A recent joint report from the World Health Organization (WHO) and the United Nations Office on Drugs and Crime (UNODC) has revealed serious vulnerabilities in the global pharmaceutical supply chain that have, in some cases, led to patient deaths. The most alarming incidents involve medicines contaminated with toxic chemicals such as diethylene glycol (DEG) and ethylene glycol (EG), which have been found in pediatric products and linked to multiple fatal poisoning events.
The report draws on eight case studies that expose systemic failures in medicine manufacturing and oversight. Four cases date back as far as 1996 in Haiti, China, Panama, and India, while four more recent incidents occurred between 2022 and 2024 in The Gambia, Uzbekistan, Indonesia, and Cameroon. While historically considered rare anomalies, WHO cautions that such contamination events may be more widespread than previously believed.
In some cases, corruption played a role. The report details instances where government officials accepted bribes or where business leaders facilitated improper payments to bypass regulatory controls. These actions undermined both the manufacturing process and subsequent investigations.
One of the most devastating examples occurred in Haiti between November 1995 and July 1996, when roughly 100 children under 13 died after consuming locally made pediatric syrups contaminated with DEG. Many of the victims presented with acute kidney failure. Investigators traced the problem to paracetamol syrups containing dangerously high DEG levels, prompting a ban, public awareness campaign, and product recall.
Across the case studies, several common risk factors emerged. Economically motivated decisions to source cheaper ingredients often led manufacturers to purchase non-pharmaceutical grade excipients mislabeled as safe for medical use. Weak regulatory oversight—especially for products intended solely for export—allowed substandard products to enter lower-income markets with minimal inspection or testing. In many affected countries, pharmacovigilance reporting rates were low, slowing the detection and recall of unsafe medicines.
Procurement practices also came under scrutiny. In multiple cases, purchasing decisions were made based solely on price and availability, with little verification of an excipient’s origin or quality. WHO investigators found invoices listing fake addresses, rented offices, or phone numbers that went unanswered. This lack of traceability created blind spots that allowed contaminated ingredients to enter the supply chain unchecked.
The report offers a set of targeted recommendations. For national regulatory authorities, it calls for incentives to reward manufacturers with strong compliance histories, public enforcement policies that include sanctions for failing to test excipients for DEG and EG, and improved data sharing between regulators, law enforcement, and customs agencies. WHO also suggests prioritizing high-risk excipients during inspections, enhancing laboratory capabilities to detect contaminants, and ensuring manufacturers source only from approved vendors with verifiable supply chains.
WHO’s proposed measures aim to close dangerous gaps in the pharmaceutical supply chain. However, implementing them will require coordinated global action, particularly in regions where regulatory systems remain underdeveloped.
For life sciences companies, this report reinforces the urgent need for strong supplier qualification programs, comprehensive risk assessments, and robust quality management systems. At EMMA International, we work with organizations worldwide to strengthen these critical controls. From ensuring Good Manufacturing Practice (GMP) compliance to designing vendor oversight processes, our team helps companies build supply chains that meet the highest safety and quality standards—protecting both regulatory standing and patient lives.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
World Health Organization & United Nations Office on Drugs and Crime, Pharmaceutical Supply Chain Weaknesses Leading to DEG/EG Contamination, 2025.
