Abhijit Acharya, product manager, and Nathan Sigworth, ceo, PharmaSecure, outline the requirements for bar coding and serialisation on pharmaceutical packaging for products exported from India.
The Indian serialisation movement, which has been supported by the Directorate General of Foreign Trade (DGFT) Mandate, has proved an extremely important milestone in the history of serialisation. It has led to the first large-scale serialisation of packages, including even inexpensive products, in a cost-effective manner.
The DGFT Public Notice No. 21, released on 10 January, 2011, requires unique numbers and barcodes for every tertiary, secondary and primary package exported from India, according to GS1 standards. While producers are not expected to implement a complete track and trace system immediately, they are required to maintain or have a third party maintain a database of their serial numbers and the associated products. Over time, authentication and track and trace systems will be encouraged among manufacturers and distributors; serialisation will probably also be expanded to domestic products.