PrintOverview:
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 2011. As India’s pharmaceutical market is poised for steady growth, reaching an estimated $13 billion, understanding of Indian regulatory issues is crucial for success.
You can purchase this 65-page report for $750. For $1500, you can purchase the report together with a 79-page appendix containing official forms and excerpts of important pharmaceutical regulations on special labeling, separate registration and price controls.
Updates for 2011 include:.
• Latest healthcare developments in India and their impact on foreign drug companies.
• India’s new regulations on clinical establishments, clinical trials and GLPs affecting foreign drug companies.
• Updated government guidelines regarding new drug manufacturing and sales in India.
• A new listing of Adverse Drug Reaction (ADR) Monitoring Centers in India. (Appendix only)
See a sample page of the report.
See a sample page of the appendix.
Table of Contents
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: 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
D. Prosecution of IP Violations
X: Drug Advertising
XI: Conclusion
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
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)
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.
