Pharmacovigilance is not new to India and has infact been going on from 19982. When India decided to join the uppasla centre for adverse event monitoring..
An adverse event is defined as any un toward medical occurrence that may present during treatment with a drug but which does not necessarily have a relationship with its use.” “An adverse drug reaction is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in human for prophylaxis, diagnosis, therapy or modification of physiological function
The processes involved in the clinical development of medicines. Once put onto the market, a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population.
At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. In some cases as few as 500 subjects, and rarely more than 5000, will have received the product prior to its release.
More information is generally needed about use in specific population groups, notably children, pregnant women and the elderly, and about the efficacy and safety of chronic use, especially in combination with other medicines
PHARMACOVIGILANCE is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.