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PvPI yet to evolve as a revenue-generation model to sustain its activities
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Laxmi Yadav, Mumbai
March 31 , 2017
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Even though the Pharmacovigilance Programme of India (PvPI) has done
remarkable work in improving the reporting rate of adverse drug
reactions (ADRs.in the country, it is yet to evolve a standardised financial model to sustain in its activities.
The government has set aside Rs.250
crore for PvPI during the 12th Five Year Plan (2012-17) to enable
better scrutiny of the safety and efficacy of the medicines consumed
within the country. There is no clarity on the revenue generation model
for maintaining and strengthening the drug safety programme thereby
raising concern over its sustainability in long term.
Besides
lack of clarity on their revenue model, the PvPI programme which
contributed to Uppsala Monitoring Centre with 2.5 lakh ADR reports,
received mainly from its 202 ADR centres comprising of government, non
government teaching hospitals, specialised and corporate hospitals
across the country, and to a lesser extent from the industry, has fallen
short of a mechanism to involve state drug regulators in strengthening
its activities.
Though pharma industry has been encouraged to
submit ADRs due to their pharmaceutical products to Indian Pharmacopoeia
Commission (IPC), NCC-PvPI in xml-E2B format since 2015, there is
hardly any mechanism for PvPI to provide feedback to the industry on
their ADR data. The PvPI received encouraging response from the industry
whose contribution to it was around 19 per cent of the total reports
received by PvPI.
The PvPI also needs to come out with a
framework to do away with ambiguity in ADR reporting by industry. At
present it is not clear if a system exists within PvPI to rein in
duplication of ADR reports related to a pharmaceutical product coming
from a pharma company as well as healthcare professionals.
In a
bid to reach out to wider population, IPC had collaborated with vital
bodies-- Indian Council for Medical Research, Indian Medical Association
as well as several public health programmes and institutions-- Revised
National Tuberculosis Control Programme, National AIDS Control
Organization, Adverse Event Following Immunization, National Vector
Borne Disease Control Programme. It also launched consumer reporting
forms in 10 regional languages to promote consumer involvement in
reporting ADRs.Mobile app and helpline were also introduced for ADR reporting.
“All
these initiatives helped PvPI achieve their short-term objective of
developing and implementing a pharmacovigilance system pan India and
collecting case reports and data related to drugs, vaccines, medical
devices and biological products from concern stakeholders including
physicians and industry. The programme is on the path of realising its
long term goal to become a benchmark of pharmacovigilance globally”,
stated Dr J Vijay Venkatraman, managing director & CEO, Oviya
MedSafe – a pharmacovigilance consulting firm, on the sidelines of his
talk on Indian Pharmacovigilance at the DIA Conference held in Mumbai on
24th & 25th March 2017.
“However, lack of clarity of
pharmacovigilance regulations, absence of quality metrics and limited
guidance availability are affecting pharma industry's compliance to
PvPI. Although there is sufficient pharmacovigilance expertise in the
country, very little of it is being utilized for Indian
pharmacovigilance. Existing expertise is limited to collection and
networking of data. Developing PV expertise in signal generation, system
management along with capacity building at all levels in line with
global standards should be focused upon to improve PvPI outcome.”
“This
approach will help do away with the excessive dependence on Uppsala
Monitoring Centre's database. Besides this, a slew of steps need to be
adopted to strengthen PvPI including collaboration with global
regulatory agencies viz. PMDA, US FDA, EMA, clearly defined
responsibilities among governmental agencies, encouraging ADR reporting
through social media, providing enforcement powers to IPC to ensure PV
compliance and so on”, he added.
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