The Allahabad High Court has allowed the Indian Drug Manufacturers Association (IDMA), an association of small, medium and large Indian drug manufacturers spread across the country, as party in the ongoing case related to the proposed implementation of 2D barcode/UID (Unique Identity Code) system for the domestic pharma market to check counterfeit medicines in the country. The court has asked the IDMA to file an affidavity by April 15 on the matter.
According to sources, counsel for the IDMA Advocate Neeraj Kumar Singh contended in the court that making of software and amending the existing rules in itself would not serve the purpose. The need is not to add some more teeth but to sharpen the teeth and claws of provisions of the Act by making its compliance more uniform and effective. Ever since the issue cropped up, the industry has been asking the authorities that instead of making the 2D barcode/UID mandatory which is not practically possible in India, the drug authorities should properly implement the track and trace system for which there is already a provision in the Drugs and Cosmetics Act.
The IDMA counsel referred various provisions in the Rules which make in dealing with cash memo from manufacturer to retailer and from retailer to end user must which in turn would ensure mentioning of details in the nature of batch no. etc, thereby cutting down the marketability of drugs scanning such details. The counsel also pointed out that the grandiose plan initiated by Teva, large generic company of the world and other companies in USA could not implement due to realistic problems and also due to its vulnerability to piracy.
In his argument, Singh also appraised the court that the proposed introduction of 2d barcode will result in increase in the prices of medicines thereby bringing the industry in conflict with drug price regulator NPPA.
Ever since the introduction of 2d barcode became an issue, the industry, especially the small and medium players, has been crying coarse that the introduction of 2d barcode system is practically not possible in India till the time the whole supply chain along with the manufacturing is automated through web and related software.
The industry, which sees the introduction of the 2d barcode system as yet another ploy to eliminate the SSIs, is of the view that if the Drugs and Cosmetics 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 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 which involves huge amount.