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Lookup NU author(s): Professor Allyson PollockORCiD, Peter Roderick
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0).
Objective To analyse sales of fixed-dose combination and single antibiotics in India in relation to World Health Organization (WHO) recommendations and national regulatory efforts to control antibiotic sales. Methods We extracted data on sales volumes of systemic antibiotics in India from a market research company sales database. We compared the market share of antibiotic sales in 2020 by WHO AWaRe category and for those under additional national regulatory controls. We also analysed sales of fixed-dose combinations that were: formally approved for marketing or had a no-objection certificate; on the national essential medicines list; and on the WHO list of not-recommended antibiotics. Findings There were 112 fixed-dose combination and 78 single antibiotics marketed in India, accounting for 7.6 and 4.5 billion standard units of total sales, respectively. Access, Watch and Reserve antibiotics comprised 5.8, 5.6 and 0.1 billion standard units of total market sales, respectively. All additionally controlled antibiotics were Watch and Reserve antibiotics (23.6%; 2.9 billion standard units of total sales). Fixed-dose combinations on the WHO not-recommended list were marketed in 229 formulations, with 114 formulations (49.8%) having no record of formal approval or noobjection certificate. While there were no not-recommended fixed-dose combinations on the national list of essential medicines, 13 of the top-20 selling antibiotic fixed-dose combinations were WHO not-recommended. Conclusion The sale of Watch group drugs, and antibiotics banned or not approved, needs active investigation and enforcement in India. The evidence base underpinning formal approvals and no-objection certificates for not-recommended fixed-dose combinations should be audited.
Author(s): Mehta A, Brhlikova P, McGettigan P, Pollock AM, Roderick P, Hasan HF
Publication type: Article
Publication status: Published
Journal: Bulletin of the World Health Organization
Year: 2022
Volume: 100
Pages: 610-619
Online publication date: 22/08/2022
Acceptance date: 04/07/2022
Date deposited: 27/08/2022
ISSN (print): 0042-9686
ISSN (electronic): 1564-0604
Publisher: World Health Organization
URL: https://doi.org/10.2471/BLT.22.287908
DOI: 10.2471/BLT.22.287908
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