India Pharmaceutical Regulatory Report 2009

Summary

The India Pharmaceutical Regulatory Report comprehensively covers all aspects of pharmaceutical regulations in India. It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. It also includes an overview of the Indian pharmaceutical market and foreign involvement in the market up to 2009. How suited the country is to different kinds of market entry - such as manufacturing, sales, or research - is discussed in relation to the regulatory and market environment. As India's pharmaceutical market is poised for steady growth, reaching an estimated $11 billion in 2008, understanding of Indian regulatory issues is crucial for success there.

Fully updated for 2009.

Contents

• I. Indian Economy Overview
• II. Overview of Healthcare System
  • A. History
  • B. Healthcare Providers
  • C. Healthcare Spending
  • D. Conclusion
• III. Pharmaceutical Industry
  • A. Market Profile
  • B. Industry Profile
  • C. Conclusion
• IV. Regulatory Overview
  • A. Governing Legislation
  • B. Agencies
• V. Drug Registration and Import
  • A. Overview
  • B. New Drug Registration
  • C. Import Registration
  • D. Import License
  • E. Adverse Event Reporting
• VI. Manufacturing
  • A. Overview
  • B. Licensing
  • C. Good Manufacturing Practice
• VII. Distribution
  • A. Overview
  • B. Licensing
  • C. Record-Keeping
  • D. Packaging and Labeling
  • E. Price Controls
  • F. Prescription Management
• VIII. Clinical Trials and R&D
  • A. Overview
  • B. Restrictions on Clinical Trials
  • C. Global Clinical Trials
  • D. Licensing and Monitoring
  • E. Good Laboratory Practice
  • F. Accreditation of Testing Laboratories
• IX. Intellectual Property Protection
  • A. History
  • B. Patent Applications
  • C. Remaining Restrictions
• X. Drug Advertising
• XI. Conclusion

• XII. Appendices:
  • Procedural Flowcharts
    • I. Importing drugs
    • II. Manufacturing drugs
  • Official Forms
    • III. Summary
    • IV. Drug registration
    • V. New drug
    • VI. Manufacturing license
    • VII. Import license
    • VIII. Wholesale license
  • Schedule Y Excerpts
    • IX. Study report format
    • X. Animal toxicology
    • XI. Animal pharmacology
    • XII. Informed consent form
    • XIII. Adverse event report form
  • Drug Lists
    • XIV. Schedules C and C(I)
    • XV. Schedule G
    • XVI. Schedule H
    • XVII. Schedule K
    • XVIII. Schedules P and P(I)
    • XIX. Schedule X
    • XX. Drugs listed in Narcotic Drugs and Psychotropic Substances Act
    • XXI. Drugs subject to price control
    • XXII. Drug Quality Standards
    • XXIII. Listing of CROs in India
    • XXIV. Healthcare Statistics and Pharmaceutical Markets in Asia (charts)