Changing the Indian Culture in Reporting Adverse Drug Reactions

By Iqpc Middle East, PRNE
Saturday, May 28, 2011

DUBAI, UAE, May 29, 2011 -

Adverse Drug Reactions (ADRs) are the sixth global leading
cause of death among hospitalised patients and the incidence of serious ADRs
in hospitalised patients is 6.7 per cent (Joshi et al).

India is the world's second most populated country with over one billion
potential drug consumers, and a value of US $ 1 billion worth of clinical
trials, therefore it is very important to focus the attention of the medical
community on the importance of the adverse drug reporting to ensure maximum
patient health.

Dr. Viraj Suvarna, Medical Director at Boehringer Ingelheim
who is speaking at the Pharmacovigilance India Summit has said that while
multinational Pharmaceutical companies which operate in India clearly have
very stringent adverse event reporting requirements, doctors are reluctant to
report adverse events.

"Doctors in India don't really understand the difference
between an adverse event and an adverse drug reaction. So they believe that
they need to report only if that particular event has a causal relationship
to that product in question. Despite the fact that we've trained so many
doctors over so many years, one will still find them to be a little
uneducated or a little hesitant to report because sometimes they feel that
they could land into a medical-legal complication because once they report,
then they think that that report will be processed and it could go against
them", added Dr Suvarna.

This culture of reluctance in reporting is now changing as The
Ministry of Health in India has launched a complete roadmap for a proactive
pharmacovigilance system which will increase the awareness about the benefits
of adverse event reporting.

This programme is called the National Pharmacovigilance
Programme and it is funded by the WHO to foster the reporting culture in
India and make sure that people are receiving safe medicine.

This first edition of Pharmacovigilance India taking place
from 27-29 June 2011 at the Hilton Mumbai International Airport will explore
the National Pharmacovigilance Programme in further detail and provide an
opportunity for industry stakeholders to meet, network, do business and share
industry best-practices. Pharmacovigilance India Summit features informative
presentations and case-studies from high profile speakers, including Dr. Y.
K. Gupta
, National Coordinator of Pharmacovigilance Programme of India and
other key speakers from organisations such as International Society of
Pharmacovigilance, UK, Bayer Healthcare Global R & D Centre, China,
Boehringer Ingelheim, Baxter Healthcare, Asia Pacific, Takeda Pharmaceuticals
International, USA, Panacea Biotec, Wockhardt, Novartis Healthcare, Astellas
Pharma, India, Bayer Healthcare, UCB, India, and Biocon, India.

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