What is generic medication?

You might have been offered generic medication or heard it mentioned as a cheaper alternative for different types of medication… But do you know what it is, why it’s cheaper, and whether it works the same? Here are the answers to all those questions (and more!)

What is a generic medicine?

A generic medicine contains the same active ingredient(s), in the same strength and dosage form, administered the same way  as the originator medicine.

Generic medication must demonstrate that it is therapeutically equivalent to the originator and meet the same regulatory standards for quality, safety and efficacy.

Generic medicines may differ from the originator medicine in colour, shape, packaging and inactive ingredients, but these differences do not change the medicine’s intended therapeutic effect when the product meets the regulatory requirements.

How is a generic medicine tested?

Generic medicines undergo rigorous regulatory assessment before they can be registered. A key requirement is demonstrating bio-equivalence with the originator.

Bio-equivalence testing establishes that the generic delivers the active ingredient into the body at a comparable rate and to a comparable extent as the originator, to achieve the same therapeutic effect. 

The medicine must also meet requirements relating to its quality, purity, stability, strength and manufacturing processes. Manufacturing facilities are subject to regulatory requirements and good manufacturing practices (GMP) oversight.

Because the safety and efficacy of the active ingredient have already been established during the development of the original medicine, a generic manufacturer generally does not have to repeat the entire clinical development programme. Instead, it must provide the evidence required by the regulator to demonstrate that its product is equivalent to the approved originator.

Why is generic medication cheaper if it is essentially the same medicine?

The lower price is primarily related to development costs and market competition.  

Developing a new medicine involves significant investment in research, development and clinical studies. Once the medicine is approved, the patent and other forms of market exclusivity can allow the originator company to market it exclusively for a defined period.

Developing a new medicine involves significant investment in research, development and clinical studies. Once the medicine is approved, the patent and other forms of market exclusivity can allow the originator company to market it exclusively for a defined period.

What is an active ingredient?

The active ingredient is the substance in a medicine that produces its intended therapeutic effect.
For example, paracetamol is the active ingredient responsible for the pain-relieving and fever-reducing effect of medicines containing paracetamol.

Medicines also contain inactive ingredients, which may perform functions such as helping to form the tablet, preserve the medicine, improve stability or affect its colour and appearance. These ingredients can differ between generic and originator medicines.

What brands can consumers trust?

Consumers should essentially look beyond the brand, and ensure that they are buying medicine registered by the South African Health Products Regulatory Authority (SAHPRA) from a legitimate, licensed pharmacy or healthcare provider.

Registration by SAHPRA means the medicine has undergone the regulatory assessment applicable to that product, and has met the required standards for quality, safety and efficacy.

Consumers should also be cautious of medicines purchased from unverified online sellers or other unauthorised sources, where the authenticity, quality and storage conditions of the product may not be guaranteed.

Do you need a different prescription if you want to switch to a generic?

Not necessarily. Generic substitution is provided for under South African medicines legislation, subject to the applicable requirements.

Where an appropriate generic equivalent is available, patients can ask their pharmacist whether their prescribed medicine can be substituted with a registered generic.

In some cases, medical aids may also encourage or require the use of generic alternatives as a way of cost-containment, if a suitable generic alternative is available.. You should not independently change, stop or substitute medicines without first speaking to your pharmacist or doctor, particularly where there may be clinical considerations specific to the individual. Pharmacists are also not allowed to switch medication if your doctor wrote “Do not substitute” on the prescription.

How can consumers make sure they are not paying more than they need to for their medication?

One of the simplest things consumers can do is ask their pharmacist whether a more affordable generic equivalent is available.

A useful question to ask at the pharmacy is: “Is there a generic equivalent of this medicine, and what would it cost?”

You can also ask your doctor whether prescribing by the medicine’s generic name or active ingredient is appropriate, rather than specifying a particular brand. For anyone on chronic medication, even a relatively small saving per prescription can add up significantly over the course of a year. Comparing available registered generic medicines and understanding what your medical aid covers can make a meaningful difference to your overall healthcare costs.

The important point is that price alone should not be used as an indicator of medicine quality, safety or effectiveness.

A registered generic has to meet the regulatory requirements applicable to demonstrate its quality, safety and therapeutic equivalence to the originator medicine.

With thanks to Pharma Dynamics, a registered generic medication provider, for answering all our many questions!

Have you used a generic medication alternative before? Let us know in the comments below, or on Facebook!