Close on the heels of its stop sale action against Crocin Advance, Crocin Suspension and Crocin Drops manufactured by pharma major GlaxoSmithKline (GSK) for overcharging, the Maharashtra Food and Drug Administration (FDA) has asked the national drug regulator NPPA to take appropriate legal action against the company for violation of new Drug Price Control Order (DPCO).
This happens to be the first such case taken up by the state FDA since the new DPCO came into effect from July last year. Crocin Advance contains paracetamol and is a well-established medicine to cure fever and pain.
Meanwhile, in the wake of the crackdown, GSK has applied to the NPPA for grant of exemption to Crocin Advance from price control. According to company spokesperson, Crocin Suspension (120 mg /5 ml), Crocin 650 tablets, and Crocin Drops (100 mg /ml) are non-scheduled formulations and their prices have not been notified by the NPPA.
As per the new DPCO, 500mg 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 60ml paracetamol is fixed at Rs. 19.20 but Crocin Suspension is priced at Rs. 37.77. Also, 15ml should cost Rs. 4.80 but a bottle of Crocin Drops is priced at Rs. 29.
While chemists say they have no option but to turn away those asking for the products, FDA maintains that we don't want public to buy overpriced medicines. "We have stopped the sale of Crocin medicines manufactured by GSK based on the stop sale order from the state FDA," says Hakim Kapasi from the Andheri Chemists' Association.
While GSK claims that Crocin Advance is a specialised product which assures faster relief compared to ordinary paracetamol as it has Optizorb technology that releases medicine up to five times faster than ordinary paracetamol tablets, an FDA official says that Paracetamol is a normal pharmacopoeia drug manufactured by several companies and stopping its sale will not affect its supply and is in the interest of public at large.
"We have issued a show cause notice to GSK and are awaiting its response. We are approaching the NPPA for taking appropriate action against the company as we have found out that the company has allegedly changed the strength of Crocin Suspension (from 120 mg /5 ml to 125 mg/5ml) and has gone ahead with overpricing it. The wholesaler and retailer are liable to be penalised under the Drugs Act if they go ahead with selling the product," informs assistant commissioner (FDA) Girish Vakhariya.