Central Drug Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It regulates the import of drugs, approves new drugs and clinical trials. CDSCO works with six zonal offices, seven sub-zonal offices, and thirteen port/airport offices. The Drug Controller General of India, who is responsible for new drug, medical device, and clinical trial approvals, advises CDSCO. At the state level, State Licensing Authorities regulate and control the licensing of drug manufacturing, distribution, and sale within the state.

1. Central Drug Standard Control
Organisation (CDSCO) &
State Licensing Authority of
lndia
-By Atul Bhombe
M.Pharmacy (RA) First yr.
Sanjivani college of pharmaceutical
education & research, Kopargaon MH
31/3/2021
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2. Central Drug Standard Control
Organisation (CDSCO)
 The Central Drugs Standard Control
Organization is India's national regulatory
body for pharmaceuticals and medical
devices.
 CDSCO under Directorate General of Health
Services, Ministry of Health & Family Welfare,
Government of India is the National
Regulatory Authority (NRA) of India.
 CDSCO is the Central Drug Authority for
discharging function assigned to the Central
Government under the Drug and cosmetics
Act 2

3. Major Role:
 Regulatory control over the import of drugs,
approval of new drugs and clinical trials,
meetings of Drugs Consultative Committee
(DCC) and Drugs Technical Advisory Board
(DTAB), approval of certain licenses as
Central License Approving Authority is
exercised by the CDSCO headquarters.
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4. Organisation and their roles
DCGI
Head Quarter
(New Delhi)
New Drug
approval
Imports,
Export
Clinical
trials,
Medical
device
Zonal
Office (6)
GMP
Audits
Coordination
with states
Sub Zonal
Off. (7)
GMP
Audits
Coordination
with states
Port/Airport
Off. (13)
Import
Export
Laboratorie
s (7)
Testing of
drug sample
Validation of
test protocols
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5. Drug Controller General of India
(DCGI)
 He is responsible for approval of new
drugs, medical devices & clinical trials to be
conducted in India.
 Is appointed by central govt.
 The DCGI is advised by the Drug Technical
Advisory Board {DTAB} and the Drug
Consultative Committe {DCC}
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6. Responsibility of CDSCO
 Approval of new drugs & clinical trials.
 Import registration & licensing.
 Licensing of Blood Banks,Vaccines,r-DNA
products & some medical devices &
diagnostic agent.
 Amendment to D & C Act & Rules.
 Banning of drug & cosmetics.
 Testing of new drug
 Oversight and market surveillance through
inspectorate of central over and above the
state authority.
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7. State Licensing Authority
 The authority created for the purpose of
regulating & controlling the licensing of the
cultivation manufacture, distribution and
sale of medical marijuana in the state.
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8. Organisation
State Licensing Authority
Drug controller/
commissioner
Drug testing laboratory
Deputy Drug Controller Govt. Analyst
Drug Inspector Analyst
Supportive Staff
Supportive Staff
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9. Responsibility of state licensing
authority
 Licensing of manufacturing site for drug
including API and finished product.
 It give Approval of drug testing laboratories.
 Monitoring of quality of drug and cosmetics
marketed in the country
 Licensing of establishment for sale or
disturbance of drug.
 Recall of sub-standard drugs.
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