The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body for pharmaceuticals, medical devices, and clinical trials in India. It is headed by the Drugs Controller General of India and has offices across the country. CDSCO is responsible for approving new drugs, medical devices, and clinical trials. It also regulates the import and manufacturing of drugs and medical devices through licensing and good manufacturing practice compliance.

1. CENTRALDRUGSTANDARD
CONTROLORGANISATION
(CDSCO)
prepared by:-Pooja

2. INTRODUCTION
• TheCDSCOof India is main regulatorybody
for regulation of pharmaceutical, medical
devices and Clinical Trials.
• Head office of CDSCOis located in NEWDELHI
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 aresponsible for approval of New
Drugs, Medical devices and Clinical Trailsto be
conducted in India.
• Heis appointed by the central governmentunder
the DCGIthe State drug control organization will
be functioning.
• TheDCGIis advised by the DrugTechnical
Advisory Board {DTAB}and the Drug Consultative
Committed {DCC}.

4. Organization Chart
HEADQUATER ZONALOFFICE(6) SUBZONAL
OFFICE(3)
PORT/AIRPORT
OFFICE(7)
LABORATIES(6)
•NEWDRUGS
•CLAA
•Imports
•DTAB/DCC
•GMPAudits
•Coordination
with states
•GMPAudits
•Coordination
with states
•Import
•Export
•Testingof
drug samples
•Validation of
test protocols

5. Zonal offices
• Mumbai
• Kolkata
• Chennai
• Ghaziabad
• Ahemdabad
• Hyderabad
Theseare involved in GMPaudits andinspection
of manufacturing units of largevolume
parental, sera, vaccine and blood products.

6. Sub-zonal office:-
I. Chandigarh
II. Jammu
III. Benglore
Thesecentre co-ordinate with state drug
control authorities under theirjurisdiction
for uniform standard of inspection and
enforcement.

7. Central DrugsTesting Laboratories
• Central Drug Laboratory, Kolkata
• Central DrugTestingLaboratory, Mumbai
• Central DrugTesting Laboratory, Chennai
• Central Drug Laboratory, Kasauli
• Regional DrugTestingLaboratory, Guwahati
• Regional DrugTesting Laboratory, Chandigarh
Theselaboratories are responsible for quality
control of drugs and cosmetics in thecountry.

8. Functions of CDSCOinCenter
• Approval of new drugs and clinicaltrials.
• Import Registration andLicensing
• Licensing of Blood Banks,LVPs,Vaccines,
r-DNAproducts and some Medical
devices and Diagnostic agents.
• Amendment to D&CAct andRules.
• Participation in WHOGMPcertification
schemes.

9. • Banning of drugs andcosmetics.
• Grant to test license,personal
license, NOC’sfor export.
• Testingof drugs by CentralLabs.
• Publication of IndianPharmacopoeia.
• Monitoring adverse drugreactions.
• Guidance on Technicalmatters.
Functions of CDSCOinCenter

10. STATEDRUGSCONTROLORGINATION
DRUGSCONTROLLER/COMMISSIONER
DEPUTYDRUGSCONTROLLER
DRUGINSPECTOR
SUPPORTINGSTAFF
DRUGSTESTINGLABORATORY
GOVT.ANALYST
ANALYST
SUPPORTINGSTAFF

11. Function of State LicensingAuthorities
• Licensing of drug testinglaboratories.
• Approval of drug formulationfor
manufacture.
• Monitoring of quality of Drugsand
cosmetics, manufactured byrespective
state and those marketed in thestate.

12. Function of State LicensingAuthorities
• Investigation and prosecution in respect
of contravention in respect of
contravention of legalprovisions.
• Administrative actions.
• Pre- and post- licensing inspection.
• Recallof sub-standarddrugs.

13. Approval For New Drugs
• New drugs are permitted to be marketedin
country in accordance with the permission
granted by DCGIafter ensuring that these
drugs are
• Safe
• Effective
• Comply with requirement of scheduleYofthe
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 fixeddose
combination which are required to be
marketed for the 1st time incountry.

15. Clinical Trials
• ScheduleYof drugs and cosmetics act explain
the guideline for grant of permission for
conducting clinical trials inIndia.
• The protocol for such trials are examined by
the office of DCGIbefore the permission are
granted.
• Office of DCGIalso grants permission for
conducting bioequivalence studies.

16. a. Registration of clinical trials hasbeenmade
mandatory with centralized clinical trial
registry of ICMRwith effect from 15th 2009.
b. Drug and Cosmetic rules are being amended
to makemandatory the registration ofclinical
research organizations.
c. Drug and Cosmetic act is proposed to be
amended to include aseparate chapteron
clinical trials.

17. MEDICALDEVICES
• Any instrument, apparatus,implement
machine, appliance, implant, invitro reagent
used for