Background: Herbal drugs obtained from medicinal plants are used by a majority of
the people because of their safety and less side effects, but it is not completely true that herbal
products do not have any side effects or toxic effects, they do carry risks. Regulatory authorities of
different countries regulate the quality and standard of herbal drugs on the basis of problems associated
with them such as herb-drug interaction, side effects, toxicity and adverse effects. The International
Drug Monitoring Program of World Health Organization (WHO) has made certain
guidelines for herbal drugs evaluation and quality control analysis. The WHO has done various
efforts for the improvement of herbal drugs in the context of their safety and efficacy. The herbal
drug toxicity arises when the drug is used without proper indications, in large doses, or with other
drugs, for longer duration without consultation of a physician, and manufactured appropriately.
Objectives: This mini review has been written to discuss the current status of regulatory and quality
aspects of herbal drugs. The regulatory guidelines of herbal drugs need to be improved along
with the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) guidelines.
Discussion: In the field of herbal drugs, various parameters/guidelines regarding their safety and efficacy,
in manufacturing and selling have been controlled thoroughly by the regulatory authorities. However, improvements
should be done w.r.t. rules and regulations of herbal drugs, particularly in the case of collection,
cultivation and toxic effects of herbs.