Government forbids cos from withdrawing stents until December to prevent shortage
NEW DELHI: The government has prevented companies that make or import coronary stents from requesting permission to discontinue their products until December to prevent a shortage of the life-saving devices.
The move may affect multinational companies that have been trying to withdraw their high-end stents from India after the drug pricing watchdog capped their maximum prices at drastically lower levels earlier this year.
Following reports of shortages of coronary stents in the market and in hospitals, the Department of Pharmaceuticals directed importers and domestic manufacturers to maintain their production, import and supplies for three months.
The department mandated companies to submit a weekly report on coronary stents produced and distributed in the country. They are expected to submit a weekly production plan to the National Pharmaceutical Pricing Authority, the country's drug price regulator, and the Drug Controller General of India, the apex drug regulator.
"This order will be valid for three months... and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period," the department said in an order dated September 27.
The order doesn't apply to US healthcare firm Abbott's two dissolvable vascular scaffold brands 'Absorb' and 'Absorb-GT1,' it said. NPPA said it was allowing Abbott to discontinue the Absorb brand immediately due to safety concerns.
"NPPA and DCGI are also empowered to extend these directions to any other producers of coronary stents in India during this three months period," it stated.
The department had earlier invoked Section 3 of the Drug (Prices Control) Order, 2013, to ask companies to maintain stent supplies for the six months ended August.
Abbott and Boston Scientific had approached the NPPA earlier this month requesting withdrawal of their premium stents. According to industry executives, their stents were priced between.`1.6 lakh and .`2 lakh before they were capped at .`29,600, excluding taxes, in February.
While Abbott has been allowed to discontinue Absorb, it has been directed to continue supplying its other highend brand XIENCE Alpine for another year. Boston Scientific, which had sought both withdrawal and higher prices for its 'Promus Premier' and 'Synergy' stents, has been told to approach the regulator after deciding whether it wants to discontinue the products or request a price revision.