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After Crocin Advance, it’s the turn of GlaxoSmithKline (GSK) Pharmaceutical’s top-selling paracetamol brand Calpol syrup to come under the regulator’s scanner for allegedly overcharging consumers. The Maharashtra Food and Drug Administration (FDA) has barred the sale of Calpol 120mg syrup in the state and issued a show-cause notice to GSK Pharmaceuticals for selling the medicine at a price higher than the ceiling.
While GSK Pharma claims the product is out of price control because of its strength, Maharashtra FDA officials maintain the company has tweaked the therapeutic dosage of the original product to skip the price control ambit. The state drug regulator is also planning to write to the National Pharmaceutical Pricing Authority (NPPA), requesting action against the company.
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“The underlining principle of the National Pharmaceutical Policy and DPCO (Drug Price Control Order) 2013 is to include those medicines under National List of Essential Medicines (NLEM) having specific strengths and dosage. Since Calpol Suspension 120mg, in market for more than 30 years, is not part of NLEM nor DPCO schedule 2013, it is outside its purview, ” said a GSK spokesperson.
Calpol is one of the best-selling prescription products of GSK Pharmaceuticals with annual sales of Rs 84.3 crore during the 12 months ended February. Paracetamol, an analgesic, is usually used for treatment of fever and pain. Recently, Crocin Advance, another leading paracetamol brand sold by the group’s subsidiary GSK Consumer Healthcare, also faced regulatory action. NPPA, the central agency monitoring prices of medicines across the country, has asked GSK to immediately reduce the maximum retail price of Crocin Advance, rejecting the company’s plea for exemption from price control. The authority is also expected to soon impose a penalty on GSK Consumer Healthcare for selling Crocin Advance at a higher price.
According to Maharashtra FDA Assistant Commissioner Girish Vakhariya, there is already a ‘stop sale’ order on various brands of paracetamol such as Crocin Advance 500mg and Crocin Suspension as these products were found overpriced. “Our investigation in the Crocin matter is over and we will soon refer this to NPPA recommending further action on the company, including penalty for overcharging.” On Friday, shares of GSK Pharmaceutical ended at Rs 2,589 on the BSE, up 0.72 per cent from the previous close.
In case of Calpol syrup, Vakhariya argues under the DPCO, 2013, the MRP of a 60-ml bottle of paracetamol suspension or syrup with strength of 125mg is fixed at Rs 20.79, whereas the company is selling Calpol syrup at a lower strength of 120mg at a higher price of Rs 32.75. “If the dosage is lower, the price should also be lower than what has been capped. Instead, the company is selling it at a higher price,” said Vakhariya.
When contacted, NPPA officials said they were yet to receive a communication from the Maharashtra state FDA but they could suo motto collect samples from the market to check Calpol prices.
GSK is one of the leading players in the paracetamol segment with many variants of the products in prescription as well as over-the-counter segment. While Calpol is a prescription product marketed by GSK Pharma, various brands of Crocin such as Crocin Advance, Crocin Pain Relief, Crocin Cold and Flu are sold by GSK Consumer Healthcare. It also has a baby and kids range of Crocin. Crocin Advance, with annual sales of around Rs 10.3 crore, is currently the fifth-largest brand among top paracetamol-based products.
The total annual sales of the paracetamol segment are pegged at around Rs 283.5 crore. The other leading brands in the segment are Micro Labs’ Dolo, Apex Pharma’s Paracetamol Apex and East India Pharma’s Pyrigesic..
