The Ministry of Health and the Ministry of Industry and Trade have approved a bill on compounding pharmacies. This is reported by FV with reference to Ayrat Farrakhov, a member of the State Duma Committee on Budget and Taxes. He is confident that the bill will proceed to the second reading and will be adopted. According to the duma member, the amendments take into account all the comments that regulators had after the first reading.
The bill stipulates for changes to the rules for the manufacture of drugs by pharmacy organizations. It was introduced to the State Duma in September 2019, and then there was a period of waiting for the appointment of the committee in charge and the relevant conclusions to be issued. The draft was adopted in the first reading only in March 2021. As Farrakhov noted, the attitude of the Ministry of Health to the initiative was controvercial at that time, since it was unclear how to control the drug production process in pharmacies.
“Medicinal products are to be produced by pharmacy organizations and veterinary pharmacy organizations licensed for pharmaceutical activities, in accordance with the established procedure and with the use of medicinal products and/or pharmaceutical substances included, respectively, in the State Register of Medicinal Products for Human Use, the State Register of Medicinal Products for Veterinary Use, and the Unified Register of Registered Medicines of the Eurasian Economic Union”, Ayrat Farrakhov quoted the agreed version of the document.
It is not allowed, however, to manufacture medicines that are already registered in Russia. The bill does not allow individual entrepreneurs to produce drugs. According to the deputy, only 16 pharmacy organizations owned by individual entrepreneurs have a license for manufacturing activities.
The authors of the bill now have to work together with regulators to prepare a regulatory framework. The law will come into force on September 1, 2023.
“Initially, it was assumed that the law would come into force immediately after its adoption, but the regulator considers it necessary to allocate some time for the development and adoption of a regulatory framework. We agree with this, because it should not be of a blocking-off nature,” Farrakhov said.
The law on compounding pharmacies will give an impetus to the development of a personalized approach in healthcare and contribute to life expectancy increase and the reduction of infant mortality, Mr. Farrakhov added.