Government has taken the decision to prohibit the use of 14 fixed-dose combinations (FDC) drugs, including Nimesulide and Paracetamol dispersible tablets, and Chlorpheniramine Maleate and Codeine syrup.
The rationale behind this action is the absence of “therapeutic justification” for these medications and the potential “risk” they pose to individuals.
The Union Health Ministry issue an official notification to enforce this ban.
The prohibited drugs encompass various combinations utilize for the treatment of common infections, cough, and fever.
These include :
- Nimesulide + Paracetamol dispersible tablets,
- Chlorpheniramine Maleate + Codeine Syrup,
- Pholcodine + Promethazine,
- Amoxicillin + Bromhexine,
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol,
- Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin,
- Salbutamol + Bromhexine.
Government bans these 14 FDC medicines; check if you have them in your home
— 2YoDoINDIA News Network (@2yodoindia) June 4, 2023
For more news visit https://t.co/98KV4yIruC#2YoDoINDIA #FDC #FDCMedicines #MedicinesBan #FixedDoseCombination pic.twitter.com/TAOX3LoVny
This decision was made based on the recommendations put forth by an expert committee.
The committee conclude that there is no valid therapeutic justification for the fixed-dose combination drugs and that they may pose risks to human health.
In the interest of public welfare, the manufacture, sale, and distribution of these FDC drugs are deemed necessary to be prohibited under section 26 A of the Drugs and Cosmetics Act, of 1940.
The notification emphasize that any form of regulation or restriction allowing their use in patients is unjustifiable.
As per notification :
“Based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient, in the interest of public welfare, to regulate and prohibit the manufacture, sale, and distribution of these drugs for human use within the country.”
Fixed-dose combination drugs are formulations that contain a combination of two or more active pharmaceutical ingredients (APIs) in fixed ratios.
In 2016, the government had already impose a ban on 344 drug combinations after an expert panel, establish by the Supreme Court, found that they were being market to patients without sufficient scientific data.
The manufacturers had challenge the order in court.
The currently ban 14 FDCs are include in the list of those 344 drug combinations.
