Even after nine years since it was proposed to regulate thousands of infertility clinics that have mushroomed over the years in the country, the Union health ministry has not yet finalised the Assisted Reproductive Techniques (Regulation) Bill (ART Bill) which would have provided a national framework for the regulation and supervision of assisted reproductive technology, better known as infertility clinics, in the entire length and breadth of the country.
According to sources, the ART Bill has not yet been finalized, and the draft of the same is gathering dust in the Union health ministry. The Bill was drafted by the Indian Council of Medical Research (ICMR) several years ago and has been given final shape by the Health Ministry after years of inter-ministerial and government-public debates and discussions. The Bill has been waiting for quite some time for its mandatory clearance from the Department of Law, after the ICMR had completed all the scientific part of the Bill.
The Bill aims at proper regulation and supervision of ART clinics and banks in the country, and for prevention of misuse of this technology, including surrogacy, and for safe and ethical practice of ART services in the country. Even though the Ministry is yet to finalise and introduce the Bill in Parliament for its final nod, surrogacy has been prohibited by the government way back in November, 2015.
Apart from putting strict parameters for the establishment of an infertility clinic, the Bill also defines the minimum requirement regarding staff in an infertility clinic and minimal physical requirements for a clinic. Besides, the Bill seeks to regulate research on human embryos in the country. As per the draft Bill, the sale of any human gametes and embryos or their transfer to any country outside India, for research is absolutely prohibited.
The import or export of frozen human gametes and embryos shall be considered as transfer of biological material for therapeutic use and shall be permitted as per the rules made in this behalf for exchange of human biological material and with the permission of the National Registry of the Assisted Reproductive Technology Clinics and Banks in India of the ICMR.
As per the Bill, the research shall be conducted on such gametes and embryos that have been donated for such purpose in India only. No research shall be conducted using embryos except with the permission of the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the ICMR. Any person or organisation, by whatsoever name called, may apply to the department of health research (DHR) for registration as a research institution permitted to conduct research on embryos.