According FDA (U.S. Food and Drug administration, to receive FDA approval, a generic medicine must: contain bioequivalent active ingredients as the original medicine (inactive ingredients may differ), be bioequivalent in strength, dosage form and mode of administration; satisfy the same batch requirements for identity, strength, quality and purity; be produced under the same fixed standards of FDA’s Good Manufacturing Practice regulations required for branded products.
To put it differently, their pharmacological effects are identical to those of their brand name counterparts.Though generic drugs are chemically bioequivalent to their branded versions, they are commonly sold at considerable discounts from the branded cost. Generic medicines are reported to save customers $8 to $10 billion annually at retail pharmacies. Even much more money is saved when hospitals use generics.
The primary reason for the relatively low price of generics is that competition escalates among makers when medicines no longer are protected by patents. Companies spend less money on creating a generic drug, and are, hence, able to sustain profitability at a lower price to consumers. The low costs allow many developing countries to easily afford them.
For instance, Thailand is going to buy millions of doses of the generic version of Plavix, a blood-thinning medication to prevent heart attacks, at a cost of 3 US cents per dose from India, the leading manufacturer of generic medications. Producers of generic drugs do not need to spend money on discovering a medication, and instead are able to reverse engineer known drug compositions to allow them to manufacture bioequivalent versions.
Manufacturers do not bear the burden of proving the safety and effectiveness of the medications through clinical trials, as these studies have already been carried out by the brand name company.Generic medicines may at times be shaped differently than branded versions, such as a generic tab versus a trade name capsule. Nonetheless, they have the same active ingredients and are manufactured under the same standards as brand name drugs.
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