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![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}.](https://image.slidesharecdn.com/cdsco-180730095653/85/Cdsco-3-320.jpg)
Uploaded byANIL SHARMA
Cdsco
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.
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Cdsco
- 1.
- 2. INTRODUCTION • TheCDSCOof Indiais 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 Generalof 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 ofdrugs 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.
- 11. Function of StateLicensingAuthorities • 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 StateLicensingAuthorities • 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 NewDrugs • 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 arerequired 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 • ScheduleYofdrugs 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 ofclinical 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