To be published in the Gazette of India Extraordinary Part-II, Section-3, Sub-Section (ii)

Government of India
Ministry of Commerce & Industry
Department of Commerce
Directorate General of Foreign Trade
Vanijya Bhawan, New Delhi

Notification No. 35/2024-25

New Delhi, 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

 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 laboratories:
  • Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh
  • CDL, Kolkata, West Bengal
  • CDTL, Chennai, Tamil Nadu
  • CDTL, Mumbai, Maharashtra
  • CDTL, Hyderabad, Telangana
  • RDTL, Chandigarh
  • RDTL, Guwahati, Assam
  • Any NABL accredited State Drugs Testing Laboratory
  • Bee Pharmo Labs Pvt. Ltd Thane, C 2 Hatkesh Udyog Nagar, Mira Bhayander Road, Mira Road (East), thane-401107, Maharastra.
  • Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol, Ahmedabad382407, Gujarat.
  • Shriram Institute for Industrial Research (A unit of Shriram Scientific and Industrial Research Foundation), 19-University Road, New Delhi-110007
 (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 laboratories:
  • Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh
  • CDL, Kolkata, West Bengal
  • CDTL, Chennai, Tamil Nadu
  • CDTL, Mumbai, Maharashtra
  • CDTL, Hyderabad, Telangana
  • RDTL, Chandigarh
  • RDTL, Guwahati, Assam
  • Any NABL accredited State Drugs Testing Laboratory
  • Bee Pharmo Labs Pvt. Ltd Thane, C 2 Hatkesh Udyog Nagar, Mira Bhayander Road, Mira Road (East), thane-401107, Maharastra.
  • Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol, Ahmedabad382407, Gujarat.
  • Shriram Institute for Industrial Research (A unit of Shriram Scientific and Industrial Research  Foundation), 19-University Road, New Delhi-110007

(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. Secretary to Govt. of India

(F. No. 01/91/180/21/AM20/EC/Part-VII/e- 21207)