With a view to bring in better clarity over the track and trace system for export of pharmaceuticals and drug consignments, the commerce ministry is planning to meet the stakeholders next week. It is understood that the ministry in consultation with Pharmaceuticals Export Promotion Council of India (Pharmexcil) is favorably inclined to listen to their issues while making best efforts to resolve their concerns.
The Directorate General of Foreign Trade (DGFT) through a notification recently, had issued the procedure for implementation of the track and trace system for exports of pharma and drug consignments. While the notification exempts requirement of barcode labeling and data uploading on central portal for exports of the drugs that were manufactured before April 1, 2015. It clearly states that from July 1, 2015, all drugs that were manufactured on or after April 1, 2015 can be exported only if both the tertiary and secondary packaging carries bar coding as applicable. It also insists that all the relevant data as prescribed by DGFT should be uploaded on the central portal.
While the main aim behind this move is to instill confidence among the consumers with access to information of the products they consume right from the inception stage to the delivery of the products. It also targets to address issues of fake counterfeiting charges, which will aptly boost the branding of the Indian drugs as well.
Even though the intention behind the track and trace system is for the greater good, that industry has been consistently raising their apprehensions over the huge cost associated with the whole procedure. While the cost factor is a major concern affecting both the small as well as big manufacturers, Pharmexcil informed that stakeholders were also worried about the clause relating to manufacturers requiring to maintain the data on the parent-child relationship for all three level of packaging i.e. primary, secondary and tertiary and their movement in its supply chain.
Similarly, for the primary level packaging, the ministry mandates 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. Dr P V Appaji director general of Pharmexcil informed that this clause is creating a lot of confusion within the industry, especially among the primary level packaging manufacturers, since they are exempted from barcoding.
“Keeping in view with the interest of the exporters, we have been persistently discussing these issues with the ministry, which has been very supportive and understanding so far in acknowledging their concerns. In fact, the ministry has assured that it will seriously consider reviewing the whole matter and that appropriate decision would be taken following the meeting that would be in the interest of all,” informed Dr Appaji.