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The Directorate General of Foreign Trade has agreed to yet another plea from drugmakers for more time to implement the Track and Trace system for export of drug formulations.
“The date for implementation of the Track and Trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on Central portal has been extended up to February 1, 2025 for both SSI and non-SSI manufactured drugs,” the DGFT said in a notification recently extending the deadline by one more year.
Conceived as a mechanism to rein in the counterfeit menace and address the challenges associated with product recall, the system has been in the offing for at least nine years with DGFT in August, in the previous extension notification, setting a February 1, 2024 deadline.
The latest extension comes on the heels of a representation from the Pharmaceuticals Export Promotion Council of India to the Commerce Department on the difficulties expressed by its member exporters with regard to implementation of track and trace and requested for extension of timelines. Pharmexcil Director General Ravi Uday Bhaskar told The Hindu the request for more time was made in the light of issues with the software during a pilot project for uploading secondary and tertiary packing data. The glitches have also been taken to the notice of C-DAC, the software developer, he said.
Towards facilitating the roll out, the government has a scheme under which it provides ₹25 lakh grant, for the barcode machinery, to SSI units. The delay in implementation continues even as drug regulators in several countries such as Uzbekistan and Nigeria either have mandated measures or are proposing norms on the lines of the Track and Trace system for those from whom they import.
