Department of Pharmaceutical Regulatory Affairs, N.G.S.M Institute of Pharmaceutical Sciences, Nitte (Deemed to be University) , Mangaluru , India.
Expert Opin Drug Saf. 2019 Oct;18(10):977-985. doi: 10.1080/14740338.2019.1651292. Epub 2019 Aug 7.
: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that 'there is no therapeutic justification' for the active ingredients in the banned FDCs and accordingly these combinations 'may involve a risk to human beings'. : The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India. : The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.
固定剂量复方制剂（FDC）含有一种以上已批准的活性药物成分（API），作为固定剂量制造并包装在单一剂型中。由于政府于 2018 年 9 月禁止 328 种不合理的 FDC，因此制药行业开始关注 FDC。药物技术咨询委员会（DTAB）建议，被禁 FDC 中的活性成分“没有治疗学上的正当理由”，因此这些组合“可能对人类存在风险”。
该综述说明了 FDC 的现状、监管框架、在印度的批准情况，并讨论了印度禁止 FDC 的实质性原因。专家强调要在印度建立一个强有力的 FDC 批准监管体系。制药行业不应将禁止不合理的 FDC 视为障碍；相反，他们应该将其视为建立更强大的医疗保健系统的机会。目前的综述为那些认为禁止 FDC 不合理的人提供了一个新视角。然而，禁止 328 种 FDC 可能被证明是印度制定更强有力医疗保健政策的一个里程碑式的决定。
