As global health officials scramble to contain antimicrobial resistance, a new study finds that hundreds of drug makers continue to manufacture and sell numerous unapproved formulations in India, which is only likely to exacerbate concerns the problem will worsen.
Of 118 different formulations of fixed-dose combination antibiotics sold in India between 2007 and 2012, the researchers found that 64 percent were not approved by the national drugs regulator, the Central Drugs Standard Control Organization, even though the sale of unapproved new medicines is illegal in India. By contrast, only five of the formulations were approved in the U.K. or U.S.
All told, more than 3,300 brand-name products were made by 476 drug companies, including a dozen multi-national manufacturers that accounted for 53 of the 118 fixed-dose combinations and that were sold using 148 different names, according to the study published in the British Journal of Clinical Pharmacology.
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