Sales of unapproved antibiotic formulations are rising in India, study finds

Sales of antibiotic fixed-dose combinations (FDCs), including unapproved formulations, are rising in India, according to a study published in the British Journal of Clinical Pharmacology
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In light of the growing problem of antimicrobial resistance (AMR) in India and across the world, the researchers said that the manufacturing of unapproved antibiotic FDCs was undermining efforts to stem AMR and should be banned from sale.

The ecological study was carried out by researchers at Queen Mary University, London and Newcastle University, who used regulatory records in India, the UK and USA to determine the approval status in each country of systemic antibiotic FDC and single-drug formulations (SDFs) marketed in India.

The researchers found that total antibiotic sales in India increased by 26% between 2007–2008 and 2011–2012. Sales of FDC formulations increased by 38% during this time, while sales of SDFs increased by 20%.

However, of 118 systemic antibiotic FDC formulations marketed in India, just 36% were approved and 64% had no record of regulatory approval. Less than 5% were approved by the Medicines and Healthcare Products Agency (MHRA) or European Medicines Agency (EMA) in the UK and/or the Food and Drug Administration (FDA) in the USA. Furthermore, just under half of all the formulations comprised dual antimicrobials, 74% of which were not approved in India.

In contrast, 93% of SDFs looked at were approved in India and over two-thirds in the UK and/or the United States.

Multinational companies were found to manufacture unapproved formulations and accounted for 19% of FDC and SDF sales annually.

“Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance,” said Patricia McGettigan, lead author of the study from Queen Mary University.

“Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator,” she added.