The Central Drugs Standard Control Organization (CDSCO) has launched a new online Dual Use System on its SUGAM Portal. This initiative is a significant step towards enhancing the “ease of doing business” by streamlining the process of issuing No Objection Certificates (NOCs) for drugs imported in bulk for non-medicinal use.
To further reduce the compliance burden on the industry, CDSCO has introduced the provision for issuing a 1-year NOC, subject to prescribed conditions. The new system is set to go live from August 31, 2025, with the registration process for new users commencing on August 5, 2025. From September 1, 2025, only users who are registered and approved by CDSCO as Dual Use NOC Traders or Actual Manufacturers will be able to apply for NOCs on the new portal.
The new online procedure for obtaining a Dual Use NOC involves a two-step process:
Step 1: Registration and NOC Application at the Zonal/Sub Zonal Office
This is a one-time registration process where applicants must first register on the SUGAM Portal by selecting the “Dual Use NoC” user role and filling out the Integrated Registration Form (IRF). The IRF, along with a prescribed checklist of documents, is then reviewed by CDSCO Headquarters and the concerned Zonal/Sub Zonal office. The NOC, with a validity of one year, may be issued within 7 working days (5 days for the Zonal office and 2 days for the port office) from the date of application.
Documents required for registration include:
- Address Proof: A copy of a government-issued document like a Certificate of Incorporation, GST Certificate, or IEC Certificate.
- Undertaking Form: A scanned copy of the duly filled, stamped, and signed undertaking.
- ID Proof of Authorized Person: A valid ID proof as specified in the undertaking form.
Step 2: Consignment Release at the Port Office
After successfully obtaining the NOC in Step 1, the applicant must submit a separate application on the portal for the release of each consignment at the relevant port office. This step requires the submission of documents such as a valid Export NOC, Certificate of Analysis (CoA), bill of entry details, and a copy of the invoice. The process also includes a supply chain module where applicants must provide details of each imported consignment, which will be verified by the concerned port office.
This new system, which also includes a guidance document and user manual, is a key move by CDSCO to provide clarity and consistency in regulating drugs imported for non-medicinal use while reducing procedural delays for the industry.