Daijiworld Media Network – New Delhi

New Delhi, Jun 27: Fertility clinics and sperm banks that are not registered under the Assisted Reproductive Technology (ART) and Surrogacy Acts will no longer be permitted to procure essential laboratory materials used in IVF procedures, following a directive from the Central Drugs Standard Control Organisation (CDSCO).

The drug regulator issued the direction after receiving reports that IVF-related products were being supplied to unregistered facilities, stating that such practices could pose risks to patient safety and welfare.

The directive covers IVF media, cryopreservation media, reagents and other consumables used in assisted reproductive procedures. IVF media are specialised laboratory solutions used for handling, preserving and developing eggs, sperm and embryos during fertility treatments.

CDSCO said these products are regulated as medical devices under the Medical Devices Rules, 2017, and require licences for their manufacture or import.

The regulator also stated that assisted reproductive technology clinics and sperm banks are governed by the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021, which aim to ensure safe and ethical reproductive healthcare practices.

As per the latest circular, manufacturers, importers and suppliers have been instructed to provide IVF media, cryopreservation media, reagents and related materials only to centres registered under the two Acts.

The circular, issued in public interest, has been shared with state and Union Territory licensing authorities, CDSCO zonal and sub-zonal offices, manufacturers, importers and other stakeholders for strict compliance.