The Ministry of Commerce and Industry in on October 18, 2024 announced significant changes to the export policy for cough syrups under Chapter 30 of the ITC (HS) 2022.
Key Amendments to the Export Policy
Expanded Testing Laboratory List
Existing Policy Condition
Previously, the export of cough syrup was permitted under the following conditions:
Cough Syrup must be tested, and a Certificate of Analysis (CoA) had to be issued by one of the following laboratories:
- Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh
- CDL, Kolkata, West Bengal
- CDTL, Chennai, Tamil Nadu
Revised Policy Condition
The revised policy expands the list of acceptable laboratories and introduces new provisions:
Cough Syrup must be tested, and a CoA must now be 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
- Oasis Test House, Ahmedabad
- Shriram Institute for Industrial Research, New Delhi
Waiver of Testing for Certain Destinations
A notable change is the waiver of the testing requirement for exports to specific countries. If manufacturers are exporting cough syrup to countries such as the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea, and Switzerland, the requirement for testing can be waived if the plants are approved by these countries’ regulatory agencies.
Broader Export Permissions
Additionally, if the cough syrup is produced in a facility that meets the regulatory standards of the aforementioned countries, it can be exported without mandatory testing. This change is aimed at facilitating smoother trade for manufacturers compliant with international benchmarks.
