Home India Ministry of Health and Family Welfare Notification of Gangavaram port...
Date: 02-Jun-2023 Category: Extra Ordinary State: Union Government Country: India

Notification of Gangavaram port

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 notification publishes the Drugs (Amendment) Rules, 2023, which further amends the Drugs Rules, 1945.
  • The amendment modifies Rule 43A of the Drugs Rules, 1945, to include Gangavaram port in addition to Krishnapatnam port.

Key Changes

  • The Drugs (Amendment) Rules, 2023 comes into force on the date of its publication in the Official Gazette, which is June 2, 2023.
  • Rule 43A of the Drugs Rules, 1945 is amended by substituting “and Krishnapatnam port” with “Krishnapatnam and Gangavaram ports”.
  • This amendment adds Gangavaram port to the list of ports mentioned in Rule 43A.

Impact Analysis

Stakeholders Impacted

  • Consumers: The amendment ensures broader availability and potentially more efficient supply chains for drugs and cosmetics.

Suggested Action Items

  • Review and update internal SOPs to reflect the inclusion of Gangavaram port.

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 central government with the power to make rules to regulate the import, manufacture, distribution, and sale of drugs and cosmetics. Drugs Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, which provide detailed regulations for the manufacture, sale, distribution, and import of drugs and cosmetics. Drug Technical Advisory Board: A statutory body constituted by the Central Government to advise on technical matters related to drugs and cosmetics. Krishnapatnam Port: One of the ports already listed in Rule 43A of the Drugs Rules, 1945. Gangavaram Port: A port that is now included in Rule 43A of the Drugs Rules, 1945, through this amendment.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-02062023-246248 xxxGIDExxx CG-DL-E-02062023-246248 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 336] नई दिल्ली, िुक्रवार, िनू 2, 2023/ज्य ष्े ठ 12, 1945 No. 336] NEW DELHI, FRIDAY, JUNE 2, 2023/JYAISHTHA 12, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 2 िून, 2023 सा.का.जन. 410(अ).—िबदक औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1) के तहत यथा अपेजित औषजध जनयमावली, 1945 म ें और संिोधन करन े के जलए कुछ जनयमों का मसौिा भारत के रािपत्र, असाधारण, भाग II, खंड 3, उप खंड (i) म ें भारत सरकार, स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) ने दिनांक 1 माचच 2023 की अजधसूचना संख्या सा.का.जन 158(अ) द्वारा प्रकाजित दकया गया था, और इससे प्रभाजवत होन े वाल े व्यजियों से उि अजधसूचना को िनता को उपलब्ध करान े की तारीख से तीस दिनों की अवजध की समाजि से पहल े आपजियां और सझु ाव आमंजत्रत दकए गए थ;े और िबदक, उि सरकारी रािपत्र की प्रजतयां 1 माचच, 2023 को िनता के जलए उपलब्ध कराई गई थीं; और िबदक, उि मसौिा जनयमों पर िनता स े प्राि आपजियों और सुझावों पर केंद्रीय सरकार द्वारा जवचार दकया गया ह;ै इसजलए, अब औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और 33 द्वारा प्रिि िजियों का प्रयोग करत े हुए, केन्द्द्रीय सरकार, औषध तकनीकी सलाहकार बोड च के साथ परामि च करने के बाि, एति द्वारा औषजध जनयमावली, 1945 में और संिोधन करन ेके जलए जनम्नजलजखत जनयम बनाती है, अथाचत् :- 3486 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 1. (i) इन जनयमों का नाम औषजध (संिोधन) जनयमावली, 2023 ह।ै (ii) ये जनयमावली सरकारी रािपत्र में इनके प्रकािन की तारीख से प्रवृि होंगे। 2. औषजध जनयमावली, 1945 के जनयम 43क म,ें "और कृष्णापटनम बंिरगाह" िब्िों के स्ट्थान पर "कृष्णापट्टनम और गगं ावरम बंिरगाह" िब्िों को प्रजतस्ट्थाजपत दकया िाएगा। [फा. स.ं एक्स. 11035/131/2022-डीआर] आराधना पटनायक, संयक्ु त सजचव नोट : औषजध जनयमावली, 1945 भारत के रािपत्र म ें अजधसूचना संख्या एफ. 28-10/45-एच(1), दिनांक 21 दिसंबर, 1945 द्वारा प्रकाजित दकए गए थ े और अजधसूचना संख्या सा.का.जन. 654(अ), दिनांक 24 अगस्ट्त, 2022 द्वारा अंजतम बार संिोजधत दकए गए थ े। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2nd June, 2023 G.S.R. 410(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. 158 (E), dated the 1st March, 2023, 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, copies of the said Official Gazette were made available to the public on the 1st March, 2023; 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 Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drug 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 (Amendment) Rules, 2023. (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 “and Krishnapatnam port”, the words “,Krishnapatnam and Gangavaram ports” shall be substituted. [F. No. X.11035/131/2022-DR] ARADHANA PATNAIK, Jt. Secy. Note : The Drugs Rules, 1945 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 G.S.R. 654(E), dated the 24th August, 2022. 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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