CDSCO Announces Interim Import Approval Process for BA/BE Export Studies
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a notice outlining the interim procedure for obtaining Form CT-16 applications through the National Single Window System (NSWS) portal for the import of Reference Listed Drugs (RLDs) and Investigational Medicinal Products (IMPs) intended for Bioavailability/Bioequivalence (BA/BE) studies for export purposes.
In the notice dated May 22, 2026, the BA/BE for Export Division under the Directorate General of Health Services, Ministry of Health and Family Welfare, stated that several stakeholders had raised concerns regarding the non-availability of system linkage between Prior Intimation (PI) applications submitted through Form CT-05 on the Sugam portal and the corresponding Form CT-16 applications filed for import permissions.
The regulator noted that the issue relates to applications involving import of RLDs/IMPs intended for conduct of BA/BE studies for export purposes under Chapter V of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
Also Read: CDSCO Issues Revised Drug Sampling Guidelines to Strengthen Rural Surveillance
Considering the operational difficulties faced by applicants and following the implementation of notification GSR 50(E) dated April 21, 2026, CDSCO has introduced an interim procedural arrangement that will remain in force until further orders.
Applicants intending to import RLD/IMP for the conduct of BA/BE studies for export purpose shall submit a stand alone Form CT-16 application through the NSWS portal along with the following documents:
- Covering letter explaining the purpose of import and reference details of Prior Intimation application;
- Copy of acknowledged Prior Intimation (Form CT-05) generated through Sugam Portal;
- Complete details of the proposed RLD/IMP to be imported;
- Copy of protocol/synopsis/reference details, wherever applicable;
- Challan of requisite fee as prescribed under Schedule VI of NDCT Rules, 2019, paid through Bharat-Kosh portal;
- Any other supporting document required in the NSWS Checkpoint list by the concerned CDSCO Zonal/Sub-Zonal Office.
Further, the notice clarified that submission of a standalone Form CT-16 application under this notice shall be treated as an interim procedural arrangement to resolve the issue faced by applicants on the subject matter and shall not exempt applicants from compliance with provisions of the New Drugs and Clinical Trials Rules, 2019 and other applicable regulatory requirements.
The notice also directed all concerned CDSCO Zonal and Sub-Zonal Offices to process such applications on a priority basis till further orders.
