An increase in drug safety concerns in recent years with some high drug withdrawals have led to raising the bar by various more importantly by the regulatory authorities. The number Adverse Drug Reactions (ADRs) reported have also resulted in an in the volume of data handled and to understand a high level of expertise is required to rapidly drug risks as well as to defend the product against an removal. Proactive pharmacovigilance throughout the life cycle is the way forward and the future direction for drug. It is a challenge to codify and standardize the act of signal and risk management in the context of clinical trials and-marketing pharmacovigilance. While major advancements of the of oharmacovigilance have taken place in the West, not much been achieved in India. However, with more clinical trials and research activity being conducted in India, there is an need to understand and implement pharmacovigilance. For this to in India, the mind set of people working in regulatory agency(DCGI Office) and the Indian Pharmaceutical companies need to change. article describes and discusses the various strategies and to build, maintain and implement a robust pharmacovigilance for various stakeholders and eventually make it happen in India!
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Biswas et al. (2007) studied this question.