The government has asked stent manufacturers to maintain an uninterrupted supply of coronary stents by invoking an emergency clause in public interest.
The move comes in the wake of various multinationals, including Abbott and Medtronic, seeking permission to withdraw some of their products from India following price control.
The Department of Pharmaceuticals (DoP) has invoked an emergency clause of the Drug Price Control Order, 2013, in public interest to ensure the companies complied with its direction.
The government took action after receiving reports of a shortage of stents in the market and hospitals.
“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,” DoP said in a notice.
The government has directed the companies manufacturing coronary stents in the country to maintain production, import, the supply of the coronary stents and submit a weekly report on coronary stents produced and distributed.
“They will also submit a weekly production plan for the next week to the NPPA and the DCGI,” said the notice, which has already been sent to Abbott Healthcare and India Medtronic, asking the companies to maintain an uninterrupted supply of stents.
The government also asked the firms to ensure compliance of the pricing capping of the coronary stents, along with maintaining its uninterrupted supply.
The government has empowered the National Pharmaceutical Pricing Authority (NPPA) and the Drug Controller General of India (DCGI) to extend these directions to any other producer of coronary stents in India in the next three months.
The order to maintain uninterrupted supply of coronary stents will be valid for the next six months and the NPPA and the DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period.
Earlier, Medtronic said it has decided to withdraw its latest stents from India following drug price regulator NPPA’s move to cap their prices. Besides, Boston Scientific has said it may follow suit.
Last week, Abbott said it was seeking to withdraw two types of its latest stent technologies — the Alpine drug eluting stent and the Absorb dissolving stent.
In February, the NPPA had brought stents under price control and capped ceiling price of coronary stents at Rs 7,260 for bare metal variety and Rs 29,600 for drug-eluting ones.
The corresponding average MRPs before the price control stood at Rs 45,100 and Rs 1.21 lakh, respectively.
Last month, the drug price regulator increased price of stents by around 2 per cent after taking into account wholesale price index.