The Centre has banned 156 widely sold fixed-dose combination (FDC) drugs used to treat fever, pain, cold and allergies, saying they were "likely to involve risk to humans".
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.
The decision was made after an expert committee and the apex panel, the Drugs Technical Advisory Board (DTAB), 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 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 was also prohibited, as Tramadol is an opioid-based painkiller.
The ban was issued 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 emphasised 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," the notification said.It said the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational".
It further stated that the DTAB also examined these FDCs and recommended that "there was no therapeutic justification for the ingredients contained in these FDCs"."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," the notification said.
"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," it added.Following the DTAB's recommendations, the notification said 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 list includes certain products which were already discontinued by many drugmakers.In 2016, the Centre banned 344 drug combinations after an expert panel found that 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 prohibited.
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.
