At least three multinational stent makers have filed applications with India’s drug pricing regulator to withdraw their “new generation” stents from the country, saying the current stent pricing regime in India makes the sale of their stents here unviable.
The decision by Abbott, Medtronic and Boston Scientific Corporation comes two months after the National Pharmaceutical Pricing Authority (NPPA) passed an order slashing the prices of cardiac stents in India by over 75%.
“Following the NPPA price ceiling decision in February 2017 and over the past two months, we have examined and re-examined whether there is a sustainable way to make available in India two of Abbott’s latest stent technologies—the Alpine drug eluting stent and the Absorb dissolving stent—considering their higher manufacturing costs and other associated costs,” an Abbott spokesperson said in a statement to ET.
“We have determined it is not sustainable and we have, therefore, applied to the NPPA to withdraw these two stents.”
Abbott said the company is disappointed that NPPA concluded there is no differentiation in coronary stent technology. “Presently, only a very small percentage of patients in India receive Alpine and Absorb,” the spokesperson said.
Abbott maintained that the product will continue to be available in the market until the drug regulator takes a call on its application. Last month, Abbott had restricted the use of Absorb from European markets, saying a two-year study found an increased rate of major adverse cardiac events in patients receiving bioresorbable stents (BVS) when compared to patients treated with the approved (and widely used) drug-eluting stent (DES).
Medtronic, an Ireland-headquartered stent maker, said it too has approached NPPA for permission to withdraw its brand Resolute Onyx from the Indian market. “We will continue to supply Resolute Onyx till we get required permissions from authorities. Our decision to withdraw or introduce products is made only after taking into consideration all guidelines set by the government,” the company said in a statement.
Massachusetts, US-based medical appliances and equipment maker Boston Scientific has also applied to the regulator to withdraw a high-end stent, two industry executives aware of the development said on condition of anonymity.
“Since the price control order in February 2017, Boston Scientific has been in a constant dialogue with the government bodies. We have sought relief available under the law and also submitted details on the superior clinical attributes of our stents Synergy and Promus Premier. Any decision to discontinue these next generation stents may be taken as a part of the corporate sustainability review. In such case, our other drug eluting stents will remain available in India as per guidelines and norms set by the law,” said the US company. NPPA told ET it has not seen the applications yet.
Medical Technology Association of India (MTaI), a lobby of research-based stent makers, said the current stent pricing system will deprive patients in India access to a wider choice. “We once again request the health ministry to consider sub-categorization among DES before more companies are compelled to file their applications for withdrawal and the patient lose more quality options,” Pavan Choudary, director general at MTaI, said in a statement to ET.
It is not yet clear if companies can indeed withdraw their products from the market as the Department of Pharmaceuticals (DoP) had recently invoked rules to prevent stent makers from taking their brands off the market before a stipulated time.
Since February, manufacturers and importers have been required to submit a weekly report on coronary stents produced and distributed in India. They also have had to submit weekly production plans to NPPA and the Drugs Controller General of India (DCGI).
“NPPA and DCGI are also empowered to extend these directions to any other producers of coronary stents in India during this three month period,” reads DoP’s letter dated February 21. “This order will be valid for next six months and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period.”
DoP had invoked Section 3 (i) of DPCO 2013, under which the government can direct any manufacturer to increase production of and sell any of their products to institutions, hospitals or any agency.
This is done in public interest to achieve adequate availability and to regulate the distribution of drugs in case of emergency or urgency, it said.