Tuberculosis :: WHO approves four new TB drugs made by Indian manufacturer

The United Nations health agency has approved four new drugs manufactured by generic producer Macleods of India for treatment of tuberculosis, with one of them being the first to be pre-qualified for strains resistant to standard treatment.

“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,” the UN World Health Organization (WHO) said in a statement.

The medicines are the first TB products to be added to the list in two years and will increase the choice of quality products available to procurement agencies to tackle the disease that killed an estimated 1.6 million people in 2005. Nearly 9 million others were suffering from TB that year.

One of the new products, Cycloserine, is particularly important because it is a second-line medicine, necessary for cases that are resistant to standard treatment, WHO said.

There is also a fixed-dose combination, ethambutol isoniazid, which is the first product combining these two basic medicines to be pre-qualified. The other two medicines are Ethambutol and Pyrazinamide.

Product assessment reports on the quality and bioequivalence of these newly pre-qualified 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, it added.

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