ART and Surrogacy Clinic Registration: What the 2021 Act Requires

For nearly two decades, India’s fertility industry grew almost entirely on the back of non-binding 2005 ICMR guidelines — a genuine regulatory gap that allowed clinics to operate with minimal oversight even as IVF and related procedures became increasingly common. The Assisted Reproductive Technology (Regulation) Act, 2021, changed that fundamentally, establishing India’s first comprehensive, legally binding framework for fertility clinics. This article walks through what registration actually requires and where the framework has continued evolving since 2021.

Two Related but Legally Distinct Acts

It’s important to understand upfront that ART and surrogacy are governed by two separate, though closely linked, pieces of legislation: the Assisted Reproductive Technology (Regulation) Act, 2021 (covering IVF, gamete donation, and related fertility procedures generally), and the Surrogacy (Regulation) Act, 2021 (covering surrogacy arrangements specifically). Both were passed by Parliament around the same time, and the National and State Boards constituted under the Surrogacy Act also function as the National and State Boards for ART regulation — but the two Acts have separate registries, separate specific eligibility rules, and separate compliance obligations. A clinic offering both ART and surrogacy-related services needs to satisfy both frameworks, not just one.

When It Came Into Force

The ART Act received presidential assent on December 18, 2021, and was formally brought into force from January 25, 2022. It was followed by the ART (Regulation) Rules, 2022, and subsequently the Assisted Reproductive Technology (Regulation) Amendment Rules, 2023 and 2024 — meaning clinics need to track not just the original Act, but a series of amendments that have refined specific requirements since initial implementation.

Mandatory Registration: The Core Compliance Requirement

Every ART clinic and ART bank in India must register under the National Registry of Banks and Clinics of India — no facility can lawfully operate an ART practice without this registration. To qualify, a facility must demonstrate specialised manpower, adequate physical infrastructure, and appropriate diagnostic capabilities, and registration is valid for five years, after which renewal is required through the appropriate national or state authority. The Central Government appoints Appropriate Authorities specifically responsible for registration, renewal, and cancellation processes, operating at both national and state levels.

Eligibility Rules for Commissioning Parties

The Act sets specific age and eligibility criteria for who can access ART services:

• Married couples: the woman must be between 21 and 50 years of age, and the man between 21 and 55 years, with the couple established as infertile.
• Single women: explicitly permitted to access ART services, including donor egg IVF, without requiring a partner — this is a notable and deliberate inclusion in the framework.
• Foreign nationals: not prohibited from accessing ART services under the Act, though clinics should separately confirm any specific documentation or additional requirements that may apply.

Donor Eligibility and Restrictions

ART banks may source semen from male donors between 21 and 55 years of age, and oocytes (eggs) from female donors between 23 and 35 years of age. A specific and important restriction: an oocyte donor must be a married woman who already has at least one living child of her own, that child being a minimum of three years old at the time of donation — a safeguard intended to ensure the donor has both a demonstrated capacity for a healthy pregnancy and some personal experience of the physical process before undergoing the additional procedure for donation.

Commercial ART Is Banned — Only Altruistic Donation Is Legal

This is one of the Act’s most consequential restrictions for how a fertility clinic can lawfully operate: commercial gamete donation is prohibited outright. Only altruistic egg or sperm donation is permitted, meaning donors can be compensated for documented medical expenses and insurance coverage related to the donation process, but not paid a commercial fee for the gametes themselves. Clinics and banks structuring any donor compensation arrangement need to ensure it stays within this altruistic framework — a donor payment structured or perceived as a commercial transaction would fall outside the Act’s protection.

Prohibited Practices

The Act specifically prohibits ART clinics from offering to determine or provide a child of pre-determined sex — directly connecting to, and reinforcing, the PCPNDT Act’s sex-selection prohibition covered elsewhere in this series. Clinics are also required to conduct genetic disease screening before embryo implantation, adding a specific clinical safeguard obligation on top of the administrative registration requirements.

Clinic Obligations Beyond Registration

• Eligibility verification: clinics must verify that the couple, woman, and gamete donor genuinely meet the Act’s eligibility criteria before proceeding.
• Sourcing gametes only from registered banks: clinics are required to obtain donor gametes from properly registered ART banks, which are themselves obligated to conduct disease screening on donors — a clinic cannot simply source gametes informally.
• Mandatory counselling: clinics must provide counselling to couples and women seeking ART services, explaining the procedure’s implications clearly, and separately uphold and communicate the rights of any child born through the procedure.
• Grievance redressal cell: every clinic and bank is required to establish its own grievance redressal mechanism, giving patients a structured internal channel for complaints.
• Confidentiality: clinics must maintain confidentiality regarding information about commissioning couples and women — a specific privacy obligation layered on top of the general patient confidentiality and DPDP Act obligations covered elsewhere in this series.

The Legal Status of a Child Born Through ART

The Act settles a question that had previously existed in some legal ambiguity: a child born through ART is deemed the biological child of the commissioning couple or woman, entitled to all the same rights and privileges as a naturally conceived child. Correspondingly, a gamete donor has no parental rights over the resulting child — this legal clarity is itself an important protection for both commissioning parents and clinics, since it forecloses a category of parentage dispute that had genuine potential to arise under the earlier, non-binding guidelines regime.

The 2023 and 2024 Amendments: What Changed

The Health Ministry has continued refining the framework since the Act’s initial implementation, notifying the ART (Regulation) Amendment Rules, 2023, specifically aimed at providing donors and patients with better care, and further amendments in 2024. Clinics should treat ART compliance as an evolving area requiring periodic review, rather than a framework fixed permanently at its 2021-2022 starting point — the amendment pattern suggests continued regulatory refinement is likely to continue.

A Recognised Structural Gap Worth Understanding

Commentators examining the parallel ART Act and Surrogacy Act frameworks have flagged a specific structural inconsistency: because the two Acts maintain separate registries and reporting requirements, a surrogacy clinic is not necessarily required to report surrogacy-specific activity to the National ART Registry, creating a potential gap where the same underlying reproductive technology industry is monitored through two only partially overlapping oversight systems. Clinics operating across both ART and surrogacy services should be particularly careful to satisfy each registry’s distinct reporting obligations independently, rather than assuming compliance with one framework automatically satisfies the other.

Frequently Asked Questions

Can a fertility clinic operate without ART Act registration?

No. Registration under the National Registry of Banks and Clinics of India is mandatory, and a clinic cannot lawfully offer ART services without it.

Can a single woman access IVF or donor egg treatment in India?

Yes. Single women over 21 who are Indian citizens are explicitly permitted to undergo ART procedures, including donor egg IVF, under the same eligibility, consent, and donor-screening framework that applies to married couples.

Can a donor be paid a fee for donating eggs or sperm?

No. Commercial gamete donation is banned under the Act — only altruistic donation is permitted, with compensation limited to documented medical expenses and insurance coverage rather than a commercial payment.

How long is ART clinic registration valid before renewal is needed?

Five years, after which the clinic must apply for renewal through the appropriate national or state authority.

Does ART Act registration also cover surrogacy services?

No. Surrogacy is regulated under the separate Surrogacy (Regulation) Act, 2021, with its own registry and requirements — a clinic offering both ART and surrogacy services needs to independently satisfy both frameworks.

Researched Sources

1. PW OnlyIAS — The Assisted Reproductive Technology (Regulation) Act, 2021: Features, Challenges and Way Forward
2. Vajiram & Ravi — ART Act: Background, Provisions, Challenges, Way Forward
3. Khurana & Khurana — Traversing the Ethical and Legal Maze: Overview of the ART Regulation Act, 2021
4. The National Medical Journal of India — Legal Subtleties of the Indian Assisted Reproductive Technology Act of 2021

Disclaimer

This article is for general informational and educational purposes and reflects the ART Act and its amendments as understood at the time of writing; this framework has been periodically revised since 2021. It is not legal advice; fertility clinics should consult a qualified healthcare lawyer and refer to the current, official ART Rules before finalising compliance processes.