“Threats to global AMR control Centrally approved and unapproved antibiotic formulations sold in India”

“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.”

Source: British Journal of Clinical Pharmacology

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