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Arun Sreenivasan, New Delhi January 30 , 2019
A multi-disciplinary expert committee of the National Pharmaceutical Pricing Authority (NPPA) will decide whether the country’s first indigenously made bio-resorbable coronary stents could get an exemption from the government’s notified price ceiling. The national drug price regulator has examined the application of Gujarat-based Meril Life Sciences for price exemption on its advanced ‘MeRes100’ stent and referred the matter to the expert panel, it is learnt.

The company has sought exemption under Para 32 of the Drug Price Control Order (DPCO) 2013 for their sirolimus-eluting bio-resorbable vascular scaffold system or naturally dissolving coronary stents, as per the minutes of the NPPA meeting reviewed by Pharmabiz. In its application, the manufacturer claimed that its product, cleared by the Drug Controller General of India last year, was the country’s first indigenously made bio-resorbable vascular scaffold. Para 32 of the DPCO 2013 is applicable when a new drug is developed through a unique, indigenous process, and is patented under the Indian Patent Act 1970. As per the DPCO provisions, the company could get a price exemption for up to five years.

The NPPA decision on Meril’s application for price exemption assumes significance. “If the company’s request was approved, it would be a change of stance on the part of the NPPA, which last year had rejected the multinational medical device manufacturers’ request for a sub-category of new generation coronary stents,” an industry lobby group official pointed out.  

The Central government capped prices of cardiac stents by up to 85 per cent in 2017. A year later, a sub-committee of experts constituted by the government rejected representations from multi-national stent makers to implement differential pricing for advanced drug-eluting stents with novel features citing inadequate clinical evidence of superiority in terms of safety or efficacy.

Within months after the NPPA order setting ceiling price on cardiac stents, multinational firms such as Abbott, Medtronic and Boston Scientific Corporation have filed applications with the regulator to withdraw their new generation stents from the country saying the pricing regime made their products unviable. Importers say that proving superiority of their drug-eluting stents is a long process as it will take years to obtain adequate clinical data. However, the domestic industry cheered the move to bring affordable medical devices to the masses.

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 around 61 per cent market share.

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