Government mandated item-unique serialization initiatives continue to face challenges. Below is an interesting piece on challenges with government mandates on serialization, with views from the Indian pharmaceutical sector. The time for mandates will come. In the short term, let's encourage voluntary company participation so that government and pharma companies alike can understand the costs AND benefits item-level serialization with patient-oriented product validation bring to the ecosystem. Chemical Weekly - March 22, 2011:
The pharma industry in the country,especially the small and medium scaleunits, has asked the Drug ControllerGeneral of India (DCGI) not to amendthe Drugs & Cosmetic Act to makethe implementation of 2D barcode/UID (unique identity code) mandatoryfor the domestic market. Instead ofmaking the 2D barcode/UID mandatory,the industry asked the DCGI toimplement the track and trace systemfor which there is already a provisionin the Act.
At a meeting convened bythe DCGI on the issue recently, the industryis learnt to have apprised the authoritiesthat as a concept there shouldbe track and trace of medicines frommanufacturing to retail using softwaresystem, but practically it is not possiblein India till the time the whole supplychain along with the manufacturingis automated through web and relatedsoftware.
Industry representatives saidthat even in USA, where most of thepharmacies (retail) are automated,the authorities have not been able toachieve the same and it is not mandatory.They have done the same in the stateof California (2D and UID) on trialbasis and the result is that drugs havebecome more expensive due to shortagesas manufacturers are not equippedwith 2D and UID and cannot supply themedicines.
The industry also pleadedthat as the implementation of the newsystem involves an investment of aboutRs.1 to 2 crores, it should be done on atrial basis or in stages. They suggestedthat larger companies who are alreadyusing such systems share their experienceon how effective it is to controlspurious drugs and the costs.
The industryis learnt to have categoricallytold the authorities that if the Act isamended to make 2D barcode/UIDmandatory, most of the small andmedium companies will have noother option but to shut down as theywill not be able to comply with thenew system as the current manpower,packaging machines, computer hardwareand software have to be upgradedand new equipment to implement2D and UID have to be purchased.