India Pharmaceutical Regulatory Report 2012

Overview:

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.

You can purchase this 72-page report for $750. For $1500, you can purchase the report together with a 89-page appendix containing official forms and excerpts of important India pharmaceutical regulations on special labeling, separate registration and price controls.

Updates for 2012 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

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: India Pharmaceutical Regulations 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

 

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