Extension of Track and Trace Implementation for Drug Formulations Export: A Focus on Parent-Child Relationship in Packaging Levels

India’s Public Notice 39/2023 extended the mandatory track-and-trace implementation deadline for drug formulation exports to 01.02.2025, requiring manufacturers to maintain accurate parent-child relationships across packaging levels and to upload serialization data to a central portal, ensuring full supply chain traceability, anti-counterfeiting compliance, and export readiness.

In a significant development for the pharmaceutical industry, as per Public Notice 39/2023, the implementation date of the track-and-trace system for the export of drug formulations has been further extended to 01.02.2025.

This extension provides manufacturers, both Small Scale Industries and non-SSI entities, with an opportunity to refine their systems, address any challenges, and ensure seamless compliance with regulatory requirements.

Understanding Track and Trace in Drug Formulation Export

The track-and-trace system is a vital component of the pharmaceutical supply chain, aimed at enhancing transparency, accountability, and security in the movement of drug formulations from manufacturers to end users.

It involves the creation of a digital trail that allows authorities to trace the entire journey of a pharmaceutical product, from its inception at the manufacturing facility to its distribution and eventual consumption.

Importance of Parent-Child Relationship in Packaging Levels

One of the key aspects of the track-and-trace system is the establishment and maintenance of the parent-child relationship at the packaging level.

In the context of drug formulations, this relationship refers to the connection between the primary packaging (individual units) and secondary packaging (cartons or boxes containing multiple units).

Ensuring an accurate and unbroken parent-child relationship is crucial for tracking and tracing each unit of the drug throughout the supply chain.

The parent-child relationship is established through the assignment of unique identifiers such as barcodes, QR codes, or serial numbers to individual units and their corresponding packaging.

This allows for precise monitoring, helping to prevent counterfeiting, diversion, and other illicit activities that could compromise the integrity of the pharmaceutical supply chain.

Uploading on the Central Portal

As part of the track-and-trace system, manufacturers are required to upload relevant information about their drug formulations to a central portal.

This centralized database serves as a repository of crucial data, allowing regulatory authorities to access real-time information on the movement and status of pharmaceutical products.

Conclusion

The extension of the track-and-trace system’s implementation date for the export of drug formulations, with a specific focus on maintaining the parent-child relationship at the packaging level, is a positive development for the pharmaceutical industry.

It reflects a commitment to fostering a secure and transparent supply chain, ultimately benefiting consumers by ensuring the safety and authenticity of pharmaceutical products.

Also, read Understanding the Basics of Track & Trace

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