Home India Ministry of Finance Notification under Rule 54 of NDPS Act...
Date: 2025-12-10 Category: Extra Ordinary State: Union Government Country: India

Notification under Rule 54 of NDPS Act

Issued by Ministry of Finance · Department of Revenue

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Executive Summary & Key Takeaways

**Executive Summary** This notification from the Ministry of Finance (Department of Revenue) permits fifteen manufacturers listed in the document to import morphine, codeine, thebaine, and their salts for the exclusive purpose of manufacturing drugs or formulations for export. It outlines the conditions for import, export, and surrender of unutilized materials, effective until December 31, 2027. Import certificates issued until December 31, 2027, remain valid for 180 days from the date of issue. **Key Points / Main Content** * **Authorization for Import:** * The Central Government authorizes the manufacturers listed in the document to import morphine, codeine, thebaine, and their salts (alkaloids). * The alkaloids are intended solely for use in manufacturing drugs or formulations that will be exported. * **Compliance Requirements:** * Manufacturers must comply with procedures specified in rules 55, 56, 58, 59, and 62 of the Narcotics Drugs and Psychotropic Substances Rules, 1985. * **Export Timeframe:** * The drug or formulation 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, but the total period (including extension) must not exceed 270 days. * **Surrender of Unutilized Material:** * Any unused quantities of morphine, codeine, thebaine, their salts, or finished formulations for export must be surrendered to the Government Opium and Alkaloids Works. * **Additional Conditions:** * Manufacturers are subject to other conditions and limitations as specified by the Narcotics Commissioner. * **Validity Period:** * The notification is effective from the date of its publication in the Official Gazette until December 31, 2027. * **Import Certificate Validity:** * Any import certificate issued in Form 4A until December 31, 2027, will remain valid for 180 days from the date of issuance. **Impact Analysis** **Key Stakeholders:** **Narcotics Manufacturers (Listed in the Table)** * **Impact:** They are permitted to import specific narcotics for manufacturing drugs or formulations exclusively for export, subject to certain conditions. * **Action Required:** Comply with the conditions specified in the notification, including export timeframes, surrender of unutilized materials, and procedures outlined in the Narcotics Drugs and Psychotropic Substances Rules, 1985. **Narcotics Commissioner** * **Impact:** Responsible for granting extensions on export timeframes and specifying additional conditions and limitations for manufacturers. * **Action Required:** Process extension requests from manufacturers and specify any additional conditions as necessary. **Government Opium and Alkaloids Works** * **Impact:** Responsible for receiving unutilized narcotics from manufacturers. * **Action Required:** Receive and manage any surrendered quantities of morphine, codeine, thebaine, their salts, or finished formulations.

Key Entities Referenced

Narcotics Drugs and Psychotropic Substances Rules, 1985: Rules governing the import and export of narcotics and psychotropic substances in India, especially rule 54 pertaining to import of morphine, codeine and thebaine. Ministry of Finance: The central ministry responsible for issuing the notification regarding the import of alkaloids. Government Opium and Alkaloids Works: The entity to which unutilised morphine, codeine, thebaine and their salts must be surrendered. Narcotics Commissioner: The authority who can grant extensions for export deadlines and specify additional conditions. India: The country to which this gazette applies.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-10122025-268396 CG-DxLx-xEG-I1D0H1x2x2x0 25-268396 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 5538] नई दिल्ली, बुधिार, दिसम्ब र 10, 2025/अग्रहायण 19, 1947 No. 5538] NEW DELHI, WEDNESDAY, DECEMBER 10, 2025/AGRAHAYANA 19, 1947 जित्त मत्रं ालय (रािस्ट्ि जिभाग) अजधसचू ना नई दिल्ली, 10 दिसम् बर, 2025 का.आ. 5726(अ).— केन्द्रीय सरकार, स्ट्िापक ओषजध और मन:प्रभािी पिार्थ जनयम, 1985 (जिन्द्हें इसम ें आग े उक्त जनयम कहा गया ह)ै के जनयम 54 के परंतुक के अनुसरण में यह अजधसूजचत करती ह ैदक नीचे िी गई सारणी में उजल्लजखत जिजनमाथताओं को मॉर्फथन, कोडीन, र्ेबाइन और उनके सॉल््स (जिन्द्ह ेंइसमें इसके पश्चात ्एल्कलॉइड्स कहा गया ह)ै को जसर्फथ आयात की िाने िाली ओषजध या जिजनर्मथजत में उपयोग करन े के जलए आयात करने की अनज्ञु ा ह ै और ये जिजनमाथताओं इन जनयम के जनयम 55, जनयम 56, जनयम 58, जनयम 59 और जनयम 62 में जिजनर्िथष्ट प्रदिया और नीचे िी गई ितों का पालन करेंग,े अर्ाथत:् - (क) आयाजतत एल्कलॉइड युक्त ओषजध या जिजनर्मथजत का जनयाथत, आयात की तारीख से एक सौ अस्ट्सी दिन की अिजध के भीतर दकया िाएगा जिसे स्ट्िापक आयुक्त को ऐस े जिस्ट्तार के कारणों और आधारों के सार् आिेिन करके तीस दिन से अनजधक की अिजध के जलए बढाया िा सकता ह ैपरंत ुइसके जिस्ट्तार सजहत कुल अिजध दकसी भी मामले म ें िो सौ सत्तर दिन से अजधक नहीं होगी; (ख) जनयाथत के जलए मॉर्फथन, कोडीन, र्ेबाइन और उनके सॉल्ट या तयै ार जिजनर्मथजत की कोई भी मात्रा, जिसका उपयोग नहीं हुआ ह,ै उसे सरकारी अफीम और एल्कलॉइड िर्कसथ को सौंप दिया िाएगा। 8316 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (ग) ऐसी अन्द्य ितें और सीमाएँ िो स्ट्िापक आयुक्त द्वारा जनर्िथष्ट की िा सकती ह।ैं सारणी िम जनमातथ ाओं का नाम और पता सख्ं या 1. मैससथ रोइका फामाथस्ट्यूटटकल्स, रोइका हाउस, सत्य मागथ, बोडकिेि , अहमिाबाि, गुिरात – 380054 । 2. मैससथ िीपेक इंटरनेिनल, 318/22-24, काकड़ कॉनथर, सर एमिी रोड, अधं ेरी (ई), लडैं माकथ-एजर्कसस बैंक के सामने, मुंबई – 400059 । 3. मैससथ रुसान फामाथ जलजमटेड, 58-डी, गिनथमेंट इंडजस्ट्रयल एस्ट्टेट, चारकोप, कांदििली (पजश्चम), मुंबई - 400067 । 4. मैससथ िॉकहाटथ जलजमटेड, िॉकहाटथ टािसथ, बांरा कुलाथ कॉम््लेर्कस, मुंबई – 400051 । 5. मैससथ एडकॉक इनग्राम जलजमटेड, 49-सी और डी, बोम्मासांरा औद्योजगक क्षेत्र, अनेकल तालुक, बेंगलुरु- 560099 । 6. मैससथ सन फामाथस्ट्युटटकल इंडस्ट्रीि जलजमटेड, सन हाउस, ्लॉट नंबर 201 बी1, िेस्ट्टन थ एर्कसप्रेस हाईिे, गोरेगांि (ई), मुंबई-400063 । 7. मैससथ जेंटटिा प्राइिेट जलजमटेड, ्लॉट नंबर 3501 से 3515, 6301 से 6313 और 16 मीटर रोड, िीआईडीसी एस्ट्टेट, अंकलेश्वर , भरूच जिला, गुिरात-393002 । 8. मैससथ श्री कृष्णा फामाथ, सी-4 औद्योजगक क्षेत्र, उ्पल खालसा (िी) उ्पल (एम), मडे चल-मलकािजगरी , हिै राबाि-500039, तले ंगाना । 9. मैससथ ििे ह्यूमन केयर लेबोरीि, ्लॉट नंबर 15ए, फामेसी, सेलाकुई, िेहरािनू -248011, उत्तराखंड । 10. एर्कमे िेनटरक प्राइिेट जलजमटेड, ्लॉट नंबर 115, एचपीएसआईडीसी इंडजस्ट्रयल एटरया िािनी, पोस्ट्ट ऑदफस गरुु मािरा, तहसील नालागढ, जिला सोलन (एचपी)-174101 । 11. मैससथ सनोफी इंजडया जलजमटेड, सनोफी हाउस, सीटीबी नंबर 117-बी, एलएडं टी जबिनेस पाकथ, साकी जिहार रोड, पिई, मुंबई-400072 । 12. मैससथ अल्फामेड जिजनर्मथजत प्राइिेट जलजमटेड, सि े नंबर 225, संपनबोले गांि, िमीरपेट, मडं ल, मेडचल- मलकिजगरी जिला, तले ंगाना-500101 । 13. मैससथ एस्ट्री केजमकल्स प्राइिेट जलजमटेड, फैर्करी ्लॉट नंबर S117, S118, S119 और S120, जसपकोट इंडजस्ट्रयल कॉम््लेर्कस, फेि- III, जसपकोट, मुगिुं रायपुरम, रानीपेट-632405 14. मैससथ माइिो ओगो केम, 57, सी-1/बी, एलआईसी सेर्कटर, िीआईडीसी, िापी-396195, गिु रात । 15. मैससथ इंटास फामाथस्ट्युटटकल्स जलजमटेड, कॉपोरेट हाउस, सोला जिि के पास, एसिी हाईिे, र्लतेि , अहमिाबाि-380054 2. यह अजधसूचना रािपत्र म ेंइसके प्रकािन की तारीख से 31 दिसंबर , 2027 तक प्रिृत रहगे ी । 3. 31 दिसंबर, 2027 तक प्ररूप 4क में िारी दकया गया कोई भी आयात प्रमाणपत्र, आयात प्रमाणपत्र िारी होने की तारीख से एक सौ अस्ट्सी दिनों तक के जलए जिजधमान्द्य रहगे ा । [फा. स. ं एन.11012/1/2013-एसओ(एनसी-II)] जिनोि कुमार, जनिेिक (स्ट्िापक जनयंत्रण)[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 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.

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