Foreign Trade Directorate streamlines export regulations in alignment with Health Ministry regulatory framework

Foreign Trade Directorate streamlines export regulations in alignment with Health Ministry regulatory framework

The Directorate General of Foreign Trade (DGFT) has decided to streamline export regulations by aligning with the evolving regulatory framework of the Union Health Ministry.

In a release issued by the Union government, it noted that 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related to the ‘Track and Trace System’ for pharmaceutical exports under the Foreign Trade Policy (FTP) are being withdrawn.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 was introduced via public notice dated January 10, 2011, and mandated barcoding at various packaging levels.

While tertiary and secondary packaging requirements were successfully implemented in 2011 and 2013, primary-level barcoding faced operational challenges and were repeatedly deferred, with the last extension valid until February 1, 2025.

Explaining the move, the release noted that the decision to withdraw these provisions is based on the fact that the Health Ministry has already implemented barcode/QR code requirements for 300 drug brands under the Drugs Rules, 1945, effective August 1, 2023, with plans for further expansion. Also, most export destinations have their own serialisation requirements, ensuring product traceability without additional domestic regulations.

The Health Ministry, as the primary regulatory authority, provides a unified framework through the Central Drugs Standard Control Organisation (CDSCO), ensuring consistency and eliminating duplication. “With this step, DGFT is enhancing ease of doing business for pharmaceutical exporters while ensuring regulatory coherence,” notes the release.