Health Ministry will take a final call soon on granting exemption to the pharma companies to continue marketing of those controversial fixed dose combination (FDC) drugs after clearance from the DTAB. For this, the recommendation of the expert panel is awaited and in that case there will be need for fresh application from the companies.
"With regard to modalities to be followed regarding filing of application to the office of DCGI for grant of permission to manufacture those FDCs, which are considered by DTAB, industry associations stated that there must be a mechanism evolved such that the individual pharma company is not put to unnecessary inconvenience of filing application in the office of the DCGI as they may have been marketing such FDCs for the last many years. Such proposal of filing application along with fees and other relevant documents would be referred to the ministry for advice," according to the minutes of the last meeting of the panel headed by DCGI on January 23 and 24.
Meanwhile, after clearing most of the 48 fixed dose combinations came under screening in the previous meeting, the panel decided to meet again soon to evaluate the drugs belonging to the musculoskeletal and anti-arthritic category. The DTAB subcommittee, two orthopaedics nominated by the office of the DCGI and three orthopaedics recommended by the pharma industry will also join the exercise. The meeting had cleared as many as 40 of the 48 FDCs came for discussion while some others were referred for further data.
After examination of data and detailed deliberations, committee observed that FDCs of amlodipine+lovastatin and losartan+perindopril are rational. Most of antibiotics in combination with lactobacillus were also cleared by the panel. "It was suggested that use of probiotics with antibiotics which were known to cause diarrhoea will be useful in reducing diarrhoea. The question of minimum number of lactobacillus spores per day required to maintain gut flora was debated. Committee observed that currently there is no consensus or guidelines available regarding the recommendations on dose of lactobacilli in combination with antibiotics. Several such FDCs containing five billion daily doses of lactobacillus spores have already been approved. In view of the above, the committee noted that antibiotic in combination with five billion spores per day of lactobacilli for adults may not be considered as irrational. For paediatric use, it was decided that such proposals need to be deliberated along with paediatricians," the minutes said. In the case of dicloxacillin/cloxacillin, which were used with lactobacillus (numbers 90 and 93 as per DCGI list), the committee suggested that bioequivalency should be established.
Panel noted that FDCs such as azithromycin+ambroxol, atifloxacin+ambroxol have been already approved by the DCGI. So those FDCs containing them (Numbers 78, 82, 287 and 288 in the DCGI list) also got the nod by the panel. Combinations like domperidone+ranitidine (No 152) and lasoprazole+domperidone (No 208) were also cleared.
"However, for FDC of lansoprazole+domperidone, it was decided that lansoprazole should be in enteric coated form and domperidone (when used in 30 mg strength) should not be in sustained release from in order to match the dosing schedule of both drugs. It was also recommended that bioequivalency for FDC of lansoprazole+domperidone should be ensured," the minutes said.
"Committee noted that FDCs of gabapentin+methylcobalamin and pregabalin+mecobalamine have already been approved by the DCGI. However supportive scientific data for combining pyridoxine, folic acid, thioctic acid etc. to these FDCs is not adequate. Therefore it was recommended that data for clinical superiority for above stated FDCs against already approved FDCs should be provided. It was also decided to seek opinion from general physician, diabetologist, neurologist and pharmacologist in the matter," the minutes said.