Following Maharashtra Food and Drug Administration (FDA) stop sale order on paracetamol brands for overpricing, National Pharmaceutical Pricing Authority (NPPA) has intimated FDA and directed the GSK to deposit Rs.1,31,94,760 to the government exchequer. The amount was earned as a profit by overcharging the customers.

This is the outcome of Maharashtra FDA approaching the National Pharmaceutical Pricing Authority (NPPA) for recovery of the excess amount earned as profit by GSK on paracetamol brands in contravention to the Drug Price Control Order (DPCO) 2013.

FDA officials maintain that GSKs paracetamol brand Calpol suspension sold in 60 ml bottle is subject to NPPA scrutiny as it has been manufactured since 2007 after tweaking the standard therapeutic dosage of 125 mg/5 ml mandated by the NPPA to 120 mg/5ml and sold at an overpriced rate.

The state FDA had a two months ago seized 6500 bottles of Calpol 60 ml worth Rs.2.11 lakh, on grounds of overcharging the product in violation of DPCO. As per the DPCO, Calpol 60 ml should be sold at Rs.20.79 per bottle but the company has been selling at Rs.32.75 per bottle. Calpol is an analgesic prescribed for moderate to severe pain and is recommended for fever.

Available in a bottle of 15ml, Crocin drops is fixed at Rs.4.80 as per the DPCO, but the company has been selling it at Rs.32. GSK in a statement to Pharmabiz, however, claims that Crocin drops (paracetamol oral suspension IP) 100 mg/ml is a non-scheduled formulation as per DPCO 2013 and its price has accordingly not been notified by the NPPA. Hence, this drug does not fall under any Price Control Order.

State FDA is planning to approach NPPA on the ground that the price of Crocin drops is exorbitantly priced. Generally prescribed for infants, the over the counter drug needs to be made affordable to the general public as it commands a big market share of above 70 per cent.

In the past, based on the FDA's action on the paracetamol brands, GSK officials have also claimed that Crocin suspension (paracetamol oral suspension IP) 120 mg/5 ml is a non scheduled formulation as per DPCO 2013 and its price has accordingly not been notified by the NPPA. The price of Crocin suspension is fixed at Rs.19.20 but company has been selling at Rs.37.77.