Blogs

Case study of Sandoz Canada (2012): Supply shortages due to non-compliance with GMP.

case study of Ranbaxy Laboratories (India): Data falsification and GMP violations → $500 million settlement with USFDA.

case study of HeLa Cells & Informed Consent: Use of Henrietta Lacks’ cells without permission sparked bioethics debates

case study of Tuskegee Syphilis Study (USA, 1932–1972): Unethical human experimentation leading to stronger clinical research ethics rules.

Case study of Ranbaxy & Glass Particles Recall (2014): Glass particle contamination in injectables.

Case study of Tylenol Cyanide Crisis (1982): Tampering case → led to tamper-proof packaging regulations.

case study of the Heparin Contamination (2008): Over sulfated chondroitin sulfate contamination caused deaths

Case Study: Valsartan Recall (2018): NDMA contamination due to changes in manufacturing process in China.

Case Study – Zolgensma (Novartis): World’s most expensive drug → debates on affordability of gene therapy

Case Study – Gilead’s Remdesivir (COVID-19): Emergency use authorization, pricing and access debates.

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