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On August 22, the Indian government enacted a significant regulatory change by banning 156 fixed-dose combination (FDC) drugs, which are commonly used to treat fever, cold, allergies, and pain. This decision underscores the government's commitment to ensuring drug safety amid growing concerns about the potential risks these medications pose to public health.
On August 22, the Indian government enacted a significant regulatory change by banning 156 fixed-dose combination (FDC) drugs, which are commonly used to treat fever, cold, allergies, and pain. This decision underscores the government’s commitment to ensuring drug safety amid growing concerns about the potential risks these medications pose to public health.
Understanding Fixed-Dose Combination Drugs
Fixed-dose combination drugs, often referred to as “cocktail drugs,” consist of two or more active pharmaceutical ingredients combined in a fixed ratio. These combinations are designed to provide multifaceted treatment in a single dosage form. The recent ban includes several widely used drugs such as the ‘Aceclofenac 50mg + Paracetamol 125mg tablet,’ known for its pain-relieving properties, and other combinations like Mefenamic Acid + Paracetamol Injection and Cetirizine HCl + Paracetamol + Phenylephrine HCl. The list also features drugs like Levocetirizine + Phenylephrine HCl + Paracetamol and Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine.
Concerns Leading to the Ban
The government’s decision follows a gazette notification issued by the Union Health Ministry on August 12, which cites significant health risks associated with these FDC drugs. The ban also includes the combination of Paracetamol, Tramadol, Taurine, and Caffeine, with Tramadol being an opioid-based painkiller. The Health Ministry has noted that safer alternatives to these FDCs are available, and the Expert Committee appointed to review these drugs found them to be irrational and potentially harmful.
According to the notification, the prohibition is based on the findings that these combinations might pose risks to human health, and thus, their manufacture, sale, and distribution have been banned under Section 26A of the Drugs and Cosmetics Act, 1940. This action reflects the government’s broader effort to safeguard public health by removing potentially dangerous medications from the market.
Background and Previous Bans
The current ban builds on earlier regulatory actions. In 2016, the government banned the manufacture, sale, and distribution of 344 drug combinations after an expert panel, established under the Supreme Court’s direction, identified them as lacking scientific validation. Although many of these combinations were discontinued by drug manufacturers, the government has continued to address the issue by periodically updating the list of banned FDCs. In June 2023, 14 FDCs from the previously banned list were also prohibited.
The latest move to ban these 156 FDCs highlights the government’s ongoing vigilance in ensuring drug safety and efficacy. It serves as a reminder of the importance of regulatory oversight in the pharmaceutical industry to prevent potential health hazards associated with the use of combination medications.
