With concerns growing among the industry, especially the small scale and medium scale units, about the proposed implementation of barcodes for pharma exporting from July 1, the commerce ministry is planning to address their apprehensions in an open house session in Delhi, tentatively around March 7.
The ministry has finally decided to listen to the concerns of the industry players after the issue was taken up repeatedly by the leaders of the industry and also the Pharmexcil. The official intimation about the meeting is expected shortly and senior officials of the Ministry and the Director General of Foreign Trade (DGFT) are expected to take part in the session, sources said.
Meanwhile, the official notification by the DGFT has 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.
And what has raised grave concerns for the SMEs is this provision seeking the introduction of the barcode at three levels, instead of just the primary packages. Industry leaders pointed out that for small companies, who will not have huge quantum of export, the bar-coding will be a huge burden as the specified machines for the same can cost upto Rs.40 lakhs.
The industry sources also claimed that the commerce ministry had decided unilaterally on introducing this barcode whereas the general feedback given to the Pharmexcil, who collected the views of the industry, was for giving option to the units to go for hologram or barcode and they never expected that it would be introduced in three levels of packaging.
The Drugs Controller General of India (DCGI) had recommended the adoption of radio frequency identification (RFID) technology to trace and track the products in circulation. The DCGI has identified 96 products to come under the trace and track system.