title: Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges.
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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Federal University of Rio de Janeiro and National Institute of Health Quality Control/Fiocruz, Rio de Janeiro, Brazil.
authors.forename: Andre
authors.initials: A
authors.lastname: Gemal
authors.forename: Joel
authors.initials: J
authors.lastname: Keravec
authors.forename: Alexandre
authors.initials: A
authors.lastname: Menezes
authors.forename: Anete
authors.initials: A
authors.lastname: Trajman
mesh_terms: D000995:Antitubercular Agents / Q000191:economics / Q000600:supply & distribution* / Q000627:therapeutic use; D001938:Brazil; D017281:Cost of Illness; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D004359:Drug Therapy, Combination; D015507:Drugs, Investigational / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000191:economics / Q000592:standards*; D011786:Quality Control; D012051:Reimbursement Mechanisms; D014376:Tuberculosis / Q000188:drug therapy* / Q000517:prevention & control; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics
chemical_list: D000995:Antitubercular Agents; D015507:Drugs, Investigational; D004364:Pharmaceutical Preparations
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