The Drugs Controller General of India (DCGI) has directed the manufacturers to submit application for category ‘d’ FDCs as per Prof. Kokate Committee Report by May 30, 2020.
The extension in time limit for submission of the applications was last given until November 22, 2019.
DCGI through a notice has directed the manufacturers to submit application along with requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019.
To download the notice, click here
A letter on the same has also been sent to all the state drugs controllers and India drug / pharmaceuticals associations.
As per the notice, “This is in continuation to the notice dated May 22, 2019. As per this said letter, manufacturers who are already holding licenses from State Licensing Authorities for such FDCs before October 1, 2012 and did not apply to DCGI were required to submit their applications to the DCGI.”
The date for filing such applications expired on November 22, 2019. Meanwhile, various representations were received requesting for extension of time for submission of such applications.
Accordingly, it has been decided that manufacturers who were holding license prior to October 1, 2012 may submit their applications w.r.t category ‘d’ FDCs by May 30, 2020, the notice stated.
For details for FDCs, click here
Union health ministry had constituted a committee under Prof C K Kokate to evaluate 324 irrational fixed dose combinations (FDCs).
After examining 418 applications of FDCs, the Kokate Committee found 324 FDCs as irrational (category a), 4 FDCs require further deliberation (category b) 28 FDCs as rational (category c), 2 FDCs require further generation of data (category ‘d) after evaluating all the data submitted.
The Kokate Committee in its report opined that these FDCs wherever recommended as “irrational (category ‘a’)” should not be allowed for their continued manufacturing and marketing in the country.
The FDCs which have been declared as irrational needs to be prohibited under Drugs and Cosmetics Act (D&C Act), 1940 as other safer alternatives to those combinations are available.