Notwithstanding strong resistance from the industry, especially the small and medium companies in the country, the union commerce ministry is all set to implement the barcoding on export consignment of pharmaceuticals and drugs for tracing and tracking purpose from October 1 this year.
Though last minute efforts are being done by the industry to repeal the notification issued by
DGFT on barcode under which implementation of barcoding has been made mandatory for all pharma exporters from October 1 this year, sources said that the chances of repealing the notification at this stage is very remote.
According to the DGFT notification, barcoding will be enforced in the country in phased manner from October 1 this year. The trace and track technology will be made compulsory for tertiary level packaging with effect from October 1, 2011 and that on secondary level packaging will be made compulsory from January 1, 2012 and the new system will be made mandatory on primary level packaging from July 1, 2012.
The move on track-and-trace system was initiated by the union commerce ministry after, among other things, instances of fake “Made in India” medicines were surfaced in Africa some time back. “Made in India” fakes in the Nigerian market last year were found to have originated in China, forcing the Indian pharmaceutical industry and the government to implement measures to protect 'Brand India'.
Meanwhile, the industry has been trying to convince the union commerce ministry about the futility of introducing the system. It said that barcodes were devised as a means of inventory control by supermarkets in the west when it became impossible to physically take stock of thousands of items even by a monthly closure of departmental store. It is true that some pharma MNCs use barcoding to prevent transfer of medicines from one country to another since their MRP is different for each country, but such high priced drugs cannot be compared to export of affordable generics from India. Barcoding can certainly never be a means of preventing fakes. Even M/s GS-1, a Canadian company to whom government has handed out the sole contract for India, refuses to make the claim that it can prevent fakes. Since barcodes can be replicated, it can strengthen acceptance of fake on the contrary, the industry felt.
Besides, the industry also pleaded the financial unviability of barcoding. The cost of registration with M/s GS-1 shall be around Rs.20,000 per month apart from monthly cost of say Rs.1,00,000 for barcoding accessories like inks etc. for an average SME, it said.
Source : pharmabiz.com