With the globalization of the pharmaceutical industry, increased use of medicines and public awareness of safety issues have come forth. India is the fourth largest producer of pharmaceuticals in the world and there is a surfeit of drug brands-more than 6,000 licensed drug manufacturers and over 60,000 branded formulations emerging as a preferred hub for clinical trials and to carry out post marketing surveillance i.e. of the approved drugs. Pharmacovigilance is particularly important in the first few years after launch, when knowledge of the safety profile is based on exposure to a much wider range of patients than is possible during clinical trials.
Pharmacovigilance in India is gaining momentum within the arena of Research and Development. As Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety. Keeping this in mind, Bioinformatics Institute of India has designed a proficiency program on Pharmacovigilance.
“This program will increase the knowledge and importance of quality assurance amongst clinical research professional, which eventually would help in increasing the quality of clinical trials in India”.
- To enable participants to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).
- The manner in which ADRs are detected and monitored, and the related historic and legal frameworks.
- To introduce participants to fundamental statistical, compliance and regulations concepts and methods.
The potential opportunities and the growth prospects in the field of pharmacovigilance are huge. The principal role of a Pharmacovigilant officer starts right from the start of preclinical studies and continues even after post marketing of the drug as drugs are evaluated for toxicity in a limited group of patients before marketing. He would be responsible for the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem both long term and short term side-effects of medicines; thereby improving the safety of drugs.