In India, 64% of antibiotics unapproved: British Journal

WION Web Team New Delhi, Delhi, India Feb 05, 2018, 05.27 AM(IST)

File photo. Photograph:( AFP )

Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University.

The research, published in the British Journal of Clinical Pharmacology, found that multinational companies continued to manufacture many unapproved formulations, despite pledging to tackle rising antimicrobial resistance.

These findings highlight serious hurdles for controlling antimicrobial resistance in India, which has among the highest antibiotic consumption rates and sales in the world and has had parliamentary investigations into failures of the country's drug regulatory system.

The researchers examined figures for fixed dose combination (FDC) antibiotics (formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (composed of a single drug) on the market in India.

Of 118 different formulations of FDCs being sold in India between 2007 and 2012, the team found that 64 per cent (75) were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation (CDSCO), even though the sale of unapproved new medicines is illegal in India. Only five of the formulations were approved in the UK or US.