Pharmacovigilance is the science and activities related to detection, assessment, understanding and prevention of adverse effects or any other medicine related problem" defined by WHO. National Pharmacovigilance Program of India reported that Pharmacovigilance system is defined as a system of drug safety monitoring and collecting, processing and forwarding the adverse drug reaction reports to licensing authority. It also involves detection of any change in benefit-risk balance during its entire life cycle. With the increasing complexity of medications available today, a comprehensive ADR monitoring system is necessary to detect, evaluate, and develop mechanisms to prevent ADRs and associated morbidity, mortality, and increased costs.
As per published reports, like other countries worldwide, the biggest challenge facing the Pharmacovigilance program in India is the gross underreporting of adverse events, and there are many reasons for this including lack of medical expertise in drug administration and adequate skilled resources in Pharmacovigilance and inadequate nationwide awareness of Pharmacovigilance.
Pharmacovigilance outsourcing industry in India has grown by leaps and bounds in the past 8 years, with the number of pharmacovigilance professionals in the country amounting to almost 15,000 people. Ranging from basic case processing activities to complex functions such as signal detection and analysis; the spectrum of pharmacovigilance capabilities available in India has been expanding. India is the preferred destination for global pharmacovigilance services.