Drug pricing regulator rejects Abbott, Medtronic requests to withdraw stents

The country's drug pricing regulator on Wednesday said it had rejected applications from multinational stent makers Abbott and Medtronic to withdraw their stents from the Indian market over commercial viability concerns.

Abbott had last wek sought permission from National Pharmaceutical Pricing Authority (NPPA) to withdraw two of its stent products - Absorb BVS and Alpine - from India, while Medtronic had wanted to pull out Resolute Onyx "post fixation of ceiling prices".

After examining the requests, NPPA said on Wednesday said that the companies cannot pull their stents from the market abruptly as the government has invoked its powers under Para 3 of the Drugs Prices Control Order, 2013 and directed the company to maintain uninterrupted supplies of all its coronary stents including BVS or bio-reabsorbable for six months from the date of the order.

It further said that both withdrawal applications were "technically and legally null and void" as the letters haven't been signed by the respective companies.

The regulator also accused both the companies of not complying with its direction to provide weekly reports on coronary stents produced and distributed in the country along with a weekly production plan.

NPPA had on February 16 issued a notification capping coronary stent prices. It capped the prices of bare metal stent at Rs 7,260 and drug-eluting stent (DES) and biodegradable stents at Rs 29,600, much lower than the market prices. Both the prices are exclusive of value added tax. DES constitutes 95 percent of the market.

NPPA has asked Abbott and Medtronic to resubmit its request two weeks before the expiry of the Para 3 restrictions, which are currently in operation.

Both the companies were advised to explore the options of price revision provided under Para 11(3), 11(4) and Para 19 of the DPCO, 2013 before exercising an exit route under Para 21(2).

NPPA also advised the stent makers to be more cautious and responsible in taking such business decisions in light of the government's commitment to ensure affordability and availability of all essential drugs to the people.

About 60 percent of the market for stents is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific.

The medical devices industry, which is opposing the regulation of stent prices, said the decision will stifle access of innovative and advanced therapies for patients.

In India, only about 3 out of 1000 coronary heart disease patients are treated with angioplasty compared to 32 in the US.

Angioplasty is the procedure of placing stent in an artery.

As per the National Interventional Council (NIC) Registry data in 2015, a total of 3,53,346 angioplasties were performed and 4,73,000 stents were implanted in India. The country's coronary stents market was valued at USD 481 million in 2015.