Even as the sub-committee of the Drug Technical Advisory Board (DTAB) is meeting for two days from today, the vexed issue over Fixed Dose Combinations (FDC) is unlikely to be settled early, as being reiterated by the authorities.

The process of clearing the FDCs is going to be long-time affair as the sub-committee is scheduled to re-examine a number of FDCs already cleared by them earlier. Apart from this, the panel will also assess 64 FDCs, out of the remaining 80 FDCs to be covered, according to the agenda fixed for sessions spread on April 19 and 20.

The sub-committee will also examine six FDCs approved before 1988, as per the decision taken by it in the meeting held on October 1, 2008. They include dicyclomine+mefenamic acid+ paracetamol, dicyclomine + paracetamol + clinidium bromide, dicyclomine + paracetamol + clinidium bromide + chlordiazepoxide, mefenamic acid + dicyclomine, paracetamol + dicycloverine + mefenamic, and propranolol + Diazepam.

The meeting will re-examine a set of 22 FDCs for rationality, as per the recommendation of the meeting of DTAB. They fall in the categories of nutritionals, orthopaedics, and antihistamines. They have been already cleared by the expert panel, but the 57th meeting of the DTAB has directed re-examination of the same.

Likewise, another set of 16 FDCs will also be re-examined by the panel for rationality, as per the direction of the last DTAB meeting. These combinations are of antimicrobial with lactic acid bacillus and had been discussed by the sub-committee at its meeting on January 23 and 24.

Thus in total, the two-day meeting of the sub-committee has to clear 107 FDCs after examining the rationality. The recommendation by the DTAB for re-examination would further prolong the process of putting a final solution to the vexed issue of FDCs, though DCGI had recently claimed that the matter would be solved within one month.