The Pakistan Chemists and Druggists Association has opposed the Drugs Regulatory Authority's proposed amendment in the drugs labelling and packaging rules for barcode labelling on medicines, saying that implementation of the rules is impossible in Pakistan.
According to the Association's spokesman, the regulators have reissued the previous draft of the barcode labelling rules without consulting the druggists and despite its opposition to the proposed rules in 2015. Since its objections and recommendations were not considered, the proposed rules on bar coding are unacceptable to the Association, he added.
He said that the majority of imported products are critically lifesaving and their packaging standards are acceptable the world over. Critically lifesaving products are extremely high in demand globally and importers in Pakistan are fighting for allocations every year.
There are no guarantees that the manufacturer, especially those in the European Union and the US, will comply with such changes, he said. According to him, Pakistani importers will be at the mercy of their principals, and the exporters will close down supplies to the local market altogether. He said that Pakistan's pharmaceuticals sector already faces many challenges and importers are importing only limited stocks of life-saving medicines, for which there is high global demand. He said that all required information is already printed on the packaging materials at the time of import. All such information is also submitted at the time of clearance of all shipments, therefore there is no need to ask for bar coding.
"We have mentioned in our proposals that in Section 3(a)(1), all information requested is already clearly printed on imported packs. The foreign principals are shipping their products the world over and local importers are not importing entire manufactured lots or batches from their principals and the manufactured product for any one lot or batch is being shipped to multiple territories globally. Therefore it will not be possible for the foreign manufacturer to customize such information just for Pakistan," he said.
At the same time, the minimum retail price will fluctuate from time to time in accordance with allowances from the regulators or within allowed parameters of the law, which again cannot be customized by the foreign manufacturers, efficiently and realistically, the spokesman said.
Printing such barcodes on primary packing for small vials, for example, 0.25ml or 0.5ml or even large volume containers is not viable for foreign manufacturer, as it is not a standard global practice, he pointed out. It is not possible to print micro barcodes leaving sufficient blank space as mentioned in Section 3(d), especially when there is ambiguity as to how much is sufficient space, he added. He said the primary level of serialization should be taken out of the rules as no country is implementing this due to its complexity.
In accordance with rule 3(h), the competent authority needs to consider the fact that specialized imported product, especially those requiring cold chain management, cannot be transported to local manufacturing facilities for bar coding, considering the extremely high cost of transportation of such materials to licensed manufacturing facilities, and considering the stringent cap on selling prices, the spokesman said.
Considering the numerousness of imported life-saving products, importers cannot manage the multiple arrangements for their various products, he added. This will produce chaos and will eventually result in the discontinuation of the products, he said. The proposal may not be viable for importers purchasing partial lots and batches in accordance with the needs and requirements of the local market, according to the spokesman.