Usha Sharma – Mumbai
Inspite of an appeal from industry associations, the Ministry of Commerce and Industry, Government of India has indicated that it will not postpone the January 1, 2013 deadline for 2D barcoding at primary and secondary packaging levels for pharmaceutical products meant for export consignments.
This is in line with a Directorate General of Foreign Trade (DGFT) notification on implementation of barcoding on export consignments of pharmaceuticals meant to facilitate track and trace of these consignments in order to reduce/prevent counterfeit medicines entering the pharma supply chain. Barcoding at the secondary level of packaging was initially scheduled to be implemented from January 2012, was postponed to September 2012, was further delayed by a stay order from a High Court in Chennai at the request of industry groups echo pleaded for more time for their member companies to implement the notification. January 2013 was then set as the deadline for barcoding at both primary and secondary packaging levels.
However, despite a delay of almost a year, industry associations have asked for more time. In presentations made to the Ministry in early December, the Indian Drug Manufacturers Association (IDMA) and Pharmaceuticals Export Promotion Council of India (Pharmexcil) had said that small-scale players were having issues arranging capital to install such machines as well as the costs of running them.
However the Ministry officials have remained firm on their stand to implement the 2D technology from January 2013.
Justifying the need for a further extension of the deadline, Dr PV Appaji, Director General, Pharmexcil said, “In our recent presentation to the Ministry of Commerce, Pharmexcil and IDMA have highlighted the issue that small scale as well as larger players need to set aside a heavy budget for these expenses. Also, getting familiar with and understanding the technology will require some more time.”
Commenting on the issues raised at the meeting with Pharmexcil and IDMA, Rajeev Kher, Additional Secretary, Ministry of Commerce and Industry, shared that feedback from industry associations and stakeholders had been incorporated into a primary research report prepared by Wipro on the implementation of 2D barcoding technology for pharma exports. Wipro, which has technology tools which support global supply chain initiatives, was commissioned by the Ministry of Health & Family Welfare to study the domestic pharma supply chain, various technologies available for track & trace, printing techniques and feasibility of track and trace solution in Indian supply chain environment.
Kher urged Pharmexcil to organise a meeting with the industry stakeholders including Wipro and GS1 to further sort out these issues.
He also said that India is lagging other countries who have already implemented these technologies for pharma exports and the Government would not like to delay it further. The authorities also feel that the technology is not as expensive nor as difficult as it is being perceived. He pointed out that there are many small companies ready to provide the required 2D barcoding solutions at reasonable rates.
Commenting on this, Manish Doshi, President, IDMA said, “As of now, no firm decision has been taken. The ministry is firm on its decision and has asked us to conduct a meeting with our members and discuss issues related to the costs involved and technology understanding with Wipro and GS1. We are going to have a meeting in Mumbai on December 24 to discuss this issue.”
2D barcoding technology implementation involves huge investment which small players find unaffordable. To make this complex issue easier, the Ministry of Commerce has set up plans for them as well.
BR Sikri, Director, President, All India Pharma Intending Agents Association (AIPIAA) said, “Though the issue is still under discussion, the Government has made a provision to give 50 per cent subsidy to small scale manufacturers for implementing 2D barcoding technology at the secondary packaging level.”
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