Irregular active pharmaceutical inputs in Brazil: descriptive analysis from 2011 to 2019
Keywords:
Boas Práticas de Fabricação; Gestão da qualidade; Recall de Medicamento; Vigilância SanitáriaAbstract
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 Objective: To perform a descriptive analysis of the IFAs withdrawn from the Brazilian market between 2011 and 2019, through the Anvisa website in the subsection “irregular products”.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.
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