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

Objectives Analysing the registration status and the presence of fixed‐dose drug combinations ( FDC s) in different drug lists and formularies, encourages the use of rational FDC s and helps to remove the irrational combinations booming in the pharmaceutical market. This study aimed to evaluate the registration status of FDC s in different formularies and drug lists of Nepal. Methods A cross‐sectional observational study was conducted to evaluate the registration of FDC s 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 FDC s were registered in Nepal. Of them, 47 were manufactured in India (58%), 33 in Nepal (41%) and one in Bangladesh (1%). Different brands of FDC s for the same generic medication were registered on the drug list. Most of the registered FDC s were for respiratory illness condition. Of the 81 registered FDC s, 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 FDC s. The number of FDC s registered was quite substantial. There were many brand‐name FDC s listed for the same generic drug. FDC s were predominantly of Indian origin. Combinations used for respiratory illness accounted for the highest percentage of the FDC s in the Nepalese market.