The Health Ministry has banned 156 fixed-dose combination (FDC) medicines, including widely used antibiotics, painkillers, and multivitamins. In a gazette notice issued on August 21, the Health Ministry announced that the production, marketing, and distribution of these drugs are now prohibited due to their associated health risks.
The notification states that the banned FDCs include antibiotics, anti-allergic medications, pain relievers, multivitamins, and combination treatments for fever and hypertension.
What are FDC drugs?
Fixed-dose combination (FDC) drugs are treatments that include a specific ratio of two or more active pharmaceutical ingredients and are commonly referred to as cocktail drugs. On August 12, the Union Health Ministry issued a gazette notification announcing the ban of the 'Aceclofenac 50mg + Paracetamol 125mg tablet', a commonly used pain reliever from leading pharmaceutical companies.
The banned 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 300 mg.
Full list of FDG drugs banned
Combination of Paracetamol, Tramadol, Taurine and Caffeine banned
The Centre has also prohibited the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol, an opioid-based painkiller, is among the ingredients in this banned mixture.
"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 issue was reviewed by an Expert Committee appointed by the Centre, which deemed these FDCs as irrational. The notification stated, "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 Drugs and Cosmetics Act 1940."
"In view of 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," the statement added.
Based on the DTAB's recommendations, the notification noted that "the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country."
