India bans 156 combination medicines used for fever, pain, allergies; check list

PTC News Desk: The government on Thursday banned 156 fixed-dose combination drugs, including antibiotics used for fever and colds, painkillers, and multivitamins, claiming they are 'likely to involve risk to human beings'.

Fixed-dose combination (FDC) drugs are medications that contain two or more active pharmaceutical ingredients in a predetermined ratio. They are also known as "cocktail" medications.

The Union Health Ministry issued a gazette notification prohibiting the manufacture, sale, and distribution of these medicines under Section 26 A of the Drugs and Cosmetics Act 1940, stating, "The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs."

The ban also includes "Aceclofenac 50mg Paracetamol 125mg tablet," which is a common combination of pain-relieving medications provided by major pharmaceutical companies.

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

The government also prohibited the combination of paracetamol, tramadol, taurine, and caffeine. Tramadol is an opioid-based painkiller.

"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," according to the notice.

It stated that the matter was investigated by a Centre-appointed Expert Committee, which deemed these FDCs "irrational".

The list includes several drugs that numerous pharmaceutical companies have previously discontinued. In June 2023, 14 FDCs among those 344 medication combinations were banned.