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Core Purpose

The Central Government permits 15 specified manufacturers to import morphine, codeine, thebaine and their salts exclusively for the manufacture of drugs or formulations to be exported, subject to certain conditions and rules.

Detailed Summary

The Ministry of Finance (Department of Revenue), through Notification S.O. 5726(E) dated 10th December, 2025, in pursuance of the proviso to rule 54 of the Narcotics Drugs and Psychotropic Substances Rules, 1985, has permitted fifteen listed manufacturers to import morphine, codeine, thebaine, and their salts (referred to as alkaloids). This permission is exclusively for using these alkaloids in the manufacture of drugs or formulations intended for export. The permitted manufacturers, including M/s. Troikaa Pharmaceuticals, M/s. Gepach International, M/s. Rusan Pharma Ltd., M/s. Wockhardt Limited, M/s Adcock Ingram Ltd., M/s Sun Pharmaceutical Industries ltd., M/s Zentiva Pvt. Ltd., M/s Sri Krishna Pharma, M/s Verve Human Care Laboratories, Acme Generics Pvt. Ltd., M/s Sanofi India Limited, M/s Alphamed Formulations Private Limited, M/s Sthree Chemicals Pvt. Ltd., M/s Micro Orgo Chem, and M/s Intas Pharmaceuticals Ltd., must comply with rules 55, 56, 58, 59, and 62 of the said rules. Key conditions include exporting the finished drug or formulation within 180 days from the import date, with a possible 30-day extension (totaling not more than 270 days) upon application to the Narcotics Commissioner, and surrendering any unutilized quantities of imported alkaloids or finished formulations to the Government Opium and Alkaloids Works. This notification is effective from its publication date until 31st December, 2027, and import certificates issued in Form 4A up to this date will be valid for 180 days from their issue. The notification was signed by VINOD KUMAR, Director (Narcotics Control) under File No. N.11012/1/2013-SO(NC-II).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-10122025-268396 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY NEW DELHI, WEDNESDAY, DECEMBER 10, 2025/AGRAHAYANA 19, 1947 No. 5538] 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. SARVESH KUMAR SRIVASTAVA

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