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India to tighten pharmaceutical quality checks amid US ‘superbug’ outbreak

  • The alarm comes as India’s drug industry has also been in the news over deaths of 90 children that the WHO has linked to Indian-made cough syrups
  • India supplies 40 per cent of US generics, is the largest provider of low-cost generics and furnishes more than half the world’s vaccines

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India is the largest provider of low-cost generics and furnishes more than half the world’s vaccines. Photo: AFP
India-made eyedrops linked to a “superbug” outbreak in the United States have put the country’s flagship pharmaceutical industry under an unwelcome spotlight over possible quality safety lapses.
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The US Food and Drug Administration (FDA) this month warned against using the eyedrops that have been potentially tied to a “rare, extensively drug-resistant” bacteria causing infections, blindness and one death in 55 people in the country. US and Indian authorities are still investigating the bacteria’s cause but the eyedrops were the patients’ only detected common link.

The eyedrops alarm comes as India’s drug industry has also been in the news over the kidney-failure deaths of 90 children – 20 in Uzbekistan and 70 in Gambia – that the World Health Organization (WHO) has linked to Indian-made cough syrups.

Gambian and Swiss tests found the syrups contained toxic industrial-grade glycol rather than the safe but costlier pharmaceutical-grade glycerine, the agency said.

Glycerine is used as a cough-syrup thickening agent. But substitution with cheaper industrial glycol – potentially deadly in the tiniest quantities – has been reported around the world, including in Indonesia where some 200 children last year died from locally-made tainted syrup.
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