Many unapproved fixed-dose combo drugs still sold in India

10 August 2015

Though India’s Central Drugs Standard Control Organization (CDSCO) has issued a comprehensive list of fixed-dose combination (FDC) drugs approved by the Drugs Control General of India (DCGI), which includes a total of 1,125 FDCs covering all therapeutic categories, millions of unapproved formulations continue to be sold across the counter in India, sometimes proving lethal, reports The Pharma Letter’s India correspondent.

Many FDC drugs that relate to antidepressants, painkillers, muscle relaxants or even antispasmodics have found their way into the market without the requisite DCGI approval, though they have been issued licences from state drug regulators.

Some FDCs like paracetamol + diclofenac + chlorzoxazone, and dicyclomine + paracetamol + mefenamic acid, as well as alprazolam + melatonin among others are under the DCGI scanner.

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