About 90 children have died after consuming cough syrup produced in India over the last two months. Why does Indian Pharma struggle with quality control?
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Largest, fastest, strongest—superlatives can make for very popular stories. In the short term, at least. For long-term staying power, narratives need to capture and maintain the trust of the audience.
Over the last two months, close to 90 children have died in two countries—Gambia and Uzbekistan—after consuming cough syrups produced in India. A little bit from a Moneycontrol opinion piece on the issue from earlier this week:
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While Indian authorities initially argued that concluding a causal link between the cough syrups and the deaths of children was premature, the WHO has doubled down on its stand that these were “contaminated syrups”.
And so we are back to contemplating an old question.
Is Indian pharma, globally known for its ability and capacity to produce generic medicines, also trustworthy in terms of quality? It’s a complex narrative to unpack, but with a simple enough premise. Big-number sales and profits can sustain the story in the short term. But for the long term, you need to buy trust with quality.
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Indian pharma’s quality-quantity balancing act
Five years ago, I attended a workshop organised by the Indian pharmaceutical industry on the quality control process of the US Food and Drug Administration (FDA). The FDA representative ran drug-makers through quality standards the way primary school teachers run their students through the alphabet.
The details matter, he said. Something as small as a hole in a lab assistant’s glove could destroy product quality; as would someone using teeth instead of scissors to open a packet in a drug plant.
But complying with such stringent standards comes at a cost. In order to meet the standards laid out by the FDA—one of the strictest drug regulators in the world—a drug maker wanting to export to the US would have to hire FDA-accredited consultants that charge about US$8,000 a day for about two years to make their factories compliant.