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Dated: 26.05.2026
BE-NOC Prior Intimation Procedure for Obtaining CT-16 Application on NSWS Portal
The process for importing Reference Listed Drugs (RLD) or Investigational Medicinal Products (IMP) for bioavailability (BA) and bioequivalence (BE) studies intended for export has recently undergone important procedural updates. This article provides a comprehensive guide to the BE-NOC Prior Intimation procedure and the steps for submitting a CT-16 application via the National Single Window System (NSWS) Portal, as per the latest regulatory notice from the Central Drugs Standard Control Organization (CDSCO).
Background
Stakeholders have reported challenges due to the lack of system linkage between the Prior Intimation (PI) application (Form CT-05) and the CT-16 application on the Sugam Portal. To address these operational difficulties, the CDSCO has issued interim guidelines for applicants until further notice, following the notification GSR 50(E) dated 21.04.2026.
Who Needs to Follow This Procedure?
Any applicant intending to import RLD or IMP for conducting BA/BE studies for export purposes under Chapter V of the New Drugs and Clinical Trials (NDCT) Rules, 2019, must adhere to this process.
Step-by-Step Procedure for Submission
Applicants must submit a standalone Form CT-16 application through the NSWS portal. The following documents are required to complete the application:
- Covering Letter
- Clearly explain the purpose of the import.
- Reference the details of the Prior Intimation application.
- Copy of Acknowledged Prior Intimation (Form CT-05)
- This should be generated through the Sugam Portal and serve as proof of prior notification.
- Details of the Proposed RLD/IMP
- Provide comprehensive information about the drug or product to be imported.
- Protocol/Synopsis/Reference Details
- Attach the study protocol, synopsis, or any relevant reference documents, as applicable.
- Challan of Requisite Fee
- Pay the prescribed fee as per Schedule VI of the NDCT Rules, 2019, via the Bharat-Kosh portal.
- Attach the payment challan as proof.
- Other Supporting Documents
- Include any additional documents required by the NSWS Checkpoint list, as specified by the relevant CDSCO Zonal or Sub-Zonal Office.
Key Points to Remember
- The CT-16 application must be submitted as a standalone process on the NSWS portal, independent of the Sugam Portal linkage.
- Ensure all documents are complete and accurate to avoid delays in processing.
- This procedure is interim and will remain in effect until further orders from the CDSCO.
Conclusion
By following the above steps and preparing the required documentation, applicants can efficiently navigate the BE-NOC Prior Intimation process for importing RLD/IMP for export-based BA/BE studies. Staying updated with regulatory notifications and adhering to the prescribed process will help ensure compliance and smooth application processing.
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Source: CDSCO
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