Abolition of Track and Trace System for Pharmaceuticals

The Commerce Ministry has recently decided to discontinue the track and trace system for pharmaceutical exports. This decision is in line with the regulatory framework set by the Ministry of Health and Family Welfare, which has introduced barcode requirements for drug brands starting in August 2023. The change aims to streamline the export process while ensuring compliance with international serialization standards without adding extra domestic regulations.

Background of the Track and Trace System

The track and trace system was introduced on January 10, 2011, and required barcoding at various packaging levels. While secondary and tertiary packaging was implemented in 2011 and 2013, primary-level barcoding faced operational difficulties and was delayed multiple times. The last extension was set to run until February 1, 2025.

Benefits of the Track and Trace System

The system was designed to prevent counterfeit drugs from entering the supply chain and improve the efficiency of drug production and distribution. It also provided solutions for handling product recalls and counterfeit issues.

Challenges in Implementation

Despite its advantages, the track and trace system encountered significant challenges. The lack of industry-wide standards, security risks related to barcode tampering, and concerns from pharmaceutical companies about increased production costs and slower processes hindered its adoption.

Recent Developments

The Directorate General of Foreign Trade (DGFT) has announced the removal of track and trace requirements from the Foreign Trade Policy. From now on, the Health Ministry will oversee the authentication of exported drug formulations by the Drug Rules of 1945. The Health Ministry has already implemented barcode requirements for 300 drug brands, with plans to expand further.

Significance of the Change

This change is important as it aligns with the serialization regulations of most export markets, ensuring traceability without imposing additional domestic rules. The DGFT highlighted that this shift will improve the ease of doing business for pharmaceutical exporters while maintaining regulatory consistency.

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