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Susanta Kumar Rout*, Durga Madhab Kar and Laxmidhar Maharana


India market has mostly seen the launch of only those products that have been already approved and marketed in the regulatory markets of USA, Europe, Japan or other countries. For accessing the benefit-risk profile of a drug and to take appropriate corrective actions. Pharmacovigilance is not new to India, and has in fact been going on from 1998 when India Decided to join the Upsala centre for Adverse Event Monitoring and already 16 years have passed. Something has been achieved during this period, but much more still needs to be done in this field in India. The occurrence of active pharmaceutical substances in the environment is of growing concern. Certain classes of biological medicinal products, however, are associated with specific safety issues. The importance of Pharmacovigilance is increasing day by day, and people became more aware about the benefit and risks of medicines. Ascertaining the causality of suspected adverse drug reactions (ADRs) still remains a challenge in resource-limited settings. With the increasing and evermore stringent regulations in pharmacovigilance, the regulatory authorities face greater demands for patient welfare and safety. In this review we focuses on strategies and current scenario of pharmacovigilance sector in India along with recent guideline for Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.

Keywords: Pharmacovigilance, adverse drug reactions, pharmaceutical product.

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