The Government has deferred till October the implementation of the usage of barcode technology for tracing and tracking purpose on export consignments of pharmaceuticals and drugs.
According to a notification by the Director-General of Foreign Trade, the implementation of the bar-coding system will begin in a phased manner from October 1 instead of the earlier slated timeline of July 1.
The system will be mandatorily applicable for tertiary level packaging with effect from October 1, 2011, while that on secondary level packaging will only be from January 1, 2012. The bar-coding will be compulsory for primary level packaging from July 1, 2012.
The pharma exporters, especially the small and medium firms, had been demanding that the deadline be deferred citing difficulties and the increase in costs regarding installation of the required facilities.
The DGFT notification said, “Exporters of pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technology as per GS1 global standards – Incorporate 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; Incorporate barcodes (1D or 2 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the secondary pack and tertiary level (shipper/carton) packaging.”
“Under the track and trace system, manufacturers would be required to maintain serialised record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product. Authentication features will be added in due course and integrated with the trace and track system,” it said.
“The Government will set up a Central Portal for tracing and tracking exported pharmaceutical products,” the notification said.