Govt Withdraws Track & Trace System for Pharma Exports

The Commerce Ministry has withdrawn the track and trace provisions for pharmaceutical exports, aligning with the Ministry of Health’s regulations under Drug Rules 1945. The system, initiated in 2011, faced challenges, particularly at the primary packaging level. The move facilitates ease of business for exporters.

The Commerce Ministry announced its decision to revoke the track and trace system provisions for pharmaceutical exports, aligning policy with the Ministry of Health and Family Welfare's regulatory framework under Drug Rules 1945. This strategic change aims to streamline export regulations.

The track and trace system, launched on January 10, 2011, required barcodes at different packaging levels. While tertiary and secondary packaging mandates were implemented in 2011 and 2013, primary-level barcoding encountered significant operational hurdles, leading to repeated deferments, with the last extension valid until February 1, 2025.

The Health Ministry has already initiated barcode and QR code mandates for 300 drug brands since August 1, 2023, under the Drugs Rules, 1945, with plans for further expansion. The decision enhances ease of doing business for pharmaceutical exporters and maintains product traceability in line with global demands.

(With inputs from agencies.)