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The Ministry of Public Health urges to choose the medicines by active substance, not by brand

15 April 2022

The war is changing the situation on the drug market: there is a certain shortage with imported medicines, and many of the Western pharmaceutical companies are still operating in the market of the aggressor country. As a consequence, Ministry of Public Health on March 8 urged Ukrainians to choose the medicines when buying based on their active substance and availability in the pharmacy, and not on the trade name or the producer's brand. The report notes that all medicines of both domestic and foreign production undego the state registration procedure, therefore, all drugs are of the same quality.

It is important to understand that 94% of medicines in Ukraine are generic drugs (also called "generics" in various sources). A generic drug is a nonproprietary medicine that reproduces the original drug for which the patent protection period has expired.

A generic has the same qualitative and quantitative composition of active substances and the same dosage form as the reference drug, and most importantly, its equivalence to the latter is proven. According to modern requirements, registration of a generic in the form of tablets, capsules or other so-called "Solid Dosage Forms" is impossible without its bioequivalence study. Bioequivalence studies prove that after taking the generic drug, the rate and volume of  the active substance absorption into the blood are almost the same as after taking the original medicine. Therefore, the therapeutic effect of the original and a generic medicine with proven bioequivalence will be the same.

Approaches to proving generity and bioequivalence in our state do fully comply with EU legislation. Also, some domestic manufacturers, such as the pharmaceutical company Darnitsa, involve EU research organizations as contract part in these bioequivalence studies. At that domestic pharmaceutical plants also meet international standards. For example, Darnitsa since 2002 is a Good Manufacturing Practice certified producer, that GMP certificate being the main document used to attest pharmaceutical industries around the world.

"During the independence of Ukraine, domestic pharma has developed into a powerful large-scale business: modern equipment, international GMP certifications, high professional level, innovative technologies. The pandemic and wartime have once again confirmed that the domestic pharmaceutical industry is an important part of the country's national security. Medicines from Ukrainian manufacturers are as high-quality and effective products as these manufactured by the international pharmaceutics leaders. WHO recently selected Darnitsa as the only manufacturer in the country to implement the mRNA technology for vaccine production. We got GMP certificate from the Australian Regulatory Authority and signed a license agreement for the generic version of Pfizer oral drug to treat COVID-19 development and production. Therefore, given the situation in the country, we consider very appropriate the initiative of the Ministry of Public Health announced now: buy medicines not by brand, trust your own country producers and be patriotic in this aspect," said Dmytro Shymkiv, chairman of the Darnitsa Group Board of Directors.

Reference

PJSC pharmaceutical company "Darnitsa" was founded in 1930. Since 1998, Darnitsa has been the leader in Ukraine in terms of drug production in physical terms. Strategic areas of products portfolio development include cardiology, neurology, and pain management.

* According to the GFK 2021 survey, the majority of Ukrainians consider domestic medicines to be of lower quality than imported ones. GfK Ukraine survey commissioned by the pharmaceutical company "Darnitsa", included 2000 respondents aged of 18-55, in the cities with 100K+ inhabitants, survey of February 2021

**According to Proxima Research 2021-2022

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