Centre Bans 156 Popular Fixed-Dose Cocktail Drugs Claiming To Involve 'Risk To Human Beings'

FDC drugs are a mix of two or more ingredients in a set amount and are sometimes also called "cocktail" drugs.

Centre Bans Comibination Drugs

According to a gazette notification issued by the Union health ministry on August 12, the government has banned several commonly consumed medicines including 'Aceclofenac 50mg + Paracetamol 125mg tablet' which is used as pain-relieving medicines and manufactured by top pharma companies.

Other drugs banned including -

• Mefenamic Acid + Paracetamol Injection,

• Cetirizine HCl + Paracetamol + Phenylephrine HCl,

• Levocetirizine + Phenylephrine HCl + Paracetamol,

• Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine

• Camylofin Dihydrochloride 25 mg + Paracetamol 300mg

The Centre also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based pain killer.

"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 that the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational".

It further stated that the apex panel Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that "there is 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 Drugs and Cosmetics Act 1940," the notification read.

"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," it added.

Following the DTAB's recommendations, the notification said 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".

The list includes certain products which were already discontinued by many drug makers.

Following the DTAB's recommendations, the notification said that "the The government in 2016 had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court, had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court, PTI reported.

According to PTI, in June 2023, 14 FDCs which were part of those 344 drug combinations, were banned. Many of the FDCs banned recently were also from those 344 drug combinations.

(With PTI inputs)