PCPNDT ACT

1. PCPNDT ACT PRESENTOR-DR RITUPARNA DAS JR-2 MODERATOR-DR ISHAN KUMAR

2. Child Sex Ratio and Development-The linkages • Child Sex Ratio is an important indicator to measure the extent of prevailing equity between men and women • Changes reflect underlying socioeconomic & cultural patterns

3. Legal Initiative • 1978: government issued a directive banning the misuse of amniocentesis in Government Hospitals and Laboratories • 1988: Law to prevent sex determination tests was passed in Maharashtra “Maharashtra Regulation of Prenatal Diagnostic Technique Act 1988” 1st state to do so. • 20th September1994: PNDT Act : This act came into force in 1996

4. THE[PRE-CONCEPTION and] PRE-NATAL By Act 14 of 2003 DIAGNOSTIC TECHNIQUES[(PROHIBITION OF For Regulation and Prevention of misuse(2003) SEX SELECTION)] ACT,1994 Received the assent of the President on May 18,2003 THE ACT SHALL EXTEND TO WHOLE INDIA EXCEPT JAMMU &KASHMIR

5. DEFINITION • “ An act to provide for the prohibition of sex selection, before or after conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting 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”.

6. What was the need for such an Act • The PNDTAct 1994 and its subsequent amendment in 2003 as the PC&PNDTAct (Prohibition of Sex Selection) Act were not brought into force because common people were resorting to sex selection,butbecause the medical fraternity made it possible and easy for them to do so. • It came following a public interest petition filed by centre for the enquiry of health and allied themes (CEHAT) and Dr Sabu George

7. OBJECTIVE • prohibit sex selection (before or after conception) • regulate pre-natal diagnostic techniques for detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital mal-formations or sex linked disorders • prevent misuse of such techniques for the purpose of sex determination

8. PROVISIONS OF THE ACT • Prohibition of misuse of PNDT for sex determination • Prohibition of advertisement of PNDT for sex determination • Permission and regulation of PNDT for specific purposes only by registered institutions • Punishments for violation

9. DEFINITIONS • APPROPRIATE AUTHORITY • Appointed by CENTRAL government for UT and STATE governments for whole or part of a state • MEMBERS a)An officer on or above the rank of Joint Director of Health and Family Welfare b)An eminent woman representing women’s organisation c)An officer of Law Department

10. FUNCTIONS OF APPROPRIATE AUTHORITY a)To grant,suspend,cancel registration of GCC b)To investigate complaints C)To create public awareness d)To take action on recommmendations of ADVISORY COMMITTEE e)Summoning of any person in possession af any information regarding violation of Act f) Issuing search warrant for any suspected place

11. ADVISORY COMMITTEE • 3 medical experts from amongst obstetricians,pediatricians and medical geneticists • 1 legal expert • 1 officer to represent department dealing with information and publicity • 3 eminent social workers

12. BOARD(CENTRAL SUPERVISORY BOARD) Ex officio Members • CHAIRMAN-Minister of Health and Family Welfare • Vice-Chairman-Secretary to GOI in charge of Department of Health and Family Welfare • MEMBER SECRETARY-An officer,not below rank of Joint Secretary in charge of Family Welfare • 3members to represent Ministry of Woman and Child Development, Ministry of Law and Justice and Indian System of Medicine and homoeopathy • The Director General of Health Servicees of the Central Government • 10 members appointed by the Center, 2 each from a)Eminent obstetricians b) Eminent medical geneticists c)Eminent pediatricians d)Eminent social scientists e)Representatives of women welfare organisations • 3 women MP • 4 members appointed by the Center to represent the states and UT by rotation TERM 3 YEARS

13. BOARD shall meet at least once in 6 months • FUNCTIONS • To advise the Center on policy matters • To monitor implementation of the Act • To lay down code of conduct for GCC • To create public awareness

14. STATE SUPERVISORY BOARD • Reviews activities of Appropriate Authorities • Shall meet at least once in 4 months • MEMBERS • Chairperson-State minister of Health and Family Welfare • Vice Chairperson-Secretary in charge of Health and Family Welfare • MEMBER SECRETARY-An officer,not below rank of Joint Director in charge of Family Welfare • Secretaries or Commissioners in charge of departments of Women and Child development,law and Indian system of medicine • 3 women MLA • 10 members appointed by the State, 2 each from a)Eminent obstetricians b) Eminent radiologists or sonologists c)Eminent pediatricians or medical geneticists d)Eminent social scientists e)Representatives of women welfare organisations TERM 3 YEARS

15. CONCEPTUS-any product of conception from fertilisation until birth. Includes extra embryonic membranes as well as embryo or fetus. • EMBRYO-Fertilisation till 8 weeks (56 days) • FOETUS-From 57 th day of fertilisation or creation till birth

16. Genetic CounsellingCentre:it means: Institute,Hospital,Nursing home or Any place which provides genetic counseling to patients • Genetic Clinic:Clinic,Institute,Hospital,Nursing home or Any place which is used for conducting pre-natal diagnostic Procedures.Genetic Clinic includes a vehicle where ultrasound machine or other equipment is used for detection of sex during pregnancy or selection of sex before conception

17. Genetic Laboratory: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. It includes a place where: ultrasound machine, Imaging machine or other equipment is used for detection of sex during pregnancy or selection of sex before conception

18. Pre-natal diagnostic procedure :all gynaecological or obstetrical or medical procedures such as Ultrasonography,Foetoscopy, Taking or removing samples of:- amniotic fluid,chorionicvilli- blood-,any tissue-fluid of a man or a woman before or after conception which is sent to a Genetic Laboratory or Clinic for conducting any type of analysis or pre-natal diagnostic tests for selection of sex before or after conception.

19. Pre-natal diagnostic test: • Ultrasonography • Test or analysis of:- amniotic fluid, chorionic villi,blood or any tissue or fluid of any pregnant woman or conceptus conducted to detect: genetic disorders,metabolicdisorders,chromosomal abnormalities, congenital anomalies,haemoglobinopathies,sex-linked diseases

20. SONOLOGIST or IMAGING SPECIALIST-A person who possesses any 1 of the recognized medical qualifications registered under Indian Medical Council or who has postgraduate qualification in ultrasonography or imaging techniques or radiology

21. Sex selection: 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

22. REGULATION OF GCC, LABORATORIES & CLINICS • no Genetic Counselling Centre,Laboratory or Clinic • unless registered can conduct, associate or help in conducting activities relating to pre-natal diagnostic techniques • can employ or take services of any person (honorary or payment) who does not possess qualifications •  no medical geneticist, gynaecologist, paediatrician, doctor or any other person can conduct any pre-natal diagnostic techniques at place that is not registered • Prohibition on sale of US machine to persons,clinics or labs not registered under the Act

23. Indications of Prenatal Diagnostic Technique • Chromosomal abnormalities • Genetic Metabolic Diseases • Hemoglobinopathies • Sex linked genetic disease • Congenital anomalies • Any other abnormalities / or disease as may be specified by the Central Supervisory Board

24. When can PNDT be conducted • only when any of the following conditions exist: • pregnant woman is above 35 years • pregnant woman has undergone 2 or more spontaneous abortions or foetal loss • pregnant woman has been exposed to potentially teratogenic agents such as drugs,radiation, infection or chemicals • pregnant woman or her spouse has a family history of mental retardation or physical deformities such as spasticity or any other genetic disease • any other condition specified by Central Supervisory Board • Reasons for conducting test to be recorded in writing.

25. Points to Remember • It is mandatory that the person conducting ultrasonography on a pregnant woman keep complete record in the clinic. • No person will conduct the pre-natal diagnostic procedures unless: • He has explained all known side and after effects of the procedures to the pregnant woman • obtained her written consent to undergo the procedures in the language which she understands • copy of her written consent is given to the pregnant woman

26. written consent will be taken as provided in Form G • any person conducting ultrasonography/image scanning on a pregnant woman will give a declaration on each report that he/she has neither detected nor disclosed the sex of foetus to any body by words, signs or in any other manner. • The pregnant woman before undergoing ultrasonography/image scanning must declare that she does not want to know the sex of her foetus

27. REGISTRATION OF GCC • Application to be made in appropriate form,with fees prescribed; to be renewed every 5 years • application time up to 60 days from date of commencement of centre • Centre shall cease to function on the expiry of 6 months from the date of commencement of this Act unless it has applied for registration. • Certificate of registration is provided by Appropriate Authority after holding an inquiry • The Unit as a whole including the place,equipment/machine and doctor using the machine, has to be registered with the Appropriate Authority.

28. Fees (a) Rs.25,000(amended 2012) for Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre. (b) Rs.35,000 (amended 2012)for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counselling Centre, or Imaging Centre or any combination thereof. • Provided application is rejected by the Appropriate Authority, no fee shall be required to be paid on resubmission within 90 days of rejection. • The application fee shall be paid by a demand draft

29. Display original certificate- waiting area/ sonography room • Appeal-within 30 days of receiving suspension order, can appeal to Central or State government against Central & State Authority respectively • Certificate of registration is non transferable-Change of ownership, management or ceasing to functions – surrender the certificate. New owner shall apply afresh

30. Points to remember • If a unit adds a new machine, is it to be registered again for Rs. 3,000? No additional registration fee is to be given, but the owner should inform the Appropriate Authority within 30 days of getting the machine and the relevant changes should be made in the Certificate of Registration • An Ultrasound machine cannot be used in a vehicle not registered as a vehicle under the Act. • If a USG machine is in a Genetic Centre but is packed and not in use does it require registration?Yes. • An application for renewal should be made in duplicate through Form A to the AA 30 days before the expiry date of the registration.

31. Prohibition of advertisement • No person, organization, Genetic Counselling Centre, Laboratory or Clinic including clinic, laboratory or center having ultrasound machine or imaging machine will:Issue,Publish,Distribute, communicate any advertisement in any form including internet regarding facilities of sex selection • Punishment –imprisonment upto 3 yr and fine upto 10,000 rupees

33. OFFENCES By Company • every person in charge and every person responsible to the company for the conduct of the business of the company at the time the offence was committed shall all be deemed to be guilty and accordingly proceeded against and punished,unless he proves the offence happened without his knowledge and he did his best to prevent it

34. An offence under this law is • Cognizable – A police officer may arrest the offender without warrant • Non-bailable – Getting bail is not the right of the accused. The courts (not less than that of Metropolitan or Judicial Magistrate, for this Act ) have discretion to grant bail • Non-compoundable - Parties to the case cannot settle the case out of court and decide not to prosecute.

35. MAINTENANCE OF RECORDS- for 2 years. However, if there is any legal proceeding pending in the court of law, then these records should not be destroyed till the proceedings have been disposed off • All records to be shown for inspection at reasonable times • Appropriate Authority can search and seize records if it has any reasonable suspicion Rules and regulations • Every rule and regulation made under this Act shall be laid before each of House of Parliament for a total period of 30 days

36. Minimum requirements for GCC • Sonologist,Imaging Specialist, Radiologist, RMP having PG degree or diploma or 6 months training or 1 year experience in sonography

37. Sale of USG machines • None is allowed to sell,distribute,rent or allow use of machine unless the centre is registered • Provider of such machines shall send a list of those to whom machine has been provided to concerned State ,once in 3 months.

38. Intimation of changes in employees, place or equipment. • Imaging Centre shall intimate every change of employee, place, address and equipment installed, to the Appropriate Authority 7 days prior and within a period of thirty days of such change

39. Code of Conduct to be observed by persons in Ultrasound Clinics, • not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus in any manner; • not conduct any techniques at a place other than those registered • display his/her name and designation prominently on the dress worn by him/her • write his/her name and designation in full under his/her signature

40. FORMS

49. Form F to be accompanied by identity proof of pregnant female,having her address. • If unavailable during emergency,it should be noted and mentioned in reports to district authorities