Kerala DC dept issues stop-sale order for statin drug ‘Lodens’ for violation of DPCO; notice issued to Anthem Biopharma
The drugs control department of Kerala has stopped the sale of ‘Lodens’ tablet (rosuvastatin drug) and issued stop-sale order to its C&F agency, Geco Agencies, Erankulam for violation of Drug Price Control Order (DPCO).
Drugs controller B. Hariprasad said notice has been issued to the marketing company, Anthem Biopharma, Bangalore to withdraw the stocks from all the wholesalers’ premises and retail outlets. He added that the office of the state drugs control administration has informed the National Pharmaceutical Pricing Authority (NPPA) about the price control violation by the marketing company and the action taken by the state department.
According to the DC, the drug has been sold by only a few retail shops in three districts and all the ADC offices and drugs inspectors’ offices have been asked to check whether any strip of the drug is left anywhere.
The price control violation of the drug was first noticed by the drugs inspector at Alappuzha and he took samples from retail shops and informed the head office. According to him, the marketing company has increased the prices of the strips of Lodens 5 mg and 10 mg tablets more than 10 per cent within one year. According to Drugs and Cosmetics Act (D&C Act), the manufacturing/marketing company can hike the price of a drug up to 10 per cent in one year and should not exceed that rate. Anthem has increased the prices threefold.
Last year the price of a strip of ten tablets of 5 mg Lodens was sold at Rs. 23, and it was raised to Rs. 66 this year. Similarly, a strip of 10 mg tablets was increased to Rs. 115 this year from its previous year’s price of Rs. 45. Santhosh K Mathew, the drug inspector said the hike in prices of both the strips was more than 10 per cent. The drug was manufactured by Pure and Cure Healthcare Ltd, Uttarakhand and was marketed in Kerala by Anthem Biopharma.
To a query, the drug inspector said rosuvastatin drug is used along with a proper diet to help lower bad cholesterol and fats, such as LDL, triglycerides, and raise good cholesterol (HDL) in the blood. It belongs to a group of drugs known as statins. It works by reducing the amount of cholesterol made by the liver.