New drug approval from dci

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Querist : Anonymous

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Querist : Anonymous (Querist)
25 September 2012 Dear All,



Kindly let me know the procedure to get new drug approval from DCI

What are the documents require for the same. How much time will be taken by DCI

or Any other information.



Pls advise.

28 September 2012 please open the below mentioned links:

http://cdsco.nic.in/html/Notification.html


http://cdsco.nic.in/html/Sec_122_A.htm


http://cdsco.nic.in/Annexure_FTS.pdf

http://www.cdsco.nic.in/challan.pdf

guidelines:

http://cdsco.nic.in/CTD_Guidance%20-Final.pdf

for export :

http://www.cdsco.nic.in/guidane_documents_export_noc.pdf

more information:

Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Phone: 91-11-23236965 / 23236975
Fax: 91-11-23236973
E-mail:- dci@nb.nic.in



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