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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.