First India Made Dissolvable Stent Gets Ministry Nod

New Delhi,Feb 2017: The health ministry has approved the country's first locally made bioresorbable cardiac scaffold, or naturally dissolving stent for clearing blockages in arteries that carry blood to the heart.

A health ministry subject expert committee (SEC) approved Gujarat-based Meril Life Science's bioresorbable vascular scaffold (BVS) at a meeting on Tuesday, a senior government official told ET on condition of anonymity.

The official government approval to market the stent is expected within a few weeks, the official said.

Sanjeev Bhatt, vice president (corporate strategy) at Meril Life Sciences, in an email response to ET said, "We have presented our case to the Subject Expert Committee and are awaiting feedback."

Unlike drug-eluting stents that are made of metal and stay in the arteries forever, Meril's 100 micron-thick BVS 'MeRes100' is made of material that degrades and is absorbed by the body over three years.

Meril would be the second company with a BVS in the country after Abbott India, which had introduced its brand 'Absorb' in the market in 2012.

Out of more than five lakh coronary stents used in the country in 2016, only around 8,000 were BVS, mainly because of its high prices, analysts said.

Before it came under price control earlier this month, BVS was often more expensive than metallic drug eluting stents and few patients would be able to afford it.

Absorb, which had a monopoly in this category of stents, had maximum retail price (MRP) of Rs 1.80 lakh at hospitals before coming under price control, industry executives and distributors told ET.

Most drug eluting stents in the market had MRPs ranging between Rs 22,500 to Rs 1.65 lakh, before National Pharmaceutical Pricing Authority (NPPA) capped their prices at Rs 29,600.

Meril had first applied for approval for MeRes100 in India in 2013, Bhatt said.

The company conducted studies in 108 patients in India and 40 patients in Brazil, European countries and South East Asian countries, he said. It has already received approvals to market the product in Columbia, Ecuador, Indonesia and the Philippines over the last month and is currently awaiting regulatory approvals from the European Union, he said.

Some doctors find BVS a good choice for young patients between 25-45 years because it dissolves and could give them a relatively better quality of life than metallic drug eluting stents.

"If you believe in the science, a scaffold that dissolves would reduce the need for patients to be on several medications for a long time," Columbia Asia senior consultant Sanjat Chiwane told ET. "It would be an ideal therapy for anybody because you don't have a device inside your body forever."

At the same time, he said no single study has proven BVS are more efficient than drug eluting stents. "They're not superior to second or third generation stents, but they're not inferior either," Chiwane said.

India's cardiac stent market is estimated to grow at a compound annual growth rate (CAGR) of 14% and cross $1.8 billion in revenues by 2026, according to a recent report by Future Market Insights.

The size of this market was estimated at $531 million (roughly Rs 3,619 crore) in 2016 end. Yet, so far, BVS have contributed to a small portion of these revenues, said an analyst on condition of anonymity.

BVS also has its own limitations from a procedure perspective. For instance, existing BVS are twice as thick as a metallic drug eluting stents and don't have as many size options, Chiwane said.