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Myths and Facts about Generic Drugs 

MYTH Generics take longer to act in the body. 

FACT Generic drugs need to deliver the same amount of active ingredient in the same timeframe as the original product. 

MYTH Generics are not as potent as brand-name drugs. 

FACT Most of the regulatory bodies require generics to have the same quality, strength, purity, and stability as brand-name drugs. 

MYTH Generics are not as safe as brand-name drugs. 

FACT All drugs should be safe and effective and that their benefits should outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts. 

MYTH Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities. 

FACT Generic companies have facilities comparable to those of brand-name companies. Most often, brand-name companies make copies of their own or other brand-name drugs but sell them without the brand name. 

MYTH Generic drugs are likely to cause more side effects. 

FACT There is no evidence of this. Adverse drug reactions are monitored.

          Generic competition helps keep the cost of drugs down. It also encourages the research based drug companies to keep finding newer and better medicines that have patent protection 

What is Bio equivalence? 
      Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary to repeat such an extensive testing in human subjects for each and every generic drug which is to be marketed. 

       Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug. Bioequivalence is a means of comparing two products (branded and generic) to determine if they deliver same amount of drug into the body at the same rate. 

How is it done?
        One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption—or bioavailability—of the generic drug, which is then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the pioneer drug. 

Why is Bioequivalence important?
         Bioequivalence is important to ensure clinical efficacy. It also helps in ensuring therapeutic equivalence of the generics to the originators. The test needs to be conducted within 80% to 125% of reference and for ratios a 90% confidence interval testing is employed.