NEW UPDATES BY CDSCO

Please see some of the updated gazettes and guidelines by CDSCO for conducting clinical trials in India.Click on the respective links to view the guidelines.

Gazette Notiification regarding import & registration of cosmetics

http://cdsco.nic.in/gazette_notification_cosmetics.htm

Draft rules regarding Umbilical cord blood

http://cdsco.nic.in/gazette_notification_g.htm

Guidance on clinical trial inspection 

http://cdsco.nic.in/CLINICAL%20TRIAL%20INSPECTION%20PROGRAMME%20OF%20INDIA.pdf

Guidelines on  Common Technical Documents(CTD)(New drug application)

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

Draft guidance for industry on Fixed Dose Combinations(FDCs)

http://cdsco.nic.in/FDC%20Guidelines%20_%20Revised1.pdf