In the country of late, the use of generic medicines is rising. While there is a push from the government, people are also enthusiastically opting for generic drugs given their cheap prices. But many still wonder if generic medicines are as effective as their branded counterparts. Lets find out.
What are the generic drugs
Generic drugs are essentially replicas of the original brands, containing the same active ingredients. They are typically more affordable than brand-name medications, costing an average of 85 percent less.
The FDA grants patent and exclusivity protection to brand manufacturers, allowing them to profit from their research and innovation for a certain period. Once the patent expires, generics can enter the market after meeting the same quality, safety and effectiveness standards as the brand. Many generic medications and active pharmaceutical ingredients are manufactured in countries such as China, India and others apart from US.
Prior to receiving approval from the Food and Drug Administration (FDA), a generic drug must adhere to stringent standards. The FDA mandates that the generic drug must be “pharmaceutically equivalent” to its brand-name counterpart.
This requirement guarantees that generic drugs possess the same level of purity, strength, stability, and quality as brand-name drugs. Nevertheless, it is important to note that not all brand-name drugs are accessible in a more affordable generic form. Continue reading to gain insight into the differences between brand-name and generic drugs in terms of price, appearance, availability, and other factors.
What are branded drugs
Branded pharmaceuticals, also referred to as innovator or originator medications, are products created and commercialized by pharmaceutical companies following thorough research, development, and clinical trials.
These drugs represent the first versions of a specific medication released to the market and are safeguarded by patents, providing the manufacturer with exclusive privileges to manufacture and distribute the drug for a designated timeframe (typically close to 20 years).
Branded medications frequently stem from extensive scientific research and groundbreaking innovation.
Are generic medications consistently safe for consumption
Generic medications are unquestionably safe. They are required to meet the same rigorous quality standards as brand-name medications in order to gain approval from the FDA. To ensure bioequivalence, generics must demonstrate that they work in the same manner and provide the same benefits as the brand version. This ensures that patients can trust the effectiveness of generic medications.
The FDA plays a crucial role in monitoring the safety of drugs. They conduct inspections of more than 3,000 drug manufacturer facilities worldwide each year. Even after approval, the FDA continues to monitor the safety of generic medications.
Also Read: This is what happens when you consume expired medicines
If any safety or quality issues are identified, the FDA takes immediate action to protect the public. This includes issuing recalls for affected medications to prevent any harm.
For instance, if there are reports of side effects or adverse reactions associated with a medication, the FDA conducts investigations and takes necessary measures.
You may have heard about recalls of certain blood pressure medications and the heartburn medication Zantac. These recalls were initiated by the FDA due to the presence of cancer-causing impurities in trace amounts. To ensure future safety, the FDA has implemented stricter safety checks to prevent any contamination issues. This demonstrates their commitment to safeguarding public health.
The FDA mandates that generic medications must adhere to various criteria prior to being approved. Here are the criteria.
- The brand drug and the generic drug are considered “pharmaceutically equivalent”.
- The generic drug can be consistently and accurately produced by the manufacturer.
- The brand drug and the generic drug contain the identical “active ingredient”.
- The appropriate dosage of the active component reaches the intended area within the body.
- The inert components in the generic medication are harmless.
- The container for the generic drug, whether it be a bottle, box, or any other type of packaging, is appropriate.
- The label on the generic drug is identical to the label on the brand drug.
- The generic drug remains stable and does not degrade with the passage of time.
- The legal protections and patents associated with the generic drug have lapsed.
The brand name and generic drugs have identical active ingredients and quantities, typically offering the same therapeutic advantages. While further research is needed to determine the superiority of branded drugs for specific conditions. FDA-approved generic drugs are notably more cost-effective as they do not require the same extensive human and animal trials as brand-name medications.
This affordability factor plays a significant role in influencing individuals to opt for generic drugs instead of their branded counterparts.
Nevertheless, it is advisable to consult with a healthcare provider regarding both brand and generic drug alternatives. This enables individuals to make informed decisions based on their health needs and personal situations.
