Rohit Shishodia
To give an opportunity in connection with 324 irrational Fixed Dose Combinations (FDCs), the Directorate General of Health Services (DGHS) has directed all concerned drug manufacturers and stakeholders to submit fresh information of irrational FDCs in the prescribed format with relevant supporting documents in hard copy as well as soft copy by June 30, 2019.

These 324 FDCs were found irrational in an April 2019 report of a panel headed by Prof CK Kokate. The panel advised that these FDCs should be banned under Drugs and Cosmetics Act.

The directions have been given in a notice issued by Mr Sanjeev Kumar, Convener, Sub-Committee of Drugs Technical Advisory Board (DTAB) of FDC division of Drugs Controller General (India) under DGHS.

The notice reads that the 82nd meeting of DTAB regarding evaluation of banned FDCs was held on April 2, 2019, under the chairmanship of DGHS.

The notice adds, “It deliberated on the report of Prof Kokate Committee with respect to FDCs considered as irrational. Accordingly, a sub-committee was formed under the chairmanship of Dr Nilima Kshirsagar, The Chair in Clinical Pharmacology, ICMR, Mumbai, to examine these FDCs declared as irrational in the assessment report the committee.

The sub-committee of DTAB took note of the matter and has desired that the drug manufacturers and other stakeholders should submit the information in the prescribed format as per Annexure ‘A’ (along with supporting documents).