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State FDA finds atorvastatin being sold at higher prices after tweaking prescribed dosage

Shardul Nautiyal, Mumbai
Friday, April 4, 2014, 08:00 Hrs  [IST]

Some of the pharmaceutical companies are understood to be selling more essential medicines at higher prices after altering the therapeutic dosages just to evade Drug Price Control Order (DPCO) as in the recent case of paracetamol formulations. Atorvastatin, a cholesterol drug, is being marketed in dosage forms of 20 mg and 40 mg as against the 10 mg dosage prescribed by the National Pharmaceutical Pricing Authority.

Atorvastatin is from the drug class known as statins, used for lowering blood cholesterol. It also stabilises plaque and prevents strokes through anti-inflammation and other mechanisms.

Says an FDA official, "Atorvastatin may face a similar kind of action from the state FDA as other overpriced brands of drugs as this drug has been overpriced five to 10 times more than the DPCO price. This kind of overcharging is a subject for investigation. Atorvastatin of 40 mg dosage is generally recommended for senior citizens."

State FDA had recently issued stop sale order of Calpol 60 ml syrup manufactured by GSK under the brand name of Calpol till further notice stating that the prices charged for this product violate the Drug Price Control Order (DPCO). A combination of the narcotic hydrocodone and non-narcotic pain reliever acetaminophen, paracetamol oral suspension is prescribed for moderate to severe pain and fever. FDA had earlier taken action against GSK for overpricing of paracetamol brands like Crocin Advance, Crocin suspension and Crocin drops and seized products to the tune of Rs.12 lakh.

Stop sale order for Calpol 60 ml syrup was issued after FDA seized 6, 500 bottles of paracetamol oral suspension IC, sold under the brand name Calpol worth Rs.2.11 lakh from the GSK's Bhiwandi Godown in the second week of March this year, in violation of DPCO. As per the new DPCO, Calpol 60 ml should cost Rs.20.79 but has been priced at Rs.32.75 per bottle. The manufacture was asked to call back the bottles from the market.

As per the new DPCO, one 500 mg paracetamol tablet 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 a bottle of 60ml paracetamol is fixed at Rs.19.20 but Crocin suspension is priced at Rs.37.77. Also, 15 ml should cost Rs.4.80 but a bottle of Crocin drops is priced at Rs.29.

The Maharashtra FDA is also recommending the National Pharmaceutical Price Authority (NPPA) to take strict action against the company which has been marketing the so-called 'faster action' antipyretic analgesic for not complying with the DPCO 2013. The action applies to all forms of 'Crocin Advance' tablets, suspension and syrup. GSK does not manufacture the medicine as it is outsourced to Remidex Pharma which manufactures Crocin for GSK Consumer Healthcare in the country.

Experts pinpoint that lack of a consistent definition and requirements of a “new drug” at both the CDSCO and NPPA has led to overpricing. In the past too, companies have made minor modifications to their drugs and received new drug status from the regulator to wriggle out of the price control regime.


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