Study Finds 64% Antibiotics Sold In India Unapproved

A study conducted by Queen Mary University of London and Newcastle University revealed that multinational companies produced and sold unregulated antibiotics in India on a large scale. According to the study, 64% antibiotics sold in India are unapproved. The British Journal of Clinical Pharmacy has published the report. These antibiotics have not been regulated in India, UK and US.

“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,” said the lead author Dr Patricia McGettigan.

It was found that among 118 formulations of fixed dose combination (FDC) (formulations composed of two or more drugs in a single pill), out of the antibiotics being sold in India between 2007 and 2012, 64% were not approved by the Central Drugs Standard Control Organisation (CDSCO), national regulatory body for Indian pharmaceuticals and medical devices. The report said that almost 500 pharmaceutical manufacturers including 12 multinationals were selling these FDC antibiotics under more than 3,300 brand names.

“Rising Antimicrobial resistance (AMR) is a global health crisis. India has among the highest resistance rates and antibiotic consumption internationally. Extensive use of fixed-dose combination (FDC) antibiotics and of unapproved formulations are claimed contributory factors but there has been no systematic examination of formulations or volumes sold,” the report stated.

As per the report, US and UK approved only 4% FDDs.

“Sales in India of antibiotic FDCs, including unapproved formulations, are rising. In the context of increasing AMR rates nationally and globally, unapproved antibiotic FDCs undermine India’s national AMR strategy and should be banned from sale,” said the report.

Antimicrobial Resistance

According to World Health Organization (WHO), “antimicrobial resistance happens when microorganisms (such as bacteria, fungi, viruses, and parasites) change when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics). Microorganisms that develop antimicrobial resistance are sometimes referred to as ‘superbugs’. As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others”.

“Antibiotics are among the most commonly prescribed drugs used in human medicine and can be lifesaving drugs. However, up to 50% of the time antibiotics are not optimally prescribed, often done so when not needed, incorrect dosing or duration,” says Centers For Disease Control and Prevention

Antibiotic consumption in India

According to a report published by The Lancet, India is world’s highest consumer of antibiotics followed by China and US. According to the report, there was a rise of 36% in the decade ending in 2010, and Brazil, Russia, India, China, and South Africa accounted 76% of this increase.

Use of colistin in poultry

Excessive use of antibiotics is not just seen in human beings, but also prevalent in the poultry industry in India. The Bureau of Investigative Journalism revealed that poultry farms in India used colistin, a drug which was termed by doctors as ‘last hope’ to protect them against diseases. “It is the only drug we have left to treat critically ill patients with a carbapenem-resistant infection. Giving it to chickens as feed is crazy,” said Professor Timothy Walsh, an advisor to the UN on antimicrobial resistance