Drug price regulator National Pharmaceutical Pricing Authority (NPPA) has initiated action against various firms, including Abbott Healthcare Ltd., Zydus Cadila Healthcare Ltd. and Dr. Reddy's Laboratories Ltd., for non-compliance with provisions for new drugs under the price control regime.
In a notification issued on Wednesday, the NPPA said that various companies have launched formulations by altering a scheduled formulation with strength dosage other than as specified in the Drugs Price Control Order (DPCO) 2013.
Some companies have also launched new drugs in combination with other non-scheduled medicines without even applying for price approval from the NPPA, it added.
Any contravention of the provisions of the DPCO 2013 is punishable in accordance with the provisions of the Essential Commodities Act, 1955.National Pharmaceutical Pricing Authority
Accordingly, it has been decided to take action against these pharma companies under the provisions of DPCO 2013, it added.
The NPPA has asked the companies, which include Alkem Laboratories Ltd., Glenmark Pharmaceuticals Ltd., Lupin Ltd., Novartis India Ltd., Sanofi India Ltd., Wockhardt Ltd., Unichem Laboratories Ltd., GlaxoSmithKline Pharmaceuticals Ltd., among others, to furnish batch-wise production and sales details along with the corresponding maximum retail price information along with reasons for non-compliance with the provisions by June 15.
"If the replies are not received by the stipulated time, NPPA will proceed for taking further action in the matter as per DPCO 2013 and Essential Commodities Act, 1955," NPPA said. Comments from the companies could not be obtained immediately.
The list of drugs issued by the NPPA contains 201 formulations marketed by various drug firms in multiple strengths.