Five months after the government added coronary stents to the list of essential medicines, the Department of Pharmaceuticals has included stents in the Drug Price Control Order 2013 or DPCO 2013. This finally gives the National Pharmaceutical Pricing Authority (NPPA) the authority to formally fix the prices of stents.
According to rules, the NPPA has to fix the prices of stents within 60 days, now. Meanwhile, the NPPA has already begun the process by collecting requisite data.
The government plans to fix separate prices for bare-metal stents and drug-eluting stents. This has spurred the debate between domestic manufacturers and multi-nationals as to whether there ought to be different prices even between drug-eluting stents or not.
The domestic and multi-national stent manufacturers have been at loggerheads on fixing prices. While the domestic manufacturers want uniform pricing on all kinds of drug-eluting stents, irrespective of their "generations", the multi-nationals argue in favour of differential pricing for their "Next generation' stents arguing that they are superior in nature. Some doctors side with the multi-nationals.
The multinational manufacturers of stents have also proposed to make one stent for each of their product base, available at CGHS price at all hospitals, in order to break the ice.
At present, prices of stents can vary from Rs 25,000 to Rs 1,25,000 at the market rate while the CGHS prices are Rs 12,000 for bare-metal stents and around Rs 23,000 for drug-eluting stents.
Lobbies also argue that fixing the price of stents will not ensure adequate availability of stents at reasonable prices citing cost of procedure in hospitals.
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Recently, domestic manufacturer SMT has started non-inferiority trials of their stents in Europe. The company has chosen Abbotts Xience against its Supraflex. The trials will be conducted in 1,430 patients across UK, Netherlands, Poland, Spain, Italy, Hungary and Bulgaria. Half of the patients will be administered Supraflex stents while another half will use Xience stents.
Rajiv Nath from the Association of Indian medical devices Industry manufacturers (AIMED) is of the opinion that the standard procedure used for computing prices of drugs should be used for stents as well. He says, "NPPA should now use the standard average pricing based methodology to derive a price capped by considering those with a market share of 1%."