CDSCO Approval Process Explained: India’s Clinical Trial Pathway, Step by Step
Getting a clinical trial approved in India means understanding the CDSCO Approval Process. Sponsors must submit their application through the Sugam portal, where it is reviewed by a Subject Expert Committee (SEC) before the Drugs Controller General of India (DCGI) grants permission. The process is governed by the New Drugs and Clinical Trials Rules, 2019
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