64% of antibiotics sold in India unapproved: UK study

Multinational companies continue to produce and sell unregulated antibiotics in India, worsening the problem of antimicrobial resistance in the country and impeding efforts to fight drug resistance globally, a UK study said.

The report, to be made public on Monday by researchers at Queen Mary University of London and Newcastle University, said millions of antibiotic pills in the Indian market have not been regulated in India, the UK or US. The research was published in the British Journal of Clinical Pharmacology.

It found that of 118 different formulations of fixed dose combination (FDC) antibiotics being sold in India between 2007 and 2012, 64% were not approved by the Central Drugs Standard Control Organisation (CDSCO), even though sale or supply of unapproved new medicines in India is illegal.

Only 4% of the FDCs (formulations composed of two or more drugs in a single pill) were approved in the US or UK. India already has one of the highest rates globally of antibiotic consumption and antimicrobial resistance.

Many of the unapproved FDCs combined poorly chosen antimicrobials likely to exacerbate resistance problems. The FDC antibiotics were sold under more than 3,300 brand names made by almost 500 pharmaceutical manufacturers, of which 12 were multinationals.

The report stated that Abbott, Astra Zeneca, Baxter, Bayer, Eli Lilly, GlaxoSmith-Kline, Merck/MSD, Novartis, Pfizer, Sanofi-Aventis, and Wyeth, manufactured 45% (53) of the 188 FDCs under 148 brand names.

Of these, 62% (33) were CDSCO-approved and just 8% (four) had been approved in the US or UK. Of the 38% (20) of FDC formulations manufactured by multinational companies which had no record of CDSCO approval, 90% (18) were manufactured by Abbott, it said. By 2011-12, FDCs made up a third of total antibiotic sales in India, with 34.5% of FDCs being unapproved formulations.


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