Stents look set to come under price control following a Union Health Ministry notification to include it in the National List of Essential Medicines (2015).

While the move brings some cheer to patients, an uneasy calm prevails over sections of the medical device industry, following the Ministry’s communication late on Tuesday.

The government has accepted the recommendations of the sub-committee looking into issues involving stents, the Health Ministry said. And the sub-committee’s recommendation to include coronary stents in the NLEM (2015) will be operational with immediate effect, the notification said.

Stents are now an “essential” product and the next move would be from the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (NPPA) to bring it under price control, a Government official familiar with the development told BusinessLine.

Currently, all drugs under the NLEM are under price control and the same rationale is expected to be extended to stents too, he said. Even the criteria by which the price would be capped would not be too different from drugs, he indicated. Drug prices are capped at an average of all products in the same formulation having a market share of one percent.

The Health Ministry’s move comes even as the medical devices industry pleads with the government to differentiate between drugs and medical devices, and not view the two through the same lens.

But coronary stents are among the categories of medical devices that have been notified as “drugs” under the Drugs and Cosmetics Act 1940, the YK Gupta-led sub-committee’s report said, recommending it be included in the NLEM.

A stent is a wire-like mesh that is inserted into blood vessels to remove blockages (largely used in the heart). And the options in India include the old generation bare metal stents, drug-coated or drug-eluting stents (DES) and the next-generation absorbable stents. The price discussion is largely around DES, with prices varying between Rs 80,000 to Rs 1.5 lakh-plus per stent.

Some industry representatives caution against measuring medical devices like stents by cost and not by the scientific research behind the product. Any product used in a patient should be put through the rigours of clinical research and peer reviews. But that should not be a reason to price it beyond the reach of patients, say doctors.

Rajiv Nath of the Association of Indian Medical Device Industry (Aimed) said there was a huge price disparity between the different stents in the marketplace. And in the absence of an industry consensus, the government’s move is good in the short term, he said, adding that there was the bigger picture of not putting drugs and devices in the same regulatory basket. Taking all factors into consideration (technology, branding, research, manufacture etc), Aimed had recommended that drug-coated stents be pegged at Rs 80,000, he said.

Domestic and foreign manufacturers are not often the villains in this context, he said, as hospitals dictate and drive the prices on stents. Bringing stents under the NLEM will stop this practice by hospitals, he added.

Representing foreign medical device makers, AdvaMed (Advanced Medical Technology Association) said that the government’s move was detrimental to the nascent medical device industry.

“Singular focus on capping prices of stents by way of their inclusion in NLEM will not help improve access to medical devices for patients, as it will not impact the overall procedure cost and limit the introduction of innovative products,” it said.

In fact, AdvaMed said, recent IMS Health Data found that stent prices were not the highest contributor to the overall angioplasty cost. And worse, significant reduction in stent prices over the last four years has not benefitted patients so far as the overall procedure cost has largely remained the same, it added.

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