WHO adds four anti-tuberculosis medicines to its list of prequalified medicines

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The World Health Organization (WHO) has added four anti-tuberculosis medicines to its list of prequalified products.

Manufactured by the generic producer MacLeods of India, these medicines will increase the choice of quality products available to procurement agencies to tackle the disease.

One of the products, Cycloserine, is particularly important because it is a second-line medicine, necessary to treat tuberculosis that is resistant to standard treatment. Cycloserine is the first such product to be included in the list. There is also a fixed-dose combination – ethambutol + isoniazid – which is the first product combining these two basic medicines to be prequalified. The other two medicines are Ethambutol and Pyrazinamide.

The four medicines are the first TB products in two years to be added to the list of prequalified medicines. Their addition to the list reflects considerable quality improvement made by manufacturers, and an increasing interest in being part of the prequalification programme.

The addition of these four medicines will reinforce efforts to scale up access to anti-tuberculosis medicines in high-burden areas and in countries which may have only limited capacity to control and monitor pharmaceuticals.

Product assessment reports on the quality and bioequivalence of these newly prequalified products and manufacturing site inspection findings will soon also be published. These procedures make the WHO prequalification process the most transparent of all similar quality assurance programmes to date.

Recent figures released by WHO put the number of TB cases in 2005 at 8,787,000. An estimated 1.6 million people died of the disease in 2005, 195,000 of them people living with HIV.

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