India’s drug pricing regulator reworked the prices of coronary stents on Monday—bringing one up marginally and cutting another further—a year after slashing prices by as much as 85%.
The National Pharmaceuticals Pricing Authority (NPPA) brought up the price of bare metal stents (BES) to Rs7,660 from Rs7,260 and reduced the price of drug-eluting and biodegradable stents to Rs27,890 from Rs29,600.
NPPA also listed regulated prices of other essential accessories used during the stenting procedure, including cardiac guidewire, balloon catheter and guiding wire, cardiac drug eluting balloon or cutting balloon and cardiac guiding catheter.
NPPA’s original price cut imposed in February last year radically lowered the prices of stents, which are mesh tubes placed in arteries to improve blood flow. Before the cap, bare metal stents sold for Rs45,000 and drug-eluting stents for Rs1.21 lakh.
NPPA also decided against multinational stent makers’ request for a new category for advanced stents. The latest order will remain valid till 31 March 2019.
For the accessories, NPPA analysed and compared the minimum and maximum landed price and found huge trade margins between the import landed price and the MRP as well as the price to the distributors and the MRP.
Based on data from manufacturers and importers, NPPA found that in case of some accessories, the trade margin between the import landed price and MRP ranged from 177% to 405%. Between price to distributors and MRP, margins ranged from 62% to 234%. The authority has sought a response from the manufacturers by 15 March.
In October, Mint reported that an expert panel had given the view that since coronary stent procedures could not be carried out without essential component accessories, these should also be regulated. In February 2017, when NPPA brought cardiac stents under price control, it had said that it had been closely monitoring and collecting market data on other medical devices that have been categorized as drugs and came under the Drug Price Control Order.
Last year’s price cap was valid till 13 February. Discussions started with NPPA meeting eminent cardiologists, who said the price cap has resulted in more angioplasties and fewer bypass surgeries. NPPA also met stakeholders on 5 and 8 February.
In November, US-based Abbott Laboratories said it would not introduce its latest stent Xience Sierra in India. In September, it had received permission to withdraw its premium Xience Alpine metallic stents as well as its dissolving stents. Boston Scientific Corp. was also considering withdrawing its high-end stents, Mint reported on 20 September.
“We are happy with NPPA’s new decision to continue with their directive on price cap by not falling to the lobby of overseas multi-national manufacturers. The government and consumers and medical professionals can be assured of support from Indian manufacturers," said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.
But Pavan Choudary, director general of Medical Technology Association of India, said the NPPA decision is “disappointing," adding, “It will limit patient choice and the availability of innovative technologies in the market."
Probir Das, chairman of industry lobby Ficci’s Medical Devices Forum and the Healthcare Federation of India’s Medical Technology Forum, said, “Given that several stakeholder meetings were conducted and there were several clear evidences that last year’s price control order had not reduced cost to patient, this order is disappointing."