Following the controversy over coronary stent pricing and companies' announcement to withdraw their product post a price cap, the National Pharmaceuticals Pricing Authority of India (NPPA) declared that applications for withdrawal of stents have been rejected.
The drug regulator declared that the multinational medical devices maker Medtronic had submitted an application for withdrawal of its drug-eluting stents on April 3 on grounds of "commercial unviability" after the price cap. Another multinational, Abbott Healthcare, too had applied for withdrawal. Both the applications have been rejected.
In a memorandum announcing the decision, the NPPA said the centre's February order, invoking the emergency clause of the Drug Price Control Order (DPCO), 2013, instructs these companies manufacturing stents to maintain production/import/supply of the coronary stents, and to submit weekly reports on stents produced and distributed.
According to the order, the companies would have to supply their product in an uninterrupted fashion for six months, starting February.
The NPPA also said a status check from the monitoring and enforcement division had revealed that the two companies—Abbott Healthcare and Medtronic—had not been complying with the government order.
While the drug regulator asked the multinationals to resubmit their request two weeks after the order expires and explore price revisions options, it also asked them to be "cautious and responsible" when taking such business decisions. In March, the US FDA had raised safety concerns about one of Abbott Healthcare's bioresorbable stents, and the NPPA pointed out that if the company was unable to address those concerns, it could approach the government again to withdraw the stent.
