Track and Trace System provisions for pharmaceutical exports under Foreign Trade Policy withdrawn

The Directorate General of Foreign Trade (DGFT) has decided to streamline export regulations by aligning with the evolving regulatory framework of the Ministry of Health & Family Welfare (MoH&FW). Accordingly, the provisions related to the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP) are being withdrawn.

The Track and Trace System, introduced via Public Notice dated 10th January 2011, mandated barcoding at various packaging levels. While tertiary and secondary packaging requirements were successfully implemented in 2011 and 2013, primary-level barcoding and parent-child data uploading faced operational challenges and were repeatedly deferred, with the last extension valid until 1st February 2025.

The decision to withdraw these provisions is based on the following key considerations:

• MoH&FW has already implemented barcode/QR code requirements for 300 drug brands under the Drugs Rules, 1945, effective 1st August 2023, with plans for further expansion.
• Most export destinations have their own serialization requirements, ensuring product traceability without additional domestic regulations.
• MoH&FW, as the primary regulatory authority, provides a unified framework through the Central Drugs Standard Control Organization (CDSCO), ensuring consistency and eliminating duplication.

With this step, DGFT is enhancing ease of doing business for pharmaceutical exporters while ensuring regulatory coherence. Accordingly, the provisions under Para 2.76 of the Handbook of Procedures (HBP) 2023 have been withdrawn.

Track and Trace requirement withdrawal aligns export serialization with national drug regulation, reducing duplication and easing exports. The Directorate General of Foreign Trade has withdrawn Track and Trace System provisions from the Foreign Trade Policy, rescinding Para 2.76 of the Handbook of Procedures 2023 and removing mandatory domestic primary-level barcoding and parent-child data upload obligations for pharmaceutical exports. The decision responds to operational challenges with primary-level serialization, the existence of national barcode/QR code requirements under the drug regulatory framework, and serialization requirements in export destinations, aiming to harmonize regulation and reduce duplication while maintaining export traceability.