Source: World Health Organisation

The World Health Organization (WHO) and the United Nations Office on Drugs and Crime (UNODC) have jointly released a landmark report unveiling critical findings on the persistent and preventable threat of contaminated medicines which claimed the lives and compromised the health of countless patients, predominantly children, through the ingestion of medicines with dangerously high levels of toxic chemicals.

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 occur often due to systemic vulnerabilities in the global supply chain of pharmaceutical excipients, and they have disproportionately affected people in low- and middle-income countries (LMICs), where regulatory oversight and access to quality-assured medicines may be limited.

Titled “Contaminated medicines and integrity of the pharmaceutical excipients supply chain”, the 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.

Since October 2022, WHO has issued 7 Medical Product Alerts concerning multiple batches of contaminated liquid oral medicines, many of which were marketed for paediatric use and exported widely to LMIC. WHO also issued 2 Alerts concerning falsified bulk chemicals masquerading as pharmaceutical quality excipients.

Following a particularly serious case in The Gambia, in which at least 66 children lost their lives, attention was once again focused on this issue. The case in The Gambia was quickly followed by similar incidents in Indonesia and Uzbekistan with a further 268 reported deaths and two further WHO Medical Product Alerts.

Most of the recent cases involve inexpensive oral liquid medicines that can be bought without a prescription.  In most cases these medicines were marketed specifically for children and are registered medicines available in pharmacies, medicine stores or informal street markets.

Key findings

The report reveals how criminal networks exploit market volatility and regulatory gaps to introduce toxic substitutes into the supply chain. Key findings include:

• The use of falsified labels and substitution of toxic chemicals for legitimate excipients such as propylene glycol.
• The marketing of falsified excipients via online platforms, including e-commerce and social media.
• A lack of regulatory oversight for manufacturers and distributors of high-risk excipients.
• Deficiencies in post-market surveillance and enforcement mechanisms in both manufacturing and importing countries.
• Intentional criminal conduct, including deliberate falsification of excipients and documentation, contributing directly to multiple contamination incidents.
• Inadequate coordination and capacity among regulatory, customs and law enforcement authorities hindering timely investigations and prosecutions in some jurisdictions.

Call to action

The report 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.

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:

• Improved regulatory frameworks and enforcement mechanisms.
• Enhanced compliance by manufacturers and distributors.
• Greater transparency and traceability in the excipient supply chain.
• Stronger collaboration between health authorities, law enforcement and the private sector.

• Closer collaboration and timely information exchange between regulatory authorities, law enforcement and customs to support investigations and prosecutions.
• Greater enforcement of existing laws, including the application of sanctions in cases of critical non-compliance with regulations related to contaminated excipients.
• Improved investigation quality and prosecutorial capacity to address intentional acts of contamination and falsification of pharmaceutical excipients.
• Strengthened post-market surveillance mechanisms to detect and respond to incidents with potential criminal dimensions.
• Enhanced legal and operational frameworks to address the deliberate falsification of labels, certificates of analysis and excipient composition.

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.

A collaborative effort grounded in global partnership

This report is the result of a collaborative effort involving national regulatory authorities (NRAs) and global health partners. Its development was made possible through the generous support of the Fleming Fund and the Gates Foundation.

WHO and UNODC extend their sincere appreciation to all stakeholders who contributed to this important work, particularly the NRAs of The Gambia, Indonesia and Pakistan, whose experiences and insights were instrumental in shaping the report’s findings.

MIL OSI United Nations News –