The Ministry of Health and Family Welfare (MoHFW) on February 16, 2026, issued the Drugs (Amendment) Rules, 2026 to further amend the Drugs Rules, 1945.
The following amendments have been stated:
• For rule 121A, the following rule shall be substituted, namely: ―
“121A. Test for Bacterial endotoxins-Pyrogens. ― Solution of substances intended for parenteral administration (as well as water or any other aqueous solvent supplied along with such substance) shall comply with a test for bacterial endotoxins or, where justified and authorised, with the test for pyrogens and the test for Bacterial endotoxins-Pyrogens shall be carried out as per current edition of Indian Pharmacopeia (I.P).”;
• In Schedule A, in Form 20B, after paragraph 2, the following paragraph shall be inserted, namely: ―
“3. The sale shall be under the personal supervision of a competent person. (Name of the competent person) ……………………………………….”;
• In Form 20G, after paragraph 3, the following paragraph shall be inserted, namely: ―
“3A. The sale shall be under the personal supervision of a competent person. (Name of the competent person) …………………………………………”;
• In Form 21B, under the sub-heading “Conditions of Licence”, after condition 1, the following condition shall be inserted, namely: ―
“1A. The licensee shall report to the licensing authority any change in competent person within one month of such change.’’;
These rules shall come into force on February 16, 2026.
[Notification No. G.S.R. 135(E)]
