Definition

Requirements for reporting adverse drug reactions in India: serious and unexpected ADRs to CDSCO/PvPI within stipulated timelines; format and channels as per CDSCO.

Example

Expedited reporting of serious domestic and foreign cases to CDSCO as per Indian timelines.

Regulatory source

CDSCO Gazette notifications, PvPI SOPs

Common mistakes

Reporting only domestic cases or ignoring 15-day type timelines.

Inspector question

What are your Day 0 and reporting timelines for India?

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