Govt bans 156 fever, cold, allergy drugs over health risks

The central government has banned 156 fixed-dose combination (FDC) drugs, including antibacterial medicines, commonly used to treat cold, allergies, fever and pain, as they pose risks to human health.

FDC drugs aka 'cocktail drugs' are a mix of two or more active pharmaceutical ingredients in a fixed ratio. The Drugs Technical Advisory Board (DTAB) along with an expert committee found that these combinations, including antibacterial medicines, lacked therapeutic justification and posed risks to human health.

The ban was issued under Section 26A of the Drugs and Cosmetics Act, of 1940. According to the law, the government can prohibit the manufacture, sale, and distribution of drugs which are found to be harmful or unnecessary.

A gazette notification issued by the Union health ministry on Aug 12 mentioned the banned drugs which 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 were also mentioned in the list.

"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 read.

Moreover, the combination of Paracetamol, Tramadol, Taurine and Caffeine has also been prohibited, as Tramadol is an opioid-based painkiller.

The DTAB emphasized that the usage of these drugs can't be justified in any way and hence there's a complete prohibition put in place for public interest.

"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.

The list includes certain drugs which were already discontinued by many drugmakers.

In June last year, 14 FDCs from the original list were banned. In 2016, the government banned 344 drug combinations after an expert panel found that they were being sold without scientific data.