A Comparative Study between Legally Imported and Smuggled Brands of Bisoprolol and Esomeprazole Tablets Marketed in Aden, Yemen

Background: While drugs are legally introduced into the Yemeni pharmaceutical market through local agents under supervision of the Ministry of Public Health and Population (MOPHP), the past year has seen a notable increase in the distribution of smuggled drugs.


Objective: The aim of this study was to perform a comparative evaluation of the quality control parameters of both legally imported and smuggled products of bisoprolol (5 mg) and esomeprazole (40 mg) tablets, which are marketed in public pharmacies in Aden, Yemen.


Methods: A hundred tablets from each studied brand were purchased from a community pharmacy, and the quality of the studied brands was assessed through evaluation of weight variation, friability, thickness, diameter, hardness, disintegration, and assay tests, as well as identification of drugs by Fourier Transform Infra-Red spectrophotometer.


Results: The result of this study showed that both legally imported and smuggled tested tablets of bisoprolol conform with quality control standards except the weight variation test of smuggled bisoprolol failed to agree with pharmacopoeias specifications. Furthermore, the legally imported esomeprazole meets the quality control specifications for the tested parameters except the hardness and disintegration tests, while the smuggled esomeprazole complies with all tests but failed to an agreement with specifications for hardness, disintegration, and assay tests, where the result shows a value of 137%.


Conclusion: These results highlight the variability in quality across different sourcing pathways and underscore the importance of stringent regulatory oversight and routine quality assessment to ensure the safety, efficacy, and consistency of marketed pharmaceutical products.