The pharma industry in the country, especially the small and medium scale units, has asked the Drug Controller General of India (DCGI) not to amend the Drugs & Cosmetic Act to make the implementation of 2D barcode/UID (unique identity code) mandatory for the domestic market. Instead of making the 2D barcode/UID mandatory, the industry asked the DCGI to implement the track and trace system for which there is already a provision in the Act.
At a meeting convened by the DCGI on the issue recently, the industry is learnt to have apprised the authorities that as a concept there should be track and trace of medicines from manufacturing to retail using software system, but practically it is not possible in India till the time the whole supply chain along with the manufacturing is automated through web and related software.
Industry representatives said that even in USA, where most of the pharmacies (retail) are automated, the authorities have not been able to achieve the same and it is not mandatory. They have done the same in the state of California (2D and UID) on trial basis and the result is that drugs have become more expensive due to shortages as manufacturers are not equipped with 2D and UID and cannot supply the medicines.
The industry also pleaded that as the implementation of the new system involves an investment of about Rs.1 to 2 crore. First it should be done on a trial basis or in stages like the pharma giants who are already using such systems and share their experience like how effective it is to control spurious drugs and the cost part of it.
The industry is learnt to have categorically told the authorities that if the Act is amended to make 2D barcode/UID mandatory in the country, most of the small and medium companies will have no other option but to shut down as they will not be able to comply with the new system as the current manpower, packaging machines, computer hardwares and softwares have to be upgraded and new equipment to implement 2D and UID have to be purchased involving huge amount.