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 CDSCO is regulatory body of India that regulate the pharmaceuticals ,
medical devices and clinical trails.
 Head office located in new Delhi and functioning under the control of
directorate general of health services ,ministry of health services govt of
India.
 DGCI [drugs controller general of India responsible for approval of new
drugs. And CDSCO is discharging functions under drugs and cosmetic act .
 DGCI is advised by the drug technical advisory board{DTAB}and drug
consultative committee {DCC}.
 Drug inspector appointed by the central and state government by section
21
 Approval of new drugs
 Importing registration and licensing
 Licensing of blood banks,LPVs,vaccines,r-DNA
 Amendments to D&C Act and rules
 Banning of drugs ang cosmetics
 Testing of drugs by central labs
 Monitoring adverse drug reaction
 guidance on technical matter
CDSCO
Head quarter Zonal office Sub zonal office laboratories
New Delhi
North :Ghaziabad
South: Chennai
East : Kolkata
West : Mumbai
1. Bangalore
2. Chandigarh
3. Jammu
4. Goa
CDL: Kausali
CDL: Kolkata
RDTL:Guwahathi
RDTL:Chandigarh
CDTL: Mumbai
CDTL: Chennai
New drugs
CLAA
GAMP
Audits
Testing of drug
samples
 Drug controller general of India
 Joint drug controller
 Assistant drug controller
 Drug inspector
 Assistant drug inspector
 Technical officer
 approval of new drugs and clinical trails
 Amendments to drugs and cosmetic rules
 Banning of drugs and cosmetics
 Grant technical license
 Laying standard of drugs ,cosmetics, diagnostic and devices
 To regulate the market authorization of new drugs
 To regulate standard of importing of drugs
 Testing of drugs by clinical labs
 Publication of Indian pharmacopeia
 approval of drug testing laboratories.
 Recall of substandard drugs.
 Licensing of establishment for sale or distribution of drugs.
 Investigation and prosecution in respect of contravention of legal
provision.
 Licensing of drugs manufacturing authority and sales establish ments
 Licensing of drugs testing laboratories
 approval of drugs formulation for manufacture.
 Pre and post licensing inspections.
 Recall of substandard drugs.
Cdsco

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Cdsco

  • 1.
  • 2.  CDSCO is regulatory body of India that regulate the pharmaceuticals , medical devices and clinical trails.  Head office located in new Delhi and functioning under the control of directorate general of health services ,ministry of health services govt of India.  DGCI [drugs controller general of India responsible for approval of new drugs. And CDSCO is discharging functions under drugs and cosmetic act .  DGCI is advised by the drug technical advisory board{DTAB}and drug consultative committee {DCC}.  Drug inspector appointed by the central and state government by section 21
  • 3.  Approval of new drugs  Importing registration and licensing  Licensing of blood banks,LPVs,vaccines,r-DNA  Amendments to D&C Act and rules  Banning of drugs ang cosmetics  Testing of drugs by central labs  Monitoring adverse drug reaction  guidance on technical matter
  • 4. CDSCO Head quarter Zonal office Sub zonal office laboratories New Delhi North :Ghaziabad South: Chennai East : Kolkata West : Mumbai 1. Bangalore 2. Chandigarh 3. Jammu 4. Goa CDL: Kausali CDL: Kolkata RDTL:Guwahathi RDTL:Chandigarh CDTL: Mumbai CDTL: Chennai New drugs CLAA GAMP Audits Testing of drug samples
  • 5.  Drug controller general of India  Joint drug controller  Assistant drug controller  Drug inspector  Assistant drug inspector  Technical officer
  • 6.  approval of new drugs and clinical trails  Amendments to drugs and cosmetic rules  Banning of drugs and cosmetics  Grant technical license
  • 7.  Laying standard of drugs ,cosmetics, diagnostic and devices  To regulate the market authorization of new drugs  To regulate standard of importing of drugs  Testing of drugs by clinical labs  Publication of Indian pharmacopeia
  • 8.  approval of drug testing laboratories.  Recall of substandard drugs.  Licensing of establishment for sale or distribution of drugs.  Investigation and prosecution in respect of contravention of legal provision.
  • 9.  Licensing of drugs manufacturing authority and sales establish ments  Licensing of drugs testing laboratories  approval of drugs formulation for manufacture.  Pre and post licensing inspections.  Recall of substandard drugs.