64% of FDC antibiotics in India are unapproved, report reveals

pharmafile | February 5, 2018 | News story | Manufacturing and Production, Sales and Marketing Antibiotics, India, antimicrobial resistance, pharma 

The majority of fixed dose combination (FDC) antibiotics that are made and sold in India are still unapproved, despite promises by multinational pharmaceutical firms to fight the growing threat of antimicrobial resistance worldwide, a study by researchers at Queen Mary University of London and Newcastle University has revealed.

There were 118 different formulations of FDCs sold in the country between 2007 and 2012, compared to just five in the US and UK. Of this number, 64% were found to not have been given approval by India’s Central Drugs Standard Control Organisation – despite the fact that approval is required to legally market medicines in the country. Even more telling, just 4% were approved in the US or UK.

However, by comparison, 93% of single dose formulation antibiotics did have marketing approval.

From these 118 FDC formulations came 3,307 branded products from 476 different manufacturers, including multinational firms GSK, Eli Lilly, Bayer, AstraZeneca, MSD, Novartis, Pfizer, Sanofi, Abbott Baxter and Wyeth, who made 53 of the formulations. Of this total, 20 were unapproved in India, while only four were approved for sale in the US and UK.

India has among the highest rates of antibiotic usage and antimicrobial resistance in the world.

“Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance,” said lead author Dr Patricia McGettigan, of Queen Mary University of London. “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.”

Senior author Allyson Pollock, of the Institute of Health and Society at Newcastle University, added: “Limiting antimicrobial resistance is a strategic goal of the WHO and countries worldwide. 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.”

Matt Fellows

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