NPPA crack down on 52 pharma firms for non-compliance

The national drug price regulator, National Pharmaceutical Pricing Authority (NPPA)  issued show cause notices to several pharmaceutical firms on Wednesday, May 17, 2017, on account of non-compliance of regulations.

About 52 pharmaceutical firms were identified by the price regulator for selling hundreds of fixed dose combination (FDC) drugs with out acquiring price approvals by the authority, besides non-compliance of several other provisions.

The firms identified includes Lupin, Zydus Cadila, Wockhardt, Abbott Healthcare, Alembic, Alkem, Zuventus Healthcare, Ranbaxy (Sun Pharma), Sanofi India, and,  GlaxoSmithKline, among others.

The pricing regulator has directed the companies to file all the details related to the drugs including the maximum retail price along with the reason of non compliance with the authority by June 15, 2017.

In case of further non-compliance, NPPA is likely to take action against the companies under the DPCO, 2013 and Essential Commodities Act, 1955 provisions.   

According to DPCO, 2013, on failing to apply for price approval for a ‘new drug’, the manufacturers will be liable to deposit an overcharged amount above the price fixed by the government along with an interest to applied from the date of launch.
  
Further, NPPA is also likely to probe into the combinations of the new drugs, including determining whether the companies have acquired approvals of CDSCO for their formulations.