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India’s Central Drugs Standard Control Organization (CDSCO) has created new, stricter guidelines for clinical trial inspections. The guidelines are part of a broader government effort to solidify India’s regulatory framework for clinical research, protect patients and foster increased confidence in research conducted in India. The guidelines provide specific direction for CDSCO inspectors and officers as well as contract research organizations involved in clinical trials of drugs, biologics and medical devices regulated by India’s Drugs and Cosmetics Act and for the clinical trial sites themselves.

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• • India tightens clinical trial guidelines (Outsourcing Pharma)
  • India issues guidance on clinical trial inspections (Pharma Times)