Indian herbal pharmacovigilance: The untamed saga

Abstract

Background: The acceptability of herbal formulations as therapeutic agents for numerous diseases has reached to its brim in the latest phytomedicine scenario. Since herbal medicinal products are complex mixtures from biological sources, regulations are necessary to guarantee the constant quality and quantity in order to break the unanimous myth related to herbal medicines consumption. Although the pharmacovigilance program in India has spread its roots in the field of medicines, amazingly there has been no benchmark regulations set up in the herbal segments. Aim: As per the latest regulatory scenario, the herbal drug regulation or herbal pharmacovigilance of India is lagging very much behind the highly regulated international herbal markets. The present article serves as a reminder of the fact that it is the high time for the Indian drug regulators to tame the herbal drug market since India has emerged as resourceful of enormous herbal medicines with full proof folk knowledge but is still lacking the specific legislative criteria to establish these herbal products as "medicine." Conclusion: This systemic herbal pharmacovigilance will definitely boost up not only the herbal market trend, but also the confidence about using of botanical medicines regarding their safe and rationale use within the ambit of pharmacotherapy.