Government to constitute committee for drug pricing, new launches
The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers will constitute multi-disciplinary committee of experts for consultation on matters pertaining to implementation of drug price control order (DPCO) including technicalities involved in pricing and new launches.
It will have member secretary of National Pharmaceutical Pricing authority (NPPA) as its convener. It will also have representatives from Central Drugs Standard Control Organisation (CDSCO), Department of Health Research/Indian Council of Medical Research (ICMR) and NIPER as members.
The committee will be constituted taking in view of the experience gained from implementation of Drugs Price Control Order (DPCO), 2013 for consultation on all technical issues related to pricing, launch of new drugs with ancillary provisions where more clarity is required.
The committee is also mandated to recommend its opinion on claims of pharma companies about any additional therapeutic features associated with any formulation. It will also recommend separate ceiling price of scheduled formulations or retail price of any new drug with specified therapeutic rationale.
It will also give its opinion on claims of pharma firms about additional pharmacoeconomics features associated with any formulation/Active Pharmaceutical Ingredient (API). Besides, it will also give opinion on technical related issues such as whether a drug is scheduled or non-scheduled on basis of ingredients used in formulation.
It will give opinion on technical issues and claims by pharma companies about novelty associated with indigenous research and development of their products, for granting exemption from price control order for period of 5 years.
The recommendations of committee will considered by NPPA which will pass reasoned order on it. The committee will be empowered to invite or co-opt any other specialist depending on exigencies of circumstances requiring resolution of any specific matter arising out of implementation of various provisions of DPCO 2013.