Is generic medicine safe to use? Does a pharmacist have to tell them that a generic alternative is available for their prescription? Here are some facts around generic versus brand-name medicine. Please share this information with your employees.

What is brand-name and what is generic medicine? Brand-name medicine is developed and manufactured by big pharmaceutical companies. Generic medicine is a copy of a brand-name medicine, and can only be produced after the developing company’s patent has expired. To be sold, a generic must be “bioidentical” to the original brand-name medicine, which means it must have exactly the same:

  • Active ingredient

  • Strength

  • Use and effect

  • Dosage form (for example a pill, inhalant or liquid)

  • Ability to reach the required level in the bloodstream within the right amount of time and to the same extent

  • Testing standards

What are the ways generics are allowed to differ? Generic medicine will always be the same in terms of safety, quality and effectiveness, but may differ in certain superficial aspects such as shape, colour and packaging. They are also allowed to have different inactive ingredients, for example flavourants and preservatives.

Why are generics cheaper? A brand-name medicine usually goes through 10 to 15 years of research and testing before it can be sold to the public. This can cost billions, which is why the company receives a patent (usually for 10 to 15 years), in which time no other company can make or sell that medicine. During the patent period, the company is able to recover its costs and make profits, free from competition. Once a patent expires, other companies can copy the medicine and sell a generic version, pending approval by the same regulatory bodies. These other companies only have to prove that their product is the same as the brand-name medicine. This process is much cheaper as they don’t have to spend money inventing the product or going through preliminary safety tests. This is why generic medicine costs less.

How available is generic medicine in South Africa? In South Africa, all medicines (including generics) must be approved by the Medicines Control Council (MCC). The MCC has a comprehensive regulatory process all medicine has to comply with before going to market. Generics are widely available in South Africa for many illnesses and conditions, among others malaria, tuberculosis, scabies and depression, cardiovascular disease and raised cholesterol.

Make sure your employees know what their rights are: The Medicines Control Amendment Act (May 2, 2003) makes it mandatory for people who dispense medicine (doctors or pharmacists) to offer a generic substitute if one is available.

Are generics safe to use? Generics are subject to the same strict controls as their branded equivalents. Some are even made by the same pharmaceutical company. The Medicines Control Council employs a team of doctors, scientists and pharmacists who check generics to ensure their safety, quality and efficacy.

Do generic drugs take longer to work in the body? Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Are generics available for all medicine? No. There are a lot of generics, but the best way for your employees to find out if a generic is available for a medicine they are taking is to ask their doctor and pharmacist. If there is a generic available but for some reason their doctor thinks they should still take the brand-name medicine, the doctor will indicate this on the prescription by writing "Do not substitute."


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