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Open Access Debate

Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges

Andre Gemal1, Joel Keravec2, Alexandre Menezes3 and Anete Trajman456*

Author Affiliations

1 Federal University of Rio de Janeiro and National Institute of Health Quality Control/Fiocruz, Rio de Janeiro, Brazil

2 Management Sciences for Health, Projeto MSH, Rio de Janeiro, Brazil

3 Global Health Strategies, Rio de Janeiro, Brazil

4 Gama Filho University, Rio de Janeiro, Brazil

5 McGill University, Montreal, Canada

6 Universidade Gama Filho, Mestrado Profissional em Ensino na Saúde, Rua Manoel Vitorino 553, Prédio AG, 5o andar, Rio de Janeiro, Piedade, 20748-900, Brazil

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BMC Public Health 2013, 13:279  doi:10.1186/1471-2458-13-279

Published: 27 March 2013

Abstract

Background

Despite the existence of effective treatment, tuberculosis is still a global public health issue. The World Health Organization recommends a six-month four-drug regimen in fixed-dose combination formulation to treat drug sensitive tuberculosis, and long course regimens with several second-line drugs to treat multi-drug resistant tuberculosis. To achieve the projected tuberculosis elimination goal by 2050, it will be essential to ensure a non-interrupted supply of quality-assured tuberculosis drugs. However, quality and affordable tuberculosis drug supply is still a significant challenge for National Tuberculosis Programs.

Discussion

Quality drug production requires a combination of complex steps. The first challenge is to guarantee the quality of tuberculosis active pharmaceutical ingredients, then ensure an adequate manufacturing process, according to international standards, to guarantee final product´s safety, efficacy and quality. Good practices for storage, transport, distribution and quality control procedures must follow. In contrast to other high-burden countries, Brazil produces tuberculosis drugs through a strong network of public sector drug manufacturers regulated by a World Health Organization-certified national sanitary authority. The installed capacity for production surpasses the 71,000 needed treatments in the country. However, in order to be prepared to act as a global supplier, important bottlenecks are to be overcome. This article presents an in-depth analysis of the current status of production of tuberculosis drugs in Brazil and the bottlenecks and opportunities for the country to sustain national demand and play a role as a potential global supplier. Raw material and drug production, quality control, international certification and pre-qualification, political commitment and regulatory aspects are discussed, as well recommendations for tackling these bottlenecks. This discussion becomes more important as new drugs and regimens to treat tuberculosis are expected in a close future.

Summary

International manufacturers of raw material for tuberculosis treatment should undergo certification and pre-qualify their active pharmaceutical ingredients as a first step to ensure quality of tuberculosis drugs. At the country level, Brazilian public manufacturers should apply for international certification and tuberculosis drugs should be pre-qualified by international organisms. Finally, only with political commitment and large-scale production will Brazilian public sector manufacturers be able to partially supply the global market.

Keywords:
Antitubercular agents; Certification; Fixed dose combination; Pharmaceuticals; Quality control; Tuberculosis