Centre bans 156 fixed-dose combination drugs used to treat fever, pain, cold and allergies

The Central government has banned 156 Fixed-Dose Combination (FDC) drugs which are widely used to treat fever, pain, cold and allergies, stating they were "likely to involve risk to humans".

Also referred to as "cocktail" drugs, the FDC drugs contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. They were banned 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 decision to ban the drugs was made after an expert committee and the apex panel, the Drugs Technical Advisory Board (DTAB), found that the combinations, including antibacterial medicines, posed risks to human health and lacked therapeutic justification.

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.

Moreover, the combination of Paracetamol, Tramadol, Taurine and Caffeine was also prohibited.

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, further adding, "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."

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.