A COMPARATIVE QUALITY STUDY OF SELECTED AUTHORIZED AND SMUGGLED MEDICINES IN ADEN, YEMEN

Abstract

In Yemen, most of the medicines are imported. Drugs that enter the country by legal means undergo some tests by Supreme Board for Drugs and Medical Appliances (SBDMA) to evaluate the quality of the product. However, some medicines enter the country illegally (smuggling) and this makes them bypass the evaluation of their quality by the SBDMA. This work was carried out to determine the physical quality control parameters of authorized and smuggled drug products marketed in Aden pharmacies. The authorized and smuggled brands of cefuroxime (CEF), atorvastatin (ATR), and carvedilol (CAR) tablets available in Aden pharmacies were selected. The tablets were evaluated for their physical properties and quality control parameters including weight variation, hardness, friability, and disintegration test. The level of drug content also was evaluated using UV spectroscopy. The physical assessment showed that the authorized and smuggled brands of the same products were uniform in shape, color, packing, and labeling information except for the registration number and manufacture date which were present only on the authorized brands. The three authorized and smuggled brands of CEF, ATR, and CAR complied with the official specifications for weight version, diameter, thickness and hardness, friability, and disintegration tests except for the hardness value of ATR. All authorized brands agreed with the label claims whereas some smuggled brands contained the appropriate active ingredients but did not contain the right amounts.