Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE

Generics/Research | Posted 10/02/2023 post-comment0 Post your comment

Generic medicines are pharmaceutical products manufactured to be equivalent to the brand or innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to ensure equivalent therapeutic outcomes

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Al Ali L et al. carried out a study aimed to evaluate the pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products being sold in the United Arab Emirates (UAE) market to enhance public confidence, promote their utilization, and reduce treatment costs [1]. 

The authors selected for the study three drugs that they considered to be representative from three different pharmacological classes from the UAE market. These generic drugs were tadalafil, rosuvastatin, and acetaminophen. At least two products for each locally (L) and regionally (R) manufactured generic drugs were evaluated according to the USP criteria in comparison with the brand (B) comparator product.

In this study, all comparative tests were performed before storage, and 3 and 6 months after storage during the accelerated stability study performed under the conditions for climatic zone IV (40°C ± 2°C / 75% RH ± 5% RH). Although results were statistically different from the comparators using ANOVA and Tukey’s Kremer post hoc tests, all performed tests (dimensions, friability, disintegration, content uniformity, and dissolution) were within the USP acceptance limits, except one generic product. Significant changes were observed following their storage over the 6 months of accelerated stability studies, however, without failing the USP limits. Only one locally manufactured acetaminophen generic product failed the USP dissolution tests before and after its storage and failed the disintegration test following its storage under accelerated conditions of zone IV.

The authors concluded that the majority of the locally and regionally manufactured generic products being sold in the UAE market were of good quality and performed similarly to their comparators. Nevertheless, a continuous independent quality evaluation for the marketed generic drugs is essential to enhance public confidence [1].

Conflict of interest
The authors of the research paper [1] declared that the work was supported by the University of Sharjah Graduate Studies’ Student Grant.

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1. Al Ali L, Jagal J, Joseph J, et al. Pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products in UAE. Saudi Pharm J. 2022;30(9):1243-51.

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