The draft rules have been published in the Gazette of India (Extraordinary), Part II, Section 3, Sub-section (i) under the authority of the Central Government. The proposal is issued in exercise of powers conferred by Sections 6, 12, and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in consultation with the Drugs Technical Advisory Board (DTAB).
The notification states that the draft rules will be taken into consideration after 30 days from the date on which copies of the Gazette containing the draft are made available to the public. During this period, the Central Government will consider objections and suggestions received from stakeholders.
"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.in" the notification added.
The amendment proposes insertion of sub-rule (9) under Rule 3A of the Drugs Rules, 1945. It specifies that the functions of the laboratory in respect of the testing of the following veterinary vaccines (viral and 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.
The draft notice stated,
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. |
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. |
To view the official notice, click the link below:
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