India Pharmaceutical Regulatory Report 2009

Publication Date	January 2009
Publisher	Pacific Bridge Medical
Product Type	Report
Pages	58
ISBN Number	not applicable
Product Code	PBM00004

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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.

Content

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)

Delivery Details

PRINT/CD-ROM:despatched via by standard US mail for US order with delivery within 1to 5 days. Orders for Europe and ROW courier dispatch with delivery within 2 to 10 days.

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