Systemic vulnerabilities in the global supply chain of pharmaceutical inactive ingredients are driving an ongoing and preventable risk of ingesting contaminated medicines, says this new report, which calls for urgent global action to close regulatory gaps, strengthen oversight of excipient supply chains and protect all populations, especially the most vulnerable such as children, from preventable and deadly poisoning.

Titled “Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain,” this report highlights a tragic and ongoing public health crisis: the contamination of medicines with industrial-grade toxic chemicals, notably diethylene glycol (DEG) and ethylene glycol (EG). These substances are used as industrial solvents and antifreeze agents but can cause severe health issues and be fatal if ingested, even in small amounts, especially for children. They are often illegally substituted for pharmaceutical-grade excipients such as propylene glycol, glycerin, and sorbitol—ingredients used in the formulation of medicines, including cough and paracetamol syrups.

Over the past 90 years, at least 25 documented incidents of excipient contamination have resulted in more than 1300 deaths worldwide, many of them children. These incidents have disproportionately affected low- and middle-income countries (LMICs), where regulatory oversight and access to quality-assured medicines may be limited. What were once considered isolated anomalies are now recognized as symptoms of deep-rooted vulnerabilities and regulatory gaps in the global supply chain of these inactive pharmaceutical ingredients.

The report reveals how criminal networks exploit market volatility and regulatory gaps to introduce toxic substitutes into the supply chain. Key tactics include the use of falsified labels and the substitution of toxic chemicals for legitimate excipients; the marketing of falsified excipients via online platforms; deficiencies in regulatory oversight, surveillance, and enforcement; and more. The report also found instances of intentional criminal conduct, including deliberate falsification of excipients an documentation, contributing to multiple contamination incidents.

WHO and UNODC perspectives: a combined health and criminal justice approach
WHO has long played a central and proactive role in preventing, detecting and responding to substandard and falsified medical products. This report reinforces the critical importance of strong and effective medicines regulatory systems to ensure access to safe, effective and quality-assured products.

Complementing this public health perspective, UNODC highlights the criminal dimension of the issue, documenting how organized criminal groups falsify documentation, substitute industrial-grade chemicals and exploit digital platforms to illegally infiltrate the global pharmaceutical supply chain with toxic and unregulated substances. Its contribution underscores the importance of criminal justice responses in parallel to regulatory action.

The report underscores the need for regulatory frameworks, enforcement mechanisms and compliance to be improved, as well as greater transparency and traceability in the supply chain. Health authorities, law enforcement, and the private sector need to deepen their collaboration, while closer information exchange among regulatory authorities, law enforcement and customs would aid the quality of investigations and prosecutions.  among other recommendations. Strengthening post-market surveillance mechanisms is essential to ensure timely detection and appropriate response to incidents that may involve criminal activity.

In many cases, contaminated medicines are the result of intentional criminal conduct. Addressing this threat requires coordinated efforts by all stakeholders, including law enforcement agencies, customs officials, prosecutors and anti-corruption bodies. The report calls for greater cross-border cooperation, investigative capacity and the use of international legal instruments such as the United Nations Convention against Transnational Organized Crime (UNTOC).

WHO and UNODC urge Member States, national regulatory authorities, criminal justice actors, law enforcement agencies, pharmaceutical manufacturers and excipient distributors to take immediate decisive action to prevent further avoidable tragedies. Failure to act now risks condemning future generations of children to the same unacceptable and avoidable harms.