Drug regulator mandates CDSCO licensing on medical device procurement

The regulator told states not to demand USFDA or EU approvals in tenders after complaints that Indian-made devices were being sidelined

The Central Drugs Standard Control Organisation (CDSCO), which regulates medicine and medical device standards in India, has directed hospitals across the country to not discriminate against devices lacking foreign certification, following concerns that many procurement agencies have been favouring imported products such as high-risk cardiac implants over Indian-made ones.

 

In a letter issued to state authorities earlier this week, India’s apex drug regulator said it had received repeated complaints that procurement agencies, including hospitals, were insisting on US Food and Drug Administration (USFDA) or European regulatory approval as a prerequisite for bidding.

 

This comes after several domestic industry executives raised concerns over the prioritisation of foreign-made devices by states and hospitals.

 

In early 2025, the Gujarat government had proposed a policy to allow higher prices for USFDA-approved coronary stents. The order was later revoked following pushback from domestic manufacturers.

 

Welcoming the central regulator’s assertion, Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (Aimed), said that the basis of procurements in public health tenders needs to be the CDSCO licensing.

 

“Buyers should not be seeking manufacturers to have overseas regulatory approvals of USFDA and CE (European standard),” he added. 

 

Despite the advisory, executives still believe that it will not change the situation for Indian manufacturers.

 

An executive told Business Standard, on the condition of anonymity, that they are uneasy with a clause in the CDSCO letter which states that any other requirements of the procurement agencies should be above or over the requirement for a CDSCO or state licensing authority (SLA) approval.

 

In India, manufacturing and sales licences for low-risk devices are issued by the SLAs, whereas the licences for domestically produced high-risk devices are issued by the CDSCO. Import licences for all risk classes of devices are also approved by the central drug regulator.

 

“The process would still allow hospitals and big buyers to specify CE or USFDA certification as a requirement along with an Indian licence, which does not change anything,” he added.

 

This, he stated, would still let procurement agencies weed out Indian manufacturers in the technical bids, putting them in an unfair spot.