The Ministry of Health and Family Welfare (MoHFW) on June 15, 2026, notified regarding the Prohibition of Fixed Dose Combination of Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + Vitamin A.
The following has been stated:
• The Government has prohibited the manufacture, sale, and distribution of the fixed dose combination (FDC) Aloe Extract + Allantoin + Alphatocopherol Acetate (Vitamin E) + D-Panthenol + Vitamin A for human use with immediate. The decision follows a detailed scientific review, which concluded that the combination lacks therapeutic justification and may pose risks to patients when safer alternatives are available.
• An Expert Committee that examined the FDC in 2021 found that the available clinical data and peer-reviewed scientific evidence do not support the rationality of combining these ingredients in a single formulation and classified the product as an irrational fixed-dose combination. The matter was subsequently reviewed by the Drugs Technical Advisory Board (DTAB), which agreed in principle with the findings and referred it to a Sub-Committee for detailed examination.
• After inviting representations from manufacturers and stakeholders through public notices, the DTAB Sub-Committee submitted its report on December 28, 2024, concluding that there was no therapeutic justification for the combination and recommending its prohibition in the larger public interest. Accepting the recommendations of the DTAB and its Sub-Committee, the Central Government has now imposed an immediate nationwide ban on the manufacture, sale, and distribution of this fixed-dose combination to protect public health.
[Notification no. - S.O. 3073(E)]
