Keeping in mind India’s increasing participation in multinational trials, this domain explores potential areas of Indian pharmacovigilance, requiring reform & provides recommendations for building a robust safety reporting system. Internal discrepancies exist between regulatory authorities regarding reporting requirements. Despite global focus on Development Safety, Indian regulators are not yet insistent on real-time update of a drug’s cumulative safety profile. Finally, the need to formulate an all-encompassing pharmacovigilance guideline for India, in sync with global practice cannot be overemphasized.
The World Health Organization defines pharmacovigilance as “the science and activities relating to detection, assessment, understanding & prevention of adverse effects or any other drug-related problem.”The goals of PV are to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. PV activities involve monitoring approved drugs and investigational medicinal products (IMPs) to: identify previously unknown adverse effects; recognize changes in the frequency or severity of known adverse effects; assess a drugs risk/benefit to determine if action is required to improve safety; ensure the accuracy of information communicated to healthcare professionals and patients, and to ensure information contained in patient information.
Pharmacovigilance begins with clinical trials that provide data on the benefits and risks of a drug. The aim of pharmacovigilance in clinical research is to determine if the benefits outweigh the risks; if they do, drug manufacturers take steps to gain approval to market the new drug.
