Pharmacovigilance in India: Present Scenario and Future Challenges.


Indian Pharmacopoeia Commission, Sector 23, Raj Nagar, Ghaziabad, 201002, India. [Email]


Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken. The National Coordination Centre was shifted from New Delhi to the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use. The culture of reporting of ADRs has achieved remarkable success, with 250 PvPI-established adverse drug monitoring centres all over India and provision of training to healthcare professionals. The programme is striving hard to build trust between the physician and the patient, thereby increasing patient safety and the confidence of people in the country's health system, in addition to the detection of substandard medicines and prescribing, dispensing and administration errors. The IPC-PvPI has now become a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services. In spite of these achievements, several challenges are faced by the PvPI, like the monitoring of generic drugs, biosimilars, and disease-specific ADRs of antidiabetic, cardiovascular and antipsychotic drugs and, above all, creating awareness, which is a continual process. At the same time, the PvPI is trying to address other challenges like counterfeit drugs, antimicrobial resistance, and surveillance during mass vaccinations and other national programmes.