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.
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.
Industry executives said that while the order introduces an additional compliance checkpoint in the procurement process, it is unlikely to disrupt operations at registered clinics, many of which already source laboratory consumables from authorised suppliers and maintain documentation and traceability systems.
Instead, the bigger impact is expected to be on clinics operating outside the statutory framework, which will now have to obtain the required approvals before accessing essential consumables.
“According to the National ART and Surrogacy Registry, India has 7,795 ART clinic applications, of which 4,244 clinics have been registered under the ART regulatory framework,” said Kshitiz Murdia, Chief Executive Officer (CEO) and Whole-Time Director of Indira IVF Hospital.
Rishi Agrawal, CEO and co-founder of regulatory compliance firm TeamLease RegTech, added 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 directive is also expected to accelerate the formalisation of India’s fragmented IVF industry. Experts said compliance, rather than the size of a clinic, will increasingly determine competitiveness as regulators tighten oversight.
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.
The circular largely formalises processes already followed by compliant fertility centres, according to Gautam Daftary, Founder and Managing Director of Mumbai-based Aksigen IVF.
He added that established clinics that procure consumables through licensed manufacturers and authorised distributors are unlikely to face operational disruptions or significant cost increases, although clinics that previously relied on unlicensed suppliers may see higher procurement costs as they shift to compliant supply chains.
While no official estimate is available, industry insiders said roughly 40-50 per cent of clinics may still be procuring products from firms that are not licensed.
“The superspeciality business is seeing an expansion into Tier-II and Tier-III cities, with several small players looking to provide services at lower-priced packages,” an industry executive told Business Standard.
He added that these centres achieve this by using devices available at lower prices from unlicensed sellers, often at discounts of at least 30 per cent.
Tighter norms not expected to increase IVF cost
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, with medication, embryology operations and clinical monitoring remaining the larger cost drivers.
The order, however, could also reshape the competitive landscape by eliminating the cost advantage enjoyed by clinics sourcing discounted products through unauthorised channels.
Daftary said the directive changes “the operating economics of non-compliance”, forcing such facilities either to enter the regulated supply chain or exit the market.
Further, experts caution that some administrative delays are possible during the transition as distributors strengthen verification processes and clinics update documentation. However, these are expected to be temporary.
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.
She added that registered clinics with established procurement systems should continue receiving supplies without major interruptions.
Beyond procurement, experts believe the directive will improve accountability across the fertility ecosystem by ensuring that specialised laboratory materials are used only in authorised centres.
Agrawal said the move creates “a practical enforcement mechanism” for compliance with the ART and Surrogacy Acts, while Taxak said stronger oversight would improve quality assurance, enhance traceability and ultimately build greater public confidence in fertility care.
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 in-vitro fertilisation (IVF) and surrogacy centres across the country.
“It has been brought to the notice of this office that ART media are being supplied to facilities other than those that are registered under the ART (Regulation) Act and the Surrogacy (Regulation) Act, thereby posing risks to patient health and welfare,” Drug Controller General of India Rajeev Raghuvanshi said in an office circular dated June 23.
India currently records around 200,000-250,000 IVF cycles annually, and the market is expected to grow to 400,000 cycles by 2030, with smaller cities accounting for a significant share of the expansion.
“Going forward, manufacturers and distributors will need robust verification mechanisms to validate ART registration before supply,” the executive quoted above said.
