Check the authenticity of the medicine by series online. Current list of low-quality drugs

Poor quality and counterfeit drugs can cause Substandard and falsified medical products harm patients and fail to treat the conditions for which they were intended. For example, due to counterfeiting of antimalarial drugs, The counterfeit anti-malarial is a crime against humanity: a systematic review of the scientific evidence almost 450,000 deaths every year.

According to WHO, the total share of low-quality and falsified medical products in countries with middle and low level income is Study of health, sanitary and economic damage of substandard and falsified medical products about 10.5%.

Confiscated in Russia in 2018 Information on the results of state control (supervision) in the field
circulation of medicines for 2018 752 series of medicines were out of circulation, the properties of which did not meet the established requirements.

What are quality medicines?

Quality medical supplies defines Federal Law 61 “On the Circulation of Medicines” and the ICH Q9 guideline “Quality Risk Management”.

Here are the criteria that the medicine must meet:

• Compliance pharmacopoeial monograph- a document that specifies quality standards.
• Safety - the medicine should not cause harm.
• Efficiency - a positive effect on the course of the disease.
• The purity of the drug is the absence of foreign contaminants.
• Identification - fitness for purpose, batch number, unexpired expiration date.

High-quality medicines are produced in accordance with the GMP (good manufacturing practice) standard and the requirements of the registration dossier.

What could be obvious signs of a fake?

Sometimes counterfeits are very well disguised and it is quite difficult to distinguish them from quality drugs. But according to some signs it is still possible 5 Tips on How to Identify Fake Drugs do.

Here's what should alert you:

• Unusual font that catches your eye, spelling errors.
• The batch numbers, expiration dates and manufacturer's address on the primary and secondary packaging do not match.
• The manufacturer's address is not indicated - only the country and city.
• The packaging is of poor quality - there are damages, tears, chips, the text is poorly printed.
• The tablets are damaged - crumble, cracks or stains are visible on them.
• There is powder or pieces of tablets at the bottom of the box or container.
• The patterns on the tablets are different or look sloppy. For example, on some lines the lines are visible well, on others they are poorly visible.

If you suspect that the drug is counterfeit, call pharmaceutical company, whose telephone number is indicated in the instructions or on the packaging. Conscientious manufacturers are always ready to confirm the authenticity of the medicine using the batch number.

Do I need to look at the composition?

Yes, if you want to make sure that the drug is safe.

You need to look at the composition for three reasons:

1. To make sure that it does not contain substances to which you are allergic.
2. To avoid buying drugs with the same active ingredients. Taking multiple medications that have the same active ingredient will result in too much of the substance in your body. This is bad Medicines: Common Questions Answered affects health.
3. To know what you will be treated with. Unfamiliar ingredients should be treated with caution. It is recommended to consult a doctor before taking any medications.

How to check the reliability of the manufacturer?

You can check how legal the activities of a pharmaceutical manufacturer are on the website of the Ministry of Industry and Trade - there is a register of licenses for the production of medicines.

Open the “Activities” section and then the “Government Services” tab. Among the list of services, find “Licensing of the production of medicines”, an information window will appear on the right, go to the “Registers” tab. Next you will see a link to the “Register of licenses for the production of medicines”. By clicking on it, you can download a table with the names of all licensees, in which you can find the pharmaceutical company you are interested in.

Ministry of Industry and Trade - register of licenses

How do manufacturers control quality?

Quality control takes place in several stages. Let's look at them using the example of the Hemofarm and Nizhpharm production sites, which was the first in Russia to introduce international GMP standards to them.

How to choose a medicine among analogues?

First, check with your doctor which drug is more effective and best suits you.

Secondly, there are several nuances that you can figure out yourself.

1. Prices for the same drugs may vary in different pharmacies. To choose the most suitable option, go to the websites of the nearest pharmacies, find the right remedy in the catalog through a search and compare where the cost is lower.
2. On the websites of some manufacturers, you can search for medications in partner pharmacies and choose the best option for yourself based on price. For example, the STADA company has it.
3. Some drugs differ in price only because there are more tablets in the package. Don't forget to check this point with your pharmacist.
4. Drugs with different international nonproprietary names ( unique name active substance medicine) may vary in price. Check with your doctor which option is best for you.

What to do if you don’t know what medicine you need?

Go to the doctor. If something hurts you and you have no idea how to treat it, do not try to find your own medicine. And here's why:

• You don't know the exact cause of the pain. Let's say your right side is bothering you. This is understandable. But what exactly hurts there? Liver, gallbladder, appendicitis?
• You don't know which ones active substances are the safest and most effective for your illness.
• The wrong treatment can harm you.

Do not use unfamiliar medications without a doctor's prescription.

I prepared this reminder for myself back in the fall, and decided to publish it after the post. poletta o using a false certificate. Perhaps it will be useful to someone.

How to check the authenticity of Herceptin from Roche/Ortat

First, there is a certificate at the pharmacy. Pharmacies are required to issue a certificate at the request of the buyer, and the law sets a period within which the pharmacy is obliged to do this (if my memory serves me, a maximum of three days). If the pharmacy refuses to do this or they answer: we’ll bring it in 2 weeks (and there have been such cases) - know that this is at least suspicious, and most likely not legal (I haven’t dug deeper into this topic, so there will be no link to the law). The pharmacy must either have a copy of the certificate or declaration of conformity, or the administration prepares the documents within several hours (this was the maximum period in a normal pharmacy). But often pharmacies themselves issue documents when purchasing an expensive medicine.

For convenience, I requested the data by phone, you can ask for it to be sent by mail, but then everything is double-checked when purchasing. If you check at a pharmacy, it is convenient to open links to sites on your phone in advance from the post below, so as not to slow down during check.

So, to check we need: drug series , certificate number and registration date , in some cases they issue a declaration of conformity, which also contains useful information.

In the case of Herceptin, which is sold in the Russian Federation, we get:

• Herceptin Ortate
• Series №3715/3 (the series number may contain letters, in which case you must remember that this is Cyrillic)
• Certificate No. ROSS RU.FM08.A02755
• Certificate registration date: dd.mm.yyyy

What can you do with this information?

1. Check the drug series on the Roszdravnadzor website . The website has two sections: Medicines on sale and withdrawn medicines. This information will allow you to see when a given batch of medicine began to be sold or when it was withdrawn from sale (if it was withdrawn, of course).
2. Check certificate on the Pharmtechexpert website. Pharmtechexpert is a company that certifies Herceptin from Ortat/Roche; its name is indicated in the certificate. If you are testing another medicine, then most likely another company will certify it, and accordingly the website address will be different. The verification occurs based on the certificate number and the date of issue; if you do not enter the date or enter it with an error, the certificate will not pass verification.
3. Call Ortat for production (in the Kostroma region) and clarify what the actual packaging should look like for a given batch of goods . The last point appeared after a conversation with an employee hotline. I asked, isn’t it easy to fake a certificate? It’s just a piece of paper, and it’s easy to find out the attributes of a batch of medicine. The employee confirmed the concerns and suggested additional method. As I understand it, the company changes something in the packaging from time to time, or when the medicine is counterfeited, it is not possible to copy it exactly appearance packaging. Such changes may not be noticeable to the average buyer, but the manufacturer can tell you what to look for. In general, I never got to the last point, so I can’t evaluate the practicality of this advice.

I realized for myself that you need to buy expensive medicine from a pharmacy or a supplier you trust.

An experiment on drug labeling began in six regions of the country on February 1. Following fur coats and alcohol, medicines will also have their own “black mark”. However, the mark is not completely black: the DataMatrix marking looks like a drawn labyrinth (see photo on the first page), it will be applied using a special printer to each package, complementing the existing barcode. The “pilot” will start with several types of medicines, and over time they will “tag” all the medicines produced in a row. Why is this necessary? What will it give to buyers? And, in the end, how much will it cost and will the drugs become more expensive?

IN Kaluga region In the Vorsino industrial park there is a modern pharmaceutical plant: several dozen types of tablets are produced and packaged here. Packs of tablets packaged in blisters run along the conveyor belt. Here is a printer that can “draw” a labyrinth of the required configuration in a split second.

“We support the idea of ​​​​introducing markings, so we decided to enter the experiment without delay,” said production director Gennady Pyatsky. “Although the government decree has already entered into force, there are no precise instructions on the marking technology, and it is also not clear what data will be encoded in it. The product identifier, serial number and batch number, expiration date - this is a minimum. The system is flexible, it can “fit” a lot of information until the summer. Our equipment allows you to apply DataMatrix, because everything. Our factories - both in Europe and in Russia - are built according to the same standards and equipped in the same way. And in Europe they have been introducing such markings since 2010.” According to Pyatsky, if labeling rules similar to European ones are introduced on the Russian pharmaceutical market, the process here can go quite quickly and painlessly.

Why was it decided to choose a special two-dimensional DataMatrix code for marking? Firstly, this is not an expensive technology (according to calculations, the cost of one package of medicine will increase by 1-1.5 rubles, or, if we talk about drugs in the middle price segment, by only 1%). On the other hand, such identification will make it possible to automatically identify substandard and counterfeit medicines. Finally, thirdly, such labeling has already been introduced in European countries, Turkey, the USA, India, and Brazil. It is also being implemented in Ukraine - so a unified type of drug identification will help different countries unite and better fight counterfeiting together. “In EU countries such marking is already mandatory; in any case, we print a two-dimensional code on all our products,” says Pyatsky.

“Labelling contains undoubted advantages for business,” says Dmitry Bagley, a specialist in marking technologies. “It will not only reduce the losses of bona fide manufacturers and sellers from counterfeit goods, but will also improve logistics, since it will be possible to quickly track the movement of goods.”

It is clear that special equipment will be needed to apply the markings. Equipping one production line, according to Dmitry Bagley, will cost pharmaceutical companies from 30 to 150 thousand euros. But the investments are long-term, and besides, thanks to labeling, manufacturers will reduce image losses from the sale of “fraudulent” drugs.

"Imagine: a person buys medicine for specific manufacturer, and inside there is a “dummy” that does not heal. But the patient does not know that he bought a counterfeit product and transfers all the negativity to the pharmaceutical company indicated on the label,” explained Gennady Pyatsky. “Therefore, all companies are interested in ensuring that if a fake or counterfeit is discovered, this batch is withdrawn from sale immediately. A barcode does not provide such efficiency, but DataMatrix does. You lean the scanner against the stamp and in a second you get an answer: is a particular pack of medicine legal or not.”

It is interesting that not only specialists - distributors, pharmacists - will be able to arrange such a “falsity” check. In the pharmacy there will be special scanners for each seller, and also publicly available in the sales area for customers. So anyone can verify the legality of the purchased medicine using such a scanner. Moreover, it will be possible to “read” the markings using a regular smartphone if you install a special application on it.

How much will DataMatrix cost the buyer?

The biggest concern is how the introduction of labeling will affect the price of the medicine. It’s one thing to mark a fur coat worth several tens or even hundreds of thousands of rubles, and quite another thing when we're talking about about a socially significant product.

However, the experts interviewed by RG do not see a serious price threat in the innovation. “It is difficult to talk about the rise in prices of drugs due to labeling, since this percentage will vary for different drugs. We can only talk about the costs of applying labeling to packaging, this is about 1.5 rubles without taking into account the costs of informatization and equipment necessary for the operation of the system at distributors and pharmacies,” says Sergei Shulyak, CEO of DSM Group.

The head of the Pharmacy Guild, Elena Nevolina, agrees with the expert. The cost of a scanner for a pharmacy is approximately 20 thousand rubles, the investment is feasible, and will not seriously affect the cost of medicines. “Of course, several scanners will be needed, but I think, since the program is state-owned, pharmacies will be helped with re-equipment,” Nevolina suggested. She recalled that from July 1, all pharmacies, like other enterprises retail, switch to using new cash registers equipped with scanners to record trade turnover in the Federal Tax Service. “It is important that the equipment is compatible. If you have to work with two different scanners, there is a risk of errors,” the expert believes.

Help "RG"

Participation in the experiment was announced by: Moscow and the Moscow region, St. Petersburg, Nizhny Novgorod, Novgorod, Belgorod regions. The “pilot” included 23 pharmaceutical manufacturers, large distribution companies, over 30 hospitals and clinics and more than 250 pharmacies, including large chains.

By June we have to launch the entire technological chain: install equipment and software, train specialists. And as we are ready to cover more and more names of drugs with labeling.

If the experiment justifies itself and the labeling covers all manufactured medicines, in a year the monitoring system will track about 6 billion packages of medicines and cover more than 350 thousand participants in the circulation, including about 1000 domestic and foreign drug manufacturers, over 100 thousand hospitals and 250 thousand pharmacies

Counterfeit drugs in best case scenario They simply will not bring any benefit; at worst, they can cause irreparable harm to health, even death. Medicines in pharmacies are checked for quality by the relevant regulatory authorities, but they are only able to cover about 20% of medicines. We will tell you in our article how to buy medicine at a pharmacy without counterfeiting.

Types of counterfeit medicines

There are 4 main types of counterfeit drugs in our pharmacies:

• “Dummy” - drugs that do not contain the substances specified in the instructions. Usually chalk, flour, starch, and sugar are used instead. In principle, pacifiers are safe, but only until recovery depends on their use;

• medicines in which more expensive and effective ingredients are replaced with less effective cheap analogues. The result from using such drugs is several times lower than expected;

• with a reduced dosage of active ingredients. The positive effect of their use is negligible;

• manufactured in violation of technology. The composition and dosage of such medications are kept within normal limits, but the quality is quite poor due to non-compliance with the production regime. Such medications may have a shorter shelf life than indicated on the package or may have a weak effect.

Another case of “wrong” drugs that cannot be classified as counterfeit, but from which people suffer, is drug substitution. For example, instead of pills that lower blood pressure, the blister may contain pills that increase it.

For more information about counterfeit medicines, watch the video:

What drugs are counterfeited most often?

In most cases, drugs are counterfeited:

• whose cost is in the price range from $4 to $35. There is no point in making very cheap ones, since their production simply may not pay off, and producing counterfeits of expensive drugs is unprofitable, since consumer demand for them is low;

• actively advertised. Advertising stimulates demand and guarantees high level sales and profits.

In most cases, the following are fake medicines in pharmacies:

Methods for identifying counterfeit drugs

Alas, there is no method that would allow us to select original pharmaceutical products and weed out counterfeit products with 100% probability. However, there are a number of rules that, if followed, will significantly reduce the chances of buying fake medicines in pharmacies.

According to the law, in Ukraine and the Russian Federation, medications cannot be returned. However, you can return a low-quality medicine, but you will have to provide an expert opinion proving that you were sold a counterfeit drug. In Ukraine laboratory tests will have to be done at your own expense, and in Russia such a service is provided only legal entities. So it is unlikely that you will be able to defend your right. Therefore, it is better to try to prevent this by checking medications in pharmacies before purchasing.

The pharmaceutical market is, first of all, sales. But here we have a specific product – medicines, which are extremely important for maintaining health and even preserving life. Their cost can reach tens of thousands of rubles or more, so counterfeiting medicines is an extremely profitable, but illegal, activity. It is worth noting that thanks to the coordinated work of various government agencies, counterfeit medicines are becoming less and less every year. However, they have not yet completely left the domestic market and continue to be found in pharmacies throughout Russia. Therefore, it is extremely important to know how to independently check the authenticity of a medicine and where to go if a counterfeit is detected.

Manufacturing counterfeit medicines is a double crime. It is clear that the goal of scammers is to illegally obtain quick and large profits. But at the same time, they endanger the health of thousands of people who expect good things from the medicine. therapeutic effect. But it does not heal (this is at best). It turns out that a person is throwing away considerable sums of money, but his health is not improving at all.

Frauds are detected more often than others antibacterial drugs, hormonal drugs, painkillers, medicines for the stomach and intestines. Previously, cases of counterfeiting of drugs produced by the pharmaceutical companies Aventis, Biosintez, Biokhimik, Doctor Reddis, ICN Tomsk Chemical Plant, KRKA, Novartis, Moskhimfarmpreparaty, Pliva, "Farmadon", "Ebeve", "Egis", "Jansen" and others.

The path of a medicine to our medicine cabinet begins from the place of its production - a pharmaceutical plant or factory. Here not only drugs are produced and packaged, but also production control of the finished drug for stability dosage form, concentration of the active substance, etc. Only after internal control are drugs shipped in batches to large and small suppliers.

The latter not only accept thousands of packages medicines and dietary supplements, but also in mandatory receive accompanying documentation for medications – Declaration of Conformity. Only after this can suppliers send drugs to pharmacies and pharmacy points, which sell the drugs to the final consumer - the patient. If necessary, employees Roszdravnadzor (Federal service for supervision in the field of healthcare) can check the quality of drugs at any stage of their delivery to the patient.

As we see, at every stage from the manufacturer to the patient, drugs undergo internal and external quality control. However, this does not prevent attackers from continuing to counterfeit medicines.

The government is working on the issue of special labeling of drugs (like alcohol or fur coats), with the help of which the authenticity of a drug can be determined in just a couple of minutes. You just need to scan the special sticker code on the packaging with your smartphone and you will immediately understand whether the medicine in front of you is real or counterfeit. Now in some regions of Russia, such marking has already been launched as a pilot test project. What will happen next - time will tell. However, it should be clearly understood that additional methods protection in the form of such labeling will certainly lead to an increase in the price of medicines (according to legislators, on average by only 1-1.5 rubles). On the other hand, patients will receive only high-quality and effective drugs.

Typically, the patient begins to think about the originality of the drug only in the absence of the proper therapeutic effect or when uncharacteristic symptoms appear. adverse reactions. However, on therapeutic effect drug and appearance side effects may also influence:

1. Incorrect diagnosis and incorrectly prescribed treatment.
2. Violations of the rules for storing and transporting the drug.
3. Failure to comply with the recommended method of use and therapeutic dosage of the drug.

If we omit all these points, then after ineffective treatment, suspicions about a counterfeit medicine are quite natural. So How to identify counterfeit medications?

1. Before or immediately after purchase, carefully look at the packaging of the drug, evaluate its integrity and quality. Look closely at the font of all letters and check the words for errors. You won’t believe it, but attackers quite often make spelling mistakes in the instructions for use and even on the packaging of the drug!
2. If you suspect a counterfeit, you have every right to familiarize yourself with the documentation confirming the quality of the drug - the delivery note from the supplier and the Declaration of Conformity for this batch. IN pharmacy organizations The invoice must be kept, and the Declaration is sent by the supplier after a corresponding request. Based on the submitted documents, you will be able to evaluate the originality of the drug.
3. If you have any doubts, you should contact the manufacturer of the drug or the person responsible for receiving claims. Manufacturers always indicate their contact information at the end of the instructions and sometimes on the packaging of the medicine. The manufacturer, more than anyone else, is interested in ensuring that patients receive high-quality treatment with real medicine.

Check medicine online

You can check the authenticity of the medicine using the barcode. To do this, look at the first 2-3 digits of the code and make sure that the country of origin matches the information on the packaging. It is important to note that such a check does not guarantee the authenticity of the drug, since fraudsters can indicate the barcode original drug. However, such a check will not be superfluous.

Barcode codes for different countries

The second step is checking the authenticity of the medicine by serial number. To do this, you need to go to the Register of Medicines Withdrawn from Circulation, which is maintained by Roszdravnadzor on the basis of daily inspection of certain batches of drugs.

To perform a search, click on the button "Advanced Search", fill in the fields TN(trade name) and Series. This will be enough for the system to operate correctly. Next, click the button "Display results". As a result, we can get one of two results:

1. “Data missing” means that according to this drug or there are no restrictions on this series of the drug. Roszdravnadzor did not find any violations in the medicine.
2. A list appears with the name of the drug - carefully read the attached information letter, check the series again. If you have a drug in your hands, the circulation of which must be stopped, then you must stop taking it.

Perhaps these are all the measures that the average person can take to check the quality of drugs. Next, professionals must step in. A more detailed analysis of drugs is carried out by Roszdravnadzor based on laboratory and visual studies of a batch of drugs. Based on the results of such a check, certain drug names may be recalled.

What to do if a fake is detected?

If a low-quality medicinal product is detected, you should:

1. Contact the pharmacy with the receipt and the drug package itself for a refund. We recommend that you take with you the information letter about the recall of this series of medicines, which Roszdravnadzor posts on its website.
2. If there is no such letter yet, and the drug is clearly counterfeit, then you need to contact expert services - the Ministry of Health of the region and Roszdravnadzor, which initiate an inspection on suspicion of a counterfeit drug. Upon completion, the executive authorities will notify the applicant about the results of the inspection and the measures taken.

How to avoid buying counterfeit medicine?

Everyone has their own methods of checking a medicine for originality...

Overall, be careful. Carefully study the packaging and instructions for use of the drug for errors, uncharacteristic defects, and inaccuracies. Check medications yourself, and if necessary, contact specialists. We hope that soon, thanks to the work of legislators, health officials and the responsibility of the population, counterfeit drugs will completely disappear from the pharmaceutical market.