Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Dr. Anjali Sharma, Mr. Rohit Mehra

ABSTRACT: Pharmacovigilance (PV) has become a cornerstone of patient safety in India due to the rapid growth of the pharmaceutical industry, expansion of clinical trials, and increased availability of generic medicines. With India being a hub for drug manufacturing and exports, ensuring safe use of medicines is a national and global priority. Current trends highlight digital reporting mechanisms, artificial intelligence in adverse drug reaction (ADR) analysis, regulatory reforms, patient participation, and international collaboration. This paper explores the evolving paradigms in pharmacovigilance in India, focusing on policy changes, technological innovations, integration with global networks, and challenges that remain in building a robust drug safety ecosystem. The study emphasizes that the success of pharmacovigilance depends on strong regulations, healthcare professional involvement, and patient engagement, supported by digital innovations.

KEYWORDS: Pharmacovigilance, India, Drug Safety, Regulatory Reforms, Patient Engagement, Artificial Intelligence, Clinical Trials, Digital Health