REGULATORY REQUIREMENTS ON PHARMACOVIGILANCE AS PER CDSCO IN INDIA COMAPARISON WITH NEW ZEALAND

Pharmacovigilance is an essential component of medicine safety that involves the Detection, assessment, understanding, and prevention of adverse drug reaction and other medicine-related problems. In India CDSCO regulates post-marketing drug safety activities through requirements for marketing authorization holders [MAHs], individual case safety reports [ICSRs], periodic safety update reports [PSURs], signal detection, risk management, and pharmacovigilance system. CDSCO’S current post-marketing framework includes guidance for MAHs and electronic PSUR submission through the SUGAM portal. In New Zealand pharmacovigilance is regulated primarily by Medsafe with safety monitoring supported by the center for adverse reactions monitoring. Sponsors are required to maintain system for collecting and evaluating adverse reaction information and to report valid serious ICSRs occuring in New Zealand generally within 15 days calendar days of receipt the comparison examines regulatory authorities ADR/ICSR reporting requirements, reporting timeline, safety monitoring, signal detection, and responsibilities of pharmaceutical companies. Overall the study highlights similarities and differences in the two national systems and emphasizes and importance of effective post-marketing surveillance for ensuring the continued safe and rational use of medicines