Definition

Central Drugs Standard Control Organisation; national regulatory authority of India for drugs and medical devices. Oversees PvPI and drug safety regulation.

Example

MAHs must report serious ADRs to CDSCO and comply with PvPI requirements.

Regulatory source

CDSCO website, Drugs and Cosmetics Rules India

Common mistakes

Treating Indian reporting as optional or delayed vs other regions.

Inspector question

How do you ensure timely reporting to CDSCO and PvPI?

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