Multinational companies continue to produce unregulated antibiotics in India

Bengaluru-February 05, 2018, India : 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 ClinicalPharmacology, found that multinational companies continued to manufacture manyunapproved formulations, despite pledging to tackle rising antimicrobialresistance. 

These findings highlight serious hurdles forcontrolling antimicrobial resistance in India, which has among the highestantibiotic consumption rates and sales in the world and has had parliamentaryinvestigations into failures of the country’s drug regulatory system. 

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

Of 118 different formulations of FDCs being sold inIndia between 2007 and 2012, the team found that 64 per cent (75) were notapproved by the national drugs regulator, the Central Drugs Standard ControlOrganisation (CDSCO), even though the sale of unapproved new medicines isillegal in India. Only five of the formulations were approved in the UK orUS.  

The 118 FDC formulations gave rise to over 3300brand-named products made by almost 500 pharmaceutical manufacturers, includingmultinational companies. By 2011-12, FDCs made up a third of total antibioticsales in India, yet 34.5 per cent of these sales (comprising 300 million Units)were unapproved formulations. Many of the FDCs combined two antimicrobials,often poorly chosen and likely to exacerbate resistance problems. 

The study also found that multinational companiesmanufactured nearly 20 per cent of the FDCs and SDFs sold. Twenty FDCformulations manufactured by multinational companies had no record of CDSCOapproval, and only four of the fifty three FDC formulations made in India bymultinational companies had UK or US regulatory approval. 

In contrast, 94 per cent of multinational companies’single drug formulations were CDSCO-approved, and over 70 per cent had UK or USregulatory approval. 

Lead author Dr Patricia McGettigan from QueenMary said: “Selling unapproved, unscrutinised antibioticsundermines measures in India to control antimicrobial resistance. Multinationalcompanies should explain the sale of products in India that did not have theapproval of their own national regulators and, in many cases, did not even havethe approval of the Indian regulator.” 

The researchers argue that changes needed to achievethe World Health Organization’s (WHO) vision of good use of antibiotics includebanning the sale of unapproved FDC antibiotics and enforcing existingregulations to prevent unapproved and illegal drugs reaching the market. 

Improved access to health care to reducenon-prescription sales is also needed, alongside research to understand whydoctors complicate problems by prescribing unapproved antibiotics. 

Professor Allyson Pollock, Director of theInstitute of Health and Society at Newcastle University,said: “Limiting antimicrobial resistance is a strategic goal of the WHO andcountries worldwide – governments and regulators must take all necessary stepsto prevent the production and sale of illegal and unapproved medicines andscrutinise the actions of multinational companies.”


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