Commerce Ministry Withdraws Track and Trace System for Pharma Exports

Current Affairs National

Posted by newadmin on 2025-02-03 08:50:51 |

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The Commerce Ministry has recently withdrawn the track and trace system for pharmaceutical exports, aligning with the regulatory framework established by the Ministry of Health and Family Welfare. This decision follows the introduction of barcode requirements for drug brands by the Health Ministry in August 2023. The move aims to facilitate ease of business for exporters while ensuring compliance with international serialization norms without imposing additional domestic regulations.

The track and trace system was originally introduced on January 10, 2011, mandating barcoding at various packaging levels. While implementation for tertiary and secondary packaging took place in 2011 and 2013, primary-level barcoding faced operational challenges and was repeatedly deferred. The last extension for its implementation was valid until February 1, 2025. Despite its challenges, the system provided several benefits, including preventing counterfeit drugs from entering the supply chain, increasing efficiency in drug production and sales, and addressing issues related to product recalls.

However, the adoption of the track and trace system faced significant hurdles. The absence of common industry standards created inconsistencies in implementation. Security concerns also arose, as barcodes could be altered or misused. Additionally, some pharmaceutical companies argued that the system slowed down production and increased operational costs.

In response to these challenges, the Directorate General of Foreign Trade (DGFT) announced the withdrawal of track and trace provisions under the Foreign Trade Policy. The responsibility for authentication of exported drug formulations will now be managed by the Health Ministry in accordance with the Drug Rules of 1945. The Health Ministry has already implemented barcode requirements for 300 drug brands and plans to expand this initiative further.

This transition aligns with the serialization requirements of most export destinations, ensuring product traceability while reducing regulatory burdens on domestic pharmaceutical companies. The DGFT has emphasized that this decision enhances the ease of doing business for exporters while maintaining regulatory coherence within the industry.

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