Date: 2025-09-23Category: Extra OrdinaryState: Union GovernmentCountry: India
Notification for prohibition of import manufacture sale and distribution of 37 antimicrobial medicinal products in line with EU regulations for use in food producing animals
**Executive Summary**
The document is a notification from the Ministry of Health and Family Welfare, Government of India, dated September 23, 2025, prohibiting the import, manufacture, sale, and distribution of certain antimicrobials and their formulations for animal use. This decision follows consultation with the Drugs Technical Advisory Board and the publication of a draft notification on May 22, 2025, without any objections or suggestions received from the public. The notification is effective from September 23, 2025.
**Key Points / Main Content**
* **Prohibition of Antimicrobials:** The Central Government prohibits the import, manufacture, sale, and distribution of specified antimicrobials and their formulations for animal use.
* **Categories of Prohibited Antimicrobials:** The prohibited antimicrobials are classified into three categories:
* **Antibiotics:** Includes 15 types, such as Ureidopenicillins, Ceftobiprole, Ceftaroline, Siderophore cephalosporins, Carbapenems, Penems, Monobactams, Glycopeptides, Lipopeptides, Oxazolidinones, Fidaxomicin, Plazomicin, Glycylcyclines, Eravacycline, and Omadacycline.
* **Antivirals:** Includes 18 types, such as Amantadine, Baloxavir marboxil, Celgosivir, Favipiravir, Galidesivir, Lactimidomycin, Laninamivir, Methisazone/ Metisazone, Molnupiravir, Nitazoxanide, Oseltamivir, Peramivir, Ribavirin, Rimantadine, Tizoxanide, Triazavirin, Umifenovir, and Zanamivir.
* **Antiprotozoals:** Includes Nitazoxanide.
**Impact Analysis**
**Stakeholder**: Manufacturers and Importers of Antimicrobials for Animal Use
**Impact**: They are prohibited from importing, manufacturing, selling, and distributing the listed antimicrobials and their formulations for animal use.
**Action Required**: Cease all activities related to the import, manufacture, sale, and distribution of the specified antimicrobials for animal use, effective September 23, 2025.
**Stakeholder**: Distributors and Retailers of Antimicrobials for Animal Use
**Impact**: They are prohibited from selling and distributing the listed antimicrobials and their formulations for animal use.
**Action Required**: Remove the specified antimicrobials from their inventory and cease their sale and distribution, effective September 23, 2025.
**Stakeholder**: Veterinarians and Animal Healthcare Providers
**Impact**: They are restricted from using the listed antimicrobials in the treatment of animals.
**Action Required**: Find and use alternative, safe medications to treat and care for animals, and avoid using these prohibited antimicrobials in their practice.
**Stakeholder**: Animal Owners and Farmers
**Impact**: They will no longer have access to the listed antimicrobials for use in their animals.
**Action Required**: To be aware of the drugs now prohibited for use, and consult with their vet to find safe medications for their animals.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation under which the order to prohibit certain drugs is issued, referencing sections 10A and 26A.
Ministry of Health and Family Welfare: The issuing ministry responsible for health policy.
Drugs Technical Advisory Board: The advisory body consulted before issuing the prohibition.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-26092025-266438
CG-DxLx-xEG-I2D6H0x9x2x0 25-266438
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 4220] नई दिल्ली, मगं लवार, जसतम्ब र 23, 2025/ आजव न 1, 1947 27, 1947
No. 4220] NEW DELHI, TUESDAY, SEPTEMBER 23, 2025/ASVINA 1, 1947 A 27, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 23 जसतम्ब र, 2025
का.आ. 4338(अ).—केंद्रीय सरकार ने ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की
धारा 26क द्वारा प्रित्त िजियों का प्रयोग करते हुए, भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संख्या का. आ. 2298 (अ), तारीख 22 मई, 2025, के
द्वारा एक प्रारूप अजधसूचना भारत के रािपत्र, असाधारण, भाग 2, खंड 3, के उप-खंड (ii) में प्रकाजित की ह,ै
जिसमें इन प्रारूप अजधसूचनाओं वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध कराए िाने की तारीख स े
तीस दिन की अवजध समाप्त होने से पूवव, इसस े प्रभाजवत होन े की संभावना वाल े व्यजियों स े आपजत्तयां और
सुझाव आमंजत्रत दकए गए थे।
और, उि सरकारी रािपत्र की प्रजतयां 22 मई, 2025 को िनता को उपलब्ध करा िी गई थीं;
और, उि जनयमों के संबंध में िनता से कोई आपजत्त और सुझाव प्राप्त नहीं हुए थे;
और, पिुओं के उपयोग के जलए उि औषजधयों के सरु जित जवकल्प उपलब्ध हैं;
6359 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
और, केंद्रीय सरकार का यह समाधान हो गया ह ै दक इस अजधसूचना में यथा जवजनर्िवष्ट पिु के उपयोग के
जलए दकसी भी रोगाणुरोधी औषधीय उत्पािों के आयात, उत्पािन, जवक्रय और जवतरण को प्रजतबंजधत करना
िनजहत में आवयक और समीचीन ह;ै
अतः अब, केंद्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 10क
और 26क द्वारा प्रित्त िजियों का प्रयोग करत े हुए, औषजध तकनीकी सलाहकार बोडव के परामिव के पश्चात,
जनम्नजलजखत रोगाणुरोजधयों और ऐसे रोगाणुरोजधयों के समूह तथा पिु के उपयोग हते ु उनके फामूवलों के आयात,
जवजनमावण, जवक्रय और जवतरण को प्रजतजषद्ध करती है, अथावत्: -
1. एटं ीबायोरटक्स
i. यूररडोपेजनजसजलन
ii. सेफ्टोजबप्रोल
iii. सेफ्टारोलाइन
iv. साइडेरोफोर सेफलोस्ट्पोररन्स
v. काबावपेनेम्स
vi. पेनेम्स
vii. मोनोबैक्टम्स
viii. ग्लाइकोपेप्टाइड्स
ix. लाइपोपेप्टाइड्स
x. ऑक्साजोजलजडनॉन्स
xi. द़िडैक्सोमाइजसन
xii. प्लाजोमाइजसन
xiii. ग्लाइजसलसाइजक्लन
xiv. एरावासाइजक्लन
xv. ओमाडासाइजक्लन
2. एटं ीवायरल्स
i. अमांताडाइन
ii. बैलोक्िाजवर माबॉजक्सल
iii. सेल्गोजसजवर
iv. फैजवजपराजवर
v. गैलीडेजसजवर
vi. लैजक्टजमडोमाइजसन
vii. लैजननामाइजवर
viii. मेजथसाजोन/ मेरटसाजोन
ix. मोलनुजपराजवर
x. जनटािोक्सानाइड
xi. ओसेल्टाजमजवर
xii. पेराजमजवर
xiii. ररबावायररन
xiv. ररमांटाडाइन
xv. टाइजॉक्सानाइड
xvi. रायजाजवररन[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
xvii. उजमफेनोजवर
xviii. िानामाइजवर
3. एटं ीप्रोटोजोल्स
नीटािोक्सानाइड
[फा. स.ं एक्स.11035/125/2024-डीआर]
जनजखल गिराि, संयुि सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 23rd September, 2025
S.O. 4338(E).—WHEREAS, the Central Government has published a draft notification, in exercise of the
powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the
Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare)
number S.O. 2298 (E), dated the 22nd May, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section
(ii), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of
thirty days from the date on which the copies of the Gazette of India containing these draft notification are made
available to the public;
AND WHEREAS, copies of the said Official Gazette were made available to the public on the 22nd May,
2025;
AND WHEREAS, no objections and suggestions were received from the public on the said rules;
AND WHEREAS, safer alternatives to the said drugs for animal use are available;
AND WHEREAS, the Central Government is satisfied that it is necessary and expedient in the public interest
to prohibit the import, manufacture, sale, and distribution of any antimicrobial medicinal products for animal use as
specified in this notification;
Now, therefore in exercise of the powers conferred by sections 10A & 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, the Central Government hereby
prohibit the import, manufacture, sale and distribution of the following antimicrobials and group of such
antimicrobials and their formulations for animal use namely: -
-
1. Antibiotics
i. Ureidopenicillins
ii. Ceftobiprole
iii. Ceftaroline
iv. Siderophore cephalosporins
v. Carbapenems
vi. Penems
vii. Monobactams
viii. Glycopeptides
ix. Lipopeptides
x. Oxazolidinones
xi. Fidaxomicin
xii. Plazomicin
xiii. Glycylcyclines
xiv. Eravacycline
xv. Omadacycline4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
2. Antivirals
i. Amantadine
ii. Baloxavir marboxil
iii. Celgosivir
iv. Favipiravir
v. Galidesivir
vi. Lactimidomycin
vii. Laninamivir
viii. Methisazone/ Metisazone
ix. Molnupiravir
x. Nitazoxanide
xi. Oseltamivir
xii. Peramivir
xiii. Ribavirin
xiv. Rimantadine
xv. Tizoxanide
xvi. Triazavirin
xvii. Umifenovir
xviii. Zanamivir
3. Antiprotozoals
Nitazoxanide
[F. No. X.11035/125/2024-DR]
NIKHIL GAJRAJ, Jt. Secy.
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.