The U.S. Food and Drug Administration confirmed on Friday that toxic cough syrups linked to children’s deaths in India had not been shipped to the United States.
The World Health Organization has said India has a “regulatory gap” in screening locally sold syrup medicines.
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The U.S. FDA said it was aware of news reports of devastating, ongoing diethylene glycol and ethylene glycol contamination in children’s cough and cold medicine in India.
Indian authorities advised the public to avoid two more brands of cough syrup on Wednesday following the deaths of 17 children under age five, linked to a toxic ingredient.
The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials said. The deaths were all linked to the Coldrif medicine brand, which was banned after a test confirmed the presence of the chemical on October 2.
India’s health authority, the Central Drugs Standard Control Organization, informed the U.S. regulator that these products were not exported from India to any other country, the FDA said.
The FDA also said it remains vigilant to prevent contaminated drugs from entering the U.S. and asked manufacturers to ensure that drugs marketed in the U.S. are safe and of the highest quality.
