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THE PHARMA REVIEW (JUNE 2008)

Jeopardise of Generic Medicine- A Case Study

Brijendra Singh Poonia, Pratim Kumar Choudhury

Introduction: When a formulation unit discovers a new drug or molecule to prevent or treat an ailment, it is put through a series of clinical trials in order to gain approval for marketing from the Central Drug Standards Control Organization (CADCO). The CADCO is a government body responsible for ensuring that all medicines that reach the Indian market meet appropriate standards of quality, efficacy and safety. If the results of clinical trials show that the new drug is safe and effective for the condition in which used, the CADCO approves the drug and gives it a licence. Now the company has exclusive rights to market the drug for a certain period, usually about 10 to 15 years. This allow the pharmaceutical company to recover the costs of research and development of the new drug or molecule, before other pharmaceutical units are allowed to produce it. Once the licence has been approved by the CADCO, the pharmaceutical company can then market the new drug under a brand name. The name chosen should be simple and easier to memorize rather than long generic name. For example, Lilly and Boehringer Ingelheim has patent rights of duloxetine used to treat generalized anxiety disorder is marketed under the brand name Cymbaltaź. Once a patent expires, other pharmaceuticals will copy and market the cheaper versions of same active ingredient (duloxetine) either under different brand names, or simply as the generic “duloxetine” because the research and development has been already incurred by the Lilly and Boehringer Ingelheim. These alternative brands are called generic medicines.

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