| According FDA (U.S. Food and Drug administration, to gain FDA approval, a generic drug must: comprise the same active ingredients as the original medication (inactive ingredients may differ), be identical in effectiveness, dosage form and route of administration; comply with the same batch requirements for identity, concentration, purity and quality; be manufactured under the same strict standards of FDA's Good Manufacturing Practice regulations mandatory for innovator drugs and medicines. To put it differently, their pharmacological effects are identical to those of their branded versions.
Although generic medications are chemically bioequivalent to their branded counterparts, they are normally sold at considerable discounts from the branded cost. According to the Congressional Budget Office, generics save customers an estimated $8 - &10 billion per year at retail drugstores. Even more billions are saved when hospitals use generics.
The principal reason for the relatively low cost of generic medicines is that competition goes up among manufacturers when drugs no longer are protected by patents. Producers spend less money on creating a generic medication, and are, thus, able to sustain profitability at a lower cost to customers. The low costs allow many developing countries to easily afford them. For example, Thailand is going to buy millions of doses of the generic version of Plavix, a blood-thinning drug to preclude heart attacks, at a price of 3 US cents per dose from India, the leading maker of generic drugs.
Manufacturers of generics do not need to spend money on discovering a drug, and instead are able to reverse engineer known medicine compounds to allow them to make bioequivalent versions. Manufacturers do not bear the burden of proving the safety and effectiveness of the medicines through clinical tests, since these studies have already been carried out by the brand name company.
Generic medications may sometimes be shaped differently than branded versions, such as a generic tablet versus a branded capsule. Still, they have the same active ingredients and are made under the same standards as trade name medicines. |
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