Date: 2026-01-28Category: Extra OrdinaryState: Union GovernmentCountry: India
Draft notification of Chaudhary Charan Singh National Institute of Animal Health, Baghpat, UP, as a CDL for testing viral and bacterial veterinary vaccines excluding BSL III under the D and C Act, 1940 and Rules
**Executive Summary**
This document is a draft notification from the Ministry of Health and Family Welfare, Government of India, proposing amendments to the Drugs Rules, 1945. The draft rules, called the Drugs (Amendment) Rules, 2026, are being published for public information and comment. Interested parties have 30 days from the date the Gazette is available to submit objections and suggestions, which will be considered by the Central Government.
**Key Points / Main Content**
* **Amendment Title and Effective Date:**
* The proposed rules are to be called the Drugs (Amendment) Rules, 2026.
* They will come into force on the date of their final publication in the Official Gazette.
* **Testing of Veterinary Vaccines:**
* Rule 3A of the Drugs Rules, 1945, will be amended by adding sub-rule (9).
* The Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh, will be the designated laboratory for testing specific veterinary vaccines (viral and bacterial).
* The Director of the said Institute will execute the testing of these vaccines.
* **List of Veterinary Vaccines for Testing:**
* A list of 42 veterinary vaccines are specified for testing at the designated institute.
* The list includes vaccines for Avian Infectious Bronchitis, Canine Adenovirus, Classical Swine Fever, Duck Plague, Ranikhet Disease, Salmonella, and others, specifying whether they are inactivated or live vaccines.
**Impact Analysis**
**Ministry of Health and Family Welfare:**
* **Impact:** Responsible for overseeing and implementing the amended rules.
* **Action Required:** Review and consider public comments on the draft rules, finalize the amendments, and publish them in the Official Gazette.
**Pharmaceutical Manufacturers of Veterinary Vaccines:**
* **Impact:** May need to comply with new testing requirements for the listed veterinary vaccines.
* **Action Required:** Be aware of the amendment and its implications on the testing of their veterinary vaccine products.
**Chaudhary Charan Singh National Institute of Animal Health:**
* **Impact:** Will be responsible for conducting tests on the specified veterinary vaccines.
* **Action Required:** Be ready to perform the tests specified in the notification once the amendment is final and effective.
**General Public/Interested Parties:**
* **Impact:** Could be impacted by the availability, quality, and safety of veterinary vaccines.
* **Action Required:** Submit objections and suggestions regarding the draft rules to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, within the specified timeframe.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation under which the amendment is being proposed, specifically referencing sections 6, 12, and 33.
Drugs Rules, 1945: The set of rules being amended by this notification, specifically rule 3A.
Ministry of Health and Family Welfare: The government body responsible for issuing the notification and overseeing the amendment process.
Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh: The laboratory designated for testing veterinary vaccines.
Drugs Technical Advisory Board: Body consulted by the Central Government for making the amendment to the Drugs Rules.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-31012026-269712
CG-DxLx-xEG-I3D1H0x1x2x0 26-269712
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 64] नई दिल्ली, बयधवार, िनवरी 28, 2026/माघ 8, 1947
No. 64] NEW DELHI, WEDNESDAY, JANUARY 28, 2026/MAGHA 8, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 28 िनवरी, 2026
सा.का.जन. 65(अ).— औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमो के जनम्नजलजखत प्रारूप,
जिसे केन्द्रीय सरकार औषजध तकनीकी सलाहकार बोडड के परामि ड स े औषजध और प्रसाधन सामग्री अजधजनयम 1940
(23के1940) की धारा 6, धारा 12 और धारा 33 द्वारा प्रित्त िजियों का प्रयोग करत े हुए,इसके द्वारा प्रभाजवत होने की
होने की संभावना वाले सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ैऔर एति द्वारा सूचना िी िाती ह ै दक
उि प्रारूप जनयमों पर उस तारीख स ेतीस दिनों की अवजध समाप्त होने पर या उसके बाि जवचार दकया िाएगा जिस तारीख
को इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतयााँ िनता को उपलब्ध कराई िाएाँगी।
केंर सरकार द्वारा उपययडि जनर्िष्टड अवजध के भीतर दकसी भी व्यजि स े प्राप्त होन े वाली आपजत्तयों और सयझावों पर
जवचार दकया िाएगा।
आपजत्त या सयझाव,यदि कोई हो,तो अवर सजचव (औषजध जवजनयमन), स्ट्वास्ट््य एवं पररवार कल्याण मंत्रालय, भारत
सरकार, य-ू 6, वकड हॉल- सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001 को अग्रेजषत दकया िाए अथवा
drugsdiv-mohfw@gov.in पर ई-मले करें ।
569 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारुपजनयम
1. (1) इन जनयमों को औषजध (.....संिोधन) जनयम, 2026 कहा िाएगा।
(2) य ेआजधकाररक रािपत्र म ें अंजतम प्रकािन की तारीख स े लागू होंगे।
2. औषजध जनयम, 1945 के जनयम 3क म ेंउप-जनयम (8) के पश्चात ्जनम्नजलजखत उप-जनयम प्रजतस्ट्थाजपत दकया िाएगा,
अथाडत:् —
“(9) जनम्नजलजखत पि यजचदकत्सा टीकों (वायरल एव ंबक्ै टीररयल) के परीक्षण के सबं धं म ेंप्रयोगिाला के काय डचौधरी
चरण वसंह राष्ट्रीय पि य स्ट्वास्ट््य संस्ट्थान, बागपत, उत्तर प्रििे म ें दकए िाएंग े और उि पिय जचदकत्सा टीकों के
संबंजधत जनिेिक के कायो का जनष्पािन उि संस्ट्थान के जनिेिक द्वारा दकया िाएगा:-”
क्रम सख्ं या पि य जचदकत्सा टीके का नाम
1 एजवयन इन्द्फेजक्ियस ब्रोंकाइरटस टीका, जनजष्क्रय(I.P.)
2 एजवयन इन्द्फेजक्ियस ब्रोंकाइरटस टीका, िीजवत(I.P.)
3 एजवयन इन्द्फेजक्ियस लैरींगोरैदकयाइरटस टीका, िीजवत(I.P.)
4 एजवयन स्ट्पाइरोकीटोजसस टीका(I.P.)
5 ब्लैकक्वाटडर टीका(I.P.)
6 ब्रूसेला एबॉटडस(स्ट्रेन-19) टीका, िीजवत(I.P.)
7 कैनाइन एडने ोवायरस टीका, िीजवत(I.P.)
8 कैनाइन कोरोनावायरस टीका, जनजष्क्रय(I.P.)
9 कैनाइन जडस्ट्टेंपर टीका, िीजवत(I.P.)
10 कैनाइन लेप्टोस्ट्पायरोजसस टीका, जनजष्क्रय(I.P.)
11 कैनाइन परै ाइन्द््लयएंिा वायरस टीका, िीजवत(I.P.)
12 कैनाइन पावोवायरस टीका, जनजष्क्रय(I.P.)
13 कैनाइन पावोवायरस टीका, िीजवत(I.P.)
14 क्लाजसकल स्ट्वाइन फीवर टीका(I.P.)
15 बहु-घटक क्लॉजस्ट्रजडयम टीका, जनजष्क्रय(I.P.)
16 क्लॉजस्ट्रजडयम नोवी(टाइप-B) टीका, पिय जचदकत्सा उपयोग हते य(I.P.)
17 क्लॉजस्ट्रजडयम सेजप्टकम टीका, जनजष्क्रय(I.P.)
18 डक पाश्चरय ेला टीका, जनजष्क्रय(I.P.)
19 डक प्लगे टीका, िीजवत(I.P.)
20 एग ड्रॉप वसंड्रोम-76 (एडेनोवायरस) टीका, जनजष्क्रय(I.P.)
21 एंटरोटॉजक्सजमया टीका, जनजष्क्रय(I.P.)
22 फाउल कॉलरा टीका, जनजष्क्रय(I.P.)
23 फाउल पॉक्स टीका, िीजवत(I.P.)
24 हमै रेजिक सेप्टीसीजमया टीका, जनजष्क्रय(I.P.)
25 हमै रेजिक सेप्टीसीजमया टीका, एलम-उपचाररत(I.P.)[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
26 इन्द्क्लूिन बॉडी हपे ेटाइरटस(IBH) टीका, जनजष्क्रय(I.P.)
27 इन्द्फेजक्ियस एजवयन एन्द्सेफैलोमायलाइरटस टीका, िीजवत(I.P.)
28 इन्द्फेजक्ियस कैनाइन हपे ेटाइरटस टीका, जनजष्क्रय(I.P.)
29 इन्द्फेजक्ियस जचकन एनीजमया टीका, जनजष्क्रय(I.P.)
30 इन्द्फेजक्ियस जचकन एनीजमया टीका, िीजवत(I.P.)
31 इन्द्फेजक्ियस कोराइजा टीका(I.P.)
32 मेरेक रोग टीका, िीजवत(I.P.)
33 पेस्ट्टे ि े पेरटट्स रूजमनेंट्स(PPR) टीका, िीजवत(I.P.)
34 रानीखेत रोग टीका, जनजष्क्रय(I.P.)
35 रानीखेत रोग टीका, िीजवत(लटें ोिेजनक स्ट्रेन) (I.P.)
36 रानीखेत रोग टीका, िीजवत(मसे ोिेजनक स्ट्रेन) (I.P.)
37 ररयो वायरस टीका, जनजष्क्रय(I.P.)
38 ररयो वायरस टीका, िीजवत(I.P.)
39 साल्मोनेला एबॉटडस इक्वी टीका(I.P.)
40 साल्मोनेला टीका, जनजष्क्रय(I.P.)
41 टेटनस पिय जचदकत्सा टीका(I.P.)
42 थीलेररयोजसस टीका, िीजवत(I.P.)
[फा. स.ं एक्स.11014/13/2025-डीआर]
जनजखल गिराि, संययि सजचव
रटप्पणी - मूल जनयम भारत के रािपत्र म ें अजधसूचना संख्या एफ.28-10/45-एच (1), दिनांक 21 दिसंबर, 1945 द्वारा
प्रकाजित दकए गए थ ेऔर अंजतम बार अजधसूचना संख्या सा.का.जन ….. (ई), दिनांक ….. द्वारा संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 28th January, 2026
G.S.R. 65(E).— The following draft of certain rules, which the Central Government proposes to make,
in exercise of the powers conferred by Section 6, Section 12 and Section 33 of the Drugs and Cosmetics Act,
1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for
information of all persons likely to be affected thereby and notice is hereby given that said draft rules shall
be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of
the Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above
will be considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs regulation),
Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya
Bhawan-1, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
DRAFT RULES
1. (1) These rules may be called the Drugs (……Amendment) Rules, 2026.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 3A, after sub-rule (8), the following sub-rule shall be substituted,
namely :—
“(9) The functions of the laboratory in respect of testing of the following Veterinary Vaccines (Viral &
Bacterial) shall be carried out at the Chaudhary Charan Singh National Institute of Animal Health,
Baghpat, Uttar Pradesh and the functions of the Director in respect of the said veterinary vaccines shall
be exercised by the Director of the said Institute:-”.
S. No. Name of Veterinary Vaccine
1. Avian Infectious Bronchitis Vaccine, Inactivated I.P.
2. Avian Infectious Bronchitis Vaccine, Live I.P.
3. Avian Infectious Laryngotracheitis Vaccine, Live I.P.
4. Avian Spirochaetosis Vaccine I.P.
5. Blackquarter Vaccine I.P.
6. Brucella Abortus (Strain 19) Vaccine, Live I.P.
7. Canine Adenovirus Vaccine, Live I.P.
8. Canine Coronavirus Vaccine, Inactivated I.P.
9. Canine Distemper Vaccine, Live I.P.
10. Canine Laptospirosis Vaccine, Inactivated I.P.
11. Canine Parainfluenza virus Vaccine, Live I.P.
12. Canine Parovirus Vaccine, Inactivated I.P.
13. Canine Parovirus Vaccine, Live I.P.
14. Classical Swine Fever Vaccine I.P.
15. Multicomponent Clostridium Vaccine, Inactivated I.P.
16. Clostridium Novyi (Type B) Vaccine for Veterinary Use I.P.
17. Clostridium Septicum Vaccine, Inactivated I.P.
18. Duck Pasteurella Vaccine, Inactivated I.P.
19. Duck Plague Vaccine, Live I.P.
20. Egg Drop Syndrome 76 (Adenovirus) Vaccine, Inactivated I.P.
21. Enterotoxemia Vaccine, Inactivated I.P.
22. Fowl Cholera Vaccine, Inactivated I.P.
23. Fowl Pox Vaccine, Live I.P.
24. Haemorrhagic Septicaemia Vaccine, Inactivated I.P.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 5
25. Haemorrhagic Septicaemia Vaccine, Alum-treated I.P.
26. Inclusion Body Hepatitis (IBH) Vaccine, inactivated I.P.
27. Infectious Avian Encephalomyelitis Vaccine, Live I.P.
28. Infectious Canine Hepatitis Vaccine, Inactivated I.P.
29. Infectious Chicken Anemia Vaccine, Inactivated I.P.
30. Infectious Chicken Anemia Vaccine, Live I.P.
31. Infectious Coryza Vaccine I.P.
32. Merek's Disease Vaccine, Live I.P.
33. Peste Des Petits Ruminants Vaccine, Live I.P.
34. Ranikhet Disease Vaccine, Inactivated I.P.
35. Ranikhet Disease Vaccine, Live (Lentogenic Strain) I.P.
36. Ranikhet Disease Vaccine, Live (Mesogenic Strain) I.P.
37. Reo Virus Vaccine, Inactivated I.P.
38. Reo Virus Vaccine, Live I.P.
39. Salmonella Abortus Equi, Vaccine I.P.
40. Salmonella Vaccine, Inactivated I.P.
41. Tetanus Veterinary Vaccine I.P.
42. Theileriosis Vaccine, Live I.P.
[F.No. X.11014/13/2025-DR]
NIKHIL GAJRAJ, Jt. Secy.
Note - The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H (1),
dated 21st December, 1945 and last amended vide notification number G.S.R. ….. (E), dated……..
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.