India CDSCO & PvPI

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.

WHO-supported adverse event reporting system used by PvPI for submission of ICSRs in India; MAHs may use Vigiflow or designated pathway for CDSCO.

Inspection of pharmacovigilance systems by CDSCO or state authorities in India; may cover QPPV, case processing, reporting to PvPI, and documentation.

Qualified Person for Pharmacovigilance for India; responsible for PV system and compliance with CDSCO/PvPI. May be same as EU QPPV or designated locally.

Date of first awareness of a reportable case for Indian regulatory reporting; used to determine expedited reporting timelines to CDSCO/PvPI.

Official gazette and notifications from CDSCO publishing regulatory updates, including PV and reporting requirements.

ADR Monitoring Centre; network of centres under PvPI that collect and report ADRs to NCC-PvPI.

Host of NCC-PvPI at Ghaziabad; coordinates PvPI and maintains national ADR database.

Many MAHs and CROs have PV operations in Mumbai; familiarity with CDSCO, PvPI, and local inspection expectations is relevant.

Form used for drug approval and related submissions in India; PV requirements may be referenced.

State-level drug regulatory authority in India; may coordinate with CDSCO for inspections.

Required format and fields for ADR reporting to PvPI (e.g., Vigiflow or specified form).

Indian Good Clinical Practice and PV requirements for clinical trials and post-market; CDSCO enforced.

PV requirement specific to India (CDSCO, PvPI, timelines, format).

Official notification from CDSCO (e.g., gazette) on regulatory change.

Annual or periodic reporting to PvPI/NCC as required.

PV operations based in Mumbai; relevance to Indian market and CDSCO liaison.