What are generics: affordable drugs or drugstore junk?

What are generics?

Generic (English generic, reproduced medicine) is a copy medicine that coincides with the original in terms of the amount of active substance and the effect on the body.

When a new drug is invented, it is researched and tested for a long time, and then a patent is issued. When a patent expires, other companies can also produce similar generic drugs. But in Russia, the rights of patent holders are often violated, and generics are registered and sold even before the patent for the original drug expires.

Do generics have complicated names?

Not necessary. Each drug has several names: chemical, international non-proprietary name (INN), and trade name.

A chemical name is an unpronounceable phrase that doesn't tell you anything. INN is a unique name for an active substance, which is approved by WHO and must be indicated on the packaging of the drug.

In addition, the drug manufacturer can assign a trade name to its product, which will be written on the package in large letters.

Example:

Chemical name: 2- (2- (2, 6-Dichlorophenylamino) phenyl) acetic acid (as sodium salt).
INN: diclofenac.
Trade names: Voltaren, Vourdon, Diklak, Dikloberl, Olfen, Ortofen and many others.

Why do people prefer generics?

Because they are much cheaper. Before patenting a new drug, manufacturers spend a lot of money on its development and testing, and this affects the final cost. The registration procedure for generics is much easier and faster. This explains their cheapness.

And no research is being done?

According to the law, for registration of a generic drug, instead of a report on one's own preclinical studies, one can provide an overview of scientific papers on the results of preclinical studies of a reproducible drug, and instead of a report on one's own clinical studies, a report on the results of bioequivalence studies of a reproduced drug.

Bioequivalence shows the extent and rate of absorption, the time to reach the maximum concentration in the blood, the distribution in tissues and body fluids, and the rate of excretion.

So studies proving the efficacy and safety of the new generic drug are still being conducted, but they are not as long-term and expensive as in the case of the original drug.

And are there many generics on the market?

According to the report of the analytical company DSM Group, in 2017 there were 86.2% of generics on the Russian market. And this is 0.5% more than in 2016.

What are generics: affordable drugs or drugstore junk?

20.1% of all sold generics are drugs that affect the digestive tract and metabolism, 14.2% are drugs for the treatment of diseases of the nervous system, 14.0% are drugs for the treatment of diseases of the cardiovascular system.

What about their effectiveness?

A 2012 study showed that out of four generics of simvastatin (drugs for lowering blood cholesterol), only two are fully consistent with the original in terms of safety and efficacy.

And in 2013, it turned out that due to the reduced effectiveness, generics can increase the duration of treatment or not give any result at all. On the other hand, if the dose of the medication is increased to speed up the treatment, negative effects can be caused.

It turns out to be a real lottery: some generics are as effective and safe as the originals, while others can prolong treatment and cause side effects.

Why generics might be less effective?

The effectiveness of the drug is influenced by many factors, including the degree of purification of the active substance and additional components that may contain generics. If a company buys a cheap active ingredient, the generic drug may not be effective enough. And additional ingredients can cause allergies or side effects.

How to distinguish a quality generic?

First of all, you can focus on the price. If the drug is very cheap, even compared to other generics, the manufacturer obviously saved something on something. For example, on the quality of the active substance or on the control during production.

Good indicator of product quality: pharmaceutical production has a GMP (Good Manufacturing Practice) certificate. If a company has such a certificate, it means that its products were manufactured under the required conditions (purity, temperature, humidity), excess substances do not get into the medicine, it is packaged properly and retains all its properties.

Should you use generics?

Considering the share of generics on the Russian market, we can say that we have all been treated with such drugs and there is nothing wrong with that. Generics make treatment affordable for anyone of any income and provide therapeutic benefits and relative safety.

When writing out a prescription, the doctor indicates the name of the active substance, so you can independently choose a specific generic or original drug (a list of original drugs and their generics can be found here). Often the doctor advises a proven generic, in which case it is better to use it. If the drug gives side effects, you need to consult your doctor: perhaps he will prescribe a more expensive generic or original drug.