Pharmacovigilance in India

New drug development is a challenging and costly process as it involves focus on quality, efficacy as well as safety. Some of the adverse drug reactions (ADRs) are predicted based upon the previous experience with the pharmacologically similar drugs and others are detected during clinical trials. For detection of ADRs, clinical trials usually provide limited information as they are conducted under strictly controlled condition and largely focus on efficacy evaluation. Some of the ADRs can be detected only after long-term use in large population and in specific patient groups due to specific concomitant medications or disease. The visual field defect of vigabatrin therapy and valve defect of fenfluramine-phenteramine therapy are few such examples. Therefore early recognition of previously unknown adverse effects of medicines during post-marketing period is the primary objective of pharmacovigilance.