According to Suda funding for a clinical trial evaluating ArTiMist versus the standard-of-care RAS is required to add endorsement and value (through MMV).1
The Australian government considers WHO prequalified RAS an outcome of their financial support for Cipla and Strides Shasun (through MMV).2 Six manufacturers submitted proposals to MMV for support to develop a RAS product that could be expedited to achieve WHO PQ status and two - Cipla and Strides were selected.3
Suda anticipated a Trade Sale H2 CY2014. Two key factors led to a halt in RAS procurements after 2014. First, in 2014, a multi-donor-agency taskforce revised its QA policy to restrict donors from procuring any anti-malarial products that were not yet SRA approved. Second, in 2015, Acino reported quality challenges with heat stability and subsequently halted RAS production altogether.3
Suda then stated RAS drawbacks as stability and cultural.1
There were reports of the product melting at the PFSA warehouse and while in the distribution chain, even where the product was transported in a controlled environment which pointed to potential product quality issues. Available guidance on the Cipla product indicates an 18-month shelf life in storage conditions between 24 and 30oC (similar to Artemether).
Interviews with stakeholders has revealed that RAS was well-received for use in children but most adults preferred alternative modes (not WHO guidelines anyway).3 No taste masking required as Levomenthol contraindicated for children under 2 years of age.4
