Clinical Trials Exposed: FDA, CDSCO & The Hidden Risks

In June 2026, India's drug regulator CDSCO suspended the Ethics Committee of HCG's Bengaluru cancer hospital for 24 months and barred new clinical trials there. Deaths and serious adverse events were not reported on time, and an ethics committee member was also working as an investigator. In this video I explain why clinical trials exist, what an Ethics Committee (IRB) does, why trial data sometimes gets hidden, how regulators catch it through BIMO inspections, and the FDA warning letter to Novo Nordisk over unreported adverse event reports. 📩 Want 1-to-1 career guidance? Book here: https://topmate.io/shubham_singh What you'll learn: • What clinical trials must prove: safety and efficacy • Who regulates trials: CDSCO (India) and FDA (US) • What happened at HCG Bengaluru and why the Ethics Committee was suspended • Who sits on an Ethics Committee / IRB and why conflict of interest matters • Why some companies hide adverse event data • How a BIMO inspection checks lab, site and CRO data • Phase 4 safety reporting and the Novo Nordisk FDA warning letter ⏱️ CHAPTERS 0:00 What clinical trials must prove 0:18 Who regulates trials: CDSCO & FDA 0:27 HCG Bengaluru case (June 2026) 0:39 What is an Ethics Committee (IRB)? 0:55 What went wrong at HCG 1:14 Why trial data gets hidden 1:40 How regulators find out: BIMO inspection 2:34 Novo Nordisk & the FDA warning letter 3:10 Final thoughts 🧠 MORE ON CLINICAL RESEARCH & INDUSTRY NEWS Clinical Programming Is Evolving | SAS, R & AI: https://youtu.be/T7twohTCWyM Should You Learn Clinical SAS in 2026?: https://youtu.be/h8Ukn1Dqma4 Top Jobs & Career Roadmap for B.Pharm & M.Pharm: https://youtu.be/64xQHbtE7Bk AI & Industry News playlist: https://www.youtube.com/playlist?list=PLPWvOKrIVbE8 🎯 CAREER GUIDANCE & TRAINING 📩 1-to-1 Counselling Session: https://topmate.io/shubham_singh 🎓 Clinical SAS Training (Live + Recorded): https://edu.clinicalstudyacademy.com/ 🤝 CONNECT WITH US 📢 Telegram Community: https://t.me/+LVejh1RxCC84Mjk1 💼 LinkedIn: https://www.linkedin.com/in/shubhamrsingh/ 👋 ABOUT CLINICAL STUDY ACADEMY (CSA) I'm Shubham Singh, Founder of Clinical Study Academy. We help students and professionals build careers in Clinical SAS Programming, Statistical Programming and Biostatistics through practical learning, structured training, interview preparation and career guidance. What you'll learn on this channel: • Clinical SAS Programming and SAS Interview Preparation • Clinical Statistical Programming and Biostatistics • SDTM, ADaM, CDISC and Clinical Trial Reporting • Clinical Research Careers and Industry Insights • Career guidance for students, freshers and working professionals Subscribe for practical learning resources, career insights and interview preparation. #ClinicalTrials #CDSCO #FDA #EthicsCommittee #ClinicalResearch #ClinicalSAS