Volume : 10, Issue : 11, November – 2023
Title:
REGULATORY REASONS BEHIND THE BAN OF VARIOUS IRRATIONAL FIXED DOSE COMBINENT DRUGS
Authors :
Koppu Vyshnavi*, M V Nagabhushanam
Abstract :
Medicines are an integral part of healthcare. More than one drug is frequently used for treatment of either single ailment or multiple comorbid conditions. Sometimes, two or more drugs are combined in a fixed ratio into a single dosage form, which is termed as fixed dose combinations (FDCs). The FDCs are justified when they demonstrate clear benefits in terms of (a) potentiating the therapeutic efficacy, (b) reducing the incidence of adverse effect of drugs, (c) having pharmacokinetic advantage, (d) better compliance by reducing the pill burden, (e) reducing dose of individual drugs, (f) decreasing development of resistance, and (g) cheaper than individual drug because of reduced cost from packaging to distribution. It is important that the above claims are adequately supported by scientific evidence.
Keywords: Fixed Dose Combinations, Regulatory Reasons.
Cite This Article:
Please cite this article in press Koppu Vyshnavi et al, Regulatory Reasons Behind The Ban Of Various Irrational Fixed Dose Combinent Drugs, Indo Am. J. P. Sci, 2023; 10 (11).
Number of Downloads : 10
References:
1. Van Boeckel TP, Gandra S, Ashok A, et al. Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. Lancet Infect Dis. 2014;14:742–750. doi: 10.1016/S1473-3099(14)70780-7. [PubMed] [CrossRef] [Google Scholar]
2. CDSCO. Report of Expert Committee on Fixed Dose Combinations (FDCs) Licensed by SLAs for Manufacture without Approval of DCG (I), Applications of Which Received by CDSCO. 2015. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/fdcexpert%2019.1.2016.pdf .
3. CDSCO. Department-Related Parliamentary Standing Committee on Health and Family Welfare Fifty-Ninth Report on the Functioning of the Central Drugs Standard Control Organization (CDSCO) 2012. [Last accessed on 2016 Jun 18]. Available from: http://www. 164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf .
4. CDSCO. Letter Dated 15.01.2013 on Approval of Safety and Efficacy of Fixed Dose Combinations Permitted for Manufacture of Sale in the Country without Due Approval from DCGI. 2013. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/Approval_of_the_safety_and_efficacy_of_FDC.pdf .
5. CDSCO. Report of Expert Committee on Evaluation of Cases of Fixed Dose Combinations (FDCs) Considered as Irrational and Where Showcause Notices were Issued to the Applicants to Submit Their Replies. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/fdcreport10_2_2016.pdf .
6. CDSCO. Prohibition of Fixed Dose Combination Drugs for Human Use Under Section 26A of Drugs and Cosmetics Act, 1940. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/SKM_12-03-2016.pdf .
7. Raghavan P. ET Bureau (March 30, 2016). Delhi High Court Refuses to Vacate Stay on Drug Ban. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.articles.economictimes.indiatimes.com/2016-03-29/news/71900265_1_drugcontroller-general-delhi-high-court-central-drug-regulator .
8. Press Trust of India. (April 4, 2016). How Can Government Ban a Drug Without Cancelling Licence, Asks High Court. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.financialexpress.com/article/industry/companies/how-can-govtban-a-drug-without-cancelling-licence-asks-high-court/232560/
9. CDSCO. Notice Dated (June 17, 2015). Examination of Safety and Efficacy of FDCs Licensed for Manufacture for Sale in the Country without Due Approval from Office of DCGI. 2015. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/notice%20letter17_6_2016_2016.pdf .
10. Brahmaiah Bonthagarala, Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic Goods Administration, International Journal of Advanced Scientific and Technical Research, ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157.
11. Brahmaiah Bonthagarala, Comparison of Regulatory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 (November-December 2016), 1-19.
12. Brahmaiah Bonthagarala, Nanomedicine Clinical Use, Regulatory and Toxicology Issues In Europe, Journal of Drug Delivery and Therapeutics, 2019; 9(4-s):846-848.
13. Brahmaiah Bonthagarala, A Review on global harmonization task force (GHTF) – principles of in vitro diagnostic (IVD) medical devices classification, The Pharma Innovation Journal 2018; 7(7): 667-672, ISSN (E): 2277- 7695.
14. Brahmaiah Bonthagarala, Compilation of Chemistry Manufacturing Controls In Abbreviated New Drug Application, Journal of Pharma Research, Vol-08, Issue 08, 2019.
15. Nayyar GML, Breman JG, Mackey TK, Clark JP, Hajjou M, Littrell M, et al. Falsified and substandard drugs: Stopping the pandemic. Am J Trop Med Hyg. 2019;100(5):1058–65.