After children mysteriously died in Gambia allegedly due to cough syrups manufactured in India, the US drug regulatory authority has come out with a guidance intended to alert pharmaceutical manufacturers, compounders, re-packers and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG). It has indicated that all components must be verified and tested before they are supplied.

According to the US Food and Drug Administration (FDA) guidance note, the suppliers should ensure specific identity analysis for each lot, which includes a limit test for DEG and EG, and testing of samples from all containers of all lots of a “high-risk” drug component before it is used in the manufacture or preparation of a drug product.

The FDA said manufacturers must perform the DEG and EG limit test on representative samples of each shipment of each lot of the component and ensure that the component contains no more than 0.10% of DEG and EG before using it in the drug.

It also recommended that all personnel in pharmaceutical manufacturing facilities – especially personnel directly responsible for receipt, testing and release of components – be made aware of the importance of proper DEG and EG contamination testing, and the potential hazards if this testing is not done.

The FDA said it continues to receive as recently as early 2023 reports about fatal poisonings of consumers who ingested drug products in a liquid dosage form (such as cough, allergy, analgesic and antiemetic drug products) that were manufactured with DEG- or EG-contaminated components.

In March, an investigation led by the United States Center for Disease Control and Prevention and Gambian scientists revealed that India-made cough syrups imported into Gambia contaminated with DEG and EG led to acute kidney jnjury among children.

“In 2022 and 2023, numerous countries reported incidents of oral liquid drug products, primarily indicated for children, with confirmed or suspected contamination with high levels of DEG and EG,” the USFDA said.