The two–day meeting of the sub-committee of the Drug Technical Advisory Board (DTAB) has failed to clear the remaining Fixed Dose Combination (FDC) drugs with no consensus evolved on the rationality of the FDCs under consideration.

Though meeting did take up most of the FDCs listed in the agenda, the experts had reservations about the rationality of the drugs came up for discussion. The lack of sufficient scientific literature, cited by the doctors, remained the biggest stumbling block for deciding on the fate of these FDCs, sources said.

The meeting, held after a long gap, ended 'futile' with no clear decision could be taken and even the date for next meeting was not fixed, claimed some industry representatives who attended the meeting.

The sessions, spread over on April 19 and 20, took up 64 of the remaining 80 odd FDCs, but no final decision was taken on any of them. The FDCs belonging to dermatological, nutritionals, CNS, anti-microbial, anti-diabetic, orthopaedics, cough and cold categories were taken up for deliberations.

The meeting also re-examined a set of 22 FDCs for rationality, as per the recommendation of the meeting of DTAB. They belonged to 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 16 FDCs were also re-examined by the panel, as per the direction of the last DTAB meeting. These combinations were of antimicrobial with lactic acid bacillus and had been discussed by the sub-committee at its meeting on January 23 and 24.

Sources said there was no clear decision on these 38 FDCs, which came for re-examination, for the lack of data. The meeting could not touch the six FDCs approved before 1988, though listed in the agenda. They included dicyclomine+mefenamic acid+ paracetamol, dicyclomine + paracetamol + clinidium bromide, dicyclomine + paracetamol + clinidium bromide + chlordiazepoxide, mefenamic acid + dicyclomine, paracetamol + dicycloverine + mefenamic, and propranolol + Diazepam.

The FDC issue became controversial when the then DCGI Dr M Venkateswarlu in June 2007 asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations and the issue became a bone of contention between the industry and the DCGI. The industry then moved court and got stay order against the DCGI order from Madras High Court, which is yet to be vacated.