Counterfeit drugs in India: significance and impact on pharmacovigilance

Authors

  • Nehal A. Shah Department of Pharmacology, Sumandeep Vidyapeeth, S.B.K.S. MI&RC, Piparia-391760, Vadodara, Gujarat
  • Bhagya M. Sattigeri Department of Pharmacology, Sumandeep Vidyapeeth, S.B.K.S. MI&RC, Piparia-391760, Vadodara, Gujarat
  • Nirav N. Patel Department of Pharmacology, Sumandeep Vidyapeeth, S.B.K.S. MI&RC, Piparia-391760, Vadodara, Gujarat
  • Haresh A. Desai Department of Pharmacology, Sumandeep Vidyapeeth, S.B.K.S. MI&RC, Piparia-391760, Vadodara, Gujarat

DOI:

https://doi.org/10.18203/2320-6012.ijrms20150596

Keywords:

Counterfeit drugs, Spurious drugs, Pharmacovigilance, Economic impact

Abstract

Counterfeit drugs have emerged as a major global problem. This issue has been brought to the centre of the Indian media due to the death of 15 women attending a sterilization camp in Chhattisgarh. India’s pharmaceutical industry exports drugs worth 15 billion dollars, which means a high prevalence of counterfeiting in India’s drug industry has global repercussions. However, accurate figures on the extent of counterfeit drugs in India are not available. The scientific literature as well as media reports often quotes figures of 10-35%, though studies done by the Indian Government dispute this. Counterfeit drug numbers have been known to be under represented by Governments due to fear of undermining their economy and health systems. On the other hand, rival companies in other countries may have an incentive to over hype India’s counterfeit problem to dent India’s growing status as the leading global supplier of generic medicines. Lack of clear definitions and differences between laws of countries further complicate reporting. A high prevalence of counterfeit drugs has a large impact on both health and economic indicators. Additionally, counterfeit drugs provide significant challenges to Pharmacovigilance programmes. Hence, here we discuss the significance of use of counterfeit drugs in India and challenges faced by Pharmacovigilance due to the extensive use of counterfeit drugs.

References

Ambroise-Thomas P. The tragedy caused by fake antimalarial drugs. Mediterranean journal of haematology and infectious diseases. 2012;4(1).

Verma S, Kumar R, Philip PJ. The Business of Counterfeit Drugs in India: A Critical Evaluation.

Who. WHO | General information on counterfeit medicines: World Health Organization; 2014 [updated 2014-10-11 21:16:00; cited 2015]. Available from: http://www.who.int/medicines/services/counterfeit/overview/en/.

Khan AN, Khar RK. Current scenario of spurious and substandard medicines in India: A systematic review. Indian journal of pharmaceutical sciences. 2015;77(1):2.

Shukla N, Sangal T. Generic drug industry in India: the counterfeit spin. Journal of Intellectual Property Rights. 2009;14(3):236-40.

A "Spurious" Definition: Need to Amend the Drug and Cosmetics Act 2015 [cited 2015]. Available from: http://spicyip.com/2009/08/spurious-definition-need-to-amend-drug.html.

India: 2010. PSM. Proposed methodology to conduct a study on the Extent of spurious drugs in the supply chain of Indian market. Available from: http://www.safemedicinesindia.in/pdf/Methodology.pdf.

New Delhi: CDSCO report 2008; 2008. [Last accessed on 2013 Nov 13]. Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under The Drug and Cosmetic (Amendment) Act; pp. 1–13. Available from: http://www.cdsco.nic.in/writereaddata/Guidelines under new penal provisions9.pdf.

Bate R, Tren R, Mooney L, Hess K, Mitra B, Debroy B, et al. Pilot study of essential drug quality in two major cities in India. PLoS One. 2009;4(6):e6003.

Odeniyi MA, Adegoke OA, Adereti RB, Odeku OA, Itiola OA. Comparative analysis of eight brands of sulfadoxine-pyrimethamine tablets. Tropical Journal of Pharmaceutical Research. 2003;2(1):161-7.

Kay M. Indian generics manufacturer Ranbaxy agrees to pay $500 m to settle US fraud and drug safety charges. BMJ. 2013;346:f3536.

Outsourcing Pc. New counterfeit report highlights worrying trends 2015 [cited 2015 3/5]. Available from: http://www.outsourcing-pharma.com/Contract-Manufacturing/New counterfeit-report-highlights-worrying-trends.

Reynolds L, McKee M. Organised crime and the efforts to combat it: a concern for public health. Globalization and health. 2010;6(1):21.

Rosina MSG, Shaver L. Why Are Generic Drugs Being Held Up In Transit? Intellectual Property Rights, International Trade, and the Right to Health in Brazil and Beyond. The Journal of Law, Medicine & Ethics. 2012;40(2):197-205.

India fully aligned with international IPR, will safeguard its own interests, says Nirmala Sitharaman 2015 [cited 2015 3/5]. Available from: http://articles.economictimes.indiatimes.com/2015-05-04/news/61800270_1_ipr-issues-patent-laws-questions-india.

Reuters India. Sterilisation deaths expose India's struggle with faulty drugs: @Reuters India; 2015 [cited 2015 3/5]. Available from: http://in.reuters.com/article/2014/11/14/india-health-drugs-chhattisgarh-idINKCN0IY1RF20141114.

Blackstone EA, Fuhr Jr JP, Pociask S. The health and economic effects of counterfeit drugs. American health & drug benefits. 2014;7(4):216.

Cobert B. Colbert’s Manual of Drug Safety and Pharmacovigilance: Jones & Bartlett Learning; 2011.

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Published

2017-01-12

How to Cite

Shah, N. A., Sattigeri, B. M., Patel, N. N., & Desai, H. A. (2017). Counterfeit drugs in India: significance and impact on pharmacovigilance. International Journal of Research in Medical Sciences, 3(9), 2156–2160. https://doi.org/10.18203/2320-6012.ijrms20150596

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Review Articles