The draft rules to amend the Drugs Rules, 1945 were published vide G.S.R. 345(E) dated May 28, 2025 inviting objections and suggestions within thirty days from the date copies were made available to the public. Copies were made available on May 28, 2025. After consideration of objections and suggestions received, the Central Government has notified these amendments. The Drugs Rules, 1945 were last amended vide G.S.R. 554(E) dated August 18, 2025.

1. Substitution of Rule 121A

“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).”

1. Amendments in Schedule A

(i) In Form 20B:

• After paragraph 2:

“3. The sale shall be under the personal supervision of a competent person.
(Name of the competent person) ……………………………………….”

• Under “Conditions of License”, after condition 2:

“2A. The licensee shall report to the licensing authority any change in competent person within one month of such change.”

(ii) In Form 20G:

• After paragraph 3:

“3A. The sale shall be under the personal supervision of a competent person.
(Name of the competent person) …………………………………………”

• Under “Conditions of Licence”, after condition 2:

“2A. The licensee shall report to the licensing authority any change in competent person within one month of such change.”

(iii) In Form 21B:

• Under “Conditions of Licence”, after condition 1:

“1A. The licensee shall report to the licensing authority any change in competent person within one month of such change.’’

1. Amendment in Schedule H

In the foot note, after entry number 5:

“6. Class of drugs mentioned at serial number 15 of Schedule K shall not be covered under this Schedule.”