Regulatory Focus™ > News Articles > 2 > NPPA Reverses Course, Allows Stent Manufacturers to Cease Sales in India

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Posted 22 February 2018 | By Ana Mulero 

NPPA Reverses Course, Allows Stent Manufacturers to Cease Sales in India

2754 Following a decision to extend imposed price controls on coronary stents through 2019, India’s National Pharmaceutical Pricing Authority (NPPA) has revised its policies to allow manufacturers to discontinue sales.

The regulatory authority had consistently directed manufacturers of coronary stents to ensure continued availability of all brands in the India market since its initial 2017 decision to the set caps that significantly slashed previously set prices, up until now – a move likely to be welcomed by industry.

NPPA extended the directive a day after it was sent to expire on 13 February, slightly increasing the cap for bare metal stents (BMS) and decreasing that of drug eluting stents (DES), to remain in effect until 31 March 2019. The DES price cap was reduced from Rs 30,180 (US $471) to Rs 27,890 (US $435), and the BMS cap increased from Rs 7,400 (US $116) vs. Rs 7,660 (US $120).

Industry associations, including medical device group AdvaMed, have contended the price controls fail to have the intended benefits, pointing to research that shows the potential savings are not passed on to patients, and can hinder R&D investments and job creation. Despite the pushback, NPPA concluded the new pricing regulations have made for a market with less unethical market practices, as well as encouraged greater competition among foreign and domestic manufacturers.

Stent manufacturers, especially those from the US, have signaled interest in pulling back from the India market, but were heavily scrutinized due to, according to NPPA, a lack of evidence in support of commercial unviability claims.

In consideration of its decision from earlier this month, however, the authority indicated on Wednesday it has “decided not to disallow any application submitted for withdrawal of stents, from the market by the stent manufacturer/importers,” upon request.

Manufacturers that intend to discontinue stent sales and/or production in the India market are directed to inform NPPA of these plans “at least six months prior to the intended date of discontinuation.”

AdvaMed’s Abby Pratt, vice president of global strategy and analysis, told Focus that NPPA’s latest decision to allow voluntary market withdrawals could “provide welcome predictability and stability” for the group’s member companies. Yet the group and its members “remain deeply disappointed with NPPA’s continued reliance on price controls, which fail to reward innovative health care solutions and may limit patient access to life-changing medical advances,” she said.  

The group plans to continue advocating for other options, such as trade margin rationalization and differential pricing, that may allow for cost savings and improved patient access to coronary stents in its ongoing discussions with NPPA, according to Pratt.


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