CDSCO Restricts Supply of IVF Media, Consumables to Registered ART Centres Only
New Delhi: In a move aimed at safeguarding ethical reproductive healthcare practices and preventing the misuse of assisted reproductive technology (ART) services, 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 procedures are supplied only to centres registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
Issuing a circular (File No. MED/71/2026-eOffice) dated June 23, 2026, the Medical Devices Division of the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare (MoHFW), stated that all medical devices are regulated under the provisions of the Medical Devices Rules, 2017 to ensure their quality, safety and performance.
The regulator clarified that the media, reagents, etc. intended for use in Assisted Reproductive Technology such as in vitro fertilisation, cryopreservation, etc. are also covered under the purview of the said rules, and a licence is required to import or manufacture such products under Medical Devices Rules, 2017.
According to the circular, currently, these products are being used by assisted reproductive technology clinics and banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 for the regulation of safe and ethical practice of assisted reproductive technology services for addressing the issues of reproductive health, and for the regulation of practice and process of surrogacy.
The use of such products by facilities other than registered centres may pose risk of misuse of the assisted reproductive technology services.
The regulator further stated that it has come to its notice that Assisted Reproductive Technology media and related products are being supplied to facilities that are not registered under the above Acts, thereby posing a risk to patient health and welfare.
In light of these concerns, CDSCO has informed,
"All the stakeholders are requested to ensure that the supply of such products shall be carried out to the centres that are registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 to safeguard ethical reproductive healthcare practices in India."
To view the official notice, click the link below:
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