SUSTAINABILITY REPORT 2013-15

People Overview Self Managed Teams Mechanisation Safety Overview The Parivartan     Journey Progress on     Roadmap Incident Statistics Robust Governance Standardised     Processes Enhanced Awareness Capability Building Safety Infrastructure Safety Audits Quality Overview Top-down    Accountability Quality by Design Quality Culture     Transformation Quality Assurance Quality     Best Practices All Time Audit     Readiness Availability Overview Strategic Sourcing Risk Management Product    Rationalisation Success stories Environment Overview Roadmap Energy Management Emissions Water Waste Case Study KPIs Community Overview Focus Areas Education Livelihoods Healthcare Infrastructure     Initiatives Creating Change     Makers Productivity Overview Productivity Streams Case Study PACE Update Initiatives Engineering Excellence Overview Digitisation Automation Mechanisation Lean Manufacturing Capital Equipment Strategy Predictive Maintenance Continuous Improvement Overview Continuous     Improvement     at Work Best Practices Annexures GRI Index Acronyms Assurance Statement   Summary Report     PRODUCT RESPONSIBILITY PRODUCT SAFETY Pharmacovigilance (PV)    |    Clinical Trials   Product safety is a hygiene factor at Dr. Reddy's. We embed safety into every step of our production processes as well as monitor our medicines during and after sales. The Pharmacovigilance team and Clinical Strategy Group are our key arms which ensure product safety. Our safety standards are in line with globally-recognised safety benchmarks like the International Conference on Harmonisation (ICH) guidelines and pharmacovigilance mandates.     Pharmacovigilance At Dr. Reddy's, pharmacovigilance is an essential function that assesses and addresses potential risks of a drug. A competent team, aided by a structured process tracks, evaluates and addresses product safety across all stages - from development to after sales. Adverse Event Monitoring Effective communication channels like toll-free numbers and websites have been put in place for various stakeholders to report adverse drug reactions (ADRs). Our medical representatives also act as an interface with our stakeholder spectrum and are trained to capture adverse events. In certain geographies, drug safety information is also received directly from Regulatory Health Authorities. All reported adverse events are continually and systematically aggregated and reviewed by pharmacovigilance drug safety physicians for untoward drug safety signals. Such an approach enhances customer satisfaction, ensures patient well-being and addresses regulatory notifications. In the reporting year, we established an electronic gateway with the US FDA for submission of adverse event reports. The gateway allowed pharmacovigilance to change from a paper-based submission process to an electronic one. We also migrated our safety database to a higher version thus ensuring compliance with the changing global drug safety reporting regulations and creating a common platform for sharing safety information for the PV staff stationed across geographies.