ART (Regulation) Act 2021: India’s law on IVF clinics and banks

India’s ART Act 2021 requires IVF clinics and gamete banks to register and sets age limits and consent rules. What it means if you plan fertility care in India.

Glossary term · Law & regulation

By Nikhil Sharma, Founder · Updated · How we write and check

Definition

ART (Regulation) Act 2021 (also: Assisted Reproductive Technology (Regulation) Act, 2021, ART Act): The ART (Regulation) Act 2021 is India’s law requiring registration of assisted reproduction clinics and banks and setting rules on consent, donors, embryos and sex selection.

The Assisted Reproductive Technology (Regulation) Act 2021 is the Indian law that regulates IVF clinics and gamete banks. It was enacted on 18 December 2021 and came into force on 25 January 2022. It requires every clinic and bank to register, sets age limits for patients and donors, and bans sex selection.

What does the Act cover?

The Act defines assisted reproductive technology as techniques that try to achieve pregnancy by handling sperm or eggs outside the body. It covers IVF, ICSI, gamete and embryo freezing and embryo transfer.

  • No clinic or bank may operate without registration. Registration lasts five years and can be renewed.
  • Treatment needs the written informed consent of everyone seeking it.
  • Offering a child of a predetermined sex is prohibited. So is sorting sperm to choose sex.
  • Pre-implantation genetic testing may only screen embryos for known heritable or genetic diseases.
  • The Act limits how many eggs or embryos may be placed in the uterus in one cycle to three.

What age limits apply?

Section 21 sets limits for people receiving treatment. A woman must be above 21 and below 50. A man must be above 21 and below 55. Section 27 sets donor limits. Semen donors must be between 21 and 55. Egg donors must be between 23 and 35.

What should an international patient check?

Check that the clinic appears on the National ART and Surrogacy Registry. Ask how the Act applies to your situation as a foreign national. The Act also prohibits transferring gametes or embryos to another party in or outside India, except your own for personal use with permission from the National Board. Importing human embryos or gametes is an offence. Ask the clinic before you plan to bring or take any biological material.

Surrogacy is separate

Surrogacy is governed by a different law, the Surrogacy (Regulation) Act 2021. Surrogacy is not available to foreign nationals in India.

Questions people ask

Can a foreign couple have IVF in India under this Act?

The Act regulates clinics and sets rules for anyone treated. It has no separate chapter for foreign nationals. Ask the clinic how it applies the Act’s eligibility, consent and age rules to you and which documents you must bring, such as proof of marriage and identity.

Can I take frozen embryos home after treatment?

The Act restricts transfer of gametes and embryos. It allows an individual’s own gametes for personal use only with National Board permission. Raise this before treatment starts so the clinic can tell you what is possible and what paperwork is needed.

Sources

General information, not medical or legal advice. Rules change: confirm with the official source. How we write and check.

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Form 21 (transplant)

Form 21 is the certificate of relationship between donor and recipient in the case of foreigners, required under India’s Transplantation of Human Organs and Tissues Rules 2014.

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