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        Deadline Extended for Pharmaceutical Track and Trace System Implementation

        8 February, 2024

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        Circular No. 39/2023 - Dated: 2-2-2024 - Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments along with maintaining the Parent-Child relationship in the levels of packaging and their movement in supply chain- Extension of date of implementation regarding.

        The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, Government of India, has released Public Notice No. 39/2023, dated 2nd February 2024. This notice pertains to the extension of the implementation date for the Track and Trace system for pharmaceutical exports. Here's a simplified breakdown of the key points.

        Track and Trace System: Purpose and Extension

        • Objective: The Track and Trace system is designed to enhance the monitoring and verification of pharmaceutical and drug consignments exported from India. It requires the maintenance of a Parent-Child relationship in the levels of packaging, which is crucial for tracking the movement of these consignments through the supply chain.
        • Extension of Implementation Date: The notice extends the deadline for implementing this system to 1st February 2025. This applies to all pharmaceutical products, regardless of whether they are manufactured by Small Scale Industries (SSI) or non-SSI entities.

        Historical Context and Amendments

        • The Track and Trace system's implementation procedures have been modified multiple times since its initial announcement. This public notice amends Para 2.90A of the Handbook of Procedure-2015-20, along with several other notices dating back to 2015.
        • These amendments collectively lay down the detailed procedure for implementing the Track and Trace system for drug formulations intended for export.

        Effect of the Notice

        • Primary Impact: The extension allows exporters additional time to comply with the Track and Trace system requirements, ensuring that the Parent-Child relationship in packaging levels is maintained and accurately uploaded to the Central Portal.
        • Applicability: The extension is applicable across the board, covering drugs manufactured by both SSI and non-SSI entities, aiming to provide a uniform compliance timeframe for all exporters.

         


        Full Text:

        Circular No. 39/2023 - Dated: 2-2-2024 - Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments along with maintaining the Parent-Child relationship in the levels of packaging and their movement in supply chain- Extension of date of implementation regarding.

        Track and Trace system extended to give exporters time to implement parent child packaging tracing and Central Portal uploads. The DGFT extended the implementation deadline for the Track and Trace system for pharmaceutical exports, requiring maintenance and upload of Parent-Child packaging relationships to the Central Portal. The extension applies to both SSI and non SSI manufacturers and amends Para 2.90A of the Handbook of Procedure to consolidate prior notices and procedural requirements for recording packaging hierarchies and supply chain movements.
                      Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
                        Provisions expressly mentioned in the judgment/order text.

                            Track and Trace system extended to give exporters time to implement parent child packaging tracing and Central Portal uploads.

                            The DGFT extended the implementation deadline for the Track and Trace system for pharmaceutical exports, requiring maintenance and upload of Parent-Child packaging relationships to the Central Portal. The extension applies to both SSI and non SSI manufacturers and amends Para 2.90A of the Handbook of Procedure to consolidate prior notices and procedural requirements for recording packaging hierarchies and supply chain movements.





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