The aim of pharmacovigilance is to protect public health by identifying, evaluating and minimizing safety issues to ensure that the overall benefits of medicines outweigh the risks. However, the recent withdrawal from the market of certain medicines has focused attention on pharmacovigilance approaches; raised concerns about improving the existing pharmacovigilance framework; and highlighted the need to ensure consistency among international regulations governing the reporting of side effects (“Adverse Drug Reactions” - ADRs). In drug regulation problems related to the safety and quality of drugs exists in many places. Effective drug regulation is required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. Regulation of drugs encompasses a variety of functions like licensing, inspection of manufacturing facilities and distribution channels, product assessment and registration, adverse drug reaction (ADR) monitoring, QC, control of drug promotion and advertising, and control of clinical drug trials.
