More India-made cough & cold syrups under WHO lens

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More cough and fever medications made by Indian drug makers are under the scanner of the World Health Organization (WHO) as member countries flag contamination or substandard medications. “To date this situation has impacted more than 20 products with two countries of origin (India & Indonesia) and more than 15 different manufacturers,” WHO spokesperson Margaret Harris told ET.

All the products are syrup-based such as paracetamol, cough, and vitamins. WHO added that though the investigations in the impacted countries are ongoing, a link has not yet been established.

The agency said it can’t divulge the names of the manufacturers at the moment but added the authorities in India should be contacted to understand the details of investigation they may be doing.

“WHO takes all reports of substandard/falsified medical products very seriously. WHO is aware of media reporting of potentially contaminated syrups in other countries than those listed above,” said Harris.

More India-made Cough & Cold Syrups Under WHO Lens

“While investigations are ongoing, WHO has not expanded its list of medical product alerts. This may change as we receive more information,” she added.The recent spate of contaminated medicines began with reports in July-October 2022 in The Gambia with subsequent reports in Indonesia, Uzbekistan, Micronesia & The Marshall Islands, all warranting WHO medical product alerts.WHO issues medical product alerts cautiously after due diligence and receiving actionable information from impacted countries. The evidence it seeks include laboratory test results and bioavailability data that identifies product, batches, dates of manufacture, manufacturer or distributor and the market where the product was acquired. WHO has mentioned in its medical product alerts names of companies of Haryana-based Maiden Pharmaceuticals, Noida-based Marion Biotech, and Punjab-based QP Pharmachem and its marketer Haryana-based Trillium Pharma, flagging their products for containing unacceptable amounts of diethylene glycol (DEG) or ethylene glycol (EG) as contaminants in their cough and cold medications.

DEG/EG are toxic to humans. The cough and cold medications have been allegedly linked to scores of child deaths in West African country Gambia in the case of Maiden and Central Asia nation Uzbekistan Marion has been identified.

The Indian drug regulator swung into action and has shut down the operations and cancelled the licences of both the companies.

WHO’s alert in October last year had warned that Maiden’s four products Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup were found to be contaminated with DEG/EG and asked member countries to remove these substandard products from circulation to prevent harm to patients.

In another alert in January this year, two products under question were AMBRONOL syrup and DOK-1 Max syrup by Marion Biotech. Experts who studied the cases said the contamination may be due to use of industrial solvents like DEG/EG to cut manufacturing costs or not testing the presence of DEG/EG in the propylene glycol solvent used to make cough syrups.

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