India’s IVF boom has a shadow side: Now comes the crackdown

Somewhere in the distance between a couple’s hope and their bank balance, a shadow economy has been quietly thriving.

India’s IVF sector is one of the fastest-growing fertility markets on earth. Valued at $864.6 million in 2024, it is projected to reach $3.4 billion by 2033, a growth trajectory powered by rising infertility rates, declining social stigma around assisted reproduction, and an expanding middle class willing to spend significant sums in pursuit of parenthood. Clinics have proliferated in tier-two cities, in smaller towns, in neighbourhoods where, not long ago, conversations about fertility were conducted only in whispers.

Many of those clinics are registered, regulated, and operate in accordance with established medical and ethical standards. Many of the Drug Controller General of India’s notes in last week’s circular are not.

On June 23, DCGI Rajeev Raghuvanshi issued a directive that illuminates, in the dry language of regulatory enforcement, the gap between the industry India’s fertility market has become and the oversight framework India has actually built for it. The instruction: cut off the supply of IVF media, reagents, and laboratory consumables to facilities not registered under the Assisted Reproductive Technology (Regulation) Act, 2021 or the Surrogacy (Regulation) Act, 2021.

It is, in its way, an acknowledgment of something that direct enforcement cannot easily accomplish.

Policing the inputs, not the clinic
The regulatory logic of the DCGI directive is significant and underappreciated. India has thousands of fertility clinics operating across a vast and heterogeneous geography. Inspecting each one, verifying registration, assessing laboratory conditions, evaluating the credentials of medical personnel, auditing equipment, demands resources and institutional capacity that state drug control authorities do not uniformly possess.

What those authorities can do, more tractably, is go upstream.

IVF media, the culture solutions in which embryos develop, are not household items. Reagents and laboratory consumables used in assisted reproduction are specialised medical devices, imported or produced by a limited number of manufacturers and distributors, and governed by supply chains that are inherently more visible than the clinical facilities that use them. If a manufacturer or distributor continues supplying an unregistered clinic, they become complicit in the risk. The regulatory burden shifts to a smaller, more legible set of actors.

This is the architecture of supply chain enforcement: govern the chokepoints, not the endpoints. It is the same logic that has been applied to pharmaceutical distribution, to the supply of controlled substances, and, increasingly, to medical device markets, where field enforcement is impractical at scale.

Whether it will work in the IVF context depends on how rigorously it is implemented. Manufacturers and distributors who ignore DCGI directives, cannot verify their customers’ registration status, or face commercial pressure to supply, regardless, remain weak links. The circular directs state and zonal CDSCO offices to strengthen monitoring and enforcement, but the quality of that monitoring will vary, and the geography of India’s informal fertility sector is deliberately difficult to map.

The patients no one is officially counting
The harder question behind the DCGI circular is not who is supplying unregistered clinics. It is who is going to them, and why.

IVF is expensive. At a registered, well-equipped urban fertility centre, a single IVF cycle in India costs between ₹1.5 lakh and ₹3 lakh or more. For many families, particularly in smaller towns and rural areas where proximity to accredited centres is limited, that figure requires borrowing, liquidating savings, or borrowing from family. Multiple cycles, the statistical reality for a large proportion of patients, multiply that burden.

Unregistered clinics, by contrast, often offer services at lower cost. They may be geographically closer. They may be socially familiar, run by practitioners who are known in the community, who don’t require patients to navigate the formal paperwork and institutional unfamiliarity of large urban hospitals. For couples who are already navigating the emotional complexity of infertility, these practical frictions are not trivial.

None of this excuses the risk. IVF is, as practitioners rightly note, a highly specialised procedure where laboratory conditions are not peripheral but central to outcomes. Embryos cultured in substandard media, handled with contaminated equipment, or stored in improperly maintained cryogenic facilities do not simply produce lower success rates, they can produce infections, failed pregnancies, and medical emergencies in patients who were not told, and may not have known to ask, whether the facility treating them met any regulated standard.

But the people using those clinics are not choosing recklessness. They are often choosing between options that have all been made inadequate by a system that has allowed a market to grow faster than the infrastructure of access and accountability around it.

A $3.4 billion market with a 2021 rulebook
India’s regulatory framework for assisted reproduction is, by global standards, recent. The ART (Regulation) Act was passed in 2021, nearly four decades after IVF was first performed in the country. The Surrogacy (Regulation) Act followed the same year. Both came after years of vacuum, during which India’s fertility sector operated without a national legislative framework, governed only by advisory guidelines from the Indian Council of Medical Research that carried no legal force.

The consequences of that long period of regulatory absence are still being worked through. Clinics that established themselves and built patient bases during the years of soft oversight did not automatically transform into compliant registered entities when the 2021 legislation came into force. Registration requires documented infrastructure, qualified personnel, and administrative compliance across multiple regulatory domains. For some clinics, meeting that bar represents a genuine operational upgrade. For others, it represents a commitment they have chosen not to make.

Meanwhile, the market has continued to grow. India’s IVF boom is driven by real demographic and social forces: rising rates of polycystic ovary syndrome and other fertility conditions linked to changing lifestyles, delayed marriage and childbearing among educated urban populations, returning NRIs seeking treatment at Indian prices, and the gradual but real erosion of the social silence that once surrounded infertility. A sector that attracted ₹864 million in revenue in 2024 will not stand still while regulators catch up.

The DCGI directive is not a systemic solution to this gap. It is an enforcement action directed at one input, laboratory consumables, within a wider informal fertility market that also includes unlicensed personnel, unapproved genetic testing, unregistered egg donors, and commercial surrogacy arrangements that exist in murky legal territory since the 2021 acts narrowed who can legally serve as a surrogate. Cutting reagent supply to unregistered clinics is a meaningful intervention. It is not, by itself, a framework.

What registration actually means, and doesn’t
The 2021 ART Act requires fertility clinics to register with the national ART registry, maintained by the National Registry Authority. Registration mandates minimum infrastructure standards, prescribed minimum qualifications for medical and embryological staff, and conditions for the ethical conduct of treatment. In theory, this creates a floor below which no registered clinic can fall.

In practice, registration is a point-in-time event, not a continuous guarantee. A clinic registered in 2022 under conditions it met at the time may not have maintained those conditions. Laboratory equipment ages. Staff turn over. Quality assurance systems erode when there is no ongoing inspection regime to create accountability for their maintenance. The supply chain intervention now being pursued by DCGI does not address what happens after registration, only what happens when a clinic has not obtained it at all.

Patients are advised, reasonably, to verify whether an IVF clinic is registered before beginning treatment. But informed consent in fertility medicine is never purely a matter of checking a registry entry. It requires understanding what that registration actually certifies, how recently the clinic was last inspected, what qualifications the attending embryologist holds, and what the clinic’s own success rate data look like, data that, in India, is not uniformly collected, standardised, or publicly available.

The fertility sector’s leading practitioners are right to welcome the DCGI directive as a step toward safeguarding patient safety. But they know better than anyone that safety in IVF is not a binary condition that registration toggles on. It is a continuous function of laboratory practice, team expertise, and quality culture, none of which a circular about reagent supply chains can produce.

The coming transparency deficit
India’s IVF market will be valued in the billions within a decade. The patients who will constitute that market deserve not just protection from the worst actors in the informal sector, but something the formal sector currently does not provide uniformly: comparable, standardised, publicly accessible outcome data.

In the United Kingdom, the Human Fertilisation and Embryology Authority publishes clinic-by-clinic success rate data, adjusted for patient age and treatment history, allowing prospective patients to make meaningful comparisons. In the United States, the Society for Assisted Reproductive Technology maintains a national database of reported outcomes. Neither system is perfect. Both are substantially more informative than what India currently offers.

A regulatory framework that is only now, in 2025, moving to cut reagent supply to unregistered clinics is a framework that has not yet reached the harder question of what it expects from the registered ones. Transparency of outcomes, not just the fact of registration, but the quality of the treatment that registration is supposed to guarantee, is the next frontier of accountability in India’s fertility sector.

The DCGI directive is, in this sense, necessary but first-order. It establishes a floor. What happens above that floor, in the formally recognised, rapidly expanding, commercially ambitious fertility market that will serve millions of Indian families over the next decade, is the question that no single circular can answer.

The supply chain crackdown will catch some clinics. The couples who needed those clinics to be affordable, accessible, and close to home will remain.

That is the part of the problem that a reagent directive cannot reach.
MB Bureau