The Kerala drug control department, the first state DCA in India to ban sale of nutraceutical products with therapeutic claims, has now embarked on another mission to weed out irrational drug combinations floating in the state drug market.
If implemented, Kerala will be the first state in the country to ban the sale of irrational combinations. The state drug controller is learnt to have directed the drug control officials in various districts to collect data and statistics on various fixed doze combinations (FDCs)/ irrational drugs available in the Rs 800-crore odd state drug market.
"Drug Inspectors have been directed to check for various irrational FDC drugs available in the medical shops, and to prepare a report on that along with the periodic inspection reports submitted to the assistant drug controllers. At present, we do not have any idea on the irrational combinations floating in the Kerala market. Once we get that data, we will think of strategies to weed out such combinations, including enforcing the ban," said M P George, deputy drugs controller, Kerala.
He said the Kerala drug control administration has not issued any FDCs or irrational combination drug manufacturing license in the past few years, as most of the 30 odd active manufacturers in the state are small time generic drug makers. "We are not ruling out that possibility. We will also verify whether we granted license for any FDCs in the past few years," added the official.
It may be noted that some of the senior drug enforcement officials in India like Dr. M Venkateswarulu, deputy drug controller of India (West Zone), had pointed out the irrational combination products currently floating in the market could be checked only by the state drug controllers, and it was difficult for the DCGI to issue an order for withdrawing/cancelling licenses already granted by state departments.
During July last year, the drug controllers from all major states of the country, in a meeting convened by the Drug Consultative Committee (DCC), had decided not to issue manufacturing licenses for new FDCs. The DCGI also had asked the state drug control departments to strictly cancel the new drug state licenses issued after May 2002. Though the state drug controllers are not authorized to issue new drug licenses including new combinations since November 2001, many of the state drug controllers were issuing numerous licenses to FDCs.
It is estimated that more than 60,000 branded formulations containing either single drug or drugs in fixed dose combination (FDC) are floating in the Indian market.