RESUMEN
ETHNOPHARMACOLOGICAL RELEVANCE: the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge. AIM OF THE STUDY: to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. MATERIALS AND METHODS: a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. RESULTS: There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. CONCLUSIONS: There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil.
Asunto(s)
Medicina de Hierbas/economía , Medicina de Hierbas/legislación & jurisprudencia , Legislación de Medicamentos , Medicina Tradicional , Plantas Medicinales , Brasil , Humanos , Fitoterapia , Preparaciones de PlantasRESUMEN
This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.
O artigo mostra o papel desempenhado por institutos públicos de pesquisa no Brasil na promoção da inclusão socioeconômica de comunidades locais por meio do uso do conhecimento tradicional e da medicina popular. Organizações não-governamentais e cooperativas são importantes para angariar recursos, defender os interesses das comunidades locais e influenciar mudanças no ordenamento jurídico. Entretanto, exigências de cunho legal relacionadas às Boas Práticas de Fabricação e à necessidade de comprovação da eficácia de medicamentos, impostas pela Agência Nacional de Vigilância Sanitária, tendem a demandar a intervenção de um instituto público de pesquisa capaz de auxiliar tais comunidades na aprovação e comercialização de medicamentos produzidos a partir de plantas medicinais. Assim, institutos públicos de pesquisa são essenciais para realizar estudos científicos que comprovem a eficácia das plantas medicinais e para auxiliar as comunidades locais a criarem a infraestrutura necessária para atender às exigências da Agência quanto a Boas Práticas de Fabricação.
Asunto(s)
Humanos , Academias e Institutos , Redes Comunitarias/organización & administración , Medicina de Hierbas/organización & administración , Conocimiento , Farmacias/organización & administración , Brasil , Redes Comunitarias/economía , Conducta Cooperativa , Conocimientos, Actitudes y Práctica en Salud , Medicina de Hierbas/economía , Innovación Organizacional , Farmacias/economía , Características de la ResidenciaRESUMEN
This paper discusses the key role played by public research institutes for promoting socioeconomic inclusion of local communities based on traditional knowledge and traditional medicine. Nongovernmental organizations and cooperatives have had an important role in raising financial resources, being involved with advocacy of local communities and advancing legislation changes. But strict best manufacturing practices regulations imposed by the Brazilian National Health Surveillance Agency on the requirements for approval and commercialization of drugs based on herbal medicine products call for the involvement of strong public research institutes capable of supporting community-based pharmacies. Thus, public research institutes are pivotal as they can conduct scientific research studies to evidence the efficacy of herbal medicine products and help building the capacity of local communities to comply with current regulations.