| According FDA (U.S. Food and Drug administration, to gain FDA approval, a generic medication must: comprise bioequivalent active ingredients as the branded medicine (inactive ingredients may differ), be bioequivalent in efficacy, dose form and route of administration; satisfy the same batch requirements for identity, concentration, quality and purity; be produced under the same established standards of FDA's Good Manufacturing Practice regulations obligatory for innovator medications. To put it differently, their pharmacological effects are identical to those of their trade name versions.
Though generics are chemically identical to their branded versions, they are normally sold at substantial discounts from the trade name price. According to the Congressional Budget Office, generic medications save customers an estimated $8 - &10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generic drugs.
The principal reason for the comparatively low cost of generic medicines is that competition increases among makers when medications no longer are protected by patents. Manufacturers spend less money on creating a generic medicine, and are, thus, able to maintain profitability at a lower cost to customers. The costs of these generic medicines are so low that many developing countries can easily afford them. For example, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning treatment to forestall heart attacks, at a cost of 3 US cents per dose from India, the leading maker of generic medicines.
Producers of generic drugs do not need to spend money on discovering a medicine, and instead are able to reverse engineer known medication compositions to allow them to make bioequivalent versions. Firms do not need to prove the safety and efficacy of the medicines through clinical tests, for these tests have already been conducted by the brand name firm.
At times, generic versions of a medicine have different colors, flavors, or combinations of inactive ingredients comparing to branded medicines. According to the U.S. Trademark laws, generics are not allowed to look exactly like trade name medications. Nevertheless, active ingredients must be the same in both preparations, insuring that both have the same pharmacological properties. |
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