Indian pharma under pressure on domestic pricing issues and fears of Trump administration

Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent.

In a notice posted on its website, the Indian regulator has held that some drugmakers have launched formulations by altering a scheduled formulation, with strength other than that as specified in the DPCO 2013 and/or in combination with other non-scheduled medicines, and have not applied for price approval from the NPPA as required.

Major companies like Abbott, GlaxoSmithKline, Alkem, Biocon, Novartis, Dr Reddy’s, Lupin, Strides Shasun, MannKind Pharmaceuticals, Ranbaxy Laboratories, Sanofi, Wockhardt and Zydus Cadila, among others are in the dock for launching new formulations without first applying for price approval.