The Centre Is Tightening Its Grip on IVF. Are Clinics Ready?
By Arunima Rajan
As the Centre locks unregistered clinics out of the IVF supply chain, three fertility leaders on what tighter oversight means for the industry.
Try buying a Schedule H drug without a prescription and the chemist will wave you away. The Centre now wants IVF supplies treated the same way. Manufacturers and distributors may sell IVF media, reagents and other laboratory consumables only to fertility clinics and sperm banks registered under the Assisted Reproductive Technology (ART) and Surrogacy Acts. No registration, no culture medium. The aim: shut unregistered operators out of the supply chain and tighten oversight of a fast-growing fertility industry.
The squeeze lands where it is aimed: no one can run an IVF cycle without media to grow embryos in. For registered clinics, the order signals that light-touch oversight is over. Written consent at every stage, ten-year records, donor traceability, advertising rules, age limits , the ART framework has already redrawn the working day of fertility medicine. Hospital chains with electronic records and quality teams absorb each new rule with a software update. A standalone clinic keeping registers by hand must build those systems from scratch. For the couple walking in, the promise is fewer surprises: counselled, documented and traceable from first consultation to embryo transfer.
Three people watch this shift from close quarters: Dr Nikita Lad, Senior Consultant, IVF at Apollo Hospitals Navi Mumbai; Anjali Ajaikumar, Executive Director of Milann Fertility & Birthing Hospital, part of Healthcare Global Enterprises Limited (HCG); and Dr Manika Khanna, Chairperson and Managing Director of Gaudium IVF. All three run organised, well-resourced networks, the kind the rules favour. The standalone clinics with the most to lose are not in the room.
Structure replaces improvisation
For patients, the clearest change is what regulation now guarantees before treatment even begins. "For patients, the biggest change is greater confidence that fertility centres are operating under consistent standards and are regularly assessed for compliance," says Khanna. "A structured regulatory framework encourages better record maintenance, stronger quality processes, and greater accountability, helping ensure that patients receive treatment from centres that meet defined clinical and ethical requirements."
Lad, who runs the day-to-day of a clinic under this new framework, describes exactly what that structure looks like on the ground. "The biggest shift has been towards structure and transparency," she says. "The ART framework now requires written informed consent at every stage, documented eligibility assessments, counselling that covers success probabilities, costs, risks and confidentiality, and records that must be maintained for a minimum of ten years." The effect, she says, is front-loaded but worthwhile: "In practice, that means effective time invested at the front end of a patient's journey, and it ensures couples arrive better prepared, ask sharper questions and feel more confident in the decisions they are making. The workflow from first consultation through stimulation, ovum pickup, embryo development and transfer is now more disciplined and more accountable, and that benefits everyone in the room."
The hardest conversations
Structure has a harder edge too. The Act draws firm lines on who can be treated and by whom, and clinicians are the ones who have to deliver that news. "These are among the most difficult conversations we have, because fertility treatment is rarely just a medical decision , it carries enormous emotional weight," Lad says. "Under the Act, ART treatment is available to women aged 21 to below 50 and men aged 21 to below 55. Gamete donation is tightly regulated: male donors must be between 21 and 55, oocyte donors between 23 and 35, a donor cannot be used for more than one commissioning couple, and an oocyte donor may donate only once in her lifetime."
When a patient falls outside those boundaries, Lad says the regulation itself is not where the conversation starts. "When a patient does not meet these criteria, I do not lead with the regulation , I lead with the person in front of me. We take the time to explain the reasoning behind these boundaries, answer questions honestly and without judgement, and then shift the conversation toward what is medically appropriate, ethically compliant and realistically achievable for them. Compassionate counselling is not a supplement to clinical care in fertility medicine. It is part of the treatment itself."
What the new rules ask of the lab
Behind the clinic floor, the regulations reach into spaces patients never see. "The impact on the laboratory has been significant, and largely positive," Lad says. "The framework now requires detailed records of donor oocytes, sperm and embryos, computerised documentation that supports retrospective review, and regular calibration and maintenance logs for laboratory equipment." What used to run on informal habits is now written down. "In practice, this has reinforced an already strong culture of precision by formalising chain-of-custody practices, tightening specimen identification protocols and making quality control a documented process rather than an assumed one. Patients rarely see what happens inside an embryology laboratory, but everything that happens there determines the outcome of their treatment. The regulations have made those processes more rigorous, more traceable and more defensible , and that ultimately strengthens confidence in the entire programme."
Marketing loses ground to accountability
In markets where patients compare clinics on price and promised success rates, new advertising rules change what a clinic can claim. "Yes, and that matters more than it might appear," Lad says. "Fertility treatment decisions should be driven by medical suitability and realistic clinical expectations, not by marketing language. Success in IVF is shaped by a combination of factors , a woman's age, ovarian reserve, sperm parameters, underlying conditions and previous treatment history , and no responsible clinician can promise a guaranteed outcome. Regulations that discourage misleading claims and require greater transparency around consent, counselling and documented processes shift the basis of comparison from advertising to accountability. For ethical practitioners, that is a fairer environment. For patients, it is a safer one. In Navi Mumbai, where patients are informed and often consult multiple centres simultaneously, clearer rules reward the clinics that have invested in genuine clinical quality rather than promotional promises."
For established players, a natural fit
If the new regime feels disruptive to smaller operators, it barely registers at institutions that were already run this way. Ajaikumar, at Milann, points to three decades of internal governance that predates the law. "Milann has been running fertility centres for over 30 years, so regulatory compliance has always been part of how we work," she says. "The recent IVF regulations haven't changed the way we run our centres, because the systems, processes, and safeguards needed to deliver high-quality fertility care were already in place. Our flagship centre is accredited by both NABH and NABL, which means we already work within stringent quality standards and well-defined clinical protocols."
The discipline, she says, has always come from within. "More importantly, our clinical governance has always been driven by our clinicians. Every Tuesday for over three decades, they have met to review cases, share what they've learned, and refine our protocols and practices. Our focus has always been on doing the right thing for our patients, ethically, clinically, at the right time, and right the first time. That culture of continuous learning, governance, and quality runs through every one of our centres. So yes, operating within a hospital framework where clinical governance and quality standards already run deep has made the new regime a natural fit. Rather than changing how we work, these regulations reinforce practices that have always been central to Milann. Their impact on our day-to-day operations has been minimal because they align with standards we have upheld for years."
The business case for regulation
For Khanna, whose Gaudium IVF crossed ₹100 crore in revenue in FY26, tighter rules are not a brake on growth but a filter that favours organised providers. "We believe a stronger regulatory framework strengthens the sector by ensuring fertility services are delivered by centres that meet defined standards of quality and ethics," she says. "Our FY26 performance demonstrates that growth and compliance can go hand in hand. We see regulation as a positive force that rewards organised, quality-focused providers with robust clinical processes, while building greater trust among patients seeking fertility treatment."
What comes next
Looking ahead, Lad expects the regulatory foundation now in place to enable, rather than slow, the sector's technological turn. "I expect the next five years to bring greater standardisation, stronger data infrastructure and deeper integration of technology into fertility care. AI-assisted embryo assessment, expanded preimplantation genetic testing, fertility preservation for medical and elective indications, and more personalised treatment protocols based on genomic and hormonal profiling are all moving from the frontier toward routine practice. The regulatory foundation that has been established creates the conditions for that evolution to happen responsibly."
Her wish list, though, is for less paperwork, not less oversight. "What I would still like to see is a simplification of compliance processes , not a lowering of standards, but a shift toward digital systems that reduce the administrative burden on clinicians so that more of our time and energy goes toward patient care and counselling. Beyond that, I would welcome a stronger national focus on fertility education, preventive reproductive health and equitable access to quality fertility services for patients who currently cannot reach or afford them. The framework has set a sound foundation. The work now is to build on it in a way that genuinely serves every patient, not just those in well-resourced urban centres."
That last line is the one worth sitting with.
The three voices in this story run organised, accredited, well-capitalised networks , exactly the operators built to absorb new compliance costs without blinking. The standalone clinics now locked out of the supply chain without ART registration are not describing the transition in their own words here, and it is an open question how many of them survive it.
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