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In United States of America , drugs are approved
by FDA. Whether it is a brand name drug or generic
drug, people have a notion that if some thing costs more,
its quality will also be better. But this is not true.
FDA on 'Generic drugs' misconceptions:
Generics are not as potent as original
drugs: FDA will only approve a drug if it meets the
standards put down by them. It should have the same quality,
purity and strength as Brand-name drugs. Only then can it
enter the consumer market.
Generics take a longer time to effect in the body: Any pharmaceutical selling a generic drug must show that its drug has all the active ingredients that the original drug carries. So, if the generic drug takes more time to act than the brand name drug, FDA will not approve it.
Generics are not as safe as Brand-name drugs: A generic drug is almost a replica of the original drug. So, it should carry the same risk-benefits as the brand name drug. FDA approves drugs, which follow the safety standards and have more benefits than risks.
Generics are made in sub standard facilities: FDA will not allow any drug-sale in the market if it is made in sub-standard qualities. It conducts about 3500 inspections a year in order to see if the firms are maintaining their standards. Most of the brand name drugs producing companies make the generic drugs of their original drug making it easier for FDA to check the quality.
Generics have more side effects: FDA has so far found no evidence on this.
FDA set of laws for Generics
- A Generic drug cannot be approved if it does not have
an FDA
approved brand name drug
- Generic drug should follow the same dosage as that of original drug
- Generic drug must be bio equivalent to the brand name drug
- The pharmaceutical must write down the drug's chemistry and quality control measures. Each step must be written in detail while giving it for FDA review
- FDA reviews the active and inactive ingredients in the Generic drug
- FDA reviews the labeling of drugs
- FDA keeps check of the drug's
quality after approval
The Orange book brought forth by FDA details all the therapeutic drugs including new and generic drugs. It is updated on a monthly basis. You can search a particular drug by its active ingredient, proprietary name, applicant holder or applicant number.
Additional clinical tests or examinations by the health care provider, is not needed when a generic product is substituted for a brand name product. It has already been checked and approved by FDA. You can use it without any skepticism.
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