The Central Drugs Standard Control Organization (CDSCO) on August 10, 2026, issued a clarification on the submission of applications for the 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.
The following has been stated:
• It has clarified the regulatory procedure for applications seeking permission to import and market new drugs that are not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are either ongoing or have been completed with participation of Indian subjects. The matter was examined by CDSCO’s internal technical committee, which recommended that such applications require comprehensive assessment of both non-clinical and clinical data.
• Accordingly, all such Investigational New Drug (IND) applications, including those under review by foreign regulatory authorities, will be examined and processed by the IND Division, CDSCO (HQ), New Delhi. The applications will be evaluated in accordance with the applicable regulatory requirements under the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules, 2019). Applicants are therefore required to submit such applications directly to the IND Division, CDSCO (Headquarters), New Delhi for further regulatory examination and processing.
[Notification No. - ND-11011(13)/2/2026-eoffice]
