Zydus Lifesciences Limited has received the WHO prequalification approval for the API and formulation of the key drug to treat Leishmaniasis, 'Miltefosine'. With this, Miltefosine will be added to WHO's pre-qualification list which will enable larger access to the drug globally.

Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies. The disease affects some of the world's poorest people and is associated with malnutrition, population displacement, poor housing, a weak immune system and lack of financial resources.

According to WHO, there are three main forms of the disease: cutaneous leishmaniasis (CL), visceral leishmaniasis (VL), also known as kala-azar, and mucocutaneous leishmaniasis (MCL). CL is the most common form, VL is the most severe form and MCL is the most disabling form of the disease. VL if left untreated, causes death in more than 90% of cases. An estimated 700 000 to 1 million new cases and an estimated 30 000 new cases of VL occur annually.

In 2018, 92 and 83 countries or territories were considered endemic for, or had previously reported cases of, CL and VL, respectively. Today, more than 1 billion people live in areas endemic for leishmaniasis and are at risk of infection.