Setting standards for proactive pharmacovigilance in India: The way forward

TLDR

Recent drug safety concerns and increased ADR reporting have raised regulatory expectations, but India lags behind Western advances, creating a need to standardize signal detection and risk management amid growing clinical research. The study advocates proactive, life‑cycle pharmacovigilance in India, calling for a shift in mindset among regulators and industry to establish a robust system. It outlines strategies and proposals to build, maintain, and implement a robust pharmacovigilance system for stakeholders in India.

Abstract

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. <br>Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety. It is a challenge to codify and standardize the act of signal detection and risk management in the context of clinical trials and post-marketing pharmacovigilance. While major advancements of the discipline of oharmacovigilance have taken place in the West, not much has been achieved in India. However, with more clinical trials and clinical research activity being conducted in India, there is an immense need to understand and implement pharmacovigilance. For this to happen in India, the mind set of people working in regulatory agency (DCGI Office) and the Indian Pharmaceutical companies need to change. This article describes and discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for various stakeholders and eventually make it happen in India!