Panel finds dosing mismatches in many FDCs
New Delhi: The expert panel which recommended a continuation of the ban on fixed dose combinations (FDCs) has found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity. Panel finds dosing mismatches in many FDCs The committee found that most pharma companies had not generated the “safety and efficacy data” of their own FDCs. After reviewing 349 fixed drug combinations (FDCs), the expert panel of the health ministry on Wednesday recommended that 343 of them be “prohibited” and the remaining six “restricted or regulated”. According to the experts, the pharma companies whose products were under scrutiny provided “irrelevant” data that relied on biased studies. “In FDCs where there is a dosing mismatch among the ingredients, FDC use would result in toxicity. An inability to adjust doses of individual ingredients is specially risky, if an ingredient has a narrow safety margin,” reads the executive summary of the report, reviewed by