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NPPA committee to decide on Meril’s request for price cap exemption on first Made-in-India bio-resorbable stent
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Arun Sreenivasan, New Delhi
January 30 , 2019
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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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