List of imported drugs and their Russian analogues. OJSC NPK "Eskom"
The largest Russian pharmaceutical companies earned from 15 billion rubles (PJSC Pharmstandard) to 182 billion rubles (JSC NPK Katren) in annual revenue at the end of 2015.
In the last two years, 2015 and 2016, the Russian pharmaceutical industry has shown significant growth - more than 20% in 2016, according to the Minister of Industry and Trade of the Russian Federation Denis Manturov.
At a briefing held at the Russian Ministry of Industry and Trade, Deputy Minister Sergei Tsyb said that the best evidence of the growth of the domestic pharmaceutical industry is that the American pharmaceutical giants are outraged: it is difficult for them to break into Russian market, as they are being replaced by large pharmaceutical companies in Russia. We analyzed and prepared the Top 7 largest Russian pharmaceutical holdings by revenue for 2015.
Pharmstandard
Legal address: Moscow
Registration date: 1996
Founders: Minin Alexander Nikolaevich, Kuznetsov Igor Gennadievich.
CEO: Kuznetsov Igor Gennadievich
- Authorized capital: 1,000,012.86 rub.
- Fixed assets: 153,955 thousand rubles
- Revenue: 21,191,811
- Accounts receivable: 2,667,522 thousand rubles
- Accounts payable: 6,961,274 thousand rubles
- Net profit: 1,042,833 thousand rubles
- Net assets: 2,646,595 thousand rubles
- INN - 7731241639
http://www.euro-service.ru/
Sia International
Joint Stock Company "Sia International LTD" is engaged in the sale of medicines and medical devices pharmacies and medical institutions.
It has warehouse complexes in Moscow and more than 35 cities of Russia. Their total area is more than 200 thousand square meters.
Legal address: Moscow city
Registration date: 1995
Founders: JSC "Rink", Rudinsky Igor Feliksovich.
CEO: Demkin Alexander Yurievich
- Authorized capital: 20,000,000 rubles
- Fixed assets: 5,624,687 thousand rubles.
- Revenue: RUB 59,438,184 thousand
- Accounts receivable: 13,597,841 thousand rubles.
- Accounts payable: 20,209,002 thousand rubles.
- Net profit: -3,111,114 thousand rubles
- Net assets: 2,908,224 thousand rubles
- TIN - 7714030099
Sources: official website: http://siamed.ru/, extract from the Unified State Register of Legal Entities, Rosstat (financial reporting data according to RAS for 2015).
R-Pharm
Joint Stock Company "R-Pharm" specializes in high-tech medicines. Currently, the company is working towards large-scale investment projects.
It is creating a production base as part of the state strategy for the development of the Russian pharmaceutical industry until 2020.
Legal address: Moscow
Registration date: year 2001
Founders: Repik Alexey Evgenievich
CEO: Ignatiev Vasily Gennadievich
- Authorized capital: 28,400 rubles.
- Fixed assets: 2,119,636 thousand rubles
- Revenue: 62,204,014 thousand rubles
- Accounts receivable: 13,435,674 thousand rubles.
- Accounts payable: 30,682,362 thousand rubles
- Net profit: 8,608,010 thousand rubles.
- Net assets: 24,205,818 thousand rubles
- TIN - 7726311464
Sources of information: official website: http://r-pharm.com, extract from the Unified State Register of Legal Entities, Rosstat (financial reporting data according to RAS for 2015).
Growth
Closed Joint-Stock Company"Growth". Total in pharmaceutical group"Rosta" includes 4 companies: "Rosta" (engaged in the distribution of medicines), "Rosta-Marketing" (trade marketing), "Raduga Production" (plant for the production of solid medicines), United Pharmacy Chain, which includes companies “Rainbow”, “First Aid”, “Ladushka”.
Legal address: Moscow region, city of Podolsk
Registration date: 2002
Founders: Joint-stock company PJSC "Tampo", Mirilashvili Mikhail Mikhailovich, Panikashvili David Isaakovich, Tseytlin Oleg Yakovlevich, Strepetov Vadim Valentinovich, Shepel Boris Albertovich, Semenyuk Alexander Vasilievich, Konev Oleg Yurievich.
The president: Panikashvili David Isaakovich
- Authorized capital: 1,000,000 rubles
- Fixed assets: 621,356 thousand rubles
- Revenue:RUB 63,384,563 thousand
- Accounts receivable: 18,293,282 thousand rubles.
- Accounts payable: 35,244,901 thousand rubles
- Net profit: 415,314 thousand rubles
- Net assets: 1,755,002 thousand rubles.
- TIN - 7726320638
Sources: official website: http://www.rostagroup.ru/, extract from the Unified State Register of Legal Entities, Rosstat (financial reporting data according to RAS for 2015).
Protek
Closed joint stock company firm "Implementation Center "Protek". The Protek group of companies is engaged in the production, distribution and retail through pharmacy chains medicines.
The holding's production and technological capacities comply with GMP standards.
Legal address: Moscow
Registration date: 1994
Founders: JSC "Protek"
CEO: Pogrebinsky Dmitry Borisovich
- Authorized capital: 40,000,000 rubles
- Fixed assets: 1,082,865 thousand rubles.
- Revenue: 166,578,310 thousand rubles
- Accounts receivable: 32,742,113 thousand rubles.
- Accounts payable: 69,059,867 thousand rubles
- Net profit: RUB 5,419,719
- Net assets: 8,094,159 rubles
- TIN - 7724053916
Sources of information: official website of the company: http://www.protek-group.ru, extract from the Unified State Register of Legal Entities, Rosstat (financial reporting data according to RAS for 2015).
Quatrain
The geography of Katren's work covers 85 constituent entities of the Russian Federation and delivers more than 18 thousand types of pharmaceutical products.
Legal address: city Novosibirsk
Registration date: 1993
Founders: Konobeev Leonid Valentinovich, Spiridonov Vladimir Nikolaevich
CEO: Konobeev Leonid Valentinovich
- Authorized capital: 1 billion 500 million rubles
- Fixed assets: 6,752,880 thousand rubles
- Revenue: 182,301,551 thousand rubles
- Accounts receivable: 30,155,368 thousand rubles.
- Accounts payable: 65,656,588 thousand rubles
- Net profit: 5,790,742 thousand rubles
- Net assets: 11,103,940 thousand rubles.
- TIN - 5408130693
Sources: official website: http://katren.ru, extract from the Unified State Register of Legal Entities, Rosstat (financial reporting data according to RAS for 2015).
Analogs and substitutes for expensive, very expensive drugs. Doctors often prescribe expensive drugs, although there are cheaper ones medicines"generics". The difference between expensive drugs and their inexpensive analogues. Replacement of expensive drugs with analogues (generics). A list of tested analogue drugs that are allowed to be purchased at a pharmacy instead of expensive brand-name drugs.
Generics (from English Generic) are unpatented medicines, they are a reproduction of the original drug, on active substance whose patent protection has expired. They may differ from the original drug in the composition of excipients; as a rule, the properties and effects of generics are retained.
Generics are much more expensive than expensive original drugs, but the therapeutic results of these drugs are sometimes quite the same. Therefore, in principle, when it is impossible to purchase an original expensive drug for yourself, or you do not agree to give money for a brand, even if its quality is impeccable, you can absolutely stop your respects at inexpensive substitutes expensive medicines. Let’s say the drug “No-shpa”, you can safely replace it with the inexpensive domestic “Drotaverine”, saving a lot on the purchase of this medicine.
Russia produces a huge number of generics and other analogues of imported drugs. Moreover, Russian analogues of imported drugs, due to the absence of various costs for duties and taxes, with sufficiently high quality, will be much cheaper than the same generic drugs imported from abroad. The assessment of the quality and safety of these drugs is underway. high level, Russian drugs higher quality and purer than, for example, Vietnamese or Chinese drugs.
Why buy an expensive drug when you are counting on real healing effect. Suppose the imported “Fervex” is a complex medicine for the treatment of colds, includes as active substances paracetamol, which lowers body temperature, ascorbic acid, which strengthens the walls blood vessels and strengthens the immune system, and pheniramine maleate, which eliminates swelling of the nasal mucosa and respiratory tract. It is not necessary to overpay a lot of money based only on the antipyretic result, when the domestic drug Paracetamol can absolutely cope with this. It should be noted that imported medicines often have complex composition. Of course, there is nothing wrong with this, because... active substances in combination provide rapid decline cold symptoms and recovery, however, the cost of the medicine increases in proportion to the increase in the number of components in the composition. In any case, even when your doctor recommends a certain drug, you have the right to ask to justify the prescription of an expensive imported drug, but also to ask for a more affordable analogue.
Remember, one thing is that you don’t need to blindly choose the best one at the pharmacy. cheap substitute expensive medicine!
Some original drugs are cheaper than generic drugs (verified fact). Sometimes you come across high-quality generics, and there are many of them.
The most important thing is not to fall for a fake medicine (counterfeit, surrogate).
Below is a table of drug analogues
Remember the rule: to find an analogue, look for international name, the drug prescribed to you, for example, the drug Zantac - international name (INN) - Ranitidine, therefore you can replace it with an analogue.
List of substitute drugs and analogues of the original ones that you can buy in Russian pharmacies
Cheap analogues of expensive drugs - table
| Expensive medicine | Cheap analogue |
| Belosalik | Akriderm SK |
| Bepanthen | Dexpanthenol |
| Betaserk | Betagistine |
| Bystrumgel | Ketoprofen |
| Viagra | Dynamics |
| Voltaren | Diclofenac |
| Gastrozol | Omeprazole |
| G eptral | Heptor |
| De -nol | Gastronorm |
| Detralex | Venarus |
| Di prosalik | Akriderm SK |
| Diflucan | Fluconazole |
| For the nose | Rhinostop |
| Zantac | Ranitidine |
| Zyrtec | Cetirinax |
| Zovirax | Acyclovir |
| Immunal | Echinacea extract |
| Imodium | Loperamide |
| Iodomarin | Potassium iodide |
| Cavinton | Vinpocetine |
| Claritin | Loragexal |
| Klacid | Clarithromycin |
| TO senical | Orthosen |
| Lazolvan | Ambroxol |
| Lamisil | Terbinafine |
| Lyoton-1000 | Heparin-acrigel 1000 , heparin ointment |
| Lomilan | Loragexal |
| Maxidex | Dexamethasone |
| Mezim | Pancreatin |
| Midriacil | Tropicamide |
| Miramistin | Chlorhexidine |
| Movalis | Meloxicam |
| Nise | Nimesulide, nimesil |
| Neuromultivitis | Pentovit |
| No-shpa | Drotaverine hydrochloride |
| Normodipine | Amlodipine |
| Nurofen | Ibuprofen |
| Omez | Omeprazole |
| Panadol | Paracetamol |
| Panangin | Asparkam |
| Pantogam | Pantocalcin |
| P reductal MV | Trimetazidine MV |
| Rhinonorm | Rhinostop |
| Sumamed | Azithromycin |
| T aufon | Taurine |
| Trental | Pentoxifylline |
| Tr iderm | Akriderm GK |
| Trichopolum | Metronidazole |
| Troxevasin | Troxerutin |
| Ultop | Omeprazole |
| At rsofalk | Ursosan |
| Fastum-gel | Ketoprofen |
| Finlepsin | Carbamazepine |
| Flucostat | Fluconazole |
| Furamag | Furagin |
| Hemomycin | Azithromycin |
| Enap | Enalapril |
| Ersefuril | Furazolidone |
On the domestic pharmaceutical market There are many different medications available, but at the same time, most of them are very expensive. As an affordable alternative, many people prefer to choose Russian analogues imported medicines, the list and compliance of which can be obtained from the attending physician or pharmacist at the pharmacy.
Painkillers and antispasmodics
Painkillers (analgesics) are intended to relieve pain syndromes of various origins. In general, analgesics are divided into 2 groups:
- Non-narcotic drugs containing acetylsalicylic acid, analgin, paracetamol, mefinamic acid, piroxicam, ibuprofen, dimexide, etc.
- Narcotic drugs that are prescribed in the most extreme and serious cases, for example, morphine, promedol, fentanyl, etc.
Antispasmodic drugs (antispasmodics, antispasmodics) are intended to relieve spasms of blood vessels and smooth muscles internal organs, for example, the gastrointestinal tract, urinary and biliary tract, female reproductive system.
Cardiac and hypotensive
Cardiac drugs combine several groups of drugs to improve ischemic and cerebral circulation, normalization heart rate, increasing the content and transport of oxygen to the heart.
Antihypertensive (antihypertensive) drugs are intended to reduce blood pressure. The required effect can be achieved by different principles actions of drugs:
- decreased tone of the sympathetic nervous system;
- suppression of renin production (a component of the blood pressure regulation system);
- vasodilation;
- increasing urine output (diuretics).
Antibacterial and antiviral
Antibacterial drugs (antibiotics) - drugs that suppress growth harmful microorganisms or causing their death.
Antiviral drugs are medications that are used to treat viral diseases of various origins. They are often used to prevent viral diseases and to increase the body’s immunity in complex therapy.
Anti-inflammatory and antipyretic
Nonsteroidal anti-inflammatory drugs (NSAIDs, NSAIDs) have an anti-inflammatory effect, to which antipyretic and analgesic effects are also added.
Antidiarrheal
Diarrhea (stomach upset) is common symptom various diseases Gastrointestinal tract, other internal organs, intoxications. Antidiarrheal drugs reduce intestinal motility, increase sphincter tone. This group also includes eubiotics (enzymes and bacteria that regulate the microflora of the gastrointestinal tract) and adsorbents (cleaning the gastrointestinal tract from toxins and allergens).
| Name | Active substance | Russian analogue |
|---|---|---|
| Imodium | Loperamide | Vero-Loperamide Diara Loperamide |
| Linux | Lactic acid and bifidobacteria | Bifidumbacterin Bifinorm Lactobacterin Lactonorm |
| Nifuroxazide | Nifuroxazide | Ecofuril |
| Smecta | Dioctahedral smectite | Diosmectite Neosmectin |
| Sorbex | Activated carbon | Activated carbon |
Antiulcer
Action antiulcer drugs aimed at eliminating ulcerative manifestations on the gastric mucosa and duodenum. They reduce excessive secretion of gastric secretions, reduce the activity of pepsin (the main enzyme gastric juice), destroy Helicobacter in the gastrointestinal tract, normalize motility upper sections digestive tract.
Antiallergic
Allergy medications (antihistamines) block histamine receptors in the body, a neurotransmitter that affects Airways, skin, gastrointestinal tract, blood vessels, smooth muscles and causes manifestations allergic reaction.
Inhalation drugs and cough suppressants
Inhalation is a method of introducing drugs into the body by inhaling steam, gas or smoke. To carry it out, nebulizer devices (inhalers, nebulizers) are used, which are filled with gaseous, liquid or volatile substances.
Mucolytic agents are cough medications that discharge mucus in the lungs and facilitate its elimination, reduce inflammatory process in the respiratory tract.
Calming
Sedatives (sedatives, psycholeptics) are a group of drugs that cause sedation or reduce emotional stress without hypnotic effect, and at the same time facilitate the process of falling asleep and improve the quality of sleep.
Preparations for external use
The group of medicines for external (local) use includes great amount preparations in the form of ointments, gels, creams, solutions, powders, etc. Depending on the composition, they have antibacterial, disinfectant, analgesic, anti-inflammatory, antihistamine and other effects.
Having addressed his illness to a doctor and received from him an impressive list of medicines, the patient rarely questions him. And only after learning the cost of the necessary drugs, a person asks the question: are the medications prescribed by the doctor really effective, and do they have cheaper analogues? This question, no doubt, interests everyone, and therefore in this article we will answer a number of questions:
- what cheap domestic analogues of expensive medicines can be found on the shelves of our pharmacies?
- Why are these drugs so cheap?
- can they provide healing effect, not inferior to the original products?
But first things first.
What are generics?
Analogs of expensive medications are called generics all over the world. In fact, these are reproduced “copies” of original medicines for which the patent has expired. Generics have the same active substance as the original medicine and a similar dosage. They differ only auxiliary components, which means there is no doubt that the therapeutic result of the original and the “copy” is practically no different.
Why are generics so cheap?
Many people are alarmed by the low cost of generics, because it is completely unclear why a “copy” that is in no way inferior to the original medicine costs several times less? In fact big secret there is no. Unlike the original, generic manufacturers do not spend a penny on the development of the active substance, which means they do not include the costs of experiments and testing in the price. In addition, domestic drugs, unlike foreign originals, are not subject to import duties and taxes. All this ultimately allows us to create a much more reasonable price.
Other advantages of generics
Low price while maintaining a decent therapeutic effect is by no means the only advantage domestic analogues expensive drugs. A huge plus of these drugs is that they are not counterfeited (it is simply unprofitable!). In addition, quality and safety assessment domestic drugs is growing year by year, which means the population Russian Federation trusts these remedies much more than the same Vietnamese or Chinese medicines.
Disadvantages of generics
Given that generics are still “copies” of the original medicines, they do not fully correspond to the original and this should not be forgotten. We list their shortcomings:
1. They are characterized by a lower degree of purification, which means big list side effects. Indeed, the cheapness of generics is also explained by the low degree of purification of the drug, which increases the number of side effects. Original medicines benefit significantly in this regard.
2. In comparison with the originals, generics, as a rule, have a “stripped-down” composition. For example, the original drug can have an anti-inflammatory effect and reduce the temperature in parallel, while its more cheap analogue will act in only one direction.
3. Original products have high cost not only because of the high degree of purification and multicomponent composition. Unlike analogues, their action is much longer, and they need to be taken less often.
And yet, given the serious difference in cost and the same therapeutic effect(compare Omez and Omeprazole, Fervex and Paracetamol), modern visitors to clinics increasingly prefer domestic analogues of the original foreign medicines. Below we give full list these medications and their substitutes.
List of cheap domestic analogues of expensive drugs
Antispasmodic and analgesic drugs, antipyretics
Cardiac and antihypertensive drugs
Antibacterial, anti-inflammatory and antiviral agents
Antidiarrheals
Antiallergic drugs
Inhalation drugs, cough suppressants
Sedatives and drugs that improve cerebral circulation
Gels, ointments and creams for external use
Other medications
| Actrapid NM | Humulin NPH |
| Potassium and magnesium aspartate | Asparkam |
| Vinblastine-Teva | Vinblastine-Lance |
| Sermion | Nicergoline |
| Oftan dexamethasone | Dexamethasone |
| Timolol | Okumed |
| Hypothiazide | Hydrochlorodiazide |
| Vermox | Mebendazole |
| Iodomarin | Potassium iodide |
| Troxevasin | Troxerutin |
| Finlepsin | Carbamazepine |
| Mezim | Pancreatin |
| Movalis | Meloxicam |
I.V.Sudarev, V.G.Gandel, Department of Industrial Pharmacy, State Educational Institution MARTIT
Recent pharmaceutical terminology is replete with a number of interesting innovations that force you to strain your brain and try to somehow understand their meaning and content in categories familiar to a specialist. For example, the term “pharmaceutics”, introduced into circulation mainly by representatives of the media, who for the most part still pronounce, understand (and often write!) the word “pharmacy” as “formation” or “pharmacy” with an emphasis in the first case on the second syllable, and in the second – on the penultimate one, and for which the term “pharmaceuticals” is socially closer. What this term is supposed to mean is unclear. A journalist I know once said that “... it’s all about drugs.” That's it, simple and pleasant. The term “cosmeceuticals” is already on its way, and “producerceuticals” may soon follow... Or another pearl – “pharmacological industry”. Who will explain what this is?
All this could be calmly experienced, understanding that it is not so easy for non-specialists to understand these complex pharmaceutical (and pharmacological!) intricacies. But not so long ago, a term was introduced into circulation that cannot be attributed to this casuistry, and it was introduced by specialists. This term is called “domestic medicines”. The term is not simple and by no means safe. Let's figure it out.
In the USSR, domestic medicines (medicines, drugs) were called everything that was developed, researched and produced by domestic researchers and production workers from domestic raw materials on predominantly domestic equipment and on the territory, of course, of the USSR. This was clear and no one raised any questions. Today, many people interpret the term “domestic medicines” in their own way, putting very diverse content into it.
For example, production workers (mainly the owners and top management of most enterprises) call domestic those medicines that are produced abroad and are simply packaged in consumer packaging in Russia and provided with an insert in Russian. Moreover, they proudly call the widespread transition to the production of generics after the 1998 crisis “import substitution,” bribing with this term many pharmaceutical officials who joyfully reported to the country’s leadership about the victory over imports. Well, who, tell me, would think of calling a Ford Focus assembled in Vsevolozhsk a domestic car: this can only happen if any serious manufacturing defects are found in it. Few people even called the VAZ “kopek”, assembled almost entirely from domestic parts and components, a domestic car. Domestic ones were “Moskvich”, “Pobeda”, “Volga”, “ZiS”, “ZiL”, “ZiM”, “IzhAvto”, etc.
Developers of original medicines, and there are literally only a few of them left in the country, classify as domestic medicines only those developed by them or their Russian colleagues. But what the population understands by this term is anyone’s guess.
If we turn to the statements of responsible officials in the sphere of drug circulation of the last decade, we will hear many calls to increase the share of “domestic drugs” in the pharmaceutical market. The most ambitious plans were recently announced in Zelenograd, where the prime minister gave an unsatisfactory assessment of the domestic pharmaceutical industry, calling for a radical change in the situation with drug supply to the country's population within a decade in favor of domestic drugs, regaining at least half of the market and ensuring the production of 85% of the most important drugs . It remains, however, not entirely clear how an industry rated as a “two” can cope with such a difficult task.
“The floors are parquet, and the doctors have questionnaires,” they called it, not without humor. medical staff"Kremlin" hospital. But there were also “Kremlin” pharmacists - specialists responsible for the drug supply to the country’s leadership necessary drugs. So, these specialists, competent and dear people, constantly strived to reduce the share of domestic drugs in the range of drugs of the “Kremlin pharmacy” towards more modern and effective drugs imports, especially from capitalist countries, and above all the USA, Switzerland, France, Great Britain, Germany, Italy, Japan, seeking appropriate funding for these purchases from the budget. And there is no need to talk about the drugs from the CMEA countries and Yugoslavia: they have always been a desired and sought-after drug for the Kremlin and the health departments of the union republics. And today, we believe, the same concept is adhered to by those responsible for the health of the nomenklatura. Moreover, there are cases when people from among the nomenklatura, bohemians and business people who have such an opportunity, in principle, give birth, receive treatment and buy medicines exclusively abroad, even if they can be purchased in Russia.
So why is it today that the question of the predominance of “domestic” drugs among drugs is so persistently raised? drug therapy? And is this even possible in principle?
To answer these questions, it is necessary, first of all, to give a clear, unambiguous, different interpretations, definition of what should be understood by domestic medicines. But first, it is necessary to take a short historical excursion to make it more clear what we are actually talking about.
After World War II, the population of the United States experienced an acute allergy to goods made in Germany, including medicines that were circulated on the American pharmaceutical market, were considered very effective and were characterized by appropriate (German) quality. The population preferred to be treated with “domestic”, American drugs, and pharmaceutical companies, which had already gained capacity, immediately responded to the consumer’s call, which is generally typical for American business, including pharmaceuticals. Large corporations independently, as well as through cooperation with universities and other scientific centers countries have carried out powerful screening of many synthetic and natural chemical compounds, having made a serious scientific, technical and innovative breakthrough and making an active pharmacological foundation for many years to come. This is what allowed the United States to make a real revolution in the pharmaceutical business in the mid-sixties, to attract dozens of outstanding scientists, including Nobel laureates, to the development of new generation drugs, to open a new direction in the development and production of drugs - biopharmacy, which became the main way to study and ensure bioavailability , without which no drug can enter the market without evaluation, begin transferring the main stages life cycle creating medicines in the format of good practices - GLP, GCP, GMP, etc. During the same period, the theoretical, scientific and technical prerequisites were laid for the creation of fundamentally new generations of medicines, which were based on the total chemical synthesis of analogues of natural biologically active substances, their derivatives, fundamentally new classes organic compounds, and Hi-tech isolation and purification of target products. This is how semi-synthetic penicillins, cephalosporin antibiotics, prostaglandin biosynthesis blockers - non-steroidal anti-inflammatory drugs, cholesterol biosynthesis blockers - statins, and whole line others chemical structures, many of which are still blockbusters in the pharmaceutical market.
The above can be fully applied to some other developed countries - global manufacturers of medicines. For example, the Japanese, after experiencing a nuclear attack in 1945, refused to use the most effective American drugs, which did not even have close analogues in Japan, only because they were created in the country of the Yankees. Residents of Japan wanted to be treated with “domestic” means: over time, a powerful Japanese pharmaceutical industry and R&D were created with an emphasis on biotechnology and the use of natural organic compounds, especially biologically active substances of aquatic organisms ( marine organisms) as the basis for anticancer drugs, diabetes therapy, cardiovascular pathologies And infectious diseases.
How is an American (or Japanese, German, French, etc.) “domestic” drug created today?
First of all, it is necessary to emphasize that the creation of a truly fundamentally new drug can only be achieved by a powerful, self-sufficient and innovatively motivated structure that has the ability to initiate basic research and enjoy their fruits. This is achieved mainly through the participation of large pharmaceutical companies and transnational corporations in the form of public-private partnerships in financing university science through the provision of national and international grants, the total amount of which reaches tens of billions of dollars. But this is not enough. It is necessary that the process of developing such a drug be led by a recognized scientific school that has proven its leadership in the chosen area of pharmacological research and pharmaceutical production for quite a long time. For example, the “pharmacy of the world,” the German pharmaceutical company Bayer, is a world leader in the development and production of anti-atherosclerotic, anti-inflammatory and antimicrobial drugs; American Merck (in other countries Merck, Sharp and Dome) - means of combating atherosclerosis and its manifestations based on statins; Ellie Lily, Novo Nordisk and Ayinomoto - human genetically engineered insulin and drugs parenteral nutrition; Pfizer – anti-cancer drugs, e.g. effective means marine origin cytosar (cytarabine, arabinoside cytosine) from sea sponges, etc. and so on.
The listed companies also produce a number of others, no less significant drugs: in the period of globalization and harmonization of the world pharmaceutical economy, the explosive development of science and technology, barriers to research and development are being eliminated everywhere. The only effective regulator of the global innovative pharmaceutical expansion of the 21st century is patent law, which reliably protects the intellectual and industrial property of developers.
The creation of a new drug, as a rule, begins with a “design”, which is based on previous accumulated experience in pharmacotherapy of a certain group or groups of diseases. But there are also exceptions. For example, Nobel laureate in physics, Linus Pauling proposed to fight viral diseases overdoses ascorbic acid without any previous experience, only on the basis of inferences. But this is the exception rather than the rule. Main path innovations in pharmaceutical science - already accumulated scientific and technological knowledge, as well as deep knowledge international law in the field of drug circulation.
It takes approximately five to seven years to develop an active pharmaceutical ingredient (substance), on the basis of which the corresponding dosage forms are then created, and the same for the GLP and GCP stages. Moreover, the longer the stage of clinical trials, the more information accumulates about long-term consequences and possible side effects of using the developed drug. For example, stage V clinical trials, which accompany the already approved use of a drug, can continue within the framework of pharmacovigilance for 15 years or more.
Further, the substance for which the declared pharmacological activity has been proven must be clothed in such dosage form, which is most suitable for the intended application. This is achieved by using appropriate auxiliary, mainly inert substances, and this is where biopharmacy comes into play - the science of the influence of pharmaceutical factors on pharmacological activity medicinal substances. This is a relatively young section pharmaceutical science, which was introduced into the practice of domestic medicine in the 70s of the last century, not without problems and resistance. By using biopharmaceutical techniques and technologies, a composition of the dosage form (solid, soft, liquid, gaseous, etc.) is achieved in which Excipients not only do not interfere, but, on the contrary, contribute to the maximum manifestation therapeutic effect substances with a minimum of unwanted side effects. With the participation of excipients, you can not only create the dosage form itself, but also give it certain properties: extend (prolong) the therapeutic effect, protect the substance from the action of gastric juice when taking the drug orally, dissolve “insoluble” substances, improve or mask bad taste or the smell of the drug, etc. In other words, the developer (designer) must ensure optimal bioavailability of the drug: make it work where, when and how much it is necessary to have a pharmacotherapeutic effect on the course of the pathological process.
In view of these circumstances, the quality of excipients is subject to the same international law requirements as for active pharmaceutical ingredients: they must be produced and controlled under the same conditions, i.e. in accordance with the requirements of GMP rules, no more and no less. Therefore, enterprises producing substances and excipients must comply with GMP requirements to the same extent as enterprises producing finished medicinal products.
So, what is a "domestic" medicine in the understanding of a European, American or Japanese layman?
This is undoubtedly a drug developed and produced by "domestic" scientists at a "domestic" company from "domestic" substances using "domestic" excipients and on "domestic" pharmaceutical technological equipment. We believe that a foreign specialist will give a similar or similar explanation. As for the territory where the medicinal product is produced, today it can be any territory recognized by the world pharmaceutical community as suitable for this kind of business.
So what should be understood by the term "domestic" medicine for us Russians?
Domestic substances are practically not produced in the country, and if they are produced anywhere, then, as a rule, using imported chemical components (synthons, catalysts, etc.) and by no means in accordance with GMP standards. The same fully applies to excipients. Validated domestic pharmaceutical processing equipment can be counted on the fingers of one hand. According to our estimates, there are no more than 10 pharmaceutical enterprises that comply with GMP in the country, and these are mainly enterprises with foreign capital. The remaining 340 (no one knows exactly how many drug manufacturers actually operate in Russia) do not meet these requirements. First, the President of the Russian Federation (August 13, 2003), then twice the Prime Minister (June 19, 2008 and October 9, 2009) unsuccessfully called for a domestic pharmaceutical industry move to the GMP standard first from January 1, 2005, then from January 1, 2010 and finally from January 1
2011, and things are still there.
But producing a medicine is not enough: in order for it to reach the market, its quality must be properly controlled. The means of pharmaceutical quality control today are as follows: control, testing, analytical and auxiliary equipment, instruments, materials, reagents, reference samples, standards, columns, media, etc. and so on. – this is all, as a rule, imported!
The desire to increase at any cost specific gravity“domestic” drugs, especially those produced at enterprises that do not comply modern requirements, to the detriment of funds received through imports, is fraught with serious consequences, especially considering the zeal with which the official rushes to carry out the lord’s decree. By cutting imports, the country may one day face a shortage of the most important modern means treatment of diabetes, cancer, cardiovascular, infectious diseases. And, in fact, why do we need to produce 85% of the drugs on the Vital and Essential Drugs list? Are we going to remain in the blockade for a long time as a belligerent side? For consumers, the main thing is that this list contains drugs that are truly modern, truly effective and safe, then the diseases in our country, which are off the charts for almost all serious nosologies, may begin to decline.
We have already become a “generic” power, i.e. a classic country of the third medicinal world, and generics, as you know, are “old men” and “old ladies” old age and their capabilities are very limited.
Thus, if it turns out that we are not able, as in the automobile industry, to organize modern production on our own, and without such production, the development of medicines does not seem relevant, outsourcing pharmaceutical production should be developed with those who are masters of this matter, i.e. with foreign companies or with the participation of foreign capital, which, in fact, is already happening in fact.
Hence the conclusion follows: medicines registered in Russia, produced in accordance with GOST R 52249-2004 and taxes on which, in accordance with Russian legislation, are paid to our treasury, will have to be called domestic. Then the figure of 85% in the Vital and Essential Drugs list will not cause serious concern. And by default, let’s not forget that substances, excipients, most materials of primary and secondary packaging, process equipment and controls are purchased abroad and what we should support friendly relations with their manufacturers and countries of registration, so that at one point they do not refuse supplies.
