New Delhi: Over 60 percent fixed-dose combination (FDC) drugs consumed for mental health disorders in India are “unapproved” and lack therapeutic benefit, an analysis has found amid a major crackdown on FDC drugs by the country’s apex drug regulator. In the study published in the Journal of Pharmaceutical Policy and Practice this month, researchers from UK, India and Qatar found that unapproved FDCs accounted for 60.3 percent psychotropic FDC sales in 2020, slightly lower from 69.
3 percent in 2008 but still too high. FDCs contain two or more drugs in a single pharmaceutical form, such as a capsule. Many FDC drugs available in India lack approval from the central regulator, the Central Drugs Standard Control Organisation (CDSCO), and are approved for manufacturing by states without showing proof of safety and efficacy.
“Psychotropic FDCs are widely marketed in India despite their absence from Indian clinical guidelines, limited evidence of therapeutic benefit, concerns about potential harm, and limited use in other markets,” the study has noted. Unapproved FDC drugs continue to account for most psychotropic FDC sales, potentially putting the public at risk because their safety and efficacy have not been evaluated, the researchers also noted. Ashna Mehta, a health economist and co-author of the study, told ThePrint that India’s FDC problem was well-known, and despite several efforts by the regulator to weed them out, unapproved FDCs continued to be on the market.
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