In March 2025, the NPPA conducted a review of antifungal medications, including ketoconazole, to assess market prices and ensure affordability for patients. While no immediate price controls were implemented, the NPPA emphasized the importance of monitoring price trends to prevent exorbitant pricing.
In January 2026, the EMA updated the product information for Ketoconazole Esteve, incorporating new safety data and reinforcing the need for regular liver function monitoring during treatment. (ema.europa.eu)
In February 2026, the FDA issued a safety communication highlighting the risk of drug interactions between ketoconazole and certain medications, advising healthcare providers to review patient medications thoroughly before prescribing ketoconazole.
In March 2026, the WHO released updated guidelines on the management of fungal infections, reaffirming the role of ketoconazole in specific cases while emphasizing the need for careful patient selection and monitoring due to potential adverse effects.
In April 2026, the CDSCO announced a crackdown on substandard antifungal medications, including ketoconazole, following reports of quality issues. Manufacturers were urged to adhere strictly to GMP standards to ensure product quality and patient safety.
These developments underscore the dynamic regulatory environment surrounding ketoconazole, highlighting the necessity for manufacturers and exporters to stay informed and compliant with evolving standards to maintain market access and ensure patient safety.
