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IPC to submit proposal to CDSCO regarding advisory note/label change for certain medicines soon
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Suja Nair Shirodkar
November 28 , 2014
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To ensure patient safety, the Indian Pharmacopoeia Commission (IPC)
which acts as the national coordination centre (NCC) for
Pharmacovigilance Program of India (PvPI) is soon planning to send a
recommendation to the Centre regarding need for urgent intervention
through advisory note or label change of certain medicines soon. The
proposal will be sent based on the analysis and review of the report
prepared by the signal review panel constituted by the IPC last year.
It
is understood that the panel comprising of experts from the industry
will take the final call on this matter following their meeting on
December 9 in Delhi. A highly placed source from the Commission informed
that around five drugs falling under different disease profiles, which
are currently available in the market, is under the scanner of the
panel.
These vital observations made by the panel members are
based on the information gathered by the PvPI database, effectively
collected from different adverse drug reaction (ADRs) centres across the
country over the time. With a view to safeguard and strengthen their
case further, the panel members are also said to be contemplating to
refer data given on other reliable sources of literature as well.
This
will be the fourth meeting of the panel post its inception, albeit a
strategic one as unlike the previous preliminary meetings which focussed
on gathering the intelligence, major decisions will be taken following
the same. Dr V Kalaiselvan, principal scientific officer from Indian
Pharmacopoeia Commission informed that the decision will be taken based
on the panels recommendation on the safety and efficacy of the drugs and
the health hazards it may cause to the patients following a detailed
and painstaking analyses of the ADRs.
Commenting on the same he
stressed, “Key decision relating to some important drugs are expected
to be taken during this meeting, issues and topics which are currently
confidential. IPC has been working very hard over the years to
strengthen its PvPI programme by developing a strong and effective ADR
system throughout the country. All the data collected by us are reliable
and based on the analyses done by the best of our team with clear
vision to safeguard the health of the patients nationwide.”
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