CURRENT TRENDS IN PHARMACEUTICAL COUNTERFEITS …

www.wjpps.com Vol 8, Issue 8, 2019.

575

Deepika et al. World Journal of Pharmacy and Pharmaceutical Sciences

CURRENT TRENDS IN PHARMACEUTICAL COUNTERFEITS WITH

ADVANCED TRACE AND TRACK TECHNOLOGY

B. Deepika* and Pooja Agarwal

Department of Pharmaceutical Management and Regulatory Affairs, Geethanjali College of

Pharmacy, Cheeryal (v), R.R. DIST, Hyderabad, Telangana, India.

ABSTRACT

Pharmaceutical counterfeiting is becoming a serious problem both in

developed and in developing countries. This paper considers the extent

of the problem and provides several examples of drugs, which have

been counterfeited. Additionally, the effects of counterfeit products on

consumers, health care providers, drug manufacturers and governments

are discussed. Several of the currently used methods for the detection

of anti-counterfeiting technologies is out lined. Finally, pharmaceutical

anti-counterfeiting measures such as the use of holograms, tracers and

taggant, electronic tracking and Rfid technologies have summarized.

DEFINATION

The World Health Organization (WHO) has defined that counterfeit

medicines is the fake medicine. It may be contaminated or may

contain wrong or no active ingredient. They could have the right

active ingredient but the wrong dose. Counterfeit drugs are illegal and may be harmful to

health.

According to US law, counterfeited medicine is pharmaceutical product, which is

produced and sold with the intent to deceptively represent its origin, authentically or

effectiveness.

INTRODUCTION

The matter of fake medications is certainly not another one to the world in spite of the fact

that it proceeding all through the ages. The issue of fake medications distinguished during the

1980s and as of late the issue has heightened numerous more cases are happening in the

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 7.421

Volume 8, Issue 8, 575-588 Review Article ISSN 2278 – 4357

*Corresponding Author

B. Deepika

Department of

Pharmaceutical

Management and

Regulatory Affairs,

Geethanjali College of

Pharmacy, Cheeryal (v),

R.R. DIST, Hyderabad,

Telangana, India.

Article Received on

04 June 2019,

Revised on 25 June 2019,

Accepted on 15 July 2019

DOI: 10.20959/wjpps20198-14413


576


creating nations as well as in created nations each nation has their own definition to the

forging drug.

WHO has indicated that India is responsible for about 35% of the world’s counterfeit

medicines with the business being worth USD 200 million?

The WHO has been collecting information about counterfeiting of medicines since 1984.

Between 1984 and 1999 there were 771 reports of counterfeiting drugs, reported with

78% of these were from developing countries.

From January 1999 to October 2000, 46 cases are reported from 20 countries among that

60% from the developed countries and 40% from the developing countries.[1]

A recent report from the international pharmaceutical student’s federation has indicated

some drugs are more counterfeited than others are. The main categories include

antibacterial, anti-protozoal, hormones and steroids although any of therapeutic classes

are counterfeited.

Main types of counterfeited drugs (January 1999-december 2002.)

Therapeutic classes % of total drug counterfeited

antibiotics 28

Harmons and steroids 18

Anti-malarial 7

So how might one approach recognizing fake drug?

Right off the bat, look at whether the bundling contain spelling botches or syntactic mistakes.

As most

fake medications are frequently produced in nations where the primary language isn't

English, the makers will in general commit spelling errors or syntactic mistakes on the

external bundling or guidelines flyer; Additionally, take a gander at the quality/state of

the bundling;

Look at the assembling and expiry dates on the external bundling and cross reference

these subtleties with the subtleties appeared on the internal bundling;

Analyze the prescription whether it looks right, has any discoloration or a foul smell. In

the event that any of these highlights show up, rather counsel your medicinal services

expert to affirm whether the prescription is authentic.[2]


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Difference between original and counterfeit medicine

WHY PHARMACEUTICALS ARE TARGETED FOR COUNTERFEITED

Reasons for Counterfeiting of medications

The issue of forging for the most part created because of the accompanying variables:

• Reduced income duty of pharmaceuticals.

• Low expense.

• Use of non-physician endorsed medications.

• Less exchange gambling.

• Enormous advantages or benefits for the producers.

• Lucrative moving of pharmaceuticals.

• Reduced enactment or law authorization.

• Carelessness of the maker.[3]

Provides a concise list of the factors that contribute to the growing trade in counterfeit

pharmaceuticals, including:

• The profitability of the activity;

• Its relative ease;

• The demand for drug products;

• The cost of prescription drugs;

• The web of country-specific regulations;

• The vast cost disparities between countries on the same products;

• The ease of transporting pharmaceuticals;[4]


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Risk of Counterfeit Drugs

• It have an immense hazard to general well-being.

• It is a negative future for pharma drugs.

• Violation of tenets by the medication makers.

• It dodges the simplicity of identification of fake medications.

• It overrides the matter of the true medication.

• Counterfeiting drugs produce several billions of misfortune to the pharmaceutical

industry.[5]

GOVERNMENT INITIATIVES TAKEN TO PREVENT PHARMACEUTICAL

COUNTERFEITING

Indian Government Initiatives

Issues related to counterfeiting of medicines were discussed in with IBSA working group

meeting held on 29th July 2008

India on behalf of South East Asia Region (SEARO) objected to draft resolution 7-8th

August 2008

Meeting of all the pharmaceutical manufacturer association called on 3rd September,

2008 by DCG(I)

Final recommendations discussed in next SEARO Regional Committee meeting on 8 to

11 September 2008.

Meeting with the Indian Pharmaceutical Industry representative on 14 Nov 2008.


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Compliance mandate

• Primary Level bundling prerequisite: Joining of 2D (GS1 Data lattice) standardized tags on

drugs at strip/vial/bottle, and so forth encoding remarkable item recognizable proof code

(GTIN) and Unique Serial Number of the Primary pack.

• Secondary Level bundling prerequisite:

Joining of standardized tags (1D or 2 D) encoding remarkable item recognizable proof code

(GTIN), Cluster Number, Expiry Date and Remarkable Serial Number of the Auxiliary pack.

• Tertiary Level bundling prerequisite: Joining of standardized tags (1 D) encoding

remarkable item recognizable proof code (GTIN), Batch Number, Expiry Date and Unique

Sequential Number of the Tertiary pack (shipper/container).

• Under the track and follow framework, makers would be required to keep up serialized

record of sent out pharmaceutical items for a base time of a half year after the expiry date of

the item.[6]

PRECAUTIONS TAKEN BY THE PHARMACEUTICAL MANUFACTURING

COMPANIES TO PREVENT COUNTERFEITING

Protection of the supply chain of medicine.

Control of collaborator.


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Delivery control.

Risk Assessment.

Information to public authorities and partners.

Create instruments to empower the detect ability and restriction of medications.

Duplicate investigations among the wholesalers and retailers, especially focusing on the

individuals who take part in parallel imports, who are increasing in presented to the

dangers of interruption of distorted prescriptions.

Limit the quantity of go-betweens in the supply frameworks while protecting free

challenge.

Buy items on the web to test and along these lines, if vital, to seek after with exhaustive

examinations and conceivable arraignment.

Approve the security of sites by granting a name and a logo to locales who lawfully move

medications and who meet the criteria of value and unwavering quality.

Distribute an authority online rundown of these reliable locales.[7]

Steps taken by Manufacturer to combat Counterfeiting

Protect the supply chain.

Weigh the balance of public health campaign.

Use the Med watch form.[8]

TECHNOLOGIES USED FOR ANTI COUNTERFEITING

SERIALIZATION SYSTEM: Serialization solution enabling easy tractability and

tracking of individual product packages.


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AGGREGATION SYSTEM: Product aggregation solution for track and

trace applications is full compliance with government and industry requirements

across the globe.

TRACK AND TRACE SOFTWARE: Fully integrated with corporate or external IT

systems to support the compliance needs of DSCSA (Drug Supply Chain Security Act)

and FMD (Falsified Medicine Directive).[9]

BARCODE: Barcode is an optical, machine -readable, representation of data. That data

usually describes something about the object that carries the barcode.[10]

Barcode


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RFID: Radio Frequency Identification. It is used to track objects. A RFID system consist of

three elements, a RFID tag, RFID reader and antenna. RFID tag contains memory, antenna

that transfers data in the form of radio waves when in contact with RFID signals.[11]

Rfid chip

HOLOGRAM: A hologram is an image that appears to be three dimensional and which can

be seen with the naked eye. Holography is the science and practice of making holograms.

Typically, a hologram is a photographic recording of a light field, rather than an image

formed by a lens.

Hologram

TRACES, TAGGANTS & INKS

To aid the recognizable proof of fakes, the inks may contain security taggant of which there

are four noteworthy types:

(a) spectroscopic taggant which include inks that might be UV safeguards and might be

joined into particles, filaments or security strings installed into paper or bundling;

(b) Natural taggant which may incorporate strands of explicit DNA. This DNA-installed ink

innovation is savvy, the ink is hard to replicate 50 and takes into account constant item

authentication;

(c) synthetic taggant which incorporate pH-delicate and other materials which must be

identified by IR spectroscopy or X-beam fluorescence and;

(d) Physical taggant, for example, the utilization of minute plastic particles which are just

unmistakable with the utilization of microscopy.


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Inks taggant

ELECTRONIC TRACKING

Electronic tracking frameworks, for example, radio recurrence chips which make utilization

of labeling of items by makers, are being created to follow items through the appropriation

chain. Such techniques can transmit a vast volume of explicit data about the item and will

permit merchants and retailers to follow their item when necessary.[12]

TRACE AND TRACK TECHNOLOGY

Track and follow arrangements help organizations track and follow the merchandise from

creation to deals and dispersion. It is imperative to comprehend its effect to your task in light

of the solid budgetary returns it conveys to your business:

- Improves generation efficiencies

- Improves the board and revealing

- Improves exactness’s and lessen botches

- Protects your image

Track and follow arrangements incorporate scanner tag marks, radio recurrence ID (RFID)

labels, multi-dimensional images and other brand security gadgets. Together with

programming arrangements, they structure an incredible asset to enhance your primary

concern.[13]


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ADVANTAGES OF TRACE AND TRACK TECHNOLOGY

How trace and track technology and serialization can drive the business value.[14]

E-PEDIGREE

An E-pedigree (some of the time alluded to as e-family or electronic family) is an electronic

archive which gives information on the historical backdrop of a specific group of a

medication. It fulfills the prerequisite for a medication family while utilizing a helpful

electronic structure.[15]


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ROLE OF PHARMACIST TO PREVENT THE PHARMACEUTICAL

COUNTERFEITING

Drug specialists assume a basic job in keeping the dissemination of fake prescriptions. By

bringing issues to light, distinguishing instruction materials with down to earth proposals, and

actualizing suggestions to guarantee the respectability of the inventory network, drug

specialists can help address the danger of fake meds.[16]

The task-force suggests that drug specialists

(1) Buy meds from known, solid sources;

(2) Caution patients of the perils of acquiring drugs over the Internet;

(3) affirm with merchants that items were bought from makers or other solid sources;

(4) Screen fake item cautions

(5) Check items for suspicious appearance;

(6) work with the pharmaceutical business, merchants, and the Nourishment and Drug

Administration (FDA) to close holes in the store network, particularly for medications hard to

find;

(7) use checking innovation in the drug store as a major aspect of a medicine confirmation

process;

(8) Teach themselves, associates, and patients about the dangers of fake meds; and

(9) Report suspicious drugs to FDA, the merchant, and the producer.[17]

Role of pharmacist

Amidst fake flood, drug specialist assumes a job of cruising boat to battle the fake.

Setting up of extraordinary team in medication.

Ensuring security, viability, nature of the medication imported.

Implementation of WHO, great drug store practice rules.

Visual review of the fake medications and finding a way to distinguish the source.

Maintaining sensible edges for drug specialist and wholesalers.

Updating the learning in preparing programs.

Developing diagnostic strategy, utilization of advanced instruments to abstain from

falsifying.

Avoiding non-managed online drug store.

Creating mindfulness among wellbeing experts.

Limit or take out buys from auxiliary wholesalers.


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except if they are ADRs that buy specifically from the maker, are on favorable terms with

their State

Board of Pharmacy, and cons do not move buy of high-chance medications among

wholesalers. Reevaluate drug store office safety efforts.

Establish composed strategies and train representatives to assess

tranquilize bundles and containers for proof of altered incognito

What more, unmistakable alter safe highlights.

Contact the maker to decide whether the bundling of a suspect item is real.

Be mindful of NABP's rundown of defenseless items that are inclined

To forging, preoccupation, or contaminated.

Educate consumers

Patient education requires timely access to accurate information of threats or documented

cases and actions recommended by FDA and manufacturers. Information should be provided

in a non-alarming manner that can be understood by consumers with limited English skills. A

pharmacist should also be prepared to discuss information consumers are likely to receive

from the communication media. Patients should be encouraged to:

Be familiar with size, shape, color, taste, and odor of medications (at the time of

dispensing, explain to patients any physical change initiated by manufacturers).

Promptly report suspect counterfeit drug products to a pharmacist and/or health care

provider.

Provide a sample of the suspect counterfeit drug for inspection within the pharmacy and

forwarding to FDA and/or the manufacturer.

Report new adverse effects to a pharmacist and prescribing health professions.[18]

CONCLUSION

Counterfeit drugs pose a public health hazard, waste consumer income, and reduce the

incentive to engage in research and development and innovation. Stronger state licensure

supervision of drug suppliers would be helpful. Technological approaches, such as the Radio

Frequency Identification devices, should also be considered. Finally, counterfeit drugs may

raise concerns among consumers about safety and reduce patient medication adherence.


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REFERENCES

1. The Business of Counterfeit Drugs in India: A Critical Evaluation Saurabh Verma*,

Rajender Kumar and P.J. Philip Research Scholar, Department of Humanities & Social

Sciences, NIT, Kurukshetra–136119, Haryana page no: 142.

2. Pharmaceutical counterfeiting Anil K. Deisingh Received 21st May 2004, Accepted 25th

November 2004 first published as an Advance Article on the web 14th December 2004

DOI: 10.1039/b407759h this journal is! The Royal Society of Chemistry 2005 Analyst,

2005; 130: 271–279 | 271.

3. Counterfeit drugs – Role of Pharmacist’s and its Prevention –A Review Rakesh Kumar*.

4. (Pharmaceutical Counterfeiting: Endangering Public Health, Society and the Economy

Kristina M.L. Acri, née Lybecker)

5. Detection of Counterfeit Drugs: Counterfeit drugs – Role of Pharmacist’s and its

Prevention –A Review Rakesh Kumar*.

6. Pharmaceutical Serialization Track and Trace (Easy guide to country-wise markets).

7. https://supplychainbeyond.com/6-trends-pharmaceutical-market/.

8. http://www.keionline.org/misc-docs/deisingh_pharmaceutical_counterfeiting.pdf.

9. https://www.mt.com/us/en/home/products/Product-Inspection_1/Track_a_Trace.html

cmp=sea_10040127&SE=BING&Campaign=MT_PI_EN_US&Adgroup=PCE-

TrackTrace&bookedkeyword=%2Bpharmaceutical%20%2Btrack%20%2Band%20%2Btr

ace&matcht ype=b&adtext=78340264261169&placement=Bing-

not_available&network=o&kclid=3e3d7f1b8e20-42c5-aecf-0d217e35a460 (technologies

used in trace and track technology)

10. https://en.wikipedia.org/wiki/Track_and_trace.

11. https://www.mt.com/us/en/home/products/Product-Inspection_1/Track_a_Trace.html

cmp=sea_10040127&SE=BING&Campaign=MT_PI_EN_US&Adgroup=PCE-

TrackTrace&bookedkeyword=%2Bpharmaceutical%20%2Btrack%20%2Band%20%2Btr

ace&matcht ype=b&adtext=78340264261169&placement=Bing-

not_available&network=o&kclid=3e3d7f1b8e20-42c5-aecf-0d217e35a460 (technologies

used in trace and track technology).

12. (Pharmaceutical counterfeiting Anil K. Deisingh Received 21st May 2004, Accepted 25th

November 2004 First published as an Advance Article on the web 14th December 2004

DOI: 10.1039/b407759h)

13. http://www.bradyid.com.sg/en-sg/brady-resources/articles/articles/track-and-trace.

https://en.wikipedia.org/wiki/Track_and_trace


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14. (COGNIZANT THOUGHT LEADERSHIP PAPER TRACK AND TRACE FOR

PHARMACEUTICAL SERIALIZATION: THE WAY FORWARD)

15. (https://en.wikipedia.org/wiki/Epedigree)

16. (Role of the Pharmacist in Preventing Distribution of Counterfeit Medications Walter G.

Chambliss, PhD; Wesley A. Carroll, BSPharm; Daniel Kennedy, BSPharm; Donald

Levine, DPh; Michael A. Moné, BSPharm, JD; L. Douglas Ried, PhD; Marv Shepherd,

PhD; Mukund Yelvigi, MS Posted: 03/06/2012; J Am Pharm Assoc., 2012; 52(2):

195-199. © 2012 American Pharmacists Association

17. (J Am Pharm Assoc (2003). 2012 Mar-Apr; 52(2): 195-9. doi:

10.1331/JAPhA.2012.11085.Role of the pharmacist in preventing distribution of

counterfeit medications. Chambliss WG1, Carroll WA, Kennedy D, Levine D, Moné MA,

Ried LD, Shepherd M, Yelvigi M.

18. ROLESFORPHARMACYINCOMBATTING COUNTERFEITDRUGS RONAL.

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CURRENT TRENDS IN PHARMACEUTICAL COUNTERFEITS …