First In­dia-made Dis­solv­able Stent Gets Health Min Nod

Gov­ern­ment ap­proval to mar­ket Biore­sorbable Vas­cu­lar Scaf­fold de­vel­oped by Gu­jarat’s Meril Life Science is likely to come in a few weeks

The Economic Times - - Companies - Our Bureau

New Delhi: 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 be-

cause 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

ON BVS

(MRP) of .₹ 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 .₹ 22,500 and .₹ 1.65 lakh, be­fore Na­tional Phar­ma­ceu­ti­cal Pric­ing Au­thor­ity (NPPA) capped their prices at .₹ 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 ap­pro- vals from the Union, he said. Some doc­tors find BVS a good choice for young pa­tients be­tween 25 and 45 years be­cause it dis­solves and could give them a rel­a­tively bet­ter qual­ity of life than metal­lic druge­lut­ing 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 .₹ 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. Euro­pean

Ab­sorb, which

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