DGFT's track and trace initiative has spurred solution providers to come up with innovative labelling options to cope with regulatory requirements
It is now more than five years after the Directorate General of Foreign Trade’s (DGFT) January 2011 announcement that all drugs and pharmaceutical products exported from India would need to incorporate track and trace systems. The roll out of the initial two phases, at the tertiary and secondary packaging levels did have its glitches but most companies are more or less in line with the mandate.
However, manufacturers realised that 2D barcoding in the third phase, at the primary packaging line, presents a different level of challenge. The primary packaging line consists of containers like bottles, vials, ampoules and blisters, which are in direct contact with the drug, unlike the boxes and cartons at the previous two levels. The information to be printed on the labels on individual products, be they bottles, vials, ampoules, or blister strips, has to be readable but expiry dates, batch numbers, unique serial numbers, etc could lose their readability on certain products like medicine strips, vials, single therapy kits etc.
As Siddhant Bhambhani, Product Management, ACG Inspection Systems explains, each primary packaging product type (bottles, vials, ampoules, blisters) presents unique labelling challenges. “The first product type, bottles are the easiest as “thermal transfer printers can be installed on the labelling lines for printing, and coordinated with labellers for product rejection. The challenge is to aggregate them with secondary serial numbers, as the 2D code is present on the circumference of the bottle. Advanced camera systems are already available in the market to pick the 2D code by scanning the bottle 360 degrees,” he says.
この記事は Express Pharma の July 16-31, 2016 版に掲載されています。
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