Following the apprehensions and resentment among the industry over the imposition of barcoding system for exports of pharmaceutical products from the country, the Commerce Ministry is all set to give more time to the exporters by enforcing the barcoding in a phased manner.
As per the new schedule finalised by the Ministry, the barcode will not be mandatory from July 1, 2011 as stipulated by the recent notification. As part of being implemented in a staggered manner, now the barcoding for tertiary packaging will be made compulsory only from October 1, 2011. The barcoding will be binding on secondary packaging only from January 1, 2012.
Giving exactly one year more year as preparation time for the industry, the system will be made mandatory for primary packaging only from July 1, 2012. A notification in this regard will be issued soon by the Director General of Foreign Trade, (DGFT) sources said.
The Ministry has decided to relax the proposed 2D barcoding and unique 'randomly generic numeric code' packaging after consultations with the stakeholders. The industry leaders and the Pharmexcil have been pressing on the Ministry to put off the deadline to give more time to the manufacturers. The industry asked the ministry to push the deadline till January next.
The ministry is also going to relax some norms to ease the difficulties of the exporters. In case any country is already having a barcoding system, that system will supersede the Indian system. Another relaxation may be in the usage of machines as the ministry is likely to allow manual coding in some ways, it is learnt.
The recent official notification by the DGFT had put the date of implementation categorically on July 1. “Exporter of pharmaceutical products will build track and trace capability for their exported medicines using barcode technology as per GS 1 global standards. The same will need to be done at primary, secondary and tertiary level packaging labels,” the notification said.
“Incorporation of 2D (GS 1 Data matrix) barcode on medicines at strip/vial/bottle level encoding unique product identification code (GTIN), batch number, expiry date and serial number of the primary pack. Incorporation of barcodes (1D or 2 D) encoding unique product identification code, batch number, expiry date and serial number of the secondary pack. Incorporation of barcode (1D) encoding unique GTIN, batch number, expiry date and serial number of the tertiary pack (shipper/carton),” according to the notification.