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Core Purpose

This notification publishes the draft Drugs (Amendment) Rules, 2026, proposing amendments to Rule 3A of the Drugs Rules, 1945, concerning the designation of a laboratory for testing specific veterinary vaccines.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued G.S.R. 65(E) on January 28, 2026, to publish the draft Drugs (Amendment) Rules, 2026. These rules are proposed by the Central Government, exercising powers conferred by Sections 6, 12, and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and in consultation with the Drugs Technical Advisory Board. The draft rules propose to amend the Drugs Rules, 1945, by substituting a new sub-rule (9) after sub-rule (8) in rule 3A. This new sub-rule specifies that the testing functions for 42 listed Veterinary Vaccines (Viral & Bacterial) shall be carried out at the Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh. Additionally, the Director of the said Institute will exercise the functions of the Director concerning these veterinary vaccines. The public is invited to submit objections and suggestions within thirty days from the date the Gazette of India, containing these draft rules, is made available. Submissions can 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 to drugsdiv-mohfw@gov.in. The final rules will come into force upon their publication in the Official Gazette.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-31012026-269712 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 64] NEW DELHI, WEDNESDAY, JANUARY 28, 2026/MAGHA 8, 1947 569 GI/2026 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.in 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. | | 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........

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