The Truth About Generic Medicines

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WHAT IS GENERIC MEDICINE

Generic medicines are, simply speaking, the same as brand-name medicines and have the same active ingredients, and are safe and effective. They are much cheaper than brand-name medicines because they do not have to go through the same expensive research and development process as brand-name medicines

Generic medicines are usually more widely available than brand-name medicines, because generic medicines do not have to be approved by the FDA as new medicines, so they can be brought to market more quickly Generic medicines do not have to go through expensive and intensive research and development, because they are manufactured based on already existing brand-name medicines which are already FDA approved

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HOW SAFE ARE GENERIC MEDICINES

Generic medicines are safe because they are subject to the same rigorous safety standards as brand-name medicines, and they are tested for both safety and effectiveness. Even then, there are small differences between generic medicines and brand-name medicines - the generic medicines may have different inactive ingredients or different colours or shapes. These differences are so minor that they do not affect the safety or effectiveness of the medicines, because the active ingredients are the same as those of brand-name medicines

What is active ingredient - it is that part of the medicine that makes the medicine work

What is inactive ingredient - it is that part of the medicine that help the medicine to work, but it does not have any medicinal properties

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THERE IS A WORD OF CAUTION

If your doctor prescribes a brand-name medicine, which also has a generic equivalent, then, before you decide to take the generic medicine, you should talk to your doctor for approval

You should read the label of generic medicine very carefully, to make sure that the generic medicine has the same active ingredients as the brand-name medicine

Your doctor may recommend that you start taking generic medicine with a small dose first. This will help both you and your doctor to see how your body reacts to the generic medicine

When you first start taking a generic medicine, monitor your symptoms closely to see how well your body is taking the medicine, and report everything to your doctor. Thereafter, let your doctor decide on the best course of action

You should not give generic medicines to children without the advice of your doctor

Pregnant or breastfeeding women should talk to their doctors before taking generic medicines

For further information click on this link - Generic Versus Non-Generic Medicines

GENERIC MEDICINES DO NOT NEED FDA APPROVAL, AND THEY DO NOT HAVE TO GO THROUGH EXPENSIVE RESEARCH AND DEVELOPMENT PROCESS

The FDA approval process for new medicines is very expensive and is a very intensive time-consuming process. It can take many years to bring a new medicine to the market. Generic medicines do not have to go through this process because they are copies of already existing FDA approved brand-name medicines

But, generic medicines have to demonstrate bioequivalence to the brand-name medicines. This means that generic medicines must prove that they work the same way in the body as the brand-name medicines

The FDA has strict standards for bioequivalence, that is why generic medicines are as safe and effective as brand-name medicines

The manufacturers of generic medicines need to submit the manufacturing process to the FDA, to establish that they are manufacturing high quality medicines identical to the brand-name medicines. These manufacturers also have to submit the details regarding the active and inactive ingredients present in the generic medicine. In addition, there may be other requirements, which the manufacturers will have to comply with mandatorily

WHY GENERIC MEDICINES DO NOT NEED FDA APPROVAL

Generic medicines use the same active ingredients that are used in brand-name medicines, these active ingredients have already been scrutinised and approved by FDA before authorising the launch of brand-name medicines in the market. That is why there is no need to repeat the process of FDA approval for the generic medicines

It is mandated that the manufacturing process for generic medicines must be the same as the manufacturing process for brand-name medicines. This ensures that the generic medicines are made to the same high standards as the brand-name medicines

It is mandatory for generic medicines to meet the same quality standards as brand-name medicines, that is why generic medicines must be manufactured under the same strict Good Manufacturing Practices (GMP) as brand-name medicines

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AUTHENTICATION OF THE MANUFACTURING PROCESS OF GENERIC MEDICINES TO PREVENT DEVIATION

This authentication is done by the Food and Drug Administration (FDA), through a process called Abbreviated New Drug Application (ANDA)

The generic medicine manufacturer must submit the ANDA to the FDA, to be eligible to market the medicine

This ANDA must consist of information about the generic medicine’s active ingredients, inactive ingredients, manufacturing process, and bioequivalence to the brand-name drug

The FDA reviews this ANDA. If the ANDA is approved by the FDA, only then the manufacturer can launch the generic medicine in the market

The FDA also conducts inspections of generic medicine manufacturing factories, to ensure that the manufacturers are following Good Manufacturing Practice (GMP)

If the FDA finds any deviations from GMP during an inspection, the manufacturer will be required to take necessary corrective actions to comply with FDA guidelines

For further information click on this link - Get more information on ANDA