Study Finds Majority of Psychotropic Drugs in India Are Unapproved

A recent study has uncovered that more than 60% of fixed-dose combination (FDC) drugs used to treat mental health disorders in India are unapproved and lack proven therapeutic benefits. This revelation comes as India’s drug regulatory body intensifies its crackdown on these drugs.

The study, published in the Journal of Pharmaceutical Policy and Practice, was conducted by researchers from the UK, India, and Qatar. It found that in 2020, 60.3% of psychotropic FDCs sold were unapproved, down from 69.3% in 2008 but still a concerning figure. FDCs are medications that combine two or more drugs into a single form, such as a capsule. Many of these combinations are available in India without approval from the Central Drugs Standard Control Organisation (CDSCO), having only been authorized by state-level authorities without thorough safety and efficacy testing.

The report highlights that psychotropic FDCs are heavily marketed in India despite their exclusion from clinical guidelines and the lack of substantial evidence supporting their effectiveness. This raises significant concerns about their safety and the potential risks they pose to patients.

Ashna Mehta, a health economist and co-author of the study, noted that the problem of unapproved FDCs in India is well-known but persists despite regulatory efforts to address it. Her earlier research revealed that nearly 70% of antibiotic FDCs in India were either unapproved or banned.

In response to these concerns, the Indian government recently imposed a ban on 156 additional FDC drugs, marking the largest crackdown since 2018. This new ban includes a range of medications, from antibiotics to treatments for fever, allergies, and pain. The list also prohibits combinations of active pharmaceutical ingredients (APIs) with herbs and multi-enzyme complexes, including those containing naphazoline, a common decongestant.

This regulatory action aims to curb the availability of potentially harmful FDCs and ensure that only safe and effective medications reach the market.