India’s Directorate General of Foreign Trade (DGFT) has instructed manufacturers to print the track and trace system export of pharmaceuticals and drug consignments on secondary level packaging including mono cartons.
As per a notification by the Union commerce ministry, DGFT has included para 2.89 A in Handbook of Procedure, 2015-2020 according to which producers will now have to print the barcode as per GS1 Global Standard at different levels of packaging from 1 April 2015, to enable tracing and tracking of products, reports Pharmabiz.com.
The rules released by the ministry will be applicable for drugs that have been manufactured after 1 April, 2015.
At the primary level, manufacturers will need to print two dimensional (2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) including batch number, expiry date and a unique serial number of the primary pack.
While these details will be needed to be printed in human readable form, the notification said that bar code labelling at this level had been exempted until further notification.
The ministry has made it mandatory to print one or two dimensional (1D or 2D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN with batch number, expiry date and a unique serial number of the secondary pack on the secondary level.
On the tertiary level, the packaging will need to include one dimensional (1D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along that would include batch number, expiry date and a unique serial number [Serial Shipping Container Code (SSCC)] of the tertiary pack.
Companies will also need to upload the data on the central portal of the Government of India before release of the drugs for sale or distribution.
The notification informed that the requirement of data uploading on central portal will be exempted till 30 June, 2015. Starting July, all products manufactured on or after 1 April, 2015 will only be allowed to be exported only if barcoding is carried on both the secondary and tertiary packaging and the necessary data is uploaded on the portal.
