Generic drugs are defined as a counterpart to branded drug sharing the same ingredients, quality, strength, safety, dosage, etc. The only difference between the two lies in their price and structure. Generic drugs are identified by their chemical name. Once the patent on brand name drugs expires, other manufacturers or the original developer apply to produce a bioequivalent of the brand name drug and make it available to the public. Even though, there are many myths appear about generic drugs, the facts are very much different from that.
Myths and facts related to Generic Drugs:
- As per the myth, Generic drugs just don't do same job as brand-name drugs. But the fact is that to get approval it is must for the generic drugs to be bioequivalent to their branded products. It means that the generics must contain the same active ingredients and strength as branded product.
- As per the myth, there is a law that permits to ignore safety and effectiveness requirements for generic drugs while branded drugs fulfill these tests. But the fact is that Generic manufacturers have to perform their own tests to verify that the active ingredients in their products are safe and effective. But branded products have been already verified all the tests that's why there is no need to test all again. Generic drugs must go through scientific testing to prove that they work same as branded products do.
- As per the myth, Generic drugs are not as powerful as brand-name drugs. But the fact is that Generic drug manufacturers have to ensure that their products are of the same quality, strength, purity, and stability as the brand-name products.
- As per the myth, Generics take longer to act in the body. But the fact is that In seeking approval for their products, generic makers must submit evidence that their drugs delivers the same amount of active ingredient in the same time frame as the Branded product and also have same quality, strength, purity, and stability as the brand-name products.
- As per the myth, Generics products are made by less reliable manufacturers therefore these drugs are cheaper than branded drugs. But the fact is that many of the generic drugs approved and manufactured by companies that also make brand name drugs. The manufacturing process of all drugs is strictly regulated and the same standards are met by all manufacturers.
- As per the myth, Generics are not as safe as brand-name drugs. But the fact is that since generics use the same active ingredients as their brand-name counterparts and work the same way in the body, generics are as safe and effective as their brand-name equivalents.
- As per the myth, Brand-name manufacturers test new drugs in thousands of patients, but it lets generic firms get by with tests in only 20 to 30 healthy volunteers. But the fact is that Generic drugs are replicas of branded products which are already tested. So there is no need to test it on thousands of patients. Generic manufacturers need only prove that their drug reacts as same way in the body as the original version.
- As per the myth Generic manufacturers only have to prove that the active ingredients in their products get to the bloodstream. That doesn't mean that their products are used by the body in the same way. But the fact is that when the same amount of the active ingredients of the generic products gets into the bloodstream at the same rate as the brand-name products, there is no scientific reason to believe that the effects of the two drugs will differ.
- As per the myth, most drugs are tested by healthy young volunteers, yet 25 percent of all prescription drugs are taken by the elderly who don't respond the same to drugs. But the fact is that while the elderly may often absorb and process drugs differently than younger people, there is no proof that drugs will perform differently in them. Further, it isn't fair to force already weakened or disabled patients to give blood samples and face the other discomforts of bioequivalence testing. Further, such patients cannot be used in bioequivalence testing because they are virtually always taking other drugs concurrently.
- As per the myth, Brand-name drugs are made in new facilities, while generics drugs are often made in poor facilities. That's why, generics are usually inferior. But the fact is that it is the responsibility of related authorities who don't allow drugs which are manufactured in imperfect facilities. These authorities are also responsible to check quality of product. Generic firms have state-of-the-art plants that compare favorably with those of brand-name firms.
- As per the myth, Generic drugs have more negative side effects than brand-name drugs. But the fact is that any side effects that generic drugs have are similar to that of their brand name counterparts.
Therefore one shouldn’t always be carried away by the myths. Myths are always different from the facts as far as generic drugs are concerned. The most important fact regarding generic drugs is that they are alike and bioequivalent to branded products in safety, strength and dosage form. People can use them with total confidence. They are also chemically identical to their branded products and typically sold at substantial discounts from the branded price.
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