DGFT : Provisions for the Track and Trace System for pharmaceutical exports have been removed under the Foreign Trade Policy.
The Directorate General of Foreign Trade (DGFT) has decided to simplify export regulations by aligning them with the evolving framework of the Ministry of Health & Family Welfare (MoH&FW). As part of this move, the provisions related to the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP) are being revoked.
The Track and Trace System, introduced in a Public Notice on 10th January 2011, required barcoding at various packaging levels. While barcoding for secondary and tertiary packaging was successfully implemented in 2011 and 2013, the requirements for primary-level barcoding and parent-child data uploading encountered operational difficulties and were repeatedly postponed, with the final extension valid until 1st February 2025.
The decision to withdraw these provisions is based on several key factors:
- MoH&FW has already introduced 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, which ensure product traceability without the need for additional domestic regulations.
- MoH&FW, as the primary regulatory authority, offers a unified framework through the Central Drugs Standard Control Organization (CDSCO), ensuring consistency and reducing redundancy.
This change will improve the ease of doing business for pharmaceutical exporters while ensuring regulatory consistency. As a result, the provisions under Para 2.76 of the Handbook of Procedures (HBP) 2023 have been withdrawn.