In 2013, almost 290 million packages of dietary supplements were sold in our country through pharmacies. The volume of this retail market is estimated at 25.5 billion rubles. Biologically active additives account for about 35% of the cost of sales with an average packaging cost of 100 rubles (and a cost of 10-20 rubles). The largest demand among consumers is for dietary supplements of a low price category (costing up to 70 rubles per package).
To date, the market of food biologically active additives is developing most rapidly, and it is dominated by domestic manufacturing companies. The leading position is held by the company Evalar, which accounts for about 23% of all additives sold through pharmacy chains. According to various sources, 70% of all dietary supplements are sold through pharmacy chains, 15% through distributors, about 8% through representative offices of manufacturing companies, 7% through special departments of other stores.
Simplified technology for the production of biologically active additives can be represented in the form of three main stages: grinding the components and mixing them, in accordance with the recipe or formula; extracting and drying; the creation of a pharmaceutical form. First, the company carries out the procurement of raw materials, monitors its quality characteristics, prepares raw materials for the production process. Preparation consists of cleaning, grinding, dissolving, drying, modifying, extracting (extracting), cryoprocessing, etc., depending on the type of raw material used. One of the most optimal ways to grind plant materials is cryo-crushing, which is a fine (pulverized) grinding of parts of plant material at a temperature close to absolute zero. To ensure such temperature conditions, liquid nitrogen is used.
Cryo-crushing is carried out using special mills in an inert gas medium with preliminary deep freezing or lipophilic drying of raw materials. This method allows you to save nutrients and nutrients in plant cells without damaging them, as well as create additives with the synergistic action of the components; provides accurate dosage of components; provides maximum bioavailability (up to 96%). Using cryo-crushing technology, very small particles (about 125 microns) can be obtained while maintaining the integrity of plant cells. Additional advantages of this method are the absence of heating, oxidation and loss of product. In traditional methods of grinding as a result of strong heating of the plant material, beneficial components in the plant cells are destroyed. And during cryo-fragmentation even the most biologically active compounds are preserved. In the process of traditional grinding, the raw material interacts with oxygen, which leads to the oxidation of biologically active compounds and to the formation of oxidation products. Liquid nitrogen helps protect plant materials from the harmful effects of oxygen without reacting with biologically active compounds.
Finally, when using other technologies in the grinding process, fine particles are sprayed in the air and volatile active substances evaporate (the yield of the finished product is markedly reduced). When using cryogenization, one kilogram of plant material at the beginning of the process corresponds to the same amount of powder at the end of the process.
There are also several main methods for producing plant extracts: extraction with water, CO2 extraction, extraction with chemical solvents, supercritical fluid extraction in CO2. Each of these methods differs from others in the temperature of extraction (the higher the temperature, the more nutrients are destroyed), the number of useful components in the final product, the amount of impurities, and the ability of each type of extraction to release allergic substances from plants.
The most advanced method is considered to be supercritical fluid extraction, since using this technology you can get the purest extracts, and it does not lead to their contamination with a working substance. In addition, the extracts obtained during supercritical fluid extraction have high bioavailability and do not contain substances that can cause allergic reactions. Finally, this technology allows therapeutic effects to be obtained in small and ultra-small amounts of active substances.
According to the sanitary and epidemiological norm 18.08.2019.1078-01 in our country, the following components are allowed to be used in the production of food additives:
- food substances: proteins, fats, fat-like substances, fish and marine animal fats, individual polyunsaturated fatty acids, their food sources, carbohydrate and their derivatives, starch, its hydrolysis products, xylose, arabinose, inulin and other polyfructosans, glucose, fructose, lactulose, lactose, ribose, vitamins and vitamin-like substances, minerals (macro- and microelements of calcium, magnesium, phosphorus, sodium, iodine, iron, zinc, chromium, boron, copper, manganese, sulfur, molybdenum, selenium, fluorine, germanium, silicon vanadium I);
- minor food components;
- edible and medicinal plants, products of the seas, rivers, lakes, mineral-organic or natural mineral substances (dry, granular, powdered, encapsulated, in liquid form - in the form of extracts, tinctures, concentrates, balms, syrups);
- probiotics and prebiotics, biologically active substances (immune proteins and enzymes, all groups of oligo- and polysaccharides, lysozyme, lactoferrin, lactoperoxidase of bacteriocins of lactic microorganisms, with the exception of preparations from the skin and human fluids);
- beekeeping products (propolis, wax, pollen, beef, royal jelly).
Pharmaceutical forms include tablets, capsules, powders, tinctures, balms, ointments, etc. There are two ways of tabletting - cold and hot. Tablet forms are most widely used despite the fact that during their production up to 50% of active substances are lost and they contain chemical fillers. Capsules can be animal (gelatin) and plant materials (eg, algae ogar-ogar).
The equipment that is required to organize the production of dietary supplements depends directly on the assortment, the technologies used and pharmaceutical forms. Despite all the disadvantages of tablet preparations, most dietary supplements are available in the form of tablets. To make them, you will need the so-called tablet presses - apparatus for pressing tablets of various diameters, herbal preparations and other pressed tablets. In addition, the list of required equipment includes mixers, granulators, counting and filling machines, devices for monitoring the quality of tablets in accordance with established requirements, and other technological equipment. In addition, packaging for dietary supplements will be required - plastic jars, disters, cardboard boxes, etc.
The organization of its own production of biologically active additives requires large investments, which are estimated at least 25-30 million rubles. This amount includes the following costs: the purchase of raw materials, special equipment for performing scientific work, the remuneration of specialist developers with all deductions, overhead and travel expenses, preliminary tests of the biological properties of dietary supplements, acceptance tests of the biological properties of dietary supplements, testing of created dietary supplements, conducting patent research, testing and examination of created dietary supplements, market research, payment for registration, issuing dietary supplements and preparing for their testing, preparation BAA production, arrangements for the marketing of dietary supplements, preparation and conduct of the state registration of BAS, measures to attract venture investors, voluntary certification, office equipment and the start of sales.
You can get by with smaller investments by ordering one or all of the production processes in a third-party company (in fact, transferring production to outsourcing). At the same time, the entrepreneur himself can take over only production control and the organization of marketing of finished products.
The quality of dietary supplements is determined by the presence of GMP (Good Manufacturing Practice) standards or a certificate of ISO Quality Management System at the manufacturing plant. Compliance with the sanitary norms during the production of dietary supplements is monitored by various state inspection organizations. The quality of the products is controlled by the Department of Sanitary and Epidemiological Supervision under the Ministry of Health of the Russian Federation (at the Institute of Nutrition of the Russian Academy of Medical Sciences) and Rospotrebnadzor. The technical regulation of the Customs Union "On food safety" contains a list of components prohibited for use in food additives (today it includes over 450 different herbs).
The procedure for organizing the production of dietary supplements for the preparation of normative documentation for the additives being developed is determined by the Decree of the Chief State Sanitary Doctor of the Russian Federation dated April 17, 2003 No. 50 “On the Implementation of the Sanitary and Epidemiological Rules and Norms of SanPiN 08/18/2019.1290-03”. According to this decision: ".... production of dietary supplements should be carried out only after conducting its state registration in the prescribed manner and in strict accordance with regulatory and technical documentation. ” To obtain state registration, the manufacturer must submit the following documents:
- Normative and / or technical documents agreed upon in the established order (technical conditions, technological instructions, formulations, etc.) previously not agreed upon, according to which it is planned to carry out industrial production of products certified in accordance with the legislation of the Russian Federation.
- Certified in the prescribed manner copies of the sanitary and epidemiological conclusions on the compliance of technical documents with the requirements of the state sanitary and epidemiological rules and standards (if any).
- Certified in the prescribed manner copies of the sanitary-epidemiological conclusions on the compliance of the production conditions with the requirements of the state sanitary-epidemiological rules and standards.
- Instructions for use (leaflet, abstract) (in the event that all the necessary information cannot be placed on the label), certified by the signature of the authorized person and the manufacturer's seal.
- Consumer (or container) label or its design, certified by the signature of the authorized person and the manufacturer's seal.
- Test reports and / or conclusions of accredited testing laboratories (if any).
- The act of sampling (samples) of the established form.
- If there is a trademark, a copy of the trademark certificate certified in the established manner.
- The manufacturer’s document that he trusts the applicant to represent his interests in the Russian Federation on the state registration of the manufacturer’s products (if the applicant is not a manufacturer).
- A document confirming the right to obtain a certificate of state registration of products (power of attorney).
According to paragraph 5 of federal law No. 184-FZ, the declaration of conformity “must be executed in Russian and must contain:
- name and location of the applicant;
- name and location of the manufacturer;
- information about the object of confirmation of conformity, allowing to identify this object;
- the name of the technical regulation, for compliance with the requirements of which the products are confirmed;
- indication of the declaration of conformity scheme;
- the applicant’s statement about the safety of the product when it is used in accordance with the intended purpose and the applicant takes measures to ensure that the product meets the requirements of technical regulations;
- information about the conducted research (testing) and measurements, the certificate of the quality management system, as well as the documents that served as the basis for confirming the conformity of the products with the requirements of technical regulations. ”
The average rate of return on investment for the production of dietary supplements is estimated at 11%. Return on invested capital can reach 55%. The payback period is 3.5-5 years.
Sysoeva Lilia
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