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Monday, December 5, 2011

Asian Generic Medicine Producers


The United States FDA or Food and Drug Administration described a generic drug as "identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use." Simply put, generic drugs have the similar pharmacological effects as their brand counterparts counterparts. People who buy generic drugs chose for a cheaper alternative to more commercialized medicines. An sample of a generic medication is metformin, used for diabetes. Its branded variant is Glucophage. There's also metorpolol, the pill for hypertension with Lopressor as the brand medicine.

Generics vs. Branded

Generic drugs are not sold at lower prices because they have lower quality. As a matter of fact, the US FDA requires all generics to work safely and effectively. Since they have similar chemical compositions, generics have the same effects as their brand-name counterpart. Most branded manufacturers are also related to 50% of generic drug production. These manufacturers also offer copies of their patented products in order to sell them for less without the brand name.

Generic meds are sold at significantly cheaper prices because they are no longer protected by patents. Since competition in the generics market increases, the medicine is offered at an affordable price in order to give it some advantage. There are less costs incurred compared to creating the original patent, so the drug manufacturer can maintain profit selling at a low price. Branded drugs on the other hand are offered at higher prices due to the expenses incurred from inventing with the actual drug. New meds introduced in the market have to attain a ROI||return of investment because of the costs incurred through research, development and marketing the product. The patent gives protection to these expenses and gives the developer exclusive rights to sell the product. Patent protection lasts for 20 years which starts from its date of submission. Towards the expiry date, the producers can apply their generic forms to the FDA.

Asian Generics

The increasing number of patent expirations and the people's need for low priced drugs has aggravate the manufacturing of generic medication in Asia. In India, many pharmaceutical companies are responsible for generic forms of in demand drugs. Some foreign firms are even creating generic versions of biotech meds. The Philippines also plays a huge role in the generic medication market, with an expanding share of thirty one percent led by three to four worldwide manufacturers.

Indian pharmaceutical companies play 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 major drug maker Ranbaxy Laboratories submitted fraudulent laboratory test results for generic drugs that were given approval for sale in the US. Even though this is a huge cause for concern, the director of compliance from the FDA, Deborah Autor says that this development is not related to the safety or effectiveness of the drugs from Ranbaxy. Several tests prove that there are no infected 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 course of action taken by the FDA against the company does not harm the quality of imported generic drugs. As a matter of fact, it reveals the high standards that the FDA has for all types of drugs. Generic pills manufactured in Asian countries have the same components and go through similar measures as drugs produced in more developed nations like US or Europe.

Americans who buy medications from India or China does not need to worry as these manufacturers are required to fully specify the drug's chemistry, production steps, and quality control measures. The generic pills or medicines must also meet the terms of the American Pharamacopoeia, the association that sets the standard for drug pureness in the US. The drug manufactured should stay potent until its expiration date and follow the good processes of the FDA. A full description of what the company uses to create, process, test, package, and label the pill is submitted also. The FDA also performs inspections to confirm if the manufacturing facilities are following with their standards.




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