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What are generic drugs?
A generic drug is a copy that is identical to a brand-name drug in dosage, safety, strength, how it’s taken, quality, performance and intended use.
Are generic drugs as safe as brand-name drugs?
Yes. The Medicines Control Council (MCC) requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
Are generic drugs as strong as brand-name drugs?
Yes, the MCC requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
Do generics take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
Why are generic drugs less expensive?
Generic drugs are less expensive because they don't require the same investment cost required for the research and development of a new drug – which may total billions.
New drugs are developed under patent protection. The patent protects the investment – including research, development, marketing and promotion – by giving the company the sole right to sell the drug while the patent is in effect, in order to recoup the money they’ve invested in research.
As patents near expiration, other manufacturers can apply to the MCC to sell generic versions. Once generic drugs are approved, competition keeps the price down.
Are brand-name drugs made under better conditions than generic drugs?
No. Both must meet the same standards of good manufacturing practice (GMP). The MCC strictly prohibits manufacturing of drugs in sub-standard facilities and biannual MCC inspections are conducted to ensure GMP standard. Generic firms have facilities comparable to those of brand-name firms.
Is my generic drug made by the same company that makes the brand-name drug?
It is possible. Brand-name firms are responsible for manufacturing a high percentage of generic drugs. Glucophage and Merck-Metformin, for example, are made in exactly the same facility.
If brand-name drugs and generics have the same active ingredients, why do they look different?
A generic drug must duplicate the active ingredient of the original drug, efficacy and safety. Colour and flavour may be different.
Does every brand-name have a generic counterpart?
No. Brand-name drugs are generally given patent protection for as long as 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial funding for research, development and marketing.
When the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the MCC.
References:
- United States Food and Drug Administration. Generic drugs: what you need to know. [online] 2002 [cited 2007 Jul 09]. Available at: http://www.fda.gov/fdac/features/2002/502_generic.html
- United States Food and Drug Administration. Savings from generic drugs purchased at retail pharmacies. [online] 2004 [cited 2007 Jul 09]. Available at http://www.fda.gov/cder/consumerinfo/savingsfromgenericdrugs.htm
- United States Food and Drug Adminstration: Office of Generic Drugs. [online] 2007 [cited 2007 Jul 09]. Available at: http://www.fda.gov/cder/ogd/
- SA Medicines Control Council. Guidelines on generic substitution. Government Gazette 2003;25145:183-5.
