Evaluation of rationality of fixed dose combinations of antimicrobials available in Indian market

Authors

  • Rohan Srivastava Department of Medicine, Breach Candy Hospital, Mumbai, Maharashtra, India
  • N. D. Kantharia Department of Pharmacology, Government Medical College, Surat, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20220411

Keywords:

Antimicrobial agents, Resistance, Fixed dose combination

Abstract

Background: The antimicrobial resistance is alarming at present. One of the important factors for resistance is use of irrational fixed dose combinations. Thus, objective was to critically analyze the rationality of FDCs of antimicrobial agents currently available in India.

Methods: The FDCs of AMAs enlisted in Indian Drug Review 2019 were analyzed by 8 point criteria tool. Analysis includes number of active pharmacological ingredients, approval by central drug standard control organization, listing in world health organization model list of essential medicines (2019) or Government of India national list of essential medicines (2015). Literature search was used for assessing efficacy, safety, pharmacokinetic and pharmacodynamic interactions and advantages of each FDC. Each criterion was assigned score one, if positive and minus one, if negative leading to total score of 12. FDC with score of ≥7 was considered as rational.                                                                         

Results: The FDCs of AMA available in Indian market were 116 while FDCs included in WHO model list, 2019 were 24. Majority of FDCs available were irrational that include combination of antibacterial with bromhexine, carbocisteine, ambroxol, serratiopeptidase, antiamoebic and antifungal etc. Most of the rational FDCs belong to antiretroviral, antitubercular and antimalarial drugs.                                

Conclusions: Most of the FDCs of AMAs available in Indian market are irrational. These needs educating the prescribers including resident doctors. There is need to critically review such FDCs by drug regulators with strict action regarding manufacturing and marketing.

References

WHO. Guidelines for registration of fixed dose combination medicinal products. Available at: https://www.who. int/medicines/areas/quality_safety/quality_assurance/GuidelinesRegistrationFixedDoseCombinationTRS929Annex5.pdf. Accessed on 20 October 2021.

Guidelines for Industry on Fixed dose combinations draft guidelines. New Delhi. Ministry of Health and Family Welfare. Government of India. 2010: 38.

Model list of essential medicines. 20th ed. Geneva: World Health Organization; 2019.

Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian Drug Review. 2019;3-5.

National List of Essential Medicines, CDSCO. Government of India. 2015.

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Tayal V, Roy V. An Assessment of availability, cost and rationality of serratiopeptidase preparations in India. MAMC J Med Sci. 2017;3(3):152-8.

Malshe PC. Orally administered serratiopeptidase: Can it work?. J Assoc Physicians India. 1998;46:492.

Joshi AS, Shah RK, Suthar MH, Keharia UH. Evaluation of rationality of antimicrobial and antidiarrheal fixed dose combination available in Indian market. Int J Med Public Health. 2021;11(2):222-6.

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Published

2022-02-23

How to Cite

Srivastava, R., & Kantharia, N. D. (2022). Evaluation of rationality of fixed dose combinations of antimicrobials available in Indian market. International Journal of Basic & Clinical Pharmacology, 11(2), 128–131. https://doi.org/10.18203/2319-2003.ijbcp20220411

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Section

Original Research Articles