'Compliance Is Lived, Not Assembled Before an Inspection': Inside IVF's New Rulebook
By Arunima Rajan
In an interview with Arunima Rajan, Dr. Gautam Daftary, Founder and Chairman, Aksigen IVF, says that "clinics that treated the earlier ICMR guidelines as advisory will find that the same operating model does not survive under a statutory regime. Some will merge into larger networks, some will exit, and what remains will be a smaller number of institutionally serious providers."
How have the new IVF regulations changed the day-to-day of running a fertility centre, and how has Aksigen IVF adapted across its practice?
The ART (Regulation) Act, 2021 has moved the day-to-day of fertility practice from a discretion-based model to a documentation-based one. Every clinical and laboratory action now sits within a defined regulatory perimeter. Clinics must register with the National ART and Surrogacy Registry. Consent is structured by patient category and formally documented. Records are retained for the periods specified under the Act. There are procedural limits on embryos transferred to protect the health of mother and babies and a formal grievance mechanism must be in place. For centres that operated on informal protocols, this represents a material shift in how a clinical day is spent.
For Aksigen IVF, the adaptation has been one of alignment rather than reconstruction. Our operational baseline was already designed around a Quality Management System supported by defined Standard Operating Procedures and internal audit cycles, with corrective and preventive action treated as a discipline rather than a paperwork exercise. Digital documentation and treatment tracking runs through ROOTS 360, Aksigen IVF’s integrated clinical ecosystem. Laboratory specimen identification is governed through RFID Technology with biometric double witnessing to strengthen traceability across every critical step of gamete and embryo handling. Informed consent has always been treated as a documented clinical conversation, not a signature at the end of a form. What the regulation has done is codify these practices as sector-wide expectations, which we welcome.
The most visible changes have been in the frequency of regulatory reporting, registry submissions, and tighter procedural requirements. Those changes are important, but they strengthen rather than redefine the way we operate. The regulatory framework doesn't create a new standard, it formalises the standard that a science-led, knowledge-driven fertility institution should already hold itself to.
Aksigen comes from a pharmaceutical lineage where regulatory rigour is a given. Does that heritage make the transition to a regulated fertility sector easier, and what can standalone clinics learn from it?
Pharmaceutical manufacturing operates under Good Manufacturing Practice, batch-level documentation, mandatory deviation reporting, corrective and preventive action as a formal discipline, and periodic regulator-facing audits. In that environment, compliance is the operating baseline. Standard operating procedures are embedded in day-to-day practice and quality metrics are reviewed regularly at the board level, reinforcing organisational accountability. Data integrity is treated as inseparable from patient safety.
For a fertility centre transitioning into the framework created by the ART Act, 2021, that inheritance is meaningful. Deviations are documented honestly. Corrective actions are closed in defined timelines. Because quality systems are embedded into our everyday operations, external inspections are viewed as a routine aspect of institutional governance rather than an exceptional event. These inform how we designed our Quality Management System, our internal audit cycles, and the accountability structures around laboratory practice.
What standalone clinics can take from this is less about specific tools and more about culture. Compliance systems work when they are lived, not when they are assembled the week before an inspection. The Standard Operating Procedure a laboratory follows on an ordinary Tuesday morning is a better measure of institutional readiness than the file that sits in the compliance cabinet. Documentation is not paperwork; it is the instrument through which patient safety is verified.
The pharmaceutical sector arrived at that understanding through decades of regulator engagement. The fertility sector has the opportunity to arrive at it more quickly, because the framework, the standards, and the international reference points already exist. What is required is the willingness to internalise them as institutional culture.
Compliance is where most clinics will struggle: registration, documentation, reporting. What systems has your organisation built that the rest of the sector could learn from?
We have approached compliance as an architecture. The reason is straightforward. The three areas your question identifies -registration, documentation, and reporting-are the visible surface of an underlying system.
At the base is our Quality Management System, which defines Standard Operating Procedures for every clinical, laboratory, and administrative process, together with internal audit cycles and a formal corrective and preventive action mechanism. Above that sits ROOTS 360, our integrated digital ecosystem, which handles patient records, treatment tracking, and clinical documentation in a form that is both auditable and continuous. Laboratory identity governance runs through a RFID Technology with biometric double witnessing system, applied at every critical step of gamete and embryo handling, which is the practice international regulators have set as a minimum standard.
Consent is structured by patient category and captured as a documented clinical conversation rather than a signature. Training and competency are logged for every clinical and laboratory staff member. Vendor qualification, equipment calibration, and preventive maintenance run on defined schedules. Complaints, deviations, and adverse events flow into a single CAPA register with root cause traceability.
Every quality system evolves by definition, and ours is no exception. What we would offer to the sector is the framing more than the specifics. A fertility centre that treats compliance as an architecture, with each layer supporting the others, will find these baseline duties straightforward to sustain. A centre that treats them as separate exercises will find them exhausting and never quite complete.
For the patient walking into an IVF centre, what do these regulations actually change in terms of safety, consent, and trust?
For the patient, the framework does several concrete things, most of which she will never see directly.
On safety, the Act formalises how gametes and embryos must be identified, handled, stored, and traced through every step of the laboratory process. A patient does not observe this in the consultation room, but it is the reason her sample cannot be confused with another patient’s and it is the reason the embryo transferred to her is verifiably her own. The double witness discipline that leading laboratories follow becomes a legal expectation rather than a best practice.
On consent, the Act requires informed consent to be documented in writing for every stage of treatment, including cryopreservation of gametes and embryos and their eventual use or disposition. It ensures that the patient understands what she is agreeing to before she signs. In practice, that is only possible when the clinic invests in explanation, not in forms alone. Our own view is that informed consent is meaningful only when the patient can articulate the treatment pathway in her own words. That is why we built the Bharat Daftary
Knowledge Centre, our patient education initiative, as a permanent institutional function rather than a marketing exercise.
On trust, the framework establishes registered clinics as the only legitimate providers of ART, sets confidentiality requirements around patient and donor data, and creates grievance mechanisms that did not previously exist. For a couple entering fertility treatment, often at an emotionally difficult time, the regulatory framework is a form of protection they should not have to negotiate for. What the Act does is make that protection standard rather than optional.
For us at Aksigen IVF, this is the layer that matters most. Ultimately, the strongest quality systems are those that patients may never see but benefit from at every stage of their treatment.
Five years from now, what does India’s fertility sector look like under this framework, and what role do science-led players like Aksigen IVF play in shaping it?
Five years is a short horizon for a regulatory framework of this scale, but the direction is discernible.
The sector will consolidate. The compliance overhead created by the ART Act, from registration and audit readiness to laboratory standards and reporting obligations, is not trivial. Clinics that treated the earlier ICMR guidelines as advisory will find that the same operating model does not survive under a statutory regime. Some will merge into larger networks, some will exit, and what remains will be a smaller number of institutionally serious providers.
Outcomes reporting will also mature over this period. The National ART and Surrogacy Registry has initiated the process of obtaining data on every registered cycle. In time, that data will become the basis for policy decisions, guideline updates, and eventually a more informed public conversation about what fertility treatment can and cannot achieve. India will develop its own reference points for outcomes rather than importing them from Western registries.
Alongside this, the expectation of evidence-based practice will become sharper. Patients, referring doctors, and the media are all likely to ask more precise questions about why a particular protocol was recommended, what the evidence base for it is, and how the clinic tracks its own outcomes. That is a healthy pressure. It moves fertility care closer to how the rest of medicine is expected to operate.
For institutions like Aksigen IVF that were built around a knowledge-driven model, this is a favourable trajectory. Our role is defined narrowly and by contribution rather than claim. We publish and disseminate credible research in reproductive medicine. We contribute real-world data to the sector’s evidence base. We invest in education for practitioners and patients through the Bharat Daftary Knowledge Centre. We aim to show that a fertility centre can operate as a clinical institution rather than a service outlet. The framework the government has set now makes it easier for other institutions to make the same choice.
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