After Abbott, two more Stent makers seek withdrawal of New Gen Stents

MUMBAI: Soon after Abbott was seen seeking withdrawal of its withdraw two types of stents from the Indian market, reports are coming in that two more multinational stent makers are following suit

ET reports that uptil now, three multinational stent makers Abbott, Medtronic and Boston Scientific Corporation have applied with India's drug price regulator, National Pharmaceutical Pricing Authority (NPPA), for withdrawal of their "new generation" stents from the country.

Reason cited for the withdrawal has been the current price regime after the Price ceiling of stents that have made the sale unviable for the companies.

In February, National Pharmaceutical Pricing Authority (NPPA) had passed an order slashing the prices of cardiac stents in India by over 75%."It has been stated that the current stent pricing regime in India makes the sale of their stents here unavailable and commercially unsustainable.

"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.

Read Also: Abbott decides to withdraw 2 stent types from India

 

It is reported that Medtronic 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.

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.

Meanwhile 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.