The Central Drugs Standard Control Organization (CDSCO) on June 23, 2026, notified regarding the Sale of In-Vitro Fertilization media, reagents, and related consumables used in assisted reproductive technology procedures.
The following has been stated:
• The advisory reiterates that Assisted Reproductive Technology (ART) media, reagents, and similar products used for procedures such as IVF and cryopreservation are regulated as medical devices under the Medical Devices Rules, 2017, and require a valid import or manufacturing licence.
• These products are intended for use only by ART clinics and banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021. The authority has observed that such products are being supplied to unregistered facilities, which could lead to misuse of ART services and pose risks to patient safety and welfare.
• Accordingly, manufacturers, importers, distributors, and other stakeholders are advised to ensure that ART media and related products are supplied only to centres registered under the ART and Surrogacy Acts, to promote safe, ethical, and compliant reproductive healthcare practices in India.
[Notification no. - MED/71/2026-eoffice]
