Indian Government Withdraws Track and Trace System for Pharma Exports

The Indian government has officially withdrawn its track-and-trace system for pharmaceutical exports, nearly 14 years after its introduction. The decision comes just before the latest extension, which was set to be valid until February 1, 2025.  

While the move is welcomed by industry representatives, who argue that the system was "ill-conceived" as companies were already complying with importing countries’ requirements, some experts are concerned about the potential negative global perception. The decision follows past incidents, such as the 2022 cough syrup-related deaths in Gambia and Uzbekistan, where Indian pharmaceutical products were allegedly linked to fatalities.  

The track-and-trace system, introduced in January 2011, required barcoding at different packaging levels. According to the Union Commerce Ministry, tertiary and secondary packaging requirements were successfully implemented in 2011 and 2013. However, primary-level barcoding and parent-child data uploading faced repeated operational challenges, leading to multiple deferrals, with the most recent extension set to last until 2025.  

The Directorate General of Foreign Trade (DGFT) stated that the withdrawal aligns with the evolving regulatory framework of the Union Health Ministry, which introduced barcode/QR code requirements for 300 drug brands starting August 1, 2023, with further expansion planned. It also noted that most export destinations already have their own serialization requirements, ensuring product traceability without additional domestic regulations.  

Pharmaceutical exporters argue that countries like Nigeria enforce strict measures to prevent counterfeit drugs, making additional Indian regulations redundant. They also highlight the complexity of complying with varying regulations across different export markets, which the DGFT’s system exacerbated.