New Delhi: The 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 are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and 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.
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 300mg. 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 an.