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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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