In a recent notice by the Directorate General of Foreign Trade (DGFT) of the Ministry of Commerce and Industry, Government of India, the deadline for implementing the Track and Trace system for exported drug formulations has been extended to February 1, 2024. This adjustment affects both small scale industries (SSI) and non-SSI manufactured drugs.
The DGFT, under its powers conferred by Paragraph 2.04 of the Foreign Trade Policy 2023, has extended the date for the implementation of the Track and Trace system, a critical step in maintaining the Parent-Child relationship in packaging levels and their movement in the supply chain. This system, vital for ensuring the quality and authenticity of drugs, will require the uploading of information onto a Central Portal. The extension provides pharmaceutical manufacturers additional time to ensure their systems meet the requirements of the Track and Trace program, promoting compliance across the industry.
This notice from the DGFT signifies the government’s commitment to facilitating a seamless transition to a more robust and transparent tracking system for drug exports. While the change introduces a more sophisticated level of control and accountability for pharmaceutical exports, it also requires the industry to adapt their processes accordingly. The deadline extension to February 1, 2024, therefore, provides manufacturers with the necessary time to align their operations with these new norms.
Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 26/2023-DGFT | Dated 4th August, 2023
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.
F. No. 01/91/180/648/AM-09/EC/E-21052.-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 or 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 and Public Notice No. 3/2023 dated 03.04.2023 on laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations.
2. In Para 2.76 (vi) and (vii) of Handbook of Procedure – 2023 (as amended erstwhile Para 90A 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 is extended up to 01.02.2024 for both SSI 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 01.02.2024 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)
