The Central Drugs Standard Control Organisation (CDSCO) has clarified that 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 the participation of Indian subjects, will be examined and processed by the Investigational New Drug (IND) Division.
The matter was examined by an internal technical committee within CDSCO. Following detailed deliberations, the committee concluded that such Investigational New Drug (IND) applications, particularly those under review by foreign regulatory authorities, require comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules, 2019).
In view of this decision, CDSCO has informed stakeholders that all such applications shall be examined and processed by the IND Division as per the applicable regulatory requirements under the NDCT Rules, 2019. Applicants have accordingly been directed to submit these applications to the IND Division, CDSCO Headquarters, New Delhi.
The clarification provides a defined regulatory route for applications concerning investigational new drugs that have not received approval anywhere in the world but are associated with Phase III global clinical trials involving Indian subjects.
