Home India Ministry of Health and Family Welfare Inclusion of Cochin and Thiruvananthapuram Ports in Rule 43A...
Date: 28-May-2024 Category: Extra Ordinary State: Union Government Country: India

Inclusion of Cochin and Thiruvananthapuram Ports in Rule 43A of Drugs Rules, 1945

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

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Executive Summary & Key Takeaways

What it means

  • The gazette notification introduces the Drugs (Third Amendment) Rules, 2024, which further amend the Drugs Rules, 1945.
  • The amendment modifies rule 43A of the Drugs Rules, 1945, expanding the list of locations mentioned in the rule.

Key Changes

  • The Drugs (Third Amendment) Rules, 2024 come into force on the date of their publication in the Official Gazette, which is May 28, 2024.
  • Rule 43A of the Drugs Rules, 1945 is amended to include 'Cochin and Thiruvananthapuram' in addition to 'Bengaluru and Visakhapatnam'.
  • The original rule 43A mentioned only Bengaluru and Visakhapatnam. The amendment expands this list to include Cochin and Thiruvananthapuram.

Impact Analysis

Stakeholders

  • Healthcare providers: May experience changes in drug availability or regulations in the specified locations.

Suggested Action Items

  • Legal departments should update internal documentation to reflect the Drugs (Third Amendment) Rules, 2024.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. Sections 12 and 33 provide the powers to the Central Government to make rules to further the objectives of the Act. Drugs Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the manufacture, sale, distribution, and quality control of drugs and cosmetics. Drugs Technical Advisory Board: A statutory body constituted by the Central Government to advise on technical matters related to drugs and cosmetics. Ministry of Health and Family Welfare: The government ministry responsible for health policy and regulation in India. The Department of Health and Family Welfare is a division within the ministry.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-28052024-254400 CG-DxLx-xEG-I2D8H0x5x2x0 24-254400 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.ं 272] नई दिल्ली, मगं लवार, मई 28, 2024/ज्य ष्े ठ 7, 1946 No. 272] NEW DELHI, TUESDAY, MAY 28, 2024/JYAISHTHA 7, 1946 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 28 मई, 2024 सा.का.जन. 293(अ).—ओषजध जनयम, 1945 का और संिोधन करन े के जलए कजतपय जनयमों का प्रारूप, ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा (1) की अपेक्षानुसार, भारत के रािपत्र, असाधारण, भाग II, खडं 3, उपखंड (i), तारीख 27 फरवरी, 2024 म ें भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) की अजधसूचना संखयांक सा.का.जन. 139(अ) तारीख 27 फरवरी, 2024 द्वारा प्रकाजित दकया गया था, जिसमें उन सभी व्यजियों स,े जिनके उससे प्रभाजवत होने की संभावना ह,ै उस तारीख स,े जिसको उि अजधसूचना वाले रािपत्र की प्रजतयां िनता को उपलब्ध करा िी िाती ह,ै तीस दिन की अवजध की समाजि से पूवव आक्षपे और सुझाव मांगे गए थे ; और, उि रािपत्र की प्रजतयां िनता को 27 फरवरी, 2024 को उपलब्ध करा िी गई थी ; और, उि प्रारूप जनयमों के संबंध में िनता स ेकोई आक्षेप और सुझाव प्राि नहीं हुए हैं; 3241 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] अत:, अब केंद्रीय सरकार, ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 द्वारा प्रित्त िजियों का प्रयोग करते हुए, ओषजध तकनीकी सलाहकार बोडव से परामिव करने के पश्चात्, ओषजध जनयम, 1945 का और संिोधन करने के जलए जनम्नजलजखत जनयम बनाती है, अथावत ् :-- 1. (1) इन जवजनयमों का संजक्षि नाम ओषजध (तीसरा संिोधन) जनयम, 2024 ह ै। (2) य ेरािपत्र में उनके प्रकािन की तारीख को प्रवृत होंगे । 2. ओषजध जनयम, 1945 के जनयम 43क म,ें “बगैं लरूू और जविाखापत्तनम” िब्िों के स्ट्थान पर, “बैंगलूरू, जविाखापत्तनम, कोचीन और जतरूवनन्तपुरम” िब्ि रखे िाएगं े । [फा. सं. एक्स.11035/131/2022-डीआर] रािीव वधावन, सलाहकार (लागत) रिप्प ण : मलू जनयम भारत के रािपत्र म ें अजधसूचना सं. एफ.28-10/45-एच(1), तारीख 21 दिसंबर, 1945 द्वारा प्रकाजित दकए गए थे और अजधसूचना सं. सा.का.जन. 216(अ), तारीख 18 माचव, 2024 द्वारा अंजतम बार संिोजधत दकए गए थ े। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 28th May, 2024 G.S.R. 293(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. 139(E), dated the 27th February, 2024, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) dated the 27th February, 2024, 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, copies of the said Official Gazette were made available to the public on the 27th February, 2024; And whereas, no objections and suggestions were received from the public in respect of the said draft rules; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), 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 (Third Amendment) Rules, 2024. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, in rule 43A, for the words “Bengaluru and Visakhapatnam”, the words “Bengaluru, Visakhapatnam, Cochin and Thiruvananthapuram” shall be substituted. [F. No. X.11035/131/2022-DR] RAJIV WADHAWAN, Adviser (Cost). Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1), dated the 21st December, 1945 and last amended vide notification number GSR 216 (E), dated the 18th March, 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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