Asian Made Generic Drugs - By: josh mckinley

The United States Food and Drug Administration (FDA) categorize a generic drug as “identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, effectiveness characteristics and intended use.” In simpler words, generic drugs have the similar pharmacological effects as their branded forms. People who buy generic drugs opt for a cheaper option to more marketable pills. An sample of a generic pill is metformin, used to treat diabetes. Metformin’s branded name is Glucophage. There is also metorpolol, the pill for hypertension with Lopressor as its brand equivalent.

Generics vs. Branded
Generic medicines are not offered at cheaper prices because they are of low quality. In fact, the FDA requires all generics to to pass their standard test. Since they have the same chemical compositions, generics have the exact risks and benefits as their branded counterpart. Most brand name manufacturers are also involved in fifty percent of generic pill production. These manufacturers also produce copies of their patented products to sell them for less minus the brand name.

Generic meds are sold at significantly cheaper prices because they are no longer protected by patents. Because competition in the generics market increases, the medicine is sold at a more affordable price to give it some advantage. There are fewer costs incurred compared to creating the original patent, so the drug company can maintain a steady profit selling at a significantly lower price. Brand drugs on the other hand are sold at higher prices because of the expenses incurred from coming up with the actual drug.
New medication brought in the market have to acquire a ROI because of the expenses incurred through researching, developing and marketing the product. The patent gives protection to these expenses and allows the manufacturer exclusive rights to sell the drug. Protection from patent lasts for twenty years starting from its date of submission. Nearing the expiry date, the manufacturers can now apply their generic forms to the Federal Drugs Administration.

Generic Drugs Produced in Asia
The growing amount of patent expiry and people’s need for cheaper drugs has intensified the creation of generic medicines in Asia. In India, several drugs producers are responsible for generic forms of popular medicines. Some Indian companies are even offering generic versions of biotech meds. The Philippines also plays a major role in the generic medication market, with a growing share of 31 percent headed by three to four international companies.

Indian producers have the biggest role in the generic meds market, having sold hundreds of generic medicines to American consumers. In 2008, the FDA said that India’s leading drug maker Ranbaxy Laboratories gave fraudulent laboratory test results for generic drugs that were approved for sale in the US. Even though this is a major cause for concern, the FDA’s director of compliance, Deborah Autor says that this incident is not connected to the safety or efficiency of the drugs from Ranbaxy. More tests prove that there are no contaminated Ranbaxy pills. Deputy drug director Dr. Douglas Throckmorton says that “there is no reason for anyone to believe that the drugs in the US from the Ranbaxy plants pose a safety problem.”

The FDA’s course of action against the company does not affect the quality of imported generic drugs. In fact, it reveals the high quality standards that the FDA has for all types of drugs. Generic medication manufactured in Asian countries have similar chemical components and go through similar processes as drugs created in more industrialized nations like US or Europe.

Americans who buy medications from India or China need not worry as these producers are required to fully document the drug’s chemistry, manufacturing procedures, and quality control measures. The generic pills or medicines must also meet the conditions of the American Pharamacopoeia, the organization that sets the standard for drug purity in the country. The drug manufactured should remain potent until its expiration date and follow the good processes of the FDA . A complete description of what the firm uses to make, process, package , test, and label the pill is submitted also. The FDA also conducts inspections to verify if the production facilities are observing with their requirements.

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