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Core Purpose

Notification amending the Export Policy condition for Cough Syrup (HSN 3004) under Chapter 30, Schedule-II of ITC (HS) 2022, expanding the list of approved testing laboratories and waiving testing requirements for exports to certain specified countries.

Detailed Summary

The Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry, by Notification No. 35/2024-25 (S.O. 4549(E)) dated 1st October 2024, exercising powers under section 3 read with section 5 of the Foreign Trade (Development & Regulation) Act, 1992, read with paragraphs 1.02 and 2.01 of the Foreign Trade Policy 2023, and in continuation of Notification No. 06/2023 dated 22.05.2023, amends, with immediate effect, the Export Policy condition for HSN 3004 (Cough Syrup) under Chapter 30, Schedule-II (Export Policy) of ITC (HS) 2022; the revised Policy Condition No. 1 permits export of Cough Syrup subject to testing of the export sample and production of a Certificate of Analysis (CoA) issued by an expanded list of laboratories, including the Indian Pharmacopoeia Commission (Ghaziabad, Uttar Pradesh), CDL (Kolkata, West Bengal), CDTL (Chennai, Tamil Nadu; Mumbai, Maharashtra; Hyderabad, Telangana), RDTL (Chandigarh; Guwahati, Assam), any NABL-accredited State Drugs Testing Laboratory, Bee Pharmo Labs Pvt. Ltd. (Thane, Maharashtra), Oasis Test House (Narol, Ahmedabad, Gujarat), and Shriram Institute for Industrial Research (New Delhi); it further provides that the testing requirement may be waived for manufacturers exporting Cough Syrup to the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland where the manufacturing plant/section has approval from those countries' regulatory agencies, and that Cough Syrup manufactured in such an approved plant/section may thereafter be exported to any country without the mandated testing; the notification states the effect is that mandatory export-sample testing of Cough Syrup under HSN 3004 is exempted in certain situations in accordance with required GMP benchmarks/standards; signed by Santosh Kumar Sarangi, Director General of Foreign Trade, Ex-Officio Additional Secretary, under F. No. 01/91/180/21/AM20/EC/Part-VII/e-21207.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-17102024-257977 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 4185] NEW DELHI, WEDNESDAY, OCTOBER 16, 2024/ASVINA 24, 1946 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 | • Indian Pharmacopoeia Commission, | | | Commission, Ghaziabad, | Ghaziabad, Uttar Pradesh | | | Uttar Pradesh | | | | | • CDL, Kolkata, West Bengal | | | • CDL, Kolkata, West | | | | Bengal | • CDTL, Chennai, Tamil Nadu | | | | | | | • CDTL, Chennai, Tamil | • CDTL, Mumbai, Maharashtra | | | Nadu | | | | | • CDTL, Hyderabad, Telangana | | | | | | | • CDTL, Mumbai, | • RDTL, Chandigarh | | | Maharashtra | | | | | | | | • CDTL, Hyderabad, | • RDTL, Guwahati, Assam | | | Telangana | | | | | • Any NABL accredited State Drugs | | | • RDTL, Chandigarh | Testing Laboratory | | | | | | | • RDTL, Guwahati, Assam | • Bee Pharmo Labs Pvt. Ltd Thane, C 2 | | | | Hatkesh Udyog Nagar, Mira Bhayander | | | • Any NABL accredited | Road, Mira Road (East), thane-401107, | | | State Drugs Testing | Maharastra. | | | Laboratory | | | | | • Oasis Test House, 24-A, B Sardar Patel, | | | • Bee Pharmo Labs Pvt. Ltd | industrial Estate, Narol, Ahmedabad- | | | Thane, C 2 Hatkesh Udyog | 382407, Gujarat. | | | Nagar, Mira Bhayander | | | | Road, Mira Road (East), | • Shriram Institute for Industrial Research | | | thane-401107, Maharastra. | (A unit of Shriram Scientific and | | | | Industrial Research Foundation), 19- | | | • Oasis Test House, 24-A, B | University Road, New Delhi-110007 | | | Sardar Patel, industrial | | | | Estate, Narol, Ahmedabad- | (ii) In case, the manufacturers are exporting the | | | 382407, Gujarat. | Cough Syrup to USA, UK, Canada, EU, Japan, | | | | Australia, Singapore, Republic of Korea and | | | • Shriram Institute for | Switzerland, the requirement of testing from the | | | Industrial Research (A unit | laboratories mentioned at (i) above may be | | | of Shriram Scientific and | waived off, in view of approval granted by these | | | Industrial Research | countries' regulatory agencies for plants/section | | | Foundation), 19-University | engaged in manufacturing and export of Cough | | | Road, New Delhi-110007 | Syrup. | | | | (iii) Further, if Cough Syrup is manufactured in a| | | | 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)

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