India’s drug price regulator has deferred a plea by Meril Life Sciences for a stent it developed two years ago to be exempted from price controls set by the government, pending a review of its efficacy and concerns raised over the device’s safety.
The National Pharmaceutical Pricing Authority, at a meeting on October 30, decided to postpone a decision on the matter, in view of safety concerns raised by the All India Drugs Action Network(AIDAN), an NGO.
Meril Life’s first locally made biodegradable cardiac scaffold, a naturally dissolving stent, is known as MeRes100. The stent was approved by the Drug Controller General of India in 2017, when prices were cut, prompting Meril, based in Vapi, Gujarat, to hold back on launching the product. While Meril has tried to get exemption from the price cap, the NPPA noted at its meeting last month that “AIDAN has raised health and safety concerns regarding the usage of MeRes100 stents.”
AIDAN had asked for Meril’s request to be put on hold until the device’s safety is proven.
The NPPA has referred the matter to a committee for revision of the National List of Essential Medicines and asked it to examine if the product had any significant therapeutic advantage.