Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-28052025-263437
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 302]
NEW DELHI, WEDNESDAY, MAY 28, 2025/JYAISTHA 7, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 28th May, 2025
G.S.R. 345(E). - The following draft of certain rules further to amend the Drugs Rules, 1945, which the
Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-
section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical
Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby
given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the
date on which the copies of the Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (Second Amendment) Rules, 2025.
(ii) These rules shall come into force from the date as specified by the Government at the time of final publication
of the rules in the Official Gazette.
2. In the Drugs Rules, 1945, 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 substances) shall comply
with a test for bacterial endotoxins or where justified and authorized, with the test for pyrogens. The test for
Bacterial endotoxins-Pyrogens shall be carried out as per current edition of Indian Pharmacopeia (I.P)."
3. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 20B,
(i). after paragraph 2, the following paragraph shall be inserted, namely: -
"3. The sale shall be made under the personal supervision of a competent person. (Name of the competent
persons)"
(ii). under the sub-heading 'Conditions of Licence', after condition 2, the following shall be inserted, namely: -
"2A. The licensee shall report to the licensing authority any change in competent person within one month
of such change."
4. In the Drugs Rules, 1945 under SCHEDULE A,
(a) In Form 20-B and Form 20-BB, under the Conditions of License,
(i). Under the proviso to the Condition of License at clause 3 (ii), the part(c), namely, the following shall be
deleted.
"(c) a manufacturer of beverages, confectionary biscuits and other non-medicinal products, where such
drugs are required for processing these products"
(ii). After the proviso with the part (c) so deleted, following words shall be inserted as second proviso,
namely:-
"Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial
drugs to a manufacturer of beverages, confectionary biscuits and other non-medicinal products, where
such drugs are required for processing these product"
(b) In Form 21-B and Form 21-BB, under the Conditions of License,
(i). Under the proviso to the Condition of License at clause 4 (ii), the part(c), namely, the following shall be
deleted.
"(c) a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-medicinal
products, where such drugs are required for processing these products"
(ii). After the proviso with the part (c) so deleted, following words shall be inserted as second proviso,
namely:-
"Provided further that the conditions shall also not apply to the sale of any drug except antimicrobial
drugs to a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-
medicinal products, where such drugs are required for processing these product"
5. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 20G,
(i). after paragraph 3, the following paragraph shall be inserted, namely: -
"3A. The sale shall be made under the personal supervision of a competent person. (Name of the competent
persons)"
(ii). under the sub-heading 'Conditions of Licence', after condition2, the following shall be inserted, namely: -
"2A. The licensee shall report to the licensing authority any change in competent person within one month of
such change."
6. In the Drugs Rules, 1945, in Schedule A: -
(a) In Form 21B,
(i). under the sub-heading 'Conditions of Licence', after condition 1, the following shall be inserted, namely: -
"1A. The licensee shall report to the licensing authority any change in competent person within one month of
such change."
7. In the Drugs Rules, 1945, after entry no. 5 under the foot note of Schedule H, the following entry shall be inserted,
namely: -
"6. Class of drugs mentioned at serial no. 15 of Schedule K shall not be covered under this Schedule."
[F.No. X.11014/01/2025-DR]
RAJIV WADHAWAN, Adviser (Cost).
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the
December, 1945 and last amended vide notification number G.S.R 127 (E), dated the 11th February, 2025.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.