In exercise of the powers conferred by the proviso to rule 54 of the Narcotic Drugs and Psychotropic Substances Rules

## Policy Analysis Report: Notification S.O. 1014(E) Regarding Import of Narcotic Substances **1. Executive Summary:** This report analyzes Notification S.O. 1014(E), issued by the Ministry of Finance, Department of Revenue, on March 3, 2021, concerning the import of morphine, codeine, thebaine, and their salts. This notification permits specified manufacturers to import these substances for use in the manufacture of products intended for export, subject to adherence to established procedures and conditions outlined in existing rules and import certificates. The notification is valid until December 31, 2022. **2. Introduction:** This report aims to provide an informative overview of Notification S.O. 1014(E), based solely on the text provided. It outlines the notification's purpose, key provisions, affected parties, and potential impact, as understood from the available information. **3. Policy Overview:** * This is a *New Policy* that builds upon existing regulations. * **Core Objective(s):** The core objective of this notification is to permit specific manufacturers to import morphine, codeine, thebaine, and their salts, exclusively for use in the production of goods intended for export. This aims to support export-oriented pharmaceutical manufacturing using these controlled substances. **4. Background and Rationale:** * **New Policy:** The notification likely addresses the need to streamline and regulate the import of specific narcotic substances by pharmaceutical manufacturers involved in export activities. It potentially facilitates the legitimate production of pharmaceuticals for international markets while maintaining control over these substances. **5. Key Provisions / Changes:** * **New Policy:** * The notification explicitly permits the manufacturers listed in the table to import morphine, codeine, thebaine, and their salts. * This import is restricted for use *only* in the manufacture of products intended for export. * Manufacturers must follow the procedure outlined in Rule 55 of the Narcotic Drugs and Psychotropic Substances Rules, 1985. * Imports are subject to conditions specified in the import certificate (Form No. 4A) annexed to the aforementioned rules. * The notification specifies three manufacturers, including their names and addresses: Medley Pharmaceuticals Limited (Mumbai), Alphamed Formulations Private Limited (Telangana), and Micro Orgo Chem (Gujarat). * The notification is valid from the date of publication (March 3, 2021) until December 31, 2022. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders directly affected by this notification are: * The three manufacturers specifically named in the notification: Medley Pharmaceuticals Limited, Alphamed Formulations Private Limited, and Micro Orgo Chem. * Related Export Businesses. * The regulatory bodies responsible for overseeing the import and export of narcotic drugs and psychotropic substances. **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies:** The Ministry of Finance (Department of Revenue) is the issuing authority. Implementation likely involves collaboration with customs officials and drug control agencies to oversee imports and ensure compliance with Rule 55 and the import certificate conditions. * **Timelines or procedures:** The notification specifies a validity period ending on December 31, 2022. Manufacturers must adhere to the procedure outlined in Rule 55 of the Narcotic Drugs and Psychotropic Substances Rules, 1985 and any timelines associated with that rule. They also must follow any procedures regarding the import certificate (Form No. 4A). * This does not change any existing regulatory structure or procedure, beyond granting the three specified companies import access to controlled substances. **8. Expected Outcomes / Impact of Changes:** * **New Policy:** * Facilitation of the export-oriented pharmaceutical industry by ensuring access to necessary raw materials (morphine, codeine, thebaine, and their salts). * Strict control over the import and use of these substances, as they are limited to manufacturing for export purposes and subject to existing rules and import certificate conditions. * Potential economic benefits through increased pharmaceutical exports. **9. Conclusion:** Notification S.O. 1014(E) provides a framework for specific manufacturers to import controlled substances for export-oriented pharmaceutical production. It balances the need to support the pharmaceutical industry with the requirement to maintain strict control over narcotic drugs and psychotropic substances. The notification's limited validity period suggests it may be subject to review and renewal based on its performance and impact.

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