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Date: 10-Jul-2024 Category: Extra Ordinary State: Union Government Country: India

Amendment in 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

Description of the Gazette Notification

  • This gazette notification proposes amendments to the Drugs and Cosmetics Rules, 1945, through a draft of certain rules called the Drugs Rules (Amendment), 2024. The amendment is proposed by the Ministry of Health and Family Welfare, Government of India and is based on powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
  • The key change involves inserting the words “Schedule G” after the words “the drugs specified in” within various clauses of rules 74, 74A, 74B, 78, and 78A of the Drugs Rules, 1945.

Key Changes

  • The proposed amendment to the Drugs Rules, 1945, adds the reference to “Schedule G” in five different clauses across rules 74, 74A, 74B, 78, and 78A. This addition clarifies which drugs are included under the specified rules. The exact content of Schedule G is not detailed in this notification.
  • The amendment will come into force on the date of its final publication in the Official Gazette.
  • A 45-day period is provided for public feedback on the proposed amendment.

Impact Analysis

Pharmaceutical Industry

  • Action Item: Pharmaceutical companies should review the proposed amendment and submit their feedback within the 45-day period. They should also prepare for potential changes to their operations based on the final rules.

Regulatory Bodies

  • Action Item: Regulatory bodies should prepare for the implementation of the amended rules and update their internal processes accordingly.

Consumers

  • Action Item: Consumers should monitor the final version of the amended rules and seek clarification if needed.

Public

  • Action Item: Individuals and organizations concerned about the proposed changes can submit their objections and suggestions to the specified authorities within the 45-day period.

Key Entities Referenced

Ministry of Health and Family Welfare (Government of India): The ministry proposing the amendment to the Drugs and Cosmetics Rules, 1945. Drugs Technical Advisory Board: The board consulted before proposing the amendment. Drugs and Cosmetics Act, 1940 (23 of 1940): The act under which the power to make the amendment is conferred. Drugs and Cosmetics Rules, 1945: The rules being amended. These rules were originally published on December 21, 1945, and were last amended on May 28, 2024. Schedule G: A schedule of drugs whose exact contents are not specified in this notification but whose inclusion is the core of the proposed amendment. Drugs Controller General of India (DCGI): The regulatory body responsible for enforcing the Drugs and Cosmetics Act and Rules.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-11072024-255341 CG-DxLx-xEG-I1D1H0x7x2x0 24-255341 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.ं 352] नई दिल्ली, बधु वार , िलु ाई 10, 2024/आषाढ 19, 1946 No. 352] NEW DELHI, WESNESDAY, JULY 10, 2024/ASHADHA 19, 1946 स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 10 िुलाई, 2024 का.आ. 375(अ).— औषध एव ं प्रसाधन सामग्री अजधजनयम (23 का 1940) 1940की धाराएं द्वारा 33 एव ं 12 प्रित्त िजियों का प्रयोग करत े हुए जनम्नजलजखत कजतपय प्रारूप जनयमों के माध्यम से औषजध एवं प्रसाधन जनयमावली, 1945 में आगे संिोधन का प्रस्ट्ताव करती ह ै और इस े प्रकािन के पश्चात औषध तकनीकी सलाहकार बोड ड के परामि ड से एतद्द्वारा इससे प्रभाजवत होने वाले सभी संभाजवत व्यजियों के सूचनार्ड प्रकाजित दकया िाता ह ैऔर एतद्द्वारा यह सूचना िी िाती ह ै दक भारत के रािपत्र की प्रजतयों को आम िनता के जलए उपलब्ध कराए िान े की जतजर् स े पैंतालीस दिनों की अवजध समाप्त होने पर या उसके बाि उि प्रारूप जनयमों को जवचारार् ड जलया िाएगा; केंद्र सरकार द्वारा उपरोि जनर्िडष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त आपजत्तयों और सुझावों पर जवचार दकया िाएगा; आपजत्तयां और सुझाव, यदि कोई ह,ैं अवर सजचव (औषजध), स्ट्वास्ट््य एवं पररवार कल्याण मंत्रालय, भारत सरकार, कमरा नं 414-ए, डी ववंग, जनमाडण भवन, नई दिल्ली -110011 को भेिे िाए ं या drugsdiv- mohfw@gov.in पर ई मले -दकए िाए।ं 4141 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] जनयमों का मसौिा 1. (1) इन जनयमों को औषध जनयम (संिोधन), 2024 कहा िाएगा। (2) ये आजधकाररक रािपत्र म ें अंजतम प्रकािन की तारीख स ेलागू होंगे। 2. औषध जनयम, 1945 म,ें - (i) जनयम 74 के खडं (त) म,ें "में जवजनर्िडष्ट औषजधयों" िब्िों के पश्चात ् "अनुसूची छ " िब्ि अंत:स्ट्र्ाजपत दकए िाएगं ;े (ii) जनयम 74 क के खंड (झ) म,ें "में जवजनर्िडष्ट औषजधयों" िब्िों के पश्चात् "अनुसूची छ" िब्ि अंत:स्ट्र्ाजपत दकए िाएंग;े (iii) जनयम 74 ख के खंड (7) म,ें "में जवजनर्िडष्ट औषजधयों" िब्िों के पश्चात ् "अनुसूची छ" िब्ि अंत:स्ट्र्ाजपत दकए िाएंग;े (iv) जनयम 78 के खडं (र्) म,ें “म ें जवजनर्िडष्ट औषजधयों" िब्िों के पश्चात ् “अनुसूची छ” िब्ि अंत:स्ट्र्ाजपत दकए िाएंग;े (v) जनयम 78 क के खडं ) 8) म,ें "म ें जवजनर्िडष्ट औषजधयों" िब्िों के पश्चात ् "अनुसूची छ "िब्ि अंत:स्ट्र्ाजपत दकए िाएंगे। [फा.स.ं एक्स.11035/47/2024-डीआरएस] रािीव वधावन, सलाहकार (लागत) रिप्पण:—मूल जनयम अजधसूचना संख्या एफ.28-10/45-एच (1), दिनांक 21 दिसंबर, 1945 द्वारा आजधकाररक रािपत्र म ें प्रकाजित दकए गए र् े और अंजतम बार अजधसूचना संख्या िीएसआर 293(ई), दिनांक 28 मई, 2024 द्वारा संिोजधत दकए गए र्े। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th July, 2024 G.S.R. 375(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration or after the expiry of a period of forty five days from the date on which the copies of the Gazette of India these draft rules are made available to public; Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES 1. (1) These rules may be called the Drugs Rules (......Amendment), 2024. (2) They shall come into force on the date of their final publication in the Official Gazette. 2. In the Drugs Rules, 1945, — (i) in rule 74, in clause (p), after the words “the drugs specified in”, the words “Schedule G,” shall be inserted; (ii) in rule 74A, in clause (i), after the words “the drugs specified in”, the words “Schedule G,” shall be inserted;[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3 (iii) in rule 74B, in clause (7), after the words “the drugs specified in”, the words “Schedule G,” shall be inserted; (iv) in rule 78, in clause (q), after the words “the drugs specified in”, the words “Schedule G,” shall be inserted; (v) in rule 78A, in clause (8), after the words “the drugs specified in”, the words “Schedule G,” shall be inserted. [F.No. X.11035/47/2024-DRS] RAJIV WADHAWAN, Adviser (Cost) Note:—The principal rules were published in the Official Gazette vide notification No.F.28-10/45-H (1), dated 21st the December, 1945 and last amended vide notification number G.S.R 293 (E), dated 28.05.2024. 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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