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CENTRAL DRUG STANDARD
 CONTROL ORGANISATION
        (CDSCO)
   prepared by:-Pooja
INTRODUCTION
• The CDSCO of India is main regulatory body
  for regulation of pharmaceutical, medical
  devices and Clinical Trials.

• Head office of CDSCO is located in NEW DELHI
  and functioning under the control of
  Directorate General of Health Services,
  ministry of health and family welfare
  Government of India.
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 under
  the DCGI the State drug control organization will
  be functioning.

• The DCGI is advised by the Drug Technical
  Advisory Board {DTAB} and the Drug Consultative
  Committed {DCC}.
Organization Chart



HEAD QUATER   ZONAL OFFICE (6)   SUB ZONAL       PORT/AIRPORT    LABORATIES (6)
                                   OFFICE (3)      OFFICE (7)



 •NEW DRUGS                                          •Import    •Testing of
                                 •GMP Audits
 •CLAA                                               •Export     drug samples
                                 •Coordination
 •Imports                                                       •Validation of
                                   with states
 •DTAB/DCC                                                       test protocols
              •GMP Audits
              •Coordination
                with states
Zonal offices
• Mumbai
• Kolkata
• Chennai
• Ghaziabad
• Ahemdabad
• Hyderabad
These are involved in GMP audits and inspection
  of manufacturing units of large volume
  parental, sera, vaccine and blood products.
Sub-zonal office:-
I. Chandigarh
II. Jammu
III. Benglore

   These centre 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

These laboratories are responsible for quality
  control of drugs and cosmetics in the country.
Functions of CDSCO in Center
• 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.
Functions of CDSCO in Center
• Banning of drugs and cosmetics.
• Grant to test license, personal
  license, NOC’s for export.
• Testing of drugs by Central Labs.
• Publication of Indian Pharmacopoeia.
• Monitoring adverse drug reactions.
• Guidance on Technical matters.
STATE DRUGS CONTROL ORGINATION

DRUGS CONTROLLER/COMMISSIONER   DRUGS TESTING LABORATORY


DEPUTY DRUGS CONTROLLER
                                         GOVT. ANALYST


DRUG INSPECTOR
                                           ANALYST

SUPPORTING STAFF
                                     SUPPORTING STAFF
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.
Function of State Licensing Authorities

• Investigation and prosecution in respect
  of contravention in respect of
  contravention of legal provisions.
• Administrative actions.
• 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 schedule Y 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
• Schedule Y of drugs and cosmetics act explain
  the guideline for grant of permission for
  conducting clinical trials in India.
• The protocol for such trials are examined by
  the office of DCGI before the permission are
  granted.
• Office of DCGI also grants permission for
  conducting bioequivalence studies.
a. Registration of clinical trials has been made
   mandatory with centralized clinical trial
   registry of ICMR with effect from 15th 2009.
b. Drug and Cosmetic rules are being amended
   to make mandatory the registration of clinical
   research organizations.
c. Drug and Cosmetic act is proposed to be
   amended to include a separate chapter on
   clinical trials.
MEDICAL DEVICES
• Any instrument, apparatus,implement
  machine, appliance, implant, invitro reagent
  used for
Central drug standard control organisation

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Central drug standard control organisation

  • 1. CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO) prepared by:-Pooja
  • 2. INTRODUCTION • The CDSCO of India is main regulatory body for regulation of pharmaceutical, medical devices and Clinical Trials. • Head office of CDSCO is located in NEW DELHI and functioning under the control of Directorate General of Health Services, ministry of health and family welfare Government of India.
  • 3. 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 under the DCGI the State drug control organization will be functioning. • The DCGI is advised by the Drug Technical Advisory Board {DTAB} and the Drug Consultative Committed {DCC}.
  • 4. Organization Chart HEAD QUATER ZONAL OFFICE (6) SUB ZONAL PORT/AIRPORT LABORATIES (6) OFFICE (3) OFFICE (7) •NEW DRUGS •Import •Testing of •GMP Audits •CLAA •Export drug samples •Coordination •Imports •Validation of with states •DTAB/DCC test protocols •GMP Audits •Coordination with states
  • 5. Zonal offices • Mumbai • Kolkata • Chennai • Ghaziabad • Ahemdabad • Hyderabad These are involved in GMP audits and inspection of manufacturing units of large volume parental, sera, vaccine and blood products.
  • 6. Sub-zonal office:- I. Chandigarh II. Jammu III. Benglore These centre co-ordinate with state drug control authorities under their jurisdiction for uniform standard of inspection and enforcement.
  • 7. 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 These laboratories are responsible for quality control of drugs and cosmetics in the country.
  • 8. Functions of CDSCO in Center • 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.
  • 9. Functions of CDSCO in Center • Banning of drugs and cosmetics. • Grant to test license, personal license, NOC’s for export. • Testing of drugs by Central Labs. • Publication of Indian Pharmacopoeia. • Monitoring adverse drug reactions. • Guidance on Technical matters.
  • 10. STATE DRUGS CONTROL ORGINATION DRUGS CONTROLLER/COMMISSIONER DRUGS TESTING LABORATORY DEPUTY DRUGS CONTROLLER GOVT. ANALYST DRUG INSPECTOR ANALYST SUPPORTING STAFF SUPPORTING STAFF
  • 11. 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.
  • 12. Function of State Licensing Authorities • Investigation and prosecution in respect of contravention in respect of contravention of legal provisions. • Administrative actions. • Pre- and post- licensing inspection. • Recall of sub-standard drugs.
  • 13. 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 schedule Y of the Drug and Cosmetic rules.
  • 14. • 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.
  • 15. Clinical Trials • Schedule Y of drugs and cosmetics act explain the guideline for grant of permission for conducting clinical trials in India. • The protocol for such trials are examined by the office of DCGI before the permission are granted. • Office of DCGI also grants permission for conducting bioequivalence studies.
  • 16. a. Registration of clinical trials has been made mandatory with centralized clinical trial registry of ICMR with effect from 15th 2009. b. Drug and Cosmetic rules are being amended to make mandatory the registration of clinical research organizations. c. Drug and Cosmetic act is proposed to be amended to include a separate chapter on clinical trials.
  • 17. MEDICAL DEVICES • Any instrument, apparatus,implement machine, appliance, implant, invitro reagent used for