The Indian National Pharmaceutical Pricing Authority today rejected applications from Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) to withdraw coronary stents from the region and asked the companies to maintain their supplies of the stents, according to a DNAIndia report.
Earlier this week, Medtronic and Abbott said they would look to withdraw select high-value stents from the Indian market in light of cost caps imposed by the NPPA.
Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents.
In a notification posted today, the agency rejected the applications and requested that the companies consider other options, including price revisions, before withdrawing the products from the market.
The rejection came based around restrictions that went into effect Feb. 21, which required stent makers, distributors and supplies to maintain supply of products for 6 months, citing public health interest, according to the report.
The agency also said that the companies had been non-complicit with governmental direction requesting weekly reports on the availability of stents.
The NPPA said the companies were free to resubmit the requests 2 weeks before the expiration of the restrictions, but also asked the 2 companies “to be more cautious and responsible in taking such business decisions in the light of government’s commitment to ensure affordability and availability of all essential drugs to the people,” according to the DNAIndia report.
Medtronic and Abbott were not alone in their consideration of an exit from the market, as reports also claim that Boston Scientific (NYSE:BSX) is mulling a withdrawal of its higher-end offerings from the region following the price caps.
Last year, Indian NPPA imposed price restrictions which set limits on the costs of metal, drug eluting and bioresorbable stents. The regulatory body also set limits on trade margins, discounts and other promotions used on higher-end products.
The move led to rumors that larger players in medtech would pull their high-cost stents from the market, with Abbott denying claims that it would withdraw from the region in February.