Pharmacovigilance and the Process of ADR reporting and Monitoring in India

Pharmacovigilance is defined as the processes of monitoring and evaluating ADRs, and it is an essential component of effective drug control systems, clinical practice, and public health programs. As the number of reported adverse drug reactions (ADRs) has increased, pharmacovigilance requires skills to identify potential risks and its removal. ADRs are a leading source of morbidity and mortality, mostly found through post-marketing surveillance. Improving ADR reporting in India, includes using novel methods like Pharmacovigilance, is critical for enhancing patient safety and public health outcomes. Active pharmacovigilance surveillance involves monitoring drug events, adverse events, and reporting them spontaneously. The monitoring of adverse drug responses, which begins with the pre-marketing of new medications and continues through the post-marketing phase of medications, is significantly influenced by pharmacovigilance. Given India's huge population, diverse illness frequency patterns, and traditional medical practices, it is important that the country implement strong pharmacovigilance programs. All the regulatory authorities, institutions even clinicians and physicians are initiating nation-wide pharmacovigilance programmes to collect, collate, analyse data on adverse drug reactions for protecting the health of the patients. The ultimate objective of this review is to understand role of pharmacovigilance and make sure that the advantages of medication use outweigh risk factors in order to protect health of Indian population.