Appendix 11: Pharmacovigilance Programme of India

To provide safe and effective healthcare system in India and promote rational use of medicines, the Pharmacovigilance Programme of India (PvPI) has been established by the Ministry of Health and Family Welfare, Government of India. The programme is being coordinated by the Indian Pharmacopoeia Commission, Ghaziabad as a National Coordination Centre (NCC). The mission of the programme is to ensure that the benefits of use of medicine outweigh the risk and thus safeguard the health of the Indian population.
The PvPI has the following objectives:
• Monitoring Adverse Drug Reactions (ADRs) in Indian population
• Creating awareness amongst healthcare professionals about the importance of ADR reporting in India;
• Monitoring benefit-risk profile of medicines;
• To generate independent, evidence-based recommendations on the safety of medicines;
• Support the Central Drugs Standard Control Organization (CDSCO) for formulating safety related regulatory decisions for medicines.
The PvPI is being supported by ADRs Monitoring Centres from across the country. This programme is on expansion mode by enabling more centres to join the reporting of ADRs to NCC and in turn to be linked up to Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. All stakeholders using this formulary are encouraged to report ADRs by downloading the Form (Suspected Adverse Drug Reaction Reporting Form) either from the website of the Central Drugs Standard Control Organization (www.cdsco.nic.in) or the Indian Pharmacopoeia Commission (www.ipc.gov.in). Integrated efforts from the regulatory authorities, pharmaceutical industry and healthcare workers are necessary for the success and effectiveness of this programme. Therefore the active participation of the all concerned in this programme will not only be useful for Indian healthcare system, but also facilitate rational prescribing globally.
A specimen form is attached at the end of the book.