Are we too reluctant about irrational nutraceutical combinations?

Authors

  • V. Krishnan Department of Pharmacology, Saveetha Medical College Chennai, India
  • Prakash Murugaiah Department of Pharmacology, Stanley Medical College, Chennai, India
  • Aruna Maria Bachmann 2nd Year MBBS Student, Saveetha Medical College Chennai, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20164128

Keywords:

Fixed dose combinations, Hypervitaminosis, Irrational multivitamins, Nutraceuticals

Abstract

Background: The objective of the study was to study the rationality of Vitamins and minerals combinations available in India and to provide comprehensive data of irrational combinations having excess and sub sufficient quantity of vitamin and minerals than recommended by National Guidelines of India.

Methods: This observational study and analysis was done between June and August 2016. Data was collected from current index of medical specialties and drug India. Rationality assessment was done using National list approved drug combinations by Central drug standard control organization (CDSCO) and essentially was cross checked using World Health Organization essential drug list 2015. Adequacy was analysed using Dietary reference intake (DRI) for Indians by Nutrional council of India draft guidance.

Results: In our analysis, we have found 1184 irrational nutraceutical preparations available in India market. Out of 461(38.9%) are based on fat soluble vitamins, 190 (16.4%) based on B-complex vitamins based and 5339 (45.1%) related to essential minerals. Among 461 fat soluble vitamins, 104 contain excessive level, 334 contain substandard levels. Similarly 128 and 62 Vitamin B-Complex based preparations are having excess and less quantity than recommended levels respectively and almost all the mineral combinations except four are not prepared following guidelines. None of these combinations were included in National essential list of medicines.

Conclusions: Multivitamins are generally considered safe; these are irrationally prescribed and taken as self-medication by public. Many of the ill effects are often unnoticed and under reported. Government of India should regulate the manufacture and sale these nutraceuticals to promote rational use of drugs and to promote wellbeing and safety of Indian population which is primary objective of ‘Health for all’.

References

McGettigan P, Roderick P, Mahajan R, Kadam A, Pollock AM. Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs. Kesselheim AS, ed. PLoS Medicine. 2015;12(5):e1001826.

Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. British Journal of Clinical Pharmacology. 2008;65(5):795-6.

Central Drug Standard Control Organization. [Updated Aug 2016 , Cited 26 Aug 206 ]. Available from: http://www.cdsco.nic.in/forms/Default.aspx

Subramanian SV, Kawachi I. Income inequality and the double burden of under‐ and overnutrition in India. Journal of Epidemiology and Community Health. 2007;61(9):802-9.

Chugh PK, Lhamo Y. An Assessment of Vitamin Supplements in the Indian Market. Indian Journal of Pharmaceutical Sciences. 2012;74(5):469-73.

Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF: Dietary supplement use in the United States, 2003-2006. J Nutr. 2011;141:261-6.

Bailey RL, Gahche JJ, Miller PE, Thomas PR, Dwyer JT: Why US adults use dietary supplements. JAMA Intern Med. 2013;173:355-61.

Gahche J, Bailey R, Burt V, Hughes J, Yetley E, Dwyer J, Picciano MF, McDowell M, Sempos C: Dietary supplement use among U.S. adults has increased since NHANES III (1988–1994). NCHS Data Brief. 2011;61:1-8.

Karelia BN, Buch JG. Analysis of hematinic formulations available in the Indian market. Journal of Pharmacology and Pharmacotherapeutics. 2012;3(1):35-8.

Balat JD, Gandhi AM, Patel PP, Dikshit RK. A study of use of fixed dose combinations in Ahmedabad, India. Indian Journal of Pharmacology. 2014;46(5):503-9.

Beste LA, Moseley RH. Too Much of a Good Thing. N Engl J Med. 2016;374:873-8.

Garg G, Khadgwat R, Khandelwal D, Gupta N. Vitamin D toxicity presenting as hypercalcemia and complete heart block: An interesting case report. Indian J Endocr Metab. 2012;16(Suppl S2):423-5

Koul PA, Ahmad SH, Ahmad F, Jan RA, Shah SU, Khan UH. Vitamin D Toxicity in Adults: A Case Series from an Area with Endemic Hypovitaminosis D. Oman Medical Journal. 2011;26(3):201-4.

Elizabeth A Yetle .Multivitamin and multimineral dietary supplements: definitions, characterization, bioavailability, and drug interactions. Am J Clin Nutr January 2007 vol. 85 no. 1 269S-276S

Ames BN: Low micronutrient intake may accelerate the degenerative diseases of aging through allocation of scarce micronutrients by triage. Proc Natl Acad Sci U S A. 2006; 103:17589-94.

Yetley EA. Multivitamin and multimineral dietary supplements: definitions, characterization, bioavailability, and drug interactions. Am J Clin Nutr. 2007;85:269S-76S.

Jadav SP, Parmar DM. Critical appraisal of irrational drug combinations: A call for awareness in undergraduate medical students. Journal of Pharmacology and Pharmacotherapeutics. 2011;2(1):45-8.

Sharma K, Sharma A, Singh V, Pilania D, Sharma YK. Irrational Fixed Dose Combinations and Need for Intervention: Understanding of Dental Clinicians and Residents. JCDR. 2014;8(12):ZC49-52.

Goswami N, Gandhi A, Patel P, Dikshit R. An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors. Perspectives in Clinical Research. 2013;4(2):130-5.

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Published

2016-12-21

How to Cite

Krishnan, V., Murugaiah, P., & Bachmann, A. M. (2016). Are we too reluctant about irrational nutraceutical combinations?. International Journal of Basic & Clinical Pharmacology, 5(6), 2585–2588. https://doi.org/10.18203/2319-2003.ijbcp20164128

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Original Research Articles