In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2020, as amended

## Report on Amendment to Foreign Trade Policy Regarding Pharmaceuticals Export **1. Executive Summary:** This report analyzes a public notice amending the Foreign Trade Policy 2015-20 concerning the implementation of a "Track and Trace" system for pharmaceutical exports. The core purpose of this amendment, as inferred from the text, is to extend the deadline for implementing the Track and Trace system, specifically regarding maintaining the "Parent-Child relationship" in packaging levels and uploading this data to a central portal. The key finding is that the implementation date has been extended from April 1, 2021, to April 1, 2022, for both SSI (Small Scale Industries) and non-SSI manufactured drugs. **2. Introduction:** This report aims to provide information and analysis regarding a specific amendment to the Foreign Trade Policy, as detailed in the provided public notice. The analysis focuses on understanding the amendment's purpose, key changes, affected stakeholders, and potential impact, based solely on the information available in the text. **3. Policy Overview:** * **Original Policy Being Amended:** Foreign Trade Policy 2015-20, specifically Para 2.90A of Handbook of Procedure 2015-20. * **Core Objective(s):** Based on the text, the original policy (and subsequent amendments) aim to implement a "Track and Trace" system for pharmaceutical exports. This likely intends to enhance transparency and accountability in the pharmaceutical supply chain. A key element of this is maintaining the "Parent-Child relationship" in packaging levels, suggesting a desire to track individual units back to their origin and batch. **4. Background and Rationale:** This public notice is an amendment to the Foreign Trade Policy, specifically extending the deadline for a previously mandated requirement. The rationale for this specific amendment is not explicitly stated. However, the extension suggests that the initial deadline of April 1, 2021, was deemed unrealistic or challenging for pharmaceutical manufacturers to meet. This could be due to technical difficulties in implementing the tracking system, logistical challenges in maintaining the "Parent-Child relationship" in packaging, or insufficient time for companies to adapt to the new requirements. **5. Key Provisions / Changes:** This public notice *amends* Para 2.90 A vi and vii of the Handbook of Procedure 2015-20. * **Specific Part of Original Policy Changed:** The amendment directly changes the deadline specified in Para 2.90 A vi and vii of the Handbook of Procedure 2015-20, as amended vide Public Notice No. 1620152020 dated 22.9.2020. * **New Rule/Provision:** The original date "01.04.2021" is substituted with "01.04.2022". * **Difference/Effect of the Change:** The key effect is a one-year extension of the deadline for implementing the "Track and Trace" system, specifically concerning maintaining the "Parent-Child relationship" in packaging levels and uploading this data to a central portal. Companies now have until April 1, 2022, to comply with these requirements. **6. Target Audience and Stakeholders:** Based on the text, the primary target audience and stakeholders are: * Pharmaceutical manufacturers, specifically both SSI (Small Scale Industries) and non-SSI manufacturers. * Exporters of drug formulations. * Potentially, companies providing Track and Trace solutions for the pharmaceutical industry. **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Directorate General of Foreign Trade (DGFT) is responsible for implementing and overseeing the policy. The text mentions a "central portal" where data needs to be uploaded, indicating the existence of a central data repository managed by a government agency or a designated service provider. * **Timelines/Procedures:** The key timeline is the extended deadline of April 1, 2022. The text implies that the implementation involves setting up a system to maintain the "Parent-Child relationship" in packaging levels and uploading this information to the central portal. Specific procedures for uploading and data management are likely outlined in the Handbook of Procedure 2015-20 or related guidelines. **8. Expected Outcomes / Impact of Changes:** The likely intended outcome of this amendment is to allow pharmaceutical manufacturers more time to implement the "Track and Trace" system. This could lead to a more thorough and effective implementation, potentially improving the accuracy and reliability of the tracking data. The extension may also prevent disruptions to pharmaceutical exports by giving companies more time to comply with the new regulations. The delay could, however, also postpone the benefits of enhanced traceability. **9. Conclusion:** The amendment to the Foreign Trade Policy, as detailed in the public notice, represents a one-year extension of the deadline for implementing the "Track and Trace" system for pharmaceutical exports. This extension is significant as it provides pharmaceutical manufacturers, both SSI and non-SSI, with additional time to comply with the requirements of maintaining the "Parent-Child relationship" in packaging levels and uploading this data to a central portal. This amendment likely aims to facilitate a smoother and more effective implementation of the Track and Trace system, contributing to greater transparency and accountability in the pharmaceutical supply chain.

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