The much awaited Assisted Reproductive Technology (Regulation) Bill, being introduced in the country to regulate thousands of infertility clinics that have mushroomed in the country over the past several years, has been finalised by the Indian Council for Medical Research (ICMR) and will be introduced in Parliament soon.

A senior ICMR official said that the ICMR has given final shape to the bill and the draft bill has already been submitted to the union health ministry. Now the ministry will introduce the bill in Parliament, possibly in the forthcoming monsoon session of Parliament that is expected to begin in July, to give the final nod to the bill.

The introduction of the bill is important as 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 assisted reproductive technology (ART) clinic. No permission is required to do so. There has been, consequently a mushrooming of such clinics throughout the country.

In view of this scenario, 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.

The bill, once it gets the Parliament nod, will provide a national framework for the accreditation, regulation and supervision of infertility clinics, for prevention of misuse of assisted reproductive technology, for safe and ethical practice of assisted reproductive technology services and for matters connected therewith or incidental thereto. It provides for the constitution of a 21-member National Advisory Board, under the chairmanship of secretary, department of health research, and also state boards, to exercise the jurisdiction and powers and discharge the functions and duties conferred or imposed on the Board by or under this Act.

Under the new Act, all infertility clinics, ART banks and research organizations using human embryos have to register themselves with the registration authority.

The Bill details about the 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.

Under the Act it is the duty of the clinic to ensure that patients,donors of gametes and surrogate mothers are eligible to avail of assisted reproductive technology procedures under the criteria prescribed by the rules under this Act and that they have been medically tested for such diseases, sexually transmitted or otherwise, as may be prescribed and all other communicable diseases which may endanger the health of the parents, or any one of them, surrogate or child.

No assisted reproductive technology clinic shall perform any treatment or procedure of assisted reproductive technology without the consent in writing of all the parties seeking assisted reproductive technology to all possible stages of such treatment or procedures including the freezing of embryos.