Clarification 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

The Central Drugs Standard Control Organization (CDSCO) has issued a clarification regarding applications for import and marketing authorization of new drugs that are not approved anywhere in the world but have undergone or are undergoing Phase III Global Clinical Trials involving Indian subjects. Following review by an internal technical committee, CDSCO determined that such investigational new drug (IND) applications require comprehensive assessment of non-clinical and clinical data and therefore must be handled by the IND Division. The committee noted that many of these products are simultaneously under review by foreign regulatory authorities, necessitating scrutiny consistent with the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019. Consequently, all applicants seeking approval for such products must submit their applications to the IND Division, CDSCO Headquarters, New Delhi, for evaluation and processing in accordance with applicable regulatory requirements.