Unapproved Psychotropic FDCs: A Regulatory and Market Challenge

A study revealed that unapproved psychotropic Fixed Dose Combination (FDC) drugs dominated sales from 2008 to 2020, peaking at 75.5% in 2014. Despite being unapproved, these FDCs continue to be widely sold in India, raising safety risks. Researchers call for stronger regulatory measures to address this issue.

A recent study has brought to light startling figures surrounding the sales of unapproved psychotropic Fixed Dose Combination (FDC) drugs. These formulations accounted for over 60 percent of psychotropic FDC drug sales between 2008 and 2020.

Published in the Journal of Pharmaceutical Policy and Practice, the study notes that the sales proportion of unapproved FDCs fluctuated over the years, peaking at 75.5 percent in 2014 before decreasing slightly to 60.3 percent in 2020. Researchers from the UK, India, and Qatar warn that the continued sale of these unapproved drugs poses significant safety risks given their unverified efficacy.

Despite their widespread marketing in India, most psychotropic FDCs are absent from clinical guidelines and have limited evidence of therapeutic benefit. The study emphasizes the need for stringent regulatory actions, including market withdrawal, tighter manufacturing controls, and greater transparency from the Central Drugs Standard Control Organisation (CDSCO). The study suggests that a holistic approach, factoring in public awareness and market dynamics, is crucial for effective regulation.

(With inputs from agencies.)