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REVIEW ARTICLE
Year : 2011  |  Volume : 1  |  Issue : 2  |  Page : 97-102

Counterfeit herbal medicine


Pharmacy Department, Oman Medical College, Oman

Date of Submission24-Jan-2011
Date of Acceptance27-Mar-2011
Date of Web Publication23-Aug-2011

Correspondence Address:
A R Mullaicharam
Pharmacy Department, Oman medical college, Azaiba, Muscat
Oman
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2231-0738.84191

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   Abstract 

The mass production of fake and substandard medications is growing global problems with deleterious impact on the individuals who ingest them. Estimates of the scale of the global trade in counterfeit medications vary widely. According to the Food and drug administration (FDA), 6%-10% of medicines sold worldwide are counterfeit. The use of herbal remedies, neutraceuticals, and dietary supplements has increased greatly over the past 40 years. Much of the increase in use can be attributed to the common belief that natural ingredients are inherently safer and healthier than synthetic ingredients. Products sold as ''dietary supplements'' are subject to significantly less regulation and are often not required to have safety testing or FDA approval before they enter the market. Without adequate safeguards and quality control mechanisms, there is no assurance that the concentrations of active ingredient are consistent from batch to batch or even that these supplements contain the ingredients they purport to contain. Professional regulation must be open, responsive, and accountable with the emphasis on both the protection of patients and the public rather than being based exclusively on the needs of practitioners. Pharmacists have a responsibility to educate themselves about herbal therapies in order to help patients discern the facts from the fiction, avoid harm, and gain what benefits may be available. Pharmacists must also cope with an environment in which there is relatively little regulation of herbal therapies by FDA.

Keywords: Anti-counterfeiting technology, counterfeit herbal medicine


How to cite this article:
Mullaicharam A R. Counterfeit herbal medicine. Int J Nutr Pharmacol Neurol Dis 2011;1:97-102

How to cite this URL:
Mullaicharam A R. Counterfeit herbal medicine. Int J Nutr Pharmacol Neurol Dis [serial online] 2011 [cited 2017 Oct 16];1:97-102. Available from: http://www.ijnpnd.com/text.asp?2011/1/2/97/84191


   Introduction Top


Counterfeit medicine is now a truly global phenomenon. It does not matter whether you live in United States, Europe, Asia, or Africa-everyone is at risk from these unsafe counterfeit drugs. All counterfeit medicines are dangerous. Besides that it has a negative impact on consumers and manufacturers as we can see in the slide.

The definition for counterfeiting differs all over the world. According to WHO, counterfeit medicines are those medicines that are described as deliberately and fraudulently mislabeled with respect to source and/or identity. [1],[2]

Counterfeiting can apply to both generic and branded products. Counterfeit products may include: Products with the correct ingredients, products with the wrong ingredients, products without ingredients, products with incorrect quantities of active ingredients, or products with fake packaging. [3],[4]

The extent of the problem

The world health organization estimates that as much as 10% of medicines sold worldwide are believed to be counterfeit. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard. These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally.

According to WHO, wealthier countries have the highest use of life style medicines such as hormones, steroids and antihistamines, cholesterol-lowering drugs and anti-cancer drugs.

In developing countries, the most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis, and AIDS. In under-developed countries all expensive drugs are mostly counterfeited. [5]

Reasons for increase of counterfeit drugs

There are three reasons. First, ordinary households, small cottage industries, or even under the shade of a tree, it is enough to carry out the production of counterfeit products. Next, it is a hugely lucrative business due to high demand and low production cost. It is also more profitable with lower risk. Last, absence of strict legislation is one of the reasons for increasing counterfeiting.

Basically, counterfeit medicines are produced in two ways like deceptive and non-deceptive types.

In deceptive type, consumer cannot recognize the counterfeit products by vision. It is perfectly made as original product. It require evaluation test to detect those products. In non-deceptive type, consumer can easily recognize as these are having non uniform colors, poor compression, and poor labeling. [6]

Impact of counterfeit medicines

Counterfeiting has significant impact on health, social and economy.

In health impact, it can harm patients in two ways. Individually and at the community level. It can harm an individual from unexpected adverse reactions and severe toxicity. [7] The regular use of counterfeit medicines leads to therapeutic failure or drug resistance: In many cases, it can lead to death, organ dysfunction, or damage and worsening of disease condition.

This growing market of counterfeit medicines has resulted in an increasing number of deaths in the past two decades. Most notably, in Nigeria in 1990, cough mixture diluted with a poisonous solvent caused the death of 100 children and in India in 1998; diethylene glycol poisoning led to the death of 30 children. [8]

In community level, it can also be life-threatening and have caused deaths all over the world. In U.K., life-threatening effects which have resulted from use of over the counter herbal medicine products tainted with anything from microbial contaminants. Heavy metal, chemical toxins are adulterated with pharmaceutical drugs.

Herbal medicine

Herbal medicines are in great demand and are used by approximately 80% of the world's population. [9] Their popularity is due largely to their presumed safety, efficacy, cultural acceptability and lesser side effects compared with prescription medications; perhaps most important, they are viewed as cost effective and accessible. [10],[11],[12],[13]

Herbal medicine is a part of alternative medicine. As per WHO, herbal medicines means that contain as active ingredients in part of plants or other plant materials or combinations thereof. Herbal medicines include herbs, herbal materials, herbal preparations, or finished herbal products. U.K., Asia, and Africa are the major countries which uses herbal medicines. The past few years in particular have seen a major increase in the use of herbal products. The global market was $5.6 billion by the end of 2006; growing at an average annual growth rate of 1.7%, it is expected to exceed $6.1 billion by 2011. [14]

However, counterfeit, poor quality or adulterated herbal products in international markets are serious patient safety threats. More than 100 countries have regulations for herbal medicines; however, it has not got the desired effect.

There are four possibilities of counterfeit in herbal medicines. The first one is herbal medicines adulterated with undeclared synthetic pharmaceuticals, with undeclared heavy metals, herbal medicines without active ingredient and herbal medicines with wrong active ingredient.

In US, U.K., and Gulf many herbal products and supplements that are reported are adulterated with undeclared synthetic pharmaceutical.

Herbal medicine adulterated with undeclared synthetic pharmaceuticals

The common synthetic adulterants are steroids, drugs for erectile dysfunction anti histamines, NSAIDs, slimming agent and anti diabetics.

In unlicensed Ayurvedic medicines and traditional Chinese and it has often been found that the content of lead and mercury has often been above the safety level which leads to heavy metal poisoning. [15]

Herbal medicine adulterated with undeclared heavy metals

(Medicines and Health care products Regulatory Agency) MHRA Agency has investigating reports of the use of, mercury, Lead and arsenic in unlicensed Ayurvedic and traditional Chinese medicines. Reports from U.S.A. in 2004, suggest that a number of patients suffered lead poisoning following use of a range of unspecified Ayurvedic medicines. The agency also received reports from Hong Kong in December 2004 that a product called Tik Dak Win of the Ng Chung brand was found during testing to contain high levels of lead.

Herbal medicine with wrong active ingredient

Cheaper and similar wrong plants are used and replaced instead of the right one as per the following table. This leads to severe toxic effects. [16]

Accessibility of the herbal medicine can be categorized as herbal medicine prescribed by licensed practitioner in approved herbal clinics like Unani, Ayurvedic and Chinese herbal clinics and herbal products available in all pharmacies. Next category is HM prescribed by unlicensed practitioners from unapproved herbal clinics and herbal medicine easily available in super markets. The third accessible herbal medicine is through advertisement in media and internet.pharmacies.

Challenges in traditional herbal medicine

  • Lack of regulation of traditional herbal medicine
  • Lack of punishment/penalties for counterfeit offences
  • Lack of controlling mechanisms for sales of traditional herbal products and internet pharmacy
  • Lack of post marketing surveillance for traditional herbal drugs
  • Lack of communication and collaboration with international police
  • Lack of public awareness on the health implications of counterfeit medicines [Table 1].
Table 1: Some counterfeit medicines and their harmful effects

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To combat counterfeit for approved or authenticated herbal medicines, there should be a development and implementation of Anti-counterfeiting strategy and technology by every country.

Similarly to combat counterfeiting of unapproved traditional herbal medicine, there are four ways to deal with. The most important approach is, complete regulation of traditional herbal medicine, which will be achieved by implementing Registration system for traditional herbal practitioners and traditional herbal products, like the system followed in U.K., which provide Traditional Herbal Medicines Registration (THR) number or product license (PL No.) for each traditional herbal product and licensing system for traditional herbal products through the Traditional Herbal Medicinal Products Directive (THMPD) and should have controlling mechanism for monitoring their sales in supermarkets. As a result of Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC, all over the counter herbal medicines in the U.K., will require either a Traditional Herbal Medicines Registration (THR) number or a full Marketing Authorization (MA). In order to achieve anti-counterfeiting of Traditional Herbal Medicines, one should develop and implement Anti-counterfeiting strategy and technology, after complete regulation of THM [Table 2].
Table 2: counterfeit medicines in some countries

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Requirement for combating counterfeit herbal medicines sales through internet pharmacies

Similarly, in order to combat counterfeit herbal medicines which are accessible through internet, we can develop accreditation system for websites like The Verified Internet Pharmacy Practice Sites (VIPPS) system, which was started in 1999 by the National Association of Boards of Pharmacy, U.S.A. to ensure that Internet Pharmacies maintain the standards of the profession. They designed accreditation mechanisms specifically for internet-based Pharmacies [8] . International Medical Products Anti-counterfeiting Task force(IMPACT), which is led by WHO, created in 2006, having 4 strategies involving, regulatory control, pharma companies initiatives, technology-based tracking and consumer education and retailer recognition.

Anticounterfeit technologies

Through anticounterfeit technology, we can use four features of overt, covert, forensic, and serialization/track and trace technology [Figure 1].
Figure 1: Anticounterfeiting technologies

Click here to view


Through anticounterfeit technology, we can use four features of overt, covert, forensic and serialization/track and trace technology.

In overt features, nonsecret technologies like, holograms and on-product marking are used. It is simple and inexpensive technology but it is easy to copy by counterfeiters.

The next one of covert features is the secret technologies of invisible fingerprinting on tablet, embedded image and digital water markings are used. It is a simple and a low cost technology and no regulatory approval is required but it cannot use widely.

The third one of the forensic features is the technologies like, chemical taggants, biological taggants and micro taggants are used. This technology is highly technical and secure against copying but is costly and has limited use as it involves the licensing system.

Of all the technologies, serialization/track and trace technology like, barcodes or radio frequency identification (RFID) are believed as most effective one till date. However, it is difficult to implement across multiple markets since the effectiveness of this technology is not yet proved.

Besides this, in countries like U.K. and China anti counterfeiting strategies have been developed keeping the local problems in mind and it is effectively implemented, like MHRA-anticounterfeiting strategies and mobile labs development in china. These modified mobile labs are used to unannounced testing of counterfeiting drugs in interior regions.

Advice for consumers when buying unlicensed herbal medicines. [17]

Consumers should be alert and cautious when buying or using unlicensed herbal medicines. Any claims that a product is safe should be backed by credible evidence. Consumers should be wary of, and avoid, products making claims such as:

  • The herbal remedy is ''100% safe''
  • Herbal remedies are ''safe because they are natural''
  • This herbal medicine ''has no side effects''
  • ''Chinese medicines will not interfere with the effects of any other medicine''
  • ''You can avoid Chinese medicines interfering with other medicines if you take them an hour apart''


Role of pharmacist to combat counterfeit herbal medicines

U.S.F DA provides L.E.A.D.E.R.S GUIDE for Pharmacist. As per the guide, the pharmacist has to learn the extent of counterfeiting through various and should know about health impact of counterfeit medicines.

Learn

  • Discover the extent of counterfeit drugs.
  • Why they are an illicit public health threat.


Educate

  • Help your customers
  • Safeguard their health


Avoid

  • Unsafe medicines and vendors
  • Sourcing-Begin by establishing a list of trusted alternative sources
  • Form a list of key drug products which are at risk of shortages, diversion or
  • Counterfeiting


Decline

  • Suspicious offers
  • Learn how to evaluate unsolicited sales offers and recognize the warning signs


Evaluate

  • Visual clues/ physical traits
  • Create a Baseline of the drug's characteristics.
  • Compare the medicine.


Report

  • Pharmacy's reporting procedure
  • Second, they have to educate customers to avoid counterfeit products by giving their recommendations as you can see in the slide, and avoid purchase of unsafe medicines and vendors and decline suspicious offers.


To know how to evaluate the different types of products and dosage forms and it is important to know the reporting system which is given by WHO and also pharmacist should have the awareness about the International organization of The World Health Organization led Taskforce which is known as International Medical Products Anti-counterfeiting taskforce (IMPACT) is a global coalition of stakeholders, created in 2006, that aims to develop international collaboration between member states, international organizations, NGOs, law enforcement agencies and health professional groups. The aim is to raise awareness of the dangers of counterfeit medical products and to curb their manufacture and distribution.

The organization of MHRA in U.K., the minister of State (Public Health) launched the (Medicines and Health care products Regulatory Agency) MHRA's Anti-Counterfeiting strategy in London in Nov 2007.

What can be done to overcome the challenges in traditional herbal medicine in the world?

First of all we need some preliminary requirement for complete implementation of national policy of traditional herbal medicine in all the developing countries.

They are the exclusive legislation for herbal medicines, regulatory status, herbal monograph, herbal Pharmacopeia, national office, expert committee and research institute for herbal medicines and copy right and intellectual property rights for herbs, herbal products or herbal supplements which are used in our country.

Secondly counterfeiting must be considered as serious criminal offence and tighter supply chain, international police collaboration, strengthening of post marketing surveillance, development of essential drug list for herbal medicine and most importantly, the public should be made aware regarding counterfeit herbal medicines and use of effective anti-counterfeiting technologies.

Resources for pharmacist

  • SafeMeds Email Alert System
  • SafeMeds Weekly Update
  • SafeMeds News Archive
  • http://www.mhra.gov.uk
  • International Medical Products Anti-counterfeiting Taskforce (IMPACT)



   Conclusions Top


The use of herbal medicines is growing at an outstanding rate all over the world. Herbal remedies are now available not only in drug stores but also in grocery stores. The basis for pharmacist involvement with herbal products is an extension of their established role in pharmaceutical care, clinical pharmacy practices and collaborative healthcare teams. To assure that comprehensive care is maintained, patients need to be encouraged to share information with their primary care providers about their herbal medicines or to allow their pharmacist to inform their providers.

Interdisciplinary cooperation of health care authorities, customs, educational institutions, Judiciary, pharmaceutical industry, health care centers, Police forces, wholesalers, healthcare professionals and patients, global approach and public awareness can solve this issues of counterfeit herbal medicines effectively.

 
   References Top

1.World Health Organization: Department of Essential Drugs and other Medicines. Guidelines for the development of measures to combat counterfeit drugs. Geneva (Switzerland): World Health Organization; 1999. Publication No.: WHO/EDM/QSM/99.1.  Back to cited text no. 1
    
2.Deisingh AK. Pharmaceutical counterfeiting. Analyst 2005;130:271-9.  Back to cited text no. 2
[PUBMED]  [FULLTEXT]  
3.Juillet Y, Vlasto A. Counterfeiting of medicinal drugs: Issues and threats. Fundam Clin Pharmacol 2005:19:621-4.  Back to cited text no. 3
    
4.FDA Counterfeit Drugs Questions and Answers. Food and Drug Administration. Available from: http://www.fda.gov/oc/initiatives/counterfeit/qa.html. [Last Accessed on 2007 Sep 14].  Back to cited text no. 4
    
5.WHO/Substandard and counterfeit medicines. Available from: www.who.int/mediacentre/factsheets/2003/fs275.   Back to cited text no. 5
    
6.FDA Initiative to combat Counterfeit Drugs. Available from: www.fda.gov/Drugs/DrugSafety/ucm180899.htm.   Back to cited text no. 6
    
7.MHRA/ Counterfeit Medicines Advice for Healthcare Professionals. Available from:www.mhra.gov.uk.  Back to cited text no. 7
    
8.Dorsey PJ Jr, Hellstrom WJ. The illicit sale of medications for the treatment of Erectile Dysfunction. Medscape Urology 2007; 6:1-9.  Back to cited text no. 8
    
9.Lee JS. Medicinal plants: A powerful health aid. Scientific Creative Quarterly. Auguest 2004. Available from: http://www.scq.ubc.ca/?p=494 [Last Accessed on 2007 April 5].  Back to cited text no. 9
    
10.Kuo FM, Hawley ST, Weiss LT, Balkrishnan R,Vok RJ. Factors associated with herbal use among urban multiethnic primary care patients: A cross-sectional survey. BMC Complement Altern Med 2004;4:18-26.  Back to cited text no. 10
    
11.Clement YN, Morton-Gittens J, Basdeo L, Blades A, Francis MJ, Gomes N, et al. Perceived efficacy of herbal remedies by users accessing primary healthcare in Trinidad. BMC Complement Altern Med 2007;7:4.  Back to cited text no. 11
    
12.Vickers KA, Jolly KB, Greenfield SM. Herbal medicine: Women′s views, knowledge and interaction with doctors: A qualitative study.BMC Complement Altern Med 2006;6:40-7.  Back to cited text no. 12
    
13.Pal SK, Shukla Y. Herbal medicine: Current status and the future. Asian Pac J Cancer Prev 2003;4:281-8.  Back to cited text no. 13
    
14.Gray L. Herbal supplements, prescription drugs, Rx-to-OTC products: A comparision. BCC Research Reports. October 2006.  Back to cited text no. 14
    
15.′Herbal remedies′ containing heavy metals. Available from: www.mhra.gov.uk.   Back to cited text no. 15
    
16.′Mistaken identity of herbal ingredients′. Available from: www.mhra.gov.uk.   Back to cited text no. 16
    
17.Using herbal medicines: Advice to consumers: MHRA Website. Available from: www.mhra.gov.uk.  Back to cited text no. 17
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2]


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