Consent in IVF: What the ART Act Requires in India

Written consent, from a registered clinic, within defined eligibility limits. The Assisted Reproductive Technology (Regulation) Act 2021 has governed every IVF clinic, ART bank and donor program in India since 25 January 2022.

Consent is explicitly mandated rather than assumed. That places a legal obligation on the clinic, not merely a procedural one, and it applies to each stage of treatment rather than being given once at the start.

• Written patient consent is mandated by the Act.
• Clinic registration with the National Registry is compulsory.
• Age eligibility: 21–50 for the woman, 21–55 for the man.
• Donor screening standards are set in law.

Those age limits are legal rather than clinical. A clinic cannot waive them however reasonable an individual case may seem, which is worth knowing before starting a process that will run into them.

Not where the material is jointly created. An embryo made from both partners' gametes generally requires the ongoing consent of both to be used, and consent given earlier can usually be withdrawn.

This is the practical difference between freezing eggs and freezing embryos, and it is a legal distinction rather than a medical one. A frozen egg remains under the control of one person; a frozen embryo does not.

• Embryos generally require both parties' continuing consent.
• Consent can typically be withdrawn before use.
• A frozen egg remains under one person's control.
• Some people freeze both, precisely to keep options open.

The asymmetry is worth understanding before storage rather than after. A couple freezing embryos together is making a decision that binds both of them to a continuing agreement, and the point at which that agreement is tested is usually the point at which it is hardest to reach.

Our article on egg freezing versus embryo freezing covers this choice, including why the ownership question often matters more than the survival rates people compare.

Each stage separately, in language you actually understood at the time. A signature obtained without explanation satisfies nobody's interest, including the clinic's.

• What happens to unused embryos, and for how long they are stored.
• What happens on separation, death, or withdrawal of consent.
• Whether donor gametes are involved and what screening applies.
• Any add-on procedures, priced and explained separately.

Add-ons deserve particular attention here, because consent to a cycle is sometimes treated as consent to whatever is offered within it. Our article on PGT-A covers a widely sold example where ASRM states the value as routine screening has not been demonstrated — and ASRM itself says informed consent should cover risks, benefits and limitations.

Ask for a copy of everything you sign. People routinely have no record of what they agreed to, which becomes a problem precisely when it matters most.

Consent forms are also where storage duration and renewal appear, and both are easy to miss. Storage is not indefinite by default, fees usually continue, and lapsing without a decision is a way of making one by accident.

Give you legal advice. This is a general description of what the ART Act requires, and any specific situation — a dispute, a separation, a question about stored embryos — needs a lawyer familiar with Indian reproductive law.

• Provisions are interpreted by courts, and interpretations develop.
• The Surrogacy (Regulation) Act 2021 governs surrogacy separately.
• Clinic policies sit alongside the law and vary.
• Written records matter enormously in any dispute.

The most useful protection is administrative rather than legal: keep copies, ask for decisions in writing, and be clear at the outset about what happens to stored material in each of the circumstances that might arise.

These conversations are uncomfortable precisely because they concern situations nobody starting treatment expects — separation, disagreement, death. Having them at the beginning, when everyone agrees, is far easier than having them later.

The registration requirement is worth using as well. A clinic operating within a statutory framework can be asked to show its registration and level, and a clinic reluctant to do so has told you something about how it handles the rest of its obligations — see our article on choosing a clinic.