PCPNDT ACT

HISTORY

Act passed in 1994 Came into force with effect from 1st January 1996 in order to

check female foeticide Act amended in 2003. Act was called as “Prenatal diagnostic techniques

(Regulation and Prevention of Misuse) act 1994”. Now “Pre-conception and Pre-natal diagnostic techniques

(Prohibition of sex selection) Act, 2003

• Prohibits determination and disclosure of the sex of foetus• Any advertisements relating to pre-natal determination of sex• Prescribes punishment for its contravention

• The use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities

• For the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female foeticide

• For matters connected there with or incidental thereto.

PNDT ACT 1994

• Extend to the whole of India except the State of Jammu and Kashmir.

Has been divided into 8 chapters• Preliminary • Regulation of Genetic counseling centers, Genetic Labs & Genetic

Clinics • Regulation of PNDT Techniques • Constitution of Supervisory Board • Appointment of Appropriate authority & Advisory Committee.• Registration of GCC,GL, & GC • Offences & Penalties • Miscellaneous Matters

Pre-natal diagnostic techniques • (A) Pre-natal diagnostic procedures • Ultrasonography;• Foetoscopy;• Taking or removing samples of:

- amniotic fluid

- chorionic villi

- blood

- any tissue

- fluid• of a man or a woman before or after conception

(B) Pre-natal diagnostic test means:• Ultrasonography• Test or analysis of - amniotic fluid, chorionic villi, blood, any tissue, fluid of any

pregnant woman or conceptus

• “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.

Regulation of GCC,GL & GC

• No GCC,GL,GC shall conduct or associate with, or help in, conducting activities relating to pre-natal diagnostic techniques;

• Shall employ or cause to be employed or take services of any person, who does not possess qualifications as may be prescribed

• No gynecologist, paediatrician, registered MP or any other person shall conduct 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.

• Ultrasound sonography machine, Imaging Machine, Scanner, IVF center, any machine capable of detecting sex of the foetus are to be registered.

Mobile Vehicle, in which such machine is used, is also to be registered. (Section3)

• SEC 3 A of the act prohibits sex selection on a woman or a man or on both or on any tissue, embryo, conceptus, fluid and

• SEC 3 B prohibits sale of ultrasound machines, etc., to persons, laboratories, clinics, etc. not registered under the Act

REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES

• No place shall be used for Conducting PNDT Techniques, except for purposes mentioned in the act.

• Techniques only for certain abnormalities

Chromosomal abnormalities, Genetic metabolic disorders, Haemoglobinopathies, Sex linked genetic diseases, Congenital anomalies.

3. Techniques are to be conducted only in following conditions• Age > 35 Years, Undergone 2 or more abortions• Exposed to teratogenic agents

(drugs,radiation,infection/chemicals)H/O Mental Retardation/physical abnormalities

• Written consent of pregnant woman and prohibition of communicating the sex of foetus.

CENTRAL SUPERVISORY BOARD 

(a)the Minister in charge of the Ministry or Department of Family Welfare, who shall be the Chairman,

(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 

(f)    three women Members of Parliament

(g)    four members to be appointed by the Central Government by rotation to represent the States and the Union territories,

(h)  an officer, in charge of Family Welfare, who shall be the Member-Secretary, ex officio.

Appropriate Authorities

A)State Appropriate Authority- It Consists of 3 members. Additional Director of Health Services F.W. Pune is the Chairperson.

B) District/Corporation Appropriate Authority- Civil Surgeons/Health Officers of Corporation are designated as Appropriate Authority for their respective areas.

Now District Collector is also designated as AA

C) Sub-District Appropriate Authority

Medical Superintendents of Rural Hospitals are designated as Appropriate Authority for their respective area.

Now Sub-Divisional Magistrate, Chief Officer Municipal Council, Tahasildar/Naib Tahasildar are also designated as AA.

Functions of Appropriate authority (Section17A)

• To grant, suspend or cancel Registration• To enforce standards prescribed & to supervise• To investigate complaints & take action• To seek & consider advice of advisory Committee• To take appropriate legal action & To initiate

independent Investigations • To create Public Awareness• To take action on recommendations of Advisory

Committee.

Powers of Appropriate Authorities

• Registration of institutions.(Section19)• Registration certificate in duplicate is granted after enquiry

and as per advice of Advisory Committee• Seal and seize-If center is unregistered( Rule11(2)• Power to search and seize records –If offence is being

committed. Enter and search examine any records, Seize and seal -(Section 30)

• Cancellation or Suspension of Registration(Section20)1,2,3)

Appropriate Authority may suo motto or on complaint, issue a show cause notice “Why registration should not be suspended/Cancelled” If satisfied regarding breach of provisions –suspend or cancel Registration. If necessary in Public Interest –Suspend Registration without issuing Notice.

• There is a ban on opening any center unless registered.• Application made to Appropriate Authority in prescribed form

& fees, accompanied by an affidavit and an undertaking

FEE STRUCTURE- (PNDT act ,96)• Rs.2000 for Genetic Counselling Centre• Rs.3000 for Genetic Laboratory• Rs.3000for Genetic Clinic and• Rs.4000 for an institute, hospital, nursing home, or any place

providing jointly the services of a GCC, GL, GC or any combination of such Centre, Laboratory or Clinic.

 REGISTRATION OF GCC,GL AND GC

• Certificate of registration in duplicate issued by the appropriate authority after enquiry & advice of advisory committee.

• it should be displayed by the genetic lab, gcc, or genetic clinic in a conspicuous place

• Non transferable• valid for a period of five years

Renewal of registration• Application for renewal in duplicate (form A) should be

submitted to AA 30 days before the date of expiry.

Maintenance of records (Section29)• Person conducting USG on Pregnant woman to keep complete

record (F-form)-Rule-10-1A• Declaration by doctor on each report that he has neither

detected nor disclosed the sex. (Rule-10-1A)• Declaration by pregnant women that she does not want to

know the sex of fetus. ( Rule10-A)• Inspection by appropriate Authority-(Rule11)

All records shall be made available for inspection• Preservation of records for two years-(Section29)

Case related record consent forms, lab results, microscopic pictures, Sonography plates or slides, recommendations and letters

• A complete report in respect of all preconception or pregnancy related procedures conducted in respect of each month by 5th day of the following month to the AA

• Intimation of changes in employees, place or equipments installed within 30 days.

• Public information

display on its premises a notice in English and in the local language, to effect that disclosure of the sex of the foetus is prohibited under law

• one copy each of the Act and these rules be available on the premises.

• In brief under this act there are 8 forms…• Form A-Form of application for registration/renewal • Form B-Certificate of registration • Form C-Form for rejection of application for grant/renewal• Form D-Form for maintenance of records by GCC• Form E-Form for maintenance of records by GL• Form F-Form for maintenance of records in respect of • pregnant women by GC/USG clinic/imaging center• Form G-Form of consent for invasive techniques • Form H-Form of maintenance of permanent record of application for

grant/rejection of registration

OFFENCES AND PENALTIES

• Prohibition of advertisement relating to pre-natal determination of sex and punishment for contravention

• Advertisement includes Any notice, circular, label wrapper or other document Through internet or in Electronic or Print form , any visible

representation made by means of any hoarding, Wall Painting, light, sound, smoke or gas.

• Imprisonment for a term -may extend to three years and with fine up to ten thousand rupees

• Subsequent conviction, with imprisonment up to five years and with fine up to fifty thousand rupees.

• Reporting the name to State Medical Council If Charge Framed by Court.-Section23(2) . Action to be Proposed. Suspension till the case is disposed off. Removal of name on conviction.

• Punishment for Persons seeking aid-Section23(3)

for sex selection or for sex determination on any pregnant woman - punishable with imprisonment up to 3 years and fine up to Rs.50000/-

On subsequent offence -imprisonment up to 5 years and fine up to Rs. 1 Lakh.

• Women compelled to under go such techniques –Exempted

• Penalty for contravention for which no specific punishment is provided-( Section25)

Imprisonment for a term -may extend to three months or with

fine-may extend to one thousand rupees or with both Continuing contravention- additional fine -may extend to five

hundred rupees for every day during which such contravention continues.

• Every offence under this Act shall be cognizable, non-bailable and non-compoundable.

• Power to search and seize records, etc.• Power to make rules – the minimum qualifications for persons employed the manner in which the person conducting ultrasonography

on a pregnant woman shall keep record code of conduct to be observed by persons working at Genetic

Counselling Centres

Amendments PNDT,2003

• The qualifications of the employees, the requirement of equipment etc. for a GCC,GL, GC -gynaecologist or a paediatrician -six months experience or four weeks training in genetic counseling

• Maintain a register -the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the date on which they first reported for such counselling, procedure or test.

• A written consent, as specified in Form G, in a language the person understands

• Anybody aggrieved by the decision of the AA at sub-district level may appeal to the AA at district level within 30 days of the order of the sub-district level AA

•  Appeal to the AA at State/UT level within 30 days of the order of the District level AA

•  Appeal shall be disposed of by the District or by the State/Union Territory AA , within 60 days of its receipt.

APPEALS

THA

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