| According FDA (U.S. Food and Drug administration, to gain FDA approval, a generic medicine must: contain bioequivalent active ingredients as the branded medicine (inactive ingredients may differ), be identical in effectiveness, dose form and route of administration; comply with the same batch requirements for identity, concentration, purity and quality; be manufactured under the same fixed standards of FDA's Good Manufacturing Practice regulations compulsory for original products. To put it differently, their pharmacological effects are exactly the same as those of their trade name counterparts.
Though generic medicines are chemically identical to their brand name versions, they are normally sold at considerable discounts from the branded price. Generic medicines are estimated to save customers $8 to $10 billion annually at retail pharmacies. Even much more cash is saved when hospitals use generic medications.
The principal reason for the comparatively low price of generic medicines is that competition goes up among producers when medicines no longer are protected by patents. Firms incur fewer costs in creating a generic medicine, and are, therefore, able to sustain profitability at a lower cost to consumers. 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 medication to forestall heart attacks, at a price of 3 US cents per dose from India, the leading producer of generic drugs.
Producers of generic medications do not need to spend money on discovering a drug, and instead are able to reverse engineer known medicine compositions to allow them to produce identical versions. Firms do not need to prove the safety and efficacy of the drugs through clinical tests, for these studies have already been conducted by the brand name company.
Generics may at times be molded differently than branded versions, such as a generic tab versus a trade name bolus. Nevertheless, they have the same active ingredients and are made under the same standards as branded medications. |
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