Drugs sold in India pose global threat to antibiotic resistance control

It turns out that drugs sold in India pose a global threat to the control of antibiotic resistance.

A new study found that multinational drug companies continue to produce dozens of unapproved formulations, despite the global health crisis of increased antibiotic resistance. The study also found that millions of unauthorized antibiotics are sold each year in India.

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In particular, India has one of the highest rates of antimicrobial resistance and antibiotics in the world, and parliamentary research has shown the country's drug control system failures. To investigate the availability of antibiotics and their approval status in India, researchers analyzed regulatory antibiotic records and sales data from 2007 to 2012.

The analysis included information on fixed-dose antibiotics (CDFs) (formulations of two or more medicines in a single tablet) and single-drug antibiotics (SDFs) on the Indian market.

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There were 118 different CDF formulations sold in India between 2007 and 2012, compared to five in the United Kingdom and the United States. Of these 118 formulations, 64% have not been approved by the National Drug Control Organization, although the sale of new unauthorized drugs is illegal in India. In contrast to CDFs, 93% of the 86 SDF antibiotics were approved in the Indian market.

The 118 FDC formulations resulted in 3307 branded products manufactured by 476 pharmaceutical manufacturers, including a dozen multinationals. Multinational companies produced 53 FDC 118 formulations. Twenty of them were not admitted in India. Only four were approved in the United Kingdom and the United States.

"The sale of unapproved and unaudited antibiotics undermines India's antimicrobial resistance measures." Multinationals should declare the sale of products in India that have not been approved by their national regulators, and in many cases even had the approval of the Indian regulator, "said lead author Patricia McGettigan.

The researchers argued that changes are needed to achieve the correct use of antibiotics by the World Health Organization (WHO). "Limiting antimicrobial resistance is a strategic goal for WHO and countries around the world." Governments and regulators should take all necessary measures to prevent the production and sale of illegal and unauthorized drugs and analyze the actions of multinational corporations, "said lead author Allyson Pollock.