Even as the industry is still discontent with the authorities on the issue of Fixed Dose Combinations (FDCs), an expert panel of the Planning Commission has called for stricter criteria for registration and regulatory review of FDCs by the Central Drugs Standard Control Organisation (CDSCO) with a view to weed out irrational FDCs.
“Irrational FDCs, non-essential vitamins/tonics, cough syrups feature in the top selling pharmaceuticals in terms of value and volume but they harm public health and patients by increasing adverse effects, imposing higher financial burden on patients and facilitating - emergence of drug resistance (in the case of FDCs of antibiotics). Therefore, stricter criteria for registration and - regulatory review of medicines by CDCSO should be a priority. This helps weed out substandard, toxic, irrational medicines from the market,” a working group of the Commission said.
It suggested that CDSCO should implement a much stricter registration regime for FDCs. Products should be selected and approved only when the combination has a proven advantage in therapeutic effect, safety, adherence or in decreasing the emergence of drug resistance in malaria, tuberculosis and HIV/AIDS, the panel said.
“Except FDCs included in the WHO’s essential Drug List, all FDCs registered in India are reviewed in terms of their therapeutic effect and legally sustainable action taken for phased out weeding of all irrational FDCs. The Drug Technical Advisory Board should set up a suitable mechanism for the purpose,” it said.
FDCs have been at the centre of a vexed controversy for over four years now. The lack of concrete rules largely led to the confusion and confrontation between the authorities and the industry, after the DCGI sought to weed out the irrational FDCs from the market.