CDSCO

Topics: Clinical trial, Pharmacology, Government of India Pages: 7 (1144 words) Published: April 2, 2015
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 with state drug control authorities under their jurisdiction for uniform standard of inspection and enforcement.

CENTRAL DRUGS TESTING LABORATORIES







Central Drug Laboratory, Kolkata
Central Drug Testing Laboratory, Mumbai
Central Drug Testing Laboratory, Chennai
Central Drug Laboratory, Kasauli
Regional Drug Testing Laboratory, Guwahati
Regional Drug Testing Laboratory, Chandigarh

FUNCTIONS OF CDSCO IN UNDER CENTRAL
GOVERNMENT
• Approval of new drugs and clinical trials.
• Import Registration and Licensing
• Licensing of Blood Banks, LVPs, Vaccines, r-DNA products and some Medical devices and Diagnostic agents.
• Amendment to D&C Act and Rules.
• Participation in WHO GMP certification schemes.
• Banning of drugs and cosmetics.
• Grant to test license, personal license.
• Testing of drugs by Central Labs.
• Publication of Indian Pharmacopoeia.
• Monitoring adverse drug reactions.
• Guidance on Technical matters.

FUNCTION OF STATE LICENSING
AUTHORITIES
• Licensing of drug testing laboratories.
• Approval of drug formulation for manufacture.
• Monitoring of quality of Drugs and cosmetics, manufactured by respective state and those marketed in the state.
• Investigation and prosecution in respect of contravention of legal provisions. • Pre- and post- licensing inspection.
• Recall of sub-standard drugs.

APPROVAL FOR NEW DRUGS
• New drugs are permitted to be marketed in country in accordance with the permission granted by DCGI after ensuring that these drugs are:
 Safe
 Effective
 Comply with requirement of
the Drug and Cosmetic rules
• Applicants are required to provide technical data in respect of safety and efficacy before these could be permitted to be marketed in country.
• Definition of new drug also includes fixed dose combination which are required to be marketed for the 1st time in country

CLINICAL TRIALS
•...
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