Good Pharmacovigilance Practice: Accountability of Ayurvedic Pharmaceutical Companies.

Abstract

© 2017 Ancient Science of Life | Published by Wolters Kluwer Medknow Sir, There is a paucity of systematic documentation apropos the occurrence of adverse drug reactions (ADRs) and other safety issues of Ayurveda medicines. National Pharmacovigilance program (NPP) for Ayurvedic drugs is concerned with re‐evaluation of marketed drugs, risk management, promoting rational drug use, and crisis preparedness. However, its successful implementation is a collective responsibility of the stakeholders viz. physicians, pharmacists, patients and pharmaceutical industry, that need to be sensitized towards reporting ADRs. This is a concern, especially in India, where there is below 1% reporting rate of ADRs as against the world rate of 5%.[1] In India, physicians are generally reluctant towards ADR reporting, due to poor awareness or lack of time/ training.[2,3] Furthermore, poor knowledge, attitude and practices of Pharmacovigilance (PV) has been observed in Ayurvedic practitioners.[4‐6] Till date, negligible number of ADRs to Ayurvedic medicines are reported/recorded in the NPP in India. This can be due to either the firm belief among practitioners that Ayurvedic drugs are safe or their lack of knowledge or awareness about the concept and significance of PV.[7] Marketing representatives (MRs) from Ayurvedic pharmaceutical companies approach physicians for the promotion of their drugs. While a new Ayurvedic drug [newly designed formula or new dosage form, which we treat as ‘New Chemical Entities’ (NCEs)] is promoted among physicians, it is important to discuss the reporting of ADRs. But, there is no data on whether such information is disseminated by MRs.