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  • October 7th, 2010

    Drug Recall System

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    Drug Recall System.

    A drug company is said to have recalled a drug when the sale of the drug from the market is suspended. This is done when the food and Drug administration (FDA) considers the drug to have violated the law. It will be worthwhile to note that the term drug in the context of this article means a medicine. This medicine can be in the form of a tablet, capsule, powder or a liquid. This is in contrast to the use of the word in general parlance, where it is taken to mean a narcotic substance.

    A drug is released in the market only after the company has stringently tested it and after these tests have been thoroughly scrutinized by the FDA. In spite of these precautions, certain undesirable effects of the drug become apparent only after it has been used by a broad spectrum of the human population. The drug is then liable to be withdrawn from the market including over the counter drugs.

    Before a drug is released in the market, it has to go through a series of tests. In the first stage called Pre Clinical Data the sponsors of the drug viz. the company, research institutions etc. must show the results of these drugs on laboratory animals and discuss how they intend to use the drug on humans. In the next stage Clinical Trials are conducted with FDA approval. In here studies are conducted to evaluate the effects of the drug on humans – healthy ones and patients. The results of the tests are submitted to the FDA, which then has to check these thoroughly and determine how the benefits of the drug compare with its adverse effects. This is the golden thumb rule – a comparison of possible benefits and risks, on which the approval or rejection is based.

    Even after the drug is released in the market the FDA monitors the effects of the drug on its users. It has an Adverse Event Reporting System. Under this the Adverse Drug Reaction, commonly known as side effects, are reported. If these are serious enough the FDA may resort to either recall or withdrawal. The former is a mild action initiated due to problems with packaging, contamination or manufacturing. In more serious cases the FDA may want to change or reassess its decision to approve the drug. This is drug withdrawal.

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