Fixed Dose Combination Of Drugs: Are They Justified?
Fixed Dose Combination Of Drugs: Are They Justified?
Keywords:
Fixed Dose Combinations (FDCs), Rational combination, Irrational combination, Drug Controller General of India (DCGI)Abstract
Background:Fixed Dose Combinations (FDCs) are combinations of two or more active drugs in a single form. Prescribing FDCs has become a routine affair in medical practice. Combination drugs increase the compliance of patient to the treatment, decrease the pill burden, but may also lead to increase in the cost of the treatment and side effects. There has been increase in the irrational FDCs in the recent past. The rationality of a fixed dose combination is the most controversial and debated issue in today’s clinical practice. The eighteenth essential medicine list (EML) of WHO includes 25 FDCs while as the 2011 national list of essential medicines (NLEM) of India includes only18 FDCs. Contrary to this Indian market is flooded with FDCs, the scientific rationale for most of these remains unknown. In India, a fixed dose combination of drugs is considered a “NEW DRUG†and has to be approved by Drugs Controller General, India (DCGI). However, the Indian laws governing the approval and marketing of FDCs are not properly defined, the pharmaceutical manufactures take advantage of these loopholes and market combination that have no pharmacological rationale. [Farooq M NJIRM 2015; 6(5):103-107]
References
2. Raju K, Elumalai A, Sridhar E. Irational drug combinations. International Journal of Experimental Pharmacology 2013;3(2):52-56.
3. Gautam CS, Saha L. Fixed dose drug combinations (FDCs): Rational or irrational: A view point. Br J Clin Pharmacol. 2008;65(5):795-6.
4. Sarwar SM, Hossain DM. Fixed dose combination and disease management. International research journal of pharmacy. 2012;3(11):17-21.
5. Dahiya A. Fixed dose combination in India-Is there enough scientific evidence. The journal of macro trends in health and medicine. 2014;1(2):85-94.
6. World health organization. Model list of essential medicine. Available from: http:// www.who.int/medicines/publications/essentialmedicines/18th_EML_Final_web_8Jul13.pdf.
Accessed on feb.28th,2015.
7. 7. National list of essential medicines of India 2011.Available from: http://cdsco.nic.in /writereaddata/National%20List%20of % 20 Essential % 20 Medicine - % 20 final % 20 copy.pdf. Acessed on feb.28th,2015.
8. Balasubramaniam R, Hariharan D, Pamulapati TV, Devarajan V, Shanmuga S, Nair MAS. A Study on Evaluation of Rationality of Fixed Dose Combinations. Am. J. PharmTech Res. 2013;3(5):538-47.
9. Nigam MP, Fernandes VLG, Rataboli PV. Fixed dose combinations- to prescribe or not to prescribe: a dilemma of medical profession. Int J Basic Clin Pharmacol. 2014;3:105-13.
10. Rayasam SP, Dudhgaonkar SS, Dakhale GN, Hire RC, Deshmukh PS, Gaikwad NN. The irrational fixed dose combinations in the Indian drug market: an evaluation of prescribing pattern
using WHO guidelines. Int J Basic Clin Pharmacol. 2013;2:452-7.
11. Sharma K, Sharma A, Singh V, Pilania D, Sharma YK. Irrational Fixed Dose Combinations & Need for Intervention: Understanding of Dental Clinicians and Residents. Journal of Clinical and Diagnostic Research. 2014 Dec;8(12):49-52.
12. Kulkarni SK, Jain NK. Nimesulide– paracetamol combination: Is it rational?. Drugs: News and Views. 2001;6(1):3-4.
13. Gulhati CM. Irrational fixed-dose drug combinations: a sordid story of profits before patients. Issues Med Ethics. 2003;11:5.
14. Diwedi P. Regulatory control on banned drug: A review article. Critical review in pharmaceutical sciences. 2012;1(3):1-12.
15. Balasubramanian J, Radhika N, Badarinath AV. The crave of fixed dose combination in Indian market. Asian J Pharm Clin Res. 2014;7(4):106-10.
16. Jain NK, Akarte A, Deshmukh PT, Kannojia P, Garud N, Akasha Y. Rationality of fixed dose combination: an Indian scenario. The Pharma Research. 2009;1:158-68.
17. Fixed-dose combination in India- Inception –marketing – a study. Available from: http://www.cdmuindia.org/Pdffiles/ Final-report-IFDCs.pdf. Accessed on Mar.13th,2015.
18. Mahajan R, Singh N, Singh J, Dixit A, Jain A, Gupta A. Assessment of Awareness among Clinicians about Concepts in Undergraduate Pharmacology Curriculum: A Novel Cross-sectional Study. Journal of Young Pharmacists. 2010;2(3):301-305.doi:10.4103/0975-1483.66797.
19. Gautam CS, Aditya S. Irrational drug combinations: Need to sensitize undergraduates. Indian J Pharmacol. 2006;38:169-70.
20. Shah S, Patel J, Desai M, Dikshit RK. Critical analysis of antimicrobial and respiratory fixed dose combinations available in Indian market. Int J Med Public Health. 2015;5:161-4.
