Government Notifies Permitted Import of Opium Alkaloids for Export-Oriented Drug Manufacturing

The Ministry of Finance (Department of Revenue) issued Notification S.O. 5726(E) on December 10, 2025, to regulate the import of specific narcotic substances for pharmaceutical manufacturing. This notification, published in the Gazette of India, permits a select group of manufacturers to import morphine, codeine, thebaine, and their salts, collectively referred to as alkaloids. The primary purpose of this allowance is for the exclusive use of these alkaloids in the manufacture of drugs or formulations intended solely for export. The issuance of this notification is in pursuance of the proviso to rule 54 of the Narcotics Drugs and Psychotropic Substances Rules, 1985, which provides the legal framework for such permissions.

The notification specifies that the fifteen permitted manufacturers, whose names and addresses are detailed in a table appended to the notification, must adhere to the procedures outlined in rules 55, 56, 58, 59, and 62 of the said rules. Crucially, it mandates that any drug or formulation containing the imported alkaloids shall be exported within 180 days from the date of import. This period may be extended by an additional 30 days upon application to the Narcotics Commissioner, provided the total period, including any extension, does not exceed 270 days in any case. Furthermore, any quantity of morphine, codeine, thebaine, and their salts or finished formulations for export that remain unutilised shall be surrendered to the Government Opium and Alkaloids Works. The Narcotics Commissioner also retains the authority to impose such other conditions and limitations as deemed necessary. The notification came into force upon its publication in the Official Gazette on December 10, 2025, and will remain effective until December 31, 2027. Import certificates issued in Form 4A up to this date will be valid for 180 days from their date of issue.

This regulatory measure aims to streamline and facilitate the operations of India's pharmaceutical export sector, particularly for products requiring controlled substances as raw materials. By explicitly listing permitted manufacturers and setting clear conditions, the Central Government seeks to balance the promotion of pharmaceutical exports with stringent control over narcotic drugs and psychotropic substances, preventing their diversion for illicit purposes. The earlier legal position, governed by the Narcotics Drugs and Psychotropic Substances Rules, 1985, provided the overarching framework, and this notification addresses the practical need to operationalize specific permissions under Rule 54's proviso.

The legislation provided: “In pursuance of the proviso to rule 54 of the Narcotics Drugs and Psychotropic Substances Rules, 1985 (hereinafter referred to as the said rules), the Central Government, hereby notifies that the manufacturers mentioned in the Table below are permitted to import morphine, codeine, thebaine and their salts (hereinafter called alkaloids) for use exclusively in manufacture of drugs or formulations to be exported and the said manufacturers shall comply with the procedure specified in rules 55, 56, 58, 59 and 62 of the said rules, and the following conditions, namely:-” This core provision underscores the legislative intent to enable controlled import for export-oriented manufacturing. The notification effectively fills a potential gap by identifying specific entities and detailing the procedural and temporal obligations for handling these sensitive raw materials. It introduces new obligations for the listed manufacturers, including strict timelines for export and the requirement to surrender unutilised stock, thereby strengthening enforcement mechanisms within the existing statutory framework. This approach ensures that while the pharmaceutical industry can access necessary raw materials for global markets, the inherent risks associated with narcotic substances are rigorously managed.

Keywords: Narcotics, Psychotropic Substances, Import, Morphine, Codeine, Thebaine, Pharmaceutical Export, Drug Manufacturing, Ministry of Finance, India, Notification Geo Tags: India, New Delhi District: Not Applicable