LAHORE: The rising threat of counterfeit products has become a serious issue for consumers and producers. The proliferation of fake products not only hurts the consumers and genuine producers of goods, it also adversely affects numerous industries which struggle with the task of separating authentic products from their counterfeit counterparts.
Despite the Pakistan Drug Regulatory Authority carrying out constant raids to curtail the notorious fake drug trade, as many as 40% of medicines in the market are counterfeit.
The Pakistan pharmaceutical industry has thus applauded the Drug Regulatory Authority of Pakistan for the implementation of the “Barcoding and Serialisation” System. The system has been introduced into the industry to check the sale of counterfeit and imitation drugs and medication.
However, reservations have been mounting regarding the so-called impractical and unrealistic timelines afforded to the pharma industry, which are expected to affect the industry as well as the patients that rely on it.
DRAP has provided the pharmaceutical industry with a time period of 6 months to ensure the printing of barcodes on all drugs and medical products. Industry professionals argue that pharmaceutical companies worldwide adopt barcoding whilst following a straightforward road map which is typically scaled out on a period of five years in order to be completely implemented, compared to which the time period of six months has been termed unviable and unachievable.
According to the industry, even developed nations such as the United States establish an average deadline of five years to implement mass barcoding and serialisation on the secondary packaging of products.
In this regard, pharmaceutical enterprises in Pakistan have sought the consultation and input of industry officials as well as foreign experts. According to pharmaceutical industry authorities, this ambitious project necessitates substantially large investments and significant modifications to the packaging lines. The overhaul must encompass equipment installation, professional staff training for proper equipment handling, management and maintenance, and the likely modification of HVAC systems of production facilities.
“In order to deal with this project in a holistic manner, it is necessary for DRAP to issue detailed implementation guidelines following consultations and discussions with all involved stakeholders,” said a spokesperson for the Pharma Bureau in regards to the matter. “In countries like Turkey, such trace and track systems for packaged products are generally executed successfully only by following comprehensive implementation guidelines.”
It was generally advised by industry experts that DRAP follow Turkey’s 2012 trace and track system model in order to streamline the successful implementation of the government’s vision for an industry free of any counterfeit products.
“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.
It is expected that once this tracing mechanism is developed and implemented by DRAP, several technical and management problems will arise. Imported products necessitate a minimum period of eight months for systemic implementation once packaging change is requested. Further, there are a number of foreign vendors who refuse to print 2D data matrix barcodes on the packaging with the product identification information.
Moreover, the SRO 470 details that locally printing imported products’ packaging requires prior approval from the Drug Registration Board. Therefore, DRAP deadlines will be impossible to meet from yet another perspective.
The industry fears that if these stringently brief deadlines are not extended, implementing this Barcode and Serialisation System will result in the industry suffering rather than prospering. Industry experts also report that this unviable timeline may also result in lack of availability of authentic drugs in the market.