The Directorate General of Foreign Trade has agreed to one more plea from drugmakers for extra 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 stated in a notification just lately extending the deadline by yet another 12 months.
Conceived as a mechanism to rein within the counterfeit menace and deal with the challenges related to product recall, the system has been within the offing for not less than 9 years with DGFT in August, within the earlier extension notification, setting a February 1, 2024 deadline.
The newest extension comes on the heels of a illustration 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 observe and trace and requested for extension of timelines. Pharmexcil Director General Ravi Uday Bhaskar instructed The Hindu the request for extra time was made within the gentle of points with the software program throughout a pilot mission for importing secondary and tertiary packing information. The glitches have additionally been taken to the discover of C-DAC, the software program developer, he stated.
Towards facilitating the roll out, the federal government has a scheme underneath which it offers ₹25 lakh grant, for the barcode equipment, to SSI items. The delay in implementation continues whilst drug regulators in a number of international locations resembling Uzbekistan and Nigeria both have mandated measures or are proposing norms on the traces of the Track and Trace system for these from whom they import.