‘The Focus Is Paperwork, Not Patients’: Experts Flag Gaps in India’s ART Law

India’s fertility sector has undergone a profound transformation over the past three decades — from a small, tightly-knit community of pioneering clinicians to a multi-billion-dollar industry spanning thousands of clinics nationwide. Alongside this growth has come the weight of statutory oversight, with the Assisted Reproductive Technology (Regulation) Act and the Surrogacy (Regulation) Act now defining the terms under which fertility care is delivered across the country.

Whether those terms are serving patients — or serving the state — was the central question at a recent panel titled “Parenthood under Regulation – Where the ART & Surrogacy Law Fall Short.” The discussion brought together some of India’s foremost voices in reproductive medicine, fertility law, and public health to examine a law that many in the sector see as both necessary and, in its current form, in need of significant refinement.

PANELISTS

Few people in India understand the arc of IVF’s evolution quite like Dr. Hrishikesh Pai, who was among the very first practitioners to establish fertility clinics in the country. His account of the field’s early years paints a picture strikingly different from today’s regulatory landscape — one shaped less by legislation and more by the informal bonds between a small community of clinicians determined to bring world-class reproductive medicine to India.

As the industry scaled and ethical concerns began to surface — around donor exploitation, unverified success claims, and inconsistent standards — calls for formal regulation grew louder. Dr. Pai was part of early consultations that helped shape draft policy frameworks. But the law that ultimately reached Parliament diverged in important ways from what the scientific community had envisioned. The final text crossed a line that most medical legislation in India carefully avoids: prescribing not just what must be achieved, but precisely how it should be done.

Yet Dr. Pai is careful not to dismiss the law’s intent. In a country where clinical quality can vary dramatically between a well-equipped private clinic in Mumbai and a smaller setup in a Tier-3 town, a binding national standard carries real value.

The tension between regulatory intent and clinical reality was sharpened by Dr. Aniruddha Malpani, whose critique of the ART Act cuts to its philosophical core. For Dr. Malpani, the law’s fundamental flaw is not its existence but its authorship — the sense that it was conceived by administrators who understand governance machinery far better than they understand the doctor-patient relationship.

His concern is not abstract. Every hour a clinician spends navigating documentation requirements is an hour not spent in consultation. Every rupee a clinic diverts to compliance infrastructure is a rupee not invested in laboratory equipment or training. These trade-offs accumulate into a measurable cost borne ultimately by patients — in the form of higher fees, shorter appointments, and a fertility ecosystem increasingly shaped by risk aversion rather than clinical excellence.

“The problem with many laws is that they are written by bureaucrats who understand paperwork. Today the focus is on documentation and compliance rather than improving pregnancy rates or patient outcomes.”

— Dr. Aniruddha Malpani, MD, Malpani Infertility Clinic

“If I spend more time filling forms than talking to my patients, that is not good for patient care.”

— Dr. Aniruddha Malpani

One of the panel’s most provocative threads concerned the law of unintended consequences. Several provisions within the ART Act — particularly those governing donor gametes — are so restrictive, panelists argued, that they risk driving demand underground rather than protecting the people they were designed to safeguard.

“India is perhaps the only country that has created an ART bank structure at the stroke of a pen.”

— Dr. Aniruddha Malpani

 

“The demand for donor eggs will not disappear. If supply becomes restricted, it risks creating a black market.”

— Dr. Aniruddha Malpani

The panel’s legal voices added a constitutional dimension to this discussion. Several provisions of the ART Act are currently being challenged in the Supreme Court of India, with petitions questioning whether certain eligibility restrictions and procedural mandates cross the line from reasonable regulation into unreasonable infringement.

“Reproductive rights are recognised as fundamental rights, but they are not absolute. The question is whether the restrictions imposed by the government are reasonable.”

— Legal expert participating in the discussion

“One critical issue is that the law recognises only altruistic or commercial arrangements, while ignoring the middle ground of compensatory frameworks.”

— Legal expert participating in the discussion

Interestingly, not all stakeholders view the law as restrictive. From an academic and public health perspective, institutions see the regulation as enabling rather than limiting. Dr. Muriel Cardoso of Goa Medical College offered a perspective that reframes the entire debate — one shaped by the realities of building a fertility programme within a public institution rather than inheriting an established private practice.

“We started IVF only two years ago, and the law helped us set up a state-of-the-art centre. Everything — from infrastructure requirements to documentation — was clearly defined.”

— Dr. Muriel Cardoso, Professor & Head, Obstetrics & Gynaecology, Goa Medical College

This divergence of experience matters. It suggests that the ART Act’s impact is not uniform — it lands differently depending on institutional context, prior capability, and resource base. For well-resourced private clinics with established protocols, the law feels like bureaucratic overreach. For newer or public-sector institutions starting from a lower baseline, that same framework can provide genuine scaffolding.

Wherever panelists stood on the merits of regulation, there was broad agreement on one concern: that the compliance costs embedded in the ART Act could structurally disadvantage smaller clinics — and by extension, the patients who depend on them. If rising compliance costs force smaller clinics to close or consolidate, the effective reach of fertility care contracts — not expands.

Perhaps the sharpest critique to emerge from the panel was not about what the ART Act regulates, but what it conspicuously fails to regulate: outcomes. For all its granular attention to equipment specifications, consent procedures, and institutional registration, the law contains no mandatory requirement for clinics to publicly report their success rates.

“A sensible law would have asked clinics to report their success rates transparently. That would help patients differentiate between good clinics and bad clinics.”

— Dr. Aniruddha Malpani

“Today any clinic can claim an 80 percent success rate. Patients have no reliable way of verifying those claims.”

— Dr. Aniruddha Malpani

WHAT THE ART ACT DOESN’T REQUIRE

Despite the breadth of criticism levelled at the law’s implementation and design, the panel did not call for its repeal. The consensus was subtler and, ultimately, more constructive: the ART Act represents a genuine step forward for a sector that operated without binding rules for too long. What matters now is whether India has the institutional will to refine it — to replace box-ticking compliance with outcome-driven accountability, and to ensure that the law evolves alongside the science and society it is meant to serve.

“We are an evolving society. The law is good, but it needs tweaking. Dialogue with the government is essential.”

— Dr. Hrishikesh Pai

That dialogue, panelists agreed, is not just desirable — it is overdue. The fertility sector, the legal community, and public health institutions each bring perspectives that a law of this complexity cannot afford to ignore. India’s millions of infertile couples deserve a regulatory framework as sophisticated as the medicine meant to help them.

DISCLAIMER & ATTRIBUTION

All original reporting rights and intellectual property belong to ETHealthWorld, The Economic Times Group. Dr. Hrishikesh Pai’s quotes are reproduced verbatim from the original article. All other editorial content is an original rewrite for presentation purposes. Refer to the original article at: health.economictimes.indiatimes.com/news/industry/ivf-in-india-the-controversy-over-regulation-and-patient-care/129441350