The Centre has banned 156 widely sold fixed-dose combination (FDC) drugs used to treat fever, pain, cold and allergies, saying they are “likely to pose risk to humans”.FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also called “cocktail” drugs.
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The decision was taken after an expert committee and the apex panel, the Drugs Technical Advisory Board (DTAB), found that these combinations, including antibacterial drugs, lack therapeutic rationale and pose risks to human health.
According to a gazette notification issued by the Union health ministry on August 12, the banned drugs include popular 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.
Additionally, the combination of paracetamol, tramadol, taurine and caffeine is also banned, as tramadol is an opioid-based pain reliever.
The ban was issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to restrict the manufacture, sale and distribution of drugs deemed harmful or unnecessary. The DTAB stressed that no regulation or ban could justify the use of these FDCs in patients, which led to the decision to impose a blanket ban on them in the interest of public health.
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“The Central Government is satisfied that the use of the fixed dose combination drug is likely to involve risk to humans while there are safer alternatives available to the said drug,” the notification said.
It said the matter was examined by an expert committee appointed by the Centre, which found these FDCs to be “irrational”.It further said that the DTAB also examined these FDCs and recommended that “there is no therapeutic justification for the ingredients contained in these FDCs”.
“The FDC may pose a risk to humans. Therefore, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act, 1940,” the notification said.
It said “In view of the above, any regulation or restriction to permit any such use in patients is not justified. Therefore, only a ban under Section 26A is recommended. Following the DTAB’s recommendations, the notification said “the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug for human use in the country”. The list includes some products that several drug manufacturers had already discontinued.
In 2016, the Centre had banned 344 drug combinations after an expert panel found they were being sold without scientific data. The ban was challenged by manufacturers in court, but the DTAB later recommended that 328 of those combinations were “irrational” and should be banned. In June last year, 14 FDCs from the original list were banned and many of the recently banned drugs were also part of the original list.
