PC AND PNDT ACT

(Prevention of sex selection)

DR. CHANDRA MOHAN 09/07/2010

HISTORY
In 1979 the first sex selection clinic opened in Amritsar, site of the Golden Temple in Punjab. It offered PNSD using amniocentesis and SFFA. In many states like Maharashtra, Gujarat, Punjab & Haryana Medical Practitioners started using ultra sound scanning technique for sex determination in a large scale. Sex determination centers mushroomed not only in big cities but also in smaller towns. Advertisements were issued in newspaper, posters etc inviting prospective mothers to under go prenatal diagnostic tests. One such advertisements read Invest Rs. 500/- now, save Rs. 5 lakhs later.

Sex ratio (females per thousand males) census 2001

India 933 Rural 946 Urban 900 State with Highest Female Sex Ratio Kerala 1,058 State with Lowest Female Sex Ratio Harayana 861 UT with Highest Female Sex Ratio Pondicherry 1,001 UT with Lowest Female Sex Ratio Daman & Diu 710 District with Highest Female Sex Ratio Mahe (Pondicherry) 1,147 District with Lowest Female Sex Ratio Daman 591 (Daman & Diu)

Reasons for reduction in child sex ratio

a) Development of Prenatal diagnostic Tests and procedures (i) Advancement in the field of Science and Technology resulted in development of prenatal Diagnostic Tests and procedures. (ii) These prenatal diagnostic Tests and procedures were intended to help the Doctors in diagnosis of congenital diseases and sex linked disorders (iii) UNFORTUNATELY in India and some other Asian Countries these tests and procedures were used to determine sex of the foetus which led to elimination of female fetuses.

Major Prenatal Diagnostic Tests & Procedures

A) INVASIVE B) NON INVASIVE a) Amniocentosis Ultra Sound Scanning b) Cordocentesis ( UltraSongraphy ) c) Chorionic Villi aspiration d) Fetal Biopsy I ) Determination of sex of the fetus by under taking invasive techniques is complicated & costly. II ) Use of Ultra Sound Scanning for determination of sex of fetus is very easy & cheaper. This method is extensively used for prenatal sex determination.

WHY WAS THE NEED FOR SUCH AN ACT?

The Supreme Court, taking a serious view of the onslaught of sex-selective discriminatory practices by the medical fraternity, and the connection it may have with the use of pre-natal sex determination, directed the Centre to implement the PC & PNDT Act in all its aspects. The order came following a public interest petition filed by the Centre for the Enquiry of Health and Allied Themes (CEHAT), The Mahila Sarvangeen Utkarsh Mandal (MASUM) and Dr. Sabu George, who had done extensive research in this area.

The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st January, 1996, in order to check female feticide.
Even though the PNDT Act and Rules came in to force they were not implemented seriously.

Supreme Court of India issued orders on 4 Jan2001, 19 Sept 2001 &7 Nov 2001 etc giving direction to Government of India and State Governments to implement the provisions of PNDT Act 1994 The PNDT Act 1994 & PNDT Rules 1996 were extensively amended and the Amended Act & Rules came in to force with effect from 14/2/2003. The Act was renamed as Preconception & Prenatal Diagnostic Tests (Prevention of sex selection) Act 1994 - (PC&PNDT act for short).

The PNDT (PRINCIPAL) ACT 1994. The PNDT (PRINCIPAL) RULES 1996. The PNDT Advisory Committee Rules, 1996. The PNDT Amendment Act, 2002. The PNDT Amendment Rule, 2003

ACT
"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 or certain chromosomal abnormalities or 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 there to.

CENTRAL SUPERVISORY BOARD

The Board shall consist of (a) the Minister in charge of the Ministry or Department of Family Welfare, who shall be the Chairman, ex officio; (b) the Secretary to the Government of India in charge of the Department of Family Welfare, who shall be the ViceChairman, 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, exofficio; (d) the Director General of Health Services of the Central Government, ex officio;

e) Ten members to be appointed by the Central Government, two each from amongst (i) Eminent medical geneticists; (ii) Eminent gynecologists and obstetricians; (ii) Eminent pediatricians; (iv) Eminent social scientists; and (v) Representatives of women welfare organizations;

f) three women Members of Parliament, of whom two shall be elected by the House of the People and one by the Council of States; (g) four members to be appointed by the Central Government by rotation to represent the States and the Union territories, two in the alphabetical order and two in the reverse alphabetical order: Provided that no appointment under this clause shall be made except on the recommendation of the State Government or, as the case may be, the Union territory; (h) an officer, not below the rank of a Joint Secretary or equivalent of the Central Government, in charge of Family Welfare, who shall be the Member-Secretary, ex officio.

ADVISORY AUTHORITY.
Officer above the rank of the Joint Director of Health and Family Welfare;

There shall be an appropriate authority at the District level & sub-district level i.e., CMO & Civil Surgeon respectively.

ADVISORY COMMITTEE.
The Advisory Committee shall consist of
(a) three medical experts from amongst gynecologists, obstetricians, pediatricians and medical geneticists; (b) one legal expert; (c) one officer to represent the department dealing with information and publicity of the State Government or the Union territory, as the case may be; (d) three eminent social workers of whom not less than one shall be from amongst representatives of women's organizations.

FUNCTIONS
To grant, suspend or cancel registration of a Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic; To enforce standards prescribed for the Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic; To investigate complaints of breach of the provisions of this Act or the rules made there under and take immediate action; and To seek and consider the advice of the Advisory Committee, on application for registration and on complaints for suspension or cancellation of registration.

The act is prohibitory as well as regulatory, in nature. The Act prohibits determination and disclosure of the sex of fetus . Prohibits any advertisements relating to pre-natal determination of sex and prescribes punishment for its contravention. The person who contravenes the provisions of this Act is punishable with imprisonment and fine.

ULTRASOUND IMAGING CLINIC

A Sonologist, Imaging Specialist, Radiologist or RMP having Post Graduate degree or diploma or six months training or one year experience in sonography or image scanning, may set up a ultrasound clinic/imaging centre. An application for registration shall be made to the Appropriate Authority, in duplicate, in Form A, duly accompanied by an Affidavit containing

i) an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Ultrasound Clinic/ Imaging Centre/ Combination thereof, as the case may be, shall not conduct any test or procedure, by whatever name called, for selection of sex before or after conception or for detection of sex of fetus except for diseases specified in Section 4(2) nor shall the sex of fetus be disclosed to any body; and

(ii) an undertaking to the effect that the Genetic Centre/Laboratory/ Clinic/ Combination thereof, as the case may be, shall display prominently a notice that they do not conduct any technique, test or procedure etc. by whatever name called, for detection of sex of fetus or for selection of sex before or after conception. Application Fee (1) Every application for registration shall be accompanied by an fee of :(a) Rs.3000.00 for Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre.

(b) Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counseling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or Imaging Centre or any combination thereof. The application fee shall be paid by a demand draft drawn in favour of the Appropriate Authority, on any scheduled bank payable at the headquarters of the Appropriate Authority concerned.

Any person conducting ultrasonography/image scanning 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 fetus of the pregnant woman to any body. The pregnant woman shall before undergoing ultrasonography/image scanning declare that she does not want to know the sex of her fetus ( Form F ).

Shall maintain a register showing, in serial order, the names and addresses of the men or women given genetic counselling, subjected to pre-natal diagnostic procedures or pre-natal diagnostic tests, the names of their spouse or father and the date on which they first reported for such counselling, procedure or test. Facilities for inspection

The Appropriate Authority or the officer authorized by it may seal and seize any ultrasound machine, scanner or any other equipment, capable of detecting sex of foetus, used by any organization if the organization has not got itself registered under the Act. These machines of the organizations may be released if such organization pays penalty equal to five times of the registration fee to the Appropriate Authority concerned and gives an undertaking that it shall not undertake detection of sex of fetus or selection of sex before or after conception.

Maintenance of records.

All records, charts, forms, reports, consent letters and all other documents required to be maintained under this Act and the rules shall be preserved for a period of two years or for such period as may be prescribed:

CODE OF CONDUCT
Any person- not conduct or associate with, or help in carrying out detection or disclosure of sex of foetus in any manner; (ii) not employ or cause to be employed any person not possessing qualifications necessary for carrying out prenatal diagnostic techniques/ procedures, techniques and tests including ultrasonography; (iii) not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or procedure for selection of sex before or after conception or for detection of sex of foetus except for the purposes specified in sub-section (2).

iv) not conduct or cause to be conducted or aid in conducting by himself or through any other person any techniques or test or procedure under the Act at a place other than a place registered under the Act/these Rules; (v) ensure that no provision of the Act and these Rules are violated in any manner; (vi) ensure that the person, conducting any techniques, test or procedure leading to detection of sex of fetus for purposes not covered under section 4(2) of the Act or selection of sex before or after conception, is informed that such procedures lead to violation of the Act and these Rules which are punishable offences; (vii) help the law enforcing agencies in bring to book the violators of the provisions of the Act and these Rules

(viii) display his/her name and designation prominently on the dress worn by him/her; (ix) write his/her name and designation in full under his/her signature; (x) on no account conduct or allow/cause to be conducted female foeticide; (xi) not commit any other act of professional misconduct.

INDICATIONS
1. Ultrasound is not indicated/advised/performed to determine the sex of foetus except for diagnosis of sexlinked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B etc. During pregnancy Ultrasonography should only be performed when indicated. The following is the representative list indications for ultrasound during pregnancy (1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability. (2) Estimation of gestational age (dating).

2.

(3) Detection of number of foetuses and their chorionicity. (4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/MTP failure.

(5) Vaginal bleeding / leaking.

(6) Follow-up of cases of abortion.

(7) Assessment of cervical canal and diameter of internal os.

(8) Discrepancy between uterine size and period of amenorrhoea. (9) Any suspected adenexal or uterine pathology / abnormality.

(10) Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and their follow-up.
(11) To evaluate foetal presentation and position.

(12) Assessment of liquor amnii.

(13) Preterm labour / preterm premature rupture of membranes. (14) Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retroplacental haemorrhage, abnormal adherence etc.).

(15) Evaluation of umbilical cord presentation, insertion, nuchal encirclement, number of vessels and presence of true knot. (16) Evaluation of previous Caesarean Section scars. (17) Evaluation of foetal growth parameters, foetal weight and foetal well being.

(18) Colour flow mapping and duplex Doppler studies.

(19) Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up.

(20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnio-infusion, intrauterine infusion, placement of shunts etc. (21) Observation of intra-partum events. (22) Medical/surgical conditions complicating pregnancy.
(23) Research/scientific studies in recognized institutions.

PRENATAL DIAGNOSTIC TECHNIQUES FORMS (A TO H)

FORM-A Application for Registration or Renewal of Registration of a Genetic Counseling Centre/ Genetic Laboratory/ Genetic Clinic / Ultrasound Clinic/ Imaging Centre under the PNDT Act . Users :- Doctors/Owners of Genetic Counseling Centre/ Genetic Laboratory/ Genetic Clinic / Ultrasound Clinic/ Imaging Centre who want to register under the PNDT Act

FORM- B Certificate of Registration for the Registration of a Centre/Clinic . Users :- Appropriate Authority (CMOs / MOs etc. of a district/sub-district). FORM C For Rejection of Application for Grant / Renewal of Registration. Users :- Appropriate Authority (CMOs / MOs etc. of a district/sub-district).

FORM D For Maintenance of Records by the Genetic Counseling Centre registered under the PNDT Act. Users :- Doctors/Owners of the Genetic Counseling Centre.

FORM E For Maintenance of Records by the Genetic Laboratory registered under the PNDT Act. Users :- Doctors/Owners of Genetic Laboratory. FORM F For Maintenance of Records in respect of Pregnant Women by the Genetic Clinic/ Ultrasound Clinic / Imaging Centre registered under the PNDT Act. Users :- Doctors/Owners of the Genetic Clinic/ Ultrasound Clinic / Imaging Centre.

FORM G Form of Consent required to be taken by the doctor from the Pregnant Woman undertaking invasive techniques under the PNDT Act Users :- Doctors/Owners of the Genetic Clinic.

FORM H For Maintenance of Permanent Record of Applications for the Grant/Rejection of Registration etc. under the PNDT Act Users :- Appropriate Authority (CMOs / MOs etc. of a district/sub-district)

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 1) Minor Offences Non-availability of copy of the PNDT Act in the registered centre Non- Display of registration certificate in the centre. Non-Display of Board in the premises in English and Local Language that Disclosure of the sex of the foetus is prohibited under law.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

PENALTIES : Punishment may extend to 3 months or with fine, which may extend to Rs. 1,000/-for first offence. Additional fine upto Rs. 500/- per day for the period of contravention for subsequent offence. Or Show cause notice for temporary suspension of registration. Or In certain exceptional cases like in the case of public interest the Appropriate Authority may suspend or cancel registration without issuing a show cause notice. However the reasons for waiving show cause notice have to be given in writing.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 2) Advertisement relating to preconception and pre-natal determination of sex.

PENALTIES :
Imprisonment which may extend to 3 years and with fine which may extend to Rs. 10,000/-.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 3) Unregistered centres. It includes all such centres where any portable equipment capable of detecting sex before or after conception is used. The owner of such equipment may be having a registered facility somewhere else. PENALTIES : Any such equipment has to be sealed and seized by the Appropriate Authority concerned. Register such centre after receiving 5 times the registration fee as penalty and after taking a undertaking as per the PNDT Rules.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 4) Irregularities in registered centre
Owner/employee conducting the ultrasonography not qualified. More ultra sound machines /equipments where as less number register. Minor deficiency in record keeping.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

PENALTIES :
The Appropriate Authority or person authorized thereupon may: Issue show cause notice or may suspend (for a reasonable period) or cancel the registration, as per the magnitude of the violation. May take Suo Moto (on its own motion) action i.e. may suspend or cancel the registration without issuing show cause notice. However the reasons for waiving show cause notice have to be given in writing.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

Note: 1.During the period of suspension of registration, the equipment needs to be sealed and signed and kept with the owner. After cancellation of the registration, the equipment has to be sealed and seized. Any body aggrieved by the above decision may appeal to the higher-level Appropriate Authority within 30 days of the action. The appeal shall be disposed of by the higher authority within 60 days of its receipt.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 5 )Record Keeping
Irregularities in record keeping as per revised form F are a major offence.

PENALTIES :
Imprisonment which may extend to 5 years; and Fine which may extend to Rs.50,000/-.

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

VIOLATIONS : 6) Sex Selection PENALTIES : I )Imprisonment which may extend to 5 years; and Fine which may extend to Rs.50,000/-.47 II) In case of a registered medical practitioner, his name shall be reported by the Appropriate Authority to the State Medical Council concerned for taking necessary action: ----Including suspension of the registration if charges are framed by the court and till the case is disposed of; and ----For the 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.49

VIOLATIONS UNDER THE PNDT ACT AND THE PENALTIES

III. )In case of a person seeking the aid of the bodies or persons referred to above for sex selection or for conducting pre-natal diagnostic techniques on any pregnant woman for the purposes other than those specified in Section 4(2), he shall be liable to be punished with: --Imprisonment which may extend to three 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.

Every offence under this Act shall be cognizable, nonbailable and non-compoundable. Under the Act no role has been assigned to the police. Police can be called only by the Appropriate Authority at the time of search & seizure if he/she believes that there is any law & order problem. There is presumption in favour of women unless proved guilty.

SECTION 4 (2).
No pre-natal diagnostic techniques shall be conducted except for the purposes of detection of any of the following abnormalities, namely:-(i) chromosomal abnormalities; (ii) genetic metabolic diseases; (iii) haemoglobinopathies; (iv) sex-linked genetic diseases; (v) congenital anomalies; (vi) any other abnormalities or diseases as may be specified by the Central Supervisory Board

SECTION 4(2)
No pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do so is satisfied that any of the following conditions are fulfilled, namely:(i) age of the pregnant woman is above thirty-five years; (ii) the pregnant woman has undergone of two or more spontaneous abortions or foetal loss; (iii) the pregnant woman had been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals

SECTION 4(2)
iv) the pregnant woman has a family history of mental retardation or physical deformities such as spasticity or any other genetic disease; (v) any other condition as may be specified by the Central Supervisory Board; (4) no person, being a relative or the husband of the pregnant woman shall seek or encourage the conduct of any pre-natal diagnostic techniques on her except for the purpose specified in clause

THANKING YOU.