In December 2021, India passed the Assisted Reproductive Technology (Regulation) Act — the first comprehensive law governing IVF, IUI, and other fertility treatments in the country. In 2023, the detailed rules under this Act were notified, setting up the regulatory machinery.

If you are currently undergoing or planning fertility treatment in India, this law affects you directly. It changes how clinics operate, how donors are screened, what success rates must be reported, and what protections you have as a patient.

But the Act is 45 pages of legal text, and the rules add another 60+ pages. Nobody expects you to read them. This article translates the parts that matter to you — as a patient — into plain language.

Why This Law Was Needed

Before 2021, India's fertility industry was governed by ICMR guidelines (2005, updated 2017) — which were advisory, not legally binding. This meant:

  • Any doctor could open an IVF clinic without specific training or accreditation
  • There was no mandatory reporting of success rates or outcomes
  • Egg and sperm donors had almost no protections
  • Patients had no specific legal recourse under ART-specific law
  • The commercial surrogacy industry operated with minimal oversight

The result was an unregulated ₹30,000+ crore industry where excellent clinics operated alongside questionable ones, and patients had no reliable way to tell the difference.

The ART Act 2021, along with the Surrogacy (Regulation) Act 2021, was meant to fix this.

Who Regulates IVF in India Now?

The Act creates a multi-level regulatory structure:

Body | Role | What It Means for You

**National ART & Surrogacy Board** | Sets policy, establishes standards, oversees national registry | Sets the rules clinics must follow

**State ART & Surrogacy Boards** | Registers clinics, enforces compliance at state level | Where you can complain if a clinic violates the law

**National ART & Surrogacy Registry** | Maintains a centralised database of all registered clinics, banks, and outcomes | Where you can verify if your clinic is registered

**Registration Authority** (at state/UT level) | Grants and revokes clinic/bank registrations | The entity that actually approves or shuts down clinics

Clinic Registration: What It Means and How to Check

What clinics must do:

  • Every ART clinic must register with the National Registry through the state Registration Authority
  • Registration is valid for 5 years and must be renewed
  • To register, clinics must meet specified infrastructure, equipment, and staffing requirements
  • Clinics must employ qualified embryologists, gynaecologists, and andrologists
  • The clinic must maintain detailed records and submit outcome data

How to verify your clinic:

  1. 1Visit the National ART & Surrogacy Registry portal (set up under the Ministry of Health & Family Welfare)
  2. 2Search for your clinic by name, city, or registration number
  3. 3Check whether the registration is active and current

If your clinic is not registered: Under Section 21 of the Act, operating an unregistered ART clinic is an offence punishable with a fine of up to ₹10 lakh for the first offence and up to ₹15 lakh with imprisonment of up to 3 years for subsequent offences.

This does not necessarily mean the clinic is bad — some legitimate clinics may still be in the registration process. But it should prompt you to ask: "Are you registered under the ART Act? Can I see your registration certificate?"

Success Rate Reporting: What the Law Now Requires

This is one of the most important provisions for patients.

What clinics must report:

  • Number of cycles performed
  • Success rates (the Act requires clinics to report "outcome" data, though the specific metrics required are defined in the rules)
  • Complications and adverse events
  • Multiple pregnancy rates

What this means for you:

  • For the first time, India is building a national database of IVF outcomes
  • In theory, this will eventually allow you to compare clinics based on verified data
  • The National Registry should make this data publicly accessible

The reality check (as of early 2026):

  • The registry is operational, but enforcement of mandatory reporting varies by state
  • Not all clinics are submitting data yet
  • Publicly accessible, clinic-level success rate data (like the UK's HFEA website) is not yet available in a comprehensive, user-friendly format
  • We are likely still 2-3 years away from the kind of transparent, audited data that patients in the UK and US have access to

What you can do now: Ask your clinic directly: "Do you submit outcome data to the National ART Registry? Can you show me your most recent submission?" Even if the data is not publicly available yet, the clinic should be able to tell you what they report.

Gamete Donation Rules: What Changed

The ART Act significantly changed how egg and sperm donation works in India:

For Egg Donors:

  • Must be a married woman with at least one living child of her own
  • Age: 23-35 years
  • Can donate eggs a maximum of 7 times in her lifetime
  • Must undergo mandatory screening (medical, genetic, psychological)
  • Donation must be anonymous — the donor's identity is not revealed to the recipient, and vice versa
  • Donor is entitled to insurance coverage for any complications arising from the donation process

For Sperm Donors:

  • Age: 21-55 years
  • Can donate to a maximum of 7 single women or couples (to limit the number of children from one donor)
  • Must undergo mandatory screening
  • Donation is anonymous

For Recipients (You):

  • You cannot choose a specific donor based on identity
  • You can specify preferences (within available donors) for characteristics like blood group
  • The clinic must provide you with the donor's medical screening report (without identifying information)
  • You must provide written consent for using donor gametes (both partners, if applicable)

What this means practically:

  • If you need donor eggs, the clinic sources donors through a registered ART bank, not directly
  • Costs for donor eggs typically range from ₹50,000-₹1,00,000 (donor compensation + screening)
  • The anonymity requirement means you will never know the donor's identity, and the donor will never know yours
  • If you were previously working with a known donor (such as a family member), this is no longer permitted for egg/sperm donation under the Act (though it was common before)

Embryo-Related Rules

The Act has specific provisions about embryos:

  • Embryo creation: Only the number of eggs needed should be fertilised (though in practice, all mature eggs are typically fertilised, and this provision is interpreted as limiting excessive stimulation rather than limiting fertilisation of retrieved eggs)
  • Embryo storage: Clinics must maintain embryos for the period consented to by the couple, with a maximum storage period defined in the rules (currently 10 years, extendable with consent)
  • Embryo disposal: Requires written consent of both partners; embryos cannot be discarded without explicit consent
  • Embryo research: Surplus embryos can be donated for research only with explicit consent and only to approved institutions
  • Embryo transfer limits: ICMR guidelines (reinforced by the Act) recommend single embryo transfer for women under 35 with good-prognosis embryos, and a maximum of 3 embryos in any transfer

Patient Rights Under the Act

The Act gives you specific rights as a fertility patient:

Right to Information

  • You must be informed of the nature of the treatment, expected success rate, side effects, and risks
  • Information must be provided in a language you understand
  • You must be given information about all available options

Right to Consent

  • Written, informed consent is mandatory before any ART procedure
  • Consent can be withdrawn at any stage
  • Both partners must consent where applicable

Right to Confidentiality

  • Your medical records and treatment details must be kept confidential
  • The clinic cannot share your information without your consent
  • Donor identities are protected

Right to Medical Records

  • You are entitled to copies of your medical records
  • This includes test results, treatment protocols, consent forms, and outcome data

Right to Complain

  • If a clinic violates the Act, you can complain to the State ART Board
  • The Board must investigate complaints and take action

Surrogacy Rules (Brief Overview)

While surrogacy is covered primarily by the Surrogacy (Regulation) Act, 2021, the ART Act intersects:

  • Commercial surrogacy is banned. Only altruistic surrogacy by a close relative is allowed.
  • Who can use surrogacy: Indian married couples (married at least 5 years, specific medical conditions required), Indian-origin single women who are widowed or divorced
  • Who can be a surrogate: A close relative of the intended couple, married with at least one child, aged 25-35, can be a surrogate only once
  • Compensation: Only medical expenses and insurance can be provided — no monetary compensation beyond that
  • Same-sex couples, live-in partners, and single men are currently not eligible for surrogacy under the Act

This is one of the most debated aspects of the law. The narrow eligibility criteria have been challenged in courts, and the law may evolve.

Penalties for Violations

The Act has serious penalties for clinics and individuals who violate it:

Offence | Penalty

Operating an unregistered ART clinic | ₹10 lakh fine (first offence); ₹15 lakh + up to 3 years imprisonment (repeat)

Sex selection of embryos | Up to ₹10 lakh fine + 5-10 years imprisonment

Selling, trading, or purchasing human gametes/embryos | Up to ₹10 lakh fine + 5-10 years imprisonment

Advertising sex-selective ART | Up to ₹10 lakh fine + imprisonment

Exploiting donors or surrogates | Up to ₹10 lakh fine + 5-10 years imprisonment

Not maintaining required records | Up to ₹5 lakh fine

What the Act Does NOT Cover (Gaps to Know About)

No law is perfect. Here are the gaps:

  1. 1No mandated publication of clinic-level success rates. The Act requires clinics to report data, but does not yet require that this data be published in a patient-friendly format (like the UK's HFEA website).
  2. 2Enforcement varies by state. Some states have set up their ART Boards and Registration Authorities promptly; others are still in process.
  3. 3Add-on regulation is weak. The Act does not specifically regulate unproven add-on treatments (laser-assisted hatching, endometrial scratching, etc.) that clinics charge for without strong evidence.
  4. 4Pricing is not regulated. Unlike some countries, the Act does not cap IVF costs. Clinics can charge whatever the market bears.
  5. 5Surrogacy eligibility is narrow. Many patient groups (unmarried couples, single men, same-sex couples) are excluded from surrogacy.

Questions to Ask Your Doctor

  1. 1"Is this clinic registered under the ART Act 2021? Can I see the registration certificate?"
  2. 2"Do you submit outcome data to the National ART Registry?"
  3. 3"Can I see the mandatory consent forms before my appointment, so I can read them at home?"
  4. 4"How are your egg/sperm donors screened? Do you use a registered ART bank?"
  5. 5"What happens to my frozen embryos if I stop treatment — what are my options?"
  6. 6"What are your fees for all components of the cycle? Can I get this in writing?"

How to Verify Your Clinic Is Registered

  1. 1Online: Visit the National ART & Surrogacy Registry portal (Ministry of Health & Family Welfare website)
  2. 2In person: Ask the clinic to display their registration certificate — they are required to
  3. 3Phone: Call the state Registration Authority (list available on the Ministry website) and ask about a specific clinic

If a clinic is not registered and cannot provide a valid reason (such as "application pending"), consider this a serious red flag. The law has been in effect since 2022 — clinics have had years to comply.

Medical Disclaimer: This article provides a general summary of the ART (Regulation) Act, 2021 and related regulations as of March 2026. Laws are subject to amendment, and judicial interpretations continue to evolve. This is not legal advice. For specific legal questions about your rights or a clinic's compliance, consult a lawyer experienced in health law. For medical questions, consult a qualified fertility specialist.