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Lookup NU author(s): Dr Paul Bogowicz, Peter Roderick, Dr Aditya SharmaORCiD, Professor Allyson PollockORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.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.
Author(s): Bogowicz P, Mehta A, Choudhary S, Brhlikova P, Roderick P, McGettigan P, Farooqui HH, Sharma AN, Pollock AM
Publication type: Article
Publication status: Published
Journal: Journal of Pharmaceutical Policy and Practice
Year: 2024
Volume: 17
Issue: 1
Online publication date: 06/08/2024
Acceptance date: 03/06/2024
Date deposited: 20/08/2024
ISSN (electronic): 2052-3211
Publisher: Taylor and Francis Ltd.
URL: https://doi.org/10.1080/20523211.2024.2372089
DOI: 10.1080/20523211.2024.2372089
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