Indian health authorities say they have halted all drug production at the Maiden Pharmaceuticals factory linked to the deaths of 69 children in Gambia.
They also ordered the firm to shutdown after finding that it had been manufacturing and testing drugs in violation of rules “across its manufacturing and testing activities”.
“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drug being produced, all the manufacturing activities of the firm is being stopped with immediate effect,” said an order by India’s drug regulators.
The India-made cough syrups had been approved for export only to Gambia, India says, although the WHO says they may have gone elsewhere through informal markets.
Last week, the WHO issued a medical product alert asking regulators to remove Maiden goods from the market.
The U.N. health agency said that laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – had “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
Diethylene glycol and ethylene glycol are used as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups.
Gambian police, in a preliminary investigation report on Tuesday, said that the deaths of 69 children from acute kidney injury was linked to the cough syrups made in India and imported via Atlanta-based Atlantic Pharmaceuticals.
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