ART Act 2021 explained: what India's IVF law means for patients

By Kanwar Nursing Home Info editors · Updated 4 November 2026

Until 2022, fertility clinics in India worked largely under guidelines issued by the Indian Council of Medical Research (ICMR). The Assisted Reproductive Technology (Regulation) Act, 2021 changed that. It came into force in January 2022, with Rules notified the same year, and it now sets legally binding standards for IVF clinics and sperm and egg banks. If you are considering IVF, IUI or egg or sperm donation, these are the parts that matter most to you.

What counts as ART

The Act defines assisted reproductive technology broadly: any technique that tries to achieve pregnancy by handling sperm or eggs outside the body and transferring the gametes or embryo into a woman's reproductive system. That includes in vitro fertilisation (IVF, often called "test tube baby" treatment), ICSI, intrauterine insemination (IUI), egg and sperm donation and freezing of gametes and embryos. Our explainer on IVF and test tube babies describes the treatments themselves.

Clinics and banks must be registered

Every ART clinic and ART bank must be registered with the National Assisted Reproductive Technology and Surrogacy Registry. The Act sets up a National Board and State Boards to frame policy and oversee the system, and an appropriate authority in each state handles registration and complaints. Registration has to be renewed periodically.

The Act distinguishes two levels of clinic. Level 1 clinics may carry out simpler procedures such as IUI. Level 2 clinics may perform IVF, ICSI and other procedures that handle embryos outside the body.

What this means for you

• Ask the clinic for its registration certificate and number, and check that it covers the procedure you are being offered.
• The National ART & Surrogacy Portal, run by the Department of Health Research, publishes the Act, Rules and notifications and links to the registry.
• Be cautious of any centre that cannot show a valid registration.

Who can receive ART services

The Act allows ART services for a married couple who are unable to conceive (the "commissioning couple") and for a woman seeking treatment on her own. It sets age limits; most official summaries describe these as roughly 21 to 50 years for women and 21 to 55 years for men. The upper age limit for women has been challenged in court, so ask your clinic about the current position.

Informed consent

Clinics must take written informed consent from all parties before any procedure. Consent forms are meant to explain the procedure, its chances of success, risks such as ovarian hyperstimulation and multiple pregnancy, costs, and what happens to any unused embryos or gametes. You may withdraw consent before the gametes or embryos are placed in the uterus.

Take time to read the forms. You are entitled to ask questions and to receive copies.

Rules for egg and sperm donors

• Donors are sourced through registered ART banks, not directly by the clinic, and their identity is kept confidential.
• An egg donor must be a married woman with at least one living child of her own, within the age range set by the Act, and she can donate only once in her life, with a cap on the number of eggs retrieved.
• The donor must be insured for complications, paid for by the couple or woman seeking treatment.
• Sperm donors must fall within the Act's age limits, and the same donor's samples may not be supplied to more than one couple.

Limits on embryo transfer and testing

• The Act limits the number of eggs or embryos that may be placed in the uterus in one cycle, to reduce the risks of multiple pregnancy. Ask the clinic how many it plans to transfer and why.
• Pre-implantation genetic testing is allowed only to screen for known genetic or inherited diseases.
• Sex selection is prohibited. Offering, advertising or carrying out sex selection is an offence, in line with the separate PCPNDT Act.

Records and the child's status

Clinics must keep detailed records and report to the National Registry. A child born through ART is treated as the biological child of the couple or woman who sought treatment, with the same rights as any other child; the donor has no parental rights.

Offences and penalties

The Act makes it an offence to sell or trade in embryos or gametes, to run unregistered clinics or banks, to exploit donors, to abandon a child born through ART and to offer sex selection. Penalties include heavy fines for a first offence and imprisonment for repeat offences.

A checklist before you start treatment

1. Confirm the clinic's registration and level.
2. Ask for success rates for patients of your age, and how they are calculated.
3. Ask for a written estimate of costs for one full cycle, including medicines and freezing.
4. Ask how many embryos they plan to transfer.
5. Read every consent form and keep copies.
6. Check whether your health insurance or employer scheme covers any part of the treatment.

If a fertility specialist suggests a diagnostic procedure first, our guides to laparoscopy and hysteroscopy for infertility explain what they involve.