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AIOCD asks traders to strictly comply with ban on 35 FDCs

Chronicle Pharmabiz

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December 11, 2025

THE All India Organisation of Chemists and Druggists (AIOCD) has issued an urgent internal circular to all its state and Union territory trade bodies, demanding immediate and strict compliance with the ban on 35 fixed dose combinations (FDCs).

- Our Bureau, Chennai

Issued under the directive of AIOCD president J S Shinde and general secretary Rajiv Singhal, the circular, dated November 19, 2025 moves to protect the retail trade sector from impending regulatory action. The move follows reports that state-level FDA authorities have already begun insisting that member chemists immediately cease the sale and purchase of these concerned FDC formulations.

The primary impetus for this aggressive internal advisory is the CDSCO circular of April 11 this year, which confirmed the ban. The Central Drugs Standard Control Organization found that these FDCs were licensed for manufacture, sale, and distribution without the mandatory prior evaluation of safety and efficacy as required under the NDCT Rules 2019.

The regulatory body warned that the unapproved nature of these combinations compromise patient safety, potentially leading to adverse drug reactions and serious health hazards, necessitating their market removal.

The AIOCD has clearly outlined the points that are advised to the state and UT branches to ensure a uniform, compliant, and protected trade environment. State and UT bodies are specifically instructed to immediately circulate the full list of banned FDCs to all local stockists and retail chemists. The national body further instructs the state branches to insist all member chemists stop the sale and purchase of these products with immediate effect.

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