The recent Ministry of Health and Family Welfare notification dt. 4th April 2020, has come under fire for the suspension of certain Rules of the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994. It has been widely reported that suspension of these Rules amounts to lifting of the ban on sex selection and sex detection. There is also an apprehension that this suspension might lead to a functioning of the Genetic labs and ultrasound clinics without any scrutiny. However, the Ministry has clarified that the suspension of the Rules will not have a negative imp0act on the operation of the Act. In that context it becomes necessary to take a comprehensive look at the PC-PNDT Act in order to understand the ramifications of the Ministry's Notification.
What is the PCPNDT ACT and why is it necessary? The PCPNDT Act is a legislation which amongst other things, "prohibits the misuse of pre-natal diagnostic techniques for determination of sex of foetus, leading to female foeticide". The object of the Act is stated as, "An Act to provide for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex linked disorders and for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female foeticide; and, for matters connected there with or incidental thereto."
At the beginning of the 20th century as per official records the sex ratio was 972 women for every 1000 men, but this steadily declined through the century. The 1991 census recorded a sex ratio of only 927. The PC-PNDT Act, 1994, was enacted in recognition of the need for banning sex selection before birth and sex determination after conception, to arrest the selective abortion of female foetuses which was a primary reason for the skewed sex ratio.
The Act also regulates the use of pre-conception and pre-natal diagnostic techniques so that the same are not misused. It acknowledges the necessity of pre-natal diagnostic techniques to detect genetic abnormalities or congenital malformations that may affect the life of the foetus after birth, or the life of the pregnant woman, and allows the use of ultrasound and other techniques for the purpose of detecting anomalies or abnormalities, but prohibits foetal sex-determination through pre-natal diagnosis.
The Act has established an elaborate system to prevent, check and control the use of medical technology for sex selection and sex determination. It sets up multiple statutory bodies to ensure implementation of the Act and creation of public awareness about. It mandates that any pre-conception and pre-natal test be only conducted by a registered clinic or centre. The process of registration and its renewal, requires for a thorough inspection of the facility, its equipment and maintenance and an inquiry into whether it has complied with all the provisions of the Act and its Rules by the Appropriate Authority. The Act requires every centre/lab or clinic to maintain a meticulous record of the information of the patients, the tests conducted or the samples taken and the diagnosis given. It creates a statutory mechanism for constant scrutiny by ensuring that the record maintained is uploaded on a daily basis and also provided to the appropriate authority monthly. It further ensures strict implementation by providing the Appropriate Authority with the power to enter, search and examine any material document or object at a registered clinic/ centre/ lab at any reasonable time with the authority to seize evidence.
What are the Rules that have been suspended?
Rule 8, 9(8) and 18A(6) of the PCPNDT Rules
What information is recorded under the Act?
Under Rule 9 of the PC-PNDT Rules, every Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic and Imaging Centres shall maintain a register showing, in serial order, the names and addresses of the men or women who have been given genetic counselling, the women who have been 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. Furthermore, Genetic and Ultrasound Clinics and Imaging Centres are required to maintain a record of the tests conducted in respect of a pregnant woman; the practitioners that conducted the tests and specify the purpose for which an ultrasound is done; and a declaration by both the practitioner and the patient that the sex of the child was neither determined nor disclosed. For this purpose a prescribed form (Form F) is provided under the Act. All such centres are required to upload the records of any such procedure on a daily basis to a government portal, thereby ensuring a detailed collection and online updation of each test conducted throughout India.
Why does the PCPNDT Act require such records to be maintained?
Given that the same medical techniques- ultrasound, amniocentesis, etc are used to detect foetal abnormalities and the sex of the foetus, the Act closely regulates and monitors the use of 'pre-natal diagnostic techniques' in order to avoid abuse. The Act enumerates that such techniques can be used only to detect certain genetic abnormalities, anomalies and diseases that are specified in the Rules. It mandates that all clinics that carry out pre-natal diagnostic tests must be registered under the Act, as this enables monitoring and supervision. The recording of information is meant to enable the linking of incidents of sex-selective abortion to the clinic/facility which detected the sex of the foetus and ensure accountability as well as criminal liability in such cases. It must be kept in mind that sex-selective abortion is not criminalised, and instead it is sex-detection which is criminalised under the PCPNDT Act. In order to tackle the issue of sex-selective abortion or female foeticide, the techniques used to detect the sex of the foetus are closely regulated and monitored under the Act.
Do records still need to be maintained?
Section 29 of the PC-PNDT Act provides for the maintenance of records including all charts, reports, consent forms and other documents for a period of 2 years or till the final disposal of a criminal proceeding. Rule 9 of the Act further elaborates on the documents that need to be maintained and the forms prescribed for the maintenance of records.
With the continued application of section 29 and Rule 9(1) to 9(7), the requirement of collecting and maintaining records of every test/technique/procedure conducted on pregnant women still remains. It is only the compulsory submission of the hard copy of these records that has been suspended under Rule 9(8). The reference to COVID-19 in the Ministry's Notification indicates that the suspension was ostensibly done in view of the administrative difficulty in complying with the said Rules. It is here imperative to note that the violation of any provision of the Act or Rules is deemed to be an offence under Section 23 of the Act.
Does this suspension legalise or make sex determination easier?
The suspension of the Rules by the Ministry pertains to mandatory administrative compliances under the Act. There has been no suspension of the provisions that prohibit sex selection and sex determination, and that lay down regulations for genetic counselling centres, labs and ultrasound clinics. The statutory obligation of every clinic and centre to maintain all records still remains intact.
The now suspended Rule 9(8) required doctors to send the hard copy of the complete report of all pre-conception or pregnancy related tests/ procedures/ techniques conducted by them to the Appropriate Authority by the 5th day of every following month. The daily uploading of information will however continue despite the suspension of Rule 9(8). The submission of hard copies under Rule 9(8) to the Appropriate Authority, among other things, acts as a corroboration of the daily information already submitted. Hence, the existing provisions of the Act and Rules can ensure scrutiny and serve as a safeguard against sex selection and determination
The question of renewal of registration The suspension of the Rule 8 that provides for renewal of registration poses the problem of expiry of certificate of genetic labs, centres and ultrasound clinics and their non renewal during this period. Section 3 provides that all such centres must have a valid certificate of registration in order to carry out tests, and Rule 7 states that such registration shall expire after five years. Thus, those centres whose registration is due to expire before June 30 2020 will be unable to re-register, and become in-operational. The process of re-registration involves conducting an enquiry by the Appropriate Authority and the same may not be possible given the Covid-19 lockdown and restrictions. The loss of registration and the absence of a re-registration mechanism could result in a wastage of existing resources and limit the number of centres where such tests can be accessed. Perhaps, the Ministry should consider extending the validity of existing certificates of registration till the time that Rule 8 stands suspended.
Even after the issuance of the Notification by the Ministry, the essence of the PC-PNDT Act remain intact. The provisions that prohibit and penalise sex selection and sex determination continue to apply. Moreover, every clinic, genetic centre and lab must continue to keep a detailed set of records as mandated. This will ensure that the policy against sex selection and sex determination continues to operate despite the limitations of the Covid-19 lockdown.
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