Introduction: What are substandard and falsified medical products? 

Substandard and falsified medical products (SFMPs) threaten public health as they often contain incorrect amounts (or are entirely absent) of the active drug ingredient and can be contaminated with harmful substances and impurities. The threats posed by SFMPs are universally experienced worldwide, especially as they can be obtained physically or virtually, and through regulated or unregulated means. Although the WHO reported in 2017 that 1 in 10 medicines in low- and middle-income countries (LMICs) are substandard or falsified, this estimate today may be higher as reported incidents have increased over the years, and high-income countries are inevitably also at risk due to the globalized nature of medicine supply chains. Furthermore, news reports and scientific publications over recent years have indicated that populations from both LMICs and high-income nations have been exposed to these dangerous drug products. 

SFMPs are pervasive globally, regardless of location and a country’s socioeconomic status, causing devastating harm in some instances, as the health impacts of these SFMPs range from insufficient effectiveness (which prolongs illness) to adverse events, including death. Yet, this global crisis of poor-quality and fake medicines has been a persistent issue that only becomes more pressing with the rise of digital platforms that more easily allow convenient, widespread access to unregulated and potentially dangerous pharmaceutical drugs. Against this backdrop, practical resources that support prevention, detection, and response across the full product lifecycle are essential. 

Recent global incidents of substandard and falsified medical products 

The global spread of SFMPs — even in high-income regions — underscores the need for greater international vigilance against criminal exploitation of trendy, shortage-prone drugs and for stronger, comprehensive oversight of medicine manufacturing and storage worldwide. 

Fake GLP-1 drugs in high-income countries 

In recent years, the synthesis and distribution of fake medical products have especially grown in popularity among criminals in high-income countries due to increasing demand for trendy, highly desirable, and heavily marketed drugs that may be susceptible to shortages. Criminal network actors are allured by how lucrative certain medicines are for manufacturers, including GLP-1 drugs. Additionally, the proliferation of such drugs through e-commerce sites, particularly in high-income nations, has normalized the purchasing of medical products from both regulated and unauthorized online sources. 

The U.S. FDA recently warned consumers about the risk of using unapproved GLP-1 drugs, including fraudulent semaglutide and tirzepatide, marketed within the U.S. that contain false product labeling, and are associated with adverse events. WHO has also issued a medical product alert for falsified Ozempic sold in LMIC and high-income countries through legitimate, regulated supply chains. Countries that have identified falsified Ozempic include Brazil (October 2023), the United Kingdom (October 2023), and the U.S. (December 2023). The off-label use of Ozempic — a drug approved by FDA to treat Type 2 diabetes — for weight loss has resulted in shortages for diabetic patients in need. The deficit in availability has driven criminals to profit from falsified versions. 

Contaminated cough syrup leading to deaths in children 

Recent mass-poisoning events caused by substandard medicines in global markets, including pediatric cough syrup contamination by toxic substances diethylene glycol and ethylene glycol (DEG/EG), have continued to cause the deaths of children worldwide. In late 2025 in India, clusters of acute illness and child deaths resulted from contaminated cough syrups. Similar incidents occurred previously, in 2022, in The Gambia, Uzbekistan, and Indonesia, with more than 300 children (mostly under 5 years old) dying of acute kidney injury associated with contaminated cough syrups that were manufactured in India. In addition, WHO reports that other countries — the Philippines, Timor-Leste, Senegal, and Cambodia — may also have been impacted. Despite ongoing prevention efforts for years by multilateral organizations, including WHO, these devastating incidents still occur, leading to mistrust in manufacturing firms and health systems globally. 

How is USP addressing these recent crises? 

USP’s core mission in strengthening medicine quality and protecting patients across the entire product lifecycle — from manufacturing to distribution to end use — plays an imperative role in consistent prevention of medical product quality failures. To support authorities at different levels of regulatory maturity, USP hosts two free, open-source toolkits that offer practical resources that national regulatory authorities can immediately use to combat SFMPs: the APEC Supply Chain Security Toolkit and the DEG Toolkit. 

APEC Supply Chain Security Toolkit 

Developed under the auspices of the Asia Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee, the APEC Supply Chain Security Toolkit offers practical guidance for preventing, detecting, and responding to SFMPs across the supply chain — from manufacturing and distribution through post-market surveillance and monitoring. Its modular design allows national regulatory authorities to select the chapters and tools most relevant to their current workstreams, objectives, or organizational development plans. It is widely used by regulators and procurement specialists to improve regulatory oversight, strengthen distribution networks, and identify vulnerabilities in supply chains. 

The Toolkit covers priority areas including surveillance and monitoring, Good Distribution Practices (GDP), Clinical and Retail Pharmacy Practices (CRPP), Internet sales, Screening technologies at ports of entry, and other topics. 

DEG Toolkit 

Targeted interventions are also needed for specific risk areas that have produced severe public health consequences. In response to global incidents of substandard medicines containing diethylene glycol (DEG) and ethylene glycol (EG) in recent years, USP developed a toolkit for manufacturers, regulators, and pharmacopeias to address DEG and EG contamination associated with allergy and cough and cold medicines. This toolkit of relevant chapters, monographs, and other resources from USP can help identify deadly contaminants in such medicines and is available for download here: Diethylene Glycol (DEG) Resources. 

USP’s core mission in strengthening medicine quality 

USP efforts to strengthen medical product quality include: 

Strengthening pharmaceutical standards: USP sets and maintains public quality standards for medicines that serve as the foundation for verifying identity, strength, quality, and purity. These standards help regulators and manufacturers ensure that products meet consistent quality expectations, reducing the risk of substandard and degraded medicines. 

Regulatory strengthening and capability building: USP partners with national regulatory authorities and health ministries around the world to strengthen medicines regulatory systems, helping improve quality oversight, policy alignment, inspection capacity, and adoption of science-based standards. Through technical assistance, training, laboratory strengthening, and development of quality assurance frameworks, USP supports governments in building sustainable regulatory capability to help ensure medicines’ quality, safety, and availability for their populations. 

Supporting Good Manufacturing Practices (GMP): USP provides scientific guidance, tools, and reference materials that support quality manufacturing processes. By helping manufacturers meet rigorous quality benchmarks, USP assists manufacturers in reducing the likelihood of formulation errors, contamination, or production inconsistencies that lead to substandard products. 

Building supply chain resilience: USP works with global and regional partners to strengthen supply chain integrity, helping ensure medicines remain safe and effective as they move from manufacturer to patient. 

Conclusion 

In light of recent global events involving SFMPs, including the proliferation of falsified GLP-1 drugs globally, fake and poor-quality medicines from both regulated and unregulated sources pose a serious, preventable threat to public health. Hence, it is vital for all stakeholders, including national regulatory authorities, academic researchers, the pharmaceutical industry, border control authorities, and other organizations with medical product expertise, to collectively remain vigilant in combatting SFMPs. Through USP’s documentary and reference standards that help ensure medicine safety and quality, as well as the APEC Toolkit, the DEG Toolkit, and other global supply chain resources, USP stands ready to support global partners in strengthening regulatory systems and protecting communities from dangerous medical products.