Government bans 14 fixed dose combination drugs in India

14 FDC banned: Citing ‘no therapeutic justification’ and potential risk to patients, The Central Government banned 14 fixed dose combination drugs including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup. 

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What is FDC? 

FDC stands for Fixed-Dose Combination, which refers to a type of medication that contains two or more active ingredients combined in a fixed ratio in a single dosage form. FDC medicines are commonly used to treat various medical conditions and offer several advantages, including simplified dosing, improved patient compliance, reduced pill burden, and potentially enhanced therapeutic efficacy.

14 FDC Banned

The move came following recommendations by an expert committee. The Health Ministry has also issued a notification on this regard. 

As per the notification issued by the Health Ministry, "And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," the notification stated.

Check out the banned medicines below

Nimesulide Paracetamol dispersible tablets, 

Chlorpheniramine Maleate Codeine Syrup, 

Pholcodine Promethazine, 

Amoxicillin Bromhexine Bromhexine Dextromethorphan, 

Ammonium Chloride Menthol,

Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin and 

Salbutamol Bromhexine

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Earlier, in 2016, the ministry launched a drive to filter out drug combinations from the Indian pharmaceutical industry by banning around 350 FDCs, affecting over 2,700 branded drugs.       

- With inputs from agencies

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