On Thursday August 22, 2024, the Indian Government imposed a ban on 156 fixed-dose combination (FDC) medicines, including antibiotics commonly used for treating fever and colds, painkillers, and multivitamins. The ban was implemented due to potential risks these medications pose to human health. (News Source). FDC drugs contain two or more active pharmaceutical ingredients combined in a specific ratio, often referred to as “cocktail” drugs.
The Union Health Ministry issued a gazette notification under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture, sale, and distribution of these FDCs. The decision followed a thorough review by an expert committee and the Drug Technical Advisory Board (DTAB), both of which concluded that the ingredients in these FDCs lack therapeutic justification.
Check out the List of 156 Banned Combination Medicines by Government
Among the banned FDCs is the well-known combination of “Aceclofenac 50mg + Paracetamol 125mg tablet,” a popular pain relief medication produced by leading pharmaceutical companies.
Other banned combinations include Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, Levocetirizine Phenylephrine HCl Paracetamol, and Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine.
The combination of Paracetamol, Tramadol, Taurine, and Caffeine, where Tramadol is an opioid-based painkiller, has also been prohibited.
Here are some of the cocktail medicines that have been banned by the government:
- Aceclofenac 50mg + Paracetamol 125mg tablet: A popular pain-relieving medicine manufactured by top pharmaceutical companies.
- Mefenamic Acid Paracetamol Injection: A combination of pain-relieving medicines.
- Cetirizine HCl Paracetamol Phenylephrine HCl: A combination of cold and flu medicines.
- Levocetirizine Phenylephrine HCl Paracetamol: Another combination of cold and flu medicines.
- Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine: A combination of cold and flu medicines.
- Camylofin Dihydrochloride 25 mg Paracetamol 300mg: A combination of pain-relieving medicines.
- Paracetamol, Tramadol, Taurine and Caffeine: A combination of pain-relieving medicines, including the opioid-based painkiller Tramadol.
Hi, here is the extended list of banned cocktail medicines:
- Nimesulide 100mg + Paracetamol 500mg tablet
- Cefixime 200mg + Azithromycin 250mg
- Cefpodoxime 200mg + Ofloxacin 200mg
- Cefuroxime 250mg + Ambroxol 50mg
- Ceftriaxone 250mg + Tazobactum 31.25mg
- Ceftriaxone 500mg + Sulbactam 500mg
- Ciprofloxacin 500mg + Tinidazole 600mg
- Ciprofloxacin 500mg + Metronidazole 400mg
- Erythromycin 250mg + Ambroxol 50mg
- Norfloxacin 400mg + Metronidazole 400mg
- Ofloxacin 200mg + Ornidazole 500mg
- Ofloxacin 200mg + Metronidazole 400mg
Also Read: Now Know The Impact of Long-Term Use of Antibiotics on Gut Health
Government Justifies Ban Due to Health Risks
The Central government expressed its satisfaction that the continued use of these FDCs poses significant risks to human health, especially when safer alternatives are available. The decision was made following recommendations from an Expert Committee appointed by the government, which deemed these FDCs “irrational.”
The notification emphasized the necessity of banning the manufacture, sale, and distribution of these drugs in the interest of public health.
Previous FDC Bans: Indian Government Bans 156 Combination Medicines
The recent ban is part of a broader effort to regulate FDCs in India. In June 2023, 14 FDCs from the 344 drug combinations previously identified were banned. This follows a 2016 decision by the government to ban the manufacture, sale, and distribution of 344 drug combinations based on the recommendations of an expert panel, which was established at the Supreme Court’s direction.
The government’s actions aim to ensure public safety by eliminating drugs with questionable therapeutic value and potential health risks.
Also Read: Urgent Alert: WHO Issues Warning on Falsified Semaglutide Medicines | Protect Your Health Now
