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LATEST NEWS UPDATES | Deaths in the Gambia: Cloud over quality of Indian pharma products -PT Jyothi Datta

Deaths in the Gambia: Cloud over quality of Indian pharma products -PT Jyothi Datta

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published Published on Oct 10, 2022   modified Modified on Oct 11, 2022

-The Hindu Business Line

Experts say authorities will need to probe and take quick action, in the interest of keeping the faith in medicine exports from India

The death of 66 children in Gambia, potentially-linked to four cough and cold syrups made in India by Maiden Pharmaceuticals, has brought up the quality question, again. How did an allegedly contaminated product slip through the regulatory cracks, casting a long shadow on the Indian pharmaceutical industry that has been working to allay quality concerns on medicines that leave Indian shores, be it for North America or Africa?

Cross-country investigations are underway at multiple levels — the World Health Organization (WHO), Gambia and in India (at Central and State levels, since health is a State subject and Maiden is located in Haryana). But pharma industry representatives, most speaking off-record, are emphatic — the buck stops with the manufacturer, they say. “You are in the business of selling medicines, there can be no compromise on QC (quality control),” a seasoned exporter to the African continent told businessline.

But don’t product batches get tested before they are shipped out and don’t importing countries test the product before distributing it locally? It depends on requirements of the importing country, explains Uday Bhaskar, Director General with the Pharmaceuticals Export Promotion Council of India (Pharmexcil). The European Union tests all batches, the United States does random sampling, but Nigeria does pre-shipment quality checks (batches are tested and quality-certified in India before they reach Nigeria), he says, of a method that some industry-insiders seem to be comfortable with.

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The Hindu Business Line, 10 October, 2022, https://www.thehindubusinessline.com/news/world/deaths-in-gambia-a-case-of-falling-through-the-regulatory-cracks/article65992678.ece


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