In a significant regulatory move, the Indian government has announced a ban on 156 fixed-dose combination (FDC) drugs, citing potential risks to human health. These FDC drugs, which combine two or more active pharmaceutical ingredients in a fixed ratio, are commonly used for treating fever, pain, cold, and allergies. The decision, issued through a gazette notification by the Union Health Ministry on August 12, reflects ongoing concerns about the safety and efficacy of these medications.
Among the banned drugs is the widely used ‘Aceclofenac 50mg Paracetamol 125mg tablet,’ a popular pain-relief combination produced by major pharmaceutical companies. The prohibition extends to other combinations such as Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, and Levocetirizine Phenylephrine HCl Paracetamol. Notably, the ban also includes the combination of Paracetamol, Tramadol, Taurine, and Caffeine, with Tramadol being an opioid-based painkiller.
The notification asserts that these FDCs pose a risk to human health, stating, “The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available.” This conclusion follows a review by an Expert Committee appointed by the government, which deemed these FDCs as “irrational” due to a lack of therapeutic justification for the combined ingredients. The Drugs Technical Advisory Board (DTAB) also supported this stance, recommending a ban on these drugs.
In its notification, the government emphasized that prohibiting the manufacture, sale, or distribution of these FDCs is in the larger public interest, invoking Section 26 A of the Drugs and Cosmetics Act, 1940. The notification further noted that no regulations or restrictions could justify the continued use of these FDCs in patients, underscoring the necessity of the ban.
This latest move follows a similar action in 2016, when the government banned the manufacture, sale, and distribution of 344 drug combinations after an expert panel, convened at the Supreme Court’s behest, found them lacking scientific validation. The recent ban includes several FDCs from this earlier list. Additionally, in June 2023, 14 FDCs previously included in the 344 drug combinations were also banned.
The new restrictions are set to impact the pharmaceutical industry significantly, especially since many of the banned FDCs were already discontinued by several drug manufacturers. The government’s ongoing efforts to ensure drug safety reflect a commitment to protecting public health while addressing concerns about irrational drug combinations.
