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.
