Author : Abhay Vasoya, Heyaben Patel* Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India.
<strong>Abstract</strong> A drug is a biochemical substance which has biological effects in the body when ingested or otherwise introduced in the body. Its takes many years to discover a new drug as it is has to undergo several operations, several tests and clinical trials leading to huge cost based on expenditure of the research. The drug is to be marketed and manufactured in pharmaceutical industry only if it has passed the USFDA standards. Once the drug passes the USFDA standard the drug is manufactured, and the discoverer is awarded patent for that same drug for certain period of time. As the drug research is much costly the discoverer sets the prices for the drug which is too high, at least not affordable by common community. For this reason, Generic drugs are introduced in the market. In the recent era generic pharmaceutical are the largest contributor of drugs in the market and are in high demand due to cost effective. As all the generic drugs are approved by USFDA and are allowed to be marketed only when the brand drugs discoverer do not hold the patent for the same drug and the brand drugs is in the market for years and well-established safety profile. Although Generic Medication appear to be same as brand drugs, but variation in manufacturing facilities may lead to unseen adverse events. On other side, generic drugs are tested for bioequivalence properties within a certain range compared to brand discoverer drugs, safety and efficacy testing are not required; therefore, it can be said that generic drugs are not therapeutically equivalent to branded innovator drugs the question of requirements of Pharmacovigilance for generic arises when there is plethora of information available for brand drugs regarding safety and adverse effects.