The Delhi High Court has confirmed a ban on the manufacture, sale, and distribution of unapproved fixed-dose combination (FDC) drugs, stating that they compromise patient safety and may lead to adverse health effects. This ruling supports an order from the Drug Controller General of India (DCGI) issued in 2025, which prohibited such drugs due to their lack of safety and efficacy studies. FDCs combine multiple active ingredients into a single dosage form, potentially simplifying treatment but also risking unnecessary medication intake. The court's decision on April 21, 2025, marks a significant shift, as it dismissed petitions from several pharmaceutical companies, including Maxford Healthcare and Ajanta Pharma, which sought to challenge the DCGI's authority. The DCGI had previously warned that many FDCs were being granted licenses without proper evaluation, leading to their availability in the market without necessary regulatory oversight. The court reiterated that all new drugs require centralized approval to ensure patient safety, highlighting the importance of adhering to the New Drugs and Clinical Trials (NDCT) Rules, 2019.