The National Pharmaceutical Pricing Authority (NPPA) would fix the ceiling price of coronary stents using the same formula it uses to determine the price of drugs in the national list of essential medicine (NLEM).
At the end of a three-day consultation process here, NPPA chairman Bhupinder Singh rejected demands from multinational companies to have a system of differential pricing for drug-eluting stents.
Instead, he asked the firms to come up with clinical data to show superiority of their stents to justify differential pricing.
The price determination exercise for coronary stents began following a Central government’s approval on the inclusion of coronary stents in the NLEM, paving the way to have a ceiling price of these life-saving medical devices.
The order amending the Drugs (Price Control) Order, 2013, would allow bare metal stents and drug-eluting stents, including the biodegradable ones, to be on the NLEM.
About 20 industries, including local manufacturers and importers in the coronary stent market, have been asked to submit their hospital invoices by January 9 to the NPPA.
The authority would subsequently fix an average price (based on price to the hospitals) taking into consideration prices of more popular brands and adding a 16% margin, sources told DH.
Earlier, an expert panel fixed a benchmark cost of Rs 19,000 for bare metal stents and Rs 28,000 for drug eluting stents. This has, however, not been accepted by the government. It is too early to close the final price as intense lobbying from the stent manufacturers continued.
Coronary stents are currently sold at hugely inflated prices, making them out of reach of a large number of people requiring angioplasty, and compelling others to spend higher than their paying capacity, according to a NPPA report, authored by a panel of medical professionals.
“A nascent sector like medical devices, which accounts for less than 2% of the overall healthcare sector of India, needs support with policies which encourage technology innovation, clinical evidence and strong quality management systems to ensure best patient outcomes,” claims Medical Technology Associations of India, which represents big importers.
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