‘DRAP’s mandatory barcode requirement for medicines a regulatory oversight’

LAHORE: Pharmaceutical industry experts expressed surprise at the Drug Regulatory Authority of Pakistan (DRAP) for announcing regulatory oversights in haste on matters that are not implemented even in the United State.
Pakistan Pharmaceutical Manufacturers Association (PPMA) former chairman Amjad Ali Jawa said DRAP has made it mandatory for all pharmaceutical manufacturers to print bar code on each product and link it with DRAP software.
He said DRAP has instructed the pharmaceutical companies to comply with this condition by December 14, 2017. This software would enable the regulator to identify each manufacturer and help in pinpointing manufacturers that produced inferior quality products.
“Use of modern technology for quality is an excellent idea. We are at a loss to understand the logic behind DRAP’s mandatory bar-coding requirement for medicines by December 14, 2017, which can facilitate spurious drug markers to copy it, and print it on their spurious drugs,” Jawa added.
Appreciating the intentions of the regulator as noble, the PPMA former chairman said the mechanism being suggested by DRAP was flawed.
“The concept needs more probe before it is launched,” he said, and added that the same condition of linking each bar code of a medicine to FDA software was also announced in the United States.
“But the US regulator postponed its implementation by one year after it found that the software needs some fine-tuning before the rule is imposed,” he said, and added that Pakistan’s bar coding law also needs some rethinking.
PPMA former chairman said that besides some technical issues, there were also financial problems for small manufactures, who were not bar-coding their drugs. “It is impossible for most of them to buy the expensive equipment required in such short time,” he said.
Larger manufacturers were using bar coding technique, but they faced technical issues in

compliance. The major flaw in the system was that the bar code could be copied and used by some other unscrupulous manufacturer, Amjad Ali Jawa pointed out.
This, he explained meant that any flawed product under the same barcode would be attributed to the original company. He urged DRAP to find a solution to this problem before going ahead with its bar-coding idea.
The PPMA former official also said DRAP had not issued details and technical specifications of barcode equipments (cameras, printers, and software) compatible with DRAP tools.
“Implementation of this law requires investments and major modifications to packaging lines, including installation of equipment (printers, cameras, scanners, reject equipment, site databases); training to handle the equipment properly and safely,” he added.
Even the HVAC systems might require modification at the production facilities. Many companies might not be able to arrange required investment within the short implementation period notified by the DRAP.
Foreign experts consulted by the pharmaceutical industry believe that even selection of the wrong type of printer/ink would be detrimental to the production environment. As printing on packaging would pollute the air with ink particles. Production of medicines takes place in a highly controlled environment to maintain proper quality and to avoid any contaminants in the products.
Certain problems would arise when tracing mechanism is established by DRAP, which has not yet been developed even for batch/lot tracing. If equipment bought by pharmaceutical industry is not compatible with DRAP trace and track equipment; for instance, cameras and scanners required for reading the barcodes; it would essentially lead to loss for not only pharmaceutical companies but also delay the implementation of serialisation.
Experts pointed out that GS1 Healthcare vice president visited Pakistan and informed DRAP that Product Identification Information (AI-240) data should be maintained in the master database instead of being in the 2D data matrix barcodes.
“There is no need for Product Identification Information (AI-240) to be printed on packaging as it can be retrieved from DRAP Master Database through scanning of barcode,” she said.