Published Paper Details:

Pharmacovigilance (PV) plays a key role in the healthcare system by assessing, monitoring and detecting drug interactions and adverse drug reactions in humans. Medicines are intended to cure, prevent or treat disease. However, there are also risks, especially adverse drug reactions (ADRs) that can cause serious harm to patients. Therefore, for safe drugs, adverse reactions should be monitored throughout the life cycle of each drug, during drug development (e.g. pre-market, including early stages of drug design, clinical trial phase and post-marketing surveillance). Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding and prevention of adverse effects or any other drug/vaccine related issues. In addition, PV has traditionally been involved in recording spontaneous reports and submitting them to national surveillance systems. An emerging trend in PV is to link pre-market data to human safety information observed in the post-market phase. The PV Systems team captures valuable additional information, building on the scientific data contained in the original report, making it even more informative. This calls for extreme demands for effective regulation of the drug approval process and conscious vigilance against adverse effects before and after approval, especially in India. Adverse events reported through the PV system can benefit the community due to their linguistic and intellectual proximity to the public and public health practitioners, and the reporter can be easily contacted electronically. Thus, PV can help patients stay healthy and manage optimally or ideally, avoiding disease. This review summarizes the objectives and approaches used in PV and provide a critical review of existing PV in India, challenges to overcome and future prospects in the Indian context.