Darnitsa’s Stand with Regard to Hydroxychloroquine/Chloroquine Production24 March 2020
Darnitsa is ready launch the production of hydroxychloroquine/chloroquine. This is possible provided that there is a government order for these drugs and active involvement of state regulatory bodies (State Expert Center, Ministry of Health) in the process.
It is important that there are no clinical trials on the effectiveness of COVID-19 treatment with these drugs. Although hydroxychloroquine/chloroquine-containing drugs have been registered worldwide, they have been indicated for use in the treatment of malaria, rheumatoid arthritis and certain dermatological diseases. In the United States, Europe and China, COVID-19 treatment with these drugs is performed within the framework of clinical trials, where the patient consents to treatment with an experimental drug.
In order for Ukraine to be able to use such drugs for the treatment of COVID-19, it is necessary to initiate clinical trials or approve treatment protocols for this disease with hydroxychloroquine/chloroquine-containing drugs at the country level. This requires the assistance of state regulatory bodies. Under the circumstances where there are no approved protocols, there are no clinical trials, even if the drug is available, no physician has the right to prescribe it to a patient, as it may entail criminal liability under current laws.
Darnitsa is currently investigating the possibility of purchasing the AFI (active pharmaceutical ingredient) and is ready to launch the production within a short time. The matter now depends on the state authorities and their willingness to actively respond to the situation and work together with pharmaceutical companies to maximize the aid to Ukrainian patients.
With the effective involvement of government agencies at all levels, Darnitsa is ready to manufacture the drug and guarantees the compliance with quality requirements and licensing procedures.