COUNTERFEIT MEDICINES: ANALYTICAL METHODS FOR DETECTION AND GLOBAL REGULATORY CHALLENGES

Abstract

This article examines modern analytical techniques used for the detection of counterfeit pharmaceutical products and evaluates their effectiveness based on scientific evidence. In particular, the advantages and limitations of high-performance liquid chromatography (HPLC), infrared (IR) and Raman spectroscopy, as well as ultraviolet–visible (UV–Vis) spectrophotometry are comparatively analyzed using data from the scientific literature. In addition, international regulatory frameworks aimed at preventing the circulation of counterfeit medicines in the pharmaceutical sector are reviewed, including regulatory approaches developed by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO).

The findings indicate that reliance on a single analytical method is insufficient to effectively combat counterfeit medicines. Instead, the combined application of multiple analytical techniques, together with strengthened international cooperation and harmonized regulatory strategies, is essential. By proposing a scientific and systematic approach to the problem of counterfeit medicines, this article highlights promising strategies for ensuring pharmaceutical quality and enhancing patient safety.