What is the difference between generic drugs and original drugs?
Surely you are faced with the fact that the medicine of the same action, with the same active substance is different, and the price may vary significantly. Pharmacies explain that one drug – the original, and the other, cheap – generics. Hence the difference in price.
What is the original drug?
A pharmaceutical company, developing a new medicine, is investing huge amounts of money in it. The whole process: from finding an effective formula to putting a drug on sale – takes about $ 2 billion and several years. It is necessary to develop the chemical composition of the drug, to identify its effectiveness, safety, allergenicity and other parameters, to minimize toxicity and side effects. For this, so-called preclinical studies of a new drug are constantly being conducted, during which the drug is tested on biological models and animals.
Then a new drug is undergoing serious clinical trials, first on healthy volunteers, then on a small group of patients, then on a large group of patients. And only if the new drug was effective, safe and meets all the requirements, it gets approval and can enter the market.
Research original drugs
This path is quite complicated: it must be said that out of 10 thousand new drugs, only one passes all tests.
In order for a developer company to return funds invested in a new medicine, it is patented and only the patent holder has the right to produce it. A patent is granted for an average period of 20 years. After that, other manufacturers can use the chemical formula of the drug, releasing their drugs, but under different names. But their drugs will be generics.
What is a generic?
A generic, in fact, is an analogue, a copy of the original drug, and uses the same active substance. It will be much cheaper, as the manufacturer does not bear the cost of developing the drug. True, generics are also undergoing clinical trials, but much less stringent. So, for example, in our country only bioequivalence of a generic is determined, that is, it should have the same therapeutic effect.
What is the difference?
Composition. In the generic can be used other auxiliary substances (fillers, stabilizers, dyes). And they can influence the effect of the active ingredient. Moreover, when registering a drug, their quality and toxicity are not taken into account. Even the content of the active substance in the generic may be different – according to Russian standards, this parameter allows a deviation of 5%, and on interaction with the body (absorption rate, start of action, removal from the body, etc.) – as much as 25%.
Production of drugs
Raw material Often, generic manufacturers use cheap low-quality raw materials (from China, India) to reduce the cost of the drug.
Technology. Generics can be produced by another technology, and it also determines the properties of the final product. In addition, we must bear in mind that the developers of drugs use the latest equipment that provides a high degree of purification of drugs. And small firms, producing generics, work on outdated equipment that does not allow to carefully observe all technological processes.
Generic – a cat in a bag
True, it is not necessary that all generics are much worse quality, less effective and unsafe. There are analogues that can easily replace the super expensive original drug, but how to determine whether this analog is good or bad. So it turns out that, not having the opportunity to purchase the original tool, we are actually buying a cat in a bag. And how he will act, one can only guess.
Of course, if it is a headache pill, cough syrup or a spray from a cold, then even from an ineffective generic there will be no particular harm. But after all, analogues are replaced by drugs, on which a person’s life sometimes depends. These are heart drugs, anticancer drugs, and insulins, which are vital for people with diabetes. And here the doctors are unanimous: if there is an opportunity, it is better to choose an original drug that guarantees safety and maximum therapeutic effect.