Irregular active pharmaceutical inputs in Brazil: descriptive analysis from 2011 to 2019

• Autor(a) principal: Pinto, Nubia Naiara
• Data de Publicação: 2021
• Outros Autores: Resende, Karina Aparecida, Couto, Renê Oliveira
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1456
• topic: Boas Práticas de Fabricação; Gestão da qualidade; Recall de Medicamento; Vigilância Sanitária

Introduction: The active  pharmaceutical ingredients (IFA)     correspond to the pharmacological  part of the medication and the  demand for these products has   generated great profits for the pharmacochemical industries. As such products are an essential part of the   drug production chain, IFA are subject  to inspection by the Brazilian National  Health Surveillance Agency (Anvisa) in  Brazil. Objective: To perform a   descriptive analysis of the IFAs withdrawn from the Brazilian market  between 2011 and 2019, through the   Anvisa website in the subsection  “irregular products”. Method: Results  were obtained from variables called:    manufactures, motivations, products   and inspection actions. The results were presented as absolute or relative frequencies, and thus the descriptive   profile of the irregular inputs was   drawn. Results: The majority (80.0%)  of the companies with collected APIs  are of international origin,  with India and China being the predominant  countries. The frequency of inspections carried out by Anvisa in the companies showcased strong correlation with amount of inputs withdraw from the market (r = 0.89). The main motivations for withdraw IFA are the deficiency in Good Manufacturing Practices (GMP), absence of registration and contamination by nitrosamines. Of the 95 irregular inputs evaluated, antimicrobials and antihypertensives (antagonists of angiontensin II) had the greatest frequency of withdrawals. Conclusions: Anvisa is in line with the quality standards of other international regulatory agencies and has effectively fulfilled its institutional aim of guaranteeing and promoting the health of the Brazilian population with regard to the inspection of IFA used in the production of medicines.