause
16(ii) to review and monitor implementation of the Act
and rules made thereunder and recommend changes in the said Act and rules to
the Central Government.
Justification:
To implement the direction of the Supreme Court
20.
Existing clause
16(iii) To create public awareness
against the practice of prenatal determination of sex and female foeticide.
Suggested
Clause
16(iii) To create public awareness against the practice
of pre-conception sex selection and prenatal determination
of sex leading to female foeticide.
Justification: Avoid antiabortion terminology
Add pre-conception sex selection
21.
Existing Clause
16(iv) to lay down code of conduct to be observed by persons
working at Genetic Counselling Centres, Genetic Laboratories and Genetic
Clinics
Suggested Clause
16(iv) to lay down code of conduct to be observed by persons
working at Genetic Counselling Centres, Genetic Laboratories, ultrasound/imaging
authorities and Genetic Clinics
22. Add
CHAPTER IV-A
“CHAPTER
IV-A”
Add Section 16A:
“16-A.
(1) Government of each State shall constitute a Board known as the State
Supervisory Board which will have the following functions in respect of the
areas falling under the State :
(i)
(i)
to create public awareness against the practice of
pre-conception sex selection and prenatal determination of sex of foetus leading to female foeticide in
the concerned State;
(ii)
(ii)
to review the activities of the Appropriate Authorities
functioning in the State and take appropriate action against the Appropriate
Authorities, as provided in their conduct rules, in case of dereliction of
duty;
(iii)
(iii)
to monitor and review implementation of the provision of the
Act and Rules in the State; and
(iv)
(iv)
to send consolidated reports as may be required under the
rules, in respect of the various activities
under this Act to the Central Supervisory Board and the Central
Government.
(v)
(v)
Any other functions as may be specified in the Act.
(2) (2)
The State Supervisory Board will consist of :-
(a)
(a)
The Minister incharge of Family Welfare in the State who
shall be the Chairman, ex-officio
(b)
(b)
Secretary Incharge of Department of Family Welfare who shall
be the Vice-Chairman, ex-officio
(c)
(c)
Representatives of Department’s of Women and Child Development
and Law
(d)
(d)
Director of Health and Family Welfare of the State
Government, ex-officio
(e)
(e)
Three women members of Legislative Assembly
(f)
(f)
Ten members to be appointed by the State Government two each
from amongst :-
(i ) eminent social scientists
(ii) eminent women activists
(iii) eminent gynaecologian & Obstetricians
(iv)
(iv)
eminent paediatrician
(v)
(v)
eminent radiologists
(h) An officer not below the rank of Joint Director incharge of Family Welfare will be Member
Secretary, ex-officio
Justification: A Supervisory Board is considered necessary
at the State level to review and monitor the activities of the Appropriate
Authorities and to ensure that quarterly reports/returns are filed to the
Central Supervisory Board correctly and timely.
(3) The Board shall meet at least once in six months.
CHAPTER V
APPROPRIATE
AUTHORITY AND ADVISORY COMMITTEE
23. Amendment
of Section 17
Existing Section 17(3)
17(3): The
officers appointed as appropriate authorities under sub-section (1) or sub
section (2) shall:
(a) when
appointed for the whole of the State or the Union Territory of or above the rank of Joint Director of Health
and Family Welfare, and
(b) when
appointed for any part of the state or Union Territory, of such other rank as the state government or the central
government, as the case may be, may deem fit.
Suggested
Section 17(3)
17(3): The
officers appointed as appropriate authorities under sub-section (1) or sub
section (2) shall :
(a) when
appointed for the whole of the State or the Union Territory consist 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 organization; and
(iii) An eminent legal expert
Justification: to make
it more efficient with the support of women member and a legal expert
24. Add the
following clauses to sub-section (4) of section 17:
(e) to take appropriate legal action against
the use of pre-conception sex selection techniques by any person at any
place, brought to its attention or suo moto and also to initiate independent investigations
in such matters.
(f) to
create public awareness against the practice of pre conception sex selection or pre-natal determination of sex
(g) to supervise the implementation of the provision of the
Act and Rules,
(h) to recommend to the Central Supervisory
Board modifications required in
the Act or Rules in accordance
with changes in technology or social condition.
Justification: I) Define functions clearly.
II)
Include pre-conception sex selection.
25. Add: Section
17A - Powers of Appropriate Authorities:
17-A. In processing a complaint
under this Act, the Appropriate Authority shall have the same powers as are
vested in a civil court under the Code of Civil Procedure, 1908 (5 of 1908),
while trying a suit in respect of the following matters, namely: -
(a) The summoning and enforcing attendance of any
person and examining him on oath or on solemn affirmation;
(b) The discovery and production of any document or
material object producible as evidence;
(c) The reception of evidence on affidavits;
(d)
(d)
Issuing of any commission for the examination of any
witness; and
(e)
(e)
Any other matter which may be prescribed.
Justification: without
these powers, appropriate authority will not be able to discharge its functions.
26. Add: Sub-Section
17(6B) - Functions of Advisory
Committee
17(6B) The Advisory Committee
shall have the following functions:
(a) (a)
to pay surprise visits or periodic visits to centres,
laboratories and clinics with a view to check compliance of the provision of
Act and Rules,
(b) (b)
to recommend to the appropriate authority cancellation or
otherwise of registration of or prosecution against a centre, laboratory or
clinic,
(c) (c)
to check and prevent contravention of provision of the Act
or Rules in the area of its purview,
(d) (d)
to advise appropriate authority about implementation of the
Act and creation of public awareness on the issue of the sex selection
(e) (e)
to seize machines as may be found appropriate
27. Existing
Section 17(7)
17(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 prenatal diagnostic techniques
for determination of sex shall be appointed as a member of the Advisory
Committee.
Suggested
Section 17(7)
17(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 prenatal diagnostic techniques
for determination of sex or pre-conception sex selection shall be
appointed as a member of the Advisory Committee.
Justification – include
pre-conception sex selection
CHAPTER VI
REGISTRATION
OF GENETIC COUNSELING CENTRES, GENETIC LABORATORIES AND GENETIC CLINICS
28. Amendment
of Section 18(1)
Existing
Section 18(1)
18(1) No person shall open any
Genetic Counselling Centre, Genetic Laboratory or genetic clinics after the
commencement of this Act unless such, Centre, Laboratory or Clinic is duly
registered separately or jointly under this Act.
Suggested
Section 18(1)
18(1) No person shall open any
Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, including clinic, laboratory or centre having
ultrasound /imaging machine/clinic
capable of undertaking determination of sex of feotus, after the
commencement of this Act unless such, Centre, Laboratory or Clinic is duly
registered separately or jointly under this Act.
Justification:
Registration of ultrasound machines which have the potential .of determining sex of the feotus.
CHAPTER
VII
OFFENCES
AND PENALTIES
29. Amendment
of Section 22
Existing Section 22(1)
22(1):No person, organisation,
genetic counseling 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.
Suggested
Section 22(1)
22(1):No person, organisation,
genetic counseling centre, genetic laboratory or genetic clinic, including clinic, laboratory or centre having
ultrasound machine capable of undertaking determination of sex of feotus
shall issue or cause to be issued any advertisement in any manner regarding
facilities of pre-natal determination of sex and pre-conception sex
selection available at such centre, laboratory, clinic or any other
place.
Justification:
To include ultrasound machines and pre-conception sex selection
30. Existing
Section 22(2)
22(2): No person or organisation
shall publish or distribute or cause to be
published or distribute any advertisement in any manner regarding
facilities of pre-natal determination
of sex available at any genetic counseling centre, genetic laboratory, genetic
clinic or any other place.
Suggested
Section 22(2)
22(2) : No person or organisation
shall publish or distribute or cause to be
published or distribute any advertisement in any manner regarding
facilities of pre-natal determination
of sex and pre-conecption sex selection available at any genetic
counseling centre, genetic laboratory, genetic clinic or any other place.
31. Add Section
22(4):
“22(4) Any
person who contravenes the provisions of sub-section (3) of section 5 shall be
punishable with fine which may extend to fifty thousand rupees and may also be
liable to cancellation of his registration as a medical practitioner by the
concerned Medical Council/ any other registering authority.”
32. Amendment
of Sub Section 23(2)
Existing Sub Section 23(2)
The name of the registered Medical
Practioner who has been convicted by the Court under Sub-Section (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.
Suggested Sub Section 23(2)
The name of the registered Medical
Practitioner who has been convicted by the Court under Sub-Section (1), shall
be reported by the Appropriate Authority to the respective State Medical
Council for taking necessary action including suspension of the registration
for two years if the charges are framed, 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.
33. Amendment
of Section 23(3)
Existing
Section 23(3)
23(3): Any person who seeks the
aid of a genetic counseling centre, genetic laboratory or genetic clinic or of
a medical geneticist, gynecologist or registered medical practitioner for
conducting prenatal diagnostics techniques on any pregnant women (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 an any subsequent conviction
with imprisonment which may extend to five years and with fine which may extend
to fifty thousand rupees.
Suggested
Section 23(3)
23(3) Any person who seeks the aid
of any genetic counseling centre, genetic laboratory, genetic clinic or
ultrasound/imaging clinic or of a medical geneticist, gynecologist, sonologist/
imaging specialist or registered medical practitioner for pre conception
sex selection or for conducting prenatal diagnostics techniques on any
pregnant women (excluding such woman) 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 fifty
thousand rupees and an any subsequent conviction with imprisonment which may
extend to five years an with fine which may extend to one lakh rupees.
34. Amendment
of Section 28(1)
Existing
Section 28(1)
Cognizance of offence: Sec
28 (1)
No court
shall take cognizance of an offence under this, except on a complaint made by-
(a) (a)
the appropriate authority concerned, or any office authorized in this
behalf by the central government or state government as the case may be, or the
appropriate authority or
(b) (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.
Suggested
Section 28(1)
Cognizance of offence: Section 28
(1)
No court
shall take cognizance of an offence under this, except on a complaint made by-
a. a.
the appropriate authority concerned, or any office authorized in this
behalf by the central government or state government as the case may be, or the
appropriate authority or
b. b.
a person who has given notice of not less than fifteen 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.
Justification: To
curtail delay on the part of Appropriate Authority to file a complaint in the court.
CHAPTER VIII
MISCELLANEOUS
35. Existing
Section 30(1)
Power to search, seize records
etc.
30(1) if the appropriate authority
has reason to believe that an offence under this Act has been or is being
committed at any genetic counseling centre, genetic laboratory or genetic
clinic, such authority or any officer authorized 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 counseling 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 offend punishable under this Act.
Suggested
Section 30(1)
Power to search, seize records
etc.
30(1) if the appropriate authority
has reason to believe that an offence under this Act has been or is being
committed at any genetic counseling centre, genetic laboratory, genetic clinic or
any other place such authority or any officer authorized 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 counseling 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 the same if such authority or officer has reason to
believe that it may furnish evidence of the commission of an offend punishable
under this Act.
Justification: offence
may be committed as places other than registered clinic / lab/ centre.
36. Amendment of Rule 4(1):
Existing
Rule 4(1) –
4(1)
An application for
registration shall be made to the Appropriate
Authority, in duplicate, in Form A.
Suggested Rule 4(1) –
4(1)
An application for
registration shall be made to the Appropriate Authority, in duplicate, in Form
A, duly accompanied by an Affidavit containing –
(i)
(i)
an undertaking to the effect that the
Centre/Laboratory/Clinic/ Combination thereof, as the case may be, shall not
conduct any test or procedure, by whatever name called, for detection of sex of
foetus nor shall the sex of foetus be
disclosed to any body;
(ii)
(ii)
an undertaking to the effect that the
Centre/Laboratory/Clinic/ Combination thereof, as the case may be, shall not
conduct any test or procedure, by whatever name called, for selection of sex
before conception;
(iii)
(iii)
an undertaking to the effect that the
Centre/Laboratory/Clinic/ Combination thereof, as the case may be, shall
display prominently a notice that they do not conduct any test or procedure, by
whatever name called, for detection of sex of foetus or for selection of sex
before conception;
37. Amendment to Rule 5:
Add
sub-rule (3) to rule 5:
“(3). The fees collected by the
Appropriate Authorities under these rules shall be utilized by them in
connection with the activities performed under the provisions of this Act and
these rules.”
38.
SCHEDULE III [See rule 3(1)]
regarding requirements for registration as a
genetic clinic capable of carrying out foetal ultra-sonography will be
amended as below:-
A.
A.
PLACE
Substitute the following in place of the existing
requirement: -
“Any place, including a mobile
vehicle, where any of the Pre-natal Diagnostic Tests/Techniques/Procedures or
pre-conception selection of sex can be performed.”
Add:
“(5) Ultrasonographic equipment and accessories capable of carrying
out foetal ultrasonography.
(6) Ultrasound
machine/Imaging machine capable of detecting sex of foetus.
(7) Equipment and accessories for carrying out separation of X and
Y cromosoms.”
C.
C.
EMPLOYEES
Add:
“(3) Sonologist/Imaging Specialist/Gynaecologist with training in
foetal ultrasonography (should have
performed atleast 20 procedures under supervision of a person experienced in
the procedure) or a Registered medical practitioner with training & experience
of atleast 100 procedures under expert in foetal ultrasonography}”
Statement of Objects and Reasons:
The
prenatal diagnostic techniques like amniocentesis and sonography are useful for
the detection of genetic or chromosomal disorders or congenital malformations
or sex linked disorders etc. However, they are being used on a large scale to
detect the sex of the foetus and to terminate the pregnancy of the unborn child
if found to be female. Techniques are
also being developed to pre-select the sex of child before conception. These practices are wholly discriminatory to
the female sex and affect the dignity and status of women. The proliferation of
these technologies may, in future, precipitate a catastrophe, in the form of
severe imbalance in male-female ratio. It is therefore necessary to enact and
implement in letter and spirit a legislation to ban the pre-conception sex
selection techniques and the misuse of pre-natal diagnostic techniques for
sex-selective abortions and to provide for the regulation of the later for the
appropriate scientific use for which they are intended.
Accordingly,
it is proposed to amend the Act with a view to include emerging technologies
such as pre-conception sex selection and ensuring effective implementation of
the Act at all levels.