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India Pharmaceutical Regulatory Report 2012 Product Image

India Pharmaceutical Regulatory Report 2012

  • ID: 2226301
  • August 2012
  • Region: India
  • 72 Pages
  • Pacific Bridge Medical

The India Pharmaceutical Regulatory Report comprehensively covers all aspects of India pharmaceutical regulations. 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 2012. As India's pharmaceutical market is poised for steady growth, reaching an estimated $13 billion, understanding of Indian regulatory issues is crucial for success.

Also available with an 89 page appendix, see below.

I: Overview of India's Economy

II: Overview of India's Healthcare System
A. India's Healthcare System: Goals and Challenges
B. Healthcare Providers
C. Healthcare Spending
D. Conclusion

III: India's Pharmaceutical Industry
A. Market Profile
B. Industry Profile
C. Conclusion

IV: India Pharmaceutical Regulations 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
D. Prosecution of IP Violations

X: Drug Advertising

XI: Conclusion

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