A generic drug is a copy of original drug whose patent has ended; and there is no R n D cost involved. Cipla, Dr.Reddy's and Ranbaxy are some leading generic drug makers. Most people believe that if something costs less, it has to be of a lower quality. In the case of generic drugs, it is not true. While the Indian government is pushing generic drugs as they are cheaper and, therefore, more affordable, not much attention is given to the quality of these drugs.

A case in point is a life-saving drug, Liposomal Amphotericin B, an antifungal medicine used in critically-ill patients. There is no limit on the number of pharmaceutical companies that can be allowed to manufacture the generic drug and the amount they can charge. The obvious risk of Amphotericin B is its high toxicity, which can lead to kidney failure and death. However, given that it's a life-saving drug for patients in terminal decline, they have little option but to use the generic version, especially for poor patients.

The quality of these drugs will immensely affect the efficacy and toxicity. Ensuring proper quality control of these life saving generic drugs will prevent them from becoming life threatening. Some quality control measures for a generic drug to get FDA APPROVAL are-

• it must contain the same active ingredients and follow the same pharmacokinetics as its original
• it must be identical in strength, purity, dosage form and route of
• it must have same labels as its brand

Mihika M. Shringarpure

S.Y.B. Pharm

Tags: MET Institute of Pharmacy