Central Government Permits Select Manufacturers to Import Morphine, Codeine, Thebaine for Export Products

The Ministry of Finance, Department of Revenue, recently issued a significant notification, S.O. 4223(E), on September 25, 2023, granting specific permissions for the import of certain narcotic drugs. This notification, published in the Official Gazette, allows a select group of pharmaceutical manufacturers to import morphine, codeine, thebaine, and their salts. The primary purpose of this permission is to facilitate the use of these controlled substances in the manufacture of products destined for export. The Central Government exercised its powers under the proviso to rule 54 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, to issue this directive. The procedure for such imports mandates adherence to rule 55 of the said rules and compliance with conditions stipulated in the import certificate issued in Form No. 4A, which is annexed to the rules. The notification specifically lists eight manufacturers who are permitted to undertake these imports, including M/s Adcock Ingram Limited, M/s Rusan Pharma Ltd., M/s Sanofi India Limited, M/s Sun Pharmaceuticals Industries Ltd., M/s Verve Human Care Laboratories, M/s Wockhardt Limited, M/s Alphamed Formulations Private Limited, and M/s Cipla Ltd., located across various states such as Karnataka, Maharashtra, Uttarakhand, and Telangana. This permission came into force upon its publication in the Official Gazette on September 25, 2023, and is set to remain effective until December 31, 2024.

The legislative intent behind this notification is to strike a balance between stringent control over narcotic drugs and the promotion of India's pharmaceutical export capabilities. The earlier legal position, governed by the Narcotic Drugs and Psychotropic Substances Rules, 1985, generally imposes strict regulations on the import and use of such substances to prevent diversion and abuse. However, the Central Government recognized the need to address statutory gaps that might hinder the legitimate manufacturing of pharmaceutical products containing these substances, particularly when those products are intended solely for international markets. By granting this specific, time-bound exemption, the government aims to support the pharmaceutical industry's role as a global supplier while ensuring that the controlled substances are utilized strictly for their intended purpose under close supervision. The legislation provided: “In exercise of the powers conferred by the proviso to rule 54 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government hereby notifies that the manufacturers mentioned in the Table below are permitted to import morphine, codeine, thebaine and their salts for use in manufacture of products to be exported, after following the procedure specified in rule 55 of the said rules and subject to such conditions as may be specified in the import certificate issued in Form No. 4A annexed to the aforesaid rules, namely:-” This provision introduces a clear mechanism for specific entities to engage in activities that would otherwise be heavily restricted, thereby fostering economic activity in the pharmaceutical sector. The enforcement mechanisms are clearly outlined, requiring adherence to established procedures and conditions, ensuring accountability and preventing misuse. The fixed timeline until December 31, 2024, indicates a controlled and reviewable approach to this policy, allowing for reassessment of its impact and necessity.

Keywords: Narcotic Drugs, Psychotropic Substances, Import, Morphine, Codeine, Thebaine, Pharmaceutical Export, Central Government, India, Ministry of Finance Geo Tags: India, New Delhi, Maharashtra, Karnataka, Uttarakhand, Telangana District: Not Applicable