1. Nalini Negi, Tarun Gautam Department of Pharmacy Practice, ISF college of Pharmacy, Moga, India. GOOD PHARMACOVIGILANCE PRACTICES; GLOBAL SCENARIO Good pharmacovigilance practices (GVP) are the minimum standard requisite to monitor safety of medicines that is exposed to the public. These are set of procedures that expedite the practice of pharmacovigilance.[1] These practices are used in relation to medicines that are legalized at the national level. These standard procedures ensure authorization holders for an adequate quality system in monitoring of the licensed medicines; maintain pharmacovigilance data and its documentation and competent staff to carry out these duties.[2] Globally GVP is governed by different organization like MHRA in United Kingdom, EMA in European Union, HPRA in Ireland, SFDA in Saudi Arabia, USFDA in USA and CDSCO in India. The basic modules of pharmacovigilance for medicines are although the same but there are some variations across the nations in aspect of methods that are used in the monitoring of safety of medicines. According to EMA, GVP assists in Monitoring of Compliance and Pharmacovigilance Inspections, Risk Management Plan (RMP) and encompasses the responsibilities of the qualified person responsible for pharmacovigilance (QPPV) and the back-up procedure to apply in their absence, Eudravigilance system and description of electronic reporting..[3] USFDA issued concepts on conducting premarketing risk assessment, developing and implementing risk minimization tools. Premarketing Guidance focuses on risk assessment during late stage clinical development. RiskMAP is a strategic safety programme that meets specific goals and objectives to minimize risks. [4] CONCLUSION : Although there is a long way to go for Indian Pharmacovigilance system to touch Shoulder to Shoulder with ahead countries, yet recent data shows promising results and great future. But clearly there is a need of strengthening GVP guidelines in India in order to be recognized on the world map of pharmacovigilance. CONCLUSION : Although there is a long way to go for Indian Pharmacovigilance system to touch Shoulder to Shoulder with ahead countries, yet recent data shows promising results and great future. But clearly there is a need of strengthening GVP guidelines in India in order to be recognized on the world map of pharmacovigilance. REFERENCES: 1.Good pharmacovigilance practice for medicines (GPvP) Available online at: https://www.gov.uk/government/collections/goodpharmacovigilancepracticeformedicinesgpvp). 2.Good Pharmacovigilance Practices. Available online at: www.hpra.ie 3.Guideline on good pharmacovigilance practices (GVP) – Module XVI (Rev 1) EMA/204715/2012 (Rev 1) Available online at: www.ema.europa.eu 4.Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Available online at: http://www.fda.gov/cder/guidance/index.htm. 5.Lihite RJ and Lahkar M (2015) An update on the Pharmacovigilance Programme of India. Front. Pharmacol. 6:194. doi: 10.3389/fphar.2015.00194. 6.WHO-Uppsala Monitoring Centre (UMC). (2014). Documentation Grading-Completeness Score. Available online at:http://www.who-umc.org PRESENTED AT ONE DAY NATIONAL CONFERENCE ON DRUG SAFETY AND PHARMACOVIGILANCE “MOVING FORWARD TOGETHER ON PATIENT SAFETY”, GGSCOP, YAMUNANAGAR, HARYANA, INDIA EMA (EU) MHRA (UK) CDSCO (India) USFD A (USA) Although Based on PvPI database, this year Drugs Controller of India has instructed manufacturers to include Steven Johnson Syndrome (SJS) in package insert of product containing carbamazepine and advised to the physicians to screen the patients for HLA-B*1502 allele before initiating treatment with carbamazepine.[5] In year 2013, India’s contribution to WHO–UMC’s global drug safety database (Vigibase) was 2%. India was 7th in position among top 10 counties contributing to global drug safety database. Among Asian countries, India is the only country having more than 1 lakhs ICSRs in Vigibase. According to WHO- UMC Documentation Grading-Completeness Score, the average completeness score of India in 3rd quarter of 2014 was 0.94 out of 1 [WHO-Uppsala Monitoring Centre (UMC), 2014]. Thus, from this completeness score it can be predicted that AMCs of PvPI are collecting all the necessary information required for ADR reporting via Vigiflow. [6] Yellow Card Scheme; Voluntary Online ADR reporting EudraVigilance Post- Authorization Module (EVPM) EudraVigilance Clinical Trial Module (EVCTM) Risk Minimization Programme (RMP) by Pharmacovigilance Risk Assessment Committee (PRAC) MedWatch; Voluntary and Mandatory Online ADR Reporting US FDA ADR Reporting System for Pharmaceutical Products (FAERS) The Pharmacovigilance Plan under Risk Minimization Action Plan (RiskMAP) Spontaneous ADR Reporting Form on AMCs with HELPLINE 1800-180-3024 Insufficient Data Management under Safety Database PvPI Data Source WHO Worldwide Database VIGIBASE