CDSCO Flags Drug Firms For Making Combination Medicines Without Approval

India’s central drug regulator, Central Drugs Standard Control Organisation (CDSCO), has flagged several pharmaceutical firms for making and marketing certain combination medicines to treat ailments like fungal infections and diabetes without its approval.

This means these drugs have not proven their safety and effectiveness to the apex regulator and could pose great risk to the patients consuming them, an unnamed senior Health Ministry official was quoted saying in a report in the Economic Times newspaper.

The regulator is considering action like cancelling the licences of these firms and even legal action, according to the official.

Over 70 fixed dose combination (FDC) medicine brands marketed by 16 pharma companies have been reportedly seized in a recent raid of two drug manufacturing facilities. These medicines are not supposed to be marketed in the country as they are not approved by the CDSCO as per the Drugs and Cosmetics Rules, 1945. Yet, these companies have managed to secure licences to market them from State Licencing Authorities in Uttarakhand, according to the regulator’s note about the raid. It was not clear when these medicines were launched and how widely they are used, as there is no market data available on them.