New expert committee to consult on drug pricing, new drug launches
NEW DELHI: The ministry of chemicals and fertilizers' pharmaceuticals department has decided to constitute a new expert committee to consult the country's drug pricing regulator on all technical issues related to pricing and new drug launches. At the same time, the regulator is not expected to be bound by the recommendations of this committee.
The Department of Pharmaceuticals' (DoP) committee consists of experts from bodies like the National Pharmaceutical Pricing Authority (NPPA), ..
“In view of the experience gained from implementation of Drugs (Prices control) order 2013, it has been decided to constitute a single multi-disciplinary "Committee of Experts"…to discharge the functions under DPCO, 2013 for consultation on all technical issues related to pricing, launch of new drugs along with other ancillary provisions where more clarity may be required, and opine on matters referred to it by the National Pharmaceutical Pricing Authority (NPPA) in discharge of its functions,” ..
The committee is empowered to deliberate on whether a drug is scheduled or non-scheduled based on the ingredients used in it. It would further recommend a separate ceiling price of scheduled formulations or retail prices of new drugs with a specified therapeutic rationale.
It is expected to deliberate on the claims of companies about the novelty associated with indigenous research and development (R&D) related to certain bulk drugs and formulations.
The new committee would be empowered to invite other specialists like those in medical devices, according to the notice.
NPPA shall decide and refer the relevant issues to the committee for its opinion within four weeks of receiving the applications, it stated. The committee, on its part, will submit its report within another 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) in hand finally," it stated.