CDSCO Bans IVF Consumables Supply to Unregistered Fertility Clinics, ETHealthworld
New Delhi: Fertility clinics and sperm banks that are not registered under the Assisted Reproductive Technology (ART) and Surrogacy Acts will no longer be allowed to procure key laboratory materials used in IVF procedures, with the Central Drugs Standard Control Organisation (CDSCO) directing that such products be supplied only to registered centres.
The regulator issued the direction after it was brought to its notice that these products were being supplied to unregistered facilities and said the practice may pose risks to patient health and welfare.
The circular applies to IVF media, cryopreservation media, reagents and other consumables used in assisted reproductive procedures. IVF media are specialised laboratory solutions used to handle, preserve and grow eggs, sperm and embryos during fertility treatment.
These products are regulated as medical devices under the Medical Devices Rules, 2017, and require licences for manufacture or import, CDSCO said. It added that assisted reproductive technology clinics and sperm banks are regulated under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 to ensure safe and ethical reproductive healthcare practices.
CDSCO has directed all stakeholders to ensure that IVF media, cryopreservation media, reagents and related consumables are supplied only to clinics and banks registered under the two Acts. The circular, issued in public interest, has been circulated to all state and Union Territory licensing authorities, CDSCO’s zonal and sub-zonal offices, manufacturers, importers and other stakeholders for compliance.
