Pharma industry calls 6-month time to print barcodes too short
Points out countries across the globe have set five-year deadlines
PHOTO: REUTERS
LAHORE:
The pharmaceutical industry has commended the Drug Regulatory Authority of Pakistan (Drap) for implementing the ‘barcoding and serialisation’ system to help check sale of counterfeit and spurious drugs.
However, it has serious reservations about 'impractical' timelines, which will affect both the industry and patients.
According to the industry, companies across the globe have adopted barcoding after being given a clear roadmap based on an average of five years to implement it whereas Drap’s deadlines to print barcodes on secondary packaging in six months is not viable.
Even developed countries, such as the US, have set deadlines of five years for barcoding and serialisation on the secondary packaging.
Health department seals 14 pharmacies in Hyderabad
Pharmaceutical companies have been consulting industry officials including foreign experts in this regard. Industry experts believe this project requires huge investments and major modifications to the packaging lines, which include installation of equipment, training of staff to handle the equipment properly and likely modification of HVAC systems of production facilities.
Commenting on the issue, a spokesperson for the Pharma Bureau said Drap must realise that the issue needed to be dealt with holistically.
“Drap should issue detailed implementation guidelines after discussion with all stakeholders. Countries such as Turkey successfully implemented the trace and track system for every pack in 2012 after issuing detailed implementation guidelines,” the official said.
By following Turkey’s model, the implementation of the plan would be streamlined and success of the government’s vision would be ensured, he added.
“Multinational companies have strict procurement procedures and they require at least a year to implement the printing of barcodes on secondary packaging since detailed plans are made that have to be approved,” the spokesperson emphasised.
Fighting counterfeits: DRAP launches barcodes for drugs
Certain problems are expected to arise when a tracing mechanism is established by Drap, which has not yet been developed.
Imported products require eight months for implementation of the system after packaging change is requested. A few foreign vendors have refused to print 2D data matrix barcodes on the packaging with the product identification information.
Also, according to the SRO 470, local printing of imported products will require prior approval from the Drug Registration Board. It would also make it impossible to meet Drap deadlines, industry officials lamented.
If the deadlines were not extended, the pharmaceutical industry may suffer. It would also affect availability of drugs in the market, they say.
Published in The Express Tribune, November 18th, 2017.
The pharmaceutical industry has commended the Drug Regulatory Authority of Pakistan (Drap) for implementing the ‘barcoding and serialisation’ system to help check sale of counterfeit and spurious drugs.
However, it has serious reservations about 'impractical' timelines, which will affect both the industry and patients.
According to the industry, companies across the globe have adopted barcoding after being given a clear roadmap based on an average of five years to implement it whereas Drap’s deadlines to print barcodes on secondary packaging in six months is not viable.
Even developed countries, such as the US, have set deadlines of five years for barcoding and serialisation on the secondary packaging.
Health department seals 14 pharmacies in Hyderabad
Pharmaceutical companies have been consulting industry officials including foreign experts in this regard. Industry experts believe this project requires huge investments and major modifications to the packaging lines, which include installation of equipment, training of staff to handle the equipment properly and likely modification of HVAC systems of production facilities.
Commenting on the issue, a spokesperson for the Pharma Bureau said Drap must realise that the issue needed to be dealt with holistically.
“Drap should issue detailed implementation guidelines after discussion with all stakeholders. Countries such as Turkey successfully implemented the trace and track system for every pack in 2012 after issuing detailed implementation guidelines,” the official said.
By following Turkey’s model, the implementation of the plan would be streamlined and success of the government’s vision would be ensured, he added.
“Multinational companies have strict procurement procedures and they require at least a year to implement the printing of barcodes on secondary packaging since detailed plans are made that have to be approved,” the spokesperson emphasised.
Fighting counterfeits: DRAP launches barcodes for drugs
Certain problems are expected to arise when a tracing mechanism is established by Drap, which has not yet been developed.
Imported products require eight months for implementation of the system after packaging change is requested. A few foreign vendors have refused to print 2D data matrix barcodes on the packaging with the product identification information.
Also, according to the SRO 470, local printing of imported products will require prior approval from the Drug Registration Board. It would also make it impossible to meet Drap deadlines, industry officials lamented.
If the deadlines were not extended, the pharmaceutical industry may suffer. It would also affect availability of drugs in the market, they say.
Published in The Express Tribune, November 18th, 2017.