The Union Health Ministry has banned 156 “irrational” fixed dose combination (FDC) medicines, including commonly used antibiotics, painkillers, and multivitamins, effective immediately. This decision, announced through a gazette notice under Section 26 A of the Drugs and Cosmetics Act 1940, prohibits the production, marketing, and distribution of these drugs due to associated health risks.
Reason for the Ban
An expert committee and the Drugs Technical Advisory Board (DTAB) reviewed these FDCs and found no therapeutic justification for their combined ingredients. The notification highlighted that safer alternatives are available and that the banned drugs, such as the combination of Aceclofenac 50 mg and Paracetamol 125 mg tablets, pose potential risks to human health.
What Are ‘Cocktail’ Drugs?
Fixed-dose combinations (FDCs), often referred to as ‘cocktail’ drugs, are medications that combine multiple drugs into a single pill. They typically include combinations of painkillers, fever reducers, anti-inflammatory agents, and sometimes antibiotics. Dr. Sudhir Kumar, a consultant neurologist at Apollo Hospitals in Hyderabad, explained that while these drugs aim to offer convenience and treat multiple symptoms, they can pose significant risks.
Health Risks and Concerns
Dr. Haricharan G, senior consultant physician at Gleneagles Hospitals, emphasized that many FDCs lack randomized controlled trials to verify their safety and efficacy. This lack of evidence makes their use irrational. The inclusion of antibiotics in these combinations can also contribute to antibiotic resistance, a major global health concern. Additionally, the risk of overdose or misuse increases if patients are unaware of each ingredient’s implications.
Safe Alternatives
Dr. Kumar pointed out that safer, clinically tested alternatives are available for treating medical conditions. He recommended using a single drug for pain and adding a second only if necessary. Combining painkillers with antihistamines, for instance, lacks rationality. Overall, Dr. Kumar praised the Health Ministry’s decision, stating it aligns with the need for safer and more rational drug prescriptions.