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Date: 18-Mar-2024 Category: Extra Ordinary State: Union Government Country: India

Modification in Rule 105 and Schedule P1 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 notification introduces the Drugs (Second Amendment) Rules, 2024, which further amends the Drugs Rules, 1945. These amendments are made in exercise of powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. The rules will come into force on the date of their publication in the Official Gazette.

Key Changes

  • Rule 105 of the Drugs Rules, 1945 is amended to include 'or 7' after 'multiples of 5' in sub-rule (2), clause (i). This change relates to some unspecified requirement linked to multiples of 5 or 7.
  • Schedule P1 of the Drugs Rules, 1945 is amended to remove the drugs 'Glyceryl Trinitrate' and 'Isosorbide Dinitrate' from the list of drugs under the heading 'PACK SIZES OF DRUGS', along with their corresponding entries in columns 2 and 3. This means that pack size regulations for these drugs are being removed or altered.

Impact Analysis

Pharmaceutical Manufacturers

  • All pharmaceutical manufacturers should take note of the amendment to Rule 105 regarding the inclusion of 'or 7' after 'multiples of 5'. They need to assess if this change affects any of their manufacturing or packaging processes and ensure compliance.

Regulatory Bodies

  • The Ministry of Health and Family Welfare needs to monitor the implementation of these amendments and address any issues that may arise.

Consumers/Patients

  • Healthcare providers should be informed about these changes to effectively counsel patients.

Action Items

  • Monitor the implementation of the amendments and address any issues that may arise.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The principal legislation governing drugs and cosmetics in India. Sections 12 and 33 provide the powers to make and amend rules. Drugs Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, which lay down the detailed procedures and requirements for the manufacture, sale, distribution, and import 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 in India. Schedule P1: A schedule within the Drugs Rules, 1945 that specifies the pack sizes of certain drugs. Glyceryl Trinitrate: A medication used to treat angina (chest pain). Isosorbide Dinitrate: A medication used to prevent angina (chest pain).
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-18032024-253209 xxxGIDHxxx CG-DLxx-xEG-I1D8E0x3x2x0 24-253209 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 202] नई दिल्ली, सोमवार, माच च18, 2024/फाल्ग नु 28, 1945 No. 202] NEW DELHI, MONDAY, MARCH 18, 2024/PHALGUNA 28, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 18 माचच, 2024 सा.का.जन. 216(अ).—ओषजध जनयम, 1945 का और संिोधन करन े के जलए ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 33 के साथ परित धारा 12 के अधीन यथा अपेजित कजतपय जनयमों का प्रारूप, भारत सरकार के स्ट्वास्ट््य और पररवार कल्याण मंत्रालय के स्ट्वास्ट््य और पररवार कल्याण जवभाग की अजधसूचना संख्या सा.का.जन. 687(अ), तारीख 25 जसतंबर, 2023 द्वारा भारत के रािपत्र, असाधारण, भाग 2, खंड 3, उपखंड (i) म ें प्रकाजित की गई थी, जिसमें उन सभी व्यजियों से, जिनके उससे प्रभाजवत होने की संभावना थी, आिेपों और सुझावों को उस तारीख से जिसको उि अजधसूचना को अंतर्वचष्ट करने वाली रािपत्र की प्रजतयां िनता को उपलब्ध करा िी गई थीं, पैंतालीस दिन के अवसान के पवू च मंगाया गया था; उि रािपत्र की प्रजतयां िनता को 26 जसतंबर, 2023 को उपलब्ध करा िी गई थीं; उि जनयमों पर िनता से प्राप्त आिेपों और सुझावों पर केंद्रीय सरकार द्वारा सम्यक रूप स े जवचार कर जलया गया ह;ै अत:, अब, केंद्रीय सरकार, ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 33 के साथ परित धारा 12 और द्वारा प्रित्त िजियों का प्रयोग करत े हुए, ओषजध तकनीकी सलाहकार बोड च से परामि च के पश्चात, ओषजध जनयम, 1945 का और संिोधन करने के जलए जनम्नजलजखत जनयम बनाती ह,ै अथाचत्:- 1. (1) इन जनयमों का संजिप्त नाम ओषजध (िसू रा संिोधन) जनयम, 2024 ह।ै 2090 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (2) य ेरािपत्र में उनके प्रकािन की तारीख को प्रवृत्त होंगे। 2. ओषजध जनयम, 1945 (जिसे इसमें इसके पश्चात,् उि जनयम कहा गया ह)ै में जनयम 105 में उप-जनयम (2) म,ें खंड (i) म,ें “5 के गणु क” अंक और िब्िों के पश्चात “या 7” अंक और िब्ि अंत:स्ट्थाजपत दकया िाएगा। 3. मूल जनयमों म,ें अनुसूची पी 1 म,ें िीषचक "िवाओं के पैक आकार" के संिभच में, स्ट्तंभ 1 में उजल्लजखत िवाओं "जललसरील ररनाइरेट" और "आइसोसोरबाइड जडजनरेट" और कॉलम 2 और 3 म ें उससे संबंजधत प्रजवजष्टयों का लोप दकया िाएगा। [फा. सं. एक् स.11035/108/2023-डीआरएस] रािीव वधावन, सलाहकार (लागत). रटप्प णी : ओषजध जनयम, 1945 को भारत के रािपत्र में अजधसूचना संख्या एफ. 28-10/45-एच (1), दिनांक 21 दिसंबर, 1945 द्वारा प्रकाजित दकया गया था और अंजतम बार अजधसचू ना संख्या सा.का.जन. 95(अ.), दिनांक 5 फ़रवरी, 2024 द्वारा संिोजधत दकया गया था। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 18th March, 2024 G.S.R. 216(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was published, as required by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number G.S.R. 687 (E), dated the 25th September, 2023, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from the persons likely to be affected thereby before the expiry of a period of forty-five 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 Gazette notification were made available to the public on 26th September, 2023; 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 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the 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 (Second Amendment) Rules, 2024. (2) They shall come into force on the date of their final publication in the Official Gazette. 2.In the Drugs Rules, 1945, (hereinafter referred to as the principal rules), in rule 105, in sub-rule (2), in clause (i), after the words, and figure, “multiples of 5”, the word and figure “or 7” shall be inserted. 3.In the principal rules, in Schedule P1, under the heading “PACK SIZES OF DRUGS”, the drugs “Glyceryl Trinitrate” and “Isosorbide Dinitrate” mentioned in column 1 and entries relating thereto in columns 2 and 3 shall be omitted. [F.No. X.11035/108/2023-DRS] RAJIV WADHAWAN, Advisor (Cost). Foot 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. 95(E), dated the 5th February, 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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