Indian government has imposed immediate ban on 156 commonly sold fixed-dose FDC drugs. The decision was taken due to alarming concerns about their irrationality and health risks, as safer alternatives are available in the market.  

The Health Ministry declared that due to the health dangers involved, they prohibited the production, and distribution of 156 medicines. These FDCs include vitamins, antibiotics and painkillers.  

FDCs Drugs that are Banned 

Often referred to as cocktail pharmaceuticals, fixed-dose combination (FDC) drugs are treatments that combine two or more active pharmacological ingredients in a specific ratio. The Health Ministry’s ban includes 156 medicines, some of these widely used FDCs: 

-Aceclofenac 50mg + Paracetamol 125mg tablet, a widely used pain reliever made by top pharmaceutical businesses.  

–Mefenamic Acid + Paracetamol Injection,  

-Cetirizine HCI+ Paracetamol+ Phenylephrine HCI, 

– Levocetirizine+ Phenylephrine HCI+ Paracetamol,  

-Paracetamol+ Chlorpheniramine Maleate+ Phenyl Propanolamine, and  

-Camylofin Dihydrochloride 25mg+ Paracetamol 300mg.  

One of the factors contributing to the crackdown, was that certain state licensing authorities granted manufacture licenses for several FDCs without obtaining prior clearance from the Central Drugs Standard Control Organization (CDSCO).  

Combination of Paracetamol, Tramadol, Taurine and Caffeine  

Combination of Paracetamol, Tramadol, Taurine and Caffeine are among the list prohibited by the Centre. Tramadol, an opioid-based painkiller, is a key ingredient in this banned mixture.  

The notification stated, “The Central government is satisfied that the use of the FDC poses risk to human health, despite of the fact that safer alternatives are available in the market.” 

The issue was reviewed by an Expert Committee appointed by the Centre, which deemed these FDCs qw irrational. “The FDC may include risk to human health. Hence in the larger public interest, it is crucial to ban the manufacture, sale and distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940,” the notification briefly explained.  

The statement concluded by stating, “In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only ban under section 26A is recommended. 

Previous Ban on Drugs 

This measure follows earlier prohibitions, with India discontinuing 344 combination drugs in March 2016 and 14 FDCs, in June 2023.  

According to reports, the latest list included specific products, which had already been discontinued by many medicine makers.  

The impact of the recent ban is expected to be less affected by large pharmaceutical companies. They have already become cautious over illogical FDCs. These businesses will probably adjust by innovating new combinations that are still in use and putting even more emphasis on safety. 

Meanwhile, analysts speculate that smaller companies may encounter more significant challenges.  

Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance stated to Financial Express, “The discussion on FDC is going on over a period of time with recommendation from Kokate committee and Nilima Kshirsagar committee. This is a right step in interest of patients and all aspects have taken into consideration.”