Within the framework of the State Program "Development of the Pharmaceutical and Medical Industry" and the government program of import substitution, the Ministry of Industry and Trade of Russia implements a project on localization of the production of a full cycle of opium analgesics in Russia, aimed at ensuring national security in the field of drug supply for the constituent entities of the Russian Federation and federal executive authorities of the country.
From the 13 international opiate generic names registered in the Russian Federation, 9 are included in the list of vital and essential drugs, the annual production of which exceeds one million packages in 19 dosage forms.
Currently Russia is completely dependent on imports of active pharmaceutical ingredients of the opium series. Only Morphine substances are imported up to 300 kilograms per year. In addition to morphine Russia imports thebaine, codeine, oxycodone, hydromorphone, nalbuphine, naltrexone, nalaxone.
As a result of measures taken at the state level to increase the availability of anaesthetics for medical indicators for those who need them, the annual demand for morphine alone is projected to reach 1000 kilograms.
In order to prevent a decrease in the level of availability of opium drugs for patients who need them, it was decided to organize a full cycle of production of narcotic analgesics in Russia, which includes the stages of cultivation of a narcotic-containing plant, opium poppy, with the conventional name opium poppy, processing of poppy straw into active pharmaceutical ingredients and production of finished forms of narcotic drugs from it.
This initiative was coordinated with the International Narcotics Control Board, which at the 120th session approved the cultivation of opium poppy by the Russian Federation to satisfy domestic needs.
In order to create the legal framework necessary for the organization of full-cycle production, a draft federal law has been developed “On Amending of the Federal Law “On Narcotic Drugs and Psychotropic Substances” in terms of improvement of the cultivation of narcotic plants”, which was approved by the State Duma on June 19 of the current year, approved by the Federation Council and sent for signature to the President of the Russian Federation.
With the entry into force of amendments to the Federal Law "On Narcotic Drugs and Psychotropic Substances", the cultivation of narcotic plants, including opium poppy, for processing of plant raw materials into the substance of centrally-acting analgesics for medical use and veterinary medicine will be allowed.
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