Notification for the Submission of Safety and Efficacy of FDC permitted to manufacture but not approved by DCGI

According to DCG (I) file No. 4-01/2013-DC (Misc 13-PSC) dated 15 Jan 2013, In respect of FDC Falling under definition of “New Drug” licensed by state licensing Authorities before 1.10.12, without the permission of DCG (I), it has been decided that the DCG (I) will ask all the state drug controllers to ask the concerned manufacturers to prove the Safety and Efficacy of such FDCs before CDSCO within a period of 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.

The new FDCs, if any, licensed by the state licensing authorities after 01.10.12 without approval of DCG(I), the same will be considered for being prohibited for manufacture and marketing in the country.