Government Prohibits Stent companies to withdraw stents for Next Six Months
New Delhi: In a bid to prevent Multinational Stent makers from removing their next generation stents from the Indian Market, the central government has invoked special clauses to Prohibits Stent companies to withdraw stents for now
TOI reports that the government through National Pharmaceutical Pricing Authority (NPPA) has invoked special powers under the law to prohibit stent makers from withdrawing their products from the market for the next six months and directed them to maintain production, import and supply of coronary stents to avoid any shortage.
The Department of Pharmaceuticals (DoP) said that it had come across reports regarding shortage of coronary stents in the market and in hospitals.
After due deliberations on the current situation and the alternatives available with the government to resume normal supply of the coronary stents, power of Section 3(i) of the Drugs Price Control Order has been invoked which empowers the government to direct companies to maintain or increase production in case of emergency, or in circumstances of urgency or in case of non-commercial use in public interest.
In addition to this the companies have also been directed to submit a weekly report on coronary stents produced and distributed, along with the production plan for the next week to the NPPA and the Drugs Controller General of India (DCGI).
Sources informed TOI similar letters had been sent to all stent manufacturers.The DoP said that for the time being the order would be valid for the next six months, and its withdrawal or extension shall only be considered before the expiry of the period.
In February, National Pharmaceutical Pricing Authority (NPPA), India’s drug price regulator had capped prices of bare metal stents at Rs 7,260, whereas MRP of both drug eluting stents (DES) and biodegradable stents were fixed at Rs 29,600.
Besides capping the MRP, the regulator had also imposed stringent norms on trade margins, discounts and other offers that companies often used to push sales of their products, particularly the high-end expensive ones.
As a result, Abbott, Medtronics and including many multinational stent makers have sought to pull out their premium dissolvable stents from the country citing “unviability” and"commercial unsustainability” as reason for the same.
It is learnt that other multinational companies besides Abbott and Medtronic are also contemplating similar moves seeking to withdraw some of their premium stents