Worldwide movement for the improvement of patient safety is gaining momentum; hence the subject of drug safety becomes even more prominent in the present day scenario. In context of ASU; with increased use of drugs of these systems, the scope for adulteration, preparation of counterfeit drugs and development of formulations which do not have conceptual basis in these systems has increased. Further cultivation of medicinal plants with laboratory generated species is being attempted on the basis of chemical composition and is likely to be used in increased manner for commercial purpose. These changes may have profound impact on the safety and efficacy of the ASU drugs in the market. Hence a mechanism is required to put in place to address them. Establishment of Pharmacovigilance set up is the first required step...