The company approached India’s National Pharmaceutical Pricing Authority nearly a month ago looking to withdraw the device, citing price caps set on stents earlier this year.
Abbott first has to issue a public notice withdrawing Alpine, the regulator told ET, which it has not yet done.
The NPPA reportedly said it was “left with no option” but to grant Abbott’s request, since the country’s Dept. of Pharmaceuticals does not allow it to exercise provisions to extend restrictions on companies from discontinuing their stents in India.
The regulatory body pushed back against Abbott’s argument that selling the device in India was not viable after the maximum prices of drug-eluting stents were capped.
“The Authority, accordingly, examined the whole issue and found that the import cost of Alpine brand is less than the ceiling price and adequate margins are there, so the reason of unviability of sales in India is not understandable,” the NPPA said in prepared remarks.
“It was also found that these brands have a sizable market share and its withdrawal will create sudden shortage of stents which will not be in the interest of public health safety.”
The NPPA invoked a public interest clause in regulations, stopping Abbott from withdrawing the device for a year’s time.
According to the rule, Abbott needs to maintain an uninterrupted supply of the Xience Alpine device – equivalent to the average imports for the device between June and August this year. After seven months, the company can start reducing supplies by 15% until it withdraws the product completely.
“The NPPA has accepted our application to withdraw our latest drug eluting stent technology Alpine. The ceiling price that has been set unfortunately makes it an unsustainable business to continue to provide Alpine given our cost of manufacture and other associated costs,” an Abbott spokesperson said to ET.