The Central Drugs Standard Control Organization (CDSCO) has directed all stakeholders to ensure that in-vitro fertilization (IVF) media, reagents and related consumables used in Assisted Reproductive Technology (ART) procedures are supplied only to centres registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
In a circular issued on Tuesday, the regulator said it had received reports that ART media and related products were being supplied to facilities that are not registered under these laws, raising concerns over patient safety and welfare.
CDSCO noted that all medical devices in India are regulated under the Medical Devices Rules, 2017 to ensure their quality, safety and performance. This includes media, reagents and other products used in ART procedures such as IVF and cryopreservation, for which manufacturers and importers must obtain the necessary licences under the rules.
According to the regulator, these products are intended for use only by ART clinics and banks registered under the ART and Surrogacy Acts, which were introduced to promote safe and ethical reproductive healthcare practices and regulate ART and surrogacy services in India.
The regulator warned that the use of these products by unregistered facilities could increase the risk of misuse of assisted reproductive technologies and compromise patient welfare.
The circular has been shared with all State and Union Territory licensing authorities, CDSCO’s zonal and sub-zonal offices, and published on the CDSCO website.
