Authors : Afreen Usmani, Rania I.M. Almoselhy
DOI : 10.18231/j.jpbs.2023.020
Volume : 11
Issue : 2
Year : 2024
Page No : 125-132
The current study examines the regulatory status and inclusion of Nigella sativa L. (N. sativa) in pharmacopeias across diverse regions. The regulatory landscape varies globally, with some countries recognizing it as a traditional medicine in pharmacopeias, while others impose restrictions due to safety and efficacy concerns. The lack of standardized guidelines complicates its status, ranging from dietary supplement to traditional herbal medicine in different regions. A pivotal shift is observed in the Egyptian Herbal Monograph Volume 3, marking Black Seed’s evolution from traditional medicinal use to a recognized pharmaceutical preparation in the pharmacopeia. This transition signifies a move towards evidence-based medicine, emphasizing rigorous scientific scrutiny and standardization. The integration of Black Seed underscores growing recognition of its efficacy and safety, transforming it into a pharmaceutical product and consolidating its position in mainstream healthcare. The inclusion not only enhances patient accessibility but also instills confidence among healthcare practitioners, solidifying Black Seed as a trusted therapeutic agent. The debate around N. sativa’s inclusion continues, with traditional medicine systems endorsing its value, while modern pharmacopeias grapple with standardization and quality control. N. sativa emerges as a promising natural resource, necessitating comprehensive documentation for its prospective inclusion in evidence-based healthcare practices and official guidelines.