The US Food and Drug Administration (FDA) has warned dozens of companies that their products contain dangerous toxins, Reuters reported. It has also warned that imports of its products to the US will be completely barred if proper procedures are not implemented. The study is particularly serious, with cough syrups made in India and Indonesia linked to more than 300 deaths.
According to Reuters, the U.S. Food and Drug Administration (FDA) has issued warnings to at least 28 drug manufacturers during inspections this year. According to the agency, ethylene glycol (EG) and diethylene glycol (DEG) lacked evidence to conduct required tests for the presence of toxins. Among the alerted companies are US manufacturers and exporters from India, South Korea, Switzerland, Canada and Egypt.
Reuters notes that experts are skeptical about the variety of products. In addition to cough syrup, these include: children’s diarrhea medications, toothpaste, and sunscreen.
The FDA has indicated that if manufacturers do not follow its recommendations, they may be barred from importing their products into the United States altogether. In the case of companies whose products performed poorly during testing, customs officials were immediately allowed to confiscate their products at the border without giving a reason.
– They raised the bar. They try to understand the industry and better identify potential threats – said Peter Lindsay from the Paul Hastings law firm, an expert in analyzing the regulations of the US agency, quoted by Reuters. Manufacturers are now forced to check entire drug containers and not just samples of the substance, he said.
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India, Indonesia. Cough syrup causes death
Reuters reports that the FDA’s exceptionally detailed investigation and warnings are related to cough syrups made in India and Indonesia that have been linked to more than 300 deaths. Tests of these drugs showed that they contained high concentrations of DEG and EG, which led to severe kidney damage and eventual death in patients. Others found the syrup was being distributed to The Gambia, where dozens of children died after taking it. According to the World Health Organization, laboratory analysis of the products confirmed the presence of toxic substances in these syrups.
According to Reuters, the discovery of the toxin in the syrup is the result of investigations, lawsuits and increased research around the world. The agency recalls that in early September, Indian drug manufacturers were unable to demonstrate that they purchased or properly tested pharmaceutical products before placing them on the market.
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