Notification for the Submission of Safety and Efficacy of FDC permitted to manufacture but not approved by DCGI
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)
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.
Recent Posts
What penalties are levied in case of Non-Compliance in obtaining Wholesale Drugs?
One must obtain a drug license to launch a business selling drugs or cosmetics. No one can sell drugs or cosmetics without a drug license. The 1940 Drugs and Cosmetics Act specifies the procedure and ..
Key factors to keep in mind while getting approval for wholesale drug license registration
A wholesale drug license is required for manufacturing, distribution, sale, or storage of drugs. The Drugs and Cosmetics Act, 1940 outlines the requirements to obtain a manufacturing license in India...
CPCB Alert - Timely Annual Report to be Submitted by PIBOs to Avoid Penalties
The Central Pollution Control Board (CPCB) issued a directive alert for submission of timely annual reports by all Pollution Implementing and Beneficiary Organisations (PIBOs) to avoid any penalties. ..
Contact us
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.