The modern problems of homeopathy and how to solve them. The system for ensuring quality in homeopathic technology

Authors

  • Н. А. Замаренов Russian homeopathic association (Moscow, Russia)
  • И. В. Бурякова Russian homeopathic association (Moscow, Russia)
  • В. В. Береговых I.M.Sechenov First MSMU (Moscow, Russia)
  • Н. В. Пятигорская I.M.Sechenov First MSMU (Moscow, Russia)
  • А. Е. Лямина I.M.Sechenov First MSMU (Moscow, Russia)
  • В. В. Пичугин I.M.Sechenov First MSMU (Moscow, Russia)

Keywords:

homeopathy, homeopathic technology, quality assurance system, proving

Abstract

Article is devoted to questions of homeopathy, technology of preparation of homeopathic remedies (HomR) and their quality ensuring system. The comparative analysis of homeopathy and standard documentation in the world and in Russia is made. The features of homeopathic technology within the Russian system of quality assurance HomR are considered. Contradictions, inconsistencies and gaps in existing documentation are found. The specificity and uniqueness of homeopathy, homeopathic technology in the preparation of HomR are noted. Solutions to problems and imbalances on the basis of domestic and foreign experience, the advice of WHO, as well as new opportunities in specialized self-regulation of HomR production by professional community are suggested.

Author Biographies

Н. А. Замаренов, Russian homeopathic association (Moscow, Russia)

N.A. Zamarenov

И. В. Бурякова, Russian homeopathic association (Moscow, Russia)

I.V. Buriakova

В. В. Береговых, I.M.Sechenov First MSMU (Moscow, Russia)

V.V. Beregovikh

Н. В. Пятигорская, I.M.Sechenov First MSMU (Moscow, Russia)

N.V. Pyatigorskaya

А. Е. Лямина, I.M.Sechenov First MSMU (Moscow, Russia)

A.E. Lyamina

В. В. Пичугин, I.M.Sechenov First MSMU (Moscow, Russia)

V.V. Pichugin

References

1. Федеральный закон Российской Федерации от 12.04. 2010 г. N 61-ФЗ «Об обращении лекарственных средств», Москва, 2010 г.<BR>2. ОСТ 42-510-98 «Правила организации производства и контроля качества лекарственных средств (GMP)».<BR>3. ГОСТ Р 52249-2009 «Правила производства и контроля качества лекарственных средств (GMP)».<BR>4. «Руководство по надлежащей практике производства лекарственных средств для человека. Методические рекомендации Росздравнадзора» под редакцией Н.В. Юргеля. Москва 2009.<BR>5. «Гомеопатический метод лечения и практическое здравоохранение» (сборник нормативных документов и информационных материалов), М, изд. МЗ МП РФ, 1996 г , 327 с.<BR>6. Фармакопея СССР XI издания.<BR>7. Фармакопея России XII издания.<BR>8. Европейские Директивы 2001/82/EC, 2001/83/ЕС, 2004/27/EC, 2004/81/EC.<BR>9. Директива 2001/83/ЕС Европейского парламента и Совета ЕС от 6.11.2001 г «О своде законов Сообщества в отношении лекарственных препаратов для человека» Official Journal of the European Communities L 311 (28.11.2001).<BR>10. European Medicines Agency (EMEA ): REPORT ON EMEA HOMEOPATHIC MEDICINAL PRODUCTS 27th October 2006, Doc. Ref. EMEA/509019/2006.<BR>11. Билль Президента США N1103 – 2000 г.<BR>12. Code of Federal Regulations Parts 210 and 211: Current good manufacturing practice in manufacturing, processing, packing or holding of drugs; general and current good manufacturing practice for finished pharmaceuticals. Rockville, MD, US Food and Drug Administration, 2006.<BR>13. Drugs and Cosmetics Act, 1940, as amended 2005: Schedule M (Good Manufacturing Practice) of Drugs and Cosmetics Act. Health Canada, Natural Health Products Directorate. Good Manufacturing Practice Guidance Document (2003).<BR>14. U.S. Food and Drug Administration. Manual of Compliance Policy Guides. Sec. 400.400. Conditions Under Which Homeopathic Drugs May Be Marketed. U.S. Food and Drug Administration Web site.www.fda.gov/ICECI/ComplianceManuals/ CompliancePolicyGuidanceManual/ucm074360.html<BR>15. Farmacopeia Homeopatica Brasileira, 1992.<BR>16. The Homoeopathy Central Council Act 1973 (No. 59 of 1973) Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy, Ministry of Health & Family Welfare, Government of India.<BR>17. Ministry of Health & Family Welfare, Government of India. Schedule M (Good manufacturing practice) of Drugs and Cosmetics Rules, 1945, as amended 2006.<BR>18. “SCIENTIFIC FRAMEWORK OF HOMEOPATHY” (Evidence Based Homeopathy), Brussels, 2008 – European Committee for Homeopathy – LMHI - Liga Medi-corum Homeopathica Internationalis – www.LMHI.net.<BR>19. Постановление Правительства РФ № 2091 «О лицензировании медицинской деятельности» от 16.04 2012, Приложение №1.<BR>20. «Методические указания по проведению экспертизы при регистрации гомеопатических лекарственных средств» (проект).<BR>21. Homoopathische ArzneiBuch, 2000-2010, (HAB) - Гомеопатическая Фармакопея Германии.<BR>22. Francaise homeopathique pharmacopee,1987 (FHP) – Французская гомеопатическая Фармакопея.<BR>23. Homeopathic pharmacopea of India, vol I-VI, 1974-2003 (HPI) - Гомеопатическая фармакопея Индии.<BR>24. Homeopathic pharmacopea of Unaited States (HPUS) - Гомеопатическая Фармакопея США.<BR>25. Фармакопея ЕС. Council of Europe. European pharmacopoeia, 6th ed. Strasbourg, Directorate for the Quality of Medicines of the Council of Europe, 2006.<BR>26. Фармакопея США. Рharmacopoeia US, US Food and Drug Administration, 2006.<BR>27. ГОСТ Р 52379-2005 «Надлежащая клиническая практика» (GCP).<BR>28. Safety issues in the preparation of homeopathic medicines, World Health Organization, 2009 WHO Press, Geneva , Switzerland, WB 930).<BR>29. Комиссаренко А.А. «К вопросу о «конце гомеопатии», в Гомеопатическом ежегоднике. Сборник материалов ХХII Московской международной гомеопатической конференции «Развитие гомеопатического метода в современной медицине», Москва, 2012, с 61-62. (в ответ на статью «The end of homoeopathy», Lancet, vol. 366, no 9487, 2005, p. 690).<BR>30. Круглый стол на тему: «Перезапуск общественных советов при органах государственной власти». Выступление В.И. Скворцовой, http://большоеправительство.рф/press/media/1561/<BR>

Downloads

Published

2012-06-30

How to Cite

Замаренов, Н. А., И. В. Бурякова, В. В. Береговых, Н. В. Пятигорская, А. Е. Лямина, and В. В. Пичугин. “The Modern Problems of Homeopathy and How to Solve Them. The System for Ensuring Quality in Homeopathic Technology”. Traditional Medicine, no. 2(29) 2012, June 2012, pp. 25-29, http://www.tradmed.ru/index.php/tm/article/view/299.

Issue

No. 2(29) 2012

Section

Homeophaty

License

Reproduction of any materials without the written permission of the publisher is prohibited.
The responsibility for the accuracy of the information contained in articles and advertisements are the authors and advertisers.