With the industry still opposed to the idea of implementing barcode in the proposed format for pharmaceutical exports from July 1, the Commerce Ministry is likely to relax the norms and implement it in a phased manner, depending on the suggestions from the industry gathered by March 31.
Though the Commerce Ministry wants to go ahead with the proposed 2D barcoding and unique 'randomly generic numeric code' packaging, it may push back the deadline as the industry wants to get it postponed till next April 1. However, indications are that the ministry may give some more time to the pharma exporters, may be till January next year.
Another suggestion under 'active consideration' is limiting the barcode system only to tertiary packaging, instead of the current proposal for making it mandatory on primary, secondary, and tertiary packaging, sources said. Thus, it will be introduced in a phased manner. This will be another big relief for the industry, especially the small scale and medium scale units which, otherwise, would be incurring huge additional and unviable expenses.
The ministry, which has already issued notification for implementing the system, has put March 31 as the deadline to receive objections and suggestions from the industry in this regard. The ministry is expected to come out with the clarification on relaxing the norms or extending the deadline after going through the suggestions from the stakeholders.
A delegation of the Pharmexcil met Rajeev Kher, additional secretary in Department of Commerce, recently to convey the apprehensions of the industry and strongly pitched for some respite in the norms, it is learnt. The Additional Secretary also met the representatives of some leading companies in this regard.
The recent official notification by the DGFT has put the date of implementation 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.