Mumbai: After months of delay, legislation designed to regulate the growing number of in-vitro fertilization (IVF) clinics and protect childless couples from exploitation by unscrupulous operators is set to be introduced in Parliament.
The Assisted Reproductive Technologies, or ART, (Regulation) Bill will be tabled in the winter session of the Lok Sabha, said Pushpa M. Bhargava, founder-director of the Hyderabad-based Centre for Cellular and Molecular Biology and one of the authors of the proposed legislation.
“The Bill is almost final now after several rounds of discussions with the stakeholders and general public,” said Bhargava. “Having prepared a set of rules and regulations, we hope (for) an early notification of the same if it gets through the Parliament.”
Since 1978, when the world’s second and India’s first IVF baby was born in Kolkata, then known as Calcutta, the field of assisted reproduction has grown rapidly. Although newer techniques helped spread its use, it has been clear that particular care needs to be taken to protect the rights of female subjects of research as well as users of such techniques.
“Infertile women, given the social pressure to reproduce as well as their own intense desire to conceive, are particularly vulnerable to commercial interests and experimentation in the medical field, since desperation might lead them to consent to hazardous techniques in the hope of conceiving,” said Mahendra N. Parekh, a gynaecologist at Mumbai’s Sushrusha Hospital.
There are no laws now to regulate the use of ART in the country, which has an estimated 200,000 IVF clinics. And in the absence of a legal — and punitive — framework, none of the ART/IVF clinics are licensed, and anecdotal evidence abounds about the exploitation of patients by quacks as well as concerns about social and ethical issues surrounding surrogate parenthood.
India has 13-19 million infertile couples, according to estimates by the World Health Organization. Infertility due to reproductive tract infections or genital tuberculosis is both preventable and treatable, and an estimated 8% of infertile couples opt for medical intervention involving the use of advanced assisted reproductive technologies, which can cost between Rs1.5 lakh and Rs10 lakh.
According to Bhargava, the proposed Bill clearly deals with issues such as the continued scrutiny and licensing of clinics, quality standards and practices at these facilities, credentials of sperm banks and confidentiality on sperm donation, and rights and liabilities of surrogate parenthood.
The proposed Bill, when it becomes law, will give constitutional validity to the functional and ethical guidelines prepared in 2005 by the Indian Council of Medical Research, or ICMR, and the National Academy of Medical Sciences, or NAMS.
Given the risk of unethical practices, exploitation by clinics, identity issues involving sperm donors and surrogate mothers, rights of parents and children, the ICMR and NAMS had issued national guidelines for accreditation, supervision and regulation of ART clinics. But without any enforcement mechanism, they remained just that: guidelines.
At the time they were issued, the guidelines drew flak from biomedical experts for their lack of vision; subsequently, specialty clinics mushroomed, providing assisted reproduction procedures using artificial insemination, sperm donation and surrogate parenthood, among others.
The Bill, prepared by a 15-member committee including experts from ICMR and the ministry of health, had been held up for almost seven months because of a delay in clearance from the ministry of law and justice.
Before placing the draft Bill for discussion in Parliament, the ministry of law will post it on its website (http://lawmin.nic.in/) for public feedback through a 30-day window.