title: [Assessment of the technical adequacy of phytotherapeutics and officinal medicine manufacturers in the State of Rio de Janeiro].
abstract: In this study we evaluated the current profile of manufacturers of officinal medicines and phytotherapeutics in relation to the Brazilian regulatory legislation. Forty-eight industries involved in manufacture and distribution of officinal medicines and phytotherapeutics were identified in one hundred current administrative processes of the National Health Surveillance Agency in Brazil. The analysis of the inspection reports of these companies considered the first nine months after the implantation of Resolution RDC 210/03 and revealed five specific company profiles: satisfactory (29.2%), satisfactory with restrictions (10.4%), unsatisfactory (6.2%), interdicted (39.6%), and applying for cancellation due to lack of conditions for complying with Resolution RDC 210/03 (14.6%). The main irregularities found in these companies involved the operational flow, quality control and product registration issues. Our results revealed a great number of companies whose activities are related to the production of officinal medicines and phytotherapeutics but that are still not totally adequate to the industrial park of Rio de Janeiro. The perspectives for the future of this category of industries are thus not favorable because of their difficulties to meet the current requirements.
authors.affiliation: Secretaria Estadual de Vigilância Sanitária do Rio de Janeiro, Centro de Vigilância Sanitaria Estadual, Rua México 128/ 3, andar, sala 231 Castelo, 20231-031 Rio de Janeiro, RJ. ndcalves@hotmail.com
authors.forename: Natália Dias da Costa
authors.initials: ND
authors.lastname: Alves
authors.forename: Tereza Cristina
authors.initials: TC
authors.lastname: dos Santos
authors.forename: Carlos Rangel
authors.initials: CR
authors.lastname: Rodrigues
authors.forename: Helena Carla
authors.initials: HC
authors.lastname: Castro
authors.forename: Luiz Marcelo
authors.initials: LM
authors.lastname: Lira
authors.forename: Camila Braga
authors.initials: CB
authors.lastname: Dornelas
authors.forename: Lúcio Mendes
authors.initials: LM
authors.lastname: Cabral
mesh_terms: D001938:Brazil; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D008517:Phytotherapy / Q000592:standards*