A herbal formulation has been developed by interdisciplinary School of Indian System of Medicine (ISISM), SRM University in collaboration with Banaras Hindu University, Varanasi for menopausal syndrome. Polyherbal formulation contains Dioscorea bulbifera, Terminalia arjuna, Bambusa arundinacea and Withania somnifera (Well established) plant extracts. The formulation has been subjected to preclinical experiments to establish safety, efficacy, acute toxicity, sub-acute toxicity and chronic toxicity studies. The effective dose of each plant ingredient was determined based on the results of pre-clinical studies by giving different doses of each plant extract in varying concentrations. The maximum optimum effect in specific dose on various targets/biomarkers involved with clinical condition was noticed and the effective dose was taken for preparation of test formulation. The major safety concern is the potential for interactions of herbal products with prescribed drugs. This issue is especially important with respect to drugs with narrow therapeutic indexes (e.g. warfarin and digoxin). This may lead to adverse reactions that are sometimes life-threatening or lethal. The identification of drugs that interact with herbs has important implications in drug development. It appears that any new drugs that are substrates for CYP3A4 have a potential to cause herb-drug interactions. Thus, caution should be taken when these drugs are co-administered with herbs. Since in vitro drug-drug and drug-CYP interaction studies have been incorporated into drug development, drug-herb and herb-CYP interactions should also be included to identify drugs that interact with herbs in the early stage of drug development. So our purpose of the study is to evaluate the drug-herb interaction of newly developed polyherbal formulation