Generic drugs are an alternative to branded drugs meeting all pharmacology standards. It is called generic drug only if it is made up of the same chemical composition its brand has. Generic drugs are taken in exact dose and strength its branded counterpart is taken. Also, precautions, warnings, manner of taking, etc. are exactly the same of two. The only difference between the two is that generic drugs are much cheaper as compared to its brand. A lot can be saved on them.
There is other way also of defining generic drugs. When a drug is first invented in company in some country, then that particular company is only permitted to make that drug for certain number of years. After the completion of those years, the other companies are permitted to make that drug. These drugs are called generic drugs. The original drug is called a brand name drug. As generic drugs are manufactured by the other companies, that’s why they are different in look than their banded counterpart.
Why do medicinal drugs at times have additional names?
It is often seen that medicinal drugs has more than one name. Most drugs have three names namely- a chemical name, a generic name, and a brand name. There are reasons for having three names. A chemical name is kept based on all scientific formulas are applied in the making of drug. Next is a generic name. A generic name is kept after the main ingredient of the medicine or drug. It is the authorized medical name. Last one is a brand name. A brand name is the trade name and is given by the producer to the medicine. Brand name is set on the standards that it can be distinguished, marked and called back by health professionals as well as members of the public.
Efficacy, Safety, and Quality of Generic Medicinal Drugs vs. Brand Drugs
Coming to safety and efficiency of generic drugs know that they are as secure and efficient as their branded counterparts. They both have the same chemical composition that work exactly in the same manner. Also, they both show precisely the similar pharmacologic and clinical results. Both of their advantages and disadvantages are also the same. Generic drugs have received approval FDA (Food and Drug Administration), which entails generic drugs is safe and effective. The FDA requires generic drugs to have the same quality, strength, purity and stability as their brand-name drugs.
Many people are doubtful about the quality of generic drugs. To prove that generic drugs are made of high quality the FDA does in-depth reexamination of all generic drugs including a review of scientific information about the generic drug’s ingredients and performance. It is done because the FDA wants that generic drugs should be made following the exact high standards which are applied for the making of brand drugs. To ensure that this rule is followed, the FDA conducts approximately 3,500 on-site inspections each year. In a survey it is found that about half of all generic drugs are made by brand name companies. They may make copies of their own medications or another other company’s brand name drugs and then sell them without the brand name.
Why are Generic Drugs less Expensive vs. Branded Drugs
Generic drugs are not made from the scratch, which reduces much of its cost and ultimately lead to lower prices. Let’s see how it happens. Generic drugs do not include research and development costs as it is already done by their branded counterpart. They are just copy of their brand. Also, generic drugs saves a lot on advertising costs as all advertising is done by their brand. New drugs or say brand drugs are manufactured under patent protection. The patent does all the investment like for research, development, marketing, and promotion-by giving the company the sole right to sell the drug while it is in effect. When patent expires, other manufacturers can apply to the FDA to sell generic versions. Because those manufacturers do not have to spend on the above things they sell their products at substantial discounts. Also, there is a greater competition for generic drugs, which keeps the price down. Many of the prescriptions are filled with generic drugs.
Generic Drugs: Benefits for the Society
Generic drugs are much beneficial for the society. Cost effectiveness of generic drugs helps the healthcare systems in saving a lot of money. About 50% of all prescriptions in the United States, and more than 40% of all prescriptions in Canada are filled with generic medications.
Generics authorization progression by the United States of America
Acted out in 1984, the U.S. Drug Price Competition and Patent Term Restoration Act unofficially acknowledged as the “Hatch-Waxman Act”, standardized U.S. procedures for identification of generic drugs.
A claimant files an Abbreviated New Drug Application or “ANDA” with the Food and Drug Administration (FDA) and seeks to manifest therapeutic comparison to a defined, antecedently sanctioned “reference listed drug”.
When an ANDA is approved, the FDA contributes the medicine to its Approved Drug Products list, also acknowledged as the “Orange Book”, and annotates the listing to demonstrate likeness amid the suggestion listed medicine and the permitted generic.
The FDA also distinguishes medicine using the same components with dissimilar bioavailability and separates them into therapeutic comparison groups.
On October 4, 2007, FDA commenced the Generic Initiative for Value and Efficiency, or else GIVE.
The proposal will use accessible resources to facilitate FDA update and make more efficient the generic drug authorization process.
GIVE aims to increment the number as well as diversity of generic drug products accessible. Featuring additional generic-drug options entails more cost-savings to customers, as generic drugs price about 30% to 80% less than trademark name drugs.
In the United States, generic drug substances are listed all the way through appraisal and commendation of the United States Adopted Names (USAN) Council.