ABSTRACT:
The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. For chronic diseases and HIV/AIDS infections FDCs are justified for the sake of patient compliance. They are also useful in areas of cardiology, oncology, neurological and respiratory infections. The basic rationale of making FDCs is either to improve adherence or to benefit from the added effects of the two medicinal products given together. Growing number of FDCs are launched by pharmaceutical companies worldwide and there are no particular guidelines for their approval. In India to approve FDCs, permission from State Licensing Authority and Drug Controller General of India is essential. It is a current hot topic of deliberation in Indian pharma industry, Drug Controller general of India and pharma trade. A critical review and rationalization of FDCs is required. As popularity of FDCs is increasing rapidly, drug regulatory authorities should pay attention to make standards to evaluate them by conducting extensive study so that those FDCs can be continued for patients benefit and this is the basis of this article.