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Cdsco: Drug Regulatory System
Cdsco: Drug Regulatory System
Seminar on Clinical Trials: The Heart of Medical Science on 4th November, 2008 at Assocham House, New Delhi By Dr. Surinder Singh Drugs Controller General (India) CDSCO, Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India, New Delhi www.cdsco.nic.in
CD SCO
The overall objective of a Drug Regulatory Authority (DRA) is to ensure that medicinal products are of acceptable quality, safety and efficacy, are manufactured and distributed in ways which ensure their quality until they reach the patient/consumer, and their commercial promotion is accurate.
C DSCO
Drugs Controller General (I)
HEAD QUARTER ZONAL OFFICE (4) SUB ZONAL OFFICE (2) PORT OFFICE (7) LABORATORY (6)
Import Export
GOVT. ANALYST
DRUGS INSPECTOR
ANALYST
SUPPORTING STAFF
SUPPORTING STAFF
Total No. of Drugs Inspectors Total No. of Drugs Manufacturers Total No. of Sales Premises
: : :
Functions of CDSCO
Approval of new drugs and clinical trials
Testing of Drugs
Monitoring of Quality of Drugs and Cosmetics marketed in the country Investigation and prosecution in respect of contravention of legal provision
Approval of IND
IND Applicant CDSCO HQ
Detailed Review by IND Committee Timeline Phase I 90 days Phase II 45 days Phase III 60 days
Approval
Recommendation to DCG(I)
Rules related to grant of Registration Certificate and Import License Information required for registration of Mfg site and Product Registration Certificate(RC) and Import License - Valid for 3 years
For RC: As per D& C Rules, 9 Months ,However in practice, 2 months For Import License
2 -3 weeks
As per Rule 24A (5), there is provision to inspect overseas manufacturing site for which manufacturer has to pay 5000 USD
Central Licensing*
CLAA Approval and Grant of License
License Prepared by State Licensing Authority
Manufacturer
Examination of Report
For Biologicals, Large volume parenterals (LVP), Blood bank and blood products & Some Medical Devices
Permission is required from CDSCO for conducting global clinical trials in the country Phase I for New Drug substance developed outside India is not permitted So far, approx. 500 permissions have been granted since 2003
CDSCO
NPAC
ZPC RPC
N N N N N N N N E S E S E S E S E S S E S E S E S E S E W W W W W
PPC
NPAC = National Pharmacovigilance Advisory Committee, ZRP = Zonal Pharmacovigilance Centre, RPC = Regional Pharmacovigilance Centre, PPC = Peripheral Pharmacovigilance Centre
Office - 1
Office - 2
Office - 3
New Drugs & Clinical Trials Enforcement Biologicals & Biotechnology products
Organizational services
Pharmacovigilance
Quality control
Collaborations
With Health Canada, US FDA, Brazil, South Africa to strengthen
Functioning in several areas including monitoring drugs for adverse reactions, regulating medical devices, clinical practices and biological drugs
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Expansion of Organization
Shifted to the state of the art FDA Bhawan Aggressive approach in filling up vacant posts and creating new vacancies Contractual staff hired for smooth functioning of the organization
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Timelines
Approval
Export NOC Dual use, Rule 37 & Neutral code Additional indication etc. Form 10 Test License First response to New Drug FDC first response Endorsement of additional products on registration Registration
Time Frame
2 Weeks 3 Weeks 4 Weeks 4 Weeks 4 Weeks 6 Weeks 6 Weeks 8 Weeks 12 weeks
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