Discrepancies in documents submitted by Meril Life Science for exempting MeRes100 from price cap; NPPA stalls decision

New Delhi: In a blow to Gujarat-based stent maker, Meril Life Sciences, the apex price regulator, National Pharmaceutical Pricing Authority (NPPA) has decided hold back the decision to exempt the firm's flagship Sirolimus-Eluting BioResorbable vascular scaffold system (MeRes100) from price cap exemption under paragraph 32 of the Drug Price Control Order (DPCO), 2013.

The decision came following the discrepancies found by NPPA in the submissions made by the firm seeking exemption from price cap for MeRe100, a drug-coated product that naturally dissolves over a period of time, after it received the drug regulator’s approval in 2017 for the stent.

The firm had moved an application with NPPA for the same. The company has been striving to clear the decks for MeRes100 since long. However, last month, with an industry association raising health and safety concerns, the application got stuck.

Also Read: With questions about the safety of Meril’s Made in India BVS stent, NPPA defers its appeal for price exemption

A month after this, the application was once again deliberated during a meeting held on December 9, 2019, under the Chairmanship of Shubhra Singh, Chairman, NPPA. The meeting was attended by other members including A K Pradhan, Deputy Drug Controller, Department of Health and Family Welfare, Dr V G Somani, Drug Controller General of India(DCGI).

NPPA examined the matter in detail. It was noted by the authority that Meril has applied for price exemption under Para 32(ii) of DPCO 2013 with respect to its product cardiac stent named “MeRes-100 – Sirolimus-Eluting Bioresorbable Vascular Scaffold System” in which Patent Registration No. 296768 dated 14.05.2018 was mentioned.

However, from the documents of the Patent office submitted by the company, it was observed that the patent is for “Annealing process for a bioabsorbable stent”. NPPA further noted that the DCGI license submitted by Meril Life Science is for “Sirolimus-Eluting bioresorbable Vascular Scaffold system (cardiac stent).

Accordingly, NPPA directed the company to furnish an explanation for submitting discrepant documents.

"The company may be asked to explain the reasons for submission of these discrepant documents for seeking price exemption under Para 32 of DPCO 2013, " NPPA noted.