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India Pharmaceutical Regulatory Report 2010

By Ames Gross

Published by Pacific Bridge Medical

January 2010

Price of Report: $750

Price of Report + Appendix: $1500

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Overview:

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.

You can purchase this 58-page report for $750. For $1500, you can purchase the report together with a 90-page appendix containing official forms, relevant excerpted regulations, and lists of pharmaceuticals with requirements such as special labeling, separate registration, or price controls.

Fully updated for 2010.

See a sample page of the report.

See a sample page of the appendix.

Table of Contents:

  1. Indian Economy Overview
  2. Overview of Healthcare System
    1. History
    2. Healthcare Providers
    3. Healthcare Spending
    4. Conclusion
  3. Pharmaceutical Industry
    1. Market Profile
    2. Industry Profile
    3. Conclusion
  4. Regulatory Overview
    1. Governing Legislation
    2. Agencies
  5. Drug Registration and Import
    1. Overview
    2. New Drug Registration
    3. Import Registration
    4. Import License
    5. Adverse Event Reporting
  6. Manufacturing
    1. Overview
    2. Licensing
    3. Good Manufacturing Practice
  7. Distribution
    1. Overview
    2. Licensing
    3. Record-Keeping
    4. Packaging and Labeling
    5. Price Controls
    6. Prescription Management
  8. Clinical Trials and R&D
    1. Overview
    2. Restrictions on Clinical Trials
    3. Global Clinical Trials
    4. Licensing and Monitoring
    5. Good Laboratory Practice
    6. Accreditation of Testing Laboratories
  9. Intellectual Property Protection
    1. History
    2. Patent Applications
    3. Remaining Restrictions
  10. Drug Advertising
  11. Conclusion
  12. Appendices:
      Procedural Flowcharts
    1. Importing drugs
    2. Manufacturing drugs
      3. Official Forms
    3. Summary
    4. Drug registration
    5. New drug
    6. Manufacturing license
    7. Import license
    8. Wholesale license
      9. Schedule Y Excerpts
    9. Study report format
    10. Animal toxicology
    11. Animal pharmacology
    12. Informed consent form
    13. Adverse event report form
      14. Drug Lists
    14. Schedules C and C(I)
    15. Schedule G
    16. Schedule H
    17. Schedule K
    18. Schedules P and P(I)
    19. Schedule X
    20. Drugs listed in Narcotic Drugs and Psychotropic Substances Act
    21. Drugs subject to price control
    22. Drug Quality Standards
    23. Listing of CROs in India
    24. Healthcare
      25. Statistics and Pharmaceutical Markets in Asia (charts)

Order now and we will ship you this report at no additional charge.

Price:
Report Only: $750
Report + Appendix: $1500

Please contact us at researchstore@pacificbridgemedical.com if you have any questions.

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