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India Pharmaceutical Regulatory Report 2013

  • ID: 3068606
  • Report
  • January 2013
  • Region: India
  • Pacific Bridge Medical
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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.

Updates for 2013 include:.

- First compulsory license granted by the Indian Patent Office and its implication for the pharmaceutical industry
- New CDSCO regulations concerning biosimilars and ethics committees
- New CDSCO guidelines on compensating for injuries and deaths during clinical trials

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1. Overview of India's Economy

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

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

4. India Pharmaceutical Regulations Overview
A. Governing Legislation
B. Agencies

5. Drug Registration and Import
A. Overview
B. New Drug Registration
C. Import Registration
D. Import License
E. Adverse Event Reporting

6. Manufacturing
A. Overview
B. Licensing
C. Good Manufacturing Practice

7. Distribution
A. Overview
B. Licensing
C. Record-Keeping
D. Packaging and Labeling
E. Price Controls
F. Prescription Management

8. 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

9. Intellectual Property Protection
A. History
B. Patent Applications
C. Remaining Restrictions
D. Prosecution of IP Violations

10. Drug Advertising

11. Conclusion


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
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. List of Adverse Drug Reaction (ADR) Monitoring Centers in India
XXIV. Listing of CROs in India
XXV. Healthcare Statistics and Pharmaceutical Markets in Asia (charts)
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown