After the issue of the stop sale order for overcharging Calpol 60 ml suspension marketed by GlaxoSmithKline (GSK), the Maharashtra FDA has now directed drug inspectors to seize 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 drug at the overpriced rate as it amounts to violation of Drug Price Control Order (DPCO). Penalty may range from suspension of license to prosecution.  
 
The state FDA had a month ago seized 6, 500 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.  

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 product as directed by the FDA. The company has written to the FDA explaining compliance with law and have also sought clarification from National Pharmaceutical Pricing Authority (NPPA) on this issue." FDA officials, however, maintain that they have deputed drug inspectors to keep a check on the illegal stocking and sale of the overpriced products. "We have launched a massive crackdown and are in the process of seizing the products," informs a senior FDA official.

Following the stop sale order, city based chemists have stopped stocking parcetamol brands like Crocin Advance and Calpol 60 ml. The state regulator has also prohibited Crocin products like Crocin Drops and Crocin Suspension for overpricing them. According to chemists in the city, GSK has stopped supplying most of the paracetamol brands like Calpol and Crocin Advance.

Meanwhile, GSK has launched a nationwide recall of its paracetamol brand, Crocin Advance, from the retailers and wholesalers following Maharashtra FDA's stop sale order issued to the company for overcharging the drug recently. Most of the retailers across the country have also stopped stock and sale of the drug.

Now, Crocin Advance will have to be sold at Rs. 14. 84 for 15 tablets, which is the ceiling price fixed for a strip of paracetamol tablets of 500 mg under DPCO 2013. Crocin Advance was being sold at Rs. 30 for 15 tablets. The price is already effective nationwide. Informs a GSK spokesperson to Pharmabiz, "GSK is reducing price of Crocin Advance Paracetamol Fast Release 500 mg as per the provisions of the DPCO with immediate effect. GSK has been and will continue to be compliant with the law of the land.”

An FDA official maintain that recall of Crocin Advance by GSK got initiated on March 26, 2014 based on NPPA's response and selling of the drug at the DPCO price will most probably be applicable once the manufacturer supplies the drug to the market again after relabeling, which might take a couple of months. "Action can be taken against the retailer for selling and stocking the drug at the overpriced rate, the official explains, in violation of DPCO rules. Penalty may range from suspension of license to prosecution, " explains an official. Last month, FDA seized stock worth Rs. 12 lakh from the firm's Bhiwandi godown which supplies to the entire state.

These happen to be the first few cases taken up by the state FDA since the new DPCO came into effect from July last year. As per the new DPCO, 500 mg paracetamol should cost 0.94 paise but Crocin Advance is priced at Rs. 2 per tablet. Besides GSK's two other products are also over priced. In liquid form, the price of Crocin suspension is fixed at Rs. 19.20 but company has been selling at Rs. 37.77. Also, 15ml Crocin Drops is fixed at Rs. 4.80 but the company has been selling at Rs. 29.