The World Health Organization (WHO) urged a Call to Action after substandard medicines identified in The Gambia, Indonesia and Uzbekistan were found to potentially contain unsafe amounts of diethylene glycol (DEG) and ethylene glycol (EG) as contaminants. In response, the USP developed a toolkit for manufacturers, regulators, and country pharmacopeias to address DEG and EG contamination associated with allergy, cold and cough medicines.
DEG can lead to acute renal failure, which can cause permanent disability or death. In addition to the recent tragedies, DEG-related poisonings have also been reported in Panama, China, Haiti, Bangladesh, Argentina, Nigeria, and India. Some of these countries have a history of multiple events even though these incidents are preventable using the right quality controls and risk assessments.
DEG can find its way into the supply chain in several ways, through mislabeled products, human error, or through intentional adulteration by manufacturers or suppliers. Testing of raw materials, active pharmaceutical ingredients (APIs) and inactive ingredients (excipients) by the manufacturer can be used to detect the presence of DEG. Such testing may be required for certain products marketed in the U.S. However, low- to middle-income countries may not have the same quality assurance requirements and resources.
Traditionally, quality assurance has focused on end-product testing, but given the complex pharmaceutical supply chain, there is a clear need for greater regulatory focus on strong quality controls for testing and analysis of raw materials, APIs, and inactive ingredients. USP works with other country pharmacopeias, regulators, and industry to strengthen supply chain resilience. This collaboration’s importance is underscored by tragic incidents like the recent deaths from DEG contamination.
The mission of USP is to improve global health through public standards. To support all those involved in the global medicine manufacturing supply chain and preventing deaths due to DEG contamination, USP is pleased to share a free toolkit for measuring and controlling levels of DEG and EG to all interested stakeholders. The toolkit includes relevant chapters, monographs, and other resources.
We also invite you to join us in our efforts around the world to advocate for quality throughout the medicine supply chain. Read more about our USP Regional Chapters.