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DGFT Withdraws Export Track and Trace Rules

  • 04 Feb 2025

In January 2025, the Directorate General of Foreign Trade (DGFT) decided to withdraw provisions related to the Track and Trace System for pharmaceutical exports, aligning with the Health Ministry's evolving regulations.

  • The withdrawal of the Track and Trace System provisions aims to streamline export regulations in the pharmaceutical sector by aligning with the Union Health Ministry's guidelines.
  • The Track and Trace System, introduced in 2011, required barcoding at various packaging levels, with tertiary and secondary packaging successfully implemented in 2011 and 2013, respectively.
  • Despite efforts to implement primary-level barcoding, operational challenges led to repeated deferrals, with the latest extension valid until February 1, 2025.
  • The decision comes after the Health Ministry introduced barcode/QR code requirements for 300 drug brands under the Drugs Rules, 1945, which became effective on August 1, 2023, with plans for further expansion.
  • The move ensures that pharmaceutical exports remain compliant with international serialisation requirements, avoiding duplicative domestic regulations and enhancing ease of business.