Withdrawal of Track and Trace System for Pharmaceuticals

February 1, 2025

The Commerce Ministry has recently withdrawn the track and trace system for pharmaceutical exports.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

Background of the Track and Trace System

The track and trace system was introduced on January 10, 2011.
It mandated barcoding at various packaging levels.
Implementation for tertiary and secondary packaging occurred in 2011 and 2013.
However, primary-level barcoding faced operational challenges and was repeatedly deferred.
The last extension was valid until February 1, 2025.

Benefits of the Track and Trace System

The track and trace system offers multiple benefits. It helps prevent counterfeit drugs from entering the supply chain. It also increases efficiency in drug production and sales. The system addresses challenges related to product recalls and counterfeit products.

Challenges in Implementation

Despite its benefits, the adoption of the track and trace system faces challenges. There is a lack of common standards across the industry. Security concerns exist as barcodes can be easily altered. Some pharmaceutical companies argue that the system slows down production and increases costs.

Recent Developments

The Directorate General of Foreign Trade (DGFT) announced the withdrawal of track and trace provisions under the Foreign Trade Policy.
The authentication system for exported drug formulations will now be managed by the Health Ministry according to the Drug Rules of 1945.
The Health Ministry has already implemented barcode requirements for 300 drug brands, with plans for further expansion.

Importance of the Change

This change is as it aligns with the serialization requirements of most export destinations. It ensures product traceability without imposing additional domestic regulations. The DGFT emphasised that this step enhances the ease of doing business for pharmaceutical exporters while maintaining regulatory coherence.

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