THE PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUE ACT PRESENTER- DR. AMITA DESWAL MODERATOR- DR. ROHIT DHAKA 1
Content Introduction Definition of Law Legal initiatives Objective of Law Provisions of Act Regulatory body Maintenance and preservation of records Strengthening the implementation of Act Challenges in implementation of Act 2
Introduction The right to live is part and parcel of human rights and denial of the same to a girl child is one of the most heinous violations which unfortunately is a universal issue. The Constitution of India stipulates equal rights for all, regardless of gender. Therefore, a woman should never be discriminated against for being a female. She has an equal role in society. Strong male preference, gender bias and illiteracy are some fundamental causes for increasing female foeticide cases in the country despite of advancements in education and social economics. Bhaktwani A. The PC-PNDT act in a nutshell. Indian J Radiol Imaging. 2012 Apr;22(2):133-4. doi : 10.4103/0971-3026.101114. PMID: 23162258; PMCID: PMC3498638. 3
Unfortunately, the progress in science and technology in this regard is furthering female foeticide to the extent that it has been used as a replacement for female infanticide. Therefore, in order to protect the rights and dignity of females, the legislature has enacted the statute namely, the Pre-conception and Prenatal Diagnostic Techniques (Prohibition of sex selection) Act, 1994 [PC&PNDT Act]. 4
Legal Initiatives 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” 1 st state to do so. 20th September1994 : PNDT Act passed Rules framed in 1996. Implementation started after Supreme Court Judgment in 2003 . 5
DEFINITION An act to provide for prohibition of sex selection, before or after conception, and for regulation of pre-natal diagnostic technique for the purposes of detecting genetic abnormality or metabolic disorder or chromosomal abnormality or certain congenital malformation or sex-linked disorder and for the prevention of their misuse for sex determination leading to female foeticide and for matter connected therewith or incidental thereto. pre-conception-pre-natal-diagnostic-techniques-act-1994 PDF ( www.indiacode.nic.in ) 6
Why PC is added in PCPNDT ACT? Even before conception sex selection is possible by interventions like Pre-implantation genetic diagnosis . So, it is technically possible to isolate “Y” chromosome after genetic testing , which can be utilized for sex selection of the foetus. Hence the word ‘pre-conception’ (pc) added to PNDT act. 7
PROVISIONS OF THE ACT 8
A. The Act provides for the prohibition of sex selection, before or after conception. B. It regulates the use of pre-natal diagnostic techniques, like ultrasound and amniocentesis by allowing them their use only to detect :
-genetic metabolic disorders -chromosomal abnormalities
-certain congenital malformations
-hemoglobinopathies -sex linked disorders. 9
C. No laboratory, centre or clinic will conduct any test for the purpose of sex determination of the foetus . D. No person, including the one who is conducting the procedure , will communicate the sex of the foetus to the pregnant woman or her relatives by words, signs or any other method. 10
Pre-natal diagnostic procedures includes: a) Ultrasonography; b) Taking or removing samples of : amniotic fluid, chorionic villi, blood or any tissue or fluid of a man or a woman before or after conception for being sent to a Genetic labs for conducting any type of analysis or pre-natal diagnostic tests for selection of sex 11
Who can do these procedures ? A. Gynecologist (and/or) Pediatrician- - In a genetic counselling centre . They must have: - 6 months experience in genetic counselling (or) - 4 weeks training in genetic counselling B. Medical Geneticist – Includes a person who possesses : degree or diploma in genetic science in the fields of sex selection and pre-natal diagnostic techniques or has experience of not less than two years in any of these fields. 12
C. Registered Medical Practitioner- For the purpose of a genetic clinic, the registered medical practitioner should have :- A Post Graduate degree or diploma or six months of training (or) one year of experience in sonography or image scanning 13
Techniques can only be conducted if: Age of the pregnant woman is above 35 years. The pregnant woman has under gone two (or) more spontaneous abortions or fetal loss The pregnant woman has been exposed to potentially teratogenic agents such as drugs, radiation, infection (or) chemicals. The pregnant woman or her spouse has a family history of mental retardation (or) any other genetic disease. 14
Prohibitions On places On persons 15
Prohibitions on Places: No genetic counselling centre , genetic clinic (or) genetic laboratory shall conduct (or) associate with (or) help in conducting pre-natal diagnostic techniques unless registered. Moreover, the registration certificate has to be displayed prominently on a board in such a place. 16
Prohibition on Persons : No person shall open any genetic counselling centre , genetic clinic or genetic laboratory having ultrasound or scanner or any other technology capable of undertaking sex determination of the foetus and sex selection unless such center, clinic or laboratory is duly registered separately or jointly. No qualified person shall conduct or aid in conducting himself or through any other person a pre-natal diagnostic technique at any place other than the place registered. 17
No person including a relative or husband of the pregnant woman shall seek or encourage the conduct of any pre-natal diagnostic techniques on her except for the purposes specified No person including the person conducting the procedure will communicate to the pregnant women or her relatives or any other person the sex of the foetus by signs, words, or in any other manner . 18
PROHIBITION OF ADVERTISEMENT No person, organization including Genetic counselling centre , Laboratory or Clinic will : Issue Publish Distribute Communicate any advertisement regarding pre-natal determination or pre-conception sex selection by any means even if its scientific. 19
OFFENCES: By Persons 1. In case of a person conducting pre-natal diagnostic techniques on any pregnant woman for the purposes other than those specified in the act, shall be liable to be punished with: Upto 3 years imprisonment and Upto Rs.10,000 fine.
Any subsequent conviction entails: up to 5 years imprisonment and Up to Rs.50,000 fine. 20
2. In case of a doctor his name will be reported by the appropriate Authority to the State Medical Council for taking necessary action: 1. Suspension of registration if charges are framed by the court till the case is disposed of.
2. Removal of his name from the register of the council on conviction for the period of: Five years for the first offence. Permanently for the subsequent offence. 21
3. Any person who seeks the aid of any establishments and professionals for conducting a pre-natal diagnostic technique on any pregnant women for the purpose of sex selection would be punishable with:- Imprisonment up to 3 years and Fine which may extend to Rs.50,000/-.
Any subsequent conviction entails: Imprisonment which may extend to 5 years and Fine which may extend to Rs.1 lakh. 22
How to Complain? A complainant can approach the designated Appropriate Authority of the State or District or sub-district. A written complaint has to be made to the Appropriate Authority (AA), which has to acknowledge receipt. If the AA takes no action within 15 days, the complainant can go to Court with the acknowledgment receipt. Alternatively, the complainant can also approach a social organization like an NGO working on women’s rights issues in the area or State. 23
Regulatory Body 24 Policy Making Body Central Supervisory Board Advisory Committee State Appropriate Authority Implementing Body State Supervisory Board State Advisory Committee Sub-District Appropriate Authority District Appropriate Authority District Advisory Committee Sub District Advisory Committee
APPROPRIATE AUTHORITY Appointed by CENTRAL government for UT and STATE governments MEMBERS a)An officer on the rank of Joint Director of Health and Family Welfare as chairperson b)An eminent woman representing women’s organization c)An officer of Law Department 25
FUNCTIONS OF APPROPRIATE AUTHORITY To grant, suspend or cancel registration of GCC or clinic or lab To investigate complaints To create public awareness To take action on recommendations of ADVISORY COMMITTEE To take appropriate legal action against the use of sex selection technique and also to initiate independent investigation To supervise the implementation of provision of the Act and rules To recommend to CS Board and States Boards modifications required in rules in accordance with change in technology or social conditions 26
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 27
BOARD(CENTRAL SUPERVISORY BOARD) 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 3 members to represent Ministries of Woman and Child Development, Dept of legal Affair/ Law and Justice and the Indian System of Medicine and Homoeopathy The Director General of Health Services of the Central Government 28
10 members appointed by the Center , 2 each from a)Eminent obstetricians b) Eminent medical geneticists c)Eminent paediatricians d)Eminent social scientists e)Representatives of women welfare organizations 3 women MP 4 members appointed by the Central govt to represent the states and UT by 29
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 30
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 the Indian system of medicine 3 women MLA 31
10 members appointed by the State, 2 each from Eminent obstetricians Eminent radiologists or sonologists Eminent pediatricians or medical geneticists Eminent social scientists Representatives of women welfare organisations 32
PROCEDURE OF REGISTRATION Submission of Form “A” in duplicate to Appropriate Authority. Affidavit : an undertaking that the clinic/ Centre shall not conduct any test or procedure for sex determination. Another affidavit undertaking that the centre / clinic prominently display a signage board of no sex determination. Particulars of USG machine/s (Including Mobile U/S), name qualification and experience certificates of Radiologist/ Sonologist to be attached. 33
Maintenance and preservation of records All Genetic Counselling, Genetic Laboratory, Genetic Clinic or ultrasound clinic or imaging center shall maintain a register showing, 1. in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre natal diagnostic procedure or test, 2. the name of their spouse or father and the date on which they first reported for such counselling, procedure of test. 34
These records are required to be maintained for a period of 2 years from the date of completion Or in Case of any legal proceeding, maintain till the final disposal of the legal proceeding. 35
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
Strengthening the implementation of PNDT ACT Inspection team to be put in place to ensure regular survey Renewal of registration to be taken on the basis of track record in terms of record keeping, etc of PNDT Clinic Mapping of mobile ultrasound machines in the states Follow-up of cases in the court by hiring advocates at the district level. Ensuring regular meeting of state supervisory board, state advisory committee and district advisory committee to review the progress of implementation at different level 37
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Monitoring and Evaluation Monitoring birth registration and sex ratio at birth by PRI institution Identification of unregistered machines in the district by community workers Monitoring of pregnancies, MTP, live births and birth registration by community workers. AAs has to take up medical audit of records of Form F kept by PNDT clinic 48
Sex Ratio at birth(month wise), Faridabad (HR) Month 2021 2022 2023 2024 January 896 898 910 902 Feb 849 846 901 906 march 915 906 913 879 April 892 887 904 902 May 885 894 900 854 June 858 828 896 870 July 871 948 901 860 August 899 913 907 932 Sept 906 849 908 956 Oct 906 980 900 940 Nov 914 843 905 874 Dec 943 909 914 907 Annual SRB 895 892 905 899 49
Raid conducted (year wise) year PNDT Raid 2021 12 2022 8 2023 8 2024 2025 1 total 39 50
Challenges in implementation of PC & PNDT Act Mobile size machines Misuse of Misoprostol drugs for abortions One operator with more than 2 USG machines Interstate sex selection f/b abortion in bordering districts Pregnancy kept secret, in cases interested for sex selection Confirmation of pregnancy at home by pregnancy kits and kept secret.