The Central Drugs Standard Control Organisation (CDSCO) has implemented comprehensive regulatory changes by directing manufacturers and distributors to supply IVF media and reagents only to registered ART clinics. According to reports from Business Standard, this move comes amid heightened regulatory scrutiny of assisted reproductive technologies following allegations of embryo mix-ups and concerns over the proliferation of unlicensed IVF and surrogacy centres across the country. Drug Controller General of India Rajeev Raghuvanshi issued an office circular dated June 23, 2026, stating that ART media are being supplied to facilities other than those registered under the ART (Regulation) Act and Surrogacy (Regulation) Act, thereby posing risks to patient health and welfare. The circular specifically targets facilities supplying Assisted Reproductive Technology Media to unverified, non-compliant medical facilities.
The regulatory action comes at a time when India is witnessing rapid growth in IVF services, with the country's total fertility rate (TFR) falling to 2.0 children per woman, below the replacement level of 2.1. As reported by Business Standard, India currently has more than 2,000 IVF clinics and a market estimated at around $1.4 billion, making it the world's second-largest IVF services market after the United States. Industry insiders indicate that roughly 40-50 per cent of clinics may still be procuring products from firms that are not licensed, with the market currently recording around 200,000-250,000 IVF cycles annually and expected to grow to 400,000 cycles by 2030. The super-speciality business is seeing expansion into Tier-2 and Tier-3 cities, with smaller players offering services at lower-price packages through devices available at lower prices from unlicensed sellers, often at discounts of at least 30 per cent.
Medical professionals have welcomed the regulatory move as essential for maintaining patient safety standards. Manisha Mehta, IVF specialist and co-founder of Delhi-based Apex Hospital, told Business Standard that the CDSCO notification introduces an additional layer of regulatory oversight by linking the procurement of IVF laboratory consumables with ART registration status. She explained that this prevents diversion of regulated products to unauthorised facilities and facilitates better post-market surveillance, batch traceability, and quality audits. Hrishikesh Pai, co-founder and medical director at Mumbai-headquartered Bloom IVF Group, emphasized that restricting the supply of these products would reduce the possibility of unauthorised IVF procedures, improve auditability of laboratory practices, and reinforce accountability among manufacturers, distributors, and ART providers. Modern IVF laboratories function under highly controlled conditions where every reagent, culture medium, and consumable is validated to maintain physiological conditions essential for gamete fertilisation and embryo development.
The regulatory action addresses serious patient safety issues associated with unregistered clinics. Dr Anupama Gangwal, senior consultant at Cocoon Hospital, Jaipur, explained to Mint that supply of IVF products to unregistered facilities can expose patients to infection risks, poor laboratory practices and misuse of reproductive technologies. She emphasized that patients should always verify whether an IVF clinic is well registered and follows approved medical and ethical protocols before beginning any medical treatment. Drug Controller General Rajeev Raghuvanshi added that all media and reagents intended for use in ART procedures such as IVF and cryopreservation are covered under the Medical Device Rules, 2017, and require licenses for import and manufacture, noting that the use of such products by facilities other than registered centres may pose risk of misuse of the ART services.
Recent systematic reviews and meta-analyses have revealed concerning findings about the effectiveness of common IVF add-ons. A comprehensive review of ten common IVF add-ons found that most are not proven to benefit patients going through IVF, with many studies excluded for trustworthiness concerns. The review, conducted by The Lancet, found that endometrial scratching appears to increase pregnancy probability with no effect on miscarriage risk, while embryo glue and PICSI show mixed results with substantial uncertainty in evidence quality. The findings highlight the critical need for well-designed, large-scale randomized controlled trials to generate reliable evidence on these interventions' effectiveness, as many studies were associated with high risk of bias or used IVF methods no longer in practice.
