Safety Pharmacology Evaluation of Herbal Formulation: A Preclinical Core Battery Approach in Alignment with ICH Guidelines

Herbal drugs are often perceived as safe, effective and of good quality. However, the increased utilisation of herbal drugs has raised concerns about adverse effects and suspected toxicity. Therefore, conducting comprehensive safety studies of herbal drugs and formulations and documenting them is of paramount importance. Siddha formulation, Bhiramiyadhi Bhavanai Choornam (BBC) is a mixture of 15 herbs in proportion according to the traditional formula and is reported to be used as a memory enhancer. However, it has not been through safety pharmacological studies. The current study used ICH 7A guidelines to provide safety pharmacological data of Bhiramiyadhi Bhavanai Choornam. For 28 days, the rats were orally administered doses of 215, 430, and 860 mg/kg/day of BBC. The impact on the central nervous system (CNS) was evaluated using a modified Irwin’s test. The cardiovascular system was assessed by analysing electrocardiogram (ECG), heart rate fluctuations, and measuring changes in blood pressure. Respiratory parameters, including respiratory rate, tidal volume, and minute respiratory volume, were measured using a whole-body plethysmograph. The results of these studies indicated increased grooming, vocalisation, aggressiveness, chromodacryrrohea and a decrease in faecal consistency indicating BBC may have CNS stimulant and parasympathetic effects. There was no significant change observed in cardiovascular and respiratory parameters. Based on these findings, it can be concluded that BBC is a safe herbal formulation that does not have substantial untoward effects on the CNS, respiratory and cardiovascular systems.