New drug approval from dci

This query is : Resolved

Querist : Anonymous

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.

RAMESH KUMAR VERMA

RAMESH KUMAR VERMA (Expert)
Follow

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