Your rights as a fertility patient in India: the ART Act explained

The Assisted Reproductive Technology (Regulation) Act 2021 is India's first comprehensive legislation specifically governing fertility treatment. Before the Act, ART clinics operated under ICMR guidelines that were advisory rather than legally enforceable. The Act makes several provisions legally binding and creates a framework of patient rights.

Key provisions relevant to patients: fertility clinics must be registered with the National ART Registry; patients must provide informed consent before any procedure; gamete donors must be tested for infectious and genetic diseases; and commercial surrogacy is prohibited for foreign nationals (though altruistic surrogacy under the Surrogacy Regulation Act 2021 remains permitted for eligible Indian nationals).

The Act established national and state-level ART regulatory boards to oversee compliance. As of 2024, implementation across India's large and diverse private fertility sector is ongoing, regulation is a baseline, not a guarantee of quality.

Under the ART Act, patients are entitled to: written informed consent before any procedure; full disclosure of the success rates of the clinic for your age group and condition; information about the qualifications of the medical team performing procedures; the right to withdraw consent at any stage before embryo transfer; and access to your medical records.

Gamete donation: if you are receiving donor eggs or sperm, the donor must be between 21 and 35 years of age (for women) or 21 and 55 years (for men). A woman can donate eggs a maximum of once to a single recipient couple (this limits the pool). Donors must be tested for HIV, hepatitis B and C, and known genetic conditions.

Embryo storage: embryos can be stored for a maximum of 5 years without specific consent for longer-term storage. After 5 years, further storage requires explicit written consent renewal. Clinics are required to notify you before the storage period expires.

Is the clinic registered under the ART Act 2021 and with the National ART Registry? Can I see the registration certificate? What are your live birth rates per embryo transfer for patients aged [my age]? What is included in the quoted price and what is not? Can I have a written list of all costs? What is your policy if a cycle is cancelled?

What consent documents will I be asked to sign and what does each cover? Who performs egg collection and embryo transfer, the same consultant or rotating staff? What is your embryo grading system and what grade embryos do you typically transfer?

These are reasonable questions. Reputable clinics will answer them. If a clinic is reluctant to provide registration details or written cost schedules, that is information worth considering.