The Government of India has banned 14 Fixed Dose Combination (FDC) drugs, including a few drugs comprised of paracetamol and codeine syrup, with immediate effect. A notification to this effect was issued by the Ministry of Health and Family Welfare on June 2. Fixed Dose Combination or FDC drugs are combination drugs, which contain one or more medicinal ingredients used to treat a particular indication or symptom. Most of the drugs in the Health Ministry’s list are ones used to treat cough, coldm and fever symptoms.
This ban was first announced back in March 10, 2016, when the government back banned 344 FDC drugs, which included these 14 drugs. However, more than 30 pharmaceutical companies, including Pfizer, Alkem Laboratories, Glenmark, Procter and Gamble (P&G) and Cipla challenged this ban at the Delhi High Court. The HC, on December 1, 2016, quashed the ban, following which the government moved the Supreme Court. The Supreme Court set aside the HC order and referred that the drugs be re-examined by a Drugs Technical Advisory Board (DTAB). An expert committee was formed as per the SC’s directions which looked into the drugs and submitted a report on April 2022.
According to the notification gazette published on June 2, the expert committee in its report submitted on April 1, 2022, had recommended that “there is no therapeutic justification” for the 14 FDCS banned, and that these combination drugs “may involve risk to human beings.” Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 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.
“In view of the above, any kind 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 manufacture, etc., of a drug or cosmetic product “in public interest”. As per the recent Health Ministry notification, the following FDC drugs are banned in India:
> Nimesulide +Paracetamol dispersible tablets
> Amoxicillin+ Bromhexine
> Pholcodine + Promethazine
> Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
> Chlopheniramine Maleate + Codeine Syrup
> Ammomium Chloride + Bromhexine + Dextromethorphan
> Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
> Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
> Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
Salbutamol + Bromhexine
> Chlorpheniramine + Codeine Phosphate + Menthol Syrup
> Phenytoin + Phenobarbitone sodium
> 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 5ml syrup
> Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine