2026.02.16 G.S.R. 135(E)_Notification for amendment in certain Drugs Rules (Related to Rule 121 – Test for Pyrogen, Footnote of Schedule H, condition of license under Form 20B, 20BB, 21B, 21BB, inclusion of name of competent person in Form 20G)

The Ministry of Health and Family Welfare has issued G.S.R. 135(E), formally amending the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. Following the publication of draft rules on May 28, 2025, and consideration of public objections and suggestions, the Central Government, in consultation with the Drugs Technical Advisory Board, has enacted the Drugs (Amendment) Rules, 2026. These rules take effect upon publication in the Official Gazette. Key changes include substitution of Rule 121A, mandating that solutions for parenteral administration and related solvents comply with bacterial endotoxin or pyrogen testing as per the current Indian Pharmacopeia. Amendments to licensing forms (20B, 20G, and 21B) require sales to be supervised by a competent person, with licensees obligated to report any change in such personnel within one month. Additionally, Schedule H is revised to exclude drugs listed at serial number 15 of Schedule K from its coverage. These updates strengthen regulatory oversight, ensuring safety, accountability, and compliance in drug manufacturing and distribution.