This document discusses the Central Drug Standard Control Organization (CDSCO) and State Licensing Authorities in India and their roles and responsibilities. CDSCO is responsible for approval of new drugs, clinical trials, laying down standards for drugs, control over imported and exported drugs. It has a head office in Delhi and zonal offices in major cities. State Licensing Authorities are responsible for issuing licenses to manufacturing and sale of drugs within a state. The document outlines the hierarchy, functions, and drug approval process of CDSCO as well as portals for online licensing.

1. CDSCO ( Central Drug Standard Control
Organization ) and State Licensing Authority
: Organization , responsibility

2. What is CDSCO ?





3.  

4. Hierarchy










5. Head office and zonal office






7.  This are involved in GMP audits and Inspection of manufactured unit of large volume
parental , sera , vaccines and blood product.

Zonal office
Mumbai Kolkata Chennai
Ahmedaba
d
Hyderabad
Sub zonal office
Chandigarh Jammu Bangalore

8. 
















9. Function of CDSCO








10. Function of central
authority









11. Function of State Authority









12. Drug approval process
Applicant
IND application filling to CDSCO headquarters
Examination by new drug division
Detailed review by IND committee
Recommendation to DCGI
IND application
Clinical trials started
Application for new drug registration to CDSCO
Review by DCGI
If completed
Licence is granted
Application to ethical committee
Report to ethical committee
If positive
Reflux to
grant
licence
If not
complete

13. Cosmetic




14. Medical device



1.
2.
3.
4.

15. SUGAM Online licencing portal


1.
2.
3.
4.

16. Types of licence can apply through Sugam portal :

1.

1.

