The government on Thursday banned 156 fixed-dose combination medicines, including antibiotics used for fever and colds, painkillers, and multivitamins, saying that they are ‘likely to involve risk to human beings’
Fixed-dose combination (FDC) drugs are medicines that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. They are also referred to as “cocktail” drugs.
Issuing a gazette notification prohibiting the manufacture, sale and distribution of these medicinesunder section 26 A of the Drugs and Cosmetics Act 1940, the Union health ministry said, “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 list includes “Aceclofenac 50mg + Paracetamol 125mg tablet.” This is one of the popular combinations of pain-relieving medicines manufactured by top pharmaceutical 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 government also banned 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,” the notification said.
It said that the matter was examined by an Expert Committee appointed by the Centre, which considered these FDCs as “irrational”.
The notification further 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 also includes certain products that many drug makers have already discontinued. In June 2023, 14 FDCs, which were part of those 344 drug combinations, were banned.
In 2016, the government announced the ban on the manufacture, sale, and distribution of 344 drug combinations after the recommendations of an expert panel set up at the Supreme Court’s behest.
