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State drug controllers to meet at IPC towards implementing pharmacovigilance practice guidelines
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Shardul Nautiyal, Mumbai
January 11 , 2018
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In order to help Indian pharmaceutical companies adopt good
pharmacovigilance practices in the country towards patient safety, state
drug controllers from across the country are scheduled to meet in
February this year at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
Central
Drugs Standard Control Organisation (CDSCO) and Pharmacovigilance
Programme of India (PvPI) have recently come out with a set of
exhaustive guidelines on par with existing global guidelines and
features pertinent areas like signal detection for risk-benefit
evaluation and risk management programmes towards drug safety.
IPC
is the national coordinating centre (NCC) for the PvPI. Since the
initiation of PvPI in 2010, adverse drug reactions (ADRs) are reported
from all over the country to NCC-PvPI, which work in collaboration with
the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the
global ADRs data base.
IPC in collaboration with CDSCO also
developed pharmacovigilance guidance document for marketing
authorization holders of pharmaceutical products to ensure smooth
functioning of PV activities by pharmaceutical companies.
This
pharmacovigilance guidance document has been introduced for
pharmaceutical companies and aimed to establish an effective
pharmacovigilance system at their sites as per recent amendment in drugs
and cosmetics rules, 1945, Schedule Y through a gazette notification
published on 8 March 2016.
Government has mandated market
authorisation holders (MAH) to set up pharmacovigilance (PV) cell in
their companies in accordance with the Drugs and Cosmetics Rules, 1945.
MAH have been mandated to collect, process and forward the report to
licensing authority for information on ADRs emerging from the use of
drug manufactured or marketed.
Under the present set of rules,
the drug exporting pharmaceutical companies have to set up a PV system
to fulfill its legal tasks in relation to pharmacovigilance, design to
monitor the safety of authorised medicinal products and detect any
change to their risk-benefit balance.
A pharmaceutical company
can meet their pharmacovigilance obligations either by setting up
in-house systems for pharmacovigilance or can enter into contractual
arrangements with contract research organizations (CROs) specializing in
pharmacovigilance function.
“Within a span of seven years, PvPI
has become a formidable force at international level for the best
pharmacovigilance practices including ADR reporting and providing skill
development. The Individual Case Safety Reports (ICSRs) are collected in
a scientific way and analysed to facilitate appropriate decisions at
CDSCO,” explains Dr GN Singh, secretary-cum-scientific director, IPC,
Ghaziabad.
Activities in PV department include ADR case
processing and reporting (electronic or hard copy), Periodic Safety
Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER),
Periodic Adverse Drug Experience Report (PADER), product quality
complaints management, medical inquiries management, safety data
exchange agreement management, signal detection for risk-benefit
evaluation, training of company employees on ADR reporting, global
compliance monitoring, audits and inspections among others.
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