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Core Purpose

Draft amendment to the First and Second Schedules of the Drugs and Cosmetics Act, 1940, adding Homoeopathic System reference texts and recognising the French Homoeopathic Pharmacopoeia and the European Pharmacopeia, published for public objections and suggestions.

Detailed Summary

S.O. 155(E), dated 11th January 2024, issued by the Ministry of AYUSH, in supersession of the earlier notification G.S.R. 668(E) dated 28th September 2021 (except as respects things done or omitted before such supersession), publishes for public information a draft amendment to the First and Second Schedules of the Drugs and Cosmetics Act, 1940 (23 of 1940), proposed under section 33-O of the Act after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board. Objections and suggestions may be sent to the Secretary, Ministry of AYUSH, AYUSH Bhawan, 'B' Block, GPO Complex, INA, New Delhi - 110023, or emailed to [email protected], before the draft is taken up for consideration after three months from public availability of the notification. The draft inserts a new heading, C - Homoeopathic System, into the First Schedule, listing 20 reference texts and pharmacopoeias, including works by Hahnemann, Hering, Allen, Clarke, Hughes, Kent and Boericke, and the Homoeopathic Pharmacopoeia India. It also amends item 4A of the Second Schedule's Class of drug entries, inserting recognition of the French Homoeopathic Pharmacopoeia or the European Pharmacopeia alongside the existing German Homoeopathic Pharmacopoeia reference, in both sub-item (b) and sub-item (c). Notification F. No. K.11024/01/2018-DCC(AYUSH) is signed by B. K. Singh, Joint Secretary.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-12012024-251311 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 148] NEW DELHI, FRIDAY, JANUARY 12, 2024/PAUSHA 22, 1945 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 [email protected]. 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:- "С. -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. | +----------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 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. 1Indian 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. | +----------+-----------------------------------------------------------------------------------------------------------------------------------------------------------------+ 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.

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