The Ministry of Health and Family Welfare (MoHFW), on June 11, 2026, prohibited the manufacture, sale, and distribution of the fixed dose combination (FDC) Gliclazide + Chromium Picolinate for human use under Section 26A of the Drugs and Cosmetics Act, 1940.
The decision was based on the recommendations of an Expert Committee, the Drugs Technical Advisory Board, and its Sub-Committee, which found that national and international treatment guidelines for Type 2 Diabetes Mellitus (Type 2 DM) do not recommend the use of Chromium Picolinate. The committees further concluded that available scientific evidence does not support the rationality or therapeutic justification of combining Gliclazide with Chromium Picolinate in a fixed dose formulation.
Considering the lack of therapeutic justification, the availability of safer alternatives, and the potential risk to public health, the Central Government has prohibited the manufacture, sale, and distribution of the fixed dose combination Gliclazide + Chromium Picolinate with immediate effect.
[Notification No. S.O. 3080(E)].
