NEW DELHI: Meril Life Sciences Pvt. Ltd’s request for exemption from price caps for its first locally-made biodegradable cardiac scaffold, a naturally dissolving stent that clears blockages in arteries, has been sent to an expert panel for review, two people aware of the matter said.
India’s price regulator, National Pharmaceutical Pricing Authority (NPPA), which took up the exemption claim at its 21 January meeting, has not accepted the proposal and has sent it for a re-examination, the people said, requesting anonymity. The exemption, if granted, would be valid for five years.
Meril based in Gujarat’s Vapi, has been trying to seek an exemption under para 32 of the Drug Price Control Orders (DPCO) that says the price cap won’t apply if a new drug developed through a unique, indigenous process, is patented under the Indian Patents Act and is not produced elsewhere.
NPPA verified the company’s submissions and decided that the matter be sent to an expert body for re-examination. “After detailed deliberations, the authority decided to refer the case to multi-disciplinary committee of experts, which after co-opting suitable experts shall make recommendation to the authority," said the minutes of the meeting. Mint has reviewed a copy of the minutes.
In February 2017, the government capped the price of stents, a mesh tube placed in arteries to improve blood flow, forcing manufacturers to cut prices by up to 85%. Since then, many foreign stent makers withdrew their high-end devices from India, and have been pressing to create a new category of stents with advanced features.
A committee was earlier set up to examine creation of a new category. Stent makers and importers like Boston Scientific India Pvt. Ltd, Abbott Healthcare Pvt. Ltd, India Medtronic Pvt. Ltd and Meril Life Sciences Pvt. Ltd have made representations before the committee on 25 January last year urging that by creating a new category, quality and innovation would be rewarded and the segment kept viable. However, the eight-member government sub-committee of experts that considered stent makers’ arguments said there were “no grounds" to create a new category.
The NPPA in a meeting on 28 June also discussed the processes developed by drug makers. “The authority noted that companies have produced documents showing that patents have been granted under Indian Patents Act, 1970 for producing the new drugs in the country by a new process developed through indigenous research and development and companies have also produced documents showing approval of such new drugs from DCGI," according to the minutes of the meeting.
The company says its stents are made of biodegradable material, and are an alternative to the traditional metal stents. The stents developed by Meril are known as MeRes100. However, the year they were granted approval by the Drug Controller General of India (DCGI)—in 2017—was also when the prices of stents were slashed by the price regulator. This prompted Meril to hold back from launching its stents in the local market.
Civil society groups, are concerned about the safety of the Meril product. “We do not believe that there is evidence to support any therapeutic advantage of this stent, given the limitations of the single arm clinical trial.
Abbott’s BVS (bioresorbable vascular scaffold) that introduced the technology on which Meril’s stent is premised was found to be associated with higher risk of major adverse cardiac events and subsequently withdrawn globally. Therefore, it is our position that a price exemption for a risky, inadequately tested technology is unwarranted and the application should be rejected," said Malini Aisola, co-convener, All India Drugs Action Network (AIDAN).