156 ‘combination medicines’ containing Cetirizine, Paracetamol and other common drugs banned by Centre
Aug 23, 2024, 15:40 IST
In a significant move to safeguard public health, the Indian government has banned 156 widely sold fixed-dose combination (FDC) drugs, many of which are used to treat common ailments such as fever, colds, allergies and pain. The banned FDCs include several popular antibacterial and pain-relief medications, which the government has declared "likely to involve risk to human beings." The ban was officially announced through a gazette notification issued by the Union Health Ministry on August 12.
FDC drugs, often referred to as "cocktail" drugs, contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. While such combinations are intended to offer multi-faceted treatment, concerns have been raised about their safety and efficacy.
Among the drugs on the banned list is the well-known combination of Aceclofenac 50 mg and Paracetamol 125 mg, a popular pain reliever produced by several major pharmaceutical companies. Other banned FDCs include Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Proanolamine, and Camylofin Dihydrochloride 25 mg Paracetamol 300 mg.
A particularly notable ban is on the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol, an opioid-based painkiller, has drawn attention for its potential for abuse and addiction, adding to the concerns surrounding its inclusion in over-the-counter FDCs.
According to the government's notification, the Central government has determined that the use of these FDCs "is likely to involve risk to human beings," and that "safer alternatives to the said drugs are available." The decision follows an in-depth examination by an Expert Committee, which found many of these FDCs to be "irrational." The apex panel Drugs Technical Advisory Board (DTAB) also reviewed the combinations and concluded that there was "no therapeutic justification" for the ingredients in these FDCs. In light of the potential risks, the government deemed it necessary to prohibit the manufacture, sale, and distribution of these drugs under Section 26A of the Drugs and Cosmetics Act, 1940.
The notification emphasised that "in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC" as regulation or restriction would not be sufficient to protect patients.
This is not the first time the Indian government has intervened to address the sale of FDCs. In 2016, the Centre had announced a ban on 344 FDCs after an expert panel — established at the direction of the Supreme Court — found that many of these combinations were being sold without sufficient scientific evidence supporting their efficacy. Although that decision was contested in court by drug manufacturers, it set a precedent for regulatory scrutiny of FDCs in India.
In June 2023, 14 FDCs from the original list of 344 were also banned. Many of the drugs included in the recent list of 156 were part of this original 344-drug combination ban, reinforcing the government's continued efforts to remove unsafe and unjustified medications from the market.
Several of the banned products had already been discontinued by manufacturers, but the new regulations ensure that these combinations will no longer be available for sale in India, further emphasising the government's commitment to public safety and rational drug use.
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FDC drugs, often referred to as "cocktail" drugs, contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. While such combinations are intended to offer multi-faceted treatment, concerns have been raised about their safety and efficacy.
Among the drugs on the banned list is the well-known combination of Aceclofenac 50 mg and Paracetamol 125 mg, a popular pain reliever produced by several major pharmaceutical companies. Other banned FDCs include Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, Paracetamol Chlorpheniramine Maleate Phenyl Proanolamine, and Camylofin Dihydrochloride 25 mg Paracetamol 300 mg.
A particularly notable ban is on the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol, an opioid-based painkiller, has drawn attention for its potential for abuse and addiction, adding to the concerns surrounding its inclusion in over-the-counter FDCs.
According to the government's notification, the Central government has determined that the use of these FDCs "is likely to involve risk to human beings," and that "safer alternatives to the said drugs are available." The decision follows an in-depth examination by an Expert Committee, which found many of these FDCs to be "irrational." The apex panel Drugs Technical Advisory Board (DTAB) also reviewed the combinations and concluded that there was "no therapeutic justification" for the ingredients in these FDCs. In light of the potential risks, the government deemed it necessary to prohibit the manufacture, sale, and distribution of these drugs under Section 26A of the Drugs and Cosmetics Act, 1940.
The notification emphasised that "in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC" as regulation or restriction would not be sufficient to protect patients.
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This is not the first time the Indian government has intervened to address the sale of FDCs. In 2016, the Centre had announced a ban on 344 FDCs after an expert panel — established at the direction of the Supreme Court — found that many of these combinations were being sold without sufficient scientific evidence supporting their efficacy. Although that decision was contested in court by drug manufacturers, it set a precedent for regulatory scrutiny of FDCs in India.
In June 2023, 14 FDCs from the original list of 344 were also banned. Many of the drugs included in the recent list of 156 were part of this original 344-drug combination ban, reinforcing the government's continued efforts to remove unsafe and unjustified medications from the market.
Several of the banned products had already been discontinued by manufacturers, but the new regulations ensure that these combinations will no longer be available for sale in India, further emphasising the government's commitment to public safety and rational drug use.