There has been a lot of debate in the past about Brand Name and Generic Medications in India and even Internationally. To get to the bottom of this it is very important that we know what they are and how we can know which one is better so that it help you buy medicine online in India.
Registering a brand name drugs involves multiple process. A brand-name drug product is originally discovered and developed by a pharmaceutical company.
What most of us are not aware that it requires a lot of time and money. Firstly the drug is discovered, researched, tested, developed, produced and marketed. All these steps are followed sequentially. First step starts in a laboratory, proceed to a clinical testing facility, and then go on to a FDA (Food and Drug Administration) office for approval before reaching a pharmacy shelf.
We have discussed in details about the whole process like what is FDA and what all the documents needs to be submitted to get an approval from them. And what is the difference between Brand name and Generic Medications.
Below is the detailed analysis on how everything works. The company goes to market and sell their product, however, they must first gain approval from the Food and Drug Administration (FDA) by submitting a New Drug Application.
In the form, the firm will submit all those data which includes a drug's clinical safety and efficacy. After the form is submitted, the other studies and research include the characteristics of the drug dosage form, the manufacturing process, drug stability, purity, strength, and how it dissolves.
Everything is clearly checked and examined and after the clearance the drug receives FDA approval, the innovator company then market and sell this 'brand-name' product for as long as the company has patent protection.
It is very important for us to know why the brand name drugs are patent protected. As we explained earlier that the price of bringing a new drug to market is very high. It may cost around hundreds and millions of dollars spent in order to develop this which may even take more than 10 years to develop and market a novel medication.
For this process a huge number of people work countless hours to provide us and veterinary communities with new medicines. The important thing to note here is during this time, other pharmaceutical companies are not permitted to make or sell the drug without taking permission from the developing company.
So in order to gain profits by the company who had worked for years in order to develop a drug, they use patent so that others do not use them without their permission.
As we have pointed out above, the patent registered by the company who developed the product will expire after 10 years. Now, other pharmaceutical companies can approach FDA for permission to manufacture and sell a generic version of the original drug.
Just like the original drug where the documentation were submitted even for generic drug the manufacturer must submit the details. They must also confirm that their drug contains the same active ingredient(s) as the brand name drug.
Generic drug is a substitute to the original brand name drug. Basically, the FDA checks and confirms that a generic drug contains all the same active ingredient in the same amount, and does the same job as the brand name product before it is used.
It basically depends on the types of ingredients used. There are some active and inactive ingredients in the drugs. In Generic drug, the active ingredient must be the same as the original drug. However generic drugs may have some different inactive ingredients such as preservatives or fillers. This is the major difference between the Brand name drug and Generic drug.
You can easily notice the difference in the appearance of the drug. Trademark laws prevent generic drugs from looking just like the brand name drug, so the color and size may be different.