In the existing process, applications for Written Confirmation (WC) for Active Pharmaceutical Ingredients exported to the European Union were processed through CDSCO via the SUGAM portal with multiple levels of review. These applications are required to comply with Article 46(2)(b) of Directive 2001/83/EC for exports to the EU. The procedure involved both zonal/sub-zonal offices and CDSCO Headquarters, leading to longer processing timelines. To streamline and ensure time-bound disposal, the procedure has now been simplified by reducing duplication in the review process.

1. Upon receipt of applications on the SUGAM portal, the Zonal/Sub-zonal offices of CDSCO shall verify the appropriateness of documents submitted by the applicant and upload the Inspection Report (IR), Compliance Verification Report (CVR), and recommendation letter, and forward the application to Headquarters within three (03) weeks of receipt.
2. The International Cell, CDSCO Headquarters shall review the adequacy of documents and dispose of the application within three (03) weeks of receipt, and queries shall be issued by Headquarters based on inputs from Zonal/Sub-zonal offices.
3. The revised procedure eliminates the double layer of review to simplify the process and ensure faster processing timelines.