India Revokes Track and Trace System for Pharmaceutical Exports: A New Era in Drug Export Regulations

India’s decision to drop the Track and Trace system for pharmaceutical exports marks a new chapter in streamlining global trade processes

The Ministry of Commerce and Industry has recently announced a major shift in the country’s approach to pharmaceutical exports. On January 31, 2025, the Health Ministry confirmed that the provisions related to the Track and Trace (TTS) system for drug exports under the Foreign Trade Policy (FTP) have been officially withdrawn. This decision marks a significant move towards streamlining the pharmaceutical export process in India while aligning with the regulations set by the Ministry of Health and Family Welfare.

Understanding the Track and Trace System: A Step Towards Transparency

Launched on January 10, 2011, the Track and Trace system was designed to enhance the transparency and traceability of pharmaceutical products during their export journey. The core objective of this initiative was to ensure that drugs manufactured in India could be easily monitored and authenticated at every level of packaging. The system mandated barcode labeling for various packaging levels, starting from primary packaging to tertiary packaging, aiming to reduce the risk of counterfeit drugs entering global markets.

While secondary and tertiary packaging requirements were successfully implemented in 2011 and 2013, primary-level barcode labeling and the parent-child data uploading feature faced operational challenges. These challenges led to repeated delays and the system’s expansion, with the final extension set to expire on February 1, 2025.

The Withdrawal of TTS Provisions: What Does This Mean for the Pharmaceutical Industry?

The Ministry’s decision to withdraw the TTS provisions is a direct consequence of the evolving regulatory landscape in India. According to a public notice issued by the Directorate General of Foreign Trade (DGFT), pharmaceutical certification for exports will now be governed in accordance with the provisions of the Drugs Rules, 1945, under the Ministry of Health and Family Welfare.

This shift is intended to streamline the export procedures for pharmaceutical manufacturers while ensuring that drugs meet domestic and international standards. The Health Ministry’s existing regulatory framework will serve as the foundation for the new export certification system, aligning with global best practices for drug quality and safety.

Key Benefits of the Revoked Track and Trace System

The withdrawal of the TTS provisions offers several potential advantages for India’s pharmaceutical sector:

  1. Simplified Export Procedures: The Track and Trace system was a complex, multi-level system that involved barcode labeling at various stages of packaging. By removing these requirements, India’s drug export regulations become more streamlined and less burdensome for manufacturers, especially for small and medium-sized enterprises (SMEs).
  2. Reduction of Operational Challenges: The implementation of primary-level barcode labeling and parent-child data uploading faced significant operational hurdles. The revocation of these provisions eliminates the need to continually update these systems, thus removing the bottlenecks that slowed down drug exports.
  3. Alignment with Health Ministry Regulations: The Ministry of Health and Family Welfare has already implemented barcode and QR code labeling for 300 drug brands under the Drugs Rules 1945. By aligning export procedures with these established regulations, India’s pharmaceutical sector can ensure that all exported drugs meet global quality standards without the additional complexity of the TTS framework.

The Health Ministry’s Role in Regulating Pharmaceutical Exports

Despite the removal of the TTS provisions, the Health Ministry’s role remains central to ensuring the continued integrity and safety of pharmaceutical exports. The Ministry has already implemented stringent barcode/QR code requirements for 300 drug brands since August 1, 2023. This regulatory framework is set to expand in the future, ensuring that products continue to meet quality standards while reducing the risk of counterfeit drugs entering international markets.

Impact on Counterfeit Drug Prevention

One of the main concerns following the withdrawal of the TTS system is the potential rise in counterfeit drugs. India, as a major global supplier of generic medicines, has long struggled with the issue of counterfeit drugs. While the TTS system was seen as a major step towards combating counterfeit products, the new regulatory framework will still require strong safeguards to maintain the integrity of exported drugs.

To address this concern, the government has emphasized the importance of continued monitoring and enforcement of drug labeling requirements. Customs authorities, along with international trade partners, will play a key role in ensuring that counterfeit drugs do not enter the global market.

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