The Central Drugs Standard Control Organisation (CDSCO) has directed that essential consumables used in in-vitro fertilisation (IVF) procedures can now be supplied only to fertility clinics and sperm banks registered under the Assisted Reproductive Technology (ART) and Surrogacy Acts.
The decision follows reports that IVF-related products were being supplied to unregistered facilities, a practice that the regulator said could compromise patient safety and welfare.
The directive covers IVF culture media, cryopreservation media, reagents, and other consumables used during assisted reproductive procedures. These specialised products are critical for the handling, preservation, and development of eggs, sperm, and embryos during fertility treatments.
According to CDSCO, these products are classified as medical devices under the Medical Devices Rules, 2017, and their manufacture and import require appropriate licences. The regulator also highlighted that ART clinics and sperm banks are governed by the Assisted Reproductive Technology (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021, which were enacted to ensure ethical and safe reproductive healthcare services.
In its public interest directive, CDSCO instructed all stakeholders to ensure that IVF media, cryopreservation media, reagents, and related consumables are supplied exclusively to facilities registered under the relevant laws. The circular has been shared with state and Union Territory licensing authorities, CDSCO’s zonal and sub-zonal offices, manufacturers, importers, and other stakeholders for strict compliance.
