General Introduction of the Central Drugs Standard Control Organization (CDSCO).

1. CENTRALDRUGS STANDARD CONTROLORGANIZATION
PRESENTED BY :- KAPIL
M. PHARMACY 1ST YEAR
DRUG REGULATORY AFFAIRS

2. CONTENT
• Introduction
• Function
• Organisation
• Drug approval process
• Drug controller general of India
• Clinical Trails
• Medical Device
• References

3. • INTRODUCTION
• The Central Drugs Standard Control Organization (CDSCO) is the national
regulatory body for Indian pharmaceuticals and medical devices, and serves
parallel function to the European Medicines Agency of the European Union ,
the PMDA of Japan , the Food and Drug Administration of the United States
and the Medicines and Healthcare products Regulatory Agency of the United
Kingdom.
• It’s headquarter is located at FDA Bhawan, Kotla road, New Delhi and
functions under the Directorate General of Health Services.

4. • The Central Drugs Standard Control Organization (CDSCO) is the Central
Drug Authority for discharging functions assigned to the Central
Government under the Drugs and Cosmetics Act. CDSCO has six zonal
offices, four sub-zonal offices, 13 port offices and seven laboratories under
its control.
• Major functions of CDSCO:
Regulatory control over the import of drugs, approval of new drugs and
clinical trials, meetings of Drugs Consultative Committee (DCC) and
Drugs Technical Advisory Board (DTAB), approval of certain licences as
Central Licence Approving Authority is exercised by the CDSCO hqrs.

6. • ZONAL OFFICES
1. Mumbai
2. Kolkata
3. Chennai
4. Ghaziabad
5. Ahmadabad
6. Hyderabad
• These are involved in GMP audits and inception of manufacturing unit of
large volume, parentral, vaccines and blood products.

7. • SUB-ZONAL OFFICES
1. Chandigarh
2. Jammu
3. Bangalore
4. Goa
5. Indore
• These centre coordinate with state drug control authorities under their
jurisdiction for uniform standard of inspection and enforcement.

8. • CENTRAL DRUG TESTING LABORATORIES
1. Central Drug Laboratory, Kolkata
2. Central Drug Testing Laboratory, Mumbai
3. Central Drug Testing Laboratory, Chennai
4. Central Drug Laboratory, Kasauli
5. Regional Drug Testing Laboratory, Guwahati
6. Regional Drug Testing Laboratory, Chandigarh
• These laboratory are responsible for quality control of drug and cosmetic in
the country.

9. • DRUG CONTROLLER GENERAL OF INDIA
Currently DCGI is Dr. S. Eswara Reddy.
He is appointed by Central Government under the DCGI.
DCGI is responsible for approval of licences of specified categories of drugs such as blood
and blood products, IV fluids, vaccines and sera in India.
DCGI lay down the standard and quality of manufacturing, selling, import and distribution
of drugs in India.
He is advised by Drug Technical Advisory Board & Drug Consultative Committed.

10. • DRUG APPROVAL PROCESS
• New drugs to be marketed in Country in accordance with the permission
granted by Drug Controller General of India (DCGI) after ensuring that these
drugs are :-
• Safe
• Effective
• Comply with requirement of schedule Y of the Drug and Cosmetic act rules.
• Applicants required to provide technical data in respect of safety and
efficiency before these could be permitted to be marketed in country.

11. • CLINICAL TRIALS
• Schedule Y of Drug and Cosmetic act explain the guideline for grant of
permission for conducting clinical trials in India.
• The protocol for such trails are examined by the office of DCGI before the
permission are granted.
• Office of DCGI also grant permission for conducting bioequivalence studies.
• Registration of clinical trials has been made mandatory with centralized
clinical trials registry of ICMR with effect from 15th 2009.

12. • MEDICAL DEVICE
• A medical device is any apparatus, appliance, software, material, or other article—
whether used alone or in combination, including the software intended by its
manufacturer to be used specifically for diagnostic and/or therapeutic purposes and
necessary for its proper application—intended by the manufacturer to be used for
human beings for the purpose of:-Diagnosis, prevention, monitoring, treatment, or
alleviation of disease.
• Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or
handicap.
• Investigation, replacement, or modification of the anatomy or of a physiological
process.

13. • REFERENCES :-
1. http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1423
2. http://www.cdsco.nic.in/forms/list.aspx?lid=2121&Id=0