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India Pharmaceutical Regulatory Report 2008

Published by: Pacific Bridge Medical

Published: Mar. 1, 2008 - 55 Pages


Table of Contents


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)

Abstract

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 2008. 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.

You can purchase this 55-page report for $750. For $1,500, 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.

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