The track and trace system for export of pharmaceuticals and drug consignments on secondary level packaging including mono cartons has come into effect in the country from April 1, 2015.
In a notification issued by the Union commerce ministry, the Directorate General of Foreign Trade (DGFT) has said that the ministry has inserted Para 2.89 A in Handbook of Procedure, 2015-2020, under which the manufacturer of drug for formulations will print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products.
As per the notification, on the primary level packaging, the ministry has mandated incorporation of two dimensional (2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack.
The bar code labelling at primary level is exempted till further notification, however the above mentioned details are required to be printed in human readable form.
On secondary level packaging, the ministry has mandated incorporation of one or two dimensional (1D or 2D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with batch number, expiry date and a unique serial number of the secondary pack.
On tertiary level, the ministry has mandated incorporation of one dimensional (1D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with batch number, expiry date and a unique serial number [Serial Shipping Container Code (SSCC)] of the tertiary pack.
The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. primary, secondary and tertiary and their movement in its supply chain. The data mentioned above, shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution. The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer, the notification said.
The above rules will not be applicable to those drug formulation manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the barcodes in their format with the permission of licensing authority appointed under Rule 21.
However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country’s requirement, if any.
The exports of the drugs having manufacturing date prior to 01.04.2015 will be exempted for requirement of barcode labelling and data uploading on central portal. The drugs with manufacturing date on or after 01.04.2015 will compulsorily carry barcode on tertiary and secondary packages as per the Notification No. 68 dated 06.08.2014.
However the requirement of data uploading on central portal will be exempted till 30.06.2015. With effect from 01.07.2015, all drugs with manufacturing date on or after 01.04.2015 can be exported only if both the tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the central portal.
In the notification, the commerce ministry has explained that primary packaging means the package which is in direct physical contact with the drug, secondary packaging means the carton containing multiple primary packs including a mono carton and tertiary packaging means a shipper containing multiple secondary packs.