Millions of unapproved antibiotics are being sold in India each year, posing a threat the global fight against spread of drug resistant microbes, researchers warned today.
A study published in the British Journal of Clinical Pharmacology showed that multinational pharmaceutical companies continue to manufacture dozens of unapproved formulations, despite the global health crisis of rising antimicrobial resistance.
India has among the highest rates globally of antimicrobial resistance and antibiotic consumption, and parliamentary investigations have highlighted failures of the country's drug regulatory system, researchers said.
"Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance," said Patricia McGettigan, from Queen Mary University of London in the UK.
"Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator," said McGettigan, lead author of the study.
To examine the availability of antibiotics and their approval status in India, researchers analysed the regulatory records of antibiotics as well as sales data from 2007 to 2012.
The analysis included information on fixed dose combination (FDC) antibiotics and single drug formulation (SDF) antibiotics on the market in India.
There were 118 different formulations of FDCs being sold in India between 2007 and 2012, compared with five in the UK and the US.
Of these 118 formulations, 64 per cent were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation, even though the sale of unapproved new drugs is illegal in India.
In contrast to FDCs, 93 per cent of 86 SDF antibiotics on the market in India had regulatory approval.
The 118 FDC formulations gave rise to 3,307 brand-named products made by 476 pharmaceutical manufacturers, including a dozen multinational companies. Multinational companies manufactured 53 of the 118 FDC formulations.
Twenty of these were unapproved in India. Only four were approved in the UK and the US.
The researchers argue that changes are needed to achieve the proper use of antibiotics set by the World Health Organization (WHO).
"Limiting antimicrobial resistance is a strategic goal of the WHO and countries worldwide," said Allyson Pollock, from Newcastle University in Australia.
"Governments and regulators must take all necessary steps to prevent the production and sale of illegal and unapproved medicines and scrutinise the actions of multinational companies," said Pollock.
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