New expert panel to help to decide pricing and launch of drugs: DoP
New Delhi: The government will set up a panel of experts for consultation on matters pertaining to the implementation of the drug price control order, including technicalities involved in pricing and new launches.
The Department of Pharmaceuticals (DoP) said the "multidisciplinary committee of experts" 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 and NIPER as members, DoP said in an order.
DoP said the decision has been made in view of the experience gained from the implementation of Drugs Price Control Order, 2013 for "consultation on all technical issues related to pricing, launch of new drugs with ancillary provisions where more clarity may be required..."
The NPPA will decide and refer relevant issues within four weeks of receiving the applications, to the committee for its opinion, it said.
In turn, the panel will submit its report along with its findings within four weeks.
"The recommendations of this committee shall be considered by the NPPA which shall pass a reasoned order within four weeks from receiving the recommendations of the committee, deciding the issue(s) finally," said the order.
It added that 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 the implementation of various provisions of DPCO 2013.
The panel will also opine on matters referred to it by the NPPA, it said.
The committee is mandated to recommend its opinion on the claims of pharma companies about any additional therapeutic features associated with any formulation and recommending 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/API, the order said.
Besides, it will also give an opinion on technical related issues such as whether a drug is scheduled or non-scheduled on the basis of ingredients used in the formulation, it added.
The technical issues will also include claims by pharma companies about novelty associated with indigenous research and development of their products, for granting exemption from the price control order for a period of five years.