Notification/Circular No.: S.O. 3068(E) to S.O. 3083(E) dated June 11, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940
Effective Date: June 19, 2026
Sixteen fixed dose combinations (FDCs) were examined by an Expert Committee in 2021, which found the available data did not support their rationality and considered each irrational. The Drugs Technical Advisory Board (DTAB) agreed in-principle and referred the matter to a Sub-Committee for detailed examination. The Sub-Committee gave manufacturers/stakeholders an opportunity to present data, and submitted its report dated 28th December, 2024, stating that prohibition was necessary in the larger public interest as there was no therapeutic justification for the FDCs. DTAB agreed with the Sub-Committee’s report.
In exercise of powers under Section 26A of the Drugs and Cosmetics Act, 1940, the Central Government has prohibited manufacture, sale or distribution for human use, with immediate effect, of the following FDCs:
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