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Date: 02-Jul-2024 Category: Extra Ordinary State: Union Government Country: India

publication of notification no t 11011 05 2019 dcc ayush dated 01 07 2024 in the gazette of india

Issued by Ministry of AYUSH · Not Applicable

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Executive Summary & Key Takeaways

Description of the Gazette Notification

  • This gazette notification announces the Drugs (Fourth Amendment) Rules, 2024, further amending the Drugs Rules, 1945. The amendment follows a public consultation period initiated on February 2nd, 2024, where objections and suggestions were invited regarding the draft rules.
  • The amendment is made under the powers conferred by sections 6(2), 12, 33, and 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board.

Key Changes

  • Rule 170 of the Drugs Rules, 1945, has been omitted.
  • Forms 26E4 and 26E5 in Schedule A of the Drugs Rules, 1945, have been omitted.

Impact Analysis

Impact on Businesses

  • Failure to comply with the amended rules may result in penalties as defined in the Drugs and Cosmetics Act, 1940.

Impact on Government Agencies

  • Agencies may need to provide updated training to their staff on the changes to the rules.

Impact on Consumers

  • The impact on consumers is indirect and depends on how businesses adapt to the changes. The amendments may lead to changes in the availability or processes related to certain drugs or cosmetics, though the specific effects are not clearly stated in the notification.

Suggested Action Items

  • Monitor government communications for further clarifications or guidelines.

Key Entities Referenced

Drugs and Cosmetics Act, 1940 (23 of 1940): The primary legislation under which the amendments are made. Sections 6(2), 12, 33, and 33N are specifically referenced. Drugs Rules, 1945: The rules being amended by the notification. Rule 170 and Forms 26E4 and 26E5 are specifically affected. Ministry of Ayush: The government ministry responsible for issuing this notification. Ayurveda, Siddha, Unani Drugs Technical Advisory Board: The board consulted before the amendments were made. Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i): The official publication where the notification was published.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-02072024-255091 CG-DxLx-xEG-I0D2H0x7x2x0 24-255091 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.ं 337] नई दिल्ली, मगं लवार , िुलाई 2 , 2024/आषाढ 11, 1946 No. 337] NEW DELHI, TUESDAY, JULY 2, 2024/ASHADHA 11, 1946 आयषु मत्रं ालय अजधसचू ना नई दिल्ली, 1 िुलाई, 2024 सा.का.जन. 360(अ).—ओषजध जनयम, 1945 की धारा 33ढ की अपेक्षानुसार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) (जिसे इसमें इसके पश्चात् उक्त अजधजनयम कहा गया ह)ै का और संिोधन करने के जलए, भारत सरकार के आयुष मंत्रालय की अजधसूचना सा.का.जन. संखयांक 98(अ) तारीख 2 फरवरी, 2024 द्वारा उन सभी व्यजक्तयों स,े जिनके उनस े प्रभाजवत होने की संभावना थी, जनयमों का प्रारूप भारत के रािपत्र, असाधारण, भाग 2, खडं 3, उपखंड (i) में प्रकाजित दकए गए थ,े उस तारीख स े जिसको उक्त अजधसूचना स े युक्त रािपत्र की प्रजतयां िनता को उपलब्ध करा िी गई थी, तीस दिन की अवजध के अवसान स े पूवव आक्षपे और सुझाव आमंजत्रत दकए गए थ े; और उक्त रािपत्र की प्रजतयां िनता को 5 फरवरी, 2024 को उपलब्ध करा िी गई थीं ; और उक्त जनयमों की बाबत िनता से प्राप्त आक्षपे ों और सझु ावों पर केन्द्रीय सरकार द्वारा जवचार कर जलया गया ह ै; अतः, अब केन्द्रीय सरकार, ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 6(2), धारा 12, धारा 33 और धारा 33ढ द्वारा प्रित्त िजक्तयों का प्रयोग करत े हुए, आयुवेि, जसद्धा, यूनानी ओषजध तकनीकी 3900 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] सलाहकार बोडव के साथ परामिव के पश्चात ् ओषजध जनयम, 1945 का और संिोधन करन े के जलए जनम्नजलजखत जनयम बनाती ह,ै अथावत ् :-- 1. संजक्षप्त नाम और प्रारंभ.- (1) इन जनयमों का संजक्षप्त नाम ओषजध (चौथा संिोधन) जनयम, 2024 ह ै। (2) य ेजनयम रािपत्र म ेंउनके प्रकािन की तारीख को प्रवृत्त होंगे । 2. ओषजध जनयम,-- (क) जनयम 170 का लोप दकया िाएगा । (ख) अनुसूची क म ेंप्ररूप 26 ङ4 और प्ररूप 26 ङ5 का लोप दकया िाएगा । [फा. स.ं टी-11011/05/2019-डीसीसी(आयुष)] बी.के. ससंह, संयक्ु त सजचव टटप्पण.-मूल जनयम भारत के रािपत्र म ें अजधसूचना सं. एफ. 28-10/45-एच(1) तारीख 21 दिसंबर, 1945 द्वारा प्रकाजित दकए गए थे और अंजतम संिोधन अजधसूचना सं. सा.का.जन. 293(अ) तारीख 28 मई, 2024 द्वारा दकया गया । MINISTRY OF AYUSH NOTIFICATION New Delhi, the 1st July, 2024 G.S.R. 360(E).—Whereas the draft of certain rules further to amend the Drugs Rules, 1945, was published as required under section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) (hereinafter referred to as the said Act), vide notification of the Government of India in the Ministry of Ayush, number G.S.R. 98(E), dated the 02nd February, 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 Official Gazette containing the said notification were made available to the public; And Whereas, the copies of said Official Gazette were made available to the public on the 5th February, 2024; And Whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 6(2), 12, 33 and 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:- 1. Short title, and commencement: - (1) These rules may be called the Drugs (Fourth Amendment) Rules, 2024. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules,- (a) rule 170 shall be omitted. (b) in SCHEDULE A, FORM 26 E4 and FORM 26 E5 shall be omitted. [F. No. T-11011/05/2019-DCC(AYUSH)] B.K.SINGH, Jt. Secy. Note: The principal rules were published in the Gazette of India, vide, notification No. F. 28-10/45-H(1), dated the 21st December, 1945 and last amended, vide, notification number G.S.R. 293(E), dated the 28th May, 2024. 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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