India sets back barcoding deadline for pharma exports

India has deferred the start date for barcoding the primary packaging of exported pharmaceutical products by 12 months to July 1, 2014.

The Director General of Foreign Trade announced the delay on the primary packaging requirements on April 5.

The intention is to incorporate 2D GS1-compliant datamatrix barcodes on the strip/vial/bottle level that will include a unique product identification code (GTIN), batch number, expiry date and serial number.

The deferment is designed to give Indian drugmakers more time to comply with the requirements for primary packaging, which is by far the most challenging aspect of the track-and-trace elements of the new regulation (which was first published in 2011).

Requirements for barcodes on the secondary packaging of exports - with either a 1D or 2D code encoding unique product identification code (GTIN), batch number, expiry and serial number - came into effect in India on January 1, despite pleas for an extension from pharma export companies.