What is generic drug and what is original drug? An original brand drug or innovator drug is simply the first drug created containing a specific active ingredient to receive approval for use.
In addition, its efficacy, safety and quality have been fully established.
As opposed to original drug, generic drug is mainly a drug with the same active ingredient to its innovator drug and also have the same efficacy, safety and quality.
Common myths about generic drug
- Generic drug is not as safe as its original drug
- It is not as effective as innovator
- It takes longer time to act in the body
A drug must comply to three major factors, Efficacy, Safety and Quality.
There is no truth in the myths surrounding generic drugs.
This is because firstly, generic drugs use the same active ingredients as the innovator drugs.
Though it may appear differently in terms of colour or appearance, it does not affect the major factors; Efficacy, Safety and Quality.
Secondly, the Drug Control Authority (DCA) imposes a stringent evaluation procedure that generic pharmaceutical manufacturers have to follow.
These products have to undergo bioequivalent (BE) studies to ensure its therapeutic effect is interchangeable to its innovator drug.
Not only does this rule apply to generic drugs produced from local pharmaceutical manufacturer companies, but even to generic drugs imported internationally.
Why do I feel original drug works better than generic drugs?
As mentioned before, generic drugs have different appearance than its innovator drugs. This in turn may cause a certain perception about the quality and efficacy of the drug, either positive or negative.
Oddly enough, perception plays a role in the way the drug works in our body.
So, it may be simply because of wrong perception of this drug.
Researches analyzing reports from scientific databases MEDLINE and EMBASE found that even though 60% of the studies reported no difference between the drugs, people taking generic medicine have higher risk of hospital visits.
However, it is important to note that the studies only show a correlation, not the effect of generic drug.
Generally, people with lower socioeconomic status tend to have worse healthcare outcomes.
They are also more likely to choose generic drugs due to its lower cost.
Additionally, the study’s researchers also state that a firm conclusion cannot be drawn due to insufficient evidence.
But why does generic drugs cost less than original brands?
Before understanding this issue, we must first understand that the process of developing new drug is not only expensive, it is also lengthy.
The processes involve synthesis, chemical identification and purification of the chemical, development into a pharmaceutical dosage form and lastly, testing and trials.
All of this may take up to 15 years with total expenditure estimated to be up to US$1bil (RM3.6bil).
The manufacturer is granted a patent for a few years, typically 5 to 15 years.
During this period, they are given the exclusivity to manufacture and market the drug.
Understandably, the cost of the innovator drug during this monopoly period tend to be high.
Soon as the patent period ends, manufacturers of generic medicines will then manufacture the generic form of the drug.
By skipping the whole extensive process mentioned, generic manufacturers are able to produce the drug chemically with shorter duration and significantly less costly.
Moreover, there will be multiple manufacturers for generic drugs. Thus, creating competition in the market and resulting in lower price.
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References
https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
https://www.medicalnewstoday.com/articles/brand-and-generic-drugs#which-is-better