Generic Drug From Asia And Its Branded Counterpart

The American FDA or Food and Drug Administration classifies a generic pill as identical

, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, effectiveness component and intended use. In other words, generic drugs have the similar effects as their branded counterparts. Consumers who buy generic drugs opt for a cheaper option to more marketable drugs. One example of a generic drug is metformin, used to treat diabetes. Its branded name is Glucophage. There is also metorpolol, the treatment for hypertension with Lopressor as branded counterpart.

Brand Name Drugs vs. Generic Drugs

Generics are not sold at more competitive prices because they are of low quality. As a matter of fact, the US FDA calls for all generics to to pass their standard test. Since they have identical chemical compositions, generic meds have the same effects as their branded counterpart. Most brand-name developers are also involved in fifty percent of generic drug production. These manufacturers also sell copies of their patented products to sell them for less minus the brand name.

Generics are sold at significantly cheaper prices because they are not protected by patents anymore. Since competition in the market gets crowded, the medication is sold at an affordable price to give it some advantage. There are fewer costs incurred compared to inventing the original patent, so the drug producer can maintain a steady profit selling at a lower price. Brand meds on the other hand are sold at higher prices because of the expenses incurred from inventing with the actual drug. New medication offered to the market need to get a ROI because of the expenses incurred through researching, developing as well as marketing the product. The patent gives protection to these costs and gives the company sole rights to sell the drug. Patent protection lasts for 20 years starting from the date it was submitted. Towards the expiry date, the producers can now apply their generic forms to the Federal Drugs Administration.

Generics Produce in Asia

The escalating number of patent expiry and peoples need for cheaper medication has aggravate the creation of generic medication in Asia. In India, many pharmaceutical companies are responsible for generic versions of successful medicines. Some foreign manufacturers are even offering generic versions of biotech medication. The Philippines also plays a huge role in the generics market, with a growing share of 31 percent controlled by three to four international producers.

Indian pharmaceutical companies play the biggest role in the generic meds market, having sold countless of generic medicines to American consumers. In 2008, the FDA reported that Indias biggest drug manufacturer Ranbaxy Laboratories gave fake laboratory tests for generic drugs that were given approval for sale in the US. Although this is a major cause for concern, the FDAs director of compliance, Deborah Autor says that this incident is not connected to the safety or effectiveness of Ranbaxys drugs. Repeated tests showed that there were no contaminated Ranbaxy products. Deputy drug director Dr. Douglas Throckmorton reiterates that there is no reason for anyone to believe that the drugs in the US from the Ranbaxy plants pose a safety problem.

The course of action taken by the FDA against the company does not affect the quality of imported generic drugs. Instead, it reveals the high standards that the FDA has for all types of drugs. Generic drugs made in Asian countries have similar components and undergo the same measures as products produced in more developed nations like US or Europe.

Americans who buy drugs from China or India doesnt need to worry as these manufacturers are required to fully document the drugs chemistry, manufacturing steps, and quality assurance measures. The generic pills or drugs must also satisfy the terms of the US Pharamacopoeia, the organization that sets the specification for drug purity in the country. The drug produced should remain effective until its stated expiration date and observe the good production of the Federal Drugs Administration . A complete description of what the firm uses to make, process, package , test, and label the medication is submitted also. The FDA also performs inspections to confirm if the manufacturing facilities are following with their standards.

by: josh mckinley

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