In 2019, there was much concern in Russia about the availability of a number of psychotropic medicinal products for patients, including children, suffering from seizure syndrome of various etiologies. Due to the withdrawal of several foreign-manufactured medicinal products from the domestic pharmaceutical market for various reasons, patients were faced with the inventory shortages. Parents of children needing medicinal products found themselves in a desperate situation. Some decided to purchase medicinal products containing psychotropic substances from abroad and import them illegally into the Russian Federation, realizing that they were violating the law.
Taking into account the existing situation, the Government of the Russian Federation authorized FSUE "Endopharm" to carry out the systematic import of psychotropic medicinal products not registered in Russia with international nonproprietary names (INN) Midazolam, Diazepam and Clobazam in convenient dosage forms in accordance with the procedure established by the law and in the amount determined by the Ministry of Health of the Russian Federation. This enabled to ensure quick availability of medicinal products for patients who needed them for medical reasons, and to avoid violations of the established legislation by the citizens. Thus, for the period from 2019 to 2020, 395 children were provided with unregistered psychotropic medicinal products with INN Clobazam, 878 children — with INN Diazepam, 57 children — with INN Midazolam.
At the same time, FSUE "Endopharm", in accordance with the import substitution strategy of the Ministry of Industry and Trade of the Russian Federation and in pursuance of action plans ("road maps") to increase the availability of narcotic and psychotropic medicinal products, as well as to improve the quality and availability of palliative medical care, began to introduce previously imported psychotropic medicinal products into the manufacture of domestic generics. Within the shortest possible period, the formulations and technologies for the manufacture of socially significant medicinal products were developed, the processing equipment was upgraded, and the necessary pre-clinical and clinical studies were fully carried out.
At the end of 2020, FSUE "Endopharm" began the production of domestic medicinal products used for the relief of epileptic seizures and suitable for children — "Midazolam, buccal solution" (from three months) and "Diazepam, rectal solution" (from six months).
In the period from 2021 to the present, the Enterprise started commercial circulation of medicinal products with INN Diazepam — 23.5 thousand packages, with INN Midazolam — 7.4 thousand packages, which found application in inpatient and outpatient practice.
In the fourth quarter of 2022, FSUE "Endopharm", having conducted all necessary studies, including preclinical and clinical, received a registration authorization for tablets with INN Сlobazam — the first domestic generic of the original medicinal product "Frisium" manufactured by Sanofi, France.
The decision to introduce a domestic analogue of the medicinal product with INN Clobazam was made in 2019 following a meeting led by the Deputy Prime Minister of the Russian Federation Tatiana Golikova.
After an accredited testing laboratory of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) confirmed that the quality of the manufactured and tested batch of 7 thousand packages met the requirements of the regulatory documentation, the medicinal product "Clobazam, tablets, 10 mg" by FSUE "Endopharm" was put into commercial circulation.
"The domesticmanufacture of a medicinal product like this is an important stage not only in the activities of "Endopharm" itself, but also in ensuring the pharmaceutical safety throughout Russia. I would like to note that the enterprise also makes an active contribution to ensuring technological sovereignty in other segments — in particular, it develops and creates local manufacture of pharmaceutical substances (including vital medicinal products), develops reference standards necessary for the manufacture and quality control of medicinal products; it has established key processes "from ground zero" as part of opium poppy cultivation for use in analgesic medicinal products,"– emphasized Deputy Prime Minister of the Russian Federation, Minister of Industry and Trade of the Russian Federation, Denis Manturov.
The medicinal product "Clobazam, tablets, 10 mg" is available only on prescription.
The indications for use of the medicinal product in adults and children over 3 years old:
- acute and chronic states of tension, excitement and anxiety;
- epilepsy (as an adjunctive therapy in patients who have not achieved remission in treatment by one or more antiepileptic medicinal products).
Clobazam is included in the Distribution Plan for Narcotic Drugs and Psychotropic Substances approved by the Ministry of Industry and Trade of the Russian Federation for 2023. All regions of the Russian Federation have been informed about readiness of FSUE "Endopharm" to meet the demand for the required medicinal product. The first supplies of the domestic medicinal product have already been made to the Krasnoyarsk Territory, Chelyabinsk, Kemerovo and Ryazan regions, and the Republic of Khakassia. Shipments to the Vladimir and Lipetsk regions, the Republic of Mari-El, and the Karachay-Cherkess Republic are planned this week.
The Russian Federation member states declared the need for psychotropic medicinal products for 2023 in the following quantities: "Diazepam, rectal solution" — 18.5 thousand packages No. 5, "Midazolam, buccal solution" — 7.9 thousand packages No. 4, "Clobazam, tablets, 10 mg" — 47.5 thousand packages No. 30.
The manufacturing capacities of FSUE "Endopharm" can cover 100% of the country's healthcare system demand for medicinal products with INN Midazolam, Diazepam and Clobazam, previously imported exclusively from abroad, including the products in convenient pharmaceutical forms.
For the Enterprise, the introduction of these medicinal products is a social mission aimed at providing the most vulnerable segments of the population with high-quality and affordable medicines, as well as at implementing the country's drug safety policy.
The next step will be the organization of full-cycle manufacture of these medicinal products. Currently, the Enterprise is studying the stability of its own active pharmaceutical ingredient midazolam; the production site for its manufacture is planned to be put into operation at the end of 2023. The technologies for the synthesis of the substance clobazam are being developed.
Overall, in the period from 2016 to the present, the Enterprise has registered 13 new medicinal products used in the provision of palliative care, 9 INN in 10 pharmaceutical forms. Thus, 29 medicinal products in 10 pharmaceutical forms and 53 dosages are now available for the Russian doctors, which allows to provide complete and effective anesthesia for 100% of suffering patients in all regions of the country, in accordance with the recommendations of the Ministry of Health of the Russian Federation. At least 8 more medicinal products containing narcotic agents and psychotropic substances are included in the implementation program of FSUE "Endopharm" by 2025.
In the current geopolitical situation, FSUE "Endopharm" makes the most effective use of its manufacturing, scientific and human resources in order to provide necessary medicinal products for the citizens of the Russian Federation to the full extent.
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