Pharmacology
Phase 1 — Introduction to Pharmacological Research & Regulatory Framework
1.6 Regulatory Framework: Governing Bodies and Guidelines
1.6.2 CDSCO and Schedule Y

1.6.2 CDSCO and Schedule Y

The Central Drugs Standard Control Organisation is India's national regulatory authority for...

PharmacologyPhase 1 — Introduction to Pharmacological Research & Regulatory Framework1.6 Regulatory Framework: Governing Bodies and Guidelines1 min readUpdated 2026-07-13

The Central Drugs Standard Control Organisation is India's national regulatory authority for pharmaceuticals. Schedule Y of the Drugs and Cosmetics Rules specifies the preclinical (and clinical) data requirements for obtaining permission to conduct clinical trials and for new drug approval within India, functioning analogously to the US FDA's IND/NDA framework.

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