With the NPPA September 15 notification, capping the prices of 43 formulations, which includes gastro-intestinal, anti-infectives drugs and vaccines, sales of the new product basket worth Rs. 450 crore is likely to get impacted by 33 to 40 per cent and trade margin by 6 per cent, say trade bodies. According to sources, pharma companies like Alkem, Ranbaxy, Cipla and Lupin would be impacted largely with the NPPA September 15 notification.  

The latest tranche of price control includes key medicines such as ciprofloxacin, cefotaxime, BCG vaccine and rifampicin. The hardest hit comes from the fixing of two different doses of ciprofloxacin 500 mg and 250 mg. All major drug makers including Alkem, Ranbaxy, Dr Reddy's Labs, Lupin, Mankind and Cadila, sell different brands of ciprofloxacin. With the new notification in place, popular medicine brands such as Pfizer's Gelusil, Serum's BCG vaccine and USV's Glycomet have also come under price control.

National Pharmaceutical Pricing Authority (NPPA) had earlier fixed the prices of 108 formulation packs of 50 non scheduled drugs in antidiabetic and cardiovascular segments effective from July 10, 2014 in the wider public interest. As per sources, the prices of antidiabetic and cardiovascular drugs across all brands vary in the range of 10 per cent to 40 per cent.

The Indian Pharmaceutical Alliance (IPA) and the Organisation of Pharmaceutical Producers of India (OPPI), had challenged the order in the Bombay and Delhi high courts, respectively. While the Delhi High Court had refused to entertain the OPPI petition seeking a stay on the DPCO, the Bombay HC is yet to hear the IPA plea. The Delhi High Court had on August 1 refused to stay NPPA's July 10 order fixing prices of 108 non-scheduled drugs, but sought responses from the pricing authority by September 29, when it will hear the petition.

Delhi HC had observed that paragraph 19 of the 2013 DPCO does not restrict price fixation to only essential drugs. Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit, the court had said.