A barcode helps in tracking and tracing of origin of drugs, which in turn helps in minimizing the chances of genuine drugs being considered spurious, substandard or counterfeit. India exports over $ 10 billion worth of drugs annually. Indian government is hoping to raise the figure more in next coming years. Industry experts say the only way Indian pharma firms can tap the market is by ensuring quality and barcoding will help ensure that.

In order to reach the objective, the GOI in 2011 prescribed a proper and systematic procedure for tracing and tracking of export consignments of primary level packaging of pharmaceutical products and published vide a gazette notification that every exporter of such pharmaceutical products will have to follow a trace and track system and incorporate certain features/particulars using barcode technology as per GS 1 global standards as follows:-

  • 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.

Earlier the requirement of affixing barcodes on Primary Level packaging was to take effect from 01.07.2013 vide the same notification. However, now this date has been deferred to 01.07.2014 vide vide Notification Notice No. 54(RE-2012)/2009-2014 in the Gazette of India, Ministry of Commerce and Industry (Department of Commerce) dated 05th April, 2013