Download 3 rd MAY 2014

Regulatory Mechanism in
Clinical Trials
Convention Hall, SIU Lavale
Name of the Speaker: Dr. Raman Gangakhedkar
Designation: Deputy Director, NARI
Topic : Regulatory Mechanism in
Clinical Trials
SUMMARY
• Sir started the presentation by giving examples of
regulatory bodies
• At National level
Drug Controller General of India (DGCI)
Clinical Trial Registry of India
ICMR
• At Institutional level
Scientific advisory committee
Independent ethics committee
What is changing now ?
Consent procedures
SAE (Serious Adverse Event Reporting)
Ethics Committee
Compensation Rules
IND Drugs have to undergo all phases of trial
First time generics need bridging studies
Documents of IEC approval :
Study protocol & informed consent template
Patient information material & advertisement
Letters of amendment
Guidelines : Milestones
1996 – ICH Guidelines
2000 – ICMR Guidelines
2001 – Indian GCP Guidelines
2003 – Revision of BE Guidelines
2003 – Revision of schedule Y
2013 – New DCGI Guidelines
Report Prepared By:
• Akhila Nayak
• Anisha Mehta
• Ebrahim Khan
• Nikhil Dhorepatil
• Shirin Khan
• Swati Sonik
• Yogita Patil
(MBA –HHM 2013-15)