**Executive Summary:**
This public notice amends the Handbook of Procedure 2015-2020 regarding the implementation of the Track and Trace system for the export of pharmaceuticals and drug consignments. It extends the deadline for implementation and uploading to the central portal to April 1, 2020, for both Small Scale Industries (SSI) and non-SSI manufactured drugs. This extension allows stakeholders more time to comply with requirements for maintaining the parent-child relationship in packaging levels.
**Key Points / Main Content:**
* **Amendment of Handbook of Procedure:**
* Para 2.90A of the Handbook of Procedure 2015-2020 is amended.
* This amendment is made under the powers conferred by Paragraph 2.04 of the Foreign Trade Policy 2015-2020.
* The amendment is in reference to the public notices: No. 43/2015-20 dated 05.12.2017, No. 52/2015-20 dated 05.01.2016, No. 05/2015-20 dated 09.05.2018 and No. 43/2015-2020 dated 01.11.2018.
* **Date Extension:**
* The date "01.07.2019" in Para 2.90 A vi and vii of Handbook of Procedure 2015-2020, as amended vide Public Notice No. 43/2015-2020 dated 01.11.2018, is substituted with "01.04.2020".
* **Track and Trace System Implementation:**
* The implementation date for the Track and Trace system for the export of drug formulations is extended to 01.04.2020.
* This extension applies to maintaining the parent-child relationship in packaging levels.
* The uploading of data to the Central Portal has also been extended to 01.04.2020.
* **Scope:**
* The extension applies to both Small Scale Industries (SSI) and non-SSI manufactured drugs.
**Impact Analysis:**
* **SSI and Non-SSI Drug Manufacturers:**
* *Impact:* Have additional time to implement the Track and Trace system and meet packaging requirements.
* *Action Required:* Utilize the extended time to implement the Track and Trace system, ensure compliance with parent-child packaging relationships, and prepare for uploading data to the central portal by April 1, 2020.
* **Directorate General of Foreign Trade (DGFT):**
* *Impact:* Responsible for enforcing the amended regulations and overseeing the implementation of the Track and Trace system.
* *Action Required:* Monitor compliance with the extended deadline and provide guidance to stakeholders as needed.
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 public notice is issued, specifically paragraph 2.04.
Handbook of Procedure 2015-20: A document that outlines the procedures related to the Foreign Trade Policy, which is being amended by this notice. Specifically, Para 2.90A is being amended
Track and Trace system: A system for tracking pharmaceuticals and drug consignments to maintain Parent-Child relationship in packaging levels.
Pharmaceuticals: Goods regulated by this public notice
Central Portal: The platform where the data related to the Track and Trace system needs to be uploaded.
Small Scale Industries: SSI units. The extension applies to both SSI and non-SSI manufactured drugs
Alok Vardhan Chaturvedi: Director General of Foreign Trade and Ex-officio Additional Secretary.
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3383 GI/2019 (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 4th July, 2019
No. 16/2015-2020
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, Public Notice No. 05/2015-20
dated 09.05.2018 and Public Notice No. 43/2015-2020 dated 01.11.2018 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. 43/2015-2020 dated 01.11.2018), "01.07.2019" may be substituted by “01.04.2020".
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 01.04.2020 for both SSI and non SSI manufactured drugs.
ALOK VARDHAN CHATURVEDI, Director General of Foreign Trade
& Ex-officio Addl. 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.