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Date: 03-Apr-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

  • The Directorate General of Foreign Trade (DGFT) has issued a public notice regarding the implementation of the Track and Trace system for export of pharmaceutical and drug consignments.
  • This notice extends the deadline for implementing the track and trace system, which includes maintaining the parent-child relationship in the packaging levels and uploading the data to a central portal.

Key Changes

  • The implementation date for the Track and Trace system for drug exports has been extended from March 31, 2023, to August 1, 2023.
  • This extension applies to both Small Scale Industries (SSI) and non-SSI manufacturers of drugs.
  • The amendment is made to Para 2.90A (vi) and (vii) of the Handbook of Procedure 2015-20, as previously amended by Public Notice No. 01/2015-2020 dated 04.01.2022.
  • The extension is issued in exercise of powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2015-20.

Impact Analysis

Pharmaceutical Manufacturers (SSI and Non-SSI)

  • Action Item: Conduct thorough testing of the implemented Track and Trace system to verify data accuracy and system functionality.

Exporters of Pharmaceuticals

  • Action Item: Ensure that all export documentation and processes align with the new Track and Trace requirements by the revised deadline.

Government Agencies (DGFT)

  • Action Item: Conduct outreach programs to educate pharmaceutical manufacturers and exporters about the Track and Trace requirements and the extended timeline.

Key Entities Referenced

Directorate General of Foreign Trade (DGFT): The DGFT is the government agency responsible for implementing and regulating foreign trade policy. Foreign Trade Policy, 2015-20: The prevailing policy governing import and export activities in India during the period 2015-2020. Handbook of Procedure 2015-20: A document providing detailed procedures and guidelines for implementing the Foreign Trade Policy. Public Notice No. 43/2015-20 dated 05.12.2017: Original notification regarding the Track and Trace system. Public Notice No. 52 / 2015-20 dated 05.01.2016: Related notification regarding the Track and Trace system. Public Notice No. 05/2015-20 dated 09.05.2018: Related notification regarding the Track and Trace system. Public Notice No. 43/2015- 2020 dated 01.11.2018: Related notification regarding the Track and Trace system. Public Notice No. 16/2015- 2020 dated 04.07.2019: Related notification regarding the Track and Trace system. Public Notice No. 66/2015- 2020 dated 30.03.2020: Related notification regarding the Track and Trace system. Public Notice No. 16/2015-2020 dated 22.9.2020: Related notification regarding the Track and Trace system. Public Notice No. 46/2015-20 dated 30.03.2021: Related notification regarding the Track and Trace system. Public Notice No. 01/2015-2020 dated 04.01.2022: Previous notification that amended the implementation date, now superseded by this notice. SSI and Non-SSI Manufacturers: Small Scale Industries and other manufacturers of pharmaceutical products.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-05042023-244931 xxxGIDHxxx CG-DL-E-05042023-244931 xxxGIDExxx असाधारण EXTRAORDINARY भाग I—खण्ड 1 PART I—Section I प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 81] नई दिल्ली, सोमवार, अप्रैल 3, 2023/चत्रै 13, 1945 No. 81] NEW DELHI, MONDAY, APRIL 3, 2023/CHAITRA 13, 1945 वाजणज्य और उद्योग मत्रं ालय (वाजणज्य जवभाग) ( ) ubZ fnYyh अप्रैल, 2023 जवषय : &le;&le; ij ;Fkk la'kkfs/kr fon's k O;kikj uhfr] 2015&20 ds iSjk 2-04 ds rgr iznÙk 'kfDr;kas dk iz;kxs djrs gq, egkfun's kd] fon's k O;kikj ,rn}kjk vkS"k/k la#i.k dh fu;kZr [kis kas ds fy, [kkstchu iz.kkyh ds dk;kZUo;u grs q izfØ;k fu/kkZfjr dju s lac/a kh fnukad 05-01-2016 dh lkoZtfud lwpuk la- 52@2015&20] fnukda 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] fnukda 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 fnukda 30-03-2021 vkSj lkoZtfud lwpuk la- 01@2015&2020 fnukda 4-01-2022 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 2247GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 2- izfØ;k iqLrd 2015&20 ds iSjk 2-90d ¼vi½ vkSj ¼vii½ es a ¼fnukad 04-01-2022 dh lkoZtfud lwpuk la[;k 01@2015&2020 }kjk ;Fkkla'kksf/kr½] ^^fnukad 31-03-2023^^ dks fnukda 01-08-2023 }kjk izfrLFkkfir fd;k tk,A vkS"k/k la#i.kksa ds blds iSdsftax Lrjkas es a ekrk&firk rqY; lac/a k cuk, j[ku s vkSj dsUnzh; iksVZy ij bls viyksM dju s ds lanHkZ esa ,l,lvkbZ vkSj xSj&,l,lvkbZ nkus ksa }kjk fofufeZr vkS"k/kks a ds fy, fu;kZr grs q [kkstchu iz.kkyh ds dk;kZUo;u dh rkjh[k 01-08-2023 rd c<+k nh xbZ gSA lark"sk dqekj lkjxa h] egkfuns'kd] fons'k O;kikj ,oa inus vij lfpo] MINISTRY OF COMMERCE AND INDUSTRY (Department of Commerce) (DIRECTORATE GENERAL OF FOREIGN TRADE) NOTIFICATION New Delhi, the 3rd April, 2023 Public Notice No. 3 /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, 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, 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 and Public Notice No. 01/2015-2020 dated 04.01.2022 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. 01/2015- 2020 dated 04.01.2022), " 31.3.2023" may be substituted by 01.08.2023". 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 upto 01.08.2023 for both SSI and non SSI manufactured drugs. SANTOSH KUMAR SARANGI, Director General of Foreign Trade, Ex-officio Addit. 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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