Sub: Procedure for Implementation of the Track and Trace system for export of drug formulations 

The manufacturer or the exporter of drug formulations will have to print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products  i.e., (a)  Primary Level,  (b) Secondary Level and (c) Tertiary Level.

(a)     Primary Level: (Packing in which the product/drug ingredients are placed)

(2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack.

(b)   Secondary Level: (Secondary packaging containing one or more primary packs and includes a mono carton containing one primary pack.)

(c)   Tertiary Level: (The tertiary packaging means a shipper containing one or more secondary packs.)

(1D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the tertiary pack i.e. Serial Shipping Container Code (SSCC). 

With effect from 01.10.2015, all drugs manufactured (with dates) on or after 01.10.2015 can be exported only if both the tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the central portal.

For original DGFT Notice and other details, please click here.