News

Indian Government requires track and trace on all pharma exports from July 2011

Published on 07 February 2011

From July 2011 all Indian pharma exports are required to carry barcodes on primary, secondary and tertiary packaging as a track and trace measure to address counterfeiting concerns.

The change to export regulations issued by The Directorate General of Foreign Trade (DGFT) states....

"Exporters of pharmaceutical products will be required to affix barcodes on their export products to facilitate tracing and tracking of their products. In order to enable exporters of pharmaceutical products for incorporation of this technology, adequate time is being given"

The deadline for compliance is 1st July 2011. After this exports must include barcodes with track and trace capabilities in line with GS1 global standards.

Primary packaging (vials and bottles) should include a 2D barcode, incorporating a unique product identification code, batch number, expiry date and serial number.

Secondary packaging requires either a 1D or 2D code containing the same information.

Tertiary packaging must use a 1D code, again with the same information contained within it.

The same regulation change also amended export documentation requirements to include a copy of the Certificate of Analysis issued either by the manufacturer, an approved laboratory in the importing country or an Indian Drugs Controller approved laboratory.

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