The Ministry of Health and Family Welfare (MoHFW), on June 11, 2026, prohibited the manufacture, sale, and distribution of the fixed dose combination (FDC) Paracetamol + Lignocaine for human use under Section 26A of the Drugs and Cosmetics Act, 1940.
The decision follows a detailed review by an Expert Committee, the Drugs Technical Advisory Board, and its Sub-Committee, which found that the available scientific data and peer-reviewed evidence do not support the rationality of combining Paracetamol and Lignocaine in a single formulation. The Sub-Committee further concluded that there is no therapeutic justification for the combination and that its use may pose a risk to patients.
Based on the recommendations of DTAB and considering the availability of safer alternatives, the Central Government determined that prohibiting the manufacture, sale, and distribution of the fixed dose combination is necessary in the interest of public health. Accordingly, the ban on Paracetamol + Lignocaine has been imposed with immediate effect.
[Notification No. S.O. 3079(E)]
