Even as the recall of Crocin Advance and Calpol syrup from the market by GlaxoSmithKline (GSK) remained incomplete, the Maharashtra Food and Drug Administration (FDA) has seized GSK's paracetamol brands worth Rs.1.03 crore.
The Maharashtra FDA has also approached the National Pharmaceutical Pricing Authority (NPPA) for recovery of the excess amount earned as profit by the company on Crocin Advance and is planning to approach NPPA for overpricing Calpol syrup sold in 60 ml bottle and Crocin drops in contravention of DPCO.
FDA officials maintain that 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 has been selling at an overpriced rate.
The state FDA had a month 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.
After the issue of the stop sale order for overcharging Calpol syrup and Crocin Advance, FDA is in the process of seizing the product from the trade channels across the state. FDA officials maintain that action can be taken against the retailer for selling and stocking the banned drug at the overpriced rate as it amounts to violation of DPCO. Penalty may range from suspension of license to prosecution.
Following the stop sale order, city based chemists have also stopped stocking paracetamol brands like Crocin Advance, Crocin drops and Calpol syrup.
According to a GSK spokesperson, "Although having fully complied and not violated provisions of any law as applicable, GSK has taken necessary steps without prejudice to its rights to recall the batches of the paracetamol brands as directed by the FDA. The company has written to the FDA explaining compliance with law and have also sought clarification from NPPA on this issue”.