Industry to move court against introduction of bar coding for exports
With the union commerce ministry standing firm on its decision to make bar coding mandatory for all pharma exports from July 1 this year to check the export of spurious (fake) drugs from the country, the pharma industry is bracing up itself to move court against the introduction of bar coding in the country which, the industry said, is alarming as a section of the exporters may lose the entire export business in one stroke of the ministry.
Sources in the industry said that just on the lines of FDC and CoPP issues, some of the affected parties are preparing to move court. A detailed petition to contest the government's decision in this regard is in the drafting stage and the industry may move high court in two or three days time if the ministry does not make any amendments in its decision which the industry contests is a 'fake solution to a fake problem.'
Contesting the government's plea that the bar coding is being implemented in the country to check spurious (fake) drugs, the industry said that the bar code technology is not fool proof. It is possible for counterfeits to copy, create and use bar codes. If ATM cards can be duplicated, so can bar codes. Spurious drugs can also have bar codes, the industry leaders said.
Industry leaders say that the implementation of bar code as per GS1 global standards is cumbersome, time-consuming and costly. And what has raised concerns for the SMEs is the provision seeking the introduction of the bar code 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 up to Rs.40 lakhs.
Industry leaders also point out that if the item number 3 of the notification is implemented, it will have a far reaching effect in the exports and there will be lot of delay in manufacturing the products and to follow the procedures which is tedious and time consuming. The item number 3 of the ministry's notification mentions that the exporter of pharmaceutical products will build track and trace capability for their exported medicines using barcode technology as per GS1 global standards. The same will need to be done at primary, secondary and tertiary level packaging labels.