Pharmacovigilance, Adverse Drug Reactions and Future Aspects of Pharmacovigilance in India: A Review Article Aravindhswamy H.1,*, Narayanan R. Sankar2, Manigandan T.3, Aswath Nalini4, Hemalatha V.T.5 1Post Graduate, Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India 2Reader, Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India 3Professor, Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India 4Professor & Head Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India 5Associate Professor, Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India *Corresponding Author: Aravindhswamy H. Post Graduate, Department of Oral Medicine and Radiology, Sree Balaji Dental College and Hospital, BIHER, Chennai, Tamil Nadu, India, e-mail: aravindhswamy95@gmail.com
Online published on 31 March, 2020. Abstract Pharmacovigilance is useful toreassure the safety of drugs and protecting the consumers from their injuries effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were non steroidal anti inflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%), liver damage (14.28%), and carcinogenic reasons. Majority of drugs have been banned since 3–5 years in other countries but are still available for sale in India. The present study says about how to manage adverse drug reactions and to prevent it in advance and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. Top Keywords Pharmacovigilance, Adverse drug reaction, drug safety, multidisciplinary approach. Top |