Fertility law in India: what it means for you

The Assisted Reproductive Technology (Regulation) Act 2021 came into force in India to regulate fertility clinics, ART banks (which store eggs, sperm, and embryos), and the practice of assisted reproduction. It sets out who can access treatment, what clinics must do before starting treatment, and what safeguards exist for donors and patients.

Importantly, the ART Act regulates clinics and banks, not patient information apps. An educational app like Appy + Yaar falls outside the scope of the Act entirely, provided content remains informational rather than diagnostic or prescriptive.

Under the ART Regulation Act 2021, access to assisted reproductive technology is available to:

• • Married couples (heterosexual), the primary intended recipients under the Act.
• • Single women, can access ART under the Act. Single men are not expressly included as intended commissioning parties.
• • Age requirements: women between 23 and 50, men between 21 and 55 years of age, as per the Act's eligibility criteria.

The ART Regulation Act 2021 sets out several protections for patients undergoing fertility treatment. These are things you can ask your clinic about:

• Informed consent: clinics must obtain written informed consent before starting any ART procedure. You have the right to understand what you are consenting to and to ask questions before signing.
• Counselling: registered clinics are required to offer pre-treatment counselling. You may ask your clinic what counselling services they provide before you start.
• Donor anonymity: gamete donors (egg and sperm donors) are entitled to anonymity under the Act. A donor cannot be the same person for more than one commissioning couple or woman.
• Limit on embryos transferred: ICMR guidelines advise transferring no more than three embryos in a single cycle to reduce multiple pregnancy risk. Your clinic should discuss the number of embryos to transfer with you.

Under the ART Act, clinics must be registered with the National ART and Surrogacy Board. Questions worth asking your prospective clinic:

• • Is this clinic registered under the ART Regulation Act 2021? Can I see the registration certificate?
• • What counselling will be offered before I start treatment?
• • What is the clinic's success rate? Are these figures from ICMR data or internal?
• • How many embryos do you recommend transferring, and why?
• • What happens to unused embryos? What are my options for storage, donation, or disposal?

The Indian Council of Medical Research (ICMR) publishes guidelines for ART clinics. These guidelines cover clinical protocols for IVF, IUI, egg donation, and embryo storage. The National ART and Surrogacy Board, established under the 2021 Act, is the regulatory body responsible for clinic registration and compliance.

ICMR does not regulate patient information apps. Its guidelines apply to clinical practice in registered fertility centres.

The Surrogacy (Regulation) Act 2021 was enacted alongside the ART Act to regulate surrogacy arrangements specifically. Key points for patients to understand:

• • Only altruistic surrogacy is permitted in India; commercial surrogacy (payment beyond reasonable expenses) is prohibited.
• • A surrogate must be a close relative and must meet age and other eligibility criteria set out in the Act.
• • The intended parents and surrogate must all provide written, informed consent before proceeding.

The Central Drugs Standard Control Organisation (CDSCO) regulates drugs, medical devices, diagnostics, and cosmetics in India under the Drugs and Cosmetics Act. It also oversees Software as a Medical Device (SaMD): meaning apps that perform clinical diagnosis or provide treatment recommendations.

Appy + Yaar does not perform clinical diagnosis. It does not tell you what condition you have or recommend a specific treatment. It provides information to support conversations with your doctor. This means Appy + Yaar falls outside CDSCO's SaMD classification requirements.