Millions of unapproved antibiotics are being sold in India and this has posed a threat to the international efforts to control antibiotic resistance, finds a UK study.
The study done by the researchers at Queen Mary University of London and Newcastle University 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.
The study, states that this could worsen the growing problem of antibiotic resistance in India and is a severe blow to the efforts made globally to fight 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.
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.
The 118 FDC formulations gave rise to over 3300 brand-named products made by almost 500 pharmaceutical manufacturers, including multinational companies.
By 2011-12, FDCs made up a third of total antibiotic sales 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 companies manufactured nearly 20 per cent of the FDCs and SDFs sold. Twenty FDC formulations manufactured by multinational companies had no record of CDSCO approval, and only four of the fifty three FDC formulations made in India by multinational companies had UK or US regulatory approval.
Some of the manufacturers who produce 45% of the 188 FDCs under 148 brand names are: Abbott, Astra Zeneca, Baxter, Bayer, Eli Lilly, GlaxoSmith-Kline, Merck/MSD, Novartis and Pfizer.