This document provides a summary of the issue of counterfeit medicines in India. It defines counterfeit drugs and discusses the global scale of drug counterfeiting. It outlines the challenges posed by counterfeit medicines, such as lost business opportunities for pharmaceutical companies and increased economic and social burdens. It also discusses strategies that can be implemented to overcome the issue of counterfeit medicines in India, including raising public awareness, implementing anti-counterfeiting measures, strengthening legal frameworks, improving cross-border collaboration, and using technology to detect counterfeits.

1. 1
RAJIV GANDHI NATIONAL UNIVERSITY OF LAW,
PATIALA
TRANSNATIONAL ORGANIZED CRIMES- PROJECT
GROUP NO. 17
THE IMPACT OF COUNTERFEITING ON INTERNATIONAL
MARKET- A REVIEW
Counterfeiting in the Pharmaceutical Industry- An Analysis
SUBMITTED BY- MS. KOPAL TEWARY
SUBMITTED TO- MS. IVNEET WALIA
ROLL NO. 17155
CRIMINAL LAW SPECIALIZATION

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TABLE OF CONTENTS
I. Acknowledgement ..........................................................................................................3
II. Introduction.....................................................................................................................4
III. Drug Counterfeiting- The Global Scenario.................................................................4
IV. Definition of counterfeit drug .....................................................................................5
V. What are counterfeit medicines?.....................................................................................5
VI. Definition under the Drug and Cosmetics Act, 1940..................................................6
VII. Role of IPR in the pharmaceutical industry ................................................................7
VIII. Challenges posed by counterfeit medicines ................................................................8
IX. Strategies to overcome the issue of counterfeit medicines .........................................9
X. WHO response..............................................................................................................14
XI. Steps taken by India ..................................................................................................15

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I. ACKNOWLEDGEMENT
I am thankful to my University, Rajiv Gandhi National University of Law, Patiala, and to
Asst. Prof. Ms. Ivneet Walia for giving me the opportunity of working on this project- ‘The
Impact of Counterfeiting on International Markets- A Review’.
I am extremely grateful to my family members for being supportive throughout these tough
times and for motivating me at every step.

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II. INTRODUCTION
The Illicit Trafficking of Counterfeit Goods and Transnational Organized Crime As a global,
multibillion dollar crime, organized criminal groups have not hesitated to cash in on the trade
in counterfeit goods. In many parts of the world, international, regional and national law
enforcement authorities have uncovered intricate links between this crime and other serious
offences including illicit drugs, money laundering and corruption.1
Some estimates put the
counterfeit business at well in excess of $250 billion a year and hundreds of billions more, if
pirated digital products and domestic counterfeit sales are included.2
There is an additional societal impact caused by counterfeiting. The trade in counterfeit
products can result in increased corruption and law enforcement costs, have a serious impact
on public health and safety, lead to social and environmental concerns, and result in the
infringement of other criminal and administrative laws such as tax and customs evasion as well
as fraud.
III. DRUG COUNTERFEITING- THE GLOBAL SCENARIO
Illegal trade takes place around the world. The World Health Organization (WHO) estimates
that counterfeit medicines worth 73 billion euros are traded annually. Dubious online
pharmacies that conceal their true location deliver globally- reaching countries such as
Germany, UK, Italy, Spain etc. or the USA. Supplies from illegal internet pharmacies – those
without appropriate certification – are up to 50 percent counterfeits.3
The extent of the problem varies greatly between regions and individual countries, and also
depends largely on temporary supplies. The problem is highly dependent on how tight legal
controls are. The WHO estimates that in some areas in Africa, Asia, and South America, more
than 30 percent of medicines in circulation are fakes. In some countries of Eastern Europe, the
proportion of fake medicines can be more than 20 percent. In Europe and in the USA, as well
as in other developed countries, less than one percent of the medications sold are counterfeits.4
1
Organization for Economic Cooperation and Development, “Magnitude of counterfeiting and piracy of
tangible products: an update”, November 2009. Available from www.oecd.org/dataoecd/57/27/44088872.pdf.
Last visited on 05/05/2021.
2
UK IP Crime Group, ‘IP Crime: Annual Report 2011-2012’, p.14, 2012. Available from
http://www.ipo.gov.uk/ipcreport11.pdf. Last visited on 05/05/2021.
3
Background Information on Counterfeit Drugs, Bayer Global. Available at
https://www.bayer.com/en/products/background-information-on-counterfeit-drugs#global-scale. Last accessed
on 02/05/2021.
4
Ibid.

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Despite this, the trend shows that counterfeits in our globalized world are no longer just a
problem of developing countries. When traveling, patients often purchase their medicines
abroad (and in some cases, bring them home for family members and friends, even though it is
prohibited to do so). Typical market structures and trading routes have been liberalized,
allowing vendors to sell medicines at lower prices. Furthermore, the internet has made sales
and trade of various articles simpler and more global.5
IV. DEFINITION OF COUNTERFEIT DRUG
The problem of poor quality medicines is already very serious and steadily growing and is
likely to cause much more damage in the near future.6
As such poor quality drug does not bear
any universal definition as it may vary from country to country7
. In general poor quality drug
are the spurious/falsely-labeled/falsified/counterfeit (SFFC) drugs that can cause treatment
failure or even death.8
Accordingly, International medical products anticounterfeiting taskforce
(IMPACT) of World Health Organization (WHO) defines SFFC medicines as “medicines
which are deliberately and fraudulently mislabelled with respect to identity and/or source, and
also which may include products with correct ingredients or with the wrong ingredients,
without active ingredients, with insufficient or too much active ingredient, or with fake
packaging”.
In 2017, WHO analysed drug samples and found that 10.5 percent of pharmaceutical drugs in
low and middle-income countries are fake or substandard.9
Many south-east Asian countries
like China and India are developing nations so may have counterfeit drugs at these levels.2
V. WHAT ARE COUNTERFEIT MEDICINES?
The definition of counterfeit drugs also varies greatly between different countries. There is an
absence of uniformly accepted definition for counterfeit drugs.10
Basically, counterfeits are
drugs that do not come from, or are not offered in the same form as, medicines from the original
manufacturer. Exempted from this are changes that have been properly and lawfully made, as
5
Ibid.
6
Furnham, Valgeirsson, “The effect of life values and materialism on buying counterfeit products.”. Socio
Economic Journal, 2007.
7
Available at Available from: http://www.ncbi.nlm.nih.gov/pubmed/22632187 . Last accessed on 29/04/2021.
8
Geneva: World Health Organization; 2012, Available at Available from:
http://www.who.int/mediacentre/factsheets/fs275/en/index.html .
9
Available at https://www.who.int/news-room/detail/28-11-2017-1-in-10-medical-products-in-developing-
countries-is-substandard-or-falsified. Last accessed 29/04/2021.
10
General information on counterfeit medicines, World Health Organization, 2014.

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in the case of parallel imports.11
Counterfeits range from complete fakes that have been made
by a counterfeiter, to original products with manipulated expiration dates.
The WHO categorizes counterfeit drugs into 6 categories based on type and prevalence:
• No active ingredients (32.1%).
• Incorrect amounts of active ingredients (20.2%).
• Incorrect ingredients (21.4%).
• Correct quantities of active ingredients but fake packaging (15.6%).
• An original product that has been copied (1%).
• High levels of impurities and contaminants (8.5%).12
Unfortunately, patients, doctors or pharmacists are not always able to distinguish such
“medications” from the real ones without a very detailed inspection.13
VI. DEFINITION UNDER THE DRUG AND COSMETICS ACT, 1940
India does not have an official definition for counterfeit drugs. In India, as per Drug and
Cosmetic (D and C) act, 1940, under section 17, 17A and 17B poor quality drug comprises of
misbranded, spurious and adulterated drugs, respectively.14
Section 17-B of Drugs and Cosmetics Act,1940 has defined spurious drugs (subsequently
amended in 1980) as "A drug shall be deemed to be spurious if it is manufactured under a name
which belongs to another drug, if it is an imitation of another drug or if it has been substituted
wholly or partly by another drug or if it wrongly claims to be the product of another
manufacturer.”15
With the 2008 amendment of the Act, Indian drug regulatory authority that is Central Drugs
Standard Control Organization (CDSCO) has categorised not of standard quality (NSQ)
11
Background Information on Counterfeit Drugs, Bayer Global, Available at
https://www.bayer.com/en/products/background-information-on-counterfeit-drugs#organizations. Last accessed
on 02/05/2021.
12
RK Khar. “Current scenario of spurious and substandard medicines in India: A systematic review”, Indian
Journal of Pharmaceutical Sciences, 2015.
13
Ibid.
14
The Drugs and Cosmetics Act and Rules (Amendment) Act, Ministry of Health and Family Welfare; 2005.
Available from: http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888
15
Section 17-B, Drugs and Cosmetics Act,1940.

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products in three categories A, B and C that is helpful in categorising the products during
quality evaluation.16
a) Category A incorporates spurious and adulterated drug products; which conceal the real
identity of the product or formulation and be similar to some well-known brand. These
products may or may not contain active ingredients and generally manufactured by
unlicensed antisocial people or sometimes by licensed manufacturers. Products that
consist of adulterant/substituted product or incorporate some filth material are known
as adulterated drugs.
b) Category B include grossly substandard drugs in which product fails the disintegration
or dissolution test and where active ingredient assay get below 70% and 5% of
permitted limit for thermolabile and thermostable product, respectively for tablets or
capsules. In case of parenteral preparation, failing sterility, pyrogen/endotoxin test or
inappropriate toxicity, and fungus presence in any liquid preparation hold such products
in this substandard category.
c) Category C involved products with minor defects like emulsion cracking, change in
formulation colour, small variation in net content, sedimentation in clear liquid
preparation, failing of weight variation test, spot or discolouration on product, uneven
coating, presence of foreign matter and labelling errors.
VII. ROLE OF IPR IN THE PHARMACEUTICAL INDUSTRY
India’s acceptance to WTO (World Trade Organization) and agreement to implement TRIPS
(Trade Related Aspects of Intellectual Property Rights) has observed the changes in Indian
pharmaceutical industry. The Intellectual property laws applicable to Indian pharmaceutical
industry have faced major changes globally. The Patents Act, 1970 provides an impulsive
growth to the generic pharmaceutical industry in India.17
During the period of 1970 to 2005,
India became the global player in the production, distribution and marketing of pharmaceuticals
including patented drugs because of the era of process patent18
. India thus became world’s
16
Guidelines for taking action on samples of drugs declared spurious or not of standard qualityin the light of
enhanced penalties under The Drug and Cosmetic (Amendment) Act; pp. 1–13. Available on:
http://www.cdsco.nic.in/writereaddata/Guidelines under new penal provisions9.pdf
17
Saurabh Verma, Rajender Kumar and P.J. Philip , “The Business of Counterfeit Drugs in India: A Critical
Evaluation”, International Journal of Management and International Business Studies, Vol 4, No. 2, 2014, pp.
141-148. Available at https://www.ripublication.com/ijmibs-spl/ijmibsv4n2spl_04.pdf. Last accessed
02/05/2021.
18
S. Chandran, A. Roy, (2005), “Implications of New Patent Regime on Indian Pharmaceutical Industry:
Challenges and Opportunities”,Journal of Intellectual Property Rights, Vol. 10, 2005, pp. 269-280.

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major supplier of generic drugs, API’s (Active pharmaceutical ingredients.19
This liberal
process patent scenario made tremendous changes in Indian pharmaceutical industry by making
the drugs easily accessible at a very cheaper rate. Local Indian firms by developing their own
drugs manufacturing processes started making copies by getting it patented too. Indian
companies were also free at that time to export their copied products to patent recognizing
countries abroad. India’s obligation to implement a TRIPS obedient patent system from 1
January 2005 brought in a product patent era for the pharmaceutical industry in which Indian
pharmaceutical companies can no longer manufacture or market patented drugs without license
from the patent holder. The generic pharmaceutical industry in India that flourished on process
patent was no longer allowed to do so in this new product patent era. This act put on restrictions
on Indian pharmaceutical industry to manufacture generic drugs and on the other hand it
opened up the gates for investment in research and development of new drugs. This era results
in increasing trend in awareness, public participation, patenting and patent enforcement in
Indian pharmaceutical sector. In India, there is about 30% share for Pharma in filing and grant
of trademarks and patents20
.
VIII. CHALLENGES POSED BY COUNTERFEIT MEDICINES
The large counterfeit trade in India has created a number of complex challenges for the health
care and life science industries.
i. Lost business opportunities: the presence of counterfeits can result in the loss of market
share and business opportunities for manufacturers of genuine pharmaceutical products.
It is estimated that counterfeit medicines contribute to a loss of $46 billion annually to
pharmaceutical companies worldwide.21
ii. Undermining the adoption of generics: an estimated 90 per cent of the value of India's
drug market is dominated by branded generics.22
In order to reduce health care costs,
many governments promote the use of less expensive unbranded generic medicines, but
the availability of counterfeits is an obstacle to uptake.
19
M.D. Nair, “TRIPS, WTO and IPR: Counterfeit Drugs”, Journal of Intellectual Property Rights, Vol. 15, pp.
380-382.
20
M.D. Nair, “Impact of TRIPS on Indian pharmaceutical industry”, Journal of Intellectual Property Rights,
Vol. 13, 2008, pp 432-434.
21
“Five worrying facts about fake medicine”, Pharmalife, 2017. Available at:
http://www.pharmafile.com/news/513663/five-worrying-facts-about-fake-medicine.
22
V Galani, “Choice of Better Medicine in India: Branded Vs Generic Medicine”, 2017. Available at:
http://medcraveonline.com/PPIJ/PPIJ-05-00125.pdf. Last accessed on 02/05/2021.

9. 9
iii. Increasing the economic and social burden: the use of counterfeit medicines results
in an increase in cost to the health care system due to the need for further interventions
for unwanted side effects and/or advanced disease progression. This is a particular issue
for Indians, where out of pocket drug spending is already high at almost 70 per cent,
and affordability levels are low.23
iv. Resourcing: to tackle the issue of counterfeits, the Indian government has employed
various anti-counterfeiting strategies, but with limited impact, largely due to India's
Central Drugs Standard Control Organization, the country's drug regulator, having only
323 employees in 2014, about two per cent the size of the FDA. This under-resourcing
is likely to undermine the success of any future strategies.24
IX. STRATEGIES TO OVERCOME THE ISSUE OF COUNTERFEIT MEDICINES
There are a number of strategies that can be implemented to tackle the issue of counterfeit
medicines.
1. Raising public awareness
Containing the spread of counterfeit medicines is a big challenge, but educating patients and
improving awareness is a good place to start. Health care professionals, medical practitioners
and pharmaceutical companies all have a role to play in notifying patients and educating them
to detect the presence of counterfeits. This is a sizeable challenge given that over a quarter of
the population is illiterate, and almost 70 per cent of the population live in rural areas where
self-medication is prevalent. However, approximately 78 per cent of India's 650 million mobile
phone users have access to the internet, and online education may be a far more effective way
to tackle the issue quickly and efficiently.25
2. Implementing innovative anti-counterfeiting measures:
Inadequate anti-counterfeiting measures by pharmaceutical companies make their products
vulnerable to counterfeiting. The presence of counterfeit medicine brands in the market lead to
23
WHO Health financing profile 2017: India. Available at: http://apps.who.int/iris/handle/10665/259642.
24
Kannan S., “Counterfeit drugs targeted by technology in India”, 2011. See also:
http://www.bbc.co.uk/news/business-15208595.
25
R. Iyengar, “India poised for smartphone revolution”, 2017. See also:
http://money.cnn.com/2017/09/26/technology/india-mobile-congress-market-numbers/index.html . Last
accessed on 02/05/2021.

10. 10
drug recalls and subsequent damage to brand image and company reputation. Most companies
are following worldwide mandatory methods like mass serialisation in which machine-readable
codes containing a serial number are added to each pack of medicines, enabling the product to
be tracked and traced.26
Pharmaceutical companies can fight the rise of counterfeiting by
implementing new generation anti-counterfeiting technologies, such as the use of forensic
markers (chemical, biological and DNA taggants), cloud-based supply chain data repositories,
and blockchain technology in supply chains. Companies can also use external providers of anti-
counterfeiting technologies to avoid the need to create their own systems.27
Recently, Pfizer discovered that their successful drug Viagra is being undermined by
counterfeits. In Hong Kong, approximately 40 percent of Viagra sales were fakes.28
This
seriously damages their sales and puts patients at risk. To combat this, Pfizer has embraced
serialisation technologies, enabling their products to be tracked. Using codes both visible and
invisible, they were able to implement the change within weeks. This is one method of
challenging counterfeit drugs.
3. Packaging plays the most vital role
A well-designed pack will be difficult to copy. As long as counterfeit products continue to
damage brands and harm consumers, the anti-counterfeiting labels and the packaging market
will continue to grow and evolve. One of the first steps that brand owners can take towards
protecting their brand is to learn about various anti-counterfeiting techniques.
4. Anti-counterfeit labels and packaging techniques:
There are mainly two types of anti-counterfeiting techniques for labels and packaging which
are often used together to create a comprehensive security solution. Overt and covert features
and hidden details make it easier to detect fakes and increase traceability across the supply-
chain, and makes it harder to counterfeit products.
• Track And Trace: 2D Barcodes — A two-dimensional (2D) barcode looks like a square
or rectangle and contains many small, individual dots. The two most popular types are
Quick Response (QR) Code and DataMatrix, but there are other options available.
26
Prateek Avhad, “Tackling Counterfeit Medicines In India”,Mondaq, 2018.Available at
https://www.mondaq.com/uk/healthcare/691144/tackling-counterfeit-medicines-in-india. Last accessed on
02/05/2021.
27
Ibid.
28
“Pfizer Combats Counterfeited Viagra in Hong Kong”, Healthcarepackaging.com, July 1, 2019. Available
from: https://www.healthcarepackaging.com/article/pfizer-combats-counterfeited-viagra-hong-kong. Last
accessed on 5/05/2021.

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According to GS1, “A single 2D barcode can hold a significant amount of information
and may remain legible even when printed at a small size or etched onto a product. 2D
barcodes are used in a wide range of industries, from manufacturing and warehousing
to logistics and healthcare.”
• Watermarks: Watermarks are images or patterns that are embedded in the design of a
package or paper to authenticate products and support brand identity. Watermarks can
be generic or customized using a logo, brand name, or other symbology.
• Microtext: Like watermarks, micro text is used to authenticate products. Extremely
small text, codes, or symbols are very hard to replicate or copy without using advanced
detection and printing equipment. Microtext can be inserted into overt images, larger
text, and other design elements without being noticeable to the naked eye. Since micro
text is indiscernible, counterfeiters would be unaware that it exists or where to look for
it.
• Holograms: A hologram is a three-dimensional image formed by the interference of
light beams from a laser or other intense light source. Hologram technology is popular
for anti-counterfeiting because it can incorporate various data forms and product
tracking information.
• RFID Tags: Radio Frequency Identification (RFID) technology uses radio waves to
automatically identify people or objects.
• Tamper evident seals with consolidated label: Tamper evident seals can be printed in
different styles to fit your security and packaging needs. At the consolidated label, we
can print shrink sleeve labels with a perforated seal or shrink bands.
Commonly known as ‘shrink sleeves’, these full-body labels make products stand out
with visually attractive graphics that completely wrap around a container. They’re
harder to counterfeit than pressure sensitive labels because they’re more complex.
Shrink bands are film strips that are shrunk to fit around the cap and neck of a bottle or
jar to show the product hasn’t been opened. You can choose between non-perforated or
perforated for easy removing, and blank or custom printed design (recommended for
brand identity and anti-counterfeiting).
Tamper evident seals and anti-counterfeiting techniques offer brand owners many
benefits like product security, brand identification, and product authentication.
• ePedigree label: The ePedigree label tracks the origin of prescription drugs through an
electronic pedigree and provides data on the history of a particular batch of a drug.

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When the system is set up, this tracking is done during the reception and the dispatching
stages of the batch. On the reception side, Pedigree IDs are automatically generated
when purchase order lines, holding batch/date controlled items, are activated for
ePedigree tracking.
Thus anti-counterfeit packaging, which is mainly intended to prevent brand reproduction can
also enable brand protection and enables clients to distinguish between original and counterfeit.
5. Developing stricter laws:
In India, The Drugs and Cosmetics Act (1940) regulates the import, manufacturing and
distribution of drugs, empowering government agencies to inspect, seize and confiscate
products found to be 'adulterated spurious misbranded'. The act was amended in 2008, which
increased the punishment to offenders, but there are still certain challenges, including
inconsistent application of laws across states, weak drug quality investigation systems, and
weak prosecution of counterfeit medicine manufacturers. According to the WHO, 50 per cent
of drugs sold online are fraudulent.29
New protocols which the EU and US aim to implement
by 2019 are intended to tackle this. The EU's Falsified Medicines Directive will require
companies to adopt mass serialisation, whereas the US Drug and Security Act will require
authentication at every supply chain juncture. The EU is also fighting illegal online pharmacies
that supply counterfeit medicines by requiring them to display a logo identifying themselves.
This logo links to the website of the national competent authority listing all legally operating
online pharmacies. More effective adherence to existing laws and adopting stricter laws has
the potential to improve the fight against counterfeiting.30
In October 2018, China’s Drug Administration Law went under review to toughen penalties
for counterfeit drug makers and improve regulation of the industry.31
The draft includes a “full
traceability” mechanism and drug recall system. Substandard products meant that the
government was forced to take action as a preventative measure.
Another solution is in use in Myanmar. The Nigerian start-up RxAll has produced a handheld
device which can assess the compound of a drug in real time.32
This is being used
29
Growing threat from counterfeit medicines. Available at: http://www.who.int/bulletin/volumes/88/4/10-
020410/en/. Last accessed on 02/05/2021.
30
Ibid.
31
“Xinhua Headlines: China considers tougher law against counterfeit drugs”, Xinhuanet.com, 2019. Available
from: http://www.xinhuanet.com/english/2018-10/23/c_137550957.htm.
32
Available at: https://www.theguardian.com/global-development/2019/jun/05/fake-medicine-makers-
blockchain-artificial-intelligence. Last accessed on 05/05/2021.

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commercially, showing that some combative techniques are not only through legislation, but
from pharmaceutical companies and distributors themselves.33
6. Opteration Panagea- INTERPOL
A number of initiatives are in place at the international level to combat counterfeit and illicit
drugs, co-ordinated by INTERPOL. Operation Pangea has been carried out since 2008, with
the number of countries participating rising from 8 to a record 123 in 2017.34
The operation
targets the online sale of counterfeit and illicit medicines and medical devices.
33
Ibid.
34
Available on www.interpol.int/en/Crimes/Illicit-goods/Pharmaceutical-crime-operations.. Last accessed on
14/05/2021.

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X. WHO RESPONSE
Measures can be taken to minimise the spread of counterfeit drugs. In 2013, WHO launched
the Global Surveillance and Monitoring System to encourage countries to report incidents of
substandard and falsified medical products in a structured format.35
Member states will pass on
information about substandard and falsified drugs to WHO, which will then add reports into a
database. Another aim of the system is to identify the scope and scale that counterfeit drugs
hold to assess the harm they may cause. This method of recording counterfeits allows patterns
to be tracked and keep the public informed.
1. WHO Member State Mechanism
The Member State Mechanism is the global platform where countries can convene, coordinate,
decide and organize actions to address substandard and falsified medical products.
It was established in order to protect public health and promote access to affordable, safe,
efficacious and quality medical products, through effective collaboration between Member
States and WHO to prevent and control substandard and falsified medical products and
associated activities.36
2. WHO Surveillance and Monitoring System
In 2013, WHO launched the Global Surveillance and Monitoring System to encourage
countries to report incidents of substandard and falsified medical products in a structured and
systematic format, to help develop a more accurate and validated assessment of the problem.
The system:
• provides technical support in emergencies, links incidents between countries and
regions, and issues WHO medical product alerts; and
• gathers a validated body of evidence to more accurately demonstrate the scope, scale
and harm caused by substandard and falsified medical products and identify the
vulnerabilities, weaknesses and trends.37
As of November 2017, WHO had issued 20 global medical product alerts and numerous
regional warnings, and has provided technical support in over 100 cases.38
35
Substandard and Falsified Medical Products, WHO. Available at https://www.who.int/news-room/fact-
sheets/detail/substandard-and-falsified-medical-products. Last accessed on 5/05/2021.
36
Ibid.
37
Ibid
38
Ibid.

15. 15
WHO has trained a global network of over 550 regulatory staff in 141 Member States to report
substandard and falsified medical products to the WHO Global Surveillance and Monitoring
System. WHO also works with 18 of the largest international procurement agencies.39
The structured reporting system allows for a fast response to emergencies and the issue of alerts
in the most serious cases. It also facilitates in-depth analyses of the medical products most at
risk, the vulnerabilities and weaknesses in health systems, the harm caused to public health and
the need for investment, training and stronger regulations and standards.40
XI. STEPS TAKEN BY INDIA TO COUNTER SPURIOUS DRUG TRAFFICKING
Around 10% of medical products in low- and middle-income countries, including India, are
substandard or falsified, according to the World Health Organization.41
In August 2003 a
special committee established in India in January 2003 with the objective of taking speedy
action against the menace of spurious drugs, sub-standard drugs and for the detection of
violations under public health laws recommended stiffer penalties for violating India's drug
laws. As a result, in December 2003 the death penalty was approved for the sale or manufacture
of fake medicines that cause grievous harm or death and the minimum prison term increased
from five to ten years.42
The committee also recommended improvements to the nation's drug
regulatory infrastructure including a central drug administration to control the licensing of all
drugs rather than the current system of state licensing, greater surveillance, laboratory
improvements, increasing the number of drug inspectors.43
1. Mandatory Barcoding
India has recently introduced mandatory barcoding of pharmaceutical products.44
Directorate
General of Foreign Trade (DGFT) announced the implementation of a track and trace system
incorporating barcode technology as per GS1 standards for all drugs and pharmaceutical
products exported from India. Under this, all export pharmaceutical consignments should be
marked and coded at various packaging levels using GS1 barcode standards.45
When drugs
39
Ibid.
40
Ibid.
41
Available at https://cen.acs.org/pharmaceuticals/India-combat-fake-drugs-blockchain/96/i34.
42
“Death Penalty for Fake Medicines”, The New York Times, pg 16, December 19, 2003..
43
“Combating Counterfeit drugs- A Concept”, WHO Concept Paper, 2005. Available at
who.int/medicines/services/counterfeit/CombatingCounterfeitDrugs_Conceptpaper.pdf.
44
“India’s pharma ingredient barcoding plan advances,” Securingindustry.com, 2019. Available on:
https://www.securingindustry.com/pharmaceuticals/india-s-pharma-ingredient-barcoding-plan-
advances/s40/a10132/. Last visited 05/05/2021.
45
Implementation Guidelines for coding and labelling pharmaceuticals and drugs using Global Supply Chain
Standards to Meet Directorate General of Foreign Trade’s Authentication, track and trace requirements,
August 2015. Available at http://dava.gov.in/files/DGFT_Drug_Track_N_Trace_Implementation_Manual.pdf6.

16. 16
are scanned, they can immediately be identified. This improves the traceability of medicines,
allowing fakes to be easily identifiable.46
2. Blockchain technology
Using blockchain-based systems is another possibility to fight counterfeit drugs. In 2018, the
National Institution for Transforming India (NITI) announced that they would be partnering
with US-based computer technology company Oracle47
to deploy blockchain technology to
advance the traceability of pharmaceutical products. Having a growing database for products
enables countries to keep track of pharmaceutical products, preventing counterfeits from
entering the system as easily.
The Central Drugs Standard Control Organization (CDSCO) in India is working to improve
medicine quality in the country.
XII. CONCLUSION
The problems that arise from counterfeit drugs in south-east Asia have and will continue to
cause many problems for patients and the pharmaceutical industry. The steps being taken to
tackle the situation include serialisation and improving traceability of drugs. Groups working
together can also help to combat the situation. These measures mean that the impacts will
hopefully be reduced, improving human health and decreasing the costs for pharmaceutical
companies.
Moreover, Counterfeit drugs arising in India have created problems across the globe.
Countries must come together to address the issue of counterfeit drugs and agree on a single
definition. There is a need to conduct reliable unbiased studies on the prevalence of counterfeit
drugs in India, which would help in improvement of the healthcare system.
46
DGFT Guidelines, Available at
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17. 17
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