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Date: 2022-02-24 Category: Not Applicable State: Union Government Country: India

Amendment in Export Policy of Remdesivir Injection and API, Amphotericin-B Injections, Enoxaparin (Formulation and API) and Intra-Venous Immunoglobulin (IVIG) (Formulation and API) – regarding

Issued by Ministry of Commerce and Industry · Directorate General Of Foreign Trade

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Executive Summary & Key Takeaways

**Policy Summary: Amendment in Export Policy for Certain Pharmaceutical Products** **Date:** February 24, 2022 **Issuing Authority:** Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry, Government of India. **Subject:** Amendment to the export policy regarding Remdesivir Injection and API, Amphotericin B Injections, Enoxaparin Formulation and API, and IntraVenous Immunoglobulin (IVIG) Formulation and API. **Notification Number:** 56/2015-2020 **Key Change:** The export restrictions on the following pharmaceutical products have been removed, making their export "Free" with immediate effect: * Remdesivir Injection and Remdesivir Active Pharmaceutical Ingredients (API) * Amphotericin B Injections * Enoxaparin Formulation and API * IntraVenous Immunoglobulin (IVIG) Formulation and API **ITC HS Codes:** The amendment applies to the products listed above falling under the HS codes mentioned in the notification or any other relevant HS code. **Legal Basis:** The amendment is issued in exercise of powers conferred by Section 3 read with Section 5 of the Foreign Trade (Development and Regulation) Act, 1992, as amended, read with Para 1.02 and 2.01 of the Foreign Trade Policy, 2015-20. It also amends Notification No. 08/2015-20 dated 14.06.2021, Notification No. 07/2015-20 dated 01.06.2021 and Notification No. 50/2015-20 dated 10.01.2022 **Contact Information:** Santosh Kumar Sarangi, Director General of Foreign Trade & Ex-Officio Additional Secretary, Government of India, Email: dgft@nic.in. F. No. 01/91/180/24/AM22/EC E-27724.

Key Entities Referenced

IntraVenous Immunoglobulin IVIG Formulation: A medication containing antibodies, export policy of which is being amended. Directorate General of Foreign Trade: An agency of the Ministry of Commerce and Industry, Government of India responsible for implementing the Foreign Trade Policy. Foreign Trade Development Regulation Act, 1992: An act of the Parliament of India to provide for the development and regulation of foreign trade. Foreign Trade Policy, 2015-2020: A policy document outlining guidelines and objectives for promoting and regulating India's foreign trade. Remdesivir Injection: An antiviral medication used in the treatment of COVID-19, export policy of which is being amended. Amphotericin B Injections: An antifungal medication, export policy of which is being amended. Enoxaparin Formulation: An anticoagulant medication, export policy of which is being amended. New Delhi: Capital of India. Place of publication of the notification.
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Ministry of Commerce & Industry Department of Commerce Directorate General of Foreign Trade UdyogBhawan New Delhi Notification No. 56/2015-2020 New Delhi, Dated: 24" February, 2022 Subject: Amendment in Export Policy of Remdesivir Injection and API, Amphotericin-B Injections, Enoxaparin (Formulation and API) and Intra-Venous Immunoglobulin (IVIG) (Formulation and API) — regarding S.O. (E) In exercise of powers conferred by Section 3 read with Section 5 of the Foreign Trade (Development & Regulation) Act, 1992 (No. 22 of 1992), as amended, read with Para 1.02 and 2.01 of the Foreign Trade Policy, 2015-20, the Central Government hereby makes following amendment in Notification No. 08/2015-20 dated 14.06.2021, Notification No. 07/2015-20 dated 01.06.2021 and Notification No. 50/2015-20 dated 10.01.2022 related to export of Remdesivir Injection and API, Amphotericin-B Injections, Enoxaparin (Formulation and API) and Intra-Venous Immunoglobulin (IVIG) (Formulation and API): S.No ITC HS Codes Description Existing Policy Revised Policy Injection Remdesivir and - IRemdesivir Active : S 207AA actos Pharmaceutical Ingredients| Seni — Ex 300490 (API) 207AB ae ‘Amphotericin — B Injections Restricted Kies Ex 2942 Enoxaparin 207 AE Ex 3001 (Formulation and API) Restricted Free Ex 3002 Intra-Venous Immunoglobulin 207 AF Ex 3002 (IVIG) Restricted Free (Formulation and API) 2. Effect of this Notification: The export policy of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (APD, Amphotericin — B injections, Enoxaparin (Formulation and API) and Intra-Venous Immunoglobulin ({VIG) (Formulation and APJ) falling under HS code as mentioned above or falling under any other HS code has been made ‘Free’ with immediate effect. yor wt (Santosh Kumar Sarangi) Director General of Foreign Trade Ex-Officio Additional Secretary, Gol Email- dgft@nic.in (Issued from F. No. 01/91/180/24/AM22/EC /E-27724)

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