Wednesday, August 20, 2008

Stop the Hue and Cry over Generic Drugs

It’s high time we doubted the efficacy of Generic drugs blindly. Now all that we need is to educate ourselves about the true facts regarding GD. Then only we can come to a conclusion about their performance. It’s ethically wrong to have a negative opinion about anything without having a thorough knowledge of the same. And Generic drugs have always been a victim of posing a sullied image.

A recently completed FDA study of the safety and efficacy of generic drugs should reassure consumers who became concerned as a result of the 1989 generic drug scandals. The FDA tested more than 400 samples of 24 different kinds of drugs from 73 different manufacturers. The drugs were selected because they are considered to have critically narrow therapeutic ranges. Drugs in this category are potentially ineffective and possibly harmful if they do not deliver to the body very specific amounts of the active drug. Most drugs have much wider margins for safety and efficacy than the 24 kinds tested.

As many as three sample batches from each manufacturer’s production of the 24 selected drugs products were tested for potency and other specifications. Out of the hundreds of batches only five from two manufacturers were found to have any problem. These were samples of aminophylline, a form of thes-ophylline used to treat Asthma. Both manufacturers have withdrawn these lots from the market and are working with the FDA to correct the problem.

FDA doesn’t allow a generic drug to exist without maintaining its equivalence with the brand version. It makes the medications go through acid tests. And only when they are proved to be hundred percent acceptable, FDA approves them.

Generic drugs pose the same active ingredients of their respective brand name drugs in the exact concentration. They even follow all the stringent good manufacturing practices. They just look different from their brand name in respect of structure and color. But these two factors are not the criterion of efficacy. Hence it doesn’t give anyone the license to doubt the same.

As the myths about GD are more popular than the facts, it doesn’t find a space of reliance sometimes. But nowadays when even doctors suggest for GD, one doesn’t have any reason to doubt its credibility. And the time has come now when people should make themselves aware of the positive characteristics of GD and stop the hue and cry about the same. Author: Mark Williams.

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