IPC to set up 300 ADR monitoring centres by 2020 with focus on North Eastern states
Having generated over three lakh adverse drug reaction (ADR)
data as part of Pharmacovigilance Programme of India (PvPI) ever since its
inception in 2010, the Indian Pharmacopoeia Commission (IPC) has set a mandate
to set up a total of 300 ADR monitoring centres (AMCs) by 2020 with focus on
North Eastern (NE) states.
Central Drugs Standard Control Organisation (CDSCO) had
launched PvPI in July 2010 with Ghaziabad-based IPC as the National
Co-Ordinating Centre (NCC).
“IPC is in the process of identifying district hospitals in
NE states which wish to participate as AMCs under the PvPI at district level.
We would be holding talks with Calcutta School of Tropical
Medicine (CSTM), Kolkata in the coming days to further the expansion in NE
states,” informed Secretary-cum-Scientific Director IPC Dr G N Singh.
CSTM, Kolkata is dedicated to research, care and cure of
tropical diseases. It is the only institution in India engaged exclusively in
research, post-graduate education and healthcare for tropical diseases.
Presently the institute is under West Bengal University of Health Sciences that
governs all the medical colleges in the state of West Bengal.
As per the mandate of PvPI, Pan India ADR information will be
taken forward with all district hospitals in the country with focus on NE
states and implemented at PHC and taluka level health centres. This will
augment government’s plan to roll out the PvPI at district level hospitals
across the country.
Drug Controller General of India (DCGI) in the past had also
recommended to explore possibilities of identifying district hospitals in NE
states to be developed as AMCs.
Medical colleges, hospitals and institutes approved by the
Medical Council of India (MCI) can also act as AMCs. Once enrolled, they are assigned
to efficiently collect the adverse event information from the patients, do
follow up with them to check the completeness of the ADR reports.
IPC has 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.
IPC in February this year identified 22 more AMCs and 13
medical device monitoring centres (MDMCs) to enhance the quality and quantity
of ADR and Serious Adverse Events (SAE) data currently generated through 250
AMCs and 10 MDMCs in the country.
The union health ministry has also mandated AMCs across the
country to report SAEs due to medical devices as part of the Materiovigilance
Programme of India (MvPI).
The MvPI, being coordinated by the IPC at Ghaziabad, was
launched in 2015. IPC functions as the NCC and SCTIMST in Thiruvananthapuram
acts as the collaborating centre. Technical support is being provided by the
National Health Systems Resource Centre (NHSRC) in New Delhi. The purpose of
the programme is to study and follow medical device associated adverse events
(MDAE) and enables dangerous ones to be withdrawn from the market.
MvPI is meant to enable safety data collection in a
systematic manner so that regulatory decisions and recommendations on safe use
of medical devices for India could be based on data generated in India.
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