Threats to global antimicrobial resistance control Centrally approved and unapproved antibiotic formulations sold in India

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 formulations or volumes sold.

Objective

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 US to determine the approval status in each country of systemic antibiotic FDC and single drug formulations (SDFs) marketed in India. Pharmatrac® sales data were used to determine the formulations and volumes sold in India (2007-2012), branded-product numbers, and manufacturers.

Results

Of 118 systemic antibiotic FDC formulations marketed in India, 43(36%) were approved but 75 (64%) had no record of regulatory approval; 5(4%) 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 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% versus 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. Multi-National Companies manufactured unapproved formulations and accounted for 19% of FDC and of 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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