How Effective Are Current Regulatory Standards in Controlling the Quality of Generic Drugs?

Abstract

The increasing global reliance on generic drugs, driven by their costeffectiveness, necessitates a critical assessment of the regulatory
frameworks that ensure their quality. This review explores the current standards governing generic drug approval and quality control, focusing on key regulatory bodies such as the FDA, EMA, and WHO. It evaluates the effectiveness of these standards, including bioequivalence testing and Good Manufacturing Practices (GMP), and highlights the importance of postmarket surveillance in identifying substandard products. Challenges in the regulation of generic drugs, particularly in developing countries, are discussed, emphasizing resource limitations, supply chain complexities, and the threat of counterfeit medications. A comparative analysis with branded drugs reveals significant differences in quality standards and public perception. Recent advancements, including technology-driven monitoring and international harmonization efforts, aim to enhance regulatory effectiveness. The review concludes with recommendations for strengthening regulatory standards, such as improving inspection capacities, expanding pharmacovigilance networks, and fostering public-private partnerships. This comprehensive assessment underscores the necessity for robust regulatory frameworks to ensure the safety and efficacy of generic drugs, ultimately safeguarding public health and enhancing patient trust in these vital medications.