| According to the U.S. Food and Drug administration (FDA), to gain FDA approval, a generic drug must: contain identical active ingredients as the innovator medication (inactive ingredients may vary), be identical in efficacy, dosage form and route of administration; comply with the same batch requirements for identity, potency, purity and quality; be manufactured under the same strict standards of FDA's good producing practice regulations mandatory for branded products. To put it differently, their pharmacological effects are identical to those of their branded versions.
A lot of people question the potency of generic medications, as the latter are frequently considerably cheaper than branded versions. They wonder if the quality and potency have been compromised to produce cheaper medications. Generic medications are compulsory to be as safe and efficacious as branded medications.
Actually, generic medications are lees expensive, since the producers have not had the expenses of developing and promoting a new drug to the pharmaceutical market. When a producer introduces a new medication to the pharmaceutical market, the business has already spent a considerable amount of money on scientific research, development, marketing and forwarding of the medication. The manufacturer that develops the medication is granted a patent - an exclusive right to sell the medication as long as the patent is in force. By the end of the expiration date of the patent, producers can ask the FDA for permission to make and sell generic versions of the drug. Without the startup costs for scientific research and development of the medication, manufacturers can afford to produce and sell it at a low price. Because of the competition on the pharmaceutical market the price can also go down.
The FDA applies the same standards for all medication manufacturing facilities a lot of companies make both brand name and generic drugs. In fact, half of generic medication production is estimated to be made by branded firms.
At times, generic versions of a drug have different colours, flavors, or combinations of inactive ingredients in comparison to original drugs. Trademark laws in the USA do not allow generic drugs to look exactly like brand name drugs. However, active ingredients must be the same in both preparations, securing that both have the same medicinal properties.
These variations are also seen between branded medications sold in different countries. A drug can be a bolus in the USA, but a pill in Canada, for example, even though it is produced by the same branded company. |
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