2025.10.16_G.S.R. 759(E) _ Notification of liquid anticeptic for household use or hospital and ohter than household use under Drug Rules

The Ministry of Health and Family Welfare has issued draft amendments to the Drugs Rules, 1945 under the authority of the Drugs and Cosmetics Act, 1940. These amendments, proposed after consultation with the Drugs Technical Advisory Board, aim to revise Schedule K, specifically Serial No. 39. The revised rules categorize liquid antiseptics into two groups: those for household use and those for hospital or other non-household use. For household antiseptics, sale licenses are required only if certain conditions are met, including manufacture by licensed producers, absence of substances listed in Schedules G, H, H1, or X, sale in original containers, and labeling with “For household use.” For hospital and non-household antiseptics, sale licenses in Form 20 or 20A are mandatory, with similar conditions plus the requirement that drugs be purchased from licensed wholesalers or manufacturers and labeled “For hospital and other than household use.” Public objections and suggestions are invited within 30 days of publication and may be submitted via mail or email to the Directorate of Drugs Regulation.