Ahmedabad, India : Zydus Lifesciences Limited has been granted WHO prequalification approval for both the Active Pharmaceutical Ingredient (API) and formulation of the crucial drug used in treating Leishmaniasis, known as ‘Miltefosine’. This inclusion of Miltefosine in the WHO’s prequalification list will significantly enhance global accessibility to the drug.

  • Leishmaniasis stems from protozoan parasites transmitted through the bite of infected female phlebotomine sandflies. It predominantly impacts some of the most economically disadvantaged populations globally, often linked with factors such as malnutrition, population displacement, inadequate housing, weakened immune systems, and limited financial resources.
  • As per the World Health Organization (WHO), there exist three primary forms of leishmaniasis: cutaneous leishmaniasis (CL), visceral leishmaniasis (VL), also referred to as kala-azar, and mucocutaneous leishmaniasis (MCL).
  • CL stands as the most prevalent form, while VL represents the most severe, and MCL is the most debilitating form of the disease. If left untreated, VL leads to fatalities in over 90% of cases. Annually, an estimated 700,000 to 1 million new cases of leishmaniasis emerge, with approximately 30,000 new cases of VL reported.

As of 2018, 92 countries or territories were identified as endemic for, or had previously reported cases of, cutaneous leishmaniasis (CL), while 83 countries or territories were similarly categorized for visceral leishmaniasis (VL). Presently, over 1 billion individuals reside in regions endemic to leishmaniasis, placing them at risk of infection.


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