Study claims 64% of antibiotics sold in India between 2007 and 2012 unapproved

According to a study published in the British Journal of Pharmacology, a huge percentage of antibiotics sold in India between 2007 and 2012 were not approved by the Central Drugs Standard Control Organization (CDSCO). Of the 118 formulations of fixed dose combinations (FDC) antibiotics sold in the country during the period, 64% were not approved by CDSCO even though supply and sale of unapproved medicines are banned in India.

“The 118 FDC formulations gave rise to over 3,300 brand-name 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% 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 conducted by researchers at Queen Mary University of London and Newcastle University said.

Continued sale of unapproved antibiotics in such a huge proportion has triggered an antimicrobial resistance in India. Author of the study, Patricia McGettigan, stated, “Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance. 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.” Tedros Adhanom Ghebreyesus, Director-General of WHO, had stated earlier, “Antimicrobial resistance is a global health emergency that will seriously jeopardise progress in modern medicine.”

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India has one of the highest rates of antibiotic consumption in the world. In such a scenario, selling of unapproved drugs and failure to curb their supply poses a global threat to antibiotic resistance control.


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