On 23 March, 2007 the World Health Organization (WHO) added four anti-tuberculosis medicines to its list of prequalified products. Manufactured by the generic producer MacLeods (India), the drugs will expand the choice of high-quality medicines available to procurement agencies to tackle the disease.
One of the drugs, Cycloserine, is particularly important because it is a second-line medicine necessary to treat the TB resistant to standard treatment. Cycloserine is the first product of this kind to be included into the list. The register also covers a fixed-dose drug (ethambutol + isoniazid) which is the first pre-qualified combination comprising two basic medicines. The other two are ethambutol and pyrazinamide.
The four medicines are the first TB drugs to be added into the list of prequalified medicines for two years. This means the manufacturers have improved quality noticeably, while the interest in participation in prequalification program is growing.
Listing four medicines will enhance access to TB medicines in the areas with high TB prevalence and in countries, which have only a limited possibility to control and monitor pharmaceuticals.
Public assessment reports on the quality and bio-equivalence of the prequalified products as well as outcomes of production facilities check-up will be published soon. These procedures make the WHO prequalification process the most transparent of all similar quality assurance programs to date.
Recent figures released by WHO show that 8,787,000 new TB cases were filed in 2005. TB killed 1.6m people in 2005, while 195,000 of them were HIV-positive.
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