India Pharmaceutical Regulatory Report 2008

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Pacific Bridge Medical - India Medical Publications India Pharmaceutical Regulatory Report 2008 Print Article

Published by Pacific Bridge Medical By Ames Gross and John Minot

2008 Price: $750

Price: $1500 Overview: 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 $1500, 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. Click here to view a sample page of this report. 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

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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

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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) Order now and we will ship you this report at NO ADDITIONAL CHARGE. Price: $750 Report only $1500 Report + Appendix Contact us at [email protected] if you have any questions.

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