Abstract
Background and Objectives: Serratiopeptidase is available as an oral preparation. The effectiveness of this enzymatic preparation is questionable. Despite this fact, serratiopeptidase is prescribed for a variety of inflammatory conditions. The study was conducted to determine the availability, cost and rationality of serratiopeptidase preparations available in Indian market. Materials and Methods: Serratiopeptidase preparations were assessed for total number, composition, strength and cost. Data were collected from ‘The Drug Today’ of the years 2009 (October–December) and 2015 (April–June). The rationality of preparations was assessed on validated 6-point scoring criteria. An extensive literature search was made using evidence-based print and electronic databases for the studies on efficacy and safety of serratiopeptidase. Results: A total of 642 serratiopeptidase preparations were available in the year 2009, which increased to 647 in 2015. Eighty percent preparations were fixed-dose combinations (FDCs) with either non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, muscle relaxants or miscellaneous drugs. Of all FDCs, 96% preparations were combinations with one or more NSAIDs. Single drug preparations showed a decline from 19.9 to 12.3%. Serratiopeptidase was available in strengths from 2.5 to 50 mg. The cost of 10 mg dose of serratiopeptidase preparations ranged between Rs. 1.35 and Rs. 8.16. The cost of FDCs was more than that of single non-serratiopeptidase agent. FDCs scored poorly on rationality assessment scale in both years, and an increase in irrational preparations was observed. Conclusion: Too many serratiopeptidase preparations are available. Evidence on their efficacy and safety is lacking. The rationality of available FDCs of serratiopeptidase is poor. The availability of expensive FDCs of unknown efficacy and safety is an important contributory factor for the irrational use of drugs.
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