Notification regarding rationalization of shelf life under Rule 31 of Drugs Rules, 1945
The Gazette of India
CG-DL-E-29102026-277502
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 850] NEW DELHI, WEDNESDAY, OCTOBER 28, 2026/KARTIKA 6, 1948
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2026
G.S.R. 951(E).— Whereas, a draft of certain rules further to amend the Drugs Rules, 1945 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940).vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 505 (E), dated the 22nd June, 2026, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, within a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 25th June, 2026;
And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely: —
1. (1) These rules may be called the Drugs (Thirteenth Amendment) Rules, 2026.
(2) These rules shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 31, for the second proviso, the following proviso shall be substituted, namely:-
“Provided further that the licensing authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import and in case of biological drugs and Radiopharmaceuticals, Sixty percent of the labelled shelf-life may be allowed:”.
[F. No. X.11014/08/2026-DR]
PUSHPENDRA RAJPUT, Jt. Secy.
Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H (1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 713 (E), dated the 6th August, 2026.
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