The Ministry of Health and Family Welfare (MoHFW) on June 15, 2026, notified regarding the Prohibition of Fixed Dose Combination of Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide.
The following has been stated:
• The Government has prohibited the manufacture, sale, and distribution of the fixed dose combination (FDC) comprising Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide for human use with immediate effect. The decision was taken after expert reviews concluded that the combination lacks therapeutic justification and poses potential risks to patients when safer alternatives are available.
• An Expert Committee constituted to examine the FDC found that combining Dicyclomine and Clidinium Bromide, both possessing anticholinergic properties, was scientifically unjustified. The committee observed that available clinical data and peer-reviewed scientific evidence did not support the rationality of the combination and classified it as an irrational FDC.
• Subsequently, the Drugs Technical Advisory Board (DTAB) and its Sub-Committee conducted a detailed review, including consultations with manufacturers and stakeholders through public notices. In its report dated December 28, 2024, the Sub-Committee concluded that the combination offered no therapeutic advantage and recommended its prohibition in the larger public interest. Accepting these recommendations, the Central Government has now banned the manufacture, sale and distribution of the drug combination across India with immediate effect to safeguard public health.
[Notification no. - S.O. 3071(E)]
