The Ministry of Health and Family Welfare (MoHFW) on June 15, 2026, notified regarding the Prohibition of Fixed Dose Combination of Amoxicillin + Serratiopeptidase.
The following has been stated:
• The Government has banned the manufacture, sale, and distribution of the fixed-dose combination (FDC) Amoxicillin + Serratiopeptidase for human use. The prohibition follows recommendations from expert bodies that found the combination to be irrational and lacking therapeutic justification, particularly when safer and more effective alternatives are available.
• An Expert Committee that examined the FDC in 2021 concluded that the combination is pharmacodynamically irrelevant, is not supported by standard treatment guidelines, and lacks sound clinical evidence for the concurrent use of Amoxicillin and Serratiopeptidase. The committee further noted that available scientific literature and peer-reviewed evidence do not establish the rationality or added therapeutic benefit of the combination.
• The Drugs Technical Advisory Board (DTAB) and its Sub-Committee subsequently reviewed the matter, invited representations from manufacturers and stakeholders, and conducted a detailed assessment. In its report dated December 28, 2024, the Sub-Committee recommended the prohibition of the FDC in the interest of public health, stating that there is no therapeutic justification for combining these ingredients. Accepting these recommendations, the Central Government has ordered an immediate nationwide ban on the manufacture, sale, and distribution of the Amoxicillin + Serratiopeptidase fixed-dose combination.
[Notification no. - S.O. 3072(E)]
