The Ministry of Health and Family Welfare, Government of India, issues a corrigendum, G.S.R. 810(E), dated October 31, 2025, regarding a draft notification published in the Gazette of India, Extraordinary Part II, Section 3, Sub-Section (i) vide G.S.R. 587 (E) dated August 27, 2025.
The corrigendum modifies para 2, condition no. 3 of the proviso of the draft rules, changing the wording "The sample size should not be more than 48" to "The sample size should be more than or equal to 18".
The Central Government will consider objections and suggestions received within 15 days of the publication of this corrigendum.
Objections and suggestions can be addressed to the Director (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011, or emailed to drugsdiv-mohfw@gov.in.
The file number for reference is F. No. X.11014/06/2025-DR.
Nikhil Gajraj, Jt. Secy.
Key Entities Referenced
Ministry of Health and Family Welfare: The primary subject of the notification, responsible for health and family welfare matters.
G.S.R. 587 (E): An earlier notification, being amended by this corrigendum, published on August 27, 2025.
G.S.R. 810(E): The notification number for this corrigendum being issued by the Ministry of Health and Family Welfare.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-04112025-267384
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 724] नई दिल्ली, सोमवार, नवम्ब र 3, 2025/कार्तकि 12, 1947
No. 724] NEW DELHI, MONDAY, NOVEMBER 3, 2025/KARTIKA 12, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
िजु िपत्र
नई दिल्ली, 31 अक् तूबर, 2025
सा.का.जन. 810(अ).— भारत सरकार, स्वास््य एवं पररवार कल्याण मंत्रालय की मसौदा अधिसूचना म,ें जो भारत
के राजपत्र, असािारण भाग II, खंड3, उप-खडं (i) म ेंजी.एस.आर. 587 (ई) ददनांक27 अगस्त, 2025 द्वारा प्रकाधित हुई ह,ै
के अनुसार:-
(i) मसौदा धनयमों के पैरा2 में, परंतुक की ित त संख्या3 म"ें नमनू ा-चयन का आकार 48 से अधिक नहीं होना चाधहए। "
िब्दों के स्थान पर धनम्नधलधखत प्रधतस्थाधपत दकया जाएगा:- "नमूना-चयन का आकार18 स ेअधिक या उसके बराबर
होना चाधहए"।
7284 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
इस िुधिपत्र के प्रकािन के15 ददनों के भीतर दकसी भी व्यधि स े प्राप्त होन े वाली आपधियों और सुझावों पर केंद्र सरकार
द्वारा धवचार दकया जाएगा।
यदद कोई आपधियों एव ं सुझावों यदद कोई हों, को धनदेिक (औषधि), स्वास््य और पररवार कल्याण मंत्रालय,
भारत सरकार, कमरा संख्या 407, एववगं , धनमातण भवन, नई ददल्ली-110011 को भेजा जा सकता ह ै या drugsdiv-
mohfw@gov.in पर ईमले दकया जा सकता ह।ै
[फा. स.ं एक्स. 11014/06/2025-डीआर]
जनजखल गिराि, संयुक् त सजिव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
CORRIGENDUM
New Delhi, the 31st October, 2025
G.S.R. 810(E).— In the draft notification of the Government of India, Ministry of Health and Family
Welfare, published in the Gazette of India, Extraordinary Part II, Section 3, Sub-Section(i) vide G.S.R. 587
(E) dated the 27th August, 2025―
(i) In para 2 under the draft rules, the condition no. 3 of the Proviso for the words “The samples size should
not be more than 48” the following shall be substituted as, :- “The samples size should be more than or
equal to 18”.
Objections and suggestions which may be received from any person within 15 days of the publication
of this corrigendum will be considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Director (Drugs), Ministry of Health
and Family Welfare, Government of India, Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011
or emailed at drugsdiv-mohfw@gov.in.
[F. No. X.11014/06/2025-DR]
NIKHIL GAJRAJ, Jt. Secy.
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.