Analysis of fixed dose combinations of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for rationality and cost variation
Keywords:Fixed dose combination, Irrational drugs, CDCSO, Banned drugs, Jan aushadhi, Mucoactive
Background: Aim of the current study was to analyze the FDCs of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for their rationality, cost, and dosage forms.
Methods: FDCs involving expectorants, antitussives, decongestants, antihistamines and mucolytics listed on Drug Today and Jan Aushadhi online portal were analysed for rationality according to the list of banned FDCs by CDSCO published on 01 Jan 2018. The FDCs with EADAM available in Jan Aushadhi online portal are compared with cost of different brands with same composition, strength and dosage form available in the Indian market as per the latest drug today. The cost ratio and percentage cost variation were calculated for each FDC.
Results: Out of total 340 oral formulations, 268 were liquid and 72 were solid formulations. 228 were Syrups, 67 were Tablets, 23 were Drops, 17 were Suspension and 5 were Capsules. Out of 47 banned FDCs, branded FDC with Ammonium chloride 50mg, Bromhexine 4mg, Dextromethorphan 5mg and Menthol in syrup form was still available for over-the-counter purchase and for online purchase with prescription. Percentage cost variation between branded and generic FDCs ranged from 99% for Terbutaline 2.5 mg and Bromhexine 8 mg to 1081% for Terbutaline 1.25 mg, Bromhexine 4mg, Guaiphenesin 50 mg and Menthol 2.5 mg.
Conclusions: One among 47 Banned FDCs was available at both online apps and drug stores. These irrational FDCs can be risk to human lives. The drug authorities need to tune the price of these FDCs as there is a huge percentage cost variation between generic and branded products.
Rubin BK, van der Schans CP, editors. Therapy for mucus clearance disorders, biology of the lung series. New York: Marcel Dekker; 2004.
Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian J Pharmacol. 2016;48:347-9.
Mohanta GP, Manna PK. Rational use of medicines - Indian perspective! Int J Risk Saf Med. 2015;27(1): S47-8.
List of banned FDCs. Available at: http://www.cdsco.gov.in/opencms/en/consumer/list of banned drugs. Accessed on 25 January 2022.
Kamath L, Satish GR. Cost variation analysis of antihypertensive drugs available in Indian market: an economic perspective. Int J Pharma Sci Res. 2016;7(5): 2050.
Product and MRP list available at pharmaceuticals & medical devices bureau of India. Available at: janaushadhi.gov.in. Accessed on 25 January 2022.
Ray A, Najmi A, Khandelwal G, Sadasivam B. A cost variation analysis of drugs available in the indian market for the management of thromboembolic disorders. Cureus. 2020;12(5):32-9.
Lejeune J, Weibel MA. Comparison of 2 antitussive agents in pediatrics. Rev Med Suisse Romande. 1990; 110:181-5.
Stewart KD, Johnston JA, Matza LS, Curtis SE. Preference for pharmaceutical formulation and treatment process attributes. Patient Prefer Adher. 2016;10:1385-99.
Roy V, Malhotra R, Tayal V, Bansal A, Gupta KS. Fixed-dose combinations for cough and common cold in India: An assessment of availability and rationality. Fundam Clin Pharmacol. 2011;25:258-66.
Singh, K, Kondal, D, Mohan, S, Jaganathan S. Health, psychosocial, and economic impacts of the COVID-19 pandemic on people with chronic conditions in India: a mixed methods study. BMC Public Health. 2021;21: 685.