New Delhi: The Indian government has prohibited use of 156 fixed-dose combination (FDC) drugs that are often administered as painkillers, multivitamins and antibiotics to treat fever, pain, cold and allergies.
These FDC, which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as ‘cocktail’ drugs, are “likely to involve risk to humans.”
According to a gazette notification issued by the Union Health Ministry on August 12, the banned drugs include popular combinations like 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.
The combination of Paracetamol, Tramadol, Taurine and Caffeine was also prohibited, as Tramadol is an opioid-based painkiller.
An expert committee and the apex panel, Drugs Technical Advisory Board (DTAB), found that these combinations, including antibacterial medicines, lacked therapeutic justification and posed risks to human health.
Under Section 26A of the Drugs and Cosmetics Act, 1940, the government can prohibit the manufacture, sale and distribution of drugs deemed harmful or unnecessary.
DTAB made it clear 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 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,” stated the notification.
The matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as “irrational.”
The Centre had banned 344 drug combinations in 2016. Manufacturers challenged the ban in court, but DTAB later recommended that 328 of those combinations were “irrational” and should be prohibited.
