A comprehensive evaluation of rationality of cough and cold medicines available in Indian market.

To analyse various cough and cold formulations available in the Indian market and to study their pharmacological rationale and cost effectiveness, a cross-sectional, observational study was carried out for evaluation of the drugs listed in Current Index of Medical Specialities (CIMS) India, September 2010.The formulations were assessed for their total number, type of dosage form, number of constituents in each formulation, their pharmacological group and rationality. The total daily cost and its association with type of dosage form was analysed. Out of a total 1297 preparations evaluated, 94% were fixed dose combination. The mean number of constituents was 3.20 +/- 1.03. Liquid oral formulations were largest in number (64.4%). The formulations contained various antitussives (30.30%), expectorants (33.92%), antihistamines (71.09%), mucolytics (35.62%), decongestants (56.28%), bronchodilators (16.81%) and analgesics/antipyretics (31.30%). None of the preparation was listed in the Model list of Essential Medicines, WHO (March 2011) under section 25 of "Medicines acting on the respiratory tract". Only 2% of the preparations had pharmacological rationale for their use in cough and common cold; 9.6% were containing more than one ingredient of the same pharmacological group and 6.85% were containing both antitussive and expectorant having opposing action. Highest number of preparations (36.85%) was having cost of therapy of Rs 6-10 per day. Liquid oral dosage forms had significantly higher cost than solid dosage form (p < 0.0001) and topical nasal dosage forms had significantly higher cost than liquid (p < 0.03) and solid (p < 0.001) dosage forms. It is conducted that various cough and cold medicines available in Indian market lacked therapeutic rationale for their use, leading to wasteful expenditure.