How and What
The PC- PNDT act ( The Pre-Conception and Pre Natal Diagnostic Techniques (prohibition of sex selection) Act, 1994 as amended by the amendment act of 2002 and titled as The Pre-Conception and Pre Natal Diagnostic Techniques (regulation and prevention of misuse) were brought into force not because common people were resorting to sex selection, but because the medical fraternity made it possible and easy for them to do so.
“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 genetic 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 foeticide and for matters connected therewith or incidental thereto”
Sex selection and sex determination are prohibited.
The act says:
No person conducting pre-natal diagnostic procedures shall communicate to the pregnant woman concerned or her relatives the sex of the foetus by words, signs or in any other manner. All clinics conducting ultrasound must be registered and only doctors qualified under the Act can use diagnostic techniques such as ultrasound. All clinics should display the following notice prominently: ‘Disclosure of sex of the foetus is prohibited under the law’ in English as well as the local language. Doctors or clinics advertising sex determination tests in any form are liable for punishment.
The amendments made to the act :
The amendment has brought ultrasound machines and the newly emerging preconception sex selection techniques used by infertility clinics under its regulatory purview. It has made it mandatory not only to register all facilities offering ultrasound services, but also to maintain records of every scan done. It has led to the constitution of an appropriate authority (AA) in the States for implementation and monitoring under the Act. It has enhanced penalties for violation of the Act. The Act gives suo moto (proactively, in absence of a formal complaint) power to the AA for search and seizure and accessibility to the records for inspection to any person authorised by AA.This, along with the amendment to the code of conduct to be observed by the employees of such institutions, has made monitoring more efficient. Section 22 of the Act has been amended to declare as illegal any sort of advertisement in any form for sex selection or sex determination. Under the amended rules, a distinction has been made between invasive and non-invasive techniques for purpose of obtaining consent. For non-invasive techniques like ultrasonography, the medical professional is required to make a declaration on each report of ultrasonography/image scanning, certifying that he/ she has neither detected nor disclosed the sex of the foetus to anybody. Before undergoing such test, the pregnant woman has to declare that she does not want to know the sex of the foetus .
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.
Sex selection is any practice that increases the likelihood of conception, gestation and the birth of a child of one sex rather than th e other. As per the Act, it includes any procedure, technique, test or administration or prescription or provision of anything for the purpose of enduring or increasing the probability that an embryo will be of a particular sex.
How it is related to the medical profession:
This Act is for medical professionals because the actions necessitating its enactment are done by them, with or without malintention. The fact is that pre-natal diagnostic techniques can only be used by medical professionals. It is they who are responsible for the use of ultrasound technology and sex-selection techniques, which have become a tool for discrimination against the girl child, Perhaps only a handful of India’s medical professionals do this for financial gains.
Pre-natal diagnostic procedures:
gynaecological or obstetrical or medical procedures such as ultrasonography; foetoscopy; and taking or removing samples of amniotic fluid, chorionic villi, embryo, blood or any other tissue or fluid of a man or a woman before or after conception for being sent to a Genetic Lab or Genetic Clinic for conducting any type of analysis or pre-natal diagnostic tests.
Diagnostic Techniques such as ultrasonography are capable of determining the sex of the foetus i.e. whether it is male or female. This process is called sex determination. When the family selects a child of the sex it will like to have and eliminates that which is unwanted, this process is called sex selection.
Techniques for sex selection:
Pre-conception techniques : Pre-implantation genetic diagnosis is used for detection of genetic disorders in conception after IVF in which genetic testing is performed on the resulting embryos and in this process it is possible to determine the sex, and hence a doctor aiding a patient who opts for sex selection, is in a position to implant only embryos of the “desired” sex.
Sperm sorting and sperm separation by a patented technology called microsort and only male sperms can be used for fertilization. Not available in our country. Simple IUI does not come under sex selection methods
Pre-natal diagnostic techniques (PNDT) : Developed in the 1970s, PND through techniques such as ultrasound scanning and amniocentesis / Chorionic villous sampling followed by sex selective abortion, remains the most common method of sex selection practiced around the world for the last three decades.
These tests can be conducted at the following premises :
Genetic Counselling Centres , Genetic Clinics , Genetic Laboratories, Ultrasound Clinics and Imaging Centres
Who can conduct these tests :
Registered Medical Practitioner with six months training or 1 year experience with any recognised medical qualification under the Indian Medical Council Act, 1956 and whose name is entered in the State Medical Register
Gynaecologist possessing a post-graduate degree in gynaecology and obstetrics
Medical Geneticist possessing a degree or diploma in genetic science
Paediatrician possessing a post- graduate degree in paediatrics
Sonologist or imaging specialist possessing any one of the medical qualifications under the Indian Medical Council Act,1956 or possessing post-graduate qualification in ultrasonography /imaging techniques / radiology
Ultrasound is not indicated/advised/performed to determine the sex of foetus except for diagnosis of sex-linked 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 of indications for us e of ultrasound during pregnancy.
1. To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
2.Estimation of gestational age (dating).
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, f oetal 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 recognised institutions.
The Act gives full right to the pregnant woman to know:
What procedure is to be performed on her the good and bad effects of such a test on her or on her foetus The types of results expected of such a test The type of information, though possible, that will not be looked for and conveyed to her with this test – she must be specifically informed that the gender of her foetus will neither be assessed nor will be conveyed to her even if it is known accidentally to the medical professional What will be the advantages if she undergoes such a test What will be the disadvantages if she refuses to undergo the test After understanding the above, she has the full ri ght to accept or refuse the advice of her medical professional to undergo the test. Informed consent of the pregnant woman has to be obtained on Form G in case of invasive techniques such as amniocentesis. It is illegal to perform any invasive pre-natal diagnostic test without such informed consent
Non invasive tests like USS doesn’t need informed consent :
But before taking the test, the woman has to give a declaration stating that she does not want to know the sex of the foetus. Similarly, the medical professional conducting the test has to declare that he/she will neither detect nor disclose the sex of the foetus to any person. The format for the declarations is contained in the Rules. A printed copy of the record shall be taken and preserved by the clinic.
Procedure for registering a Genetic Clinic, Counselling Centre or a Laboratory :
The owner has to apply to the Appropriate Authority (the Chief Medical Officer at the district where the unit is situated or the officer appointed in the sub-district). All applications are to be made in duplicate in Form A and must be accompanied by enclosures (see annexure 3) containing details of equipment available, the make and model of each equipment and the names, qualifications, registration number and experience of medical professionals. All this must be done before commencing business.
One copy of the certificate of registration should be prominently displayed by the unit in a conspicuous place at its place of business
The registration fee of a Genetic Clinic is Rs. 3,000. However, if the centre is providing more than one service as a Genetic Counselling Centre, Genetic Laboratory and Genetic Clinic, then the registration fee is Rs. 4,000. This fee is non-refundable and is irrespective of the number of USG machines in the centre. But the owner has to inform the Appropriate Authority about the number of sonography machines in the centre.
The Unit as a, whole including the place, equipment/machine and doctor using the machine, has to be registered with the Appropriate Authority
If the application is rejected, the owner of the Genetic Centre can reapply within 90 days of the rejection and need not pay the fee again. But if it is rejected again, then the applicant has to pay the fee on any subsequent application.
If the complainant is not satisfied with the decision of the AA at sub-district level she/he may appeal to the AA at district level; if she/he is not satisfied with AA at the district level, she/he may appeal to State Appropriate Authority/Union Territory / Appropriate Authority within 30 days of receiving the order. The Appellate authority must give its decision within 60 days. The appeal must be made to the Central Government if the order is passed by the Central Appropriate Authority . Similarly the appeal shall be made to the State Government if the order is passed by the State Appropriate Authority. The owner should inform the Appropriate Authority within 30 days of getting a new machine and the relevant changes should be made in the Certificate of Registration.
Portable ultrasound machines can be used in case of any emergency. The vehicle need not be an ambulance or a van. Such vehicles are obliged to maintain records for any ultrasound carried out on the portable machines. It is important to note that the vehicle has to be registered as a unit .
A person with non –allopathic qualifications cannot perform sonography.
Even if an USG machine is lying packed or is not being used, the registration of the centre where it is located/stored is mandatory and such a machine must be reported to the Appropriate Authority.
The registration is non-transferable.
The validity of the registration certificate is Five years, provided there is no violation under the Act An application for renewal should be made in duplicate through Form A to the AA 30 days before the expiry date of the registration. The registration would be renewed after conducting an enquiry and with suggestions from the Advisory Committee. The renewal fee is half of the original fee. If the AA does not respond within 90 days, then it will be presumed that renewal has been granted.
What should the Scan Centers do under the Act?
Display – Registration certificate, PNDT board & pamphlets; Mandatory records Register showing in serial order
Name & Addresses of men or women given genetic counselling and /or subjected to prenatal procedure or test.
Names of their spouses or fathers;
Date on which they first reported for such counselling
FORM D/E/F under the Rules.
The scan centre shall send consolidated report on Form F statutorily by 5th for the previous month
to the AA or any officer so authorized
Other kinds of records include :
Forms of consent
Sonographic plates or slides
Recommendations & letters.
The referrals of the doctor recommending scan and a declaration from the pregnant mother
regarding her non interest in knowing the sex of the foetus is a must for every case.
All records should be maintained for at least two years Records at all reasonable times are to be made available for inspection to the AA or a person authorized by the AA.
RESPONSIBILITY OF THE MEDICAL PROFESSIONALS
1. To say “No” to requests for performing sex selection, sex detection and gender-specific MTPS and to discourage colleagues from doing so
2. To register Genetic Centres
3. To counsel women/ couples and their families and dissuade them from knowing the sex of the foetus.
4. To enlighten society about erring doctors who conduct pre-natal sex detection and female-specific MTPs.
5. To regularly have stock-taking on the prevalence of sex determination and sex selection by professional bodies such as IMA and to publish articles and statements on the subject to give prominent focus to the issue.
6. To himself/herself sincerely abide by the Act and its spirit.
7. To blow the whistle on those in the fraternity who are conducting these tests and practices. They should immediately be reported to the concerned Appropriate Authority.