Introduction: The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, Government of India, has issued Public Notice No.39/2023- DGFT on February 2, 2024. This notice addresses the implementation of the Track and Trace system for the export of pharmaceuticals and drug consignments, emphasizing the maintenance of the Parent-Child relationship in packaging levels within the supply chain. This article delves into the key details of the notice, including the amendment to Para 2.90A of the Handbook of Procedure- 2015-20 and the extension of the implementation date.

Detailed Analysis:

1. Amendment to Para 2.90A: The DGFT, exercising powers under Paragraph 2.04 of the Foreign Trade Policy 2023, has amended Para 2.90A of the Handbook of Procedure- 2015-20. This amendment, in conjunction with various public notices issued over the years, lays down the procedural framework for the implementation of the Track and Trace system for export consignments of drug formulations.

2. Extension of Implementation Date: The crucial aspect of the public notice revolves around the extension of the date for implementing the Track and Trace system. Specifically, in Para 2.76 (vi) and (vii) of Handbook of Procedure – 2023, the deadline for the Track and Trace system’s implementation for export of drug formulations, considering the Parent-Child relationship in packaging levels, has been extended until February 1, 2025. This extension applies to both SS1 and non-SSI manufactured drugs.

Conclusion: In conclusion, Public Notice No.39/2023- DGFT serves as a significant update for stakeholders in the pharmaceutical export sector. The extension of the implementation date for the Track and Trace system provides businesses with additional time to ensure compliance with the regulations. DGFT’s commitment to facilitating a seamless export process, while ensuring the integrity of pharmaceutical supply chains, is evident in this notice. Stakeholders are advised to review their processes and make necessary adjustments to align with the revised deadline of 01.02.2025. For further details and clarification, individuals can contact the Directorate General of Foreign Trade via the provided email: dgft@nic.in.

***

Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade

Public Notice No.39/2023- DGFT | Dated 02 February, 2024

Subject: 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.

In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy 2023, as amended from time to time. the Director General of Foreign Trade hereby amends Para 2.90A of Handbook of Procedure- 2015-20, as notified vide Public Notice No. 43/2015-20 dated 05.12.2017 read with Public Notice No. 52/ 2015-20 dated 05.01.2016, Public Notice No. 05/2015-20 dated 09.05.2018. Public Notice No. 43/2015-2020 dated 01.11.2018, Public Notice No. 16/2015-2020 dated 04.07.2019, Public Notice No. 66/2015-2020 dated 30.03.2020, Public Notice No. 16/2015-­2020 dated 22.9.2020, Public Notice No. 46/2015-20 dated 30.03.2021, Public Notice No. 01/2015-­2020 dated 04.01.2022, Public Notice No. 3/2023 dated 03.04.2023 and Public Notice No. 26/2023 dated 04.08.2023 on laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations.

DGFT Extends Track and Trace System Deadline for Drug Exports

2. In Para 2.76 (vi) and (vii) of Handbook of Procedure – 2023 (as amended erstwhile Para 90 A of HBP 2015-2020). the date for implementation of Track and Trace system for export of drug formulations with respect to maintaining the Parent-Child relationship in packaging levels and its uploading on Central Portal has been extended up to 01.02.2025 for both SS1 and non SSI manufactured drugs”’.

3. Effect of this Public Notice:

The date for implementation of Track and Trace system for export of drug formulations with respect to maintaining the Parent-Child relationship in packaging levels and its uploading on Central Portal has been extended up to 01.02.2025 for both SSI and non SSI manufactured drugs.

(Santosh Kumar Sarangi)
Director General of Foreign Trade
Ex-officio Additional Secretary, Government of India
E-mail: dgft@.nic.in

(Issued from F. No. 01/91/180/648/AM-09/EC/E-21052)

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