The Directorate General of Foreign Trade (DGFT) issued Notification No. 35/2024-25 on 1st October 2024, amending the export policy for cough syrup under Chapter 30 of Schedule-II (Export Policy) of ITC (HS) 2022. This amendment affects HSN 3004 and changes the conditions under which cough syrup can be exported. Previously, all exports required testing and a Certificate of Analysis (CoA) from specified laboratories. However, the revised policy allows manufacturers exporting to the USA, UK, Canada, EU, Japan, Australia, Singapore, South Korea, and Switzerland to bypass this testing requirement if the manufacturing plants are approved by the regulatory agencies of these countries.
Moreover, if the plant manufacturing the cough syrup is approved for any product by these regulatory agencies, the syrup can be exported to any country without the mandatory testing. This change simplifies the export process for compliant manufacturers while ensuring that necessary standards are met for other markets.
The notification seeks to streamline the export of cough syrup while maintaining adherence to Good Manufacturing Practice (GMP) standards and ensuring regulatory approvals are in place where required.
MINISTRY OF COMMERCE and INDUSTRY
(Department of Commerce)
(DIRECTORATE GENERAL OF FOREIGN TRADE)
Notification No. 35/2024-25 – DGFT | Dated: 1st October, 2024
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 Condition No. | Existing Policy Condition | Revised Policy Condition |
| 1 |
|
(i) Cough Syrup shall be permitted to be exported subject to the export sample being tested and production of Certificate of Analysis
(CoA) issued by any of the following
(ii) In case, the manufacturers are exporting the Cough Syrup to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland, the requirement of testing from the laboratories mentioned at (i) above may be waived off, in view of approval granted by these countries’ regulatory agencies for plants/section engaged in manufacturing and export of Cough 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)
