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USAIS to Cover the Manufacture of Pharmaceutical Substances

A draft of law “On amendments to the Federal Law “On Public Regulation of Manufacture and Circulation of Ethanol, Alcoholic and Alcohol-Containing Products, and on Limitation of Consumption (Drinking) Alcohol Products” and individual statutes of the Russian Federation” has been passed by the State Duma of the Russian Federation in the third reading.

The draft of law makes provisions for introduction of a public reporting system (USAIS) for production and circulation of alcohol-containing drugs, medical ethanol and medical devices. USAIS will cover manufacture of pharmaceutical substance (ethanol) and its supply for manufacture of alcohol-contianing drugs. It means that facilities manufacturing products containing over 0.5% ethanol, should be connected to the USAIS.

Sergey Shuliak, General Director of DSM Group expects that introduction of USAIS will lead to a 1.5-fold price increase for alcoholic tinctures (Boyarishnik, Pustirnik etc.), while the current average unit price is 20-30 rubles. However, additional expense of pharma companies may be covered by price increase for other products – ointments, tablets for cough etc. , he adds. According to the expert, the increase in price of alcohol containing drugs is unlikely to affect the demand, as the sales volume has been decreasing in recent years. The share of these drugs in the total pharmacy turnover is currently about 0.2%.

Declaration of manufacture, storage, delivery and purchase of drugs containing ethanol at over 25% of the volume of finished products is also provisioned, if the annual volume of manufacture, storage and delivery and purchase exceeds 200 decaliters. This requirement will not affect medical drugs for veterinary use.

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