Journal of Pharmacovigilance and Drug Safety http://www.journalofsopi.com/index.php/sopi <p style="text-align: justify;">In the modern era of clinical application of knowledge of pharmacology, it is a big dilemma in hoosing between the good and the best drug. In making a decision for treatment planning clinician must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug.</p> <p style="text-align: justify;">There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastically in last 20 years. What it was with the western/ developed world is now shifting over to developing world.</p> <p style="text-align: justify;">India is set to grab clinical trial business, making the subcontinent world's preferred destination for clinical trials. The big reason being low cost of trial along with friendly drug control system with&nbsp;competent work force and patient availability. Indian investigators and clinical trial research professionals have already demonstrated their medical and scientific skills in various global clinical trials. It is time now to capitalize on this opportunity. Indian investigators and research professionals can prove their ability and show to the world and register their presence now as well as for future.</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> Society of Pharmacovigilance, India en-US Journal of Pharmacovigilance and Drug Safety 0972-8899 Drug-Induced Liver Injury (DILI): A Short Review on Current Scenario http://www.journalofsopi.com/index.php/sopi/article/view/63 <p><em>Drug Induced Liver Injury (DILI) is acute and chronic liver injury secondary to drugs and herbal compounds. DILI can be caused by overdose or even at therapeutic doses of some drugs such as NSAIDs and antitubercular drugs. It can be direct, indirect or idiosyncratic based on the mechanism of liver injury caused by the drug. It is also classified based on the histopathological and clinical features. Several mechanisms and hypotheses like immune mediation, mitochondrial injury and Hapten’s role are proposed to cause DILI. It can result in acute liver failure and even death if the suspected drug is not stopped. In India, antitubercular drugs are the major group of drugs known to cause DILI, apart from other antimicrobial drugs and NSAIDs. The International DILI Expert Working Group under CIOMS has put forward a grading system to assess severity of DILI based on clinical and laboratory findings. FDA evaluates hepatotoxicity of a drug before approval using Hy's rule, which states that 3 times elevation of Alanine aminotransferase (ALT) enzyme along with jaundice results in 5 to 50% fatality.&nbsp;The most useful approach for DILI detection and risk assessment is based on comprehensive hepatic data collection, assessment, and interpretation during clinical trials of drug development.</em></p> CP Hanan Syed Ziaur Rahman Copyright (c) 2021 CP Hanan, Syed Ziaur Rahman https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 1 4 Community pharmacy staff’s barriers and factors motivating to report adverse drug reactions: A prospective, cross-sectional study in Tamil Nadu http://www.journalofsopi.com/index.php/sopi/article/view/64 <p><strong><em>Background: </em></strong><em>The goal of this study is to assess community pharmacy staffs’ barriers and motivating factors towards ADR reporting system in Tamil Nadu, India. </em></p> <p><strong><em>Methods:</em></strong><em> A cross-sectional study was conducted among the community pharmacy staffs. A questionnaire was distributed to all consented pharmacy staffs after ethics approval. The statistical significance of nominal and ordinal items was determined using the Chi square test and the relative important index (RII). </em></p> <p><strong><em>Results: </em></strong><em>The study received a total response rate of 70.09% (n=214). The top three barriers to ADR reporting were found to be “Reporting forms are too complicated” (RII=0.900), “Not clear how to report ADR” (RII=0.982), and “Not confident whether it is an ADR”(RII=0.913). “Reporting should be made as mandatory” as a high priority among the various factors encouraging community pharmacy staffs to report ADR. </em></p> <p><strong><em>Conclusion: </em></strong><em>The study concludes that ADR reporting form should be simplified for community pharmacy staffs in Tamil Nadu.</em></p> S Darshna MG Rajanandh Copyright (c) 2021 S Darshna, MG Rajanandh https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 5 8 Proceedings of a Panel Discussion on “Better Public Health through Pharmacovigilance” held during Vice-Chancellor’s Conclave organized by IES Institute of Pharmacy, IES University, Bhopal http://www.journalofsopi.com/index.php/sopi/article/view/65 <p><strong>Proceedings of a Panel Discussion on “Better Public Health through Pharmacovigilance” held during Vice-Chancellor’s Conclave organized by IES Institute of Pharmacy, IES University, Bhopal in collaboration with Society of Pharmacovigilance India (SOPI) and Healthcopeia Foundation on December 18, 2021</strong></p> Mohammad Ishaq Geer Copyright (c) 2021 Mohammad Ishaq Geer https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 9 11 National Pharmacovigilance Week Celebration 2021 http://www.journalofsopi.com/index.php/sopi/article/view/66 <p>The Department of Pharmacology, AIIMS, Bhopal, which is a Regional Training Centre cum ADR Monitoring Centre (RTC-AMC) under the Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission (PvPI-IPC), Ghaziabad, celebrated National Pharmacovigilance Week from 17th to 23rd September 2021</p> AIIMS Bhopal Copyright (c) 2021 AIIMS Bhopal https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 12 13 Drug Safety Alerts from July – December 2021 http://www.journalofsopi.com/index.php/sopi/article/view/67 <p><strong>Drug Safety Alerts issued by Indian Pharmacopoeia Commission, National Coordination Center-Pharmacovigilance Programme of India from&nbsp;</strong><strong>July – December 2021</strong></p> Deepa Chaudhary Copyright (c) 2021 Deepa Chaudhary https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 14 15 Medical Device Safety Alerts from August – December 2021 http://www.journalofsopi.com/index.php/sopi/article/view/68 <p><strong>Medical Device Safety Alerts issued by Indian Pharmacopoeia Commission, National Coordination Centre-Materiovigilance Programme of India (MvPI) from August – December 2021</strong></p> Mohd Faizan Khan Copyright (c) 2021 Mohd Faizan Khan https://creativecommons.org/licenses/by-nc/4.0/ 2022-01-12 2022-01-12 18 2 16 18