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Shardul Nautiyal, Mumbai March 13 , 2025
The Directorate General of Foreign Trade (DGFT) has invited pharma industry stakeholders, pharma exporters, Pharmaceuticals Export Promotion Council (Pharmexcil), and trade associations to submit their inputs on proposed amendments to the export authorization process for "Stock and Sale" of SCOMET (Special Chemicals, Organisms, Materials, Equipment, and Technologies) items.

DGFT has called for responses, views and recommendations within ten days of the issuance of this Trade Notice. Feedback can be sent via email to scomet-dgft@gov.in.

The amendments aim to enhance regulatory clarity, ensure compliance with international export control norms, and facilitate a streamlined authorization process for bulk exports of sensitive items.

The draft amendments pertain to Paragraph 10.10 of Chapter 10 in the Handbook of Procedures (HBP) 2023, which governs the bulk export of SCOMET items from Indian pharma exporters to foreign entities, known as stockists, for subsequent transfers to end users. The initiative aligns with Para 1.07A of the Foreign Trade Policy (FTP) 2023, emphasizing stakeholder consultation in policy formulation and amendments.

The revised framework outlines specific conditions under which an Indian exporter can obtain authorization for exporting SCOMET items (excluding certain categories) to an overseas stockist. The stockist may be a subsidiary, principal (parent) company, affiliate, or an Original Equipment Manufacturer (OEM)/Electronic Manufacturing Services (EMS)/Contract Manufacturer (CM).

Approval would be granted by the Inter-Ministerial Working Group (IMWG) based on documentary verification of the corporate relationship between the exporter and stockist, end-use declaration from the stockist through a specified End User Certificate (EUC), list of approved countries where re-export will be permitted, subject to IMWG clearance, compliance requirements, including submission of contracts, purchase orders, and adherence to export control regulations of the destination countries.

Procedural changes and compliance include a pre-approved country list. Authorization will be granted for export to stockists and their re-export to designated countries without requiring additional approvals.

Indian exporters must submit details of all transfers, including EUCs and Bills of Entry, within three months of each transaction. Exporters must seek fresh authorization from IMWG for re-exports to countries not included in the original approval.

Subsequent shipments to the same stockist and pre-approved end-users will be fast-tracked without needing further IMWG consultation. Exporters must provide a yearly statement on stockist inventory and transfers to final end-users by January 31 of the following year. Failure to adhere to reporting requirements may result in penalties or revocation of authorization.

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