The central 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 medications that have a combination of two or more active pharmaceutical ingredients in a fixed ratio. These drugs are also known as “cocktail” drugs.
This decision comes after the Drugs Technical Advisory Board (DTAB) and an expert committee found that these combinations, including antibacterial medicines, lacked therapeutic justification and posed risks to human health.
According to a gazette notification issued by the Union Health Ministry on August 12, the banned drugs include combinations such as ‘Aceclofenac 50mg + Paracetamol 125mg tablet’, 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.
Along with these, the combination of Paracetamol, Tramadol, Taurine and Caffeine was also prohibited because Tramadol is an opioid-based painkiller. The government issued the ban under Section 26A of the Drugs and Cosmetics Act, 1940 which allows the government to prohibit the manufacture, sale, and distribution of drugs deemed harmful or unnecessary.
The DTAB highlighted that no form of regulation or restriction could justify the use of these FDCs in patients, leading to the decision for a complete prohibition in the interest of public health. The gazette notification said, “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.”
It also said that the DTAB also examined these FDCs and recommended that “there was no therapeutic justification for the ingredients contained in these FDCs”.
The notification said, “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 the Drugs and Cosmetics Act 1940.
“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 also highlighted that “the Central government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country.”
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.
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.
(With inputs from PTI)