Tackling Medicine Fraud: WHO's 2025 Report Explores Global Detection Technology Use

The WHO’s 2025 report highlights global disparities in the detection of substandard and falsified medical products, emphasizing the need for stronger legal frameworks, technical capacity, and accessible screening technologies. It underscores the growing role of portable tools alongside traditional lab methods to enhance regulatory response and public health protection.

In a landmark effort to map the global response to the growing threat of substandard and falsified (SF) medical products, the World Health Organization (WHO) has released a comprehensive 2025 report highlighting current detection technologies. This groundbreaking initiative was driven by the WHO Department of Regulation and Prequalification, with pivotal research input from the Institute for Medicines and Medical Devices of Montenegro (CInMED) and the Egyptian Drug Authority (EDA). Under the technical direction of Anita Sands and with coordination by CInMED’s David Kočović, the report consolidates feedback from Member States to explore the challenges, gaps, and progress in deploying technologies that can identify falsified and low-quality medicines across the globe.

A Global Health Threat Hiding in Plain Sight

The spread of fake and substandard medicines ranging from counterfeit pills with no active ingredients to legitimate drugs that fail to meet quality standards remains a serious public health risk. While these issues are global, they are especially acute in low- and middle-income countries where infrastructure and regulatory oversight are often underdeveloped. In many settings, visual inspection is the primary line of defense. However, such assessments are error-prone and offer little protection against sophisticated falsification. Confirmatory lab testing can take weeks or months, during which the harmful products remain in circulation, posing risks to patients and undermining public trust. WHO Member States have increasingly turned to portable screening technologies like infrared and Raman spectrometers, colorimetric tests, and thin-layer chromatography to fill this gap, offering the promise of fast, on-the-spot screening.

Surveying the State of Detection Around the World

The WHO’s survey, disseminated across six official UN languages, received 83 valid responses from Member States, though only 22 were fully completed. Interestingly, no low-income countries were represented in the dataset, reflecting ongoing challenges in resource-limited settings. The findings point to major disparities in regulatory readiness. Ten Member States reported having no legal provisions in place for detecting SF products, while nine had no established procedures. In the absence of these frameworks, regulatory action can be delayed or deemed unenforceable. Conversely, sixteen countries reported having both legal provisions and standard operating procedures, enabling them to take swift action when SF medicines are detected.

When it comes to responsibility for quality control, 15 countries said their national regulatory authorities oversee testing. Others shared the burden with marketing authorization holders or relied on third-party entities. The purpose of testing varies across borders some countries focus solely on detecting falsified products, others aim to catch substandard ones, while many systems attempt to do both. Notably, most countries still rely on reactive detection, responding only when reports of poor-quality products arise from hospitals, pharmacies, or manufacturers. However, a proactive minority regularly samples the market in anticipation of potential risks, pointing to a more advanced level of regulatory capacity.

From Laboratories to the Field: Technologies in Action

The range of technologies employed spans both high-end lab instruments and portable field devices. In laboratories, the most commonly used methods include high-performance liquid chromatography (HPLC), UV/Vis spectrophotometry, thin-layer chromatography, and infrared spectroscopy. These offer high accuracy but require trained personnel, reliable electricity, and sophisticated infrastructure conditions that are often difficult to meet in remote or resource-limited areas.

In contrast, field-friendly tools are gaining traction for their ability to deliver quick insights without the need for complex logistics. Devices like the MiniLab, paper analytical tools, and handheld spectrometers are used for rapid screening at pharmacies, warehouses, and border checkpoints. However, these tools are limited in scope many are only compatible with specific formulations or drug classes and must be supplemented by confirmatory lab testing. Technologies with non-destructive testing capabilities, which allow for analysis through sealed packaging, are particularly valued for inspecting large quantities without wasting doses.

Roadblocks on the Path to Safer Medicines

The report identifies significant hurdles that prevent countries from fully deploying detection systems. A lack of technical knowledge is the most commonly reported issue, including uncertainty about which technologies offer the best results at a manageable cost. Many governments also cite insufficient funding as a barrier to purchasing equipment, training staff, and maintaining infrastructure. Some respondents acknowledged that their supply chains are poorly regulated, making detection even more difficult. A few Member States flagged opposition from stakeholders such as importers, pharmacies, or procurement agencies, though this was not widespread.

Laboratory limitations also emerged as a major theme. There is a shortage of facilities equipped to test biologics, vaccines, or plasma-derived products. In some cases, laboratories lack the ability to conduct even basic tests for contaminants. The issue is exacerbated by a general lack of trained personnel, particularly in countries with large markets or complex distribution networks.

What’s Getting Detected and What’s Not

Despite the challenges, 24 Member States confirmed recent detections of substandard or falsified medical products. Some reported over 100 cases per year. The most commonly affected drug categories included treatments for the alimentary tract and metabolism, cardiovascular and nervous systems, and systemic anti-infectives. Tablets and capsules accounted for nearly half of all detected cases, followed by liquids and injectables. Most problematic products were prescription-only medicines, though several countries also reported issues with over-the-counter drugs. In terms of regulatory reach, 18 countries said their authorities oversee both wholesalers and pharmacies, while others had more fragmented oversight structures.

The WHO’s report is more than a compilation of data it is a call to action. It underscores the urgent need for stronger legal frameworks, enhanced technical capacity, better funding, and wider use of scalable, context-appropriate technologies. As WHO moves toward creating formal guidance on technology selection and use, this report provides a critical foundation for Member States striving to secure their pharmaceutical supply chains and protect public health.