CDSCO, PvPI, NCC-PvPI, Indian regulatory requirements, and Mumbai/India-specific PV practice.
20 terms
Central Drugs Standard Control Organisation; national regulatory authority of India for drugs and medical devices. Oversees PvPI and drug safety regulation.
Pharmacovigilance Programme of India; national programme under CDSCO for monitoring ADRs. NCC-PvPI at IPC Ghaziabad coordinates AMCs and reporting.
National Coordination Centre for PvPI; located at Indian Pharmacopoeia Commission (IPC), Ghaziabad. Coordinates ADR monitoring centres and national database.
Requirements for reporting adverse drug reactions in India: serious and unexpected ADRs to CDSCO/PvPI within stipulated timelines; format and channels as per CDSCO.