India is a primary source for generic drugs being sold worldwide and in the course of a few weeks, they made unconventional changes by restricting the export of 13 active pharmaceutical ingredients (APIs) and 13 associated medicines. India also postponed the Regulatory Deadline during a 21 day countrywide lockdown.
In the midst of these big changes, India’s Central Government launched the iVEDA portal (India’s new portal, iVEDA tracks and traces drugs meant for export) that went into effect from April 1, 2020 onward. As per the latest update, Implementation for Track and Trace for export of drug formulations has been extended from 01 April, 2020 to 01 October, 2020 for both SSI (small scale industry) and non-SSI manufacturers.
This new iVEDA portal has replaced India’s Drugs Authentication and Verification Application (DAVA) portal. DAVA had faced technical glitches that provided challenges for manufacturers and exporters when uploading data on 2D barcodes on secondary and tertiary packs of drugs meant for export and with maintenance of parent-child relationship between them.
The Department of Commerce assembled a committee to consult with supply chain stakeholders regarding the issues and concerns with DAVA which led to creating an entirely different portal for validation and authentication of drugs for export i.e. The iVEDA portal, a repository database meant to archive serialized batch data.
With iVEDA, manufacturers and exporters are required to upload data on barcodes on secondary and tertiary packaging of drugs meant for export on the portal. However, maintaining parent-child relationship between secondary and tertiary packaging is optional. It’s important to note that the key objective for iVEDA is not to track and trace India’s drug supply. The manufacturer uploading data on the central portal must have manufacturer code and product code allotted by GS1 India and must have Digital Signature Certificate of Class-II or Class-III issued by any Certifying Authority (CA) in India.
This online system is expected to be more user-friendly as it’ll allow uploading of product and production data as well as helping manufacturers and merchant exporters to generate and utilise tertiary and secondary level coded data.