0
0
August 23, 2024 — In a significant move to protect public health, the Indian government has imposed a ban on 156 fixed-dose combination (FDC) drugs, including some widely used medications for fever, cold, and allergies. The decision, announced through a gazette notification from the Union Health Ministry dated August 12, 2024, highlights concerns over the safety and therapeutic justification of these drugs.
Fixed-dose combination drugs are formulations that contain two or more active pharmaceutical ingredients (APIs) in a single dosage form. They are often prescribed to simplify treatment regimens, improve patient compliance, and enhance the efficacy of treatments. However, concerns have been raised about the safety and efficacy of certain combinations, prompting a detailed review by health authorities.
Among the banned FDCs are several commonly prescribed drugs, including the popular ‘Aceclofenac 50mg + Paracetamol 125mg tablet,’ which has been widely used for pain relief. Other banned combinations include Mefenamic Acid + Paracetamol Injection, which is frequently used for pain and inflammation management.
The decision to ban these drugs was based on the findings of an Expert Committee and the Drugs Technical Advisory Board (DTAB), which conducted a thorough assessment of the safety and efficacy of the FDCs in question. The committee concluded that these combinations lacked sufficient therapeutic justification and posed potential health risks to patients. As a result, the Central government determined that the manufacture, sale, and distribution of these FDCs should be prohibited to safeguard public health.
The Health Ministry’s notification emphasized that safer and more effective alternatives are available for the treatment of conditions that these FDCs were intended to address. This ban aims to ensure that patients receive medications that are both safe and efficacious, in line with international standards.
The move has been welcomed by health experts, who have long raised concerns about the proliferation of irrational FDCs in the Indian market. However, it is expected to have a significant impact on the pharmaceutical industry, particularly for companies that manufacture these now-banned formulations.
In the coming days, the focus will be on the implementation of the ban and ensuring that these drugs are swiftly removed from the market. Pharmacists, healthcare providers, and patients are advised to be aware of the banned FDCs and to seek safer alternatives as recommended by medical professionals.
This decision marks a critical step in the government’s ongoing efforts to regulate the pharmaceutical sector and enhance the safety and efficacy of medicines available to the public.
