Prevalence of Unregistered, Substandard, and Falsified Veterinary Antimicrobials in Ethiopia: A National Postmarket Quality Surveillance Study.

BACKGROUND

The proliferation of unregistered, substandard, and falsified (SF) veterinary pharmaceuticals represents a critical global threat to animal health, food security, and environmental conservation. In sub-Saharan Africa, these products exacerbate the emergence of antimicrobial resistance (AMR), potentially accelerating the transition toward a "post-antibiotic" era. Despite Ethiopia's relatively developed regulatory framework compared to neighboring states, vulnerabilities such as inadequate diagnostic facilities, porous supply chains, and limited postmarketing surveillance results in enforcement persist.

OBJECTIVE

This descriptive study was conducted to determine the prevalence and quality profile of selected veterinary antimicrobials, including antibacterials, anthelmintics, and antiprotozoals, circulating in the Ethiopian market.

METHODS

Postmarket quality surveillance (PMS) study was conducted across five administrative regions. A total of 142 samples were collected and evaluated through three distinct regulatory tiers: verification of Ethiopian Agricultural Authority (EAA) registration status, standardized visual/physical screening, and official pharmacopeial (compendial) laboratory testing.

RESULTS

The majority of sampled products (95.7%) were imported, predominantly from China (75.7%) and India (15.0%). Primary sampling sites included veterinary retail outlets (50.7%) and clinics (22.9%). Regulatory analysis revealed that 17.9% (n = 25) of samples were unregistered. Visual screening identified an administrative substandard prevalence of 24.3% among registered products. Of the 44 samples subjected to compendial laboratory analysis, 22.7% (n = 10) failed to meet established pharmacopeial specifications. While suspected falsified products were identified through labeling discrepancies, laboratory confirmation of falsification is ongoing.

CONCLUSIONS

Unregistered and substandard veterinary medicines are circulating in the Ethiopian supply chain, posing severe risks to animal health and contributing to the regional AMR crisis. These findings necessitate urgent, concerted efforts from stakeholders to strengthen the national regulatory system, enhance EAA laboratory capacity, and secure the pharmaceutical supply chain through targeted postmarketing enforcement.