Pharmacovigilance Programme of India (PvPI)
- The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in association with Indian Pharmacopeia commission, Ghaziabad is initiating a nation-wide Pharmacovigilance Programme for protecting the health of the patients by promising drug safety.
- The Programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The center will operate under the supervision of a Steering Committee.
- The Pharmacovigilance Programme of India (PvPI) was started by the Government of India on 14th July 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country for safe-guarding Public Health.
- In the year 2010, 22 ADR monitoring centres including AIIMS, New Delhi was set up under this Programme.
- To safeguard implementation of this programme in a more effective way, the National Coordination Centre was shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh on 15th April 2011
Mission: Safeguard the health of the Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use.
Vision: To improve patient safety and welfare in Indian population by monitoring the drug safety and thereby reducing the risk associated with use of medicines.
To analyses the benefit – risk ratio of marketed medications
• To generate the evidence based information on safety of medicines
• To support regulatory agencies in the decision making process on use of medications
• To communicate the safety information on use of medicines to various stakeholders to minimize the risk
• To emerge as a national center of excellence for pharmacovigilance activities
• To collaborate with other national centers for the exchange of information and data management
• To provide training and consultancy support to other national pharmacovigilance centers located across globe Implementation of PvPI IPC assumed the need for establishing local hospital based centers across the nation for the better patient safety. It was significant to monitor both the known and previously unknown side effects of medicines in order to determine any new information available in relation to their safety profile. In an enormous country like India with a population of over 1.2 billion and with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it was imperative to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation.
Short term goals
• To develop and implement pharmacovigilance system in India
• To enroll, initially, all MCI approved medical colleges in the program covering north, south, east and west of India
• To encourage healthcare professionals in reporting of adverse reaction to drugs, vaccines, medical devices and biological products
• Collection of case reports and data Long term goals
• To expand the pharmacovigilance programme to all hospitals (govt. & private) and centers of public health programs located across India
• To develop and implement electronic reporting system (e-reporting)
• To develop reporting culture amongst healthcare professionals
• To create a nation-wide system for patient safety reporting
• To identify and analyze the new signal (ADR) from the reported cases
To make ADR reporting mandatory for healthcare professionals Causes of failure of implementation of pharmacovigilance in India
1. Lack of funds
2. Negligible motivation
3. Lack of education & awareness in patient
MCQ on Pharmacovigilance given at the end of Lecture see above lecture