Definition

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

Example

Day 0 = date company first knew of serious unexpected ADR; 15-day clock for India.

Regulatory source

CDSCO, PvPI

Common mistakes

Using different Day 0 logic for India vs other regions.

Inspector question

How do you define Day 0 for CDSCO reporting?

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