This notification, G.S.R. 554(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, on August 18, 2025, announces the Drugs 2nd Amendment Rules, 2025. These rules further amend the Drugs Rules, 1945, in exercise of powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940). The amendments include revisions to rule 96, specifically sub-rule 7, clause (vii) regarding the date of expiry, and the insertion of clause (ix) requiring qualitative details of excipients. These rules will come into force on March 1, 2026. The draft of these rules was previously published on July 12, 2024, vide notification number G.S.R. 391(E), inviting public feedback, which was subsequently considered by the Central Government. The notification was issued under the authority of the Central Government after consultation with the Drugs Technical Advisory Board. Contact person for queries is Jt. Secy. NIKHIL GAJRAJ, F. No. X.11035/44/2024-DRS.
Key Entities Referenced
Drugs Rules, 1945: A set of rules pertaining to drugs, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament governing drugs and cosmetics. Sections 12 and 33 are referenced in this notification.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy. The Department of Health and Family Welfare is issuing this notification.
New Delhi: The capital of India, where the notification is issued from.
Drugs Technical Advisory Board: A board consulted by the Central Government when amending the Drugs Rules, 1945.
Drugs 2nd Amendment Rules, 2025: The short title for the rules being introduced by this notification.
Central Government: The government of India, responsible for making the amendments.
1st March, 2026: The date from which the Drugs 2nd Amendment Rules, 2025 shall come into force.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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सी.जी.-डी.एलxx.x-GअID.-E2x0xx0 82025-265531
CG-DL-E-20082025-265531
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 510] नई दिल्ली, सोमवार, अगस्ट्त 18, 2025/श्रावण 27, 1947
No. 510] NEW DELHI, MONDAY, AUGUST 18, 2025/SHRAVANA 27, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय जवभाग)
अजधसचू ना
नई दिल्ली, 18 अगस्ट् त, 2025
सा.का.जन. 554(अ).––औषजध जनयम, 1945 का और सिं ोधन करन े के जलए कजतपय जनयमों का प्रारूप,
औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा
(1) के अधीन अपक्षे ा अनुसार, भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण
जवभाग) की अजधसूचना संखयाकं सा.का.जन. 391(अ), तारीख 12 िलु ाई, 2024 द्वारा भारत के रािपत्र, असाधारण,
भाग-2, खडं 3, उपखंड (i) में प्रकाजित दकया गया था, जिसमें उससे प्रभाजवत होने वाले संभाव्य व्यजियों से, उस तारीख
से तीस दिनों की अवजध समाप्त होने से पहले, जिसको उि अजधसूचना को अंतर्विष्ट करने वाले रािपत्र की प्रजतयां िनता
को उपलब्ध कराई गई थी, आक्षेप और सुझाव आमंजत्रत दकए गए थे;
और, उि रािपत्र की प्रजतयां 12 िुलाई, 2024 को िनता को उपलब्ध करा िी गई थीं;
और, उि प्रारूप जनयमों पर िनता से प्राप्त आक्षेपों और सुझावों पर केन्द्रीय सरकार द्वारा जवचार दकया गया है;
5493GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
अत: अब, केन्द्रीय सरकार, उि अजधजनयम की धारा 12 और धारा 33 द्वारा प्रित्त िजियों का प्रयोग करते हुए,
औषजध तकनीकी सलाहकार बोडि के साथ परामि ि के पश्चात, औषजध जनयम 1945 को और संिोजधत करन े के जलए,
जनम्नजलजखत जनयम बनाती ह,ै अथाित:् -
1. (1) इन जनयमों का संजक्षप्त नाम औषजध (िसू रा संिोधन) जनयम, 2025 ह।ै
(2) य े01 माच,ि 2026 से प्रवत्तृ होंगे।
2. औषजध जनयम, 1945 के जनयम 96 के उपजनयम (7) म,ें -
(क) खंड (vii) में, “समाजप्त की तारीख; और” िब्िों के स्ट्थान पर “समाजप्त की तारीख” िब्ि रखे िाएंगे;
(ख) खंड (viii) के पश्चात, जनम्नजलजखत खंड अतं :स्ट्थाजपत दकया िाएगा, अथाित्: -
(ix) “एक्सीपीएन्द्टस का गुणात्मक जववरण”।
[फा.सं. एक्स. 11035/44/2024-डीआरएस]
जनजखल गिराि, संयुि सजचव
रटप्पण : मलू जनयम, भारत के रािपत्र, में अजधसूचना संखयाकं एफ. 28-10/45- एच (1), तारीख 21 दिसम्बर 1945
द्वारा प्रकाजित दकए गए थे तथा अंजतम बार अजधसूचना संखयांक सा.का.जन. 127 (अ) तारीख 11 फरवरी, 2025 द्वारा
संिोजधत दकये गये।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th August, 2025
G.S.R. 554(E).–––Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was
published, as required under sub-section (1) of sections 12 and sub-section (1) of 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. 391 (E), dated the 12th July, 2024, in the Gazette
of India, Extraordinary, Part II, Section 3, sub-section (i), inviting objections and suggestions from persons likely to
be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette
containing the said notification were made available to the public;
And whereas copies of the said Gazette were made available to the public on the 12thJuly, 2024;
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 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 ( 2nd Amendment) Rules, 2025.
(2) They shall come into force from 1st March, 2026.
2. In the Drugs Rules, 1945, in rule 96, in sub-rule (7), —
(a) In clause (vii), for the words “date of expiry; and”, the word “date of expiry” shall be substituted;[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
(b) After clause (viii), the following clause shall be inserted, namely:-
“(ix) qualitative details of excipients.”
[F. No. X.11035/44/2024-DRS]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated the
21st December, 1945 and last amended vide notification number G.S.R. 127(E), dated 11th February, 2025.
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