Professional Documents
Culture Documents
Regulations - DR - Bangaruranjan-Well-drfine-Drug-ministry - CDSCO
Regulations - DR - Bangaruranjan-Well-drfine-Drug-ministry - CDSCO
Ethics
Manufacture
Sale
What is Regulated under Rules
Clinical New
Trials Drugs
Exports
Functions of CDSCO
CDSCO, HQ
New Delhi
•Mumbai
• Legal Requirement
• Protects the rights, integrity & confidentiality of
research subjects
• Provides assurance that the data & results are
credible & accurate
• Global Acceptance
Ethics Committee Registration:
Sponsor / Investigator
(within 10 calendar days after analysis of SAE)
DCG(I)*
(order within 3 months of occurrence)
*If required DCG(I) can constitute Expert Committee in cases of SAE other than death
Formula on Quantum of Compensation
Compensation = BxFxR/ 99.37
B= Base Amount (8 lakhs)
F= Factor depending on age (Workmen Compensation Act)
R= Risk Factor (severity & seriousness, co-morbidities etc. 0.5-
4.0)
State-Wise List of Ethics Committee
Registered By CDSCO (Total 745)
Andhra Pradesh 80 Madhya Pradesh 09
Assam 03 Maharashtra 178
Bihar 04 Mizoram 01
Chhattisgarh 01 Orissa 10
Delhi 48 Puducherry 04
Goa 04 Punjab 14
Gujarat 86 Rajasthan 24
Haryana 09 Sikkim 02
Himachal Pradesh 02 Tamilnadu 70
Jammu & Kashmir 01 Uttarakhand 02
Karnataka 75 Uttar Pradesh 32
Kerala 48 West Bengal 38
Clinical Trials Registration (CTRI)
To enhance:
- Transparency
- Accountability &
- Accessibility of clinical trials,
• Made mandatory by the DCGI’s office from June 15, 2009.
• 20 data set points of the WHO, as well as details of India
Investigators, ethics and DCGI approval (including submission
or approval documents)
• For Global clinical trials, specific information regarding the
number of patients being recruited and the date of first
enrollment in India
• www.ctri.nic.in
Other Regulations and Office Orders