New Delhi: The fate of India-made dissolvable stents is likely to be decided this month with the government all set to consider exempting stents made by Meril Life Sciences Pvt. Ltd from price caps.
Meril Life Sciences has been seeking an exemption for their first locally made biodegradable cardiac scaffold—naturally dissolving stents that clear blockages in arteries. The National Pharmaceuticals Pricing Authority (NPPA), a government agency, in a meeting on 21 January is likely to take up the exemption claim, two people aware of the matter said. The exemption, if granted, will be valid for five years.
The stents developed by Meril, based in Vapi, Gujarat, 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 control regulator. This prompted Meril to hold back from launching its stents in the Indian market.
Now, Meril Life has sought exemption under a section of the Drug Price Control Order (DPCO) 2013 that says the price cut won’t apply if a new drug is developed through a unique, indigenous process, is patented under the Indian Patent Act and is not produced elsewhere. “The firm has provided adequate justification to the government for launching its product at the price it wants," the people cited above said on condition of anonymity.
The NPPA in a meeting on 28 June 2018 discussed such processes developed by drugmakers. “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.
NPPA will now verify the company’s submissions and discuss the exemption in the meeting this month, added one of the officials cited above.
The company says its stents are made of biodegradable material, and are an alternative to the traditional metal stents.
A price exemption, if granted, may pinch foreign manufacturers, some of whom withdrew their products from India after the government turned down their demand for a new category of “advanced stents" which would be exempt from price caps.
Civil society groups, however, are concerned about the safety of the Meril product and say the government is not doing enough to safeguard patients. “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)
Sanjeev Bhatt, vice president (corporate strategy), Meril Life Sciences, said the company is awaiting the decision of the NPPA on its stents.
In 2017, the government capped the prices of stents—mesh tubes placed in arteries to improve blood flow—by up to 85%.
In February 2018, NPPA reduced the price of drug-eluting and biodegradable stents again to ₹27,890 from ₹29,600.