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REGULATING ART CLINICS

Ramesh Shankar
Wednesday, August 17, 2022, 08:00 Hrs  [IST]

Regulation of Assisted Reproductive Technology (ART) clinics, better known as infertility clinics in common parlance, has been a major issue in the country for quite a long time as the country witnessed mushrooming of infertility clinics ever since the successful birth of the world's first baby conceived by IVF and embryo transfer on July 25, 1978, in the UK. The world's second IVF baby was born 67 days later on October 3, 1978 in Kolkata. But, India's first scientifically documented IVF baby was born on August 6, 1986 in Mumbai with the support of the Indian Council of Medical Research (ICMR).  The advent of any new technology that affects mankind raises several technical and moral dilemmas and poses many ethical and technical challenges. And ART cannot be an exception. For the last more than three decades, the country witnessed the establishment of thousands of infertility clinics. In the Indian context where barrenness is looked down upon, infertile patients looked up to these infertility clinics as the last resort to parenthood. Many of these technologies require enormous technical expertise and infrastructure. But, in the absence of a regulation, many of these clinics did not have the adequate trained manpower and infrastructure facilities to deliver these highly sophisticated technologies and even services provided by some of these clinics were highly questionable. In several cases, the infertile couples were cheated by providing relatively simple procedure and charged for complicated and expensive procedures. In was under this background, the Indian government felt the need for bringing a Bill for regulating the infertility clinics across the country.
So, after years of discussions and deliberations, the Indian government in 2020 gave its approval to the much awaited ART Regulation Bill to regulate the thousands of infertility clinics spread across the country which have so far remained unregulated in the absence of any law. Eventually, the ART (Regulation) Act was notified by the Central government on December 21, 2021 and the Surrogacy (Regulation) Act was notified on December 25, 2021. Through these new laws, the government wanted to ensure that infertile couples are assured and confident of ethical practices in these infertility clinics. The new laws provided a national framework for the accreditation, regulation and supervision of infertility clinics that have mushroomed across the country during the last more than three decades. Under the new law, all infertility clinics, ART banks and research organizations using human embryos are required to register themselves with the registration authority. Till then, anyone could open infertility or ART clinics in any part of the country as no permission was required for it. It is a fact that in the recent times, India has become one of the major centres of fertility treatment industry, with reproductive medical tourism becoming a significant activity, mainly because of higher success rates and affordable cost. For implementing these laws, the Union Health Ministry has recently constituted the National Assisted Reproductive Technology and Surrogacy Board (NARTSB) headed by the Union Health Minister as the chairperson. Under the new law, the NARTSB has powers to advise the Central government on policy matters relating to the ART, to review and monitor the implementation of the Act, rules and regulations, to lay down code of conduct to be observed by persons working at clinics and banks, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by the clinics and banks. Of course, the constitution of the Board will go a long way in regulating the ART clinics, banks and surrogacy in the country.

 

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