Executive Summary:
This notification amends the export policy condition for cough syrup under Chapter 30 of Schedule II Export Policy of ITCHS 2022, effective immediately. It revises the list of laboratories authorized to issue Certificates of Analysis (CoA) for exported cough syrup and introduces exemptions for manufacturers exporting to specific countries with stringent regulatory approvals. The notification aims to align with required GMP benchmarks and standards.
Key Points / Main Content:
Revised Policy Condition for Cough Syrup Export:
* Cough syrup export is permitted subject to export sample testing and CoA issuance by specific laboratories.
* The list of approved laboratories now includes: Indian Pharmacopoeia Commission (Ghaziabad), CDL (Kolkata), CDTL (Chennai, Mumbai, Hyderabad), RDTL (Chandigarh, Guwahati), Any NABL accredited State Drugs Testing Laboratory, Bee Pharmo Labs Pvt. Ltd (Thane), Oasis Test House (Ahmedabad), and Shriram Institute for Industrial Research (New Delhi).
Exemptions from Mandatory Testing:
* Testing from the listed laboratories may be waived for manufacturers exporting cough syrup to the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea, and Switzerland, if their plants are approved by these countries' regulatory agencies.
* If cough syrup is manufactured in a plant section approved by the regulatory agencies of the countries mentioned above, export to any country is permitted without mandatory testing.
Impact Analysis:
Manufacturers/Exporters of Cough Syrup:
* Impact: Modified requirements for exporting cough syrup, including changes to approved testing laboratories and potential exemptions from testing based on destination country and manufacturing plant approvals.
* Action Required: Review and comply with the updated list of approved laboratories for CoA issuance, and determine eligibility for testing exemptions based on export destination and regulatory approvals of manufacturing plants.
Testing Laboratories:
* Impact: Revised list of approved laboratories authorized to conduct export sample testing of cough syrup.
* Action Required: Ensure adherence to required standards and guidelines for testing and certification of cough syrup intended for export.
Directorate General of Foreign Trade (DGFT):
* Impact: Responsible for implementing and enforcing the amended export policy condition.
* Action Required: Monitor and ensure compliance with the revised policy condition for cough syrup exports.
Key Entities Referenced
Foreign Trade Development Regulation Act, 1992: Indian Act that confers powers to the Central Government in relation to import and export policies.
Foreign Trade Policy 2023: The prevailing Foreign Trade Policy of India.
Directorate General of Foreign Trade: The agency of the Ministry of Commerce and Industry, Government of India responsible for implementing the Foreign Trade Policy.
ITC HS 2022: Indian Trade Classification based on Harmonized System (HS) codes, used for classifying goods in import and export.
Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh: An autonomous institution of the Ministry of Health & Family Welfare, Government of India, responsible for setting standards for drugs and pharmaceuticals in India, located in Ghaziabad, Uttar Pradesh.
CDTL, Kolkata, West Bengal: Central Drugs Testing Laboratory located in Kolkata, West Bengal, India.
CDTL, Mumbai, Maharashtra: Central Drugs Testing Laboratory located in Mumbai, Maharashtra, India.
RDTL, Guwahati, Assam: Regional Drugs Testing Laboratory located in Guwahati, Assam, India.
(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
cares aicemav WR iaiiawth
New Delhi, Dated: | October 2024
Subject: Amendment in Export Policy condition of Cough Syrup under Chapter 30 of
Schedule-II (Export Policy) of ITC (HS) 2022-reg.
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
|Condition
INo.
Cough Syrup shall be permitted t
1
sample being tested and
production of Certificate of
ithe following laboratories:
Uttar Pradesh
e CDL, Kolkata, West
Bengal
Nadu
« CDTL, Mumbai,
Maharashtra
« CDTL, Hyderabad,
Telangana
« RDTL, Chandigarh
[Revised Policy Condition
to (i) Cough Syrup shall be permitted to be
be exported subject to the export exported subject to the export sample being
tested and production of Certificate of
[Analysis (CoA) issued by any of the following
Analysis (CoA) issued by any of laboratories:
Indian Pharmacopoeia Commission,
e Indian Pharmacopoeia Ghaziabad, Uttar Pradesh
Commission, Ghaziabad,
CDL, Kolkata, West Bengal
CDTL, Chennai, Tamil Nadu
CDTL, Mumbai, Maharashtra
e CDTL, Chennai, Tamil 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
me+ RDTL, Guwahati, Assam |
e 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, Ahmedabad-|
382407, Gujarat.
Shriram Institute for
Industrial Research (A unit}
of
~~ Bhayander | Road, Mira Road (East), |
thane-401107, Maharastra.
Oasis Test House, 24-A, B Sardar
Patel, industrial Estate, Narol,
Ahmedabad-382407, Gujarat.
e 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
IKorea 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
Shriram Scientific and
agencies for plants/section engaged in
Industrial Research
manufacturing and export of Cough Syrup.
Foundation), 19-
University Road, New (iii) Further, if Cough Syrup is manufactured
Delhi-110007 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.
Bom
(Santosh Kumar Sarangi)
Director General of Foreign Trade
Ex-Officio Additional Secretary, Government of India
E-mail: dgft@nic.in
(Issued from F. No. 01/91/180/21/AM20/EC/Part-VII/e- 21207)