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Licensing requirements under Indian law

The Assisted Reproductive Technology (Regulation) Act, 2021 is the primary statute governing ART clinics and banks. Section 2 defines ART by reference to techniques involving handling sperm or oocytes outside the body and transferring gametes or embryos into a woman’s reproductive system. Section 15 prohibits establishing or operating an ART clinic or bank without registration.

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Section 16 provides for a decision on registration within 30 days, written reasons if an application is rejected, and an opportunity of hearing before rejection. Registration cannot be granted without inspection of the premises. The Rules, 2022 classify clinics into Level 1, for IUI, and Level 2, for more advanced ART procedures such as IVF, gamete retrieval, embryo transfer, and embryo storage.

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Remote fertility treatment does not create an automatic exemption from licensing. Teleconsultation, counselling, or review of records may be conducted remotely where otherwise lawful, but clinical procedures involving gametes, embryos, laboratory facilities, or embryo transfer must be performed through appropriately registered and equipped facilities. The legal question is whether the remote service is merely informational or forms part of a regulated ART procedure.

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Section 22 requires written informed consent from all relevant parties before treatment. Sections 23–28 impose duties relating to accurate records, use of gametes and embryos, genetic diagnosis, sex selection, sourcing, storage, and handling. These requirements remain relevant when consultation or monitoring is conducted digitally.

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Case laws

1. Arun Muthuvel v. Union of India, Supreme Court, 2025
The Supreme Court considered challenges involving the Surrogacy and ART regulatory framework, particularly eligibility restrictions and the rights of intending couples who had already begun reproductive treatment before the new legislation came into force. The judgment addressed whether statutory restrictions could retrospectively defeat rights that had crystallised through earlier embryo creation. It illustrates that fertility regulation must be interpreted with attention to statutory purpose, transitional circumstances, and reproductive autonomy. It was not a direct ruling on remote clinic licensing.

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2. Jessy Joy v. Union of India, Kerala High Court, 8 April 2025
The Court interpreted the age requirements in Section 21(g) of the ART Act as applying individually to the woman and man, rather than as a combined age limit for the couple. It permitted the eligible wife to pursue ART with donor gametes where the husband provided the required written consent. The decision shows that licensing authorities and clinics must apply eligibility provisions according to their statutory wording, rather than impose additional restrictions.

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3. Samira Kohli v. Dr. Prabha Manchanda, (2008) 2 SCC 1
The Supreme Court held that medical consent must be voluntary and informed, and that consent for one procedure does not ordinarily authorise a materially different procedure. Although decided before the ART Act, the principle is relevant to remote fertility services: digital consent must adequately explain the treatment, risks, and procedures proposed.

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Conclusion

Remote fertility treatment is legally possible only within the applicable ART framework. Remote counselling and digital communication do not themselves replace statutory registration, qualified personnel, approved facilities, inspection, informed consent, or recordkeeping. The ART Act, 2021 and Rules, 2022 establish the central licensing requirements, while case law protects lawful reproductive choice and requires statutory eligibility rules to be applied correctly. There is no identified Indian Supreme Court judgment creating a separate licence category for “remote fertility treatment”; therefore, legality depends on the actual services delivered and whether regulated procedures are conducted by a duly registered clinic.