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Three Gambian lawyers said this is the highest profile case of its kind against the nation's health ministry and the drug regulator, as well as against Maiden itself. It adds that the regulator and the health ministry failed to ensure that drugs were prescribed "with the expected standard of care." Gambia's health ministry did not respond to requests for comment. By this stage, the Gambian health ministry had sent samples of the Maiden syrups abroad for testing. The drugs regulator, the Medicines Control Agency, which is part of the health ministry, did not respond to a request for comment for this story.
Persons: syrups, Maiden, vomited, Amie Jammeh, Mafugi Jassey, Mafugi, Jammeh, Loubna Farage, Jude Nwokike, Markieu Janneh Kaira, Kaira, Edward McAllister, Michele Gershberg, Sara Ledwith Organizations: Suit, Reuters, World Health Organization, WHO, Pharmaceuticals, EG, World Bank, Medicines, Pharmacopeia, Medicines Control Agency, Thomson Locations: Serekunda, Gambia, India, DAKAR, Indonesia, Uzbekistan, Senegal, Africa
At least 70 children in Gambia, most under 5 years old, died from acute kidney injury between June and October. Tests by the WHO found that the Maiden cough syrups contained the lethal toxins diethylene glycol (DEG) and ethylene glycol (EG), used in car brake fluid. Indian officials have said the WHO failed to prove a causal link to the Gambia deaths, accusing the agency of denigrating its $41 billion pharmaceutical industry. However, cough syrups made by a second Indian drugmaker have been linked to the deaths of 19 children in Uzbekistan. India has since made drug testing mandatory for cough syrups before export.
Persons: Sagnia, Lamin, Edward McAllister, Dawda Jallow, Jallow, syrups, Maiden, Adama Barrow, Dawda, Shilpa Jamkhandikar, Sara Ledwith, Michele Gershberg, Bill Berkrot Organizations: Reuters, World Health Organization, WHO, Maiden Pharmaceuticals, EG, World Bank, Thomson Locations: Serekunda, Gambia, BANJUL, India, Uzbekistan
The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. "If you ask and you don't get informed, it's a dead end," Rutendo Kuwana, the WHO's team lead for incidents with substandard and falsified medicines, told Reuters in an interview on March 31. Drug inspectors found a dozen violations at Maiden last October related to the production of the cough syrups sold to Gambia, a government document showed. Among these, some of the COAs of raw ingredients used in making the syrups, including propylene glycol, were missing batch numbers. Kuwana said the WHO was sure of its own cough syrup test results from two separate independent laboratories, both of which showed contamination.
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