Ankush Taneja
Adverse drug reactions (ADRs) are considered as one among the leading causes
of morbidity and mortality.
According to WHO, Adverse Drug Reaction is any noxious, unintended,
and undesired effect of a drug, which occurs at doses used in humans for prophylaxis,
diagnosis, or therapy. Pharmacovigilance is an important and integral part of
clinical research. While major advancements of the discipline of pharmacovigilance
have taken place in the West, not much has been achieved in India. However,
with more clinical trials and clinical research activity being conducted in
India, there is an immense need to understand and implement pharmacovigilance.
For this to happen in India, the mind set of people working in regulatory agency
(DCGI ) and the Indian pharmaceutical companies need to change.