CDSCO Cracks Down on Unlicensed IVF and ART Medical Devices in India

The Central Drugs Standard Control Organization has issued a directive to all State Drug Controllers requiring strict enforcement of licensing requirements for medical devices used in In Vitro Fertilisation and Assisted Reproductive Technology procedures. The directive targets the widespread sale and distribution of IVF-related devices, including intrauterine insemination kits and centrifuges for sperm washing, by firms that have not obtained the requisite licence under the Medical Devices Rules, 2017. CDSCO has asked state authorities to maintain active vigilance over the supply chain for these devices and take enforcement action against unlicensed operators.

The Regulatory Framework for Medical Devices

Medical devices in India are regulated under the Drugs and Cosmetics Act, 1940, read with the Medical Devices Rules, 2017. Under this framework, all medical devices, except Class A non-sterile and non-measuring devices, require appropriate licensing from the Central Licensing Authority (for imports) or State Licensing Authority (for domestic manufacture) before they can be imported, manufactured, sold, or distributed. IVF and ART devices fall squarely within the definition of medical devices under these rules. The licensing requirement applies to manufacturers, importers, and distributors alike. Operating without a valid licence is an offence under the Drugs and Cosmetics Act and can attract both criminal penalties and administrative action including seizure of stock and cancellation of any related licences.

Scale of Non-Compliance

The CDSCO directive responds to reports that a significant proportion of IVF clinics across India have been sourcing devices from unlicensed suppliers. Reports suggest that as many as 40 to 50 percent of clinics may be purchasing IVF-related devices from firms that lack valid licences under the Medical Devices Rules. The problem is compounded by the rapid growth of the ART industry in India, which has seen a proliferation of fertility clinics in both metropolitan and smaller cities. Many of these clinics, particularly newer and smaller establishments, may not have robust procurement compliance processes in place. The result is a parallel supply chain of unlicensed devices that have not been subject to the quality and safety checks mandated by the regulatory framework.

Connection to the ART Regulation Act, 2021

The enforcement push should be read alongside the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021, which together established a comprehensive regulatory framework for ART practices in India. The ART Act requires all ART clinics and banks to register with the National ART and Surrogacy Board or the relevant State Board. Registered clinics are expected to maintain standards of care that include using only licensed and quality-assured medical devices. The CDSCO directive reinforces this requirement by targeting the supply side: ensuring that the devices available in the market are themselves compliant. The two regulatory regimes, one governing clinic operations and the other governing device quality, are complementary and both must be satisfied for a compliant ART practice.

Practical Takeaways

IVF clinics and ART centres should immediately audit their medical device supply chains and verify that all suppliers hold valid licences under the Medical Devices Rules, 2017. Procurement policies should mandate licence verification as a condition for vendor empanelment. Manufacturers and importers of IVF-related devices who have not obtained the necessary licences should apply immediately, as continued unlicensed operations now carry heightened enforcement risk. Distributors should verify their own licensing status and that of their upstream suppliers. Legal counsel advising healthcare entities in the fertility space should factor this directive into compliance advisory, particularly where clients are scaling operations or onboarding new device suppliers.