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India Pharmaceutical Regulatory Report 2008

India Pharmaceutical Regulatory Report 2008

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Published by Karrie Wang
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 2007. 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.
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 2007. 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.

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Published by: Karrie Wang on Jan 15, 2009
Copyright:Attribution Non-commercial

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04/08/2011

 
Pacific Bridge Medical
- India Medical Publications
 
India Pharmaceutical Regulatory Report 2008
 
Published by Pacific Bridge Medical
Print Article
By Ames Gross
and
John Minot2008Price: $750Price: $1500Overview:
The India Pharmaceutical Regulatory Report comprehensively covers all aspects of pharmaceutical regulations in India. Itincludes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, researchand development, and intellectual property protection. It also includes an overview of the Indian pharmaceutical market andforeign involvement in the market up to 2008. How suited the country is to different kinds of market entry – such asmanufacturing, 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 appendixcontaining official forms, relevant excerpted regulations, and lists of pharmaceuticals with requirements such as speciallabeling, separate registration, or price controls.
Click here
to view a sample page of this report.
Table of Contents:I. Indian Economy OverviewII. Overview of Healthcare System
A. HistoryB. Healthcare ProvidersC. Healthcare SpendingD. Conclusion
III. Pharmaceutical Industry
A. Market ProfileB. Industry ProfileC. Conclusion
IV. Regulatory Overview
A. Governing Legislation
1/15/2009 Asia Medical Consulting, Regulatory Apacificbridgemedical.com//India_Ph1/4
 
B. Agencies
V. Drug Registration and Import
A. OverviewB. New Drug RegistrationC. Import RegistrationD. Import LicenseE. Adverse Event Reporting
VI. Manufacturing
A. OverviewB. LicensingC. Good Manufacturing Practice
VII. Distribution
A. OverviewB. LicensingC. Record-KeepingD. Packaging and LabelingE. Price ControlsF. Prescription Management
VIII. Clinical Trials and R&D
A. OverviewB. Restrictions on Clinical TrialsC. Global Clinical TrialsD. Licensing and MonitoringE. Good Laboratory PracticeF. Accreditation of Testing Laboratories
IX. Intellectual Property Protection
A. HistoryB. Patent ApplicationsC. Remaining Restrictions
X. Drug Advertising
1/15/2009 Asia Medical Consulting, Regulatory Apacificbridgemedical.com//India_Ph2/4
 
XI. ConclusionXII. Appendices:Procedural Flowcharts
I. Importing drugsII. Manufacturing drugs
Official Forms
III. SummaryIV. Drug registrationV. New drugVI. Manufacturing licenseVII. Import licenseVIII. Wholesale license
Schedule Y Excerpts
IX. Study report formatX. Animal toxicologyXI. Animal pharmacologyXII. Informed consent formXIII. Adverse event report form
Drug Lists
XIV. Schedules C and C(I)XV. Schedule GXVI. Schedule HXVII. Schedule KXVIII. Schedules P and P(I)XIX. Schedule XXX. Drugs listed in Narcotic Drugs and Psychotropic Substances ActXXI. Drugs subject to price controlXXII. Drug Quality StandardsXXIII. Listing of CROs in IndiaXXIV. 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 + AppendixContact us at researchstore@pacificbridgemedical.com if you have any questions.
Read more >> Publications IndexGo to home 
Pacific Bridge Medical
, 7315 Wisconsin Avenue, Suite 609E, Bethesda, MD 20814Phone: (301) 469-3400, Fax: (301) 469-3409, Email:info@pacificbridgemedical.com 
1/15/2009 Asia Medical Consulting, Regulatory Apacificbridgemedical.com//India_Ph3/4

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