Home India Ministry of Health and Family Welfare Corrigendum to GSR 587 E dated 27th August 2025 reg applicat...
Date: 2025-11-03 Category: Extra Ordinary State: Union Government Country: India

Corrigendum to GSR 587 E dated 27th August 2025 reg application of unapproved drugs for conduct of BA BE Studies for export purpose

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

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.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-04112025-267384 CG-DxLx-xEG-I0D4H1x1x2x0 25-267384 xxxGIDExxx 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.

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