Karnataka Drugs Control department has informed that multinational drug major, GlaxoSmithKline, has paid Rs.47.87 crore to National Pharmaceutical Pricing Authority (NPPA) towards overcharging Crocin Advance on May 21, 2014. The company made the payment via a bank draft. The drug was ordered to be recalled earlier because of a stop sale order issued by the regulatory authorities for its violation of Drug Price Control Order (DPCO) 2013.
GSK has taken strategic steps to recall all old stocks with maximum retail price (MRP) printed as Rs.30 on a strip of 15 tablets. The company has been selling the product at this price although the DPCO 2013 mandated Crocin Advance as a price controlled drug and NPPA fixed a price of Rs.14.94 for a strip of 15 tablets. The higher price charged by the company for Crocin Advance has been now paid up. The company has so far recalled over 40 lakh strips of Crocin Advance across India, However, the recall exercise continues, Raghurama Bhandary, drugs controller, government of Karnataka told Pharmabiz.
In Karnataka, in all the 23,000 pharmacy trade outlets Crocin Advance strips are sold at Rs.14.94 for 15 tablets.
“We have been checking out if any over priced Crocin Advance strips are sold in the state but did not come across any such case so far. However, we will continue our checks because this is an over the counter drug”, said Karnataka drugs controller Bhandary.
Pharma experts watching the issue of overcharging of price controlled drugs have expressed surprise that GSK did not challenge the NPPA directive and instead went on to pay the overcharged amounts. This was probably because the GSK has firmed up its plans of expanding in India as the country is an important market in its marketing and manufacturing game plan.
According to the Bangalore Districts Druggist and Chemists Association, the pharmacy outlets were responsible to ensure that no drug was overpriced and did not violate DPCO 2013 because their first concern was the poor patient purchasing the drug.
GSK manufactures Crocin Advance at third party facility in Bengaluru known as Remidex Pharma over a decade. The facility is located in the Peenya Industrial Area in the outskirts of Bengaluru.
A panel of general practitioners have stated Crocin Advance is the first point of medicine for pain and fever in most households across age-groups of 10 to 70 years.
Pharmabiz had earlier reported that GSK too has come out with versions of Crocin covering Crocin Pain Relief, Crocin Cold & Flu and Crocin Quick to target the fever reducing, cold-flu, pain killer and anti-inflammatory conditions. There was also Crocin 1000 introduced in 2001 which was withdrawn in 2004. Indian market brims with leading formulations containing paracetamol in the antipyretic space which included Dolo-650, D’Cold, Calpol, etc. The country’s anti-pyretic and analgesics market registered a growth of 15-18 per cent in 2012-13.