DGFT extends dates for track and trace system for export of drug formulations

The extended dates are April 1, 2016 and April 1, 2017 for non-SSI manufacturers and SSI manufacturers, respectively

Directorate General of Foreign Trade (DGFT) has extended the dates for implementation of track and trace system for export of drug formulations and maintenance of the parent-child relationship in packaging. The revised deadlines are April 1, 2016 for non-SSI manufactured drugs and April 1, 2017 for SSI manufactured drugs.

As per the new notice, small-scale pharma manufacturers get an additional year as compared to non-SSI manufacturers to comply with data maintenance and uploading of data requirements. The manufacturers failing to comply may face ban/prevention on export of their drug consignment, unless DGFT grants another exemption.

As per DGFT’s earlier notice issued dated May 22, 2015, notification and uploading of track and trace data into a central portal was exempt for drugs manufactured prior to October 1, 2015. The same deadline was given for maintenance of parent-child relationship between primary and secondary packaging. The notice had also announced that they will be issuing separate guidelines on maintenance and uploading in a central portal of the parent-child relationship of packaging (e.g., primary, secondary, and tertiary) of each drug designated for export.

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