OneWorld Health collaborated with the Indian pharmaceutical company Gland Pharma to manufacture PMIM at no-profit, no-loss and worked with the Indian government to assist in uptake of PMIM into the public health programs to achieve this goal.
As a result of OneWorld Health efforts, PMIM was approved for the treatment of VL by the Drug Controller General of India in 2006. In 2007, OneWorld Health launched a phase 4 pharmacovigilance study of PMIM in India and worked with the principal investigators and nongovernmental organizations to investigate and demonstrate the safety and efficacy of PMIM in an outpatient setting in resource-constrained parts of Bihar state.
OneWorld Health completed the phase 4 study in 2009 and leveraged its successful data to expand its work to other VL-endemic countries of South Asia, primarily Bangladesh and Nepal. OneWorld Health has worked with key stakeholders in pursuit of gaining approval for PMIM in these countries and in support of PMIM adoption in national elimination programs. As a result of these efforts, PMIM was included on the Essential Medicine List of Bangladesh (2008) and Nepal (2011), signifying a major vote of confidence from the government and moving PMIM closer toward widespread use. PMIM was also registered by the government of Nepal in 2012.
In addition, OneWorld Health launched activities to better understand the impact of VL in rural communities and the most effective way to deliver PMIM in remote areas. In 2008, OneWorld Health initiated a 500-patient public health access study in Bihar, India, and also completed field research studies in 2009. In addition, data from the field research has informed stakeholders on incidence and prevalence of the disease in Bihar.
Commitment activities are continuing. OneWorld Health is working towards achieving registration of PMIM in Bangladesh. It is currently completing a safety and efficacy study for PMIM in that country to evaluate its feasibility for inclusion in the government health system and build local capacity for research and treatment of VL. OneWorld Health is also collaborating with other global health partners to establish new methods for controlling and treating VL in South Asia's most endemic regions.
Most recently, in October 2011, OneWorld Health joined a major international consortium led by the Drugs for Neglected Diseases initiative and in partnership with the Special Programme for Research Training in Tropical Diseases aimed at establishing and implementing new treatment modalities as successful tools towards VL elimination in South Asia.