Setback to Meril Lifesciences MeRess100: NPPA refuses to give relief of price cap exemption for the biodegradable stent
New Delhi: In a major setback to Meril Lifesciences, the drug price regulator National Pharmaceutical Pricing Authority(NPPA) has refused to give it relief in terms of price cap exemption for its biodegradable stents.
The NPPA, however, has decided to refer to its application to 'Standing National Committee on Medicines for revision of NLEM' with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit an exemption under para 32 of DPCO, 2013.
Medical Dialogues had earlier reported that the case in question was related to Merrill's naturally dissolving stents that clear blockages in arteries
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.
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 a recommendation to the Authority
Thereafter, a meeting of "Multidisciplinary Committee of Experts" was held on February 7 2019, wherein the committee found that the submission of documents by Meril met the requirements of para 32(ii) of DPCO, 2013 and hence held that the product is eligible for price cap exemption.
NPPA verified the committee's submission and referred the applications to the Standing National Committee on Medicines. However, the authority noted that the any decision to exempt drugs from price regulation has to be taken in holistic perspective
"Authority noted that the expert Committee had not applied itself fully to the important agenda pertaining to public interest as stated above. It was decided to refer both applications to 'Standing National Committee on Medicines for revision of NLEM' with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit exemption under para 32 of DPCO, 2013."
NPPA states that any decision to exempt drugs from price control has to be taken in holistic perspective;
"In public health, choice of consumer is impeded by information asymmetry and lack of knowledge regarding quality and efficacy of drugs/ medical devices. Often, high priced items are prescribed/ preferred on the premise of improved quality. It is, therefore, important that pricing policy is not operated in silos. Any decision to exempt drugs from price regulation has to be taken in holistic perspective."