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India's law regulating IVF and other fertility clinics and gamete banks, setting age limits, donor rules and penalties for unethical practice.
The Assisted Reproductive Technology (Regulation) Act, 2021 is the central law that brings India's fertility industry — IVF clinics, sperm banks and egg banks — under statutory regulation for the first time. 'Assisted reproductive technology' is defined as all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or embryo into a woman's reproductive system; in-vitro fertilisation (IVF), intracytoplasmic sperm injection (ICSI) and gamete donation all fall within it. The Act is administered by the Ministry of Health and Family Welfare and was passed alongside the Surrogacy (Regulation) Act, 2021 as a deliberate pair — surrogacy is regulated by one statute and the clinics and banks that make it technically possible by the other. Its stated purposes are the regulation and supervision of ART clinics and ART banks, prevention of misuse, and safe and ethical practice of ART services.
Type: LawCompulsory registration — no ART clinic or ART bank may operate unless registered in the National Registry through the State registering authority; registration is valid for five years and is renewable for a further five years
National Registry — the Act requires a National Assisted Reproductive Technology and Surrogacy Registry to be set up as the central database of every ART clinic and bank in the country, along with their staff and equipment
Age eligibility (Section 21(g)) — ART services may be provided to a woman above 21 and below 50 years, and to a man above 21 and below 55 years
Donor rules — a bank may obtain semen only from a man aged 21-55 and oocytes only from a woman aged 23-35; an oocyte donor may donate only once in her lifetime (Section 27(4)), and the commissioning couple must take out insurance cover in the donor's favour
A donor has no parental rights — a child born through ART is the biological child of the commissioning couple, who cannot disown it, and the child has the same rights as a natural-born child
Sex selection is banned — an ART clinic may not offer to provide a child of a pre-determined sex, reinforcing the bar already in the PCPNDT Act, 1994
Sale or trade in human gametes and embryos, and the use of intermediaries to procure donors, are prohibited outright
Three-tier oversight — the National ART and Surrogacy Board at the apex, State Boards, and appropriate authorities at the state and UT level to register clinics and investigate complaints
Frequency: High — the ART and Surrogacy Acts have been recurring Prelims and GS-II material since 2021, and the 2026 High Court rulings on the age cap have pushed them back into the news
India became one of the world's largest fertility-treatment markets through the 2000s while its clinics operated under nothing more than voluntary ICMR guidelines. Successive draft Bills failed to become law for over a decade before the two 2021 statutes finally closed the gap.
Kanupriya alias Durga, India's first IVF baby, is born in Kolkata — the world's second, 67 days after Louise Brown
ICMR and the National Academy of Medical Sciences issue National Guidelines for Accreditation, Supervision and Regulation of ART Clinics — advisory only, with no statutory force
A series of draft ART Bills is prepared and lapses; commercial surrogacy grows into a large unregulated industry
The government bars foreign nationals from commissioning surrogacy in India, effectively ending inbound commercial surrogacy
Parliament passes both the ART (Regulation) Act and the Surrogacy (Regulation) Act; the ART Act receives assent on 18 December 2021
The ART (Regulation) Act comes into force
High Courts including Delhi, Gujarat, Kerala and Madras deliver differing rulings on the Section 21(g) age cap; challenges to both Acts are pending before the Supreme Court
National Assisted Reproductive Technology and Surrogacy Board
Apex policy and advisory body under both the ART Act and the Surrogacy Act; lays down a code of conduct for clinics and banks
State ART and Surrogacy Boards
Mirror the National Board at the state level and monitor implementation within the state
Appropriate Authority (State/UT)
Grants, renews, suspends and cancels registration of ART clinics and banks, investigates complaints and takes enforcement action
National ART and Surrogacy Registry
Central database of all registered ART clinics and banks in India
Indian Council of Medical Research (ICMR)
Issued the 2005 voluntary ART guidelines that governed the field before the Act, and remains the technical authority on ART standards
| Aspect | ART (Regulation) Act, 2021 | Surrogacy (Regulation) Act, 2021 |
|---|---|---|
| What it regulates | ART clinics and ART banks — IVF, ICSI, gamete donation, embryo handling | The practice of surrogacy and surrogacy clinics |
| Act number | Act No. 42 of 2021 | Act No. 47 of 2021 |
| Commercial transaction | Sale of gametes and embryos prohibited; intermediaries barred from procuring donors | Commercial surrogacy banned; only altruistic surrogacy permitted |
| Insurance requirement | 12 months' cover for the oocyte donor | 36 months' cover for the surrogate mother |
| Regulator | National and State ART and Surrogacy Boards — the SAME boards serve both Acts | National and State ART and Surrogacy Boards |
| Who may access | A married couple, or a woman (including a widow or divorcee) | An intending couple with a medical indication, or an intending woman who is a widow or divorcee aged 35-45 |
Before 2021 one of the world's biggest fertility industries ran on guidelines nobody could enforce, which produced real harm: undisclosed donor health risks, repeat egg harvesting from poor women arranged by touts, clinics with no reliable record of what they had implanted in whom, and no statutory way for a child born of donor gametes to establish parentage. The Act's most durable contributions are the registry, the donor-protection rules and the statutory clarity that the commissioning couple — not the donor — are the legal parents. The criticism is equally standard and worth carrying into an answer: by limiting access to a married couple or a single woman, the Act leaves out single men, live-in partners and LGBTQ+ persons; the upper age limit is a hard cut-off with no transitional provision for couples already midway through treatment, which is exactly what the High Courts have been asked to fix; and the ban on all payment to donors sits awkwardly with the fact that oocyte donation is an invasive medical procedure. The statute is best understood as a first regulatory framework that will be amended, rather than a settled one.
Section 3, ART Act
Provides for the National Assisted Reproductive Technology and Surrogacy Board
Section 21(g), ART Act
Age eligibility — woman above 21 and below 50, man above 21 and below 55; the provision under challenge in the High Courts
Section 27(4), ART Act
An oocyte donor may donate her oocytes only once in her lifetime
Section 33, ART Act
Penalties — Rs 5-10 lakh for a first contravention; 3-8 years' imprisonment and Rs 10-20 lakh for a repeat offence
Surrogacy (Regulation) Act, 2021
Companion statute passed the same month; shares the National and State Boards with the ART Act
PCPNDT Act, 1994
Pre-Conception and Pre-Natal Diagnostic Techniques Act — the pre-existing ban on sex selection that the ART Act reinforces
Medical Termination of Pregnancy Act, 1971 (amended 2021)
The other pillar of India's reproductive-health law; often examined alongside the ART and Surrogacy Acts
Article 21
Reproductive autonomy has been read into the right to life and personal liberty — the constitutional basis of the challenges to the age cap
ART (Regulation) Act, 2021 = Act No. 42 of 2021; assent 18 December 2021; in force 25 January 2022; Ministry of Health and Family Welfare
Age limits: woman 21-50, man 21-55 (Section 21(g))
Oocyte donor 23-35, may donate ONCE only; semen donor 21-55
Insurance: 12 months for the oocyte donor (ART Act) vs 36 months for the surrogate mother (Surrogacy Act)
One National ART and Surrogacy Board serves both the ART Act and the Surrogacy Act
Registration of clinics and banks in the National Registry is compulsory, valid 5 years, renewable 5 years
Penalty: Rs 5-10 lakh first offence; 3-8 years' jail and Rs 10-20 lakh on repeat
Sex selection, sale of gametes and embryos, and use of intermediaries are all prohibited
Section 21(g) allows ART services for a woman above 21 and below 50 years of age, and for a man above 21 and below 55 years. Several High Courts read the limit down in 2026, and challenges are pending before the Supreme Court.
It received Presidential assent on 18 December 2021 as Act No. 42 of 2021 and came into force on 25 January 2022.
No. Section 27(4) of the ART Act permits an oocyte donor to donate her oocytes only once in her lifetime, and she must be aged between 23 and 35.
The commissioning couple. The Act gives the donor no parental rights, bars the couple from disowning the child, and gives the child the same rights as a natural-born child.
The ART Act regulates fertility clinics and gamete banks and the techniques they use; the Surrogacy Act regulates the practice of surrogacy itself. Both were passed in December 2021 and share the same National and State Boards.