India's fertility sector is set to see tighter regulatory oversight after the Central Drugs Standard Control Organisation (CDSCO) instructed manufacturers, importers, and distributors to supply IVF laboratory consumables only to fertility clinics and sperm banks registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021. The directive follows concerns that specialized IVF laboratory products had been reaching facilities operating outside the regulatory framework. According to CDSCO, unrestricted distribution of these materials could compromise patient safety and quality standards in assisted reproductive care.
The order covers a broad range of laboratory essentials, including IVF culture media, cryopreservation media, reagents, and other consumables routinely used during assisted reproductive procedures. These products play a…
