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U.S. Department of Health and Human Services

International Programs

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India Office

Presentation in Pdf Format [220 KB]

Slide 1: Understanding Regulatory Structure

Information researched and gathered

  • Complex regulatory structure 
  • Opportunities identified for capacity-building

Capacity-building

Engaged with stakeholders (especially with regulators and industry)

  • 15 Programs, presentations and classes delivered

Compliance and Inspectional Issues

On-going assessments and inspections

  • Focus on quality and improved systems 
  • Analyze FDA data to improve inspectional assignments

Slide 2: Goals for 2010

Strengthen relationships and collaborations

  • FDA Centers 
  • GOI regulators – DCGI, FSSA, EIC 
  • Indian Industry Associations 
  • Other USG agencies

Improved reporting on Indian regulatory environment

  • Cross-comparison to U.S. statutes and regulations 
  • Status of pending legislation and evolving personnel assignments

Develop, initiate or expand capacity-building programs 

  • GMP inspections (foods and drugs) 
  • LACF and HACCP trainings 
  • DCGI’s international cadre of drugs inspectors 
  • Medical device inspectorate

Increase inspections 

  • Targeted and smarter 
  • Joint inspections
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