The Ministry of Health and Family Welfare (MoHFW) on June 15, 2026, notified regarding the Prohibition of Fixed Dose Combination of Acetyl Salicylic Acid + Ethoheptazine.
The Central Government, based on expert evaluation, has determined that the fixed dose combination (FDC) of Acetyl Salicylic Acid + Ethoheptazine poses a risk to human health, especially when safer alternatives are available. The matter was initially reviewed by an Expert Committee in 2021, which found that available scientific evidence does not support the rationality of this combination and classified it as irrational.
Subsequently, the Drugs Technical Advisory Board (DTAB) reviewed the findings and referred the matter to its Sub-Committee for detailed examination of irrational FDCs. The Sub-Committee provided an opportunity to stakeholders and manufacturers to submit relevant data. After thorough evaluation, it concluded in its report dated December 28, 2024, that the combination lacks therapeutic justification and should be prohibited in the interest of public health.
The DTAB accepted the Sub-Committee’s recommendations, agreeing that continued use of this drug combination is not justified. Based on these expert opinions, the Central Government concluded that it is necessary to take regulatory action to safeguard public health.
Accordingly, exercising powers under Section 26A of the Drugs and Cosmetics Act, 1940, the Government has prohibited the manufacture, sale, and distribution of the fixed dose combination of Acetyl Salicylic Acid + Ethoheptazine for human use in India with immediate effect.
[Notification No. S.O. 3068(E)]
