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Changing the Indian Culture - Reporting Adverse Drug Reactions

Author: IQPC Middle East

Published: 2011-05-29


Focusing the attention of the medical community on the importance of Indian adverse drug reporting to ensure maximum patient health in India.

Main Digest

Adverse Drug Reactions (ADRs) are the sixth global leading cause of death among hospitalized patients and the incidence of serious ADRs in hospitalized 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 program is called the National Pharmacovigilance Program 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 Program 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 Program of India and other key speakers from organizations such as International Society of Pharmacovigilance, UK, Bayer Healthcare Global R & D Center, 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.

About International Quality and Productivity Center (IQPC) Middle East: For over thirty years, IQPC has helped the world's leading corporations solve their business challenges through the sharing of practical industry solutions and global best practice. In the process, the company has built a formidable reputation for quality and value. During this time, the Middle East's most progressive companies have benefited from IQPC's unrivaled global reach, which has connected international expertise with regional and local leaders. For more information, visit

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