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Date: 04-Aug-2023 Category: Extra Ordinary State: Union Government Country: India

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

Issued by Ministry of Commerce and Industry · Directorate General of Foreign Trade

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Executive Summary & Key Takeaways

What it means

  • This Public Notice extends the deadline for implementing the Track and Trace system for pharmaceutical exports, specifically concerning the maintenance of parent-child relationships in packaging levels and uploading this data to a central portal.

Key Changes

  • The implementation date for the Track and Trace system, related to maintaining parent-child relationships in drug packaging and uploading to the central portal, has been extended to February 1, 2024.
  • This extension applies to both SSI (Small Scale Industries) and non-SSI manufactured drugs.
  • The amendment is made to Para 2.76 (vi) and (vii) of Handbook of Procedure - 2023, which corresponds to the erstwhile Para 2.90A of Handbook of Procedure 2015-2020.
  • This notice is issued by the Director General of Foreign Trade, exercising powers under Paragraph 2.04 of the Foreign Trade Policy 2023, as amended.

Impact Analysis

Pharmaceutical Manufacturers (SSI and Non-SSI)

  • Action Item: Utilize the extended timeline to ensure full compliance with the Track and Trace requirements. Review and update internal systems and processes to meet the new deadline.

Exporting Companies

  • Action Item: Communicate the updated timeline to all relevant departments and stakeholders. Verify that systems are in place to meet the February 1, 2024 deadline.

Government Agencies (DGFT)

  • Action Item: Update relevant documentation and communication channels to reflect the new implementation date. Continue providing guidance and support to pharmaceutical manufacturers and exporters.

Key Entities Referenced

Director General of Foreign Trade (DGFT): The authority issuing the public notice and responsible for amending the Handbook of Procedure. Foreign Trade Policy 2023: The overarching policy under which the DGFT exercises its powers. Handbook of Procedure 2023: The document being amended by this public notice, specifically Para 2.76 (vi) and (vii). Handbook of Procedure 2015-2020: The previous version of the Handbook of Procedure, with reference to Para 2.90A. SSI (Small Scale Industries): Small scale industries involved in manufacturing of drugs. Public Notice No. 43/2015-20 dated 05.12.2017: Original notification regarding Track and Trace implementation. Other Public Notices: 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
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रिज(cid:7021)(cid:7069)ी स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.x-xअxG.-I0D5H0xx8x2 023-247885 CG-DL-Exx-x0G5I0D8E2x0xx2 3-247885 असाधारण EXTRAORDINARY भाग I—ख(cid:7003)ड 1 PART I—Section 1 (cid:7079)ािधकार से (cid:7079)कािशत PUBLISHED BY AUTHORITY सं. 188] नई (cid:7408)द(cid:7016)ली, शु(cid:7059)वार, अग(cid:7021)त 4, 2023/(cid:7088)ावण 13, 1945 No. 188] NEW DELHI, FRIDAY, AUGUST 4 2023/SHRAVANA 13, 1945 ( ) ( ) ubZ (cid:7408)द(cid:7016)ली, 4 अग(cid:7021) त, 2023 &le;&le; ij ;Fkk la'kksf/kr fons'k O;kikj uhfr] 2015&20 ds iSjk 2-04 ds rgr iznÙk 'kfDr;ksa dk iz;ksx djrs gq, egkfuns'kd] fons'k O;kikj ,rn}kjk vkS"k/k la#i.k dh fu;kZr [ksiksa ds fy, [kkstchu iz.kkyh ds dk;kZUo;u gsrq izfØ;k fu/kkZfjr djus laca/kh fnukad 05- 01-2016 dh lkoZtfud lwpuk la- 52@2015&20] fnukad 09-05-2018 dh lkoZtfud lwpuk la- 05@2015&20] fnukad 01-11-2018 dh lkoZtfud lwpuk la- 43@2015&2020] lkoZtfud lwpuk la- 16@2015&20] fnukad 04-07-2019] lkoZtfud lwpuk la- 66@2015&2020] fnukad 30-03-2020] lkoZtfud lwpuk la- 16@2015&20 fnukad 22-09-2020 lkoZtfud lwpuk la- 46@2015&20 fnukad 30-03-2021 vkSj lkoZtfud lwpuk la- 01@2015&2020 fnukad 4-01- 2022 vkSj lkoZtfud lwpuk la- 03@2023 fnukad 03-04-2023 ds lkFk ifBr fnukad 05-12-2017 dh lkoZtfud lwpuk la- 43@2015&20 }kjk ;Fkk vf/klwfpr izfØ;k iqLrd] 2015&20 ds iSjk 2-90d dks la'kksf/kr djrs gaSA 5046 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC.1] 2- izfØ;k iqLrd 2023 ds iSjk 2-76 ¼vi½ vkSj ¼vii½ ¼izfØ;k iqLrd 2015&2020 ds iSjk 2-90d esa iwoZ eas ;Fkk la”kksf/kr½ esa vkS"k/k la#i.kksa ds blds iSdsftax Lrjksa esa ekrk&firk rqY; laca/k cuk, j[kus vkSj dsUnzh; iksVZy ij bls viyksM djus ds lanHkZ esa ,l,lvkbZ vkSj xSj&,l,lvkbZ nksuksa }kjk fofufeZr vkS"k/kksa ds fy, fu;kZr gsrq [kkstchu iz.kkyh ds dk;kZUo;u dh rkjh[k 01-02-2024 rd c<+k nh xbZ gSA vkS"k/k la#i.kksa ds blds iSdsftax Lrjksa esa ekrk&firk rqY; laca/k cuk, j[kus vkSj dsUnzh; iksVZy ij bls viyksM dju s ds lanHkZ esa ,l,lvkbZ vkSj xSj&,l,lvkbZ nksuksa }kjk fofufeZr vkS"k/kksa ds fy, fu;kZr gsrq [kkstchu iz.kkyh ds dk;kZUo;u dh rkjh[k 01-02-2024 rd c<+k nh xbZ gSA larks"k dqekj lkjxa h] egkfuns'kd] fons'k O;kikj ,oa insu vij lfpo MINISTRY OF COMMERCE AND INDUSTRY (Department of Commerce) (DIRECTORATE GENERAL OF FOREIGN TRADE) PUBLIC NOTICE New Delhi, the 4th August, 2023 No. 26/2023 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 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 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 2.90A 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 01.02.2024for 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 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.

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