Viсtor Dmitriev spoke about this while speaking at the XXIV annual all-Russian conference «PHARMMEDCIRCULATION 2022» (PHARMMEDOBRASHENIE), held in Moscow.
The medical and patient communities are constantly wondering if there will be Russian analogues of selective factor Xa inhibitors, which are so in demand by the healthcare system. In 2021, the state spent 28 billion rubles of taxpayers on foreign drugs of this group, produced in unfriendly countries. And here is the light at the end of the tunnel. The Russian company «PharmaDiol» announced the development of a domestic competitor to foreign 28 billion worth drugs.
An attempt to overcome the registration barrier the first time was futile. The regulator, referring to the documents of the US FDA (unfriendly country!), considered that 6 pills per dose is too much for a Russian patient. For this reason, the registration of «Dimolegin», namely, such a trade name the developer gave to the Russian dioxaban, was denied.
The second attempt was preceded by a procedure of scientific consulting for the developer at Sechenov University with the referral of the Ministry of Health. The reasons for the first denial were resolved and removed. And there goes the second attempt to register a drug that will reduce the burden on the budget and leave at least some of the 28 billion rubles in Russia. A long-awaited event that everyone who has ever registered a drug is waiting like manna from heaven. On September 8, the developer receives a draft registration certificate for approval. It would seem that it remains to take a step before the launch of the first Russian direct selective factor Xa inhibitor on the market. But it was not there! Already on September 9, a letter appears on the appointment of a re-expertise, and after that, unscheduled inspections begin (recall that scheduled inspections are suspended today) of the clinical bases where trials of Dimolegin were carried out «due to the receipt of information about the threat of harm to the life and health of citizens in connection with the possible falsification of clinical trial data».
“This is the first time I have come across such a situation in 30 years of work in the industry. Either we are all witnesses of a big scam with a Russian anticoagulant, and we will be ashamed of the domestic pharmaceutical industry, or we are faced with the sabotage, and this is a field for law enforcement to work,” Victor Dmitriev said.