Govt bans 156 popular fixed-dose combination drugs citing safety concerns

FDC drugs, often referred to as "cocktail" drugs, contain a combination of two or more active ingredients in a fixed ratio. (Representational image)

The central government has banned 156 widely sold fixed-dose combination (FDC) drugs, including commonly used antibacterial medicines for fever, cold, allergies, and pain, stating that these drugs pose a risk to human health.

FDC drugs, often referred to as "cocktail" drugs, contain a combination of two or more active ingredients in a fixed ratio.

According to a gazette notification issued by the Union health ministry on August 12, the government has banned 'Aceclofenac 50mg + Paracetamol 125mg tablet', one of the popular combinations used as pain-relieving medicines manufactured by top pharma companies.

The list also includes 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 government also prohibited the use of the combination of paracetamol, tramadol (an opioid-based painkiller), taurine, and caffeine, citing potential risks to human health.

According to the notification, the decision followed recommendations from an expert committee and the apex panel, the Drugs Technical Advisory Board (DTAB). Both panels found that these FDCs lacked therapeutic justification and posed risks to human beings.

"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.

The ban has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to prohibit the manufacture, sale, and distribution of drugs that are deemed harmful or unnecessary. The DTAB emphasized 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.

(With PTI inputs)