CDSCO clarifies processing of applications for unapproved new drugs undergoing global clinical trials with Indian subjects

CDSCO has clarified that applications for permission to import and market new drugs not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are ongoing or completed with Indian subjects, must be processed by its Investigational New Drug (IND) Division. Applicants are required to submit such applications to CDSCO Headquarters, New Delhi, under the NDCT Rules, 2019.