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Sales of unapproved antibiotics thrive in India – even multinational corporations are involved

Posted February 7, 2018

The world is trying to address the antibiotic resistance. Scientists seem to agree that it was caused by excessive use of antibiotics. However, in some places in the world antibiotics are still being sold almost like candy. For example, in India, as a new research, conducted by Newcastle University and Queen Mary University of London, revealed that a huge number of antibiotics on Indian market are not even approved.

A lot of antibiotics sold in India are actually unapproved neither in India, nor in US or UK. Image credit: Sage Ross via Wikimedia(CC BY-SA 3.0)

Scientists found that out of 118 fixed dose combination antibiotics (formulations composed of two or more drugs in a single pill) sold in India, 64% were not approved by the national drugs regulator. The approved ones weren’t much better – only five of the formulations were approved in the UK or US, which have stricter standards. Of course, as you might imagine, it is not legal to sell unapproved drugs in India, but companies still find ways to introduce them to people seeking treatment. Although it is only 118 formulations, there are more than 3300 brand-named products made by almost 500 pharmaceutical manufacturers.

Do sales of unapproved drugs enhance antibiotic resistance in the country? Sure they do. In 2011-12 a third of antibiotics sales in India were fixed dose combination antibiotics and 34.5% of them were unapproved. Scientists say that these drugs typically combined two antimicrobials, usually poorly chosen, sometimes ineffective. This does exacerbate resistance problems. Interestingly, multinational companies are involved in this and they do keep manufacturing and selling drugs that are not approved in India. It is also interesting that single drug formulation antibiotics are much more commonly approved – 94% of multinational companies’ single drug formulations were approved by the Central Drugs Standard Control Organisation, and more than 70% had UK or US regulatory approval.

World Health Organization has a strategic goal of limiting antimicrobial resistance. In order to succeed in this, all governments and multinational corporations must contribute. Dr Patricia McGettigan, lead author of the study, said: “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”.

Now it is on Indian government to try and do something to stop these unapproved drugs from reaching the market. However, people should also be more considerate and avoid using antibiotics when it is not necessary. And when it is needed, people should research if the drug is approved.


Source: Newcastle University

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