Home India Ministry of Finance Notification S.O. 5726(E) dated 10.12.2025 under Rule 54 of ...
Date: 2025-12-10 Category: Not Applicable State: Union Government Country: India

Notification S.O. 5726(E) dated 10.12.2025 under Rule 54 of NDPS Act, 1985

Issued by Ministry of Finance · Department of Revenue

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Executive Summary & Key Takeaways

**Executive Summary** This notification, issued by the Ministry of Finance (Department of Revenue), permits specified manufacturers to import morphine, codeine, thebaine, and their salts (alkaloids) for use exclusively in the manufacture of drugs or formulations to be exported. The notification is effective until December 31, 2027. Any import certificate issued in Form 4A up to December 31, 2027, will be valid for 180 days from the date of issue. **Key Points / Main Content** * **Import Permission:** * The Central Government authorizes manufacturers listed in the notification to import morphine, codeine, thebaine, and their salts (alkaloids). * These alkaloids must be used exclusively in the manufacture of drugs or formulations intended for export. * **Compliance Requirements:** * Manufacturers must adhere to the procedures outlined in rules 55, 56, 58, 59, and 62 of the Narcotics Drugs and Psychotropic Substances Rules, 1985. * **Export Timeframe:** * Drugs or formulations containing imported alkaloids must be exported within 180 days from the date of import. * An extension of up to 30 days may be granted by the Narcotics Commissioner upon application with valid reasons. * The total export period, including any extension, cannot exceed 270 days. * **Surrender of Unutilized Alkaloids:** * Any unused quantities of morphine, codeine, thebaine, their salts, or finished formulations intended for export must be surrendered to the Government Opium and Alkaloids Works. * **Additional Conditions:** * Manufacturers must adhere to any further conditions and limitations specified by the Narcotics Commissioner. * **Validity:** * The notification is valid from the date of its publication in the Official Gazette until December 31, 2027. * Import certificates issued in Form 4A up to December 31, 2027, are valid for 180 days from the date of issue. * **List of Manufacturers:** The notification provides a table listing fifteen manufacturers, along with their addresses, who are authorized to import the specified substances. **Impact Analysis** **Manufacturers Listed in the Table** * **Impact:** * Manufacturers are granted the authority to import morphine, codeine, thebaine, and their salts for export-oriented drug or formulation production. * These manufacturers must comply with the specified procedures and conditions to maintain import privileges. * **Action Required:** * Comply with all rules, regulations, and conditions outlined in the notification, including export timeframes and reporting requirements. * Surrender any unutilized alkaloids to the Government Opium and Alkaloids Works. **Narcotics Commissioner** * **Impact:** * The Narcotics Commissioner has the authority to grant extensions to the export timeframe, up to a maximum of 30 days. * The Narcotics Commissioner has the authority to set additional limits or conditions. * **Action Required:** * Process extension requests from manufacturers, ensuring they meet the specified requirements. * Oversee compliance with the rules and regulations of this notification.

Key Entities Referenced

Narcotic Drugs and Psychotropic Substances Rules, 1985: Governs the import and export of narcotic drugs and psychotropic substances in India. Narcotics Commissioner: Authority that can grant extensions to the time allowed for exporting drugs or formulations, and specify other conditions and limitations. Government Opium and Alkaloids Works: The entity to which unused morphine, codeine, thebaine, their salts or finished formulations meant for export have to be surrendered. New Delhi: Location where the notification was issued. Ministry of Finance: Primary department responsible for the notification regarding import of narcotics
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स.ं .ए.-33004/99 REGD.No.D.L.-33004/99 सी.जी.-डी.एल.-अ.-10122025-268396 CG-DxLx-xEG-I1D0H1x2x2x025-268396 xxxGIDExxx अाधा EXTRAORDINARY भाII—ण3—उ-ण(ii) PART II—Section 3—Sub-section (ii) पाधापा PUBLISHED BY AUTHORITY .ं 5538] ईदल,बुधा,दमब 10, 2025/अगाय 19, 1947 No. 5538] NEW DELHI, WEDNESDAY, DECEMBER 10, 2025/AGRAHAYANA 19, 1947 त ं ाय (ास भा) अधचू ा ई दल, 10 दमब, 2025 ा.आ. 5726(अ).— नय ा, सा ध औ :पभा ाथ य, 1985 (न इ आ उकयाया)  य54 ंु अुयअधूचदचईाउल ाथाओॉरफथ,,बाइऔउ ॉल(नइइ ाएलॉइडाया) थ आया ी ा ा ध या थ  उय   ए आया  ी अजु ा  औ य ाथाओ इ य य55, य56, य58, य59औय62 रथषपदयाऔ चई ो ाा , अाथ: - () आया एलॉइ युक ध या थ ा याथ, आया ी ा  ए  अस द ी अध  भ दया ाएा  सा आयुक  ऐ सा  ा औ आधा  ा आ   द  अध ी अध  ए बढाया ा ा ंुइ सा  ु अध द भ ा    त द  अध; () याथ एॉरफथ,,बाइऔउ ॉलयाय ाथीईभाा,ाउय  हआ , उ ाअफी औ एलॉइ थ  ौ दया ाएा। 8316 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] () ऐ अनय े औ ाएँ सा आयुक ाारथष ी ा  ।ै ा  ाथ ाओ ा ाऔ ा खं या 1. थ इा फााथसयूटल, इा ाउ, य ाथ, ब , अाबा, ुा –380054 । 2. थ  इं, 318/22-24, ा ॉथ,  ए , अधं (ई),ै ाथ-ए बै  ा, ुंबई – 400059। 3. थ ा फााथ , 58-, थ इंसय एस, चा, ांद (), ुंबई - 400067 । 4. थ ॉाथ , ॉाथ ाथ, बांा ुाथ ॉम्, ुंबई – 400051 । 5. थ एॉ इगा , 49- औ , बमाांा औ , अ ाु, बु- 560099 । 6. थ  फााथसयुट इंस ,  ाउ, ्ॉ ंब 201 ब1, सथ एप ाई, ां (ई), ुंबई-400063। 7. थ टा पाइ , ्ॉ ंब 3501  3515, 6301  6313 औ 16  , आई एस, अंश , भच ा, ुा-393002 । 8. थ  ृा फााथ, -4 औ , उ् ाा () उ् (ए),  च-ा ,  ाबा-500039,  ंाा। 9. थ  यू य ब, ्ॉंब 15ए, फा, ाुई, ाू -248011,उतां । 10. ए ट पाइ , ्ॉ ंब 115, एचएआई इंसय एटया ा, स ऑदफ ु ाा,  ााढ, ा (एच)-174101 । 11. थफीइंया,फीाउ,बंब117-ब,एएं बाथ,ाीा , ई, ुंबई-400072। 12. थ अलफा थ पाइ ,  ंब 225, ंब ां, , ं , च- ा,  ंाा-500101 । 13. थ एस ल पाइ , फ ्ॉ ंब S117, S118, S119 औ S120,  इंसय ॉम्, फ- III, , ुुं ायु, ा-632405 14. थ ाइ  , 57, -1/ब, एआई , आई, ा-396195, ु ा । 15. थ इंा फााथसयुटल , ॉ ाउ, ा ि  ा, ए ाई,  , अाबा-380054 2. यअधूचाा इ पा ी ा  31दंब, 2027  पृ   । 3.31दंब,2027प4ादयायाईभआयापा,आयापााीा  ए  अस द  ए धानय  ा। [फा. .ं ए.11012/1/2013-ए(ए-II)]  ुा, (सा यं)[भाII—ण 3(ii)] भााा:अाधा 3 MINISTRY OF FINANCE (Department of Revenue) NOTIFICATION New Delhi, the 10th December, 2025 S.O. 5726(E).— 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:- (a) 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; (b) 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. (c) such other conditions and limitations as may be specified by the Narcotics Commissioner. TABLE Sl. No. Name and Address of manufacturers 1. M/s. Troikaa Pharmaceuticals, Troikaa House, Satya Marg, Bodakdev, Ahmedabad, Gujarat – 380054. 2. M/s. Gepach International, 318/22-24, Kakad Corner, Sir M.V. Road, Andheri (E), Landmark-Opp Axis Bank, Mumbai – 400059. 3. M/s. Rusan Pharma Ltd,, 58-D, Government Industrial Estate, Charkop, Kandivali (W), Mumbai – 400067. 4. M/s. Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai – 400051. 5. M/s Adcock Ingram Ltd., 49-C and D, Bommasandra Industrial Area, Anekal Taluk, Bangaluru-560099 6. M/s Sun Pharmaceutical Industries ltd., Sun House, Plot No. 201 B1, Western Express Highway, Goregaon (E), Mumbai-400063 7. M/s Zentiva Pvt. Ltd. Plot No. 3501 to 3515, 6301 to 6313 & 16 meter road, GIDC Estate, Ankleshwar, Bharuch District, Gujarat-393002 8. M/s Sri Krishna Pharma, C-4 Industrial Area, Uppal Khalsa (V) Uppal (M), Medchal-Malkajgiri, Hyderabad-500039, Telangana 9. M/s Verve Human Care Laboratories, Plot No. 15A, Pharmacity, Selaqui, Dehradun-248011, Uttarakhand 10. Acme Generics Pvt. Ltd., Plot No. 115, HPSIDC Industrial Area Davni, P.O. Guru Majra, Tehsil Nalagarh, Distt. Solan (H.P)-174101 11. M/s Sanofi India Limited, Sanofi House, CTB No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai-400072 12. M/s Alphamed Formulations Private Limited, Survey No 225, Sampanbole Village, Shamirpet, Mandal, Medchal-Malkajgiri Dist. Telangana-500101 13. M/s Sthree Chemicals Pvt. Ltd., Factory Plot No. S117, S118, S119 & S120, Sipcot Industrial Complex, Phase-III, Sipcot, Mugundarayapuram, Ranipet-632405 14. M/s Micro Orgo Chem, 57, C-1/B, LIC Sector, GIDC, Vapi-396195, Gujarat 15. M/s Intas Pharmaceuticals Ltd., Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad- 380054 2. This notification shall remain in force from the date of its publication in the Official Gazette till the 31st day of December, 2027. 3. Any import certificate issued in Form 4A upto 31st day of December, 2027 shall be valid for a period upto one hundred and eighty days from the date of issue of the import certificate. [F. No. N.11012/1/2013-SO(NC-II)] VINOD KUMAR, Director (Narcotics Control) Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. S SA RIR VV AE SS TH A VKU AMAR DSDRi agItVi etA:a 2Sll 0Ty 2A s 5Vig .A1n 2 e .1d 0 b 2y 2 S :2A 3R :V 57E S +H 0 5K 'U 30M 'AR

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