Ending the confusion and apprehensions among the pharmaceutical exporters for some time now, the Director General of Foreign Trade (DGFT) has issued formal notification to defer the date of effect for implementation of barcoding on export consignment of pharmaceuticals and drugs for tracing and tracking purpose.

Instead of July 1, 2011, the system now will be enforced in phased manner from October 1. The trace and track technology will be made compulsory for tertiary level packaging with effect from October 1, 2011 and that on secondary level packaging will be from only January 1, 2012. Likewise, the technology will be made mandatory on primary level packaging only from July 1, 2012, according to a notification by the DGFT.

The exporters have been planning to suspend the exports of pharma products from July 1 as no formal announcement was made till yesterday, despite assurances and feelers from the Commerce Ministry on deferring the deadline in view of the hardships by the pharma companies, especially the small and medium scale players due to the high costs in installing the required facilities.

“In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, Director General of Foreign Trade hereby amends Public Notice No. 21 dated 10th January, 2011 and prescribes the following procedure for tracing and tracking of export consignments of pharmaceutical products,” according to the notification.

“Exporters of pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technology as per GS1 global standards. Incorporate 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.  Incorporate barcodes (1D or 2 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the secondary pack and tertiary level packaging,” as per the notification.

“In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the stipulations at serial number a, b & c of para 2 above. Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.  Authentication features will be added in due course and integrated with the trace and track system. Government will set up a Central Portal for tracing and tracking exported pharmaceutical products,” said the notification, adding that the amended notification will come into effect from July 1.