Toxicological Evaluation of Traditional Preparations

Abstract

Systematic toxicological evaluation is the foundation of pharmaceutical safety assessment, with well-defined methodology pathways covering acute toxicity, subchronic and chronic toxicity, reproductive and developmental toxicity, genotoxicity, and carcinogenicity. For traditional Ayurvedic preparations, systematic toxicological evaluation has developed more recently and unevenly, with substantial variation in methodological rigour across product categories. Specific categories deserving particular toxicological attention include classical metallic-mineral preparations (bhasmas and rasa aushadhi), polyherbal formulations with complex composition, non-standardised commercial preparations subject to contamination risks, and preparations intended for extended clinical use where chronic exposure profiles become important. European regulatory requirements for traditional herbal medicinal products (Directive 2004/24/EC and related frameworks) establish toxicological evidence expectations that shape clinical deployment. This study reviews 54 primary toxicological studies published between 2008 and 2021 on traditional Ayurvedic preparations, grouped under five approach frames: TX1 (acute and subacute toxicity evaluation), TX2 (chronic toxicity and repeated-dose evaluation), TX3 (genotoxicity and carcinogenicity assessment), TX4 (reproductive and developmental toxicity), and TX5 (integrated safety pharmacology assessment). Each frame was scored with the Toxicological Evaluation Comprehensive Index (TECI). Integrated safety pharmacology (TX5) scored highest at TECI 0.812, with chronic toxicity (TX2) at 0.788 and acute and subacute toxicity (TX1) at 0.772