Challenges in Quality Control of Herbal Pharmaceuticals: Standardization, Analytical Methodologies, and Regulatory Frameworks

Abstract

Herbal pharmaceuticals have long been utilized as natural therapeutic agents and are increasingly recognized for their

potential in modern healthcare. However, the advancement and global acceptance of these products are significantly hindered

by persistent challenges in quality control, standardization, and regulatory compliance. This review critically examines the

core issues impeding the development and validation of herbal medicines. The variability in phytochemical profiles

attributed to genetic diversity, environmental factors, and post-harvest conditions complicates efforts to ensure consistency

and reproducibility in product quality. Additionally, widespread adulteration and the lack of well-defined pharmacokinetic

and clinical data limit their credibility in evidence-based medicine.