Regulatory Guidance

Alarming Amount of FDCs Sold in India Without Central Regulatory Approval

May 14, 2015


A large number of fixed-dose drug combinations (FDCs) have been licensed by state drug authorities in India without approval by CDSCO (the Indian central drug licensing agency), according to new research from Queen Mary University of London published in PLOS Medicine.

This study provides specific evidence in support of a 2012 committee report that found that "a very large number" of FDCs are being sold without CDSCO approval, despite concerns over the safety and efficacy of these combination treatments. Of 175 FDC formulations marketed in India between 2011-2012 in the therapeutic areas studied, the researchers found CDSCO approval for only 60 (34%).

The study strongly suggested that India should immediately ban sales and manufacturing of FDCs not approved by the CDSCO and called for a "complete overhaul of the new Drugs Bill" by Indian goverment.

Read the eurekalert! summary