larification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019

Source: CDSCO

Category: Drug Regulation

Published: 2026-08-10T00:00:00.000Z

larification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019