Two drugs were illegal

Two well-known dietary supplements for improving potency in men - Sialex Forte and Ali Caps - may disappear from pharmacy shelves. The decision to ban them was published on its official website by Rospotrebnadzor. It will be impossible to sell miracle pills for heroic strength due to the substance tadalafil, which is included in the composition of dietary supplements, but is not declared by the manufacturer on the packaging.

“Sialex Forte” and “Ali Caps” received state registration as biologically active food additives in Kazakhstan. Therefore, the decision to ban them, cancel all licensing documents and withdraw batches from circulation on April 26 was made by the Kazakh Committee for the Protection of Consumer Rights.

Now the scandal has reached Russia. As Rospotrebnadzor indicated in its message, the Kazakh authorities recognized both drugs as counterfeit due to the discovery of tadalafil in them, which was not declared by the manufacturer. In turn, Russian officials pledged to strengthen supervision over the production of dietary supplements and remove illegal pills from pharmacy chains.

The detection of tadalafil in a drug automatically transfers it from the category of dietary supplement to the category of medicines,” explained Leonid Maryanovsky, an expert on dietary supplements and a representative of the association of their manufacturers.

As the expert said, tadalafil is a synthetic drug used to treat erectile dysfunction. However, according to the law, such substances should not be present in dietary supplements in principle.

If we are talking about medicinal herbs, then according to the rules they can be half the minimum therapeutic dose. Only if these conditions are met can the pill be called a dietary supplement.

Manufacturers of potency supplements, meanwhile, told us that they had sent a request to Kazakhstan demanding clarification. However, Rospotrebnadzor reported that information about the presence of an illegal component in dietary supplements sold in the Customs Union also came from Belarus and Armenia. In addition, the Moscow department of the Investigative Committee has already managed to conduct an investigation into this fact.

All these checks began with the fact that we purchased 29 copies of popular dietary supplements for potency of 8 names,” says Leonid Maryanovsky. “We conducted research on the composition of the drugs in three different laboratories. And at 25 tadalafil was found.

According to Maryanovsky, dietary supplements produced in Russia, the USA, Malaysia and China were sent for testing. After the publication of disappointing results, the Americans immediately recalled their product from all pharmacies. The Malaysians fought a little, but lost all the arbitrations in Belarus, where their pills were registered, and after that they gave up. The expert is confident that the same fate awaits the current heroes of the drug scandal.

Distributors assure that it is simply impossible to reliably detect the presence of synthetic drugs in dietary supplements - as a representative of the pharmaceutical company stated, at the moment such methods do not exist.

In fact, there is a technique, but it is young and, perhaps, not everyone has had time to become familiar with it,” explains Maryanovsky. “At the end of last summer, we, together with the Research Institute of Nutrition of the Russian Academy of Medical Sciences and experts from RUDN University, began to develop it, and at the beginning of this year Rospotrebnadzor issued fully legitimate guidelines on the procedure for identifying tadalafil in drugs.

The dietary supplement market is rocked by the biggest scandal in the last 10 years. The protracted story with the discovery of the banned substance tadalafil in the best-selling potency supplements on the Russian market, Sealex and Alicaps, which at first glance appears to be a competitive squabble between manufacturers, actually revealed systemic problems in controlling the circulation of dangerous products and dispelled the myth of the omnipotence of Rospotrebnadzor.

When in May 2015 it first became known about the discovery of prohibited tadalafil in the drugs Sealex and Alicaps, the scenario for the development of events seemed to be the only possible one - a lightning-fast reaction from Rospotrebnadzor, the recall of dangerous products from the market, and the punishment of those responsible. But the all-powerful Rospotrebnadzor seems to have stumbled over Sealex.

The powerful agency, famous for the fact that it can close the market for Moldovan wines or Dutch tulips in a day or even an hour, in this situation seems to have demonstrated inertia and helplessness that was previously unusual for it.

It turned out that analyzes of dubious products for the content of tadalafil, which have been common throughout the world for decades, are illegitimate in Russia due to the lack of an approved special technique. But if there is no methodology, there is no tadalafil, and the fact that every day the health of hundreds and thousands of Russian men is at risk remains outside the brackets of bureaucratic formalities.

It is unknown how long the issue with the methodology would have been in limbo, but Olga Golodets intervened. In the summer of 2015, at a meeting with the Deputy Prime Minister, the issue of the sensational problem with falsified dietary supplements was raised, and immediately after the meeting, the chairman of the State Duma Committee on Health Protection, Sergei Kalashnikov, announced that he was preparing a bill to transfer powers to control the market of dietary supplements from Rospotrebnadzor to Roszdravnadzor, which It will simply register drugs and check each of them for drug content.

After this, Rospotrebnadzor began developing the methodology, and on January 30, 2016, it officially announced that the document had been developed and officially approved.

Rospotrebnadzor, as you can understand, chose to remain silent about the fact that the official method is no different from the unofficial one, which discovered tadalafil back in May 2015. And this is understandable - after all, then it was necessary to explain why it took five months to develop it, while dangerous products continued to be sold unhindered in Russian pharmacies. Be that as it may, Russia has now officially adopted the document MUK 4.1.3331-16 “Methodology for measuring the mass fraction of synthetic phosphodiesterase-5 inhibitors (tadalafil, vardenafil and sildenafil) in dietary supplements using high-performance liquid chromatography with ultraviolet and mass spectrometric detection ", which allows you to accurately determine the presence of the active synthetic substance of the PDE-5 group tadalafil in dietary supplements and food products. Rospotrebnadzor press secretary Anna Brycheva officially confirmed to NG that the methodology adopted by the department makes it possible to determine the presence of tadalafil.

According to NG, immediately after the adoption of the official methodology, a study was conducted in accordance with it, the results of which were published on February 25, 2016. Tadalafil was found in the drug Sealex in amounts from 10.0 to 11.4 mg per capsule, in the drug Alicaps - from 3.9 to 12.4 mg per capsule.

And a month earlier, on December 30, 2015, as part of a criminal case opened regarding the discovery of tadalafil in dietary supplements, the Investigative Committee of Russia conducted its own examination of samples seized from pharmacies and distribution networks. The examination confirmed the content of tadalafil in Sealex and Alicapse.

Based on its results, the Investigative Committee sent an appeal to Rospotrebnadzor with a request to withdraw Sealex and Alicaps from the market.

On February 17, 2016, the Ministry of Health of the Republic of Belarus adopted a resolution to withdraw Sealex and Alicapsa from the market due to the discovery of tadalafil. However, at the time of preparation of the material, Rospotrebnadzor had not yet seen Belarus’ appeal on this issue. “We have not officially received an appeal from Belarus, and accordingly, we cannot yet answer questions regarding further actions,” says the official response from the press service. Let us recall that earlier in a similar situation in July 2015, when the Ministry of Health of the Republic of Belarus decided to recall Togkat Ali Platinum, which also contained tadalafil, a similar decision was made by the Russian Rospotrebnadzor. On July 29, 2015, Rospotrebnadzor of Russia issued an order to terminate the state registration of Togkat Ali Platinum and withdraw it from circulation.

That is, there is already a precedent. Professor, head of the criminal law sector of the Institute of State and Law of the Russian Academy of Sciences Sergei Maksimov believes that if there are free customs borders, “measures to suspend the free circulation of dangerous products should be taken immediately after receiving official notification of the decision of the authorized body.”

Using this story as an example, we become witnesses to a unity of views of a variety of interest groups, very atypical for Russian realities - public organizations, the Investigative Committee, parliamentarians. Surprisingly, the only body that in a different situation would have been the first to take the lead in the fight against unscrupulous producers, Rospotrebnadzor, seems to be in the opposite phase.

“The question arises: why does Rospotrebnadzor not fulfill its direct responsibilities when a number of dietary supplements containing a medical formula are sold, and no measures are taken to remove these drugs from sale?” – asks Sergei Kalashnikov. “Rospotrebnadzor must, by law, impose fines on the manufacturers of these dietary supplements by applying the Code of Administrative Offenses and, of course, prohibit their sale. This is an amazing inaction of Rospotrebnadzor, if not criminal,” he concludes.

The slowness of Rospotrebnadzor in resolving this issue raises the question of whether the once all-powerful agency can protect Russian citizens today. Well, increasingly louder accusations of criminal inaction are often separated from more serious accusations of corruption by just one step.

What will be the incentive for the department under the leadership of Anna Popova to finally apply its own methodology, make an official verdict and put an end to this scandal? Maybe a meeting with the president?

The drugs Sealex Forte and Ali Caps are being withdrawn from circulation

The Federal Service for Supervision of Consumer Rights Protection (Rospotrebnadzor) has banned the sale in Russia of two dietary supplements allegedly intended to strengthen male potency.

As reported on the department's website, on April 26, the Committee for the Protection of Consumer Rights of the Ministry of National Economy of Kazakhstan revoked the state registration of biologically active food additives Sealex Forte and Ali Caps produced by the Russian company LLC "VIS".

Previously, information was received from Belarus and Armenia, as well as from the Moscow department of the Investigative Committee of the Russian Federation, about the identification of individual batches of falsified dietary supplements on sale. They contained the pharmaceutical substance tadalafil, which was not declared during state registration.

“In order to exclude falsified dietary supplements for food from circulation on the territory of the Russian Federation, instructions were given to the territorial bodies of Rospotrebnadzor to strengthen supervision over the production and circulation of dietary supplements for food and to take appropriate measures to stop the sale and withdraw these falsified products from circulation,” noted Rospotrebnadzor .

The president of the RIA Panda company, which produces these supplements, Dmitry Dergachev, told Kommersant that the company learned about the revocation of registration of the drugs the day before from its distributors in Kazakhstan.

“We have not received official notifications, they were not provided upon request, and we have not yet been informed about the seizure of products from pharmacies,” Dergachev said.

He expressed confidence that this situation is a continuation of the competitive war, since the leadership of the Committee for the Protection of Consumer Rights resigned immediately after the revocation of the registration of dietary supplements RIA "Panda" and the products were never produced under the registration certificate numbers indicated by Kazakh specialists.

Some Russian pharmacies no longer sell Sealex and Ali Caps. According to Kommersant's source in the pharmaceutical market, at the beginning of 2015, the manufacturer of Sealex and Ali Caps tried to register these drugs as medicines and submitted an application to Roszdravnadzor. According to DSM Group, Sealex and Ali Caps are among the top 10 dietary supplements in terms of pharmacy sales in Russia (in March, the volume of the entire supplement market exceeded 2.7 billion rubles). In February of this year, Sealex even topped this rating, occupying 2.79% of the market in monetary terms.

Tadalafil is a medication intended to treat erectile dysfunction, that is, the inability to achieve and maintain an erection necessary for sexual intercourse. In Russia, it is a prescription drug not intended for free sale.

In Russia, a recall has begun from pharmacies of two popular dietary supplements (dietary supplements) for increasing potency - Sealex Forte (1–3 places in sales in the Russian Federation) and Ali Caps (7–8 places). The basis was the order of Rospotrebnadzor, in turn, provoked by the revocation of registration of these drugs... by the Committee for the Protection of Consumer Rights of the Ministry of National Economy of Kazakhstan. These are the features of the economy of the Customs Union.

Let's try to figure out what happened and why popular dietary supplements suddenly became prohibited.

Hidden danger

The Union of Professional Pharmaceutical Organizations (Evalar, KRKA, etc.) back in 2015 began a “hunt” for dietary supplements to combat erectile dysfunction - in September a criminal case was opened regarding the falsification of dietary supplements in Sealex and Ali Caps " It is interesting that the union carried out the relevant examination independently, on its own initiative.

The reason for the claims was the discovery in some batches of Sealex Forte and Ali Capsa of the substance tadalafil, which was not specified in the description of the drug. The manufacturer called these batches fake - we don’t presume to judge, but it is possible that one of the competitors actually released a similar batch for the purpose of provocation. And tadalafil, by the way, can lead to a heart attack, doctors say, not always adding that absolutely all means to strengthen potency, that is, to increase blood flow to a certain organ, are an external and undesirable effect on the cardiovascular system.

Tadalafil is a legal substance approved in Russia, which, however, is not actually included in the declared composition of the dietary supplements Sealex and Ali Caps. Medicines containing tadalafil are considered medications and are sold only with a doctor's prescription. It must be said that the manufacturer - St. Petersburg LLC VIS - really tried to register its drugs as medicines, and, according to market cleanliness fighters, this is evidence of the use of tadalafil in dietary supplements.

According to the laws of a detective

At the same time, pressure from social activists began from below. The Altai regional public organization “Center for the Protection of Consumer Rights” filed a lawsuit against the manufacturer of additives, St. Petersburg LLC “VIS”, in order to ban dietary supplements. Probably, Altai social activists have already solved all the other problems of the region, which is why they had to pay attention to the St. Petersburg erection.

After the Altai initiative, the story took on a detective flavor. Based on the lawsuit and the discovery of the presence of tadalafil, Rospotrebnadzor published a letter calling for the withdrawal of Sealex and Ali Caps from sale. And on April 5, “in one of the Barnaul cafes,” a resident of Novosibirsk, not named by the investigation, allegedly handed over 2 million rubles to the head of the Altai consumer rights defenders in exchange for withdrawing the statement of claim against the St. Petersburg company! The thief was detained and released on his own recognizance.

It’s funny that this story was most actively covered by the media of the Siberian Media Group, owned by... the Evalar company. Well, the sales volume in the country of dietary supplements to increase potency is about 10 billion rubles a year, and the fight for this market is being waged by all means.

It will be even funnier if it turns out that the Kazakhstan revocation of registration, which became the basis for the active actions of Rospotrebnadzor, has no legal force at all: the manufacturer claims that these products were never produced under the numbers of the revoked documents.

However, another partner in the Customs Union - Belarusian consumer rights defenders - banned these funds on March 3, 2016, without even waiting for the decision of the Kazakh registrars. At the same time, there are no cases of harm to health from the use of these dietary supplements proven in court. However, such cases are generally reluctant to be considered due to difficulties in establishing the true causes of deterioration in health.

In war as in war

Tadalafil is a cheap and cheerful drug, the effectiveness of which is not in doubt, as well as possible side effects. It is entirely possible that the manufacturer actually added it to its dietary supplements, thereby violating Russian laws. Dietary supplements became more effective, sales grew, but since buyers did not know about the presence of tadalafil, they could not take into account possible negative consequences. When the truth was revealed, the manufacturer, through the “Novosibirsk anonymous person,” tried to “resolve the issue” amicably, as is customary everywhere in Russia, but underestimated the puppeteers of the process.

At the same time, the form of pressure from the puppeteers on the manufacturer, the courts and Rospotrebnadzor - all this leaves no doubt that we are facing the displacement of a popular product from the pharmacological market, inspired by the largest competitors. Well, dangerous dietary supplements have been recalled, now it’s up to the investigation and the judicial system. If there are no arrests for the falsification of dietary supplements, we can say with confidence that the whole story is a provocation from beginning to end.

And then it will be necessary to judge completely different people.

Between the May holidays, it became known that Rospotrebnadzor began to withdraw from circulation the dietary supplements Sealex Forte and Ali Caps, intended to strengthen male potency. The reason is the allegedly detected content of the substance tadalafil in the drugs. This substance was not indicated when registering dietary supplements, so they were considered counterfeit.

Previously, another dietary supplement for men had the same fate - “Tongkat ali platinum” and “Tongkat ali platinum forte”, in which the pharmaceutical substance tadalafil was also allegedly discovered. As a result, Rospotrebnadzor banned state registration of these additives.

The main complaint about the drugs is the presence of an active substance that was not declared during registration, since there is nothing dangerous in tadalafil itself - it is contained in almost all dietary supplements for increasing a man’s sexual performance.

Thus, at the end of April 2015, the Association of Manufacturers of Biologically Active Food Additives (SRO NPP BAD), together with the Union of Professional Pharmaceutical Organizations and the Pharmacy Guild, made a test purchase and examined dietary supplements advertised as natural potency stimulants. For analysis, samples of six brands included in the top 10 in terms of sales volumes in Russia in 2014 were selected. The results of laboratory examination showed that they contained undeclared synthetic components of prescription drugs, and in the vast majority of cases it was tadalafil.

Why is it needed?

The substance tadalafil was developed for the treatment of erectile dysfunction by the pharmaceutical company Icos Corporation, which was subsequently absorbed by the American corporation Eli Lilly. The drug entered the market under the brand name “Cialis” and became one of the main competitors of the famous “Viagra” from the pharmaceutical giant Pfizer. Another medicine for potency - Levitra - was invented by another representative of Big Pharma, the Bayer company. All these drugs have one purpose - increasing potency, although the active ingredients in the drugs are different (sildenafil and vardenafil).

Tadalafil is distinguished by its duration of action; the desired effect is achieved due to the substance’s ability to relax muscles and increase blood flow in the reproductive organs for almost 36 hours. For this reason, the drug has become widespread among the male population of different countries, including Russia. Today, the tablets are freely sold in almost all pharmacies in the country.

Recently, dietary supplements with a similar effect have been gaining popularity. Thus, according to the DSM Group, in 2014, the top 7 best-selling dietary supplements in Russia included three drugs for improving potency: Sealex, Ali Caps and Tongkat - they accounted for 11.5 percent of all-Russian sales of dietary supplements .

According to the head of the SRO NPP NPP Dietary Supplements Leonid Maryanovsky, the volume of the market for dietary supplements for potency is approximately five billion rubles per year. In March alone, according to the marketing agency DSM Group, which specializes in monitoring the pharmaceutical sectors, Russians bought 968 thousand packs of Sealex Forte, 31 thousand packs of Ali Caps, 13 thousand packs of Vuka-Vuka, eight thousand packs of Lovelace. .

And with such huge sales, there have been no complaints about the effects of these supplements. Rospotrebnadzor became interested in the drugs only after contacting... SRO NPP BAA - a kind of trade union of manufacturers of dietary supplements (read more about this in the publication). According to representatives of this organization, the drug tadalafil, if taken uncontrolled, can cause cardiac arrest, and therefore should be sold with a doctor's prescription. Interestingly, Cialis itself, as well as Viagra and Levitra, can be easily purchased without a prescription. Moreover, the manufacturer of Cialis itself - the Eli Lilly company - several years ago announced plans to make the drug over-the-counter.

The effect of tadalafil on human health is small, Doctor of Medical Sciences Veniamin Kurchiashvili told Lenta.ru: “Like any medicine, this pharmaceutical substance has side effects, but there are not many of them - for example, it can be headaches and back pain.” His words are confirmed by a study by Russian scientists published in 2011 in the Russian Medical Journal. According to its results, tadalafil effectively fights impotence and has few side effects. 268 men took part in the experiment. “The study did not identify any serious side effects,” the study said. The most common were dyspepsia (disturbances in the functioning of the stomach), headache, lower back pain, “flu-like symptoms,” arterial hypertension (increased blood pressure), nasopharyngitis (inflammation of the mucous membrane of the throat and nose). There was no talk of any cardiac arrest.

“Even if synthetic tadalafil was found in dietary supplements along with substances of plant origin, from a safety point of view there can be no questions,” says Elena Lesiovskaya, professor of the department of organization and management in the field of drug circulation at Sechenov First Moscow State Medical University.

According to her, the entire group of drugs for erectile dysfunction and the corresponding dietary supplements deserve attention not for their side effects. They are often used by men over 45 years of age, who may have problems with the cardiovascular system, and excessive use of stimulants in this case can have a negative effect. However, Elena Lesiovskaya believes that the patient himself should be responsible for the use of drugs that are not vital. “In addition, as we see from statistics, consumers themselves have been voting for the quality of dietary supplements for many years, as their sales have been growing,” says Lesiovskaya. “It is unlikely that men would continue to use substances that had no effect or caused discomfort.”

Photo: Evgeny Pavlenko / Kommersant

From whom is the demand?

According to various sources, the capacity of the Russian market for drugs for erectile dysfunction is 12-13 billion rubles per year, of which the corresponding dietary supplements today account for six to seven billion rubles. And, according to experts interviewed by Lenta.ru, the ban on the use of known substances in dietary supplements is caused solely by economic reasons.

“Dietary supplements have been declared counterfeit, and a whole system of attacks on specific companies is based on this,” says Lesiovskaya. Veniamin Kurchiashvili also agrees with her - in his opinion, behind all this hype are pharmaceutical giants who have colossal resources, both financial and administrative.

The manufacturer of the disgraced Sealex Forte and Ali Capsa, President of RIA Panda Dmitry Dergachev, is of the same opinion and claims that they are being forced out of the pharmacy market during a competitive war. After all, a pack of Sealex (four capsules) costs less than one Cialis tablet. This version is also supported by the role of SRO NPP BAA, which is so noticeable in this whole story. As Evgeniy Feshter, the founder of Teskom Pharma (a former supplier of the also banned drug Tongkat Ali Platinum), said in a March interview with Lenta.ru, the SRO, little known a few years ago, became more active in 2015, after Pfizer became one of its founders. (there is also another market player in the ranks of the partnership - Bayer).

Since then, the SRO has begun to flood the State Duma and the Investigative Committee with letters demanding a ban on dietary supplements. Perhaps this is a coincidence. As Lenta.ru has already written, Pfizer annually receives about two billion dollars from sales of the drug Viagra, but its position on the Russian market is weakening every year: if in 2010 the turnover of Viagra in our country was 2. 7 billion rubles, then in 2015 - 2.3 billion. In packaging, the drop is even more noticeable: in 2010, 3.85 million units were sold, and in 2015 - only 1.96 million (data from the DSM Group marketing agency, specializing in monitoring the pharmaceutical sectors).

The patent for the production of Viagra from the American giant expires in 2019, and the patent for Cialis will expire in 2017. This means that there is not much time left to skim off the cream, and a place in the sun is expensive - billions of rubles annually, which Russian men are willing to pay.