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Date: 12-Jan-2024 Category: Extra Ordinary State: Union Government Country: India

publication of notification no k 11024 01 2018 dcc ayush dated 11 01 2024 in the gazette of india

Issued by Ministry of AYUSH · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The gazette notification proposes amendments to the Drugs and Cosmetics Act, 1940, specifically concerning the inclusion of the Homoeopathic system in the First Schedule and updates to the Second Schedule regarding drug categories.
  • This notification supersedes the earlier notification G.S.R. 668(E) dated September 28, 2021, with exceptions for actions already taken or omitted before the supersession.

Key Changes

  • Inclusion of 'Homoeopathic System' in the First Schedule of the Drugs and Cosmetics Act, 1940, listing 20 specific books and publications related to Homoeopathy.
  • Amendment to the Second Schedule, item 4A, under 'Class of drug', to include 'French Homoeopathic Pharmacopoeia or the European Pharmacopeia' after 'the German Homoeopathic Pharmacopoeia' in sub-items (b) and (c).

Impact Analysis

Homoeopathic Medicine Manufacturers

  • Action Item: Homoeopathic medicine manufacturers should review their practices and ensure compliance with the newly included standards and references.

Consumers of Homoeopathic Medicines

  • Action Item: Consumers can expect greater consistency and reliability in the Homoeopathic medicines available in the market.

Regulatory Bodies (Ministry of AYUSH, Central Government)

  • Action Item: The Central Government will consider any objections or suggestions received regarding the draft amendment within three months of the notification's publication.

Practitioners of Homoeopathic Medicine

  • Action Item: Practitioners should familiarize themselves with the listed books and pharmacopoeias to ensure their practices align with the updated regulations.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The primary legislation being amended by this notification. It regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. Ministry of AYUSH: The Ministry responsible for the development and promotion of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy in India. It is the issuing authority for this notification. Ayurveda, Siddha, Unani Drugs Technical Advisory Board: A technical advisory board consulted by the Central Government in making amendments to the Drugs and Cosmetics Act, 1940, related to Ayurveda, Siddha, and Unani drugs. Homoeopathic Pharmacopoeia India: A set of standards and guidelines for the quality, purity, and strength of Homoeopathic medicines in India, published by the Government of India. Central Council for Research in Homoeopathy: An autonomous body under the Ministry of AYUSH that undertakes research and development in the field of Homoeopathy.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-12012024-251311 CG-DxLx-xEG-I1D2H0x1x2x0 24-251311 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 148] नई दिल्ली, िुक्वार, िनवरी 12, 2024/पौष 22, 1945 No. 148] NEW DELHI, FRIDAY, JANUARY 12, 2024/PAUSHA 22, 1945 आयषु मत्रं ालय अजधसचू ना नई दिल्ली, 11 िनवरी, 2024 का.आ. 155(अ).— जनम्नजलजखत प्रारूप संिोधन ओषजध और सौंियय प्रसाधन अजधजनयम, 1940 (1940 का 23) का और संिोधन करन े के जलए भारत सरकार, आयुष मंत्रालय की भारत के रािपत्र, असाधारण, भाग II, खंड 3, उपखंड (i) में सा.का.जन. 668(अ) तारीख 28 जसतंबर, 2021 में प्रकाजित अजधसूचना को अजधक्ांत करते हुए जसवाय ऐसे अजधक्मण स े पूवय की गई या करने स े लोप की गई बातों की बाबत प्रकाजित दकया गया था, केंद्रीय सरकार आयुवेि, जसद्धा, यूनानी ओषजध तकनीकी सलाहकार बोड य के साथ परामि य के पश्चात ् उक्त अजधजनयम की िसू री अनुसूची म ें ओषजध और सौंियय प्रसाधन अजधजनयम, 1940 (1940 का 23) की धारा 33ण द्वारा प्रित्त िजक्तयों का प्रयोग करते हुए उक्त अजधजनयम की पहली और िसू री अनुसूची में संिोधन करन े का प्रस्ट्ताव करती है, उनसे प्रभाजवत होने वाले सभी संभाजवत व्यजक्तयों की सूचना के जलए प्रकाजित दकया िाता ह ै और सूचना िी िाती ह ै उक्त प्रारूप संिोधन पर उस तारीख से, जिसको भारत के रािपत्र म ें यथा प्रकाजित उक्त अजधसूचना की प्रजतया ं िनता को उपलब्ध करा िी िाती ह,ैं तीन मास की कालावजध की समाजि पर या उसके पश्चात् जवचार दकया िाएगा ; कोई आक्षेप और सुझाव, िो प्रारूप संिोधन की बाबत पूवोक्त कालावजध के अवसान से पूवय दकसी व्यजक्त से प्राि होत े ह,ैं पर केंद्रीय सरकार द्वारा जवचार दकया िाएगा 261 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] इस प्रारूप संिोधन की बाबत आक्षेपों और सुझावों, यदि कोई हों, को सजचव, आयुष मंत्रालय, आयुष भवन, ‘बी’ ब्लॉक, िीपीओ काम्पलेक्स, आईएनए, नई दिल्ली – 110003 को भेिा िा सकता ह ै या dcc-ayush@nic.in पर ई-मेल दकया िा सकता ह ै प्रारूप सिं ोधन 1. ओषजध और सौंिय य प्रसाधन अजधजनयम, 1940 (1940 का 23) (जिसे इसम ें इसके पश्चात ् उक्त अजधजनयम कहा गया ह)ै की पहली अनुसूची म ें िीष य “ख. यनू ानी जतब्ब प्रणाली” और उससे संबंजधत प्रजवजियों के पश्चात् जनम्नजलजखत अंत:स्ट्थाजपत दकया िाएगा, अथायत ् :- “ग. होम्योपजै थक प्रणाली Serial. No. Name of book 1. Hahnemann Samuel. Materia Medica Pura. Volume I-II. 3rd edition London: Hahnemann Publishing Society; 1830 or reprint edition 1986. 2. Hahnemann Samuel. The Chronic Diseases Their Peculiar nature and their homoeopathic cure. (Theory and Practice). 1st edition New York: W Radde; 1845. 3. Hering Constantine. The Guiding Symptoms of Our Materia Medica. Volume I-X. 1ST edition Philadelphia: American Homoeopathic Publishing Society; J.M. Stoddart and Corporation; 1879. or Reprinted edition New Delhi: B. Jain Publishers; 1989. 4. Allen TF. The Encyclopaedia of pure Materia Medica. Volume I-XII. 1stedition New York, Philadelphia: Boericke and Tafel; 1877. or Reprinted edition New Delhi: B. Jain Publishers; 1986. 5. Allen HC. The Materia Medica of Nosodes with proving of X-rays. 1st edition Philadelphia: Boericke and Tafel; 1910/ New Delhi: Jain Publishing Co; 1977. 6. Clarke JH. A Dictionary of Practical Materia Medica. Volume I-III. 1st edition London: The Homoeopathic Publishing Company; 1902. 7. Hughes Richard. A Manual of Pharmacodynamics. 5th edition London: Leath and Ross; 1886. 8. Hughes R, Dake JP. Cyclopaedia of Drug Pathogenesy. 1st edition London: Gould; 1886. 9. Julian OA. Materia Medica of Nosodes with Repertory. 1stIndian edition New Delhi: B. Jain Publishers; 1980/ New Delhi: B. Jain Publishers; 1981. 10. Julian OA. Materia Medica of New Homoeopathic Remedies. French edition UK: Beaconsfield Publishers Limited; 1971/ Beaconsfield Bucks UK: Beascons field Publishers Limited; 197. 11. Paterson John. The Bowel Nosodes. 1st edition Calcutta: Hahnemann Publishing Company Private Ltd; 1950/Calcutta: Hahnemann Publishing Company Private Limited. 12. Ghose SC. Drugs of Hindoostan. edition Calcutta: Hahnemann Publishing Company Private Limited; 1952/ 9th edition Calcutta: Hahnemann Publishing Company Private Limited; 1984. 13. Anshutz’s EP. New, Old and Forgotten Remedies. 1st edition Philadelphia: Boericke and Tafel; 1900. 14. Boericke William, Dewey Willis A. The Twelve Tissue Remedies. 1st edition Philadelphia: Boericke and Tafel; 1888. 15. Kent JT. Lectures Homoeopathic MateriaMedica. 1th edition Calcutta: Roy Publishing House: 1904. 16. Boericke OE. Pocket Manual of Homeopathic MateriaMedica, Boericke and Runyon. 6th edition New York: Boericke and Tafel; 1916/New Delhi: B. Jain Publishers; 1971. 17. Stephenson J. Hahnemannian Provings, A Materia Medica and Repertory. New York: Boericke & Tafel; 1963/ New Delhi: B. Jain Publishers; 1986 18. Homoeopathic Pharmacopeia India -all volumes published by Govt. of India 19. Study of Homoeopathic Medicines through Clinical Verification all Volumes published by Central Council for Research in Homoeopathy, New Delhi. 20. Homoeopathic Drug Provings- all Volumes published by Central Council for Research in Homoeopathy, New Delhi.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 घ. सोवा-ररग्पा प्रणाली4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)][भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5 2. अजधजनयम की िसू री अनुसूची में ‘ओषजध का वग’य के अधीन मि सं. 4 क म,ें -- (क) उपमि (ख) म ें “िमयन होम्योपैजथक भेषिी” िब्िों के पश्चात् जनम्नजलजखत अंत:स्ट्थाजपत दकया िाएगा, अथायत ् :--6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] “या फ्रेंच होम्योपैजथक भेषिी या यूरोजपयन भेषिी ” (ख) उपमि (ग) म ें “िमयन होम्योपैजथक भेषिी” िब्िों के पश्चात् जनम्नजलजखत अंत:स्ट्थाजपत दकया िाएगा, अथायत ् :-- “या फ्रेंच होम्योपैजथक भेषिी या यूरोजपयन भेषिी ” [फा. सं. के.11024/01/2018-डीसीसी(आयुष)] बी. के. ससंह, संयुक् त सजच व MINISTRY OF AYUSH NOTIFICATION New Delhi, the 11th January, 2024 S.O. 155(E).—The following draft amendment further to amend the Drugs and Cosmetics Act, 1940 (23 of 1940), in supersession of the notification of the Government of India, Ministry of Ayush, published in the Gazette of India, Extraordinary Part-II, Section 3 Sub-section (i) vide G.S.R. 668 (E) dated the 28th September, 2021, except as respect things done or omitted to be done before such supersession, the Central Government after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, proposes to make amendment in the First and Second Schedule of the said Act, in exercise of the powers conferred by section 33-O of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published for information of all persons likely to be affected thereby and notice is hereby given that said draft amendment shall be taken into consideration on or after the expiry of a period of three months from the date on which the copies of this notification, as published in the official Gazette, are made available to the public; Any objections and suggestions which may be received from any person in respect of draft amendment before the expiry of the aforesaid period above shall be considered by the Central Government. Objections and suggestions to this draft amendment, if any, may be addressed to the Secretary, Ministry of Ayush, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in. DRAFT AMENDMENT 1. In the First Schedule to the Drugs and Cosmetics Act, 1940 (23 of 1940),( hereinafter referred to as the said Act), after heading “B. UNANI TIBB SYSTEM” and the entries relating thereto, the following shall be inserted, namely:- “C. —HOMOEOPATHIC SYSTEM Serial.no. Name of book 1. Hahnemann Samuel. Materia Medica Pura. Volume I-II. 3rd edition London: Hahnemann Publishing Society; 1830 or reprint edition 1986. 2. Hahnemann Samuel. The Chronic Diseases Their Peculiar nature and their homoeopathic cure. (Theory and Practice). 1st edition New York: W Radde; 1845. 3. Hering Constantine. The Guiding Symptoms of Our Materia Medica. Volume I-X. 1ST edition Philadelphia: American Homoeopathic Publishing Society; J.M. Stoddart and Corporation; 1879. or Reprinted edition New Delhi: B. Jain Publishers; 1989. 4. Allen TF. The Encyclopaedia of pure Materia Medica. Volume I-XII. 1stedition New York, Philadelphia: Boericke and Tafel; 1877. or Reprinted edition New Delhi: B. Jain Publishers; 1986.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 7 5. Allen HC. The Materia Medica of Nosodes with proving of X-rays. 1st edition Philadelphia: Boericke and Tafel; 1910/ New Delhi: Jain Publishing Co; 1977. 6. Clarke JH. A Dictionary of Practical Materia Medica. Volume I-III. 1st edition London: The Homoeopathic Publishing Company; 1902. 7. Hughes Richard. A Manual of Pharmacodynamics. 5th edition London: Leath and Ross; 1886. 8. Hughes R, Dake JP. Cyclopaedia of Drug Pathogenesy. 1st edition London: Gould; 1886. 9. Julian OA. Materia Medica of Nosodes with Repertory. 1stIndian edition New Delhi: B. Jain Publishers; 1980/ New Delhi: B. Jain Publishers; 1981. 10. Julian OA. Materia Medica of New Homoeopathic Remedies. French edition UK: Beaconsfield Publishers Limited; 1971/ Beaconsfield Bucks UK: Beascons field Publishers Limited; 197. 11. Paterson John. The Bowel Nosodes. 1st edition Calcutta: Hahnemann Publishing Company Private Ltd; 1950/Calcutta: Hahnemann Publishing Company Private Limited. 12. Ghose SC. Drugs of Hindoostan. edition Calcutta: Hahnemann Publishing Company Private Limited; 1952/ 9th edition Calcutta: Hahnemann Publishing Company Private Limited; 1984. 13. Anshutz’s EP. New, Old and Forgotten Remedies. 1st edition Philadelphia: Boericke and Tafel; 1900. 14. Boericke William, Dewey Willis A. The Twelve Tissue Remedies. 1st edition Philadelphia: Boericke and Tafel; 1888. 15. Kent JT. Lectures Homoeopathic MateriaMedica. 1th edition Calcutta: Roy Publishing House: 1904. 16. Boericke OE. Pocket Manual of Homeopathic MateriaMedica, Boericke and Runyon. 6th edition New York: Boericke and Tafel; 1916/New Delhi: B. Jain Publishers; 1971. 17. Stephenson J. Hahnemannian Provings, A Materia Medica and Repertory. New York: Boericke & Tafel; 1963/ New Delhi: B. Jain Publishers; 1986 18. Homoeopathic Pharmacopeia India -all volumes published by Govt. of India 19. Study of Homoeopathic Medicines through Clinical Verification all Volumes published by Central Council for Research in Homoeopathy, New Delhi. 20. Homoeopathic Drug Provings- all Volumes published by Central Council for Research in Homoeopathy, New Delhi.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] D. SOWA-RIGPA SYSTEM[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 910 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)][भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 11 2. In the Second Schedule to the said Act, in item number 4A, under ‘Class of drug’, - (a) in sub-item (b), after the words “the German Homoeopathic Pharmacopoeia”, the following shall be inserted, namely:- “or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia.” (b) in sub-item (c), after the words “the German Homoeopathic Pharmacopoeia”, the following shall be inserted, namely:- “or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia.”. [F. No. K.11024/01/2018-DCC(AYUSH)] B. K. SINGH, Jt. Secy. 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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