Drug makers have urged the commerce ministry to delay the date of mandating track and trace technology on drug exports to July 2013 from July 2011, and implement it in a phased manner, failing which they warn the drug exports from the country would come to a standstill after the proposed deadline. Additionally, the drug makers have sought to ease the norms of mandatory labelling in a representation to the ministry.
While they have sought a complete exclusion of two dimensional bar coding on primary level packaging (it is the material that first envelops the product and is in direct contact with the contents such as ampoule, vial, bottle, cartridge,blisters), they have agreed to incorporate one-dimensional barcode on tertiary level packaging (used for bulk handling, warehouse storage and transport shipping such as cartons) starting July 2013. Further, drug makers have agreed to incorporate barcoding on secondary packaging (intermediate medical packing) starting July 2014.
The government in a public notification earlier this year said that, from July 1, 2011, all exported medicines from India would bear two dimensional barcoding in conformity with specific global standards. This, the ministry said would have to be done at a primary, secondary and tertiary level of pharma packaging. The government officials say that it is a step to build a clean reputation of Indian pharmaceuticals in the international market, to prempt the bad name a few stray incidents have brought to the Indian pharma industry without basis. The government expects the step to also clear up other illegal channels of trade, for instance spurious drugs found in Nigeria in 2009 which were labelled made in India but were finally traced back to China.
The industry argues that implementing such a step to avert bad reputation is an indirect admission of guilt of a crime they have not committed. Besides, ?it is physically impossible to put two dimensional barcoding on all primary packaging?, the representation said. ?Also the text matter on the label is approved by the importing country and to change it would require permission from individual countries? an Indian drug manufacturers association member told FE.
As the deadline for mandating track and trace technology draws closer, drug makers said that the uncertainty around the issue is very disturbing and have requested the commerce ministry to examine technical and cost implication of the proposal, specially because the importing countries are not insisting on such measures.
