Barcoding & serialization: pharma industry hails Drap's move

The pharma industry has commended the Drug Regulatory Authority of Pakistan (DRAP) on implementation of 'barcoding and serialization' to eventually help contain the menace of counterfeit and spurious drugs, however, it has some serious issues with the impractical timelines which will affect both the industry and patients.
As per details, globally, countries have adopted barcoding after giving a clear roadmap based on an average five years to implement it whereas the DRAP's deadlines of printing barcodes on secondary packaging is not viable to implement in six months. A developed country such as USA has a deadline of five years for barcoding and serialization on secondary packaging.
Pharmaceutical companies have been tirelessly consulting industry experts including foreign experts in this regard. The industry experts believe that this project requires huge investments and major modifications to packaging lines that includes installation of equipment (printers, cameras, scanners, reject equipment, site databases) and training to staff to handle the equipment properly and safely.
Commenting on the issue, spokesperson of Pharma Bureau said that the DRAP must realize that the issue has to be dealt with holistically. "Detailed implementation guidelines should be issued by the DRAP after discussion with all stakeholders. Countries such as Turkey successfully implemented the trace and track system on every pack in 2012 after issuing a detailed implementation guideline," the spokesperson said, adding that following Turkey's example would streamline the implementation and ensure the success of government's vision.
The spokesperson said: "Multinational companies have strict procurement procedures and they require at least a year to implement this printing of barcodes on secondary packaging, since detailed plans are made that have to be approved."
He added that certain problems would arise when tracing mechanism is established by the DRAP which has not yet been developed even for batch/lot tracing. Imported products require eight months of implementation after packaging change is requested. Some foreign vendors have refused to print 2D datamatrix barcodes on packaging with product identification information. Also, as per the SRO (470), local printing of imported products will require prior approval from the Drug Registration Board. This will also make it impossible to meet DRAP deadlines, the industry sources said.
The government's effort to increase Pakistan's pharmaceutical exports will be affected, as the barcodes on secondary packaging after the deadline of December 14, 2017 will have manufacturing date and product identification information in the barcodes that is in addition to international practices, sources said. Market analysts fear that many countries might prohibit the sale of pharmaceutical products from Pakistan.