DGFT eases policy conditions on Cough Syrup Exports to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland 

NEW DELHI : The Directorate General of Foreign Trade ( DGFT ) has eased export policy conditions on the export of cough syrups to select countries, including the USA, UK, Canada, the European Union, Japan, Australia, Singapore, the Republic of Korea, and Switzerland. The announcement, made through a notification dated October 1, 2024, significantly relaxes the mandatory testing requirements that were previously in place for cough syrup exports.

Key Changes in the Cough Syrup Export Policy

Previously, all cough syrup exports under HSN 3004 required mandatory testing of export samples in designated laboratories within India. The export of cough syrup was subject to the issuance of a Certificate of Analysis (CoA) by authorised laboratories such as the Indian Pharmacopoeia Commission in Ghaziabad, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, and others.

However, the revised policy now exempts exporters from this mandatory testing requirement if the products are being exported to the aforementioned countries. This exemption applies if the cough syrup is manufactured in facilities approved by the regulatory agencies of these countries. The DGFT’s notification recognizes the stringent regulatory approvals provided by these international bodies, allowing Indian manufacturers to bypass additional domestic testing for exports to these specific markets.

1. Regulatory Approval: If the cough syrup is manufactured in a plant or section approved by the regulatory agencies of the USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea, or Switzerland, the requirement for testing from Indian laboratories is waived. This approval applies to plants that are already certified for manufacturing and exporting any product to these countries.

2. Wider Export Flexibility: Cough syrup manufactured in such approved facilities may also be exported to any other country without the need for mandatory testing in Indian laboratories. This move aims to reduce redundancy and streamline the export process for pharmaceutical companies operating under internationally approved standards.

The relaxation of the export policy is expected to facilitate faster clearance and enhance the competitiveness of Indian pharmaceutical companies in global markets, especially in regions with stringent regulatory standards. This decision aligns with India’s objective of promoting its pharmaceutical exports while ensuring compliance with Good Manufacturing Practices (GMP) benchmarks.

By recognizing the regulatory standards of advanced markets, the DGFT has opened the door for more efficient export processes, reducing time and costs for Indian manufacturers.