NPPA exempts Merril's MeRes 100 stent from price caps despite safety concern

The National Pharmaceutical Pricing Authority (NPPA) has exempted Merril Life Sciences Pvt Ltd's drug-eluting stent MeRes-100 from ceiling prices.

The regulator exempted the stent from price caps even as concerns were raised around the stent's safety and the company was unable to prove significant therapeutic advantage and increased efficacy than other such products.

"The safety concerns of the product in question are not required to be examined by the Authority in order to consider a case for grant of exemption under para 32(ii) of DPCO 2013. The ‘new drug” approval certificate of the DCGI and the grant of Indian Patent being the two essential conditions," NPPA said in its minutes of meeting of 25 February. A copy of the minutes was reviewed by Mint.

Under paragraph 32(ii) of the Drug Price Control Order, the NPPA can exempt from price control 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 had in February 2017 put prices of cardiac stents under price control after the government had classified these as drugs.

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.

However, the All India Drug Action Network (AIDAN) last year had raised concerns related to the safety of the product.

"We do not know the basis for the experts to be satisfied by the (safety & efficacy) data of the stent. It has been our concern that the only data submitted by Meril are limited to a small, non-randomised, single-arm trial which was inadequate to prove safety," AIDAN said in a statement.

It added that it is concerned no specific plan has been drawn up for post-marketing evaluation of safety and efficacy a drug eluting stent, even as close monitoring has been recommended.

The organisation has also challenged the exemption provisions of the DPCO 2013 in the Delhi High Court and the "severe legal defects" of paragraph 32 of the Order.