Drug Pricing Regulator Turns Down Medtronic, Abbott’s Stent Withdrawal Applications
Abbott can resubmit its withdrawal application.
India’s drug pricing regulator has rejected applications made by medical device maker India Medtronic Pvt. Ltd. and Abbott India Ltd. for withdrawing their premium coronary stents after the country imposed price caps.
The National Pharmaceutical Pricing Authority (NPPA) disallowed Abbott from withdrawing 'Alpine' and 'Absorb' stent variants, for which the company had made an application last week citing commercial unviability. The NPPA, in its order on Wednesday, also advised the company to be more “cautious and responsible” with its business decisions. In a separate order, the regulator also rejected Medtronic’s application.
A stent is a tubular insertion used to open up a blocked artery in the heart. The regulator, in February, imposed a ceiling on the prices of stents after noting that many hospitals were overcharging for it. The government had also written to stent manufacturers, instructing them to maintain the supply for six months since the order. Manufacturers were also to submit a weekly report on coronary stents produced and distributed.
The NPPA found that Abbott and Medtronic had not complied with the government's order of submitting weekly reports and keeping stents available for six months.
The companies had sought to withdraw the stents with “immediate effect”, to which, the regulator said that there is no such provision in the Drug Pricing Control Order of 2013.
The third reason for rejection was a technical one. A statutory “Form IV” was submitted without any signatures to the NPPA.
The companies are free to resubmit their withdrawal applications till two weeks before the government’s order to maintain stent supply lapses, the NPPA said.
Abbot India is currently reviewing the memorandum issued by the NPPA, the company said in a statement to BloombergQuint. Medtronic India could not be immediately reached for a comment.
Clarification Needed
One of the stents that Abbott wanted to withdraw has been under the radar across the globe. The 'Absorb' stent has seen safety concerns raised by the U.S. Food and Drug Administration (FDA), European Union (EU), Australia's Therepeutic Goods Administration (TGA), and India's Central Drug Standard Control Organisation (CDSCO).
The NPPA told Abbott that if they are withdrawing the particular variant due to safety concerns, then their reasons for withdrawal should clearly say so.
Abbott India, in an emailed statement to BloombergQuint last week, had claimed that their withdrawal of 'Absorb' stent was only because of commercial unsustainability.