Union Government Banned 14 Fixed Dose Combination (FDC) Drugs Used To Treat Common Ailments
The Union government banned 14 fixed-dose combinations (FDC) drugs used to treat common ailments used in India because of a lack of therapeutic justification and potential risks to humans according to the professional panel’s recommendations. FDCs mix two or more active ingredients in a fixed ratio. The FDCs that have been banned include Nimesulide & Paracetamol dispersible supplement and Pholcodine Promethazine, amongst others.
14 fixed-dose combinations (FDC) drugs contain one or more medicinal ingredients used to treat a particular indication or symptom. Most of the fixed-dose combinations in the Health Ministry’s list are ones used to treat cold cough, and fever symptoms. The Banned decision has been taken after an earlier restriction of 344 FDCs was challenged by manufacturers in court.
As per the recent Health Ministry notification, This ban was first announced back on March 10, 2016, when the government back-banned 344 FDC drugs, which included these 14 drugs
- Nimesulide + Paracetamol dispersible tablets
- Amoxicillin + Bromhexine
- Pholcodine + Promethazine
- Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
- Chlorpheniramine Maleate + Codeine Syrup
- Ammonium Chloride + Bromhexine + Dextromethorphan
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
- Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
- Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5 ml
- Phenytoin + Phenobarbitone Sodium
- Chlorpheniramine + Codeine Phosphate + Menthol Syrup
- Salbutamol + Bromhexine
- Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
- Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
According to the Central Drugs Standard Control Organisation (CDSCO), FDCs refer to the Union government banning 14 fixed-dose combinations (FDC) drugs used to treat common ailments drugs because the combination contains one or more active ingredients used for a particular indication(s). Published on June 2. According to the notification gazette, the expert committee in its report submitted on the date April 1, 2022, had recommended that “there is no therapeutic justification” for the 14 FDCS banned, and that these combination supplements “may involve risk to human beings or lives.”
In addition, in the larger public interest, it is compulsory to prohibit the manufacture, sale or distribution of this FDC under article 26 A of the Drugs and Cosmetics Act, 1940,” the expert committee said in the case of the 14 banned combination drugs, according to the notification. Any type of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended,” the notification said, referring to the expert committee’s recommendations. Section 26A is related to the powers of the Union Government to regulate, restrict or prohibit the manufacture, etc., of a drug or cosmetic product “in the public interest”.
