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IPC Ghaziabad starts functioning as WHO collaborative centre for PV to support member countries

Shardul Nautiyal, Mumbai
Monday, November 6, 2017, 08:00 Hrs  [IST]

In order to support World Health Organization (WHO) member countries in establishing pharmacovigilance programme (PV), Indian Pharmacopoeia Commission (IPC) Ghaziabad has formally started functioning as WHO collaborative centre for PV.

IPC-PV division has been assigned the status of WHO collaborating centre which will help promote medicine safety not only in India and globally but will also provide guidelines and support in policy decision making process of WHO.

IPC has also been assigned to update information on ADRs that is being reported in India from across all its centres through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

“This will help Pharmacovigilance Programme of India (PvPI) to share WHO responsibility on expanding the scope of PV for the global population and effective integration of PV with national health programmes globally and in India,” said Dr.V Kalaiselvan, principal scientific officer at the IPC.

Central Drugs Standard Control Organization (CDSCO) under the Union health ministry had initiated a nation-wide PvPI in July 2010. This got further expanded and for administrative reasons was shifted to Ghaziabad based IPC.

This step is very much relevant as many of the medicines employed by these public health programmes are new and/or have safety concerns associated with them. This includes collaboration with WHO and others on the establishment and training of a pharmacovigilance field force to actively assemble case information from the programme treatment centres.

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.

Other organisations provide staff to enter this data into country-specific databases, using the UMC's VigiFlow software. A team of signal reviewers will be trained to analyse the collected case information and to highlight any indication of new patient safety concerns. Such information will be provided to programme managers and regulatory authorities in each country in which the system is operating as well as to the international community where relevant.

UMC has a key role to play 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 the Pharmacovigilance Programme of India (PvPI) free of cost and prescribed to Adverse Drug Monitoring Centres (AMCs) based on their efficiency to deliver in terms of frequency and quality of reports.


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Vishnu goel Jun 13, 2019 5:41 PM
Good site to report adr
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