Health ministry directs faculties in 35 institutes to guide studies for intensive ADR monitoring exercise under PvPI
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Shardul Nautiyal, Mumbai
September 22 , 2017
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In order to carry out intensive Adverse Drug Reaction (ADR) monitoring
for data generation as per stipulated guidelines, the Union health
ministry has directed respective faculties in 35 institutions to act as
guides in the country to carry out studies in a focused manner related
to specific drugs.
The institutions have been provided
guidelines to follow a specific protocol for prospective studies on
specific drugs having ADRs. Institutions are encouraged to carry out
intensive ADR monitoring for data generation .This would enable
government to take regulatory decisions in an effective manner to combat
ADRs.
Around 35 institutions have been identified to carry out
intensive ADR monitoring exercise under the Pharmacovigilance Programme
of India (PvPI). Indian Pharmacopoeia Commission (IPC) had recently came
out with a draft protocol and guidelines focused on targeted drugs to
generate and report India specific adverse drug reactions.
Health
ministry has also started training Pharm D institutions to undertake
specific projects. Till date, 35 institutions have been identified to
carry out such Intensive ADR monitoring exercise which will be done
through a clearly defined protocol and will generate data as per health
ministry stipulated guidelines in terms of reporting specific events.
“We
have recommended faculties to act as guides for the prospective studies
done by the institutions for proper ADR monitoring, reporting and
analysis. Institutions have been provided guidelines on study protocol
of drugs of current interest,” informs Dr V Kalaiselvan, Principal
Scientific Officer, IPC, Ghaziabad.
The exercise has been
primarily initiated keeping in view that data from spontaneous reporting
of ADRs have generally been mis-spelt.
To track ADRs in Indian
population, Union health ministry launched PvPI which has outreach all
over the country but only a small portion of healthcare professionals
have formal training in pharmacovigilance (PV).
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.
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