Is Substituting Your Medication a Safe Choice?

What are Substitute or Generic Medicines?

Substitute medicines, also known as generic medicines, are biosimilar to their branded counterparts. They are identical in every aspect to branded medicines, including route of administration, safety, action, and strength. When comparing a generic to a non-generic, the generic version should have the same effect as the non-generic.

Generic medicines work the same way as the original branded versions but are often significantly cheaper. Generic medications are economical because they are not subject to the same expensive research, development, and marketing costs as their branded counterparts.

Additionally, generic medicines typically undergo a rigorous approval process that ensures they meet the same regulatory standards as their branded counterparts. This means that generic medication can provide a cost-effective solution to branded medicines.

How are substitute medicines different from branded ones?

Before a new medication is made available to the public, it must undergo a rigorous testing process conducted by the U.S. Food and Drug Administration (FDA) to gain approval.

Once it passes the tests, the company that created the medication obtains a patent, meaning it is the only one with the right to market and sell it for a specific period.

When the patent expires, other companies can contact the FDA to request permission to produce and distribute a generic version of the same medication.

The FDA has determined that a generic drug can be up to 15% lower or higher in its blood absorption rate when compared to the original. Data from 2,000 studies revealed an average difference of 3.5%.

In other words, when comparing generic and brand-name medications, you can expect similar outcomes concerning their effectiveness.

Are Substitute Medicines Safe?

Generic drugs tend to be more affordable yet just as effective as their name-brand counterparts.

• Generic medicines are safe and effective: They contain the same active ingredients as branded drugs and work the same way in the body.

• More affordable, equally reliable: Generic medicines are usually cheaper because manufacturers save on costs like research, clinical trials, and advertising.

• FDA evaluation and licensing: Once the patent on a branded medicine expires, other companies can produce its generic version after obtaining a license. These generics are then reviewed and approved by the FDA or other regulatory bodies.

• Clinically proven ingredients: The active ingredient in generic drugs is the same one that was used in the original clinical trials for the branded drug, ensuring safety and efficacy.

• Monitored by pharmacovigilance teams: The safety risks and side effects of generic drugs are continuously tracked by pharmacovigilance departments.

• Expert oversight: These departments investigate complaints and keep consumers, doctors, and manufacturers informed to ensure the continued safety and effectiveness of products.

Where Can You Get Substitute/Generic medicines?

Generic drugs are available throughout India, with pharmacies located in cities and states.

• Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is committed to making therapeutic medications accessible to the general populace, and you can purchase generic medicines from Jan Aushadhi Stores.
• The Drugs Technical Advisory Board of India has recently changed a ruling within the constitution to allow pharmacies the freedom to offer generic medications to customers, even when their prescriptions specify the branded version.

Takeaway Message

Generic medications should be promoted more actively as they make quality medical care accessible to the public. The economic effect of the COVID-19 pandemic has meant that most people are now unable to spend as much as before. However, such medications do not impede or obstruct medical innovation and research, which should be encouraged.

Disclaimer– The information in this article is accurate to our best knowledge; we recommend you consult your healthcare professional before practising any information mentioned in this article.

References

• Center for Drug Evaluation, & Research. (2024, October 4). Generic Drugs: Questions & Answers. U.S. Food and Drug Administration. https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers
• Kairi, J. K., & Sharma, A. K. (2017). Substitutes of prescription medicines – A review of concerns relevant to doctors and patients. Journal of Clinical and Diagnostic Research: JCDR, 11(8), FE01–FE05. https://doi.org/10.7860/JCDR/2017/28552.10439
• Center for Drug Evaluation, & Research. (2021, October 22). Generic Drug Facts. U.S. Food and Drug Administration. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts