Characterization of Potentized (Homeopathic, Anthroposophical and Antihomotoxic) Medicines Registered and Notified In Brazil

  • Robelma Frande de Oliveira Marques Agencia Nacional de Vigilancia Sanitaria
  • Ana Cecília Bezerra Carvalho Agência Nacional de Vigilância Sanitária
  • Marco Antonio Costa Universidade Estadual de Maringá
Keywords: Homeopathy, Anthroposophic medicine, Antihomotoxic medicine, Drug surveillance, ANVISA, Potentized medicine

Abstract

Background: Potentized medicines include, according to the Brazilian legislation, homeopathic, anthroposophic, and antihomotoxic medicine and are regulated by the Brazilian Health Surveillance Agency (ANVISA). Aim: This study aims to analyze and describe a profile of potentized medicines manufactured in Brazil, either registered or notified. Methodology: Information was obtained by data analysis related to ANVISA’s electronic medicine registration system. Results: The results, obtained as of September 2012, showed that 106 potentized medicines were registered and 519 were notified. Among the registered medicines, 92.0% were combined and 100.0% of the notified were simple medicines. For registered medicines, there were equivalent manufacturing scales among them, whereas for notified medicines, there was a predominance of centesimal scales. Active pharmaceutical ingredients (API’s) of vegetal origin were the most commonly used for potentized medicine manufacturing processes; the oral route was the most common form of administration. Potentized medicines manufacturing units are more often located in southeast region of Brazil. In addition, homeopathic medicines prevail as registered or notified medicines, followed by anthroposophic medicines. Conclusions: The results of the study are expected to be useful as reference material for ANVISA to improve its regulatory activity as well the industry sector and other stakeholders.
Published
2015-09-28
Section
Pharmaceutical Research