Different regulatory approaches to excipient requirements: the case of EG/DEG contamination risk in pharmaceuticals

Ethylene glycol (EG) and diethylene glycol (DEG) contamination of pharmaceutical excipients has repeatedly resulted in severe poisoning events, particularly in oral paediatric medicines, with fatalities continuing to be reported outside highly regulated regions. These incidents have largely been attributed to economically motivated adulteration of widely used excipients

such as glycerol and propylene glycol. In response, regulatory authorities and pharmacopeial bodies have implemented measures to mitigate this risk; however, the scope, stringency, and regulatory philosophy of these measures vary significantly across jurisdictions.