US investigating links of its 'superbug' outbreak to Indian eyedrops

“We can’t brush it off,” says the head of the Pharmaceuticals Export Promotion Council of India.
Loukia Papadopoulos
An illustration of eye drops.jpg
An illustration of eyedrops.

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India-made eyedrops have been traced back to a “superbug” outbreak in the United States, putting the country’s pharmaceutical industry in a very negative spotlight.

This is according to a report by the South China Morning Post (SCMP) published on Saturday..

The U.S. Food and Drug Administration (FDA) issued a warning against using foreign eyedrops.

The drops have been potentially tied to a “rare, extensively drug-resistant” bacteria causing infections, blindness, and one death in 55 people in the country.

The bacteria’s cause is still under investigation by U.S. and Indian authorities, but for now, the eyedrops remain the patients’ only detected common link.

India’s drug industry has also been in the news over the kidney-failure deaths of 90 children linked by the World Health Organization (WHO) to Indian-made cough syrups that contained toxic industrial-grade glycol.

Three years ago, 12 children’s deaths in India were also traced back to contaminated syrup.

“The recent incidents, including the eyedrop issue, are going to reflect badly on the image of Indian pharma despite our significant contribution to protecting the (world) healthcare system,” R. Uday Bhaskar, who heads the Pharmaceuticals Export Promotion Council of India told SCMP .

“We can’t brush it off,” he added.

A quick uncontrolled growth

India’s drug sector has been growing so quickly that the issue of quality control has risen to the surface. Currently, millions of people around the world consume Indian-made drugs without cause for concern, but the few incidents of dangerous products cannot be ignored.

India has some regulatory issues when it comes to quality control. Domestic inspections in the industry can be rare and Indian drugs are not always of standard quality.

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There are currently 3,000 Indian companies running 10,500 generic manufacturing plants, and not enough drug inspectors to keep them all under control.

“With our limited resources, our regulators are trying to do the best,” told SCMP Subhash Mandal, a regulatory affairs executive at the Indian Pharma Association. 

A 2014 study by the U.S. National Bureau of Economic Research found that Indian-made antibiotics and tuberculosis drugs sent to Africa were substandard.

“These countries rely on India to ensure the drugs are safe. People can get sick, die even, if they don’t perform their duty,” told SCMP Deepak Thakur, an ex-pharmaceutical executive turned industry critic and co-author of a new book, The Truth Pill: The Myth of Drug Regulation in India.

If the country wants to maintain its reputation, it needs to weed out rogue drug makers. Will it be able to do so in time to avoid another scandal and possible health incidents? Only time will tell.

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