The Central Drugs Standard Control Organization (CDSCO) on March 27, 2026, notified regarding the procedure for disposal of applications for "Written Confirmation" (WC) for Active Substances Exported to the EU for Human Use.
The following has been stated:
• The notification introduces a simplified and time-bound procedure for processing applications for Written Confirmation Certificates (WCC) for Active Pharmaceutical Ingredients (APIs) exported to the European Union.
• The revised process eliminates the earlier double-layer review and mandates that CDSCO zonal/sub-zonal offices must verify documents (Inspection Report, Compliance Verification Report, and recommendation letter) and forward applications to headquarters within three weeks, while the International Cell at HQ must also review and dispose of applications within an additional three weeks.
• The requirement for WCC arises from EU Directive 2001/83/EC, which mandates that APIs exported to the EU shall comply with Good Manufacturing Practices. The SOP defines the responsibilities of the Reviewing Officer (RO), Senior Reviewing Officer (SRO), Decision Authority (DA), and Licensing Authority (JDC(I)), and lays down a structured workflow including document verification, query handling, reassessment, and final approval or rejection.
• Once approved, the certificate is issued electronically and uploaded to the portal. Overall, the amendment aims to enhance efficiency, ensure accountability, and guarantee disposal of complete applications within a strict three-week timeline at the HQ level.
[Notification no. - I C-21011/41/2026-eoffice/34688]
