Overview of PNDT Act: Prohibition and Regulations

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This content provides detailed information on the Pre-Conception and Pre-Natal Diagnostic Techniques Act, including its history, definitions, provisions, and regulations. It covers the prohibition of sex selection, regulation of diagnostic techniques, registration requirements, and penalties for violations.

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PNDT ACT DR MEERA PATIL

PNDT ACT Act assented by President on 20th September 1994 Forced with effect from 1stJanuary 1996 Amended in 2002 and 2003 Act was called as Prenatal diagnostic techniques(Regulation and Prevention of Misuse) Act 1994 now known as PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES (PROHIBITION OF SEX SELECTION) ACT

DEFINITIONS PRE-NATAL and PRE-CONCEPTUAL DIAGNOSTIC TECHNIQUES include Ultrasonography Fetoscopy Amniocentesis, chorionic villus sampling, cordocentesis or testing any tissue/fluid of a man or a woman before or after conception

This bill provides for.. Prohibition of preconception and pre-natal diagnostic techniques(prohibition of sex selection) for determination of sex of fetus leading to female feticide. Prohibition of advertisement of PNDT techniques for detection or determination of sex. Permission and regulation of use of PNDT techniques for purpose of detection of specific genetic abnormalities or disorders. Permitting use of such techniques only under certain conditions by registered institutions

Contd Prohibition of sale of USG and other machines Punishment for violation of the provisions

GENETIC COUNSELLING CENTRE Any place which offers genetic counseling GENETIC CLINIC Any place which conducts pre-natal diagnostic procedures. (Includes USG Clinics, Imaging centres and portable machines) GENETIC LAB Any place which conducts analysis of the samples received from Genetic Clinics

REGISTRATION Registration is mandatory whether the body is government, private, voluntary, honorary. The organization has to be registered with the appropriate authority appointed by the State. For Mumbai city, the Municipal Corporation is the concerned authority. At the district level the Chief Medical Officer is the concerned authority.

Ultrasound machine, imaging machine, scanner, IVF centre, any machine capable of detecting the sex of the fetus are to be registered. Mobile vehicle in which such machine is used, is also to be registered.

REQUIREMENTS The Act requires that an ultrasound clinic should be manned by a sonologist, radiologist or a registered medical practitioner having six months training / one year experience in sonography. The center can be owned by any person. He need not have the requisite qualifications as long as he has employees who meet the qualifications required by the Act. If the center has more than one ultrasound machine, each does not require a separate registration.

REGULATION OF PRENATAL DIAGNOSTIC TECHNIQUES No place shall be used for conducting PNDT techniques except for purposes mentioned in the Act. TECHNIQUES FOR CERTAIN ABNORMALITIES Chromosomal abnormalities Genetic metabolic disorders Hemoglobinopathies Sex linked genetic disease

TECHNIQUES ARE TO BE CONDUCTED ONLY UNDER FOLLOWING CONDITIONS: Age > 35 yrs Undergone 2 or more abortions Exposed to teratogenic agents

REGISTRATION FORM A Prescribed application form which is to be filled in duplicate Affidavit assuring that the center will not indulge in sex determination Requisite registration fee

PROCESS OF CERTIFICATION The Committee holds an enquiry to verify that the applicant has complied with all the requirements under the Act and then grants the certificate. Two copies of the certificate are given, of which one is to be displayed at a conspicuous place in the clinic.

The certificate is non-transferable. In the event of change in ownership, the new owner has to register afresh. The registration certificate must mention the number of ultrasound machines in the center, including the portable machines.

RENEWAL OF REGISTRATION The certificate is valid for 5 years. Application for renewal has to be made 30 days before the date of expiry in the prescribed Form A

CANCELLATION OR SUSPENSION OF REGISTRATION On receipt of a complaint the authority can issue a show cause notice to the center. After giving the center an opportunity to defend itself, the authority can either suspend or cancel the registration depending on the gravity of offence

PROVISION FOR APPEAL The center can appeal against the suspension / cancellation within 30 days If the order was issued by the authority at sub-district level, then the appeal may be made to the Appropriate Authority at the district level If the order was issued by the authority at district level, then the appeal may be made to the Appropriate Authority at the state level and so on

PROHIBITIONS PROHIBITIONS ON CENTERS No center shall conduct prenatal tests unless it is registered employ persons not having requisite qualification conduct prenatal tests except for the purposes specified in the Act (viz ..) conduct prenatal tests for sex determination

PROHIBITIONS ON PERSONS No person shall open a center performing prenatal tests unless it is registered No qualified person shall perform prenatal tests at a place which is not registered. This has important implications for sonologists doing portable ultrasounds The sonologist should neither detect nor reveal the sex of the fetus nor communicate sex of the fetus by words,signs or by any manner. No person shall conduct procedures unless written consent is obtained.

PROHIBITION ON ADVERTISEMENTS It is illegal for any person or organization to advertise regarding facilities for prenatal sex determination BUT every centre shall display a notice of the copy of the Act and its rules in English and/or local language

Form A : Application for Registration / Renewal Form B : Certificate of Registration Form C : Rejection of Application Form D : Maintenance of records by Genetic Counseling Center Form E : by Genetic Laboratory Form F : by Genetic Clinic/USG Form G : Form of Consent Form H : Maintenance of permanent record of applications for registration

MAINTAINING PROPER DOCUMENTS Forms G & F are the prescribed formats in which Genetic and Ultrasound Clinics have to maintain records. Every center has to maintain a register of FormsF and G for every patient FORM G The pregnant lady gives an undertaking that she does not want to know the sex of the fetus. The sonologist also signs a declaration that he has neither detected nor disclosed the sex of the fetus to anybody.

FORM F Name, address and Reg. No. of the Clinic Patient s name Age Husband s name Address, Tel No Referring doctor weeks of pregnancy h/o genetic disease in family Indication for prenatal diagnostic test Procedure carried out on patient (invasive/noninvasive) Any complication of procedure Result of the test To whom the result was conveyed to Was MTP advised or conducted and when

A complete report of all pregnancy related procedures done by the center in each month has to be sent to the authorities by the 5th day of following month. Intimation of change in employees, places or equipments within 30 days. All records have to be preserved for a minimum period of 2 years or in the event of any legal proceeding, till the final disposal of the legal proceeding

SEARCH AND SEIZURE The authorities are empowered to enter and search at all reasonable times any Genetic Clinic, Lab or Ultrasound Clinic. They can inspect all the documents like registers, consent forms, referral slips, pamphlets, equipments and seize and seal if there is reason to believe that any offence is being committed

REGULATORY AND SUPERVISORY AUTHORITIES CONSTITUTION OF STATE SUPERVISORY BOARD HEALTH MINISTER-CHAIRMAN Assisted by officials and non-officials Functions of state supervisory board To create public awareness against the practice of preconception sex selection and prenatal determination of sex of fetus leading to female feticide. To review activities of appropriate authorities and recommend appropriate action To monitor the implementation of provisions of act To send consolidated reports to Central Government.

APPROPRIATE AUTHORITIES STATE APPROPRIATE AUTHORITY Consists of 3 members. Additional director of Health Services is the chairperson One officer from law department Other eminent woman activist are the two additional members.

DISTRICT/CORPORATION APPROPRIATE AUTHORITY Civil surgeons/health Officers of corporation are designed as appropriate authority for their respective areas TALUKA OR SUB-DISTRICT AUTHORITY Medical superintendents of rural hospitals are designated as appropriate authority for their respective areas.

POWERS OF APPROPRIATE AUTHORITIES REGISTRATION OF INSTITUTIONS SEAL AND SEIZE POWER TO SEARCH AND SEIZE RECORDS CANCELLATION OR SUSPENSION OF REGISTRATION

OFFENCES AND PENALTIES All offences under the Act are cognizable : Arrest can be made without warrant non-bailable : getting bail is not the right of the accused non-compoundable : no settlement between the parties is possible to drop the criminal charges

OFFENCES AND PENALTIES If a medical practitioner is found guilty of conducting pre- natal sex determination, he shall be punished with imprisonment up to 3 years, fine up to Rs. 50,000/- and removal of name from the State Medical Council Register for 5 years for the first offence

OFFENCES AND PENALTIES Any subsequent conviction entails imprisonment up to 5 years, fine up to Rs. 1 lakh and permanent removal of name from the Register

CONTRAVENTION OF PROVISION BY THE PRACTITIONERS OR OWNER Any person who owns a centre/clinic/laboratory or the medical practitioner who contravenes provisions shall be punishable with imprisonment upto 3 years and with fine upto Rs 10000/- On subsequent conviction with imprisonment upto 5 years and with fine upto Rs 50000/-

CONCLUSION There are serious social implications due to imbalance in sex ratio Implementation of this act is done by health department Violation of provision by professional colleagues Ignorance about law is not an excuse. There are heavy penalties for offenders including doctors patients and relatives Powers are given to appropriate authorities Monitoring is by district and state authorities Honorable supreme court and high court give directives and guidelines.