The Director General of Foreign Trade of India has the powers under paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, to make necessary amendments in public notices.
One such public notice is the notice number 59(RE-2010)/2009-14 dated 30.06.2011 read with Public Notice No. 10 (RE-2010)/2009-2014 dated 11.07.2012 that prescribed the condition of bar coding of Primary level packaging for export consignment of pharmaceuticals and drugs for tracing and tracking purpose.
Indian bar coding requirements have come into force on 1st January 2013 after the government rejected appeals for another postponement. The legal effect of this notification is that the packaging of any finished drug products manufactured for export after January 1 2013 must feature a barcode.
The intention was 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.
According to the previous notice, the requirement of affixing barcodes on Primary Level packaging was to take effect from 01.07.2013. Now this date has been deferred to 01.07.2014.
The same has been done through an amending Public Notice No. 54 (RE-2012)/2009-2014, New Delhi, Dated the 5th April, 2013. This deferment would give Indian pharmaceutical manufacturers 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.