Based on the guidelines and norms set by the Indian Council of Medical Research (ICMR), the Union health ministry is finalising a legislation to regulate the growing number of fertility clinics in the country, in view of the rising popularity of the same.

The government has accepted the national guidelines for accreditation, supervision and regulation of Assisted Reproductive Technology (ART) clinics in the country, developed and announced by the ICMR. To effectively implement the guidelines, the ministry is finalising the Assisted Reproductive Technology (Regulation) Bill, sources informed.

The draft of the bill has been published for the comments from the stakeholders. The bill details procedures for accreditation and supervision of infertility clinics (and related organizations such as semen banks) handling spermatozoa or oocytes outside of the body, or dealing with gamete donors and surrogacy, ensuring that the legitimate rights of all concerned are protected, with maximum benefit to the infertile couples/individuals within a recognized framework of ethics and good medical practice.

“It is estimated that 15 per cent of couples around the world are infertile. This implies that infertility is one of the most highly prevalent medical problems. The magnitude of the infertility problem also has enormous social implications. Besides the fact that every couple has the right to have a child, in India infertility widely carries with it a social stigma. In the Indian social context specially, children are also a kind of old age insurance. With the enormous advances in medicine and medical technologies, today 85 per cent of the cases of infertility can be taken care of through medicines, surgery and/or the new medical technologies such as In-Vitro Fertilization (IVF) or intracytoplasmic sperm injection (ICSI),” according to the draft bill.

Most of the new technologies aimed at taking care of infertility, involve handling of the gamete – spermatozoa or the ooctye – outside the body; they also often involve the donation of spermatozoa or oocyte, or the use of a surrogate mother who would be carrying a child with whom she has no biological relationship. These technologies not only require expertise but also open up many avenues for unethical practices which can affect adversely the recipient of the treatment, medically, socially and legally, it said.

The last nearly 20 years have seen an exponential growth of infertility clinics that use techniques requiring handling of spermatozoa or the oocyte outside the body, or the use of a surrogate mother. As of today, anyone can open infertility or ART clinic; no permission is required to do so. There has been, consequently a mushrooming of such clinics around the country.

“In view of the above, in public interest, it has become important to regulate the functioning of such clinics to ensure that the services provided are ethical and that the medical, social and legal rights of all those concerned are protected,” according to the bill.