Mumbai: India’s assisted reproductive technology (ART) ecosystem, once driven largely by clinician-led innovation and peer learning, now operates under one of the most detailed regulatory frameworks in the world. While the ART Act and Surrogacy Act were designed to curb exploitation, improve transparency, and standardise fertility care, experts say the laws have also triggered an intense debate around clinical autonomy, access, and patient interests.
At a recent panel discussion titled “Parenthood under Regulation – Where the ART & Surrogacy Law Fall Short,” Dr. Hrishikesh Pai, Founder and Medical Director, The Bloom IVF Group, Dr. Aniruddha Malpani, MD, Malpani Infertility Clinic, Advocate Radhika Thapar Bahl, Founder & Chief Mentor, Fertility Law Care (FLC)
Dr. Muriel Cardoso, Professor & Head, Obstetrics and Gynaecology, Goa Medical College examined how the balance has shifted from clinical freedom to statutory oversight—and whether regulation is strengthening the fertility ecosystem or inadvertently complicating it. The session was moderated by Prathiba Raju, Senior Assistant Editor, ETHealthworld,The Economic Times Group.
Recounting the early years of IVF practice in India, Dr Pai, said the field initially evolved through collaboration among clinicians rather than regulatory mandates.
“In 1990, when we started IVF, there were barely ten of us practising in the country,” he said. “Everything evolved clinically—through interaction, learning from international centres, and gradually building IVF practices and professional organisations like ISAR.”
Over time, concerns around ethical practices prompted discussions around regulation. According to Dr. Pai, early policy drafts were shaped through extensive dialogue with scientists such as Dr. Pushpa Bhargava, but the final legislation eventually took a different form after parliamentary deliberations.
While acknowledging the need for regulation, he cautioned that the law has moved beyond oversight into prescriptive territory.
“Most medical laws are regulatory—they tell you what should be done but not how to do it. This law crosses that line slightly by specifying equipment and processes,” he said. “How to perform procedures should ideally be left to the scientific community.”
At the same time, he acknowledged that regulation can help bring uniformity in a country with wide variations in clinical standards.
“In a country like India, sometimes you need a law to ensure uniformity,” Dr. Pai noted. “It brings transparency, reproducibility and standardisation.”
Paperwork Over Patient Care?
However, not all clinicians share the same optimism. Dr. Malpani, argued that the regulatory framework risks prioritising compliance over patient care.
“The problem with many laws is that they are written by bureaucrats who understand paperwork,” he said. “Today the focus is on documentation and compliance rather than improving pregnancy rates or patient outcomes.”
According to him, the administrative burden may ultimately translate into higher treatment costs and reduced doctor–patient engagement.
“If I spend more time filling forms than talking to my patients, that is not good for patient care,” Dr. Malpani said.
He also questioned why IVF is being regulated more strictly than many other medical procedures.
“Nowhere else do you tell doctors exactly how to perform a surgery. The medical profession traditionally operates with autonomy and professional accountability,” he said.
Regulation and the Risk of Black Markets
Another major concern raised during the discussion was that restrictive provisions could unintentionally create informal markets.
For instance, Dr. Malpani pointed out that India has introduced unique regulatory concepts such as ART banks, which are uncommon globally.
“India is perhaps the only country that has created an ART bank structure at the stroke of a pen,” he said.
Similarly, tight restrictions on egg donation could push the practice underground rather than eliminate it.
“The demand for donor eggs will not disappear,” he explained. “If supply becomes restricted, it risks creating a black market.”
Legal expert on the panel emphasised that regulation is necessary, especially in areas involving multiple stakeholders such as patients, donors, and surrogates.
“ART treatments involve processes that take place outside the human body and involve several parties. Law therefore becomes inevitable to protect the interests of everyone involved,” said a legal expert participating in the discussion.
However, they acknowledged that certain provisions may have overlooked practical realities.
“One critical issue is that the law recognises only altruistic or commercial arrangements, while ignoring the middle ground of compensatory frameworks,” the expert said.
Highlighted the constitutional question emerging from eligibility criteria is embedded in the legislation.
“Reproductive rights are recognised as fundamental rights, but they are not absolute. The question is whether the restrictions imposed by the government are reasonable,” the expert explained.
Several petitions challenging these provisions are currently pending before the Supreme Court of India, which could potentially reshape aspects of the regulatory framework.
Public Sector Experience: A Different Perspective
Interestingly, not all stakeholders view the law as restrictive. From an academic and public health perspective, some institutions see the regulation as enabling rather than limiting.
Dr Cardoso, said the law actually helped the institution establish a structured IVF facility.
“We started IVF only two years ago, and the law helped us set up a state-of-the-art centre,” she said. “Everything—from infrastructure requirements to documentation—was clearly defined.”
According to her, the regulatory blueprint simplified the process of establishing a public sector fertility centre.
“We simply followed the framework provided in the law, and the implementation was smooth,” she added.
The discussion also raised concerns about how regulatory requirements could affect smaller clinics, particularly in tier-2 and tier-3 cities.
While national standards are essential, stricter compliance norms could increase operational costs.
“Implementation costs may go up,” Dr. Pai noted. “And smaller centres may find it difficult to sustain operations, which could affect access to care.”
At the same time, he emphasised that India remains globally competitive in reproductive medicine due to its combination of clinical expertise and affordability.
“Our strength has always been skill combined with affordability,” he said. “We must maintain that balance.”
Regulating Processes or Outcomes?
One of the most striking criticisms of the current regulatory framework was the absence of mandatory transparency around treatment outcomes.
Dr. Malpani argued that requiring clinics to publicly report success rates would have been a far more effective reform.
“A sensible law would have asked clinics to report their success rates transparently,” he said. “That would help patients differentiate between good clinics and bad clinics.”
Without such mechanisms, he warned, patients struggle to evaluate the quality of care.
“Today any clinic can claim an 80 percent success rate,” he said. “Patients have no reliable way of verifying those claims.”
Despite the differences in perspective, panelists broadly agreed that the regulatory framework is still evolving and could benefit from ongoing dialogue between clinicians, policymakers, and legal experts.
“We are an evolving society,” Dr. Pai said. “The law is good, but it needs tweaking. Dialogue with the government is essential.”
Ultimately, the debate highlighted a deeper policy question on how to regulate a rapidly growing fertility industry without stifling innovation, access, or patient choice.
As India positions itself as a global hub for reproductive medicine, the challenge will be ensuring that regulation strengthens the ecosystem while keeping the infertile couple the central stakeholder at the heart of the policy conversation.
