Health Ministry Amends Drugs Rules, Mandates Endotoxin Testing and Updates Licensing Conditions

New Delhi: The Ministry of Health and Family Welfare has issued a notification introducing amendments to the Drugs Rules, 1945, reinforcing quality control and licensing requirements.

The amendments follow the publication of draft rules vide G.S.R. 345(E) dated May 28, 2025, which invited objections and suggestions from stakeholders. The government stated that Gazette copies were made available to the public on May 28, 2025, and that feedback received during the consultation period has been duly considered.

Issued under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board (DTAB), the revised framework will be known as the Drugs (Amendment) Rules, 2026. The rules take effect from the date of their publication in the Official Gazette.

A major regulatory change involves the substitution of Rule 121A, which now mandates that solutions of substances intended for parenteral administration, including any aqueous solvent supplied with such substances, must comply with the test for bacterial endotoxins or, where justified and authorised, the test for pyrogens, in accordance with the current edition of the Indian Pharmacopoeia (I.P.).

Regarding the above, the notice stated,

"In the Drugs Rules, 1945 (hereinafter to as the said rules), ―

(a) 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).”;

The notification also introduces modifications under Schedule A impacting Forms 20B, 20G, and 21B. The revised provisions require that:

• Drug sales must be conducted under the personal supervision of a competent person, whose name must be specified.
• Licensees inform the licensing authority within one month of any change in the competent person.

In connection with the above, the notice added,

"in the said rules, in Schedule A, ―

(i) in Form 20B, ―

(A) 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) ……………………………………….”;

(B) under the sub-heading “Conditions of License”, after condition 2, the following condition shall be inserted, namely: ―

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

(ii). in Form 20G, ―

(A) 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) …………………………………………”;

(B) under the sub-heading “Conditions of Licence”, after condition 2, the following condition shall be inserted, namely:

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

Additionally, a clarification has been inserted in the footnote of Schedule H, specifying that the class of drugs listed at serial number 15 of Schedule K will not fall within the scope of Schedule H.

The notice further added,

"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.’’;

(c) in the said rule, in Schedule H, in the foot note, after entry number 5, the following entry shall be inserted, namely: ―

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

To view the official notice, click the link below:

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