Regulatory Requirement for Pharmacovigilance System in India: Gaps and Future Direction

Authors:

Harsh Pant, Dr. Mohit Gupta

Abstract

Background:
Pharmacovigilance plays an important role in ensuring the safety of medicines after they are introduced into the market. It involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other medicine-related problems. In India, the Pharmacovigilance Programme of India (PvPI) has significantly improved the monitoring and reporting of ADRs. However, challenges such as under-reporting, limited awareness among healthcare professionals and patients, inadequate use of digital technologies, and variations in reporting practices continue to affect the effectiveness of the pharmacovigilance system.

Objective:
This review aims to examine the current regulatory requirements governing pharmacovigilance in India, evaluate the existing gaps and challenges within the system, and explore future directions for strengthening drug safety monitoring and patient protection.

Methods:
A comprehensive review of published literature, regulatory guidelines, government reports, and scientific articles was conducted. Relevant information was collected from sources such as PubMed, Google Scholar, Scopus, CDSCO publications, Indian Pharmacopoeia Commission (IPC) reports, and World Health Organization (WHO) documents. The collected data were analysed to understand the regulatory framework, reporting mechanisms, stakeholder responsibilities, major challenges, and emerging trends in pharmacovigilance.

Results:
The review found that India has established a structured pharmacovigilance framework through PvPI, supported by the Central Drugs Standard Control Organization (CDSCO) and the Indian Pharmacopoeia Commission (IPC). Despite these advancements, several issues remain, including low ADR reporting rates, limited participation of healthcare professionals and patients, insufficient integration of real-world data, and inadequate adoption of advanced digital technologies. Comparisons with pharmacovigilance systems in the United States, Europe, and Japan indicate that further improvements are needed in areas such as active surveillance, signal detection, risk management, and regulatory harmonization.

Conclusion:
India has made notable progress in strengthening its pharmacovigilance system; however, significant gaps still exist that may affect the timely identification and management of drug safety concerns. Enhancing awareness, improving reporting practices, expanding digital pharmacovigilance tools, integrating real-world evidence, and aligning regulatory practices with international standards can help build a more effective and patient-centred pharmacovigilance system. Continuous regulatory reforms and technological advancements will be essential for improving medicine safety and public health outcomes in the future.

Keywords: Pharmacovigilance, Adverse Drug Reactions, PvPI, CDSCO, Drug Safety, Regulatory Framework, India, Pharmacovigilance Programme of India, Patient Safety, Future Directions.