Rastogi Shruti, Sharma Surendra Kumar, Chauhan Jaishiv, Saini Pawan Kumar, Kumar Robin, Raghuvanshi Rajeev Singh, Jadaun Gaurav Pratap Singh
Indian Pharmacopoeia Commission, Sector 23, Raj Nagar, Ghaziabad 201002, U.P., India.
Saudi Pharm J. 2022 May;30(5):613-618. doi: 10.1016/j.jsps.2022.02.009. Epub 2022 Feb 14.
The Coronavirus Disease (COVID-19) is sweeping around the world at a rapid pace resulting in severe health crises across the globe. The pandemic condition has forced the government, regulatory authorities, bio/pharmaceutical industry, and healthcare system to take novel measures to address the crisis. The race for development of medicines and vaccines for treatment of COVID-19 is well under way and regulatory authorities are making efforts to safely deliver it into hands of public. As ever, pharmacopoeias played an active role in providing a framework of standards for the development, manufacturing, and quality of life-saving COVID-19 related medicines. The COVID-19 crisis has compelled the pharmacopoeias to redefine their role and show unprecedented levels of flexibility in extending their services to the stakeholders, developing new drug standards, and simultaneously ensuring the safety of their staff. During this pandemic, pharmacopoeias operated in a triangular chain system with regulators and pharmaceutical manufacturers to evaluate potential products for treatment of COVID-19. The present article provides an insight on the roles, challenges, and responses of the pharmacopoeias to deal with the current situation due to COVID-19 and emphasizes on new opportunities for collaborations to set standards for COVID-19 related drugs.
冠状病毒病（COVID-19）正在全球迅速蔓延，导致全球范围内严重的健康危机。大流行状况迫使政府、监管机构、生物制药行业和医疗保健系统采取新措施来应对危机。治疗COVID-19的药物和疫苗的研发竞赛正在紧锣密鼓地进行，监管机构正在努力将其安全地交付给公众。与以往一样，药典在为挽救生命的COVID-19相关药物的研发、生产和质量提供标准框架方面发挥了积极作用。COVID-19危机迫使药典重新定义其作用，并以前所未有的灵活性向利益相关者扩展服务、制定新的药品标准，同时确保其工作人员的安全。在这次大流行期间，药典在与监管机构和制药商组成的三角链系统中运作，以评估治疗COVID-19的潜在产品。本文深入探讨了药典在应对COVID-19当前形势时所发挥的作用、面临的挑战和应对措施，并强调了合作制定COVID-19相关药物标准的新机遇。
