“These companies have launched formulations by altering a scheduled formulation with strength/dosage other than as specified in DPCO, 2013 and secondly in combination with other non-scheduled medicines without even applying for price approval from NPPA as required under Para 1 (2) of DPCO, 2013,” NPPA said.
The national drug price regulator on Wednesday issued show cause notices threatening penal action against dozens of pharmaceutical firms selling hundreds of fixed dose combination (FDC) drugs without complying with various provisions of drug price control order.
National Pharmaceutical Pricing Authority (NPPA) has identified 52 companies selling 201 FDC formulations without applying for price approval.
Some big names in the list include Lupin, Zydus Cadila, Wockhardt, Abbott Healthcare, Alembic, Alkem, Zuventus Healthcare, Ranbaxy (Sun Pharma), Sanofi India, GlaxoSmithKline, among others.
The pricing regulator asked the concerned companies to furnish batch-wise production and sales details along with the corresponding maximum retail price (MRP) duly certified by a chartered or cost accountant for the formulations indicated in the list, from the date of launch of production till date, along with reasons for non-compliance of the provisions related to new drug, to this office positively by June 15.
NPPA said if replies are not received by the stipulated date, it will proceed for taking further action in the matter as per DPCO, 2013 and Essential Commodities Act, 1955.
FDC is a combination of two and more drugs, and is considered as new drug.
"During the monitoring of compliance of various provisions of Drug (Prices Control) Order, 2013 (DPCO 2013) by drug manufacturers, it is seen that the provisions related to 'new drugs' have not been followed by some pharmaceutical companies,” NPPA said in a statement.
“These companies have launched formulations by altering a scheduled formulation with strength/dosage other than as specified in DPCO, 2013 and secondly in combination with other non-scheduled medicines without even applying for price approval from NPPA as required,” NPPA added.
NPPA also requested pharma industry associations to sensitize their members to obtain prior approval of prices from this office, before launching any formulation that may be categorised as 'new drug'.
According to DPCO, 2013 if the existing manufacturer failed to apply for prior approval of the price of the new drug, such manufacturer will be liable to deposit the overcharged amount over and above the price fixed and notified by the government, along with interest thereon from the launch date.NPPA also said it is also not clear whether these formulations have the approval of CDSCO and whether these are rational or irrational combination drugs, as many of these are fixed dose combinations.