An Analysis of Antiasthmatic preparations available in Indian Market

 

Dr. Anitha Elango1, Dr. K. Punnagai2, Dr. Darling Chellathai3, Dr. Arul Amutha Elizebeth4

1Assistant Professor, Department of Pharmacology, Sree Balaji Medical College, Chromepet, Chennai.

2Professor, Sree Balaji Medical College, Chromepet, Chennai.

3HOD and Professor, Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Porur, Chennai-600116.

4HOD and Professor, Department of Pharmacology, Sree Balaji Medical College,Chromepet,Chennai.

*Corresponding Author E-mail: dr.anishan@gmail.com

 

ABSTRACT:

Objective: To analyse various anti-asthmatic preparations available in the Indian market and to study their cost effectiveness and rationality of drug preparations. Materials and methods: Various formulations which is used for asthma mentioned in Current Index of Medical Specialities (CIMS) (2018) were noted down. Their rationality and irrational combination of drug preparations were recorded as per Drug Controller General of India (DCGI) (2018). Moreover they are classified into number of ingredients present in each preparation, type of dosage forms, different pharmacological groups to which they belong and cost analysis of the anti-asthmatic preparations. Results: Among 598 preparations which has been analysed, 360 (60%) were fixed dose combinations (FDC). Out of 360 FDC, 250(42%) preparations were of irrational formulations. Preparations were categorised into different pharmacological groups like expectorants (18.73%), antihistamines (17.22%), beta 2 adrenergic agonists (50.17%), mucolytics (20.57%), cromones (1%), methylxanthines (16.38%), corticosteroids (24.08%), antileukotrienes (23.91%), anticholinergics (3.85%).187 preparations were inhalants and 10 of the preparations were nasal formulations. Solid formulations (244) are more when compared to other formulations and liquid oral formulations are costlier. Conclusion: Many of the drugs which was considered as irrational by DCGI is still available in Indian market and it is widely used by the people. This indicates the poor governance in the pharmaceutical sector. Through proper awareness and education to the pharmacist, physician and patient this problem could be solved. Moreover it also leads to the wasteful expenditure and effectiveness of the drug is also questionable.

 

KEYWORDS: Anti-asthmatic medicines,cost evaluation,rationality analysis.

 

 


INTRODUCTION:

Various anti-asthmatic preparations are available in Indian market with ingredients ranging from single drug to Fixed Dose Combination (FDC).[1] Some of the FDC were banned by government of India (Drugs banned in India.[2] These FDCs were listed in drugs prohibited for manufacture and sale through gazette notifications under section 26A of drugs and cosmetic act 1940 by the ministry of health and family welfare.[3]

 

Due to this irrational formulations so many drug interactions related adverse effects has been noted in pharmacovigilance database.[4] In this study, we have analysed the anti-asthmatic preparations available in Indian market for their cost effectiveness and rationality.

 

MATERIALS AND METHODS:

Various formulations which are used for asthma mentioned in CIMS (2018) were noted down.Their rationality and irrational combination of drug preparations were recorded as per DCGI (2018).

 

They are classified into:

1)  Number of ingredients present in each preparation,

2)  Type of dosage forms,

3)  Different pharmacological groups to which they belong and

4)  Cost analysis of the anti-asthmatic preparations.[5]

 

It was tabulated in excel sheet as mentioned above and respective percentages were calculated. The pharmacological groups are classified as antitussives, expectorant, anti histamines, beta 2 adrenergic agonists, mucolytics, cromones, xanthine derivatives, corticosteroids, antileukotrienes, anticholinergics and miscellaneous.[5] Then finally bar diagram were made by comparing number of ingredients in each preparations and cost analysis of different types of formulations.

 

RESULTS AND DISCUSSION:

The number of ingredients present in each preparations was classified and was tabulated in percentages [Table:1] and was represented in graph [Figure:1].

 

Table: 1 Classification of number of ingredients present in each preparations (%) (n=598)

Number of ingredients

Total number of preparations (%)

1

238(39.79)

2

239(39.97)

3

63(10.54)

4

54(9.03)

5

0(0)

6

3(0.50)

>6

1(0.17)

Total

598(100)

 

Figure:1-Number of ingredients present in each preparations(%)

 

These preparations were categorised into different pharmacological groups like expectorants (18.73%), antihistamines (17.22%), beta 2 adrenergic agonists (50.17%), mucolytics (20.57%), cromones (1%), methyl xanthines (16.38%), corticosteroids (24.08%), antileukotrienes (23.91%), anticholinergics (3.85%) as shown in [TABLE:2].

 

Table:2-Classification according to different pharmacological groups(n=598)

Pharmacological group

Number of preparations (%)

Anti-tussives

0(0)

Expectorant

112(18.73)

Antihistamine

103(17.22)

Beta2 adrenergic agonist

300(50.17)

Mucolytics

123(20.57)

Cromones

6(1.00)

Xanthine derivatives

98(16.38)

Corticosteroids

144(24.08)

Antileukotrienes

143(23.91)

Anticholinergics

23(3.85)

Miscellaneous

65(10.87)

Among 598 preparations which have been analysed,360 (60%) were of fixed dose combinations(FDC).Out of 360 FDC, 250(42%) preparations were of irrational formulations.Irrational formulation were Preparations containing >3 different pharmacological groups=58(23.2%), Preparations containing >1 constituent of same pharmacological group=17(6.8%), Preparations containing 3 or <3 different pharmacological groups=192(76.8%) .This was depicted in [Table:3].

 

Table:3-Analysis of irrational formulations(n=250)

Irrational formulations

Number of formulations (%)

Preparations containing >3 different pharmacological groups

58(23.2)

Preparations containing >1 constituent of same pharmacological group

17(6.8)

Preparations containing 3 or <3 different pharmacological groups

192(76.8)

 

Further these were categorised into different types of formulations available in the Indian market and their cost therapy per day according to the adult dose has been calculated and was represented in [Table:4] and the same was figured out in [Figure:2] .Among them 187 preparations were inhalants and 10 of the preparations were nasal formulations.

 


 

Table:4-Cost of therapy per day for different types of formulations

Cost/day(INR)

No.of liquid oral formulations (%)

No. of solid formulations (%)

No. of nasal formulations (%)

No. of inhalants (%)

No. of injections (%)

Total  (%)

Upto 10

31(20.67)

116(47.54)

2(20)

98(52.41)

3(42.86)

250(41.81)

More than 10

115(76.66)

113(46.31)

6(60)

88(47.06)

4(57.14)

326(54.52)

Not mentioned

4(2.67)

15(6.15)

2(20)

1(0.53)

0(0)

22(3.67)

Total

150(100)

244(100)

10(100)

187(100)

7(100)

598(100)

 


 

 


Figure:2-Cost therapy per day for different types of formulations

 


Solid formulations (244) are more when compared to other formulations and liquid oral formulations are costlier.Number of preparations having cost of  >Rs.10 is 326 (54.52%) followed by preparations having cost of <Rs.10 is 250(41.81%)

 

There are no references for cost analysis for anti asthmatic preparations but the study which analysed cough and cold preparations showed the similar results.

 

CONCLUSION:

Many of the drugs which was considered as irrational by DCGI is still available in Indian market and it is widely used by the people.This indicates the poor governance in the pharmaceutical sector . Through proper awareness and education to the pharmacist , physician and patient this problem could be solved . Moreover it also leads to the wasteful expenditure and effectiveness of the drug is also questionable.

 

ACKNOWLEDGEMENT:

We are thankful to Sree Balaji medical college and Sri ramachandra university and Department of Pharmacology to help us complete the study.

 

CONFLICT OF INTEREST:

Nil.

 

FUNDING SOURCES:

Nil.

 

REFERENCES:

1.     Desai P, Patel S, Shah R, Desai S. A comprehensive evaluation of rationality of cough and cold medicines available in Indian market. J Indian Med Assoc 2013;111:94-8.

2.     Drugs banned in India.[ONLINE] available at: http://cdsco.nic.in/html/Drugsbanned.html [accessed september 12,2011].

3.     Prakash S. Pharmacovigilance in India. Indian J Pharmacol 2007; 39:123.

4.     Mudiganty SSP, Dang A and Rataboli PV;Crippled Pharmacovigilance: A Qualm of Medical Profession. Journal of Clinical and Diagnostic Research, 2008; 2:1110-1118.

5.     Barnes PJ.2010 Pulmonary Pharmacology.In:Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th Edition.Edited by Brunton L, McGraw-Hill, New York, NY: 36:1143-1167.

 

 

 

 

 

Received on 23.06.2019           Modified on 21.07.2019

Accepted on 30.08.2019          © RJPT All right reserved

Research J. Pharm. and Tech 2020; 13(2):624-626.

DOI: 10.5958/0974-360X.2020.00118.3