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Union finance ministry permits 15 firms to import morphine, codeine & thebaine with conditions
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Gireesh Babu, New Delhi
December 12 , 2025
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The Union ministry of finance has issued permission to 15 companies including Sun Pharmaceutical Industries, Workhardt, Sanofi India, and Intas Pharmaceuticals to import morphine, codeine, thebaine and their salts for manufacturing of drugs or formulations to be exported within a timeframe of 180 days from the date of import.
The Ministry also amended the form to be submitted by the companies for such imports, specifying the timeframe for export of the finished products.
In a notification listing the companies, the Department of Revenue, under the ministry of finance, said that under the provisions of the Rule 54 of the Narcotics Drugs and Psychotropic Substances Rules, 1985, the central government is notifying the manufacturers mentioned in the list 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," with certain conditions.
The manufacturers permitted to import these products through the notification include Sun Pharmaceutical Industries, Wockhardt Ltd, Sanofi India, Intas Pharmaceuticals, Troikaa Pharmaceuticals, Gepach International, Rusan Pharma, Adcock Ingram, Zentiva, Sri Krishna Pharma, Verve Human Care Laboratories, Acme Generics, Alphamed Formulations, Sthree Chemicals, and Micro Orgo Chem.
The permission is subject to conditions including that "the drug or the formulation containing the imported alkaloids shall be exported within a period of one hundred and eighty days from the date of import which may be extended by a further period not exceeding thirty days by making an application to the Narcotics Commissioner with the reasons and grounds of such extension provided that the total period including extension thereof shall not exceed two hundred and seventy days in any case".
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. Besides, the permission is subject to such other conditions and limitations as may be specified by the Narcotics Commissioner, said the notification.
The notification shall remain in force from the date of its publication in the Official Gazette till December 31, 2027. Any import certificate issued in Form 4A upto December 31, 2027 shall be valid for a period upto 180 days from the date of issue of the import certificate.
In another notification, the Department has also substituted the Form 4A, under which the companies can import these products, to include the condition that the consignment containing the drug shall be imported before a specific date and exported 180 days from the date of issue of import certificates, to the airport or seaport in India.
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 notification freshly directs that accounting for this purpose shall be submitted to the Narcotics Commissioner at the end of the period made available to the licensee for import under the certificate and subsequent export of the formulation and alkaloids.
The Rule 54 of the Narcotics Drugs and Psychotropic Substances Rules, 1985 prohibits the import of opium, concentrate of poppy straw, and morphine, codeine, thebaine and their salts with an exemption that if they are manufactured by manufactures notified by the government, for use in manufacture of products to be exported, among others, by following due procedure.
Rule 55 deals with application for import certificate, in such cases, Rule 56 with issue of import certificate, Rule 58 with application for export authorisation, Rule 59 with issue of export authorisation, and Rule 62 with diversion of consignment.
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