Author(s): Bhumeshwar Sharma, Sourabh Kosey, Neelesh Kumar Mehra, Deepanshu Kumar Chitra, Raj Kumar

In recent years an increase in drug safety concerns, accompanied by some high profile drug withdrawals has steeped the bar of drug safety by various stakeholders, more significantly by the regulatory authorities. With the increasing reporting of Adverse Drug Reactions, volumes of data to be handled have simultaneously increased. Rapid detection of drug risks as well as the ability to defend the marketed product against an inappropriate serves as the essential expertise, skills, which are attained by those personnel having a sound understanding of Pharmacovigilance. The future path and providence of drug safety is solely dependent on Proactive pharmacovigilance throughout a product’s life cycle. In the context of clinical trials and post-marketing pharmacovigilance codification followed by standardization of the act of signal detection and risk management remains a great challenge in the progression and fluorishment of the field. Advancements of the discipline are at an infancy stage in India whereas the west has already reached the mountain in the same prospect. By the passage of time and with more clinical trials and clinical research activity being conducted in India, understanding and implementation of pharmacovigilance have become an essential need. A positive change can occur in Indian Scenario if the outlook of the workforce of regulatory agency (DCGIOffice) and the Indian Pharmaceutical companies is varied. This review describes and discusses the various policies and propositions to build, maintain and implement a stout pharmacovigilance system for various stakeholders and eventually make it functional in India.