Why Generic Drugs are Important

Doctors recommend Generic drugs as they provide the same medicines as the brands with the same results, but their prices are much more affordable for patients.

A generic medicine has to meet the same high standards as its brand counterpart to receive approval from the Food and Drug Administration (FDA). This means that the FDA must ensure that the generic and the brand have the same amount of active ingredients at the same strength, as well as the same dosage form, labeling and use. Generics must also follow the same high-quality manufacturing standards as the brand equivalents.

An active pharmaceutical ingredient is what makes a drug work in the body. Inactive ingredients are things such as colors, flavors and binders. As the size or color of a pill may be trademarked, the FDA makes sure different manufacturers use different inactive ingredients.

All inactive ingredients used in generic drugs are previously approved by the FDA. Companies that make generics often obtain their active and inactive ingredients from the very same suppliers as the brand companies.

In Bioequivalence studies, generic and brand drugs are administered, and blood or plasma levels of the drug are measured over time. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the brand drug. Based on these comparisons, the FDA can determine if the brand and generic products are equivalent.

The FDA also has high-quality and product-specific standards that must be adhered to for each batch of product as well as rigorous standards, known as good manufacturing practices.

Even after being introduced in the market, generic manufacturers are further required to assure the safety of their products through post-marketing surveillance and reporting. Generic manufacturers must file quarterly adverse drug experience reports for the first three years after their product has been approved, and annually thereafter.