Sales and regulatory status of fixed dose combination psychotropic drugs in India: a retrospective longitudinal study.

Background: There is limited evidence to support use of fixed dose combination (FDC) drugs in the treatment of psychiatric disorders. This study aimed to examine the sales and regulatory status of psychotropic FDCs in India, in the context of two government regulatory initiatives.

Methods: Official documents were searched to establish an account of the initiatives and measures targeting psychotropic FDCs. This was integrated with private market data (2008 to 2020). Descriptive statistics were used to examine changes in FDC numbers/formulations and sales volumes in standard units (SU) over time.

Results: Psychotropic FDC sales volumes (percentage market share) increased from 0.8 billion SU (18.4%) in 2008 to 1.4 billion SU (20.1%) in 2020. The numbers (formulations) of FDCs also increased, from 28 (101) in 2008 to 33 (143) in 2020. Unapproved FDCs accounted for 69.3% of psychotropic FDC sales in 2008, decreasing slightly to 60.3% in 2020. Of 21 psychotropic FDCs considered under the regulatory initiatives, three went on to be banned, and two of these remained on the market in 2020.

Conclusions: Unapproved FDCs continue to account for most psychotropic FDC sales, potentially putting the public at risk because their safety and efficacy have not been evaluated.