Professional Documents
Culture Documents
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
1
Legal Enactments to Regulate
Import, Manufacture & Sale of Drugs
Drugs and Magic
Drugs and Remedies
Cosmetics Act, (Objectionable
Advertisements)
1940
Act, 1954
2
C DSCO
Drugs Controller General (I)
•Import
•GMP Audits •GMP Audits •Export •Testing of drug
•Coordinations •Coordinations Samples
•New Drugs with States with States •Validation of
•CLAA Test protocol
•Imports
•DTAB/ DCC
3
Functions of CDSCO
Testing of Drugs
4
Approval of Clinical Trials, Import, &
Manufacture of New Drugs
Approval of IND
IND Applicant CDSCO HQ
Examination by New
Drug Division
Timeline –
Phase I – 90 days
Phase II – 45 days Recommendation
to DCG(I)
Phase III – 60 days
5
Import, Registration and Licensing
Mfg sites and Products are required to be Registered
6
Central Licensing*
CLAA
Approval and
Grant of License
License Prepared by
State Licensing
Manufacturer Authority
7
National Pharmacovigilance
Programme
NPAC
CDSCO
ZPC
RPC
NN N
N N
N N N E
S E
S E
S E
S S
E E
S S
E S
E S
E E
S W W W W W
PPC
8
Proposed Structure of CDA
Central
Drug
Administration
Biologicals &
Division for Import Training & Services
Biotechnology products
Collaborations
• With Health Canada, US FDA, Brazil,
South Africa to strengthen
9
Clinical Trial Inspection
• Inspection of clinical trial sites is an
important tool to ensure subject protection
and integrity of data.
• To develop knowledge and skill in
inspecting clinical trial sites, implementing
GCP inspection programme, CDSCO has
collaborated with US FDA.
10
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
11
Timelines
Approval Time Frame
12
13
14
15
16
17
18
19
20
21
22
23
24