The Ghaziabad-based Indian Pharmacopoeia Commission (IPC), which has been accorded the status of World Health Organisation (WHO) collaborating centre to support public health programmes, will soon roll out a series of training programmes for drug regulators at the centre and the states for effective implementation of Pharmacovigilance Programme (PV) in low and middle income countries.
This will help promote medicine safety globally and will also provide guidelines and support in policy decision making process of WHO.
Launched in 2010, Pharmacovigilance Programme of India (PvPI) has so far reported around 3 lakh adverse drug reactions (ADRs) and has further expanded phenomenally through addition of 40 more ADR monitoring centres (AMCs) last year. As of today, PvPI has under its fold 250 AMCs.
IPC which is an autonomous institution under the union health ministry has been assigned to update information on ADRs that is being reported in India from 250 AMCs through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.
IPC's PV division was accorded the status of WHO collaborating centre on July 18, 2017 to support WHO in areas of pharmacovigilance in public health programmes and regulatory services. There are 7 WHO collaborative centre globally in pharmacovigilance and WHO collaborative centre for PV in public health and regulatory services from India will serve as the 8th centre.
Uppsala Monitoring Centre (UMC) was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO programme for international drug monitoring was transferred to Sweden.
The WHO programme for international drug monitoring is a group of more than 150 countries that share the vision of safer and more effective use of medicines. UMC has been responsible for the technical and operational aspects of the programme since 1978.
The UMC is involved closely with WHO HQ in initiatives in promoting pharmacovigilance in HIV/AIDS, malaria and tuberculosis treatment programmes that major donors (Global Fund, Gates Foundation etc) are supporting in countries where only rudimentary systems for pharmacovigilance exist.
Many of the medicines employed by these public health programmes are new and have safety concerns associated with them.
UMC has a key role by providing a number of services like training of the field force in the collection of relevant patient and case details, access to the VigiFlow software for management of individual case safety reports, providing tools for data analysis, training of staff in case assessment, signal analysis and benefit/harm evaluation and communicating results to relevant national authorities and international partners.
Vigiflow is a software given to PvPI free of cost and prescribed to AMCs based on their efficiency to deliver in terms of frequency and quality of reports.