Evaluation of the registration status of fixed-dose drug combinations in Nepal

Objectives Analysing the registration status and the presence of fixed-dose drug combi- nations (FDCs) in different drug lists and formularies, encourages the use of rational FDCs and helps to remove the irrational combinations booming in the pharmaceutical market. This study aimed to evaluate the registration status of FDCs in different formula- ries and drug lists of Nepal. Methods A cross-sectional observational study was conducted to evaluate the registration of FDCs in the national drug list and their availability in the Nepalese National Formulary (NNF) 1997, the World Health Organization (WHO) Model List of Essential Medicines (15th Edition) 2007 and the Essential Drug List (EDL) of Nepal (third revision) 2002. Key findings A total of 81 FDCs were registered in Nepal. Of them, 47 were manufac- tured in India (58%), 33 in Nepal (41%) and one in Bangladesh (1%). Different brands of FDCs for the same generic medication were registered on the drug list. Most of the registered FDCs were for respiratory illness condition. Of the 81 registered FDCs, 7.0% were listed in the NNF, 6.0% on the EDL of Nepal and 11.0% on the WHO model list. Only three combinations were present in all the formularies and drug lists. Conclusions This study was successful in evaluating the registration status of different FDCs. The number of FDCs registered was quite substantial. There were many brand- name FDCs listed for the same generic drug. FDCs were predominantly of Indian origin. Combinations used for respiratory illness accounted for the highest percentage of the FDCs in the Nepalese market. Keywords fixed-dose drug combinations; Nepal; pharm aceutic al market; re gistra tion statu