FTP - Export - pharmaceuticals – Bar-coding – Not from Today
EXPORTERS of pharmaceutical products were required to adopt a trace and track system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards as detailed below:
a. Primary Level packaging requirement: Incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and Unique Serial Number of the Primary pack.
b. Secondary Level packaging requirement: Incorporation of barcodes (1D or 2D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Secondary pack.
c. Tertiary Level packaging requirement: Incorporation of barcodes (1D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton).
This was to come into effect from today – 01.07.2011. Now it is extended to 01.07.2012, 01.01.2012 and 01.10.2011, for (a), (b) and (c) respectively.
In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the stipulations at serial number a, b & c above.
Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.
DGFT Public Notice No. 59/2009-2014 (RE-2010), Dated: June 30, 2011