India has banned 156 widely sold fixed-dose combinations or FDC drugs with immediate effect, citing concerns about their irrationality and potential risks to human health with safer alternatives available.
FDCs are also called ‘cocktail drugs’ as they combine two or more active pharmaceutical ingredients (APIs) in fixed ratios.
The latest list of banned drugs covers various therapeutic areas from pain and fever relief, antiallergy treatments, antibiotics, medications for acidity and nausea, joint and arthritis treatments, and health supplements.
“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,” a notification from the health ministry read.
One of the reasons for the crackdown was due to some state licensing authorities issuing manufacturing licenses for several FDCs without prior clearance from the Central Drugs Standard Control Organization (CDSCO), leading to the availability of untested and potentially unsafe FDC combination drugs.
This action follows previous bans. India banned 344 combination drugs in March 2016 and, most recently, 14 FDCs in June 2023.
According to reports, the latest list includes certain products which were already discontinued by many drug makers.
The impact of the latest ban is expected to be limited for large pharmaceutical companies, which have begun being cautious about irrational FDCs.
But smaller companies, according to analysts, may be affected. Larger pharma companies would be less impacted as they can innovate to create different combinations which are not banned and overall focus on the safety aspect even more.
According to the notification issued by the health ministry, the government has banned ‘Aceclofenac 50mg + Paracetamol 125mg tablet’. 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 Centre also banned the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol is an opioid-based painkiller.
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Source: CNBC
