Abbott Healthcare has got the green light from the National Pharmaceutical Pricing Authority (NPPA) to discontinue selling its high-end metallic stent Xience Alpine Premium from the Indian market.

The authority okayed a ‘change in date of withdrawal’ of Xience Alpine stents proposed by the company, according to the minutes of the meeting held on April 23.

The NPPA, after rejecting the multinational medical device manufacturers’ request for a sub-category of new generation coronary stents, had decided not to stop any manufacturer or importer of coronary stents from pulling out of Indian market. According to a circular issued by the pricing authority, companies will be allowed to discontinue production after giving six months’ notice.

Within months after the NPPA passed an order slashing the prices of cardiac stents by as much as 85 per cent, multinational stent makers such as Abbott, Medtronic and Boston Scientific Corporation filed applications with the regulator to withdraw their new generation stents from the country saying the pricing regime made their products unviable. However, the Department of Pharmaceuticals (DoP) invoked the powers under Section 3 of Drug Price Control Order (DPCO) to restrict the companies from withdrawing their products. The Section 3 of DPCO allows the government in cases of emergency or non-commercial use to direct any manufacturer to ensure adequate availability of drugs or devices in public interest. It also enables the government to regulate the distribution of products. Abbot had applied for withdrawal of its premium stents in August last year.

According to the NPPA, following the price cap on coronary stents, the market share of domestic stent makers has risen. Data suggests a 4 per cent shift in favour of domestic manufacturers who now have 61 per cent market share. Post revision, the drug-eluting stents (DES) and bare metal stents (BMS) have the ceiling price of Rs.27, 890 and Rs.7,660 respectively.

The domestic medical device market in India is expected to grow 15 per cent annually between 2014 and 2020 to $8.6 billion, according to a joint report by Deloitte and Healthcare Federation of India. But official figures reveal 59 per cent fall in foreign direct investment (FDI) in the sector during the January-September 2017 period compared to the corresponding period of the previous year. Many industry representatives lay the blame for the fall in FDI on unnuanced market interventions and atmosphere of regulatory unpredictability.