The Central Drugs Standard Control Organisation (CDSCO), on May 22, 2026, issued a notice prescribing an interim procedure for applicants seeking import permission of Reference Listed Drugs (RLDs) or Investigational Medicinal Products (IMPs) for conducting Bioavailability/Bioequivalence (BA/BE) studies meant for export purposes under Chapter V of the New Drugs and Clinical Trials Rules, 2019. The clarification was issued following stakeholder representations regarding the absence of system linkage between Prior Intimation applications filed through Form CT-05 on the Sugam Portal and corresponding Form CT-16 applications.
Under the interim arrangement, applicants are permitted to submit standalone Form CT-16 applications through the National Single Window System (NSWS) portal along with specified supporting documents including a covering letter, acknowledged Form CT-05, details of the proposed RLD/IMP, protocol or synopsis wherever applicable, Bharat-Kosh fee challan, and other documents required by CDSCO Zonal/Sub-Zonal Offices. CDSCO clarified that this arrangement is temporary and does not exempt applicants from compliance with the NDCT Rules, 2019 or other applicable regulatory requirements.
Further, all CDSCO Zonal and Sub-Zonal Offices have been directed to process such applications on priority until further orders. The notice has been issued to facilitate operational continuity after implementation of GSR 50(E) dated April 21, 2026 and to address procedural difficulties faced by industry stakeholders.
[Notice No. F.NODC-DT-15011(11)/125/2025-eoffice]
