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DGFT - Highlights / Catch Notes

Home Highlights February 2025 Year 2025 This

DGFT has withdrawn Para 2.76 of Handbook of Procedures 2023 ...


Drug Authentication System for Export Formulations Shifts from DGFT to Health Ministry Under Drug Rules 1945

February 1, 2025

Circulars     DGFT

DGFT has withdrawn Para 2.76 of Handbook of Procedures 2023 (formerly Para 2.90A of HBP 2015-2020) regarding Track and Trace system for export of drug formulations, exercising powers under Paragraphs 1.03 and 2.04 of Foreign Trade Policy 2023. The responsibility for implementing authentication systems for exported drug formulations now transfers to Ministry of Health and Family Welfare, to be administered under Drug Rules 1945. The withdrawal takes immediate effect, marking a significant shift in regulatory oversight of pharmaceutical exports from trade authorities to healthcare regulators.

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