Executive Summary:
This public notice concerns the implementation of a Track and Trace system for the export of pharmaceuticals and drug consignments, emphasizing the maintenance of a Parent-Child relationship in packaging. It amends Para 2.90A of the Handbook of Procedure 2015-2020, specifically regarding the procedure for implementing the Track and Trace system. The key action is the extension of the implementation date to July 1, 2019.
Key Points / Main Content:
* **Amendment Details:** Para 2.90A of the Handbook of Procedure 2015-2020 is amended.
* **Date Extension:** The implementation date in Para 2.90 A vi and vii, previously set as November 15, 2018, is substituted with July 1, 2019.
* **Track and Trace System:** The Track and Trace system applies to the export of drug formulations and maintaining the Parent-Child relationship in packaging levels.
* **Scope:** This extension applies to both Small Scale Industries (SSI) and non-SSI manufactured drugs.
* **Central Portal Upload:** The deadline for uploading the Track and Trace system data on the Central Portal is also extended to July 1, 2019.
Impact Analysis:
* **SSI and Non-SSI Drug Manufacturers:**
Impact: The deadline for implementing the Track and Trace system for exported drug formulations is extended, providing additional time for compliance.
Action Required: Update internal systems and processes to comply with the Track and Trace system by the new deadline of July 1, 2019, and ensure data uploading to the central portal by this date.
Key Entities Referenced
Directorate General of Foreign Trade: The issuing authority of the public notice, responsible for foreign trade policy.
Foreign Trade Policy, 2015-2020: The governing policy under which the Director General of Foreign Trade is exercising its powers.
Handbook of Procedure 2015-20: A document providing detailed procedures related to the Foreign Trade Policy 2015-2020.
Track and Trace system: A system for monitoring the movement of pharmaceuticals and drug consignments in the supply chain.
Pharmaceuticals: Goods regulated under the Track and Trace system.
drug consignments: Goods regulated under the Track and Trace system.
01.07.2019: The new extended date for implementation of the Track and Trace system.
New Delhi: Location of publication of the gazette.
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6509 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1)]
MINISTRY OF COMMERCE AND INDUSTRY
(Department of Commerce)
(DIRECTORATE GENERAL OF FOREIGN TRADE)
PUBLIC NOTICE
New Delhi, the 1st November, 2018
No. 43/2015-2020
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 (Vol.II).—In exercise of the powers conferred under Paragraph 2.04 of the
Foreign Trade Policy, 2015-20, 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 and No. 05/2015-20 dated 09.05.2018 on laying down the
procedure for implementation of the Track and Trace system for export consignments of drug formulations.
2. In Para 2.90 A (vi) and (vii) of Handbook of Procedure - 2015-20 (as amended vide Public Notice No. 05/2015-
20 dated 09.05.2018), “15.11.2018” may be substituted by “01.07.2019”.
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 01.07.2019 for both SSI and non SSI manufactured drugs.
ALOK VARDHAN CHATURVEDI, Director General of Foreign Trade Ex-officio Add. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.