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Threats to antimicrobial resistance control: an ecological study of centrally approved and unapproved formulations sold in India

Lookup NU author(s): Peter Roderick, Professor Allyson PollockORCiD



This is the authors' accepted manuscript of an article that has been published in its final definitive form by Wiley-Blackwell, 2018.

For re-use rights please refer to the publisher's terms and conditions.


Introduction: 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 evidence to support the claims.Objective: To investigate the sales and regulatory approval status of antibiotics marketed in India.Methods: This was an ecological study of systemic antibiotics marketed in India (2007-2012) using Pharmatrac® sales data to determine the volumes of FDC and single drug formulations (SDFs) sold, product numbers, and manufacturers. Regulatory records were used to determine the approval status of the formulations in India, the UK and US.Results: Of 118 systemic antibiotic FDC formulations marketed, 43(36%) were approved in India and 5(4%) in the UK and/or US. Almost half of FDC formulations (58/118,49%) comprised dual antimicrobials, most unapproved in India, and many pharmacologically problematic. Two formulations were approved in the UK and/or US. In contrast, 80/86(93%) SDFs were approved in India and over two-thirds in the UK and/or US. Sales increased by 26% from 2055.86 Million-Units (2007-08) to 2583.07 Million-Units (2011-12). FDC sales rose by 38% versus 20% for SDFs. By2011-12, FDCs comprised one-third of systemic antibiotics sold. Multi-National Companies accounted for approximately 19% of 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 are likely to undermine India’s national AMR strategy.

Publication metadata

Author(s): McGettigan P, Roderick P, Kadam A, Pollock AM

Publication type: Article

Publication status: Published

Journal: British Journal of Clinical Pharmacology

Year: 2018

Volume: 85

Issue: 1

Pages: 59-70

Print publication date: 01/01/2019

Online publication date: 04/02/2018

Acceptance date: 24/12/2017

Date deposited: 03/01/2018

ISSN (print): 0306-5251

ISSN (electronic): 1365-2125

Publisher: Wiley-Blackwell


DOI: 10.1111/bcp.13503


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