A COMPARATIVE STUDY OF POST-MARKETING SURVEILLANCE REQUIREMENT FOR CERIVAL CANCER MEDICINES: CDSCO VS US-FDA

Abstract

Post-Marketing Surveillance (PMS) is an essential component of pharmacovigilance that ensures the continued safety, efficacy and quality of medicines after regulatory approval. Cervical cancer medicines, including chemotherapy agents, targeted therapies, immunotherapies and HPV vaccines, require extensive monitoring due to serious adverse drug reactions and long-term safety concerns. This dissertation compares the PMS requirements and pharmacovigilance frameworks of the Central Drugs Standard Control Organization (CDSCO) and the United States Food and Drug Administration (USFDA) for cervical cancer medicines. The study evaluates the regulatory frameworks, adverse drug reaction reporting systems, PSUR/PBRER requirements, risk management systems, signal detection methods, pharmacovigilance obligations and enforcement mechanisms of both agencies. Data were collected from official regulatory guidelines, pharmacovigilance guidance documents, and published scientific literature. The findings indicate that the USFDA operates a more advanced and technology-driven pharmacovigilance system built around the FDA Adverse Event Reporting System (FAERS), MedWatch and Risk Evaluation and Mitigation Strategies (REMS), whereas CDSCO is progressively strengthening its PMS framework through the Pharmacovigilance Programme of India (PvPI) and revised requirements under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The comparative analysis highlights similarities and differences in adverse event reporting timelines, periodic safety reporting obligations, signal detection capability, risk management approaches and enforcement mechanisms, and offers recommendations for strengthening the Indian pharmacovigilance system.