NPPA to decide on Merrills Request for price cap exemption for its biodegradable stent

New Delhi: A Year after Abbott's launch of biodegradable stents which was later withdrawn globally, Meril Life Sciences has moved the National Pharmaceutical Pricing Authority (NPPA) to seek an exemption from the authority from the price ceiling for its products. The move has drawn the ire of civil society which doubted the move, in light of questioned safety of the product.

The case in question is related to Merrill's naturally dissolving stents that clear blockages in arteries. The fate of this biodegradable cardiac scaffold is likely to be decided soon. The expert committee of the National Pharmaceutical Pricing Authority (NPPA) will decide whether the coronary stent could get an exemption from the government notified price ceiling.

The stents developed by this Gujarat based firm is known as MeRes100. The company says its stents are made of biodegradable material and are an alternative to the traditional metal stents.

It is learnt that the firm has forwarded an application to the NPPA to consider exempting MeRes100 from price cap. In case the exemption is granted, it will be valid for five years.

On January 21, the NPPA held a meeting, where the issue was discussed. the minutes of the meeting recorded

The Authority noted that Deptt of Pharmaceuticals vide its letter dated 31.12.2018 directed NPPA that as per Government of India's Resolution dated 29.08.1997, NPPA has the power to regulate its procedure for performing the functions entrusted to NPPA. Hence, NPPA is competent to decide procedure/ methodology for deciding cases under para 32 of DPCO, 2013. After detailed deliberations, the Authority decided to refer the case to the Multi Disciplinary Committee of Experts, which after co-opting suitable expert/(s) in the Committee, shall make recommendation to the Authority

The expert panel is likely to take up the exemption claim, two people aware of the matter told Livemint. NPPA will now verify the company's submissions and discuss the exemption in the meeting this month, added one of the officials cited above.

Currently, Meril Life has sought exemption under a section of the Drug Price Control Order (DPCO) 2013 that states 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 on condition of anonymity told the daily.

On 28 June 2018, NPPA in a meeting discussed such processes developed by drugmakers. "The authority noted that companies have produced documents showing that patents have been granted under the 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.

Exemption May Come But What about Safety?

Civil society groups, however, are not very pleased with the move. They 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," Malini Aisola, co-convener, All India Drugs Action Network (AIDAN) told Livemint.

On the other hand, Sanjeev Bhatt, vice president (corporate strategy), Meril Life Sciences, said that the company is awaiting the decision of the NPPA on its stents.

In 2017, the Drug Controller General of India (DCGI) granted approval for the stents developed by Meril. However, in the same year, the cost of the stents was cut down by the price control regulator which held back the firm from launching its stents in the Indian market. In 2017, the government capped the prices of stents—mesh tubes placed in arteries to improve blood flow—by up to 85% and In February 2018, NPPA reduced the price of drug-eluting and biodegradable stents again to Rs 27,890 from Rs 29,600.