Pharmacovigilance is to monitor:

National pharmacovigilance programme was launched in in India in 2005. It is sponsored by the WHO and funded by the World bank. It monitors the adverse drug reactions, institute periodic safety update recording, exchange pharmacovigilance information with other international regulatory bodies, recommend label amendments, product withdrawals or suspension, and inform end users. Pharmaceutical companies are required to submit periodic safety update repos of all new drugs, every six months for the first two years following market launch in India, and then annually for the next two years. Ref: Global Clinical Trials: Effective Implementation and Management edited by Richard Chin page 150