Alarming Quality Issues in Seized Antibiotics

A groundbreaking study published on February 21, 2026, by researchers at Sciensano, Belgium's national public health institute, has exposed serious quality problems in substandard and falsified antibiotics seized within the country. Analyzing 40 samples confiscated by the Federal Agency for Medicines and Health Products (FAMHP) between early 2024 and late 2025, the report found that 43% failed pharmaceutical quality control tests. Even more concerning, 35% contained active pharmaceutical ingredients (APIs) from the World Health Organization's (WHO) Watch list—antibiotics with a higher potential for fostering antimicrobial resistance (AMR).

These findings underscore the hidden dangers lurking in illegal supply chains, often entering Europe via postal services or online pharmacies. Dissolution defects, the most common failure affecting 29% of tested samples, mean these drugs may not release their active ingredients properly, leading to sub-therapeutic doses that exacerbate treatment failures and resistance development.

The Growing Threat of AMR and Substandard Medicines

Antimicrobial resistance occurs when bacteria, viruses, fungi, and parasites evolve to withstand drugs designed to kill them, turning common infections into life-threatening conditions. In 2021 alone, AMR contributed to nearly five million deaths globally, with projections estimating 39 million more over the next 25 years if unchecked. Belgium, like much of Europe, faces rising challenges despite robust healthcare systems.

Substandard and falsified medical products (SFMPs) worsen this crisis. Substandard drugs suffer quality defects from legitimate manufacturers, while falsified ones deliberately misrepresent their composition or origin. In low- and middle-income countries, up to one in 10 medicines may be affected, but even regulated markets like Europe see infiltration through illicit channels. The WHO's AWaRe classification—Access (first-line), Watch (higher resistance risk), and Reserve (last-resort)—guides stewardship, yet SF antibiotics bypass these safeguards.

Europe's One Health Action Plan (2017) integrates human, animal, and environmental efforts against AMR, but transnational SF flows demand vigilance. Belgium's new National Action Plan on AMR (2026-2030) emphasizes surveillance and prudent use amid declining but still high antibiotic consumption.

How FAMHP Seized These Samples

The FAMHP, Belgium's regulatory body for medicines, intercepted these 40 samples primarily from international couriers and postal parcels. Each contained over 20 dosage units of oral or injectable antibiotics, suspected as unregistered or unlicensed. Unlike legitimate products with EU data matrix codes for traceability, these lacked approval, hinting at origins from unregulated markets.

Seizures reflect proactive border controls amid global shortages and prescription restrictions driving online demand. From 2015-2019, Sciensano noted fewer, simpler SF cases; now, diversity has surged, including macrolides and tetracyclines previously rare.

This uptick mirrors European trends, where e-commerce fuels SF entry despite low baseline prevalence compared to Asia or Africa.

Rigorous Testing Methods Employed

Sciensano's Official Medicines Control Laboratory (OMCL) applied comprehensive protocols compliant with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) standards. Here's a step-by-step breakdown:

• API Screening: Liquid chromatography-mass spectrometry (LC-MSⁿ) identified APIs against in-house libraries.
• Quantification: High-performance liquid chromatography (HPLC/UPLC-PDA) measured content from triplicate units (accuracy ±5%).
• Dissolution: Basket/paddle apparatus tested release in simulated media; failure if <60% in specified time.
• Residual Solvents: GC-MS screened for toxic volatiles like dichloromethane.
• Bioburden: Membrane filtration cultured microbes; MALDI-TOF MS identified contaminants.

Thirty-five samples underwent dissolution; all 40 others.

Breakdown of Antibiotic Types Tested

Samples spanned multiple classes, reflecting broad falsification targets:

• β-Lactams (38%): Amoxicillin (± clavulanic acid), phenoxymethylpenicillin, cloxacillin, ceftriaxone.
• Tetracyclines (20%): Doxycycline.
• Macrolides (18%): Azithromycin.
• Fluoroquinolones: Ciprofloxacin, levofloxacin.
• Nitroimidazoles: Metronidazole, tinidazole.
• Rifamycins: Rifaximin, rifampicin.
• Others: Ethambutol, isoniazid.

β-Lactams dominated, vital for common infections but prone to shortages.

WHO Watch List: The Critical 35%

The WHO AWaRe Watch group flags antibiotics like ciprofloxacin, azithromycin, ceftriaxone, levofloxacin, rifampicin, and rifaximin for their broader spectra and resistance risks. Fourteen samples (35%) featured these, potentially misused for routine cases, accelerating AMR. For instance, fluoroquinolones risk tendon ruptures; ceftriaxone, used injudiciously, depletes gut flora.

Full WHO AWaRe list emphasizes stewardship; SF circumvents it.

Specific Quality Failures Uncovered

Failures varied:

• Dissolution (29%, 10/35): Poor bioavailability; e.g., doxycycline tablets released insufficiently.
• API Content (18%, 7/40): Below 90% or above 120% labeled.
• Residual Solvents (5%, 2/40): Rifaximin samples exceeded limits (dichloromethane >600 ppm).
• Bioburden (7.5%, 3/40): Aspergillus sydowii (opportunistic fungus), others.

View detailed results in the full Sciensano study.

Public Health and Patient Risks

Beyond AMR, risks include allergic reactions, superinfections, hepatotoxicity (rifampicin/isoniazid), vision loss (ethambutol), and cardiac issues (azithromycin). Contaminants like Aspergillus threaten immunocompromised patients. Therapeutic failures prolong illnesses, increasing hospitalization costs—estimated at €30.5 billion annually globally for SFMPs.

In Europe, low SF prevalence masks impacts; studies link SF to higher AMR in affected regions.

Driving Antimicrobial Resistance

Sub-lethal doses from poor dissolution select resistant mutants. Watch list overuse in SF amplifies this. Global evidence ties SF antibiotics to elevated resistance rates, undermining stewardship. Belgium's declining consumption (14% drop 2014-2023) is positive, but SF threatens gains.

Case studies: Ukraine (40% SF antibiotics), Cyprus (100% in some surveys) show correlations; Europe-wide BSI from resistant bacteria rose recently.

Regulatory Responses in Europe and Belgium

FAMHP's seizures exemplify vigilance; EU's Falsified Medicines Directive mandates safety features. Belgium's 2026-2030 NAP-AMR prioritizes surveillance. Sciensano's prior work (e.g., ivermectin, PDE-5 SF) builds expertise; lead author Celine Vanhee specializes in illegal meds analysis.

Challenges persist: online anonymity, LMIC manufacturing. Solutions include track-and-trace, post-market testing.

Recommendations and Path Forward

Sciensano urges:

• Awareness campaigns against online buys.
• Strengthened quality assurance in supply chains.
• International cooperation for surveillance.
• Integrating SF monitoring into AMR plans.

Stakeholders—policymakers, pharmacists, researchers—must collaborate. For academics, this highlights pharmacovigilance roles; check research jobs advancing AMR solutions.

Future: Enhanced EU-OMCL networks, AI screening could curb threats. Belgium's proactive stance positions it well.

Photo by Piron Guillaume on Unsplash

Conclusion: A Call to Action

Sciensano's study spotlights SF antibiotics as AMR accelerators in Europe. With 43% failures and 35% Watch list hits, urgent reforms are needed. Professionals, visit higher ed jobs, rate my professor, career advice, university jobs for AMR research roles. Stay informed to safeguard public health.