Centre bans 156 fixed dose combination drugs over health risk concerns

The Union government has banned 156 widely sold fixed-dose combination (FDC) drugs including antibacterial medicines used for fever, cold, allergies and pain, saying that they are "likely to involve risk to human beings".

FDC drugs which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio are also referred to as "cocktail" drugs.

According to a gazette notification issued by the Union health ministry on August 12, the government has banned 'Aceclofenac 50mg Paracetamol 125mg tablet', one of the popular combinations used as pain-relieving medicines manufactured by top pharma companies.

'Safer alternatives available'

The list also includes Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg Paracetamol 300 mg.

The Centre also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based pain killer. "The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available," the notification said.

It said that the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational". It further stated that the apex panel Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that "there is no therapeutic justification for the ingredients contained in these FDCs".

"The FDC 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 Drugs and Cosmetics Act 1940," the notification read.

"In view of 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," it added.

'Necessary in public interest'

Following the DTAB's recommendations, the notification said that "the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country".

The list includes certain products which were already discontinued by many drug makers.

The government in 2016 had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court, had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court, sources said.

In June 2023, 14 FDCs which were part of those 344 drug combinations, were banned. Many of the FDCs banned recently were also from those 344 drug combinations, the sources said.

(With agency inputs)