A new stent made by the Gujarat based firm Meril Life Sciences has been exempted from price control by the National Pharmaceutical Pricing Authority (NPPA).
This exemption implies that that the firm has provided adequate justification to the government for launching its product at “any price” it wants.
The National Pharmaceutical Pricing Authority (NPPA), at a meeting held on February 25, decided “that exemption may be granted to M/s Meril Life Sciences Pvt. Ltd under para 32(ii) of DPCO, 2013 for their coronary stents ‘MeRes 100- Sirolimus Eluting Bio-Resorbable Vascular Scaffold System’ as per the recommendation made by the Multidisciplinary Committee of Experts,” said the minutes of the meeting.
Para 32 of the Drugs (Prices Control) Order, 2013 lists out certain conditions a product has to meet to stay out of the provisions of the regulation.
This includes new drugs developed through indigenous research and development that are patented under the Indian Patent Act, 1970 and not produced elsewhere as well as new drugs produced in the country by a new process developed indigenously and patented.
The NPPA’s exemption came only after DCGI’ found clinical data and three-year follow up data on 108 patients submitted by Meril to be “satisfactory”.
Meril had approached 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.