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Three years after setting cap on stents, NPPA exempts Meril’s device from price control
- Meril had approached the NPPA for exemption under this provision after it received the Indian drug regulator’s approval in 2017 for the stent, a drug-coated product called MeRes-100 that naturally dissolves over a period of time.
- The All India Drug Action Network (AIDAN) last year had raised concerns related to the safety of the product.
- The authority took the decision after DCGI, which convened a meeting of experts on the issue, had found clinical data and three-year follow up data on 108 patients submitted by Meril to be “satisfactory”