Directorate General of Foreign Trade (DGFT) has issued Public Notice No. 44/2024-25-DGFT on January 31, 2025, announcing the withdrawal of Para 2.76 from the Handbook of Procedures 2023. This paragraph previously outlined the procedure for the Track and Trace system for drug formulation exports. The withdrawal, effective immediately, means the responsibility for implementing the authentication system for drug exports now falls to the Ministry of Health and Family Welfare, in accordance with the provisions under the Drug Rules of 1945. This decision aligns the drug export process with the relevant health regulations, removing the previously planned system under the DGFT.
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Ministry of Commerce & Industry
DGFT streamlines export regulations in alignment with Ministry of Health & Family Welfare regulatory framework
Track and Trace System provisions for pharmaceutical exports under Foreign Trade Policy withdrawn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related to the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP) are being withdrawn.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.
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Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 44/2024-25-DGFT | Dated: 31st January, 2025
Subject: Withdrawal of Para 2.76 of Handbook of Procedure – 2023 regarding Track and Trace system for export of drug formulations -reg
S.0(E) : F. No. 01/91/180/648/AM-09/EC/E-21052- In exercise of the powers conferred under Paragraphs 1.03 and 2.04 of the Foreign Trade Policy 2023, as amended from time to time, the Director General of Foreign Trade hereby withdraws Para 2.76 of the I Iandbook of Procedures 2023 (previously Para 2.90A of HBP 2015-2020), which outlined the procedure for implementing the Track and Trace system for export consignments of drug formulations.
Effect of this Public Notice: Para 2.76 of the Handbook of Procedures 2023, concerning the Track and Trace system for the export of drug formulations, is hereby withdrawn with immediate effect. The implementation of the authentication system for drug formulations being exported shall be undertaken by Ministry of Health and Family Welfare in line with the provisions under Drug Rules 1945.
(Santosh Kumar Sarangi)
Director General of Foreign Trade &
Ex-officio Additional Secretary, Government of India
E-mail: dgft@nic.in
(Issued from F. No. 01/91/180/648/AM-09/EC/E-21052)
