Global Supply Chain Failures are Causing Pharmaceutical Contamination

By Maximilian Malawista
NEW YORK, Aug 7 2025 – The contamination of pharmaceutical medicines through toxic excipients is killing many and harming others. The UN agencies for health and drugs and crime warn that systemic vulnerabilities in the global supply chain have been exploited to introduce industrial-grade toxic chemicals into medicines, harming thousands of people, including children.

On July 24, the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) released a 120-page report on the persistent, yet preventable threat of contaminated medicines that have claimed lives and compromised the health of many people. The report, titled “Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain” reveals findings of illegal criminal substitutions on pharmaceutical grade substances like glycerin, propylene glycol, and sorbitol through toxic excipients. With industrial-grade toxic chemicals like diethylene glycol (DEG) and ethylene glycol (EG), these substances typically used as industrial solvents and antifreeze can cause detrimental health issues, even being fatal in small amounts. Yet they are making their way into pharmaceutical supply chains.

In the past 90 years, twenty-five documented incidents have revealed over 1300 deaths worldwide, many of them children, because of excipient contamination. More recently, incidents in The Gambia, Indonesia and Uzbekistan that resulted in 334 deaths in total drew further attention to the issue and has prompted further investigations. These incidents have occurred far more commonly in low- and middle-income countries (LMICs), where there has been little regulatory oversight and limited access to quality-assured medicine. In the report, case studies find that pharmaceutical manufacturers were “quick to produce the medicine, and market demand was very strong, outstripping the ability for oversight”.

The first reported case was in 1937 in the United States, where DEG was used as an excipient for sulfanilamide, killing 105 people. These once-considered “anomalies” have been reported up until 2022, with over 300 people in Africa dying just in October of that year. The highest reported deaths from one case were found in Bangladesh, where DEG was being used as an excipient for Paracetamol syrup, killing 339 people from 1990 to 1992.

The report revealed instances of criminal networks exploiting “market volatility and regulatory gaps” to introduce these toxic excipients into the supply chain, including:

• • The use of falsified labels and the substitution of toxic chemicals for illegitimate excipients,
• • Marketing of falsified excipients on online platforms,
• • Lack of regulatory oversight, including surveillance and enforcement, and
• • Inadequate coordination and capacity among regulatory devices, law enforcement and customs, hindering timely investigations and prosecutions.

The Problem

To regulate the entire pharmaceutical supply chain for development, production, distribution and inspection, principles collectively known as GxP (Good x Practice), or cGxP (current good x Practice) are used to currently set guidelines. These systems are supposed to ensure a set of principles implementing quality, safety, efficacy, and risk management in the full supply chain of medicine. But when they are lag in certain areas, this can increase the odds of failure.

Through these guidelines, WHO defines pharmaceutical excipients as: “A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a medicine delivery system”. Their functions can include:

• · Aid in the processing of medical delivery systems during manufacturing.
• · Support, protect, or enhance stability, bioavailability, or patient acceptability.
• · Assist in product identification; or

· Enhance any other attribute of the overall effectiveness and safety of the medicine during use and storage.

The estimated size of the global market for pharmaceutical excipients in 2024 was at 9.4 billion USD, with at least one thousand different pharmaceutical excipients being used as “fillers, diluents, binders, solvents, suspension and viscosity agents, coatings, flavoring agents, disintegrants, colorants and preservatives”.

A main issue is the fact that excipient manufactures are not subject to regulatory oversight. But now WHO is calling for an “appropriate” level of Good Manufacturing Practice (GMP) guidelines to be present at the production, packaging, repackaging, labelling, quality control, release, storage, and distribution of an excipients intended for pharmaceutical use.

Recommendations

To remedy this growing issue, the report provided policy recommendations which could prevent these problems from any point of the supply chain, including:

• • Improved regulatory framework, including enforcement devices.
• • Greater compliance by distributors and manufacturers.
• • Enhanced traceability and transparency in the excipient supply chain.
• • Stronger collaboration between law enforcement, health authorities and the private sector.
• • Enhanced legal and operational frameworks to address deliberate falsification of labels, and certificates of analysis and excipient composition.
• • Greater post-market surveillance devices to detect and respond to incidents involving potential criminal activities.
• • Improved quality of investigations and prosecutorial capacity to address intentional criminal acts of contamination and falsification.

• Heightened enforcement of existing laws, including the implementation of sanctions in cases of critical non-compliance with regulations.

The report underscores the need for collaboration across all levels. That includes international organizations like WHO and UNODC, member states, national regulatory authorities, criminal justice components, law enforcement agencies, manufacturers, and excipient distributors to take the proper measures towards avoiding further harm. If not, pharmaceutical supply chains can be further manipulated to creating deficiencies and death, not efficiency and life.

IPS UN Bureau Report

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