The Centre has introduced new restrictions on sales of key media, reagents and cryopreservation consumables, limiting access to only registered fertility clinics. According to the latest directive issued by the Central Drugs Standard Control Organisation (CDSCO), manufacturers and distributors must verify the registration status of Assisted Reproductive Technology (ART) clinics and banks before supplying critical laboratory consumables. As reported by Business Standard, the measure effectively links access to essential ART media, especially those used in in-vitro fertilisation (IVF), with regulatory compliance, making it significantly harder for unregistered fertility centres to continue operations. ART media are specialised chemical solutions and culture media used in laboratories to support the survival, growth and development of gametes (eggs and sperm) and embryos outside the body.
According to industry data reported by Business Standard, India has 7,795 ART clinic applications, of which 4,244 clinics have been registered under the ART regulatory framework. Rishi Agrawal, CEO and co-founder of regulatory compliance firm TeamLease RegTech, noted that the CDSCO directive fundamentally strengthens traceability across the IVF supply chain, with suppliers now having to verify the registration status of every purchasing ART clinic or bank before dispatching products. The circular largely formalises processes already followed by compliant fertility centres, with established clinics unlikely to face operational disruptions or significant cost increases. As per Business Standard, the directive is also expected to accelerate the formalisation of India's fragmented IVF industry, with compliance, rather than the size of a clinic, increasingly determining competitiveness as regulators tighten oversight.
Despite tighter sourcing norms, industry executives do not expect any material increase in IVF treatment costs for patients, as laboratory media and reagents account for only one component of an IVF cycle. According to Gautam Daftary, Founder and Managing Director of Aksigen IVF, established clinics that procure consumables through licensed manufacturers and authorised distributors are unlikely to face operational disruptions or significant cost increases. However, clinics that previously relied on unlicensed suppliers may see higher procurement costs as they shift to compliant supply chains, with industry insiders estimating that roughly 40-50 per cent of clinics may still be procuring products from firms that are not licensed. The order could also reshape the competitive landscape by eliminating the cost advantage enjoyed by clinics sourcing discounted products through unauthorised channels, as Daftary noted the directive changes "the operating economics of non-compliance".
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 US. As reported by Business Standard, the market is expected to grow to 400,000 cycles by 2030, with smaller cities accounting for a significant share of the expansion. The superspeciality business is seeing expansion into Tier-II and Tier-III cities, with several small players providing services at lower-priced packages by using devices available at lower prices from unlicensed sellers, often at discounts of at least 30 per cent. According to industry executives, the move comes at a time when fertility centres are under scrutiny following allegations of embryo mix-ups and concerns over the proliferation of unlicensed IVF and surrogacy centres across the country.
The directive is expected to improve accountability across the fertility ecosystem by ensuring that specialised laboratory materials are used only in authorised centres. Drug Controller General of India Rajeev Raghuvanshi stated in an office circular dated June 23 that ART media are being supplied to facilities other than those registered under the ART (Regulation) Act and the Surrogacy (Regulation) Act, thereby posing risks to patient health and welfare. Sonu Taxak, Director and Senior IVF Consultant at Yellow Fertility, said many manufacturers have already begun seeking proof of ART registration before supplying laboratory consumables, indicating that the industry has started aligning with the new regulatory framework. The move creates "a practical enforcement mechanism" for compliance with the ART and Surrogacy Acts, while stronger oversight would improve quality assurance, enhance traceability and ultimately build greater public confidence in fertility care.
