Home› India› Ministry of Health and Family Welfare› Omission of Glyceryl Trinitrate and Isosorbide Dinitrate fro...
Date: 26-Sep-2023 Category: Extra Ordinary State: Union Government Country: India

Omission of Glyceryl Trinitrate and Isosorbide Dinitrate from Schedule P1 and modification in Rule 105.

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • The gazette notification pertains to a draft amendment to the Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940. The Central Government, after consulting with the Drugs Technical Advisory Board, proposes these changes and invites public comments before finalizing them.

Key Changes

  • Rule 105(2)(i) of the Drugs Rules, 1945 is proposed to be amended by substituting “multiples of 5” with “multiples of 5 or 7”.
  • Schedule P1 of the Drugs Rules, 1945 is proposed to be amended to remove the entries for “Glyceryl Trinitrate Sapnsules (Long Acting) 25” and “Isosorbide Dinitrate Sapnsules (Long Acting) 25” from the table specifying the name of the drug, dosage form, and pack size.
  • The draft rules will be called the Drugs (Amendment) Rules, 2023 and will come into force on the date of their final publication in the Official Gazette.
  • The public has 45 days from the date the gazette is made available to submit objections and suggestions regarding the proposed amendments.

Impact Analysis

Pharmaceutical Manufacturers

  • Manufacturers should review their production and distribution strategies for affected products.

Healthcare Providers

  • Hospitals and pharmacies should update their inventory management systems to reflect the changes.

Consumers/Patients

  • Patients should be informed about the changes in the Drugs Rules and their potential impact on medication availability.

Regulatory Bodies

  • Regulatory bodies need to ensure compliance with the amended rules by pharmaceutical manufacturers and other stakeholders.

Suggested Action Items

  • Update internal processes and systems to comply with the amended Drugs Rules.

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 the Central Government to make rules. 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. 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 and family welfare policies and programs in India. It is responsible for framing and amending the Drugs Rules. Schedule P1: A schedule in the Drugs Rules, 1945, that lists drugs and their respective dosage forms and pack sizes.
Official Source Record View Original Source →
See Full Document Text
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-27092023-249002 xxxGIDHxxx CG-DL-E-27092023-249002 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.ं 545] नई दिल्ली, मगं लवार, जसतम्ब र 26, 2023/ आजिन 4, 1945 No. 545] NEW DELHI, TUESDAY, SEPTEMBER 26, 2023/ ASVINA 4, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 25 जसतम्ब र, 2023 सा.का.जन. 687(अ).— औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 द्वारा प्रित्त िजियों का प्रयोग करत े हुए कजतपय जनयमों का जनम्नजलजखत मसौिा, जिसे केन्द्र सरकार बनान े का जवचार रखती ह,ै औषध तकनीकी सलाहकार बोड ड के साथ परामि ड के बाि इससे प्रभाजवत होन े की संभावना वाले सभी व्यजियों की सूचना के जलए प्रकाजित दकया िाता ह ै और इसके द्वारा यह सूचना िी िाती ह ै दक उि मसौिा जनयमों पर उस तारीख स,े जिस तारीख को इन मसौिा जनयमों वाले भारत के रािपत्र की प्रजतयां िनता के जलए उपलब्ध कराई िाती हैं, पैंतालीस दिनों की अवजध की समाजि पर या उसके बाि जवचार दकया िाएगा। उपरोि जनर्िष्टड अवजध के भीतर दकसी भी व्यजि से प्राि होने वाली आपजत्तयों और सुझावों पर केंर सरकार द्वारा जवचार दकया िाएगा। आपजत्तयां और सुझाव, यदि कोई हों, तो अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, कमरा संख्या 437, सी ववंग, जनमाडण भवन, नई दिल्ली- 110011 को भेिी िा सकती ह ै या drugsdiv- mohfw@gov.in पर ईमले की िा सकती ह।ैं मसौिा जनयम 1. (1) इन जनयमों को औषध (...... संिोधन) जनयम, 2023 कहा िाएगा। (2) व ेसरकारी रािपत्र में अपने अंजतम प्रकािन की तारीख से प्रवृत्त होंगे। 6107 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 2. औषजध जनयमावली, 1945 (जिन्द्ह ेंइसमें इसके पश्चात् उि जनयम कहा िाएगा) में, जनयम 105 में, उपजनयम (2) म,ें खडं (i) म ें िब्िों, अक्षरों और अंकों, "5 के गुणक", जनम्नजलजखत िब्ि, अक्षर और अकं अथाडत ् "5 या 7 के गणु क" द्वारा प्रजतस्ट्थाजपत दकए िाएंगे। 3. उि जनयमों म,ें अनुसूची पी 1 में, ताजलका म,ें औषजध के नाम और संबंजधत खुराक फॉमड और पैक के आकार के तहत जनम्नजलजखत प्रजवजष्टयों का जवलोप दकया िाएगा। “जललसरील राइनाइरेट सैप्नन्द्यूल्स (लंबे समय तक ) 25 आइसोसोर्बडड डाइनाइरेट सैपन्द्यूल्स (लबं े समय तक) 25” [फा.सं. एक्स11035/108/2023-डीआरएस] आराधना पटनायक, संयुि सजचव पाि रटप्नपणी: औषजध जनयमावली, 1945 को भारत के रािपत्र म ें दिनांक 21 दिसंबर, 1945 की अजधसूचना संख्या एफ.28-10/45-एच (1) के माध्यम से प्रकाजित दकया गया था और इसमें अंजतम बार 2 िून, 2023 की अजधसूचना संख्या सा॰का॰जन॰ 410 (अ) के माध्यम से संिोधन दकया गया था। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 25th September, 2023 G.S.R. 687(E).— The following draft of certain rules, 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), is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to the 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. 437, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES 1. (1) These rules may be called the Drugs (......Amendment) Rules, 2023. (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 said rules), in rule 105, in sub-rule (2), in clause (i), the words, letters and figures, “multiples of 5”, following words, Letters and figures shall be substituted namely.- “multiples of 5 or 7.” 3. In the said rules, in Schedule P1, in the table, the following entries under the Name of the Drug and respective Dosage form and Pack Size, shall be omitted. “Glyceryl Trinitrate Sapnsules (Long Acting) 25 Isosorbide Dinitrate Sapnsules (Long Acting) 25” [F.No. X.11035/108/2023-DRS] ARADHANA PATNAIK, Jt. Secy. 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. 410(E), dated the 2nd June, 2023. 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.

Continue your research

Related Documents from Ministry of Health and Family Welfare