COMPARATIVE SAFETY OF HERBOMINERAL VERSUS PURELY HERBAL FORMULATIONS: AN EVIDENCE-BASED REVIEW
Introduction: Ayurvedic formulations are broadly categorized into purely herbal preparations and herbomineral (Rasaushadhi) formulations, the latter incorporating metals and minerals in processed forms. While herbal formulations are generally regarded as safe, concerns have been raised regarding the safety of herbomineral preparations, particularly related to heavy metal toxicity. The debate requires careful evaluation based on classical Ayurvedic principles and modern scientific evidence. Methods: A systematic literature search was conducted across PubMed, Scopus, Web of Science, AYUSH Research Portal, and Google Scholar (2000–2025). Classical Ayurvedic texts (Charaka Samhita, Sushruta Samhita, Rasa Ratna Samucchaya) were also reviewed. Studies on safety assessments, clinical trials, pharmacological evaluations, case reports, and toxicological studies were included. Both preclinical and clinical evidence were analyzed, focusing on safety outcomes of herbomineral and purely herbal formulations. Results: Herbal formulations show a favorable safety profile, with adverse events typically mild and linked to improper usage or contamination. Herbomineral formulations, when prepared following traditional detoxification (Shodhana, Marana), display therapeutic efficacy with minimal toxicity, supported by animal studies and clinical reports. However, safety concerns arise when manufacturing deviates from classical methods or when products are unregulated. Comparative studies suggest that purely herbal formulations are generally safer for long-term use, while herbomineral formulations may pose higher risks if improperly prepared, but are safe under Good Manufacturing Practices. Discussion: Myths about herbomineral toxicity are largely due to extrapolating data from raw heavy metals without considering their processed forms. While purely herbal formulations require quality control for pesticide and microbial contamination, herbominerals need stricter regulation due to their metal content. Conclusion: Both herbal and herbomineral formulations are safe when manufactured under pharmacopeial standards and used under medical supervision. The real challenge lies in standardization, regulation, and consumer education rather than inherent toxicity.
KEYWORDS: Ayurveda, herbomineral formulations, herbal formulations, safety, toxicity