Regulator should fix prices for drugs not in essential list too: Panel

The National Pharmaceutical Pricing Authority (NPPA) might no longer be limited to fixing prices of only those drugs listed in the National List of Essential Medicines, if the recommendation of an expert committee on restructuring the drug price regulator is to go by. 

"It will be given the authority to assess and choose which drug ought to be brought under the price fixation category," a senior government official who is aware of this recommendation told Business Standard. This essentially widens the scope of the NPPA to regulate prices.

At present, the NPPA monitors drugs which are part of the National List of Essential Medicines and identifies players that over charge. Issues on overcharging and price cap have been areas of tension between the pharmaceutical industry and the NPPA. Not agreeing with various drug price orders, the players have appealed to the Department of Pharmaceuticals for several cases in the past.

The NPPA has to recover a total of Rs 4,566.55 crore, including interest, from various pharmaceutical companies for overcharging on thousands of drug formulations as of June this year.

Since its inception, demand notices have been issued by NPPA to pharmaceutical companies in 1,389 cases.

A sum of Rs 4,953.46 crore has been demanded as overcharged amount, including interest whenever updated, out of which Rs 386.91 crore has been realised till June end this year.

Further, the NPPA has been issuing show-cause notices to drug manufacturers for not registering themselves on the Integrated Pharmaceutical DataBase Management System, where the companies would declare their products to the drug price regulator.

NPPA's mandate is to fix or revise the prices of controlled bulk drugs and formulations, and to enforce prices and availability of the medicines in the country. It has been entrusted with fixation of prices of scheduled drugs under the Drug (Price Control) Order, 1995 (DPCO) 1995 and DPCO 2013.

NPPA is waiting for the Department of Pharmaceuticals to amend the DPCO 2013 and give it a direction to fix prices of those drugs for which the regulator doesn't possess details, like in the case of stents.