In June 2025, the FDA updated its guidance on the labeling requirements for caffeine-containing products, emphasizing clearer dosage instructions to prevent misuse. This regulatory change impacts exporters by necessitating revisions to product labeling to align with the new standards.
In September 2025, the European Medicines Agency (EMA) initiated a review of caffeine citrate products to assess their safety profile in neonatal care. The outcome of this review may influence market dynamics and regulatory requirements for exporters targeting the EU market.
In December 2025, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of caffeine citrate for neonatal apnea treatment. This inclusion underscores the global recognition of caffeine's therapeutic value and may influence procurement policies in various countries.
In February 2026, the NPPA in India revised the ceiling price for caffeine formulations under the DPCO, affecting pricing strategies for domestic manufacturers and exporters. Compliance with the new pricing regulations is essential for market access and profitability.
In March 2026, the CDSCO issued new guidelines for the export of pharmaceutical products, including caffeine, emphasizing the need for stringent quality control measures and documentation. Exporters must adhere to these guidelines to ensure uninterrupted access to international markets.
These developments highlight the dynamic regulatory environment surrounding caffeine exports and underscore the importance of continuous monitoring and compliance for Indian exporters.
