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Core Purpose

This notification introduces the Drugs (Sixth Amendment) Rules, 2026, to further amend the Drugs Rules, 1945, by substituting sub-rule (9) of rule 3A to designate a specific laboratory for testing certain veterinary vaccines.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) has issued notification G.S.R. 496(E) on 18th June, 2026, enacting the Drugs (Sixth Amendment) Rules, 2026. These rules, made by the Central Government in exercise of powers conferred by sections 6, 12, and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, amend the Drugs Rules, 1945. Specifically, sub-rule (9) of rule 3A of the Drugs Rules, 1945, is substituted. The new sub-rule mandates that the functions of the Laboratory for testing 42 specified Veterinary Vaccines (Viral and Bacterial), including Avian Infectious Bronchitis Vaccine and Canine Distemper Vaccine, shall be carried out at the Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh. The Director of this Institute will also exercise the functions of the Director concerning these veterinary vaccines. A draft of these rules was previously published as G.S.R. 65(E), dated 28th January, 2026, inviting public objections and suggestions, which were made available on 31st January, 2026; however, no objections or suggestions were received. The rules come into force on the date of their publication in the Official Gazette. The Drugs Rules, 1945, were originally published on 21st December, 1945, and last amended by G.S.R. 477(E), dated 9th June, 2026.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-20062026-273682 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 445] NEW DELHI, THURSDAY, JUNE 18, 2026/JYAISTHA 28, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 18th June, 2026 G.S.R. 496(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was published as required under sections 12 and 33 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 G.S.R. 65(E), dated the 28th January, 2026 in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), 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 Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 31st January, 2026; And whereas, no objections or suggestions were received from the public on the said draft rules for consideration by the Central Government; Now, therefore, in exercise of the powers conferred by sections 6, 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:- 1. (1) These rules may be called the Drugs (Sixth Amendment) Rules, 2026. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, in rule 3A, for sub-rule (9), the following sub-rule shall be substituted, namely :— "(9) The functions of the Laboratory in respect of 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:- +-------+---------------------------------------------------------+ | 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, Inactivated 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 Leptospirosis Vaccine, Inactivated I.P. | | 11. | Canine Parainfluenza Virus Vaccine, Live I.P. | | 12. | Canine Parvovirus Vaccine, Inactivated I.P. | | 13. | Canine Parvovirus Vaccine, Live I.P. | | 14. | Classical Swine Fever Vaccine, Live 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 Vaccine, Inactivated I.P. | | 21. | Enterotoxaemia 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 Anaemia Vaccine, Inactivated I.P. | | 30. | Infectious Chicken Anaemia Vaccine, Live I.P. | | 31. | Infectious Coryza Vaccine, Inactivated I.P. | | 32. | Marek'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, Inactivated 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] HARSH MANGLA, Jt. Secy. Note – The Drugs Rules, 1945 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. 477(E), dated 9th June, 2026. 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.

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