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Lookup NU author(s): Alex Mehta, Dr Patricia McGettigan, Professor Allyson PollockORCiD, Peter Roderick, Dr Habib Farooqui
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Objectivesi) to examine how antibiotic sales in India in 2020 align with WHO's AWaRe classification and its 'not recommended' list of fixed dose combinations (FDCs), and for antibiotic FDCsii) to determine their status under India’s tightened rules for controlling sales (Schedule H1) and government measures to control centrally unapproved FDCs.MethodsSingle and FDC systemic antibiotics were extracted from the PharmaTrac sales database and analysed by AWaRe category and Schedule H1 listing. Official documents were used to determine formal approval and essential medicine listing (NLEM 2015) status of FDCs ‘not recommended’ by WHO, and whether their marketing had been effectively approved (No Objection Certificate, NOC), or prohibited.FindingsThere were 78 single and 112 FDC antibiotics on the market, accounting for 62.7% (7.6 billion standard units) and 37.3% (4.5 billion standard units) of total sales, respectively. Access, Watch and Reserve antibiotics accounted for 47.9%, 46.7%, and 1.0% of sales, respectively. All Schedule H1 antibiotics are Watch and Reserve antibiotics, accounting for 23.6% of sales.WHO ‘not recommended’ FDCs were marketed in 229 formulations (41.5% of FDC sales). Of these, 114 (49.8%) had no record of central approval or NOC. Thirteen of the 'top 20' selling antibiotic FDCs were ’not recommended’. NLEM 2015 lists no ‘not recommended’ FDCs.59.7% (236/395) of marketed FDC formulations (15.4% of antibiotic FDC sales) had no record of central approval or NOC, and had not been banned.ConclusionHigh sales of Watch antibiotics, not centrally approved, and banned formulations need active investigation and enforcement.The evidence base underpinning formal approvals and NOCs for ‘not recommended’ FDCs should be audited. WHO should publish its justifications for the ‘not recommended’ list.
Author(s): Mehta A, Brhlikova Sevcikova P, McGettigan P, Pollock AM, Roderick P, Farooqui HH
Publication type: Article
Publication status: Published
Journal: WHO Bulletin
Year: 2022
Online publication date: 22/08/2022
Acceptance date: 04/07/2022
Date deposited: 05/07/2023
Publisher: WHO
