Coronary stents: Govt invokes emergency clause to maintain production of medical device

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New Delhi: In an attempt to ensure availability of coronary stents, the government on Tuesday invoked an emergency clause under drug price control law, directing stent makers to maintain production and supply of medical device.

The development came after the government had last week slashed prices of stents by up to 85 per cent by capping them at Rs 7,260 for bare metal ones and Rs 29,600 for the drug eluting variety.

Following reports of shortage of coronary stents in the market/hospitals, the Department of Pharmaceuticals invoked the the powers of Section 3 (i) of DPCO, 2013, to ensure that medical devices are being made available in the market.

"After due deliberations on the current situation and alternatives available with the government to resume normal supply of the coronary stents, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013," Department of Pharmaceuticals said in a letter to stent makers.

Under the Section 3 (i) of DPCO, 2013, the government can regulate distribution and direct any manufacturer to increase production and sell products to institutions, hospitals or any agency as the case may be in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest.

In its letter to the manufacturers, the department said: "The companies manufacturing stents in India are directed to maintain production/import/supply of the stents and to submit a weekly report on stents produced and distributed. They will also submit a weekly production plan for the next week to NPPA and DCGI".

The National Pharmaceutical Pricing Authority (NPPA) and the Drug Controller General of India (DCGI) are also empowered to extend these directions to "any other producers of coronary stents in India during this three months period," it added.

The order will be valid for next six months and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period, it added.

Meanwhile, the NPPA had asked hospitals to prominently display revised price list of stents while ordering manufacturers and importers to report to it in case of withdrawal or non-availability of products.

(With PTI inputs)