Threats to global antimicrobial resistance control: centrally approved and unapproved antibiotic formulations sold in India
Open accessAbstract
AIMS: Rising antimicrobial resistance (AMR) is a global health crisis. India has among the highest resistance rates and antibiotic consumption internationally. Extensive use of fixed-dose combination (FDC) antibiotics and of unapproved formulations are claimed contributory factors but there has been no systematic examination of formulations or volumes sold. The aim of the present study was to investigate the regulatory approval status and sales volumes of systemic antibiotics marketed in India. METHODS: This was an ecological study using regulatory records in India, the UK and the US to determine the approval status in each country of systemic antibiotic FDCs and single-drug formulations (SDFs) sold in India. Pharmatrac® sales data were used to determine the formulations and volumes sold (2007-2012), branded-product numbers and manufacturers. RESULTS: Of 118 systemic antibiotic FDC formulations sold in India, 43 (36%) were approved but 75 (64%) had no record of regulatory approval; four (3%) formulations were approved in the UK and/or US. Almost half of formulations (58/118; 49%) comprised dual antimicrobials, most unapproved in India (43/58; 74%), and many were pharmacologically problematic. In contrast, 80/86 (93%) SDFs were approved in India and over two-thirds in the UK and/or US. Total antibiotic sales increased by 26%, from 2056 million units (2007-08) to 2583 million units (2011-12). FDC sales rose by 38% vs. 20% for SDFs. By 2011-12, FDCs comprised one-third of sales (872 million units). Over one-third of FDCs sold (300.26 million units; 34.5%) were of unapproved formulations. Multinational companies manufactured unapproved formulations and accounted for 19% of all FDC and SDF sales annually. CONCLUSIONS: Sales in India of antibiotic FDCs, including unapproved formulations, are rising. In the context of increasing AMR rates nationally and globally, unapproved antibiotic FDCs undermine India's national AMR strategy and should be banned from sale.
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The study used PharmaTrac, a national-level private-sector drug sales audit dataset created by AIOCD Ltd., used by government agencies for policy decisions, including price regulation, and by researchers.
“We used PharmaTrac, a national-level private-sector drug sales audit dataset created by the All-Indian Origin Chemists and Distributors Ltd. (AIOCD Ltd.), used by government agencies for policy decisions, including price regulation, and by researchers.13,14,17, 18, 19”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [14]
The Data sources section (page not provided) says the study used PharmaTrac, a commercial database of Indian pharmaceutical sales, and that its audits were projected to estimate national sales. The paper does not identify AIOCD Ltd. as its creator or say that government agencies use it for policy decisions or price regulation. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe widespread use of antibiotic FDCs is a significant concern due to decreased therapeutic efficiency and difficulty in dose-scheduling, resulting in either under-dosing or over-dosing.
“However, the widespread use of antibiotic FDCs is a significant concern due to the decreased therapeutic efficiency and difficulty in dose-scheduling, resulting in either under-dosing or over-dosing.14”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [14]
The Pharmacological problems of FDCs section says that some commonly used combinations contain drugs requiring different dosing frequencies that a fixed-dose formulation cannot accommodate. The sales discussion (Table 3) also shows that antibiotic FDC use was high in India. The paper does not explicitly establish decreased therapeutic efficiency or state that these scheduling problems resulted in under-dosing or over-dosing. (LLM, conf=0.83)
Experimental — accuracy not yet measuredAn analysis of the Indian drug market during 2007-12 showed that a considerable proportion of antibiotics are unapproved by the CDSCO.
“An analysis of the Indian drug market during 2007-12 showed that a considerable proportion of antibiotics are unapproved by the CDSCO.14”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [14]
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Consumption of systemic antibiotics in India in 2019
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- Authors
- McGettigan, P., Roderick, P., Kadam, A., & Pollock, A.
- Affiliations
- Queen Mary University of London (GB)
- Newcastle University (GB)
- Lakshya Society for Public Health Education and Research Pune Maharashtra India
- Corresponding author
- McGettigan, Patricia
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2018-02-21
- Volume
- 85
- Issue
- 1
- Pages
- 59-70
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- PMC
- PMC6303201
- OpenAlex
- W2790872043
- Cited by
- 53
- References
- 14
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 5 · 2023: 7 · 2022: 10 · 2021: 11 · 2020: 8 · 2019: 3 · 2018: 3
- FWCI
- 3.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- Funders
- Indian Council of Medical Research
- School of Social and Political Science, University of Edinburgh
- Topics
- Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antibiotic Use and Resistance
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Antibiotic Resistance in Bacteria
- Keywords
- antimicrobial resistance, antibiotic sales, systemic antibiotics, multinational pharmaceutical companies, India, AMR policy, sales data
- MeSH terms
- Anti-Bacterial Agents, Commerce, United Kingdom, Humans, India, United States, Drug Approval, Drug Resistance, Bacterial
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