In pursuance of the orders of the Government of the Russian Federation from September 5, 2019 No. 1986-r and from September 25, 2019 No. 2170-r, the Ministry of Industry and Trade of the Russian Federation and the FSUE Moscow Endocrine Plant promptly carried out measures for the import, distribution and delivery to 69 constituent entities of the Russian Federation of nonregistered psychotropic drugs to help children (540 children) for health reasons.
So, the following drugs were imported into the Russian Federation:
October 27, 2019 Clobazam, 5 mg capsules, 10 mg tablets (Sanofi, France), November 26, 2019 Diazepam, 5 mg/2.5 ml, 10 mg/2.5 ml rectal solution (Desitin, Germany), December 6, 2019 Midazolam, 2.5 mg/0.5 ml, 5 mg/1 ml, 7.5 mg/1.5 ml, 10 mg/2 ml oromucosal solution (Takeda, Japan, Scheyer, Ireland) and March 3, 2020 Phenobarbital, 15 mg/5 ml 500 ml elixir (Thornton and Ross, Scotland).
According to the order of the Government of the Russian Federation from February 13, 2020 No. 270-r of the FSEU Moscow Endocrine Plant organized work on the import of the second batch of nonregistered psychotropic drugs for 750 children from 58 constituent entities of the Russian Federation. Currently, contracts have been signed with manufacturers and the necessary permits are being drawn up for their import into the Russian Federation. It is expected that the following drugs: Clobazam, 5 mg capsules, 10 mg tablets in the amount of 4 935 packages, Diazepam, 5 mg/2.5 ml, 10 mg/2.5 ml rectal solution
in the amount of 3 677 packages, Midazolam, 2.5 mg/0.5 ml, 5 mg/1 ml, 7.5 mg/1.5 ml, 10 mg/2 ml oromucosal solution in the amount of 402 packages and Phenobarbital, 15 mg/5 ml 500 ml elixir in the amount of 500 packages will be delivered to the constituent entities of the Russian Federation in April - June of this year.
At the same time, managerial decisions were made on state registration and introduction into production at the territory of the Russian Federation of a number of the above nonregistered drugs.
FSUE Moscow Endocrine Plant purchased technological equipment - additional equipment for the production of the above drugs: a new die manufactured by BREVETTI ANGELA, Italy, on a BFS SYFPAC S.v.P. machine for the production of microclysters and plastic oromucosal vials, productivity is about 6000 per hour. The Enterprise successfully carried out commissioning, the equipment is ready for the release of these drugs.
As part of the pre-registration procedure, the composition of the drug was developed, the production technology was developed, a full range of necessary preclinical studies was carried out. Currently a clinical trial of the I phase of these drugs with the participation of healthy volunteers is being completed. It is planned to submit the registration dossier to the Ministry of Health of Russia after carrying out of a clinical trial of the first phase of the study, in parallel with carrying out of a clinical trial including pediatric patients.
By the end of 2020 the Ministry of Industry and Trade of Russia and the FSEU Moscow Endocrine Plant plan to organize the production of the drugs Diazepam, rectal solution and Midazolam, oromucosal solution.
Comment type is not specified in the component properties.