| As the U.S. Food and Drug administration (FDA) has put it, to receive FDA approval, a generic medicine must: contain the same active ingredients as the original drug (inactive ingredients may differ), be identical in potency, dose form and mode of administration; comply with the same batch requirements for identity, concentration, purity and quality; be produced under the same strict standards of FDA's Good Manufacturing Practice regulations mandatory for original drugs and medicines. In other words, their pharmacological effects are exactly the same as those of their brand name versions.
Though generics are chemically identical to their brand name counterparts, they are commonly sold at substantial discounts from the brand name price. Generic drugs are estimated to save consumers $8 - &10 billion a year at retail drugstores. Even more billions are saved when hospitals use generics.
The major reason for the comparatively low cost of generic medications is that competition increases among makers when drugs no longer are protected by patents. Companies spend less money on creating a generic drug, and are, thus, able to maintain profitability at a lower price to customers. The costs of these generic medicines are so low that many developing countries can easily afford them. For instance, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning medicine to forestall heart attacks, at a price of 3 US cents per dose from India, the leading producer of generics.
Producers of generic medicines do not need to spend money on discovering a drug, and instead are able to reverse engineer known medicine compounds to allow them to manufacture identical versions. Companies do not have to prove the safety and effectiveness of the medicines through clinical trials, for these studies have already been carried out by the trade name firm.
Generic drugs may at times be shaped differently than branded versions, such as a generic pill versus a trade name capsule. Still, they have the same active ingredients and are made under the same standards as branded drugs. |
Article Details