The Preconception and Prenatal

Diagnostic Techniques Act

(PCPNDT)
J A N E T. S . B , A S S I S TA N T P R O F E S S O R , D E PA RT M E N T O F H O S P I TA L A D M I N I S T R AT I O N , S T.
J O H N ’ S M E D I C A L C O L L E G E H O S P I TA L
Introduction
 Prenatal Sex determination of the child, with the help of advanced
technology such as ultrasonography, amniocentesis etc. aimed at
aborting the child if it’s a female.
 This has become a serious crime that has been on increase during
the last 2-3 decades in many parts of the country.
 It has affected so much that the male: female ratio has become so
grossly distorted in some regions.
 In 1994, the GOI enacted a legislation called the Prenatal Diagnostic
Techniques Act, 1994.
Definition:
 An Act to provide for the prohibition of sex selection, before or after
conception, and for regulation of prenatal 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 feticide and for
matters connected therewith or incidental thereto.
Important provisions of the Act:
 Regulation of Genetic Counselling Centers/Laboratories/Clinics:
Prohibits-
• Conducting or involvement in any way in prenatal diagnostic
techniques by any Genetic Counselling Center /Laboratory/Clinic,
unless registered under this Act.
• Employment/ involvement in any pre-natal diagnostic technique of
any person not possessing the qualifications prescribed under this Act.
• Anyone conducting any activities related to pre-natal diagnostic
techniques at a place other than a place registered under this Act.
Important provisions of the Act:
 Prohibits any person from conducting sex selection on a woman or
a man or on both or any tissue, embryo, conceptus, fluid or gametes
derived from either or both.
 Prohibits the sale of any ultrasound machine/imaging
machine/scanner or any other equipment capable of detecting sex
of fetus to any genetic counseling center/laboratory/clinic or any
other person not registered under this Act.
Regulation of Prenatal Diagnostic
Techniques:
 No place including a registered Genetic Counselling Centre or Genetic
Laboratory, or Genetic clinic shall be used for conducting prenatal diagnostic
techniques except for the reasons and conditions specified below.
 No prenatal diagnostic techniques shall be conducted except for the
purposes of detection of any abnormalities such as chromosomal
abnormalities, genetic metabolic diseases, Hemoglobinopathies, sex-linked
genetic diseases, congenital anomalies, other abnormalities/diseases
specified by central supervisory board.
Regulation of Prenatal Diagnostic Techniques:
 Conditions laid down as mandatory (to be recorded in writing) for
conducting the prenatal diagnostic techniques:
 Age of the pregnant woman is above thirty-five years.
 History of two or more spontaneous abortions or fetal loss
 Exposure to potentially teratogenic agents such as, drugs, radiation,
infection or chemicals.
 Family history of mental retardation or physical deformities such as
spasticity or any genetic disease in the pregnant woman/her spouse.
 Any other condition as specified by the board.
Regulation of Prenatal Diagnostic
Techniques:
 Failure to maintain a complete record of ultrasonography (on a pregnant
woman) as prescribed to be viewed as contravention.
 Even encouraging conduct of any prenatal diagnostic techniques on a
pregnant woman, except for the reasons and the conditions specified.
 Essential Requirements:
 All known side and aftereffects of such procedures to be explained to the
pregnant woman concerned.
Regulation of Prenatal Diagnostic
Techniques:
Written consent of the pregnant woman (a copy to be given to her)
Prohibition on communicating the sex of the fetus to any one in any
manner.
 No person or place (Genetic Counseling Center or Genetic clinic) is allowed
to conduct any prenatal diagnostic technique including ultrasonography, for
the purpose of determining the sex of fetus.
Regulation of Prenatal Diagnostic Techniques:
 Administrative structure for implementation: Constitution of Central and
State Supervisory Boards, the appointment of officers/other employees,
their system of functioning and the functions. Appointment of appropriate
authorities for registration/ enforcement of standards at the genetic
clinics/centers/laboratories and the appointment of advisory committees to
advise the appropriate authorities.
 No person shall open any genetic counseling center/laboratory/clinic,
having any technology capable of determining sex of the fetus or render
services to any of them, unless such center is duly registered under the Act.
Regulation of Prenatal Diagnostic Techniques:
 Conditions of sale of Equipment: it is mandatory that the manufacturer/ the
supplier of USG/ imaging equipment provides ultrasound machines or any
other equipment capable of detecting sex of fetus only to those registered
under this Act, only after receiving an affidavit that the equipment will not be
used for detection of sex of the fetus or sex selection before or after
conception.
 Further, every manufacturer or supplier of such equipment will submit a
quarterly report to the appropriate authority and to the central government
containing a list of those to whom the equipment has been provided.
Regulation of Prenatal Diagnostic
Techniques:
 Procedure for Registration: the application for registration, and the fees
prescribed will also be accompanied by:
 An affidavit containing an undertaking that no test/procedure for sex
selection before/after the conception except for the diseases specified will
be carried out nor shall the sex of the fetus ne disclosed to anybody.
 They shall display prominently a notice that they do not carry out any
tests/procedures for detection of sex before or after conception.
Regulation of Prenatal Diagnostic
Techniques:
 Conditions for conduct/analysis of Prenatal Diagnostic Procedures:
 A written prior consent of the woman in Form G.
 Person Conducting the test 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 the fetus of pregnant woman to anybody.
 The pregnant woman shall, before undergoing ultrasonography/image
scanning will declare that she does not want to know the sex of her fetus.
 No Genetic laboratory shall accept for analysis or test any sample, unless
referred to it by a Genetic Clinic.
Regulation of Prenatal Diagnostic
Techniques:
 Periodic Inspections: The facilities are subject to periodic inspections and in
case of any suspicion of violation of rules, the premises/records/equipment
can be searched/seized by the authorities.
 Public information: Every genetic counseling center/laboratory/clinic shall
prominently display on its premises a notice in English and in the local
language for public information, that “disclosure of the sex of the fetus is
prohibited under law”
Importance for the
Hospitals/Clinics/Diagnostic Centers
 Every medical facility equipped to carry out such tests must ensure
absolute compliance with the regulations.
 This must involve full understanding, commitment and cooperation
of the medical/ paramedical staff and a discrete vigil by the
administrative authorities.
 Ensuring that only the staff possessing the prescribed qualifications
are employed at such centers
Importance for the
Hospitals/Clinics/Diagnostic Centers
 Prominent display of the mandatory notices in the department
informing public that Preconceptual/Prenatal sex determination is
prohibited under the PNDT Act, and no such tests are conducted in
this center.
 Full briefing to the pregnant ladies of the side effects/aftereffects of
the test procedure to be conducted
 written consent of the pregnant woman on whom the test is to be
carried out.
Importance for the
Hospitals/Clinics/Diagnostic Centers
 Timely submission of reports as per the prescribed proforma, filled
completely in respect of ultrasonography done on every woman.
 Maintenance of records of all such procedures carried out by the
hospital/center for the mandatory period of 2 years or more.
Offences and Penalties
 Advertisements: any advertisement relating to prenatal
determination of sex is prohibited and any contraventions are
punishable with imprisonment up to three years and fine up to ten
thousand rupees.
 On subsequent conviction, imprisonment up to five years and fine
up to fifty thousand rupees.
Offences and Penalties
 Suspension/removal of the name from the register of the council
for a period of five years for the first offence and permanently for the
subsequent offence.
Seeking the Aid of any person/Agency for sex selection purposes
other than those specified is also punishable with imprisonment for
up to three years and fine up to fifty thousand rupees for the first
offence and for any subsequent offence with imprisonment up to five
years and fine up to one lakh rupees.
Offences and Penalties
 Every offence under this Act shall be cognizable, non-bailable and
non compoundable.
All records, charts, forms, reports, consent letters and other
documents required to be maintained under this Act and the Rules,
shall be preserved for two years or for such period as may be
prescribed.
Thank You!!!