A proposal to barcode drugs to check counterfeits medicine is in limbo for a year now with the small domestic drug manufacturers up in arms against the move claiming that it would shoot up their production cost.
As per the draft note issued by the Union Health Minister last year, all the domestic drug manufacturers have to ensure that medicine strips have a 2D/3D barcode on the packaging labels which can be tracked and traced by a central portal system. This technique is intended to ensure genuineness of the medicines reaching the retail outlets.
However, small and medium enterprises in the sector are opposing the move tooth and nail claiming that it would increase their production cost and hence margins. They pointed out that they will have to incur additional cost of 6 paise per strip to print the unique identity number on all its drug packages along with setting up of separate software systems at each production line.
The barcodes are expected to include a unique product identifier, batch number, expiry date and serial number. Under the track and trace system meant to identify counterfeits, manufacturers would be required to maintain serialised records of the sold drugs.
Bar-coding of medicine strips has been introduced by the Commerce Ministry in 2012 when all the export packages (tertiary boxes) were bar-coded for tracking the supply chain and curbing export of spurious and low quality drugs from India.
Next year, it initiated bar-coding on secondary packaging and even the mono-cartons were mandated to be bar-coded. Sources say 80 per cent of the companies failed to comply with the rules and the bar-code was also very cumbersome and incomprehensible.
In April 2014, the Commerce Ministry finally relaxed the rule and made mono-carton bar-coding optional.