Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges
Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges
Data
2013
Autores
Gemal, Andre
Keravec, Joel
Menezes, Alexandre
Trajman, Anete
Journal Title
Journal ISSN
Volume Title
Publisher
BMC Public Health
Resumo
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.
Description
Palavras-chave
Antitubercular agents, Certification, Fixed dose combination, Pharmaceuticals, Quality control, Tuberculosis.
Citação
Gemal A, Keravec J, Menezes A, Trajman A. Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges. BMC Public Health. 2013 Mar 27;13:279. doi: 10.1186/1471-2458-13-279.