8.3 Quality-assured anti-TB drugs

Using sub-standard anti-TB drugs can be disastrous both to the individual and the community. This includes treatment failure resulting in death or resistance and transmission of resistant strains to other individuals. Only quality-assured drugs must be used.

There are several internationally recognized mechanisms that evaluate the quality of TB drugs. These mechanisms are: the WHO pre-qualification programme1 , approval by Stringent Regulatory Authorities2 or evaluation and temporary approval by the Expert Review Panel of Global Fund/Global Drug Facility3 .

Ref Notes
1 WHO Prequalification Scheme: http://apps.who.int/prequal/
2 The national drug regulatory authorities, which are members of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are considered as Stringent Regulatory Authority (SRA) as per the Global Fund Quality Assurance Policy for pharmaceutical products from July 1, 2009.
3 http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp