64% of antibiotics sold in India unapproved: UK study

64% of antibiotics sold in India unapproved: UK study

Multinational organizations continue to manufacture and sell unregulated antibiotics in India, declining the issue of antimicrobial resistance in the nation and impeding endeavors to battle drug resistance all globally, a UK consider said.


The report, to be made open on Monday by analysts at Queen Mary University of London and Newcastle University, said a huge number of antibiotic pills in the Indian market have not been regulated in India, the UK or US. The survey was published in the British Journal of Clinical Pharmacology.

It found that of 118 unique details of different formulations of fixed dose combination (FDC) antibiotics being sold in India in the vicinity of 2007 and 2012, 64% were not approved by the Central Drugs Standard Control Organization (CDSCO), despite the fact that sale or supply of unapproved new drugs in India is illegal.


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


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