PRE NATAL DIAGNOSTIC TECHNIQUES

( REGULATION AND PREVENTION

MISUSE) ACT 1994
 Pre- conception and Pre-natal
Diagnostic Techniques
(Prohibition of Sex Selection)
Act
Pre natal diagnostic technique act was enacted on
20th sep 1994
Came into force on 1st January 1996
Aim of the act is to check female feticide.
Act prohibits:
1) determination and disclosure of sex of
the fetus leading to female feticide.
2) any advertisement related to pre natal
determination of sex of fetus.
Act prescribes punishment for person who
contravenes the provision of the act.
Act regulates the use of pre natal technique
for detection of genetic / metabolic disorder
or chromosomal / sex linked abnormalities
or congenital malformation.
Act prevents misuse of above such
technique for sex determination of fetus
leading to female feticide.
The act is enforced in all part of India
except in the state of Jammu and Kashmir
“Genetic counselling centre” means a hospital,
institute, nursing home or any other place, what
ever name called by which conducts Genetic
counselling to patients
 “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.
Sex selection includes any procedure, technique,
test, any administration or prescription for
purpose of ensuring or increasing the probability
that the embryo is of particular sex.
 "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.
Includes place where USG / scanner or
imaging machine or other equipment or
portable equipment has capable of detecting
sex of fetus or sex selection before
conception.
Pre-natal diagnostic procedures" means all
gynaecological or obstetrical or medical
procedures such as ultrasonography,
fetoscopy, taking or removing samples of
amniotic fluid, cordocentesis, chorionic villi,
blood or any tissue of a pregnant woman to
a Genetic Laboratory or Genetic Clinic for
conducting pre-natal diagnostic test.
“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 hemoglobinopathies or sex-
linked diseases.
“Pre-natal diagnostic techniques" includes
all pre-natal diagnostic procedures and pre-
natal diagnostic tests.
Following person shall be qualified to conduct
Pre-natal diagnostic procedure under this act
Gynaecologist, Paediatrician
"Medical geneticist" means a person who
possesses a degree or diploma in genetics science
in the fields of pre-natal diagnostic techniques and
sex selection or has experience of not less than two
years in such field after obtaining--
(1)any one of the medical qualifications
recognised under the Indian Medical Council Act,
1956
(2) a post-graduate degree in biological
sciences.
Regulations of Genetic centers
Genetic counselling centers, Genetic clinic
and Genetic laboratories unless registered
shall not conduct / help in / aiding or
associated with activities related to pre natal
diagnostic techniques.
 Genetic counselling centers, Genetic clinic
and Genetic laboratories shall not employ
any person or take service of any person who
does not possess prescribed qualification.
Medical geneticist, OG cian, pediatrician
RMP or any other person shall not conduct
or aid in conducting by himself or through
any person, any pre natal diagnostic test at a
place other than a place registered under the
act.
 Regulation of PNDT
No registered Genetic clinic /laboratory /
counselling shall conduct Pre-natal diagnostic test
except for purpose of detection of any of the
following abnormalities.
1) chromosomal abnormalities,
2) genetic metabolic disorder,
3) hemoglobinopathies,
4) sex linked genetic disease,
5) congenital abnormalities,
6) any other abnormalities or disease
specified by central supervisory board.
Qualified person prescribed under the act shall
conduct Pre natal diagnostic procedure, if any one of
the following condition are fulfilled
1) age of the pregnant women is above 35 yrs of age,
2) pregnant women had 2 or 3 spontaneous
abortion or fetal loss.
3) pregnant women had been exposed to
teratogenic agents( drugs, chemicals, radiation
and infection )
4) pregnant women or her husband with family
history of mental retardation or spastic deformity
or other genetic disease.
5) any other condition specified by central
supervisory board.
No one either husband of the pregnant
women or relative shall seek or encourage to
conduct Pre natal diagnostic test on her
except for the conditions said above.
No one including a relative or husband of the
pregnant women or relative shall seek or
encourage to conduct any sex selection
technique on her or him or both.
No Qualified person under the act shall
conduct Pre-natal diagnostic procedure,
unless
1) he has explained all known side and after
effects of such procedures to the pregnant
woman concerned,
2) he has obtained in the prescribed form
her written consent (form G) to undergo
such procedures in the language which she
understands.
A copy of her written consent obtained is
given to the pregnant woman
No 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
No person conduct pre-natal diagnostic
technique including USG for purpose of sex
determination
Central Supervisory Board
The Central Supervisory Board shall exercise the
powers and perform the functions under this Act.
 The Board shall consist of—
a) the Minister in charge of the Ministry of
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) three 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,
Indian system of medicine and homeopathy
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,
(v) representatives of women welfare
organisations--- 3 years
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--- 3 years
(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 ( 1 year)
(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.
The board shall meet at least once in six months
Functions:
1) advice Central Govt on policy matter related to
sex selection and pre-natal diagnostic techniques
2) to review and monitor implementation of act
3) to create public awareness against procedures
and test and its misuse
4) to lay down conduct code for person employed
in genetic centers
5) to oversee the performance of various bodies
State / UT Supervisory Board
Board Members are
1) Minister in charge of Health and Family
Welfare of the state / UT – Chairperson
2) Secretary in charge of Dept of Health and
Family Welfare- Vice Chairperson
3) Secretaries or commissioners in charge of Dept
of Women and Child Development, Social
Welfare, Law and Indian System of Medicine and
Homeopathy
4) Directors of Health and Family Welfare and
Indian System of Medicine and Homeopathy of
the state
5) three MLA
6) ten Members, two from each categories
a) eminent social scientists and legal experts
b) eminent Women activists from NGO
c) eminent OGcians
d) eminent pediatricians and medical
geneticists
f) eminent radiologists and sonologists
7) an officer not below the rank of Joint Director
of Family Welfare- Member secretary.
Functions
1) to create public awareness
2) to review the activities of Appropriate
Authority
3) to monitor the implementation of
provision the Act
4) to send consolidated report of respect
various activities undertaken in the state.
5) any other activities prescribed in the act
Appropriate authority and Advisory
committee
Central govt shall appoint one or more
appropriate authority to each union
territory for the purposes of the act.
State govt shall appoint one or more
appropriate authority for whole or part of
the state for the purposes of the act,
depending upon intensity of problem of pre
natal diagnostic test leading to female
feticide.
Appropriate authority appointed for the whole
state or union territory shall consists of 3 members
1) An officer of or above the rank of Joint
Director of Health and Family Welfare.
2) an eminent women representing women’s
organisation.
3) an officer of law department of state / UT
Appropriate authority appointed for the part of
state or union territory shall be of such other rank
may deemed fit.
Function of Appropriate Authority
to grant, suspend or cancel registration of a Genetic
Counselling Centre, Genetic Laboratory or Genetic
Clinic.
 to enforce standards prescribed for the Genetic
Counselling Centre, Genetic Laboratory and Genetic
Clinic.
to investigate complaints of breach of the provisions
of this Act or the rules and take immediate action.
to seek and follow the advice of the Advisory
Committee, on application for registration and on
complaints for suspension or cancellation of
registration
Takes legal action against the use of sex
selection technique
 Creates public awareness against sex
selection / sex determination.
Recommends central/ state board
regarding modification of rules according to
social condition and change in technology
Supervise implementation of the provision
of the act
Powers of Appropriate Authorities
1) summons any person who has
information related to violation of
provisions of the Act
2) production of any document or material
related above clause
3) issues search warrant for any place
suspected to be involved in sex selection
technique or PNDT
 Advisory Committee
The Central Government or the State
Government, shall constitute an Advisory
Committee for each Appropriate Authority
to aid and advise the Appropriate Authority
in the discharge of its functions,
 shall appoint one of the members of the
Advisory Committee to be its Chairman
The Advisory Committee shall consist of—
a) three medical experts from amongst
gynaecologists obstetricians, 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,
d) three eminent social workers of whom,
minimum one shall be from amongst
representatives of women organisations.
 Person associated with the use or
promotion of pre-natal diagnostic technique
for determination of sex shall not be
appointed as a member of the Advisory
Committee
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. ( 2 months)
 No person, organisation, Genetic
Counselling Centre, Genetic Laboratory or
Genetic Clinic shall issue any advertisement
in any manner regarding facilities of pre-
natal determination of sex available at such
Centre, Laboratory, Clinic or any other
place.
 "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
Any person who contravenes the above
provisions shall be punishable with
imprisonment for a term which may extend
to three years and with fine which may
extend to ten thousand rupees.
 Registration of Genetic Centers / USG / imaging
. Centers( form A)
Application for registration is made to AA in duplicate
with affidavit containing
an undertaking that no sex selection pre or
after conception, sex determination or disclosure of
sex.
an undertaking that a notice will be displayed
prominently stating that no technique, test or
procedure for detection of sex of fetus or pre
conception sex selection
Application fee; Rs 3000 for GCC,GC, GL USG clinic
and Imaging clinic.
Rs 4000 for institute, hospital nursing
home jointly providing the service of GCC,GC, GL
USG clinic and Imaging clinic.
 Registration or cancellation of application shall be
communicated to the applicant within 90 days
 certificate of registration will be valid for 6months.
Every change of employee, place, address and
equipment installed should be intimated to the AA
within 30 days of the change.
Lab shall not accept samples from clinic other than
registered clinic under the act.
 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 contravening
any of the provisions of this Act or rules shall be
punishable with imprisonment for a term which may
extend to three years and with fine which may extend
to ten thousand rupees
on any subsequent conviction, with imprisonment
which may extend to five years and with fine which
may extend to fifty thousand rupees.
Appropriate Authority should report the
name of the convicted Medical Practioner 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
Any person who seeks the aid of genetic
clinic, lab, counselling centre, USG clinic,
imaging clinic, medical geneticist, OGcian
and sonologist for sex selection or
conducting PNDT for sex determination on
any pregnant women will be punished with
imprisonment for term of 3yrs and fine 1000
rupees
On subsequent offence term may extent to
5yrs and fine up to 1 lac
Every offence conducted under the act is
cognizable, non bailable and non compoundable
Metropolitan Magistrate or a Judicial Magistrate
of 1st class shall try any offence punishable under
this act.
Court shall take cognizance of offence on
complaint made by 1) AA, 2) person who has
given notice to AA within 15 days of alleged
offence and of his intention to make complaint
to the court.
Maintenance of records
All records, forms, charts, reports, consent
letters and other documents shall be
maintained for period of 2years (form D for
GCC, form E for GL, form F for GC/ USG/IC)
If any criminal or other proceeding against the
centers, the records should be preserved till the
disposal of such proceedings.
Any records shall be made available for
inspection by Appropriate Authority or to any
person authorised by the AA
Power to search and seize records
Declaration of pregnant women.
I---------------------------( name of pregnant women)
declare that by undergoing USG / imaging scanning ,
I do not want to know the sex of my fetus.

signature/ thumb impression of

pregnant women
Declaration of Doctor/ person conducting USG /
image scanning.
I ---------------------------------(name) declare that
while conducting USG / image scanning on Ms------
( pregnant women), I have neither detected nor
disclosed the sex of the fetus to any person in any
manner.

Name and signature of person conducting

USG/ image scanning/ Director or owner of
genetic clinic/USG clinic/ imaging centre.