Your Questions Answered
- You can trust generic medicines because they are approved by the South African Health Products Association (SAHPRA).
- Generics medicines and branded medicines are equally effective and safe because they undergo the same registration processes
- Generics medicines are in 99% of cases less expensive than the original
WHAT IS A GENERIC MEDICINE?
A generic medicine is a safe and effective alternative to a brand-name drug. It contains the same active ingredients, is produced at the same dosage strength, and delivers the same therapeutic benefits as the original medication. Because of this, it is interchangeable with the brand-name product while maintaining the same quality, safety, and efficacy standards.
Generic medicines are identified either by their own brand name or by their internationally approved scientific name, ensuring consistency and reliability in treatment.
HOW ARE GENERICS DEVELOPED?
When a pharmaceutical company develops a new medicine, it applies for a legal patent, typically lasting 20 years. This patent grants the company exclusive rights to manufacture and sell the medicine, allowing it to recover the research and development costs invested in creating the drug.
Once the patent expires, generic medicine manufacturers can legally produce, register, and distribute an equivalent version of the original medication. These generic medicines must meet strict regulatory standards, ensuring they are as safe, effective, and high-quality as the brand-name product.
DO I NEED TO KNOW ABOUT GENERIC SUBSTITUTION?
The Medicines Control Amendment Act which came into force on May 2, 2003, places a legal obligation on person dispensing the medicine, either the pharmacist or the doctor, to inform patients of generic medicine options is one exists.
WHY GENERIC MEDICINES?
Generic medicines provide a major benefit to you as they ensure that you and your family have access to quality, safe and effective medicines while reducing your medicine costs and if you are a medical aid member ultimately increase your medicine benefits further.
Generic medicines account for a major percentage of all prescriptions dispensed in Britain, according to their Department of Health, likewise in the USA. In South Africa generic medicine use is between 50% and 60% of dispensed medicines.
WHY ARE GENERIC MEDICINES LESS EXPENSIVE?
- Considering that the active molecule has already been designed, Generic companies spend their research money on reverse engineering the original product, which is a shorter process than drug discovery.
- By the time an original drug’s patent expires, the generic companies can utilise more efficient manufacturing processes and the volumes required allow economies of scale.
- The effectiveness of the drug has already been proven so the requirement for clinical trials is substantially reduced.
ARE THERE HAZARDS TO GENERIC SUBSTITUTION?
Strict control of safety, quality and efficacy of medicines in South Africa means that generic substitution makes good sense. Many doctors already prescribe generically where they feel that the use of a generic rather than a branded medicine would be of equal benefit to their patients.
Both originator and generic medicine companies are obliged to have a tracking system, which is called pharmaco-vigilance. Through this system any problems with medicines can be reported by healthcare professionals or even patients. Should there be any problems the South African Health Products Association (SAHPRA) would order the recall of a medicine.
WHO IS GENERIC AND BIOSIMILAR MEDICINES OF SOUTHERN AFRICA (GBMSA)?
Generics and Biosimilar Medicines of Southern Africa (GBMSA) is a leading industry association representing manufacturers and suppliers of generic and biosimilar medicines. Our membership includes both local and international pharmaceutical companies committed to increasing access to safe, effective, and affordable medicines.
Formerly known as the National Association of Pharmaceutical Manufacturers (NAPM), the organisation was originally established in 1977 to promote the use of generic medicines in South Africa. In 2017, the name was changed to GBMSA to reflect the growing importance of biosimilar medicines—highly effective alternatives to biotechnology drugs whose patents have expired. By incorporating biosimilars into our advocacy efforts, we aim to ensure that more patients can benefit from these targeted treatments at a lower cost.
As a Not-for-Profit Company, GBMSA continues to support, educate, and advocate for policies that drive the availability and affordability of high-quality medicines, ensuring a healthier future for all.
ARE GENERIC MEDICINES AS EFFECTIVE AS BRANDED MEDICINES?
Generic medicines are subject to the same stringent controls as branded products. In fact branded and generic medicines are sometimes made by the same company.
Generic medicines contain the same active ingredients, are of the same dosage form and are identical in strength to the original medicine. They work in the same way in the body and are associated with the same benefits of the original medicine.
The South African Health Products Association (SAHPRA) employs a team of doctors, scientists and pharmacists who investigate the product to ensure its safety, quality and efficacy.
While the generic has the same key clinical characteristics as the branded product, it can be of a different shape or colour, or may be packaged differently.
ARE GENERIC MEDICINES APPROVED BY THE South African Health Products Association (SAHPRA)
In South Africa, all medicines including generics must be approved by the South African Health Products Association (SAHPRA), an independent and impartial statutory council that exercises its powers in terms of the Medicines and Related Substances Control Act (101 of 1965).