How to distinguish fake from counterfeit?
The Federal Service for Supervision of Healthcare and Social Development of the Russian Federation (Roszdravnadzor) announced a number of rules that will help distinguish a fake medicine from a real one when buying. Experts advise first of all to pay attention to the quality of packaging, in particular, to the font and spelling.
If after examination there are doubts, it is necessary to require accompanying documentation for the medicine (declaration of conformity and invoice) at the pharmacy. Subsequently, by the number and date of the declaration, you can check on the website of Roszdravnadzor whether such a tool is actually registered.
Another option is to contact the manufacturer directly. The address and telephone number are usually indicated either on the packaging or in the instructions. Then, according to the source data, they will talk about the batch of the drug.
We must not forget about the territorial administration of Roszdravnadzor, where funds can be tested. In the event that testing shows a discrepancy in quality, a person has the right to sue to recover material and moral damage.
According to representatives of Roszdravnadzor, drugs that are in seasonal demand (for example, for flu) are usually faked. But more often all the same, it is not fake that is encountered, but poor-quality drugs. That is, they were stored incorrectly and there is damage.
In general, the department had to talk about the rules for identifying bad goods after the police seized a large shipment of fake antiviral drug Arbidol from Moscow pharmacies in early 2012.
The drug was produced in an underground workshop in the suburbs, and a native of Georgia was engaged in its marketing. The fake consisted mainly of ordinary starch and there were obvious spelling errors in the instructions for use.
The pharmaceutical business is considered the third most profitable after the arms and drug trade. This attracts dishonest entrepreneurs to him. In Russia, until 1991, the problem of falsification of drugs was practically absent. After the collapse of the USSR, and the resulting reduction in the production of own drugs and a sharp increase in imports, the problem became relevant. About a tenth of all drugs sold on the world market are fake or counterfeit.
1998 The first official case of detecting fake drugs in Russia is registered
2004 Introduction to the Russian legislation of the concept of “counterfeit medicines”
It is necessary to distinguish between falsification of drugs and counterfeit drugs. This is especially important in view of the total legal and pharmaceutical illiteracy, when all drugs produced with any violations are called “counterfeit”.
Counterfeiting is a conscious change in the formulation of a drug. Replacing expensive components with cheaper ones, or reducing the content (and in the worst case, completely lacking) of the necessary component of the drug. For example, replacing the more expensive cefazolin with cheaper (and less effective) penicillin. In addition, other violations during production are possible: violation of the time and sequence of the process, underestimation of the degree of purification, poor-quality packaging materials, etc.
Counterfeit medicines are medicines manufactured without the permission of the patent holder, the developer’s company.
The effectiveness of the drug is primarily determined by the active substance. According to international law, the formula or composition of the active substance cannot be the secret of the company. But this information for some time (about several years) is closed to other manufacturers, which even under a different name cannot produce this medicine without the permission of the patent holder.
Even at the end of the allotted time, other companies cannot use the name of the medicinal product (Brand) registered by the patent holder company (the so-called patented form).
Manufacturers of drugs have the temptation, knowing the formula, to release drugs bypassing the patent holder. An example is the No-Shpa drug (registered brand name). In fact, this is a fairly simple synthesized drug, the active substance of which has the generic name “drotaverine”. However, for several generations of people have used No-Shpo and do not know anything about some drotaverin. Accordingly, the price of a branded drug is 10 times higher than the price of drotaverin, which is exactly the same in composition, manufacturing technology and action. It is not surprising that in some factories that produce cheap domestic medicines during the day, the same medicines are packaged in foreign branded packages at night. It should be added that this usually does not affect the quality of the medicine, since the counterfeit manufacturer is afraid to raise even the slightest suspicion from the inspection authorities.