Generic Drug, What is Generic Equivalent Drug?

What does mean Generic drug?

Generic drug is the bio-equivalent copy of its brand drug version. A pharmaceutical company file patent right application for the drug it has developed. Maximum time span during which patent holder company enjoys exclusive right to produce that drug is 20 years. After that patent expires and other company are legally allowed to produce its generic version with different name, taste, size, shape and color.

Are generics same to its brand in terms of effectiveness and safety?

Yes. Since generic drug is bio equivalent of its brand drug it produce same effects.

What does Bioequivalent mean?

The term bioequivalent refers to the drug which is.....
exactly same to its brand in.....

• Dosage
• Effects
• Strength
• Indications
• Working Mechanism
• Safety Precautions in manufacturing process
• Pharmacokinetics
• Manner to take (liquid, tablets, gel, injection etc)

different to its brand drug in....

• Name
• Shape
• Taste
• Color
• Size

Thus, bio-equivalency means generic drugs are to be taken in same manner to treat certain health condition, same in therapeutic effects, same in mechanism in body and equally safe to its brand.

What are FDA precautions to ensure safety?

• FDA experts are on frequent visit to ensure manufacturing plant meets the monographs.
• Generic drug producer company has to submit result of clinical trials to FDA panel to prove bio-equivalency of generic drug.
• Generic drug must get approval from FDA to get into market
• While on visit FDA experts determine purity and safety of raw materials.

Why generic drug is different in appearance and taste?

Appearance properties of brand drug is protected by intellectual property right. Rights of intellectual properties are also applicable in 148 countries as per TRIPs (Trade-Related aspects of Intellectual Property rights). Patent protection on formulation of brand drug expires after 15-20 years but intellectual properties protection remains forever. This makes a generic drug different in appearance and taste from brand drug.

What about safety of generics manufactured in foreign countries (India, china, Israel)?

There are two groups (PRMA: Pharmaceutical Research and Manufacturers of America and GPhA: Generic Pharmaceutical Association) that monitor both American and foreign drug manufacturing plants to ensure that drug-maker adhere safety precautions outlined by FDA. Inspection includes cross check of raw material suppliers.
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