Fixed‐dose combinations for cough and common cold in India: an assessment of availability and rationality

Abstract

This study was conducted to determine the number and composition of the various cough and cold formulations available in the Indian market and to study their pharmacological rationale over a period of 7 years. Data for the study was collected from an annual Drug Compendium entitled ‘THE DRUG TODAY’ of the years 2001, 2004, and 2007. Medications were assessed for total number, different formulations, and number of constituents present in each formulation, their pharmacological group and amount of each constituent per dose. Rationality of available preparations was assessed on a seven‐point scoring criteria. There are over thirteen hundred drug products for cough and cold in the Indian market, which is an increase of 71.2% from the year 2001. More than 90% of the preparations were fixed‐dose combinations (FDCs). Majority of the cough and cold preparations had 3–4 constituents. Many preparations contained more than one constituent of the same pharmacological group. Some preparations had constituents with opposing action. A wide variation in the amount of each constituent present per dose in different formulations was observed. The number of banned drug combinations for cough and cold showed an increase from 9 in 2001 to 27 in 2007. Rationality assessment of the FDC preparations revealed that most of the preparations were irrational and had no documented benefit in the treatment of common cold. Availability of such a large number of irrational FDCs for cough and cold requires serious review of the legal provisions in India for drug manufacturing and marketing.

Critical analysis of antimicrobial and respiratory fixed dose combinations available in Indian market

“…Majority of RP FDCs (86%) in our study were irrational, many of them targeting cough and the common cold, a self-limiting condition that does not require medicine to cure or prevent it. [10] Similar observations have been reported by Roy et al [11] and Desai et al [10] Interestingly, our tool found 14 RP FDCs rational with respect to effi cacy, safety, and compliance. For example, the combination of long acting β 2 agonist with corticosteroid is rational because corticosteroids increase the expression of β 2 receptors by increasing gene transcription and reduces the adverse effects of β2 agonist, whereas β 2 -agonists potentiates the local anti-inflammatory actions of corticosteroids by increasing nuclear localization of glucocorticoid receptors and additive suppression of infl ammatory mediator release.…”

Prescription pattern of medicines in a tertiary care hospital: a cross-sectional study

“…The pharmacological rationality of FDCs is established if drugs act by different mechanisms and have supra-additive effect, have similar pharmacokinetics profile, and drugs do not have supraadditive toxicity. 9,10 However, irrational prescribing of FDCs is a major health concern in India as irrational fixed dose combination products can be equally harmful. Many of the FDC available in Indian market lack therapeutic rationale for their use, leading to wasteful expenditure.…”

Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study

“…These benefits have led to an increase in the availability of FDCs for the treatment of cough and cold. Over the past decade, the availability of liquid FDCs for the treatment of cough has increased from 67.9% in 2004 to 71.8% in 2007 [25].…”