The Ministry of Health and Family Welfare (MoHFW), on June 11, 2026, prohibited the manufacture, sale, and distribution of the fixed dose combination (FDC) Dicyclomine + Paracetamol + Clidinium Bromide for human use under Section 26A of the Drugs and Cosmetics Act, 1940.
The decision was taken following examination by an Expert Committee, the Drugs Technical Advisory Board, and its Sub-Committee, which concluded that the combination lacks therapeutic justification. The Expert Committee observed that both Dicyclomine and Clidinium Bromide possess anticholinergic properties, making their combination irrational, and noted that available scientific evidence does not support the efficacy or rationality of the formulation.
Based on the recommendations of DTAB and its Sub-Committee, and considering that safer alternatives are available and the FDC may pose a risk to human health, the Central Government has prohibited the manufacture, sale, and distribution of the fixed dose combination with immediate effect in the interest of public health.
[Notification No. S.O. 3078(E)]
