CDSCO
REGULATORY ENVIRONMENTS
IN INDIA – CDSCO
BY:
SANJANA P RAO
4NM12BT029
DEPT OF BIOTECHNOLOGY,
NMAMIT
EVOLUTION OF INDIAN DRUG LEGISLATION
• Drug is in the concurrent list of the Indian Constitution.
• It is governed by both Central and State governments under the Drugs and
Cosmetics Act, 1940 and Rules 1945 thereunder.
• The Act was put forth with the objective of ensuring that the public are supplied with safety, efficacy and good quality of drugs.
• It regulates the manufacture, sale, distribution, and import of drugs, cosmetics, and other medical devices in the country
CDSCO
• It was under this Act that CDSCO was set up as a part of the Ministry of Health and
Family Welfare, Government of India.
• The Central Drug Standard Control Organization (CDSCO) is the main regulatory body for regulation of pharmaceutical, medical devices and Clinical Trials in India.
• The Head office of CDSCO is located in New Delhi and is functioning under the Control of Directorate General of Health Services.
DRUGS CONTROLLER GENERAL OF
INDIA
[DCGI]
• He/she is a responsible for approval of New Drugs, Medical devices and
Clinical Trails to be conducted in India.
• He is appointed by the central government.
• The State drug control organization functions under the DCGI.
• The DCGI is advised by the Drug Technical Advisory Board {DTAB} and the Drug
Consultative Committee {DCC}.
DIVISIONS OF CDSCO
CDSCO
Headquarters
• New drugs
• CLAA
• Imports
• DTAB/DCC
Zonal Offices
• GMP Audits
• Coordination with states
Sub Zonal
Offices
• GMP Audits
• Coordination with states
Laboratories
• Testing of drug samples
• Validation of test protocols
Port/ Airport Office
• Import
• Export
ZONAL
OFFICES
•
•
•
•
•
•
Mumbai
Kolkata
Chennai
Ghaziabad
Ahmedabad
Hyderabad
• These are involved in GMP audits and inspection of manufacturing units of large volume of sera, vaccine and blood products
SUB ZONAL OFFICES
•
•
•
•
Sub-zonal office:Chandigarh
Jammu
Bangalore
• These centres co-ordinate
IN INDIA – CDSCO
BY:
SANJANA P RAO
4NM12BT029
DEPT OF BIOTECHNOLOGY,
NMAMIT
EVOLUTION OF INDIAN DRUG LEGISLATION
• Drug is in the concurrent list of the Indian Constitution.
• It is governed by both Central and State governments under the Drugs and
Cosmetics Act, 1940 and Rules 1945 thereunder.
• The Act was put forth with the objective of ensuring that the public are supplied with safety, efficacy and good quality of drugs.
• It regulates the manufacture, sale, distribution, and import of drugs, cosmetics, and other medical devices in the country
CDSCO
• It was under this Act that CDSCO was set up as a part of the Ministry of Health and
Family Welfare, Government of India.
• The Central Drug Standard Control Organization (CDSCO) is the main regulatory body for regulation of pharmaceutical, medical devices and Clinical Trials in India.
• The Head office of CDSCO is located in New Delhi and is functioning under the Control of Directorate General of Health Services.
DRUGS CONTROLLER GENERAL OF
INDIA
[DCGI]
• He/she is a responsible for approval of New Drugs, Medical devices and
Clinical Trails to be conducted in India.
• He is appointed by the central government.
• The State drug control organization functions under the DCGI.
• The DCGI is advised by the Drug Technical Advisory Board {DTAB} and the Drug
Consultative Committee {DCC}.
DIVISIONS OF CDSCO
CDSCO
Headquarters
• New drugs
• CLAA
• Imports
• DTAB/DCC
Zonal Offices
• GMP Audits
• Coordination with states
Sub Zonal
Offices
• GMP Audits
• Coordination with states
Laboratories
• Testing of drug samples
• Validation of test protocols
Port/ Airport Office
• Import
• Export
ZONAL
OFFICES
•
•
•
•
•
•
Mumbai
Kolkata
Chennai
Ghaziabad
Ahmedabad
Hyderabad
• These are involved in GMP audits and inspection of manufacturing units of large volume of sera, vaccine and blood products
SUB ZONAL OFFICES
•
•
•
•
Sub-zonal office:Chandigarh
Jammu
Bangalore
• These centres co-ordinate