The Ministry of Health and Family Welfare (MoHFW) on June 15, 2026, notified regarding the Prohibition of Fixed Dose Combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes.
The Central Government has determined that the fixed dose combination (FDC) of Amoxicillin, Serratiopeptidase, and Lactobacillus Sporogenes poses potential risks to human health, particularly when safer alternatives are available. The combination was reviewed by an Expert Committee in 2021, which found it to be pharmacodynamically inappropriate and not aligned with standard treatment guidelines. It also noted the absence of credible clinical evidence supporting the concurrent use of Amoxicillin and Serratiopeptidase, thereby classifying the combination as irrational.
The Drugs Technical Advisory Board (DTAB) examined the Expert Committee’s findings and referred the matter to its Sub-Committee for a detailed review of irrational FDCs. Stakeholders were given an opportunity to submit relevant data. After thorough evaluation, the Sub-Committee, in its report dated December 28, 2024, concluded that the combination lacks therapeutic justification and recommended its prohibition in the interest of public health.
The DTAB accepted the Sub-Committee’s recommendation, agreeing that continued use of this FDC is not justified. Based on these expert opinions, the Government concluded that regulatory intervention is necessary to safeguard public health.
Accordingly, in exercise of powers under Section 26A of the Drugs and Cosmetics Act, 1940, the Central Government has prohibited the manufacture, sale, and distribution of the fixed dose combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes for human use in India with immediate effect.
[Notification No. S.O. 3070(E)]
