Control over alcohol-containing medicines should be reasonable

     The Federal Service for the Regulation of the Alcohol Market (RAM) has explained to participants of the pharmaceutical market who should install the counters, and who does not need it.


     Based on the requirements of the Federal Law №61-FL, article 45, paragraphs 3 and 4 «Organizations that manufacture the API of ethanol for the production of alcohol-containing medicines and individual entrepreneurs and legal entities that purchase and use the API of ethyl alcohol, as well as the production, manufacturing and (or) turnover (excluding retail sale) of alcohol-containing medicines, are required to carry out accounting and declaration according to the Federal Law of November 22, 1995 №171-FL «About the state regulation of production and turnover of ethyl alcohol, alcohol and alcohol-containing products and on limiting consumption (drinking) of alcohol products». Thus, manufacturers are not exempted from setting up of counters, recording and declaring purchases of ethyl alcohol API or ethyl alcohol, and it does not matter if alcohol is delivered to them in tanks or in individual cans — canisters, the Federal Service for the Regulation of the Alcohol Market (RAM).


     After the entry into force on 01.01.2018 of amendments to the law №171-FL regarding the strict registration of equipment producing alcohol, many pharmaceutical manufacturers had questions on the enforcement of alcohol-containing medicines manufacturers. Experts expressed the opinion that there are contradictions in the text of the law. Meanwhile, as early as 2nd of July, the inspection may come to the manufacturers and claim for the necessary information.


     The initiator of the amendments was the Federal Service for the Regulation of the Alcohol Market. The department believes that this is necessary for the full control of the strong alcohol trade. To clarify details and explain how to work in the new conditions, the RAM, with the assistance of the Association of the Russian Pharmaceutical Manufacturers, at the end of May gathered the leading players of the pharmaceutical market and specialists of the department for a special meeting.


     «In any regulator, reasonable sufficiency is important, ensuring achievement of the goals and not leading to negative consequences for business and the population. Unfortunately, we have a negative experience of the «Gorbachev’s» fight against alcoholism, leading to the loss of elite vineyards and the growth of home-distilled alcohol and toxicomania. In the implementation of 171-FL, in our opinion, there are also some points that will lead to the cost of medicines increase, which none of sane person will consume like liquors. Our common goal is not to allow these go too far», — Viktor Dmitriev said, the General Director of the Association of the Russian Pharmaceutical Manufacturers.


     The purpose of introducing the accounting system — USAIS  is good — to maintain control over the turnover of alcohol in our country, to identify counterfeit, to determine whether at all stages of production and sale of alcohol companies do their obligations. Including the payment of taxes. However, which pharmaceutical manufacturers are in the system, and who is not, in fact it was not clear until the last moment.


     The USAIS system was launched in 2006. Initially it involved producers and importers of spirit, alcohol and alcohol-containing products, and then other segments joined. Since 1st of January 2016, the biggest change occurred, wholesale and retail were added to the system. At the same time, as part of the fight against the illegal market of liquors, the issue of the ethyl alcohol API and so-called pharmaceutical alcohol is relevant for RAM. Regulation of this industry is a serious problem, experts noted at the meeting.

     Entrepreneurs, for obvious reasons, accept the new changes negatively. This is an additional «headache» for them: the work with documents becomes more complicated. Many of them had a reasonable question: what are the alcohol-containing medicines.


     For example, how to deal with the «brilliant green», manufacturers have asked specialists of the RAM for clarifications during the meeting. «Brilliant green» is the most famous medicinal product. It consists of the «brilliant green» and ethyl alcohol as a solvent. The drug monograph to this medicine says: «brilliant green» is an active ingredient, alcohol is a solvent, an auxiliary substance. While producing there is no use of ethyl alcohol, therefore, according to the Federal Law №171-FL it is not an alcohol-containing medicinal product. Here regulators indicated an incorrect interpretation of the law, considering the drug as alcohol-containing, since it contains alcohol. However, the producers have noted, the experts agree with them, if the «brilliant green» is equated to alcohol-containing medicines and obliges manufacturers to install meters at plants, the price of the product will instantly soar, although at the very beginning it was clear to everyone that nobody would drink it. This nuance concerns many medicines based on alcohol.


     In addition, referring to the Federal Law № 171-FL, article 2, paragraph 3: «alcohol-containing products — food or non-food products, alcohol-containing medicines, alcohol-containing medical devices with an ethyl alcohol content of more than 0,5 percent of the finished product volume; (paragraphs 3 as amended by the Federal Law of 3rd of July 2016 №261-FL)». How to deal with the drug forms, where it is not possible to isolate and calculate the amount of alcohol in the finished product — entrepreneurs ask the question — but, in its composition, the drug has residual solvents and a tiny alcohol content — no more than 0,3 permille.


     Such cases are solved individually. Manufacturers of antiseptic wipes, whose product was also subjected to alcohol-containing medications, also asked the RAM because of «incorrect interpretation of the law». As a result, the specialists have decided: it is impossible to determine the amount of alcohol and the law does not work for this product.


     Experts agree on the need for a clear classification of the alcohol-containing drugs definition and its introduction into the law. In the meantime, at a special meeting with RAM an offer was made to set up a working group under the expert council of the Federal Service for Alcohol Market Regulation, Rosalkogolregulirovanie, which will be attended by representatives of associations, major manufacturers and the regulators. The decisions of the working group in the form of a protocol will be taken into account when adopting the resolutions of the department. Thus, it will be possible to establish interaction and to take into account the interests of all market players.

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