Photo credit: RTI International/Katie G. Nelson
India-based manufacturer Medopharm Pharmaceutical Private Limited is now the second manufacturer of quality-assured praziquantel 600mg film-coated tablets to receive WHO prequalification – a major accomplishment in broadening the drug’s reach. Praziquantel is an anti-parasite prescription drug used to treat schistosomiasis, a parasitic infection that occurs when people come into contact with fresh water infected with schistosome parasites (worms) from snails –the intermediary host. The adult worms then live in human blood vessels that drain either the bladder or intestines. Most of the eggs they lay become trapped in the body’s tissues, which can cause severe reactions and unpleasant side effects. The recommended strategy for schistosomiasis is annual mass treatment with praziquantel, which effectively clears the body of worms.
The WHO prequalification program aims to ensure that medicines for high burden diseases meet global standards of quality, safety, and efficacy, in order to optimize the use of health resources and improve health outcomes. There are several steps in WHO’s prequalification process which includes conducting a scientifically sound assessment. Prequalification, in conjunction with the evaluation of other procurement criteria, is used by procurement agencies in making purchasing decisions for medicines.
With continued assistance from USAID’s Neglected Tropical Diseases Division, USAID’s Promoting the Quality of Medicines Plus (PQM+) program helped Medopharm achieve this accomplishment. Under the predecessor PQM program, a systematic review was finalized and submitted to the WHO prequalification team in September of 2019. In late April of 2021, WHO completed their evaluation and officially accepted Medopharm’s praziquantel for prequalification. You can read more about this exciting addition on the WHO website. USAID thanks the PQM and PQM+ teams and Medopharm for their tireless efforts to reach this achievement.