Publication:

Assessment and comparison of adverse drug reactions reporting by USFDA and CDSCO: an audit

Background Drug safety is a critical component not only during the development of pharmaceutical products but also throughout their post-marketing lifecycle. Pharmacovigilance systems play a vital role in monitoring and evaluating adverse drug reactions (ADRs), with many national programs contributing data to the World Health Organization’s Pharmacovigilance Programme headquartered in Uppsala, Sweden.

Methods The present study aimed to assess and compare ADR reports submitted by various stakeholders in the United States and India. Publicly available pharmacovigilance data from both countries were systematically reviewed and analysed, excluding information related to dyes, medical devices, and blood-related products.

Results The comparison indicated that the United States Food and Drug Administration (USFDA) receive a substantially higher number of ADR reports compared to India. However, the number of safety alerts issued over the past four years appears to be relatively consistent between the two countries. Antibacterial agents and drugs acting on the endocrine system were among the most frequently reported therapeutic categories.

Conclusions This study highlights differences in reporting trends and underscores the need for strengthening ADR reporting mechanisms to enhance drug safety monitoring.