The national pharmaceutical regulator NPPA has exempted a new coronary stent developed by Meril Life Sciences from price control for five years under a provision of the Drug Price Control Order 2013.
The company said in a statement that it has got exemption for its product MeRes100TM BRS-Sirolimus eluting bioabsorbable vascular scaffold system from the National Pharmaceutical Pricing Authority. It plans to start commercial production of the product in a couple of months.
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The Authority decided that exemption may be granted to Meril Life Sciences Pvt. Ltd. under para 32 (ii) of DPCO 2013 for their coronary stents ‘MeRes 100 - Sirolimus eluting bioabsorbable vascular scaffold system' as per the recommendation made by the multidisciplinary committee of experts,” the NPPA said in minutes of its meeting.
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The authority also directed the Drug Controller General of India to ensure close safety monitoring of the coronary stents that have been exempted in public interest, as per the minutes of the meeting held on Feb. 25.
The government had in 2017 had slashed the prices of life-saving coronary stents by up to 85 percent.
Sanjeev Bhatt, vice president of the company's corporate strategy, told PTI: “The positive decision by NPPA confirming non-applicability of DPCO 2013 under Para 32 for MeRes100 BRS, made post an exhaustive multi-stakeholder review, demonstrates the commitment of the Indian Government to encourage not only ‘Make in India', but also Research in India.”
MeRes100 BRS is backed by three-year efficacy and safety clinical trial data, and has received eight patents worldwide, he added.
“We are committed to introducing MeRes100 BRS in India and the world responsibly by undertaking a range of measures to ensure effective access and right use, including conducting a 2,000-patient large scale randomized study, building 1,000-patient Indian and global patient registries and ongoing education of interventional cardiologists,” Bhatt said.
Under para 32 (ii) of the DPCO 2013, the provisions of DPCO 2013 order shall not apply to “a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country”.
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