The irrational fixed dose combinations in the Indian drug market: an evaluation of prescribing pattern using WHO guidelines

Somesh P. Rayasam, Sujata S. Dudhgaonkar, Ganesh N. Dakhale, Rohan C. Hire, Prashant S. Deshmukh, Nilesh N. Gaikwad


Background: Evaluation of the pattern of fixed dose combinations (FDCs) prescribing amongst the practitioners in a tertiary care hospital in Central India.

Methods: Nine hundred and ninety four prescriptions, containing 639 FDCs were scrutinized in the tertiary care hospital. After excluding the total and the interdepartmental repetitions, the numbers of FDCs were 278, which were considered for final analysis. Inclusion criteria were FDCs from the major out-patient department (OPD) of the tertiary care hospital from January 2011 to December 2011. FDCs from the wards, casualty, infectious disease unit, intensive cardiac care unit (ICCU), tuberculosis and chest and HIV unit were excluded from the study. FDCs were analysed for the different pattern of prescribing and rationalism. Results were expressed as percentages.

Results: Out of 639 FDCs, the most commonly prescribed FDCs were B complex (12.20%), pantoprazole plus domperidone (9.55%) and amoxicillin plus clavulanic acid (7.35%). Seventy percent of the FDCs were prescribed to the age group of 21-60 years. The FDCs were maximum from the department of medicine (25.59%), followed by surgery (15.47%) and ENT 13.69%. Out of 278 FDCs, only 5.4% were rational, and rest of the FDCs were irrational. Ninety five percent of all FDCs were brand names. The physicians were unaware of the active pharmacological ingredients (APIs) of 20.86% FDCs. Ninety two percent FDCs were available as over the counter (OTCs). Forty eight percent FDCs were costing from Rs. 0-50. There were 2.87% FDCs whose price was above Rs. 500.

Conclusions: Irrational FDCs are prescribed by all the departments. Physicians were ignorant about the essential drugs and FDCs. Patients didn’t have access to rational medicines. Therefore, physicians and regulators should be alerted in time. Regulatory actions or government laws should be made mandatory. Availability and access to 348 essential medicines for basic health care should be the priority of the government. Implementation of central drug standard control organisations (CDSCO) guidelines on industries for manufacture of FDCs must be made compulsory.


Fixed dose combination, Irrational, OTC drugs, Prescription analysis, WHO guidelines

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