F. No. : ND-11011(13)/2/2026-eoffice dated August 10, 2026
Applicable Act: New Drugs and Clinical Trials Rules, 2019
The Central Drugs Standard Control Organization (New Drugs Division) stated that various applications had been received for permission to import and market new drugs that were not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) were ongoing or had been completed with participation of Indian subjects. The matter was examined by an internal technical committee within CDSCO.
The circular states that such investigational new drug (IND) applications, which are under review by foreign regulatory authorities, are required to be processed by the IND Division because the applications require evaluation of non-clinical and clinical data in accordance with the New Drugs and Clinical Trials Rules, 2019. Accordingly, all such applications shall be examined and processed by the IND Division as per the applicable regulatory requirements under the NDCT Rules, 2019. Applicants are required to submit such applications to the IND Division, CDSCO (HQ), New Delhi.
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