Spontaneous adverse drug reaction reporting in India: Challenges and methodologies for enhancing reporting culture-Srinath Alluri

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Spontaneous adverse drug reaction reporting is one of the major sources for pharmacovigilance activities worldwide. It provides a significant contribution for establishing a transparent benefit-risk profile of a pharmaceutical medicinal product. However, the spontaneous reporting rate is not in proportion to the extent of population exposure to the medicinal product’s side effects due to underreporting. Underreporting is a global serious issue in the field of drug safety for decades. The various reasons for underreporting are due to lack of awareness and lack of knowledge on the process of reporting, lack of established facilities in health care centers to report a safety issue on medicines, physician and other health care professional’s attitude towards adverse drug reporting, uncertainty on the attribution of adverse experiences to the medicinal product. This concern of underreporting noticed by regulatory bodies in the developed countries and addressed by establishing the standardized process for spontaneous reporting and patient safety reporting systems in their countries. India is a country with a 1.37 billion population having huge potential to build the largest comprehensive drug safety database in the world by stimulating adverse drug reaction reporting and establishing the systems for reporting from health care professionals and consumers.

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