| According FDA (U.S. Food and Drug administration, to gain FDA approval, a generic medicine must: contain bioequivalent active ingredients as the innovator medication (inactive ingredients may vary), be bioequivalent in efficacy, dosage form and mode of administration; satisfy the same batch requirements for identity, concentration, purity and quality; be manufactured under the same fixed standards of FDA's Good Manufacturing Practice regulations required for original drugs and medicines. In other words, their pharmacological effects are identical to those of their brand name versions.
Though generic medications are chemically identical to their trade name versions, they are normally sold at considerable discounts from the brand name cost. It is estimated that generic drugs save consumers $8 to $10 billion per year at retail pharmacies. Even much more money is saved when hospitals use generic medications.
The key reason for the comparatively low cost of generic medications is that competition rises among producers when drugs no longer are protected by patents. Producers incur fewer costs in creating a generic drug, and are, therefore, able to maintain profitability at a lower cost to customers. The costs of these generic drugs are so low that many developing countries can easily afford them. For example, Thailand is going to buy millions of doses of the generic version of Plavix, a blood-thinning drug to forestall heart attacks, at a cost of 3 US cents per dose from India, the leading maker of generic medicines.
Producers of generic medicines do not incur the price of medication discovery, and instead are able to reverse engineer known drug compositions to allow them to make identical versions. Producers do not bear the burden of proving the safety and effectiveness of the drugs through clinical tests, because these studies have already been conducted by the trade name company.
At times, generic versions of a medicine have different colors, flavors, or combinations of inactive ingredients comparing to trade name medications. According to the U.S. Trademark regulations, generic drugs are not allowed to look exactly like trade name drugs. Still, active ingredients in both preparations must be identical, ensuring that both have the same medicinal properties. |
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