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Date: 16-Oct-2024 Category: Extra Ordinary State: Union Government Country: India

Amendment in Export Policy condition of Cough Syrup under Chapter 30 of Schedule II Export Policy of ITC HS 2022 reg

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

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Executive Summary & Key Takeaways

What it means

  • This gazette notification from the Directorate General of Foreign Trade (DGFT), Ministry of Commerce and Industry, India, amends the export policy condition for cough syrup (HSN 3004) under Chapter 30 of Schedule-II (Export Policy) of ITC (HS) 2022.
  • It modifies the mandatory testing requirements for cough syrup exports, introducing exemptions under specific circumstances.

Key Changes

  • The notification revises the policy condition for exporting cough syrup (HSN 3004).
  • Previously, all cough syrup exports required testing and a Certificate of Analysis (CoA) from specified laboratories.
  • The revised policy introduces exemptions:
  • (i) If the cough syrup is exported to the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea, or Switzerland, testing may be waived if the manufacturing plant/section has approval from those countries' regulatory agencies.
  • (ii) If the cough syrup is manufactured in a plant/section approved by the regulatory agencies of the aforementioned countries for any product, it can be exported to any country without the mandatory testing.
  • The list of approved laboratories for testing has been expanded to include:
  • • Bee Pharmo Labs Pvt. Ltd, Thane
  • • Oasis Test House, Ahmedabad
  • • Shriram Institute for Industrial Research, New Delhi
  • • Any NABL accredited State Drugs Testing Laboratory

Impact Analysis

Impact on Exporters

  • Action Item: Exporters should review the updated notification to determine if they qualify for the testing exemptions. They should also update their testing procedures accordingly.

Impact on Testing Laboratories

  • Action Item: Laboratories should assess the potential impact on their business and adjust their capacity and marketing strategies accordingly.

Impact on Regulatory Agencies

  • Action Item: Regulatory agencies should continue to collaborate to ensure the quality and safety of exported cough syrups.

Impact on Consumers

  • Action Item: Consumers should remain vigilant and check for product authenticity and quality.

Key Entities Referenced

Directorate General of Foreign Trade (DGFT): The issuing authority of the notification, responsible for regulating foreign trade in India. Ministry of Commerce and Industry: The parent ministry under which DGFT operates. Foreign Trade (Development & Regulation) Act, 1992: The legal basis for the notification's issuance. Foreign Trade Policy 2023: The policy document under which the amendment is made. ITC (HS) 2022: The Integrated Tariff of India (Harmonized System) 2022, which classifies goods for customs purposes. Indian Pharmacopoeia Commission: One of the approved laboratories for testing cough syrup. Central Drugs Laboratory (CDL), Kolkata: One of the approved laboratories for testing cough syrup. Central Drugs Testing Laboratory (CDTL): One of the approved laboratories for testing cough syrup, with multiple locations. Regional Drugs Testing Laboratory (RDTL): One of the approved laboratories for testing cough syrup, with multiple locations. NABL accredited State Drugs Testing Laboratory: Any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories is also approved. Bee Pharmo Labs Pvt. Ltd: A newly added approved laboratory for testing cough syrup. Oasis Test House: A newly added approved laboratory for testing cough syrup. Shriram Institute for Industrial Research: A newly added approved laboratory for testing cough syrup.
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.-17102024-257977 CG-DxLx-xEG-I1D7H1x0x2x0 24-257977 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 4185] नई दिल्ली, बुधवार, अक्त बू र 16, 2024/आज‍व न 24, 1946 जतवार, जसतम्ब र 25, 2024/भाद्र 21, 1946 No. 4185] NEW DELHI, WEDNESDAY, OCTOBER 16, 2024/ASVINA 24, 1946 MBER 25, 2024/BHADRA 21, 1946 fons'k O;kikj egkfuns'kky; vf/klwpuk ubZ fnYyh] 1 vDrwcj ] 2024 II का. आ. 4549(अ).–––le;&le; ij ;Fkk la'kkfs/kr fons'k O;kikj uhfr 2023 ds iSjk 1-02 vkjS 2- 01 ds lkFk ifBr fons'k O;kikj ¼fodkl ,oa fofu;eu½ vf/kfu;e] 1992 dh /kkjk 5 ds lkFk ifBr /kkjk 3 }kjk çnÙk 'kfä;ks a dk ç;kxs djrs gq,] vkSj vf/klwpuk la[;k 06@2023 fnukda 22-05-2023 ds Øe eas] dsaæ ljdkj vkbVhlh ¼,p,l½ 2022 dh vuqlwph&II ¼fu;kZr uhfr½ ds v/;k; 30 ds varxZr ,p,l,u 3004 ds fy, fu;kZr uhfrxr 'krZ dks rRdky çHkko ls fuEukuqlkj la'kkfs/kr djrh gS% 6745 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] शर् त श शर् त शर्त 1 dQ flji dks fu;kZr djus dh i dQ flji dk s fu;kZr djus dh vuqefr vuqefr fu;kZr uewus ds ijh{k.k vkSj fu;kZr uewus ds ijh{k.k vkSj fuEufyf[kr es a fuEufyf[kr es a ls fdlh Hkh ls fdlh Hkh ç;kxs 'kkyk }kjk tkjh fd, x, ç;kxs 'kkyk }kjk tkjh fo'ys"k.k fo'ys"k.k çek.ki= ¼lhvks,½ ds çLrqr djus çek.ki= ¼lhvk,s ½ çLrqr djus ds ds v/khu gkxs h% v/khu gkxs h% • bafM;u QkekZdksfi;k deh” ku] • bafM;u QkekZdksfi;k deh” ku] xkft;kckn] mÙkj çns'k xkft;kckn] mÙkj çns'k • lhMh,y] dksydkrk] if'pe caxky • lhMh,y] dksydkrk] if'pe caxky • lhMhVh,y] pUs ubZ] rfeyukMq • lhMhVh,y] pUs ubZ] rfeyukMq • lhMhVh,y] eaqcbZ] egkjk"Vª • lhMhVh,y] eaqcbZ] egkjk"Vª • lhMhVh,y] gnS jkckn] rsyaxkuk • lhMhVh,y] gnS jkckn] rsyaxkuk • vkjMhVh,y] pMa hx<+ • vkjMhVh,y] pMa hx<+ • vkjMhVh,y] xqokgkVh] vle • vkjMhVh,y] xqokgkVh] vle • ,u,ch,y ekU;rk çkIr dkbs Z Hkh jkT; • ,u,ch,y ekU;rk çkIr dkbs Z Hkh vkS"kf/k ijh{k.k ç;kxs 'kkyk jkT; vkS"kf/k ijh{k.k ç;kxs 'kkyk • ch QkekZs ySCl çkboVs fyfeVsM Bk.k]s lh • ch QkekZs ySCl çkboVs fyfeVsM 2 gVds'k m|kxs uxj] ehjk Hkk;anj jksM] Bk.k]s lh 2 gVds'k m|kxs uxj] ehjk ehjk jkMs ¼iow ½Z ] Bk.k&s 401107] egkjk"VªA Hkk;anj jkMs ] ehjk jkMs ¼iow Z½] • vk,s fll VsLV gkml] 24&,] ch ljnkj Bk.k&s 401107] egkjk"VªA iVsy] vkS|ksfxd ,LVsV] ukjksy] • vk,s fll VsLV gkml] 24&,] ch vgenkckn&382407] xtq jkrA ljnkj iVsy] vkS|ksfxd ,LVsV] • Jhjke baLVhVîVw Q‚j baMfLVª;y fjlpZ ukjksy] vgenkckn&382407] xqtjkrA ¼Jhjke lkbafVfQd ,aM baMfLVª;y fjlpZ • Jhjke baLVhV~îwV Q‚j baMfLVª;y QkmaMs'ku dh ,d bdkb½Z ] 19&;wfuoflVZ h fjlpZ ¼Jhjke lkbafVfQd ,aM jkMs ] ubZ fnYyh&110007 baMfLVª;y fjlpZ QkmaMs'ku dh ,d ii ;fn fuekZrk dQ flji dk s ;w,l,] bdkb½Z ] 19&;wfuoflVZ h jkMs ] ubZ ;wds] dukMk] bZ;w] tkiku] v‚LVªsfy;k] fnYyh&110007 flaxkiqj] dkfsj;k x.kjkT; vkSj fLoV~tjySaM dk s fu;kZr dj jg s gSa] rks mfYyf[kr ns” kka s ds fy, fu;ked ,tsfal;kas }kjk dQ flji ds fofuekZ.k ,o a fu;kZr eas yxs la;a=kas@[k.Mkas ds fy, nh xbZ eatwjh ds eíus t+j] Åij ¼i½ eas mfYyf[kr ç;kxs 'kkykvks a ls ijh{k.k dh vko';drk ls NwV nh tk ldrh gSA iii blds vykok] ;fn dQ flji fdlh mRikn ds fy, ¼ii½ eas mfYyf[kr ns'kka s ds fy, fu;ked ,tsfal;kas }kjk vuqeksfnr la;a=@[kaM eas fofufeZr fd;k tkrk gS] rks[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 ,ls s dQ flji dks Åij ¼i½ eas vfuok;Z ijh{k.k ds fcuk fdlh Hkh ns'k eas fu;kZr djus dh vuqefr gkxs hA ,p,l,u 3004 ds rgr ^dQ flji^ ds fu;kZr uewus ds vfuok;Z ijh{k.k ls vko” ;d th,eih ekun.Mks@a ekudkas ds vuqlkj Åij ;Fkk of.kZr fLFkfr;ks a es a NwV nh xbZ Gs a lark"s k dqekj lkjaxh Ekgkfuns'kd] fons'k O;kikj ,oa insu vij lfpo ¼Qk- l-a 01@91@180@21@,,e20@bZlh@Hkkx&VII@bZ&21207 ls tkjh½ MINISTRY OF COMMERCE and INDUSTRY (Department of Commerce) (DIRECTORATE GENERAL OF FOREIGN TRADE) Notification New Delhi, the 1st October, 2024 No. 35/2024-25 Subject: Amendment in Export Policy condition of Cough Syrup under Chapter 30 of Schedule-II (Export Policy) of ITC (HS) 2022-reg. S.O. 4549(E).— In exercise of powers conferred by Section 3 read with section 5 of the Foreign Trade (Development & Regulation) Act, 1992, read with Para 1.02 and 2.01 of the Foreign Trade Policy 2023, as amended from time to time, and in continuation of the Notification No. 06/2023 dated 22.05.2023, the Central Government amends the Export Policy condition for HSN 3004 under Chapter 30, Schedule-II (Export Policy) of ITC(HS) 2022, with immediate effect as under: Policy Existing Policy Condition Revised Policy Condition Condition No. 1 Cough Syrup shall be permitted to (i) Cough Syrup shall be permitted to be be exported subject to the export exported subject to the export sample being sample being tested and tested and production of Certificate of Analysis production of Certificate of (CoA) issued by any of the following Analysis (CoA) issued by any of laboratories: the following laboratories: • Indian Pharmacopoeia Commission, • Indian Pharmacopoeia Ghaziabad, Uttar Pradesh Commission, Ghaziabad, Uttar Pradesh • CDL, Kolkata, West Bengal • CDL, Kolkata, West • CDTL, Chennai, Tamil Nadu Bengal • CDTL, Mumbai, Maharashtra • CDTL, Chennai, Tamil • CDTL, Hyderabad, Telangana Nadu4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] • CDTL, Mumbai, • RDTL, Chandigarh Maharashtra • RDTL, Guwahati, Assam • CDTL, Hyderabad, • Any NABL accredited State Drugs Telangana Testing Laboratory • RDTL, Chandigarh • Bee Pharmo Labs Pvt. Ltd Thane, C 2 • RDTL, Guwahati, Assam Hatkesh Udyog Nagar, Mira Bhayander Road, Mira Road (East), thane-401107, • Any NABL accredited Maharastra. State Drugs Testing Laboratory • Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol, Ahmedabad- • Bee Pharmo Labs Pvt. Ltd 382407, Gujarat. Thane, C 2 Hatkesh Udyog Nagar, Mira Bhayander • Shriram Institute for Industrial Research Road, Mira Road (East), (A unit of Shriram Scientific and thane-401107, Maharastra. Industrial Research Foundation), 19- University Road, New Delhi-110007 • Oasis Test House, 24-A, B Sardar Patel, industrial (ii) In case, the manufacturers are exporting the Estate, Narol, Ahmedabad-Cough Syrup to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and 382407, Gujarat. Switzerland, the requirement of testing from the • Shriram Institute for laboratories mentioned at (i) above may be waived off, in view of approval granted by these Industrial Research (A unit countries’ regulatory agencies for plants/section of Shriram Scientific and engaged in manufacturing and export of Cough Industrial Research Syrup. Foundation), 19-University (iii) Further, if Cough Syrup is manufactured in a Road, New Delhi-110007 plant/section approved by the regulatory agencies for above mentioned countries at (ii) for any product, such Cough Syrup shall be permitted to be exported to any country without testing as mandated at (i) above. Effect of this Notification: The mandatory testing of the export sample of ‘Cough Syrup’ under HSN 3004 is exempted in certain situations as mentioned above in accordance with the required GMP benchmarks/standards. SANTOSH KUMAR SARANGI, Director General of Foreign Trade, Ex-Officio Addl. Secy. ( F. No. 01/91/180/21/AM20/EC/Part-VII/e- 21207) 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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