Most Indian fertility clinics take consent the way they did fifteen years ago. A form at registration. A signature. A file in a cupboard.
The Digital Personal Data Protection Act 2023 asks for something different. The DPDP Rules were notified on 13 November 2025, and full substantive compliance — notice, consent, data principal rights, retention limits, breach reporting — becomes enforceable on 13 May 2027.
That is not far away. And in fertility, the gap between what clinics do now and what the Act requires is wider than almost anywhere else in medicine.
Why fertility is harder
A fertility patient's data travels further than most. Registration. Consultation notes. Hormone panels. Semen analysis. Embryo grading. Cryostorage that may last a decade. Pharmacy. Insurance. Registry submissions under the ART Act.
Three things make it harder still.
The consent is often joint. Two people, one embryo, and sometimes different wishes about what should happen if circumstances change. A single signature does not resolve that.
Storage outlasts treatment. Cryopreserved material carries a consent period measured in years. When it lapses, an obligation follows. In most clinics that tracking lives in an embryologist's spreadsheet.
Two laws run alongside each other. The ART (Regulation) Act 2021 has its own consent and record-keeping requirements. Meeting one does not mean meeting the other.
What the Act says
On purpose-specific consent
The Act describes consent as free, specific, informed, unconditional and unambiguous, given for a defined purpose.
On that reading, a single signature covering "treatment" sits awkwardly alongside the separate purposes a fertility clinic actually processes data for — sending a report to a pharmacy, storing an embryo for eight years, submitting outcomes to a registry. Most clinic consent forms I have seen are a single page covering everything at once.
On language
The Act provides for notice in English or any language listed in the Eighth Schedule of the Constitution — 22 languages in total.
It is worth sitting with what that means for a clinic where consultations happen in Tamil, Punjabi or Bengali but the paperwork does not. Building consent flows in 22 languages is expensive, and English is easier — which is why most clinical software in India does not do it.
On withdrawal
The Act provides that withdrawing consent should be no harder than giving it was.
That raises a practical question for any clinic: at any given moment, what has this patient agreed to, and what have they taken back? A paper file in a cupboard struggles to answer it. So do most EMRs, because they record the signature rather than the current state.
On stored material
Cryopreserved material carries a consent period, and when it approaches its end something has to happen — a conversation with the patient, a renewal, or acting on wishes recorded years earlier. Knowing which specimens are approaching that point is the first step, and in most clinics that information lives in a spreadsheet.
Three questions worth asking this week
Questions worth working through with your own advisors
- Can you produce, for any patient, a record of what they consented to and when?
- If a patient asks you to withdraw consent for one purpose but not others, can your system do that?
- Do you know which stored specimens have consent periods expiring in the next 90 days?
None of those has a single right answer, and the right answer for a two-doctor clinic in Tiruppur is not the same as for a chain with forty centres. But they are the questions I have found most useful when clinics ask me where to start.
The part that matters more than the deadline
None of this is really about penalties.
A couple going through IVF hands over the most private information they have, at the most vulnerable point in their lives. They are asked to trust a clinic with it at a moment when they have very little capacity to ask hard questions about where it goes.
I went through IVF as a patient before I started building software for clinics. That is the part I keep coming back to.
This is a general summary of publicly available law, written from a software builder's perspective rather than a legal one. It is not legal advice and should not be relied on as such. Consult a qualified advocate about your clinic's specific obligations under the DPDP Act 2023 and the ART (Regulation) Act 2021.
Building for this from the ground up
Fertiva Pro handles consent, consultation documentation and patient communication across 22 Indian languages — built to the requirements of the DPDP Act 2023 and the ART (Regulation) Act 2021, rather than adapted to them afterwards.
See it in your clinic →