CDSCO Bars Supply Of IVF Consumables To Unregistered ART Centres, Tightens Fertility Regulations

Mumbai, July 2, 2026: The Central Drugs Standard Control Organisation (CDSCO) has directed that IVF media, reagents and other consumables used in Assisted Reproductive Technology (ART) procedures be supplied only to centres registered under the ART (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021.

The directive, issued by Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), last week, follows reports that IVF products were being supplied to unregistered facilities, raising concerns over patient safety, ethics and misuse of fertility technologies.

Supply Restrictions Enforced

IVF media, embryo culture media, cryopreservation media and related laboratory reagents are regulated as medical devices under the Medical Devices Rules, 2017. CDSCO has instructed manufacturers, importers, distributors and suppliers to sell these products only to registered ART clinics and banks. The order has also been forwarded to all state licensing authorities and CDSCO zonal offices for enforcement.

Health activist Chetan Kothari said the move will prevent unregistered fertility centres from accessing essential consumables required for procedures such as IVF, ICSI, embryo culture, embryo transfer and cryopreservation, making it harder for illegal clinics to operate.

Experts say the directive will improve traceability of IVF consumables, strengthen accountability during product recalls or adverse events, and encourage patients to seek treatment only at registered centres that meet prescribed quality, safety and ethical standards. It is also expected to curb illegal IVF practices and boost regulatory compliance across India's growing fertility sector.

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Statewide Crackdown Planned

Meanwhile, in the wake of the alleged illegal egg extraction and sale racket in Badlapur, the Maharashtra government announced a statewide crackdown on fertility clinics, with the Health Department set to constitute special inspection teams to scrutinise IVF and sonography centres across the state.

The minister said the government is examining the possibility of invoking the Maharashtra Control of Organised Crime Act (MCOCA) against those involved in organised illegal egg trafficking and related offences.

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