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Counterfeit Drugs
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An Enduring Challenge for India?
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This case was written by Dr. Azmal Hussain and reviewed by Dr. A. Saravanan Naidu, Amity Research
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Counterfeit Drugs: An Enduring Challenge for India?
Author: Dr. Azmal Hussain
Abstract: The age-old problems of drug counterfeiting had long been faced by the government
authorities and the pharma industries alike. It had been a problem of global scale with some
countries and regions showing more vulnerability. There had been a range of factors causing the
problem of drug counterfeiting that included inadequate regulatory measures, perceived
profitability, difficulties associated with their accurate detection and so on. With time the trade
became a formidable challenge to the global community, so much so, it came to be termed as ‘The

crime of the 21st century’. Countries like India largely faced the menace of counterfeit drugs owing to
its very socio-ecological dynamics, sometimes even putting the country’s hard earned reputation in
the pharma sector at stake. While the problems were increasingly becoming acute, there had been
measures initiated by both the government and the corporate fraternity to counter them in an
emphatic way. But every measure was having a challenge or two entangling it. Inconclusiveness of a
drug to be declared as counterfeit was one of the major challenges alongside regulatory bottlenecks.
Still, some positive endeavours had been underway in the relentless strife against the illicit trade of
counterfeiting drugs. Now it remained to be seen to what extent countries like India would succeed
in combating the challenges of drug counterfeiting, which had manifold economic implications
among others.
Case Study
“While it is impossible to determine an exact figure, studies have suggested that up to 20 percent of
drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health
and safety.”1
– The Office of the US Trade Representative
G lobally, drug counterfeiting had become a problem of concerning magnitude. This had aroused a
significant degree of attention among analysts, managers and policy makers. Defined as “The
crime of the 21st century”, the practice of counterfeiting was there in nearly every industry. Asia
arguably appeared as the single largest producer of counterfeit drugs.2 According to experts, the
worth of the global fake drug industry could be around $90 billion, which allegedly caused nearly 1
million deaths every year besides contributing to an increase in drug resistance.3 A counterfeit drug
could be the one that was contaminated or had the incorrect or no active ingredient. Such medicines
could even contain the right active element, but at the inaccurate dose. These illegal drugs were
considered potentially harmful to health. Regulatory agencies like the US Food and Drug
Administration (FDA) were known to take all reports concerning suspected counterfeits with utmost
1
Brennan Zachary, “USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries”,
nd
http://www.raps.org/regulatoryDetail.aspx?id=24854#, May 2 2016
2
Verma Saurabh, et al., “The Business of Counterfeit Drugs in India: A Critical Evaluation”,
http://www.ripublication.com/ijmibs-spl/ijmibsv4n2spl_04.pdf, 2014
3
“India becomes a hub for fake medicines”, http://www.safemedicinesindia.in/patients1.php
“© 2016, Amity Research Centers HQ, Bangalore. All rights reserved.”
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seriousness. In order to fight counterfeit medicines, the agency had reportedly been working with
other agencies as well as the private sector so that drug supply could be protected from the hazard
of counterfeits.4
One of the major risks underlying counterfeit drugs could be that patients might be deprived of the
otherwise therapeutic benefit from the product. For instance, a drug for arresting a cancerous tumor
might not benefit the patient as it might contain very little or even none of the active ingredients.
Conversely, it might contain active ingredients beyond a concerning limit. It could even contain other
potentially dangerous contaminants that could as well be harmful. Counterfeit drugs could lead to
economic burden by causing rise in ‘morbidity, adverse drug reactions and drug resistance’. Besides,
an increased mortality could also result in loss of economic potential. Genuine drugs could see their
sale affected due to sale of counterfeit drugs, and this could in turn affect companies that invested in
‘quality, research and development of drugs’. Companies could also be deterred from investing in
new research and development. Government’s tax revenues could also suffer a significant loss. At
the national level, alongside manifold economic consequences of drug counterfeiting, huge amounts
must be spent for the protection of drug supply chain as well as creation of systems to detect
counterfeit drugs. Such drugs could result in the ban of pharma companies in the domestic as well

the global markets over and above the fines involving additional cost.5
In many countries, regulation of drugs made for export did not match the standard meant for those
produced for domestic consumption. Besides, ‘free trade zones’ were also used for export thereby
increasing the scope of repackaging as well as re-labelling. Such a system could create opportunities
for counterfeiters to bring illegal drugs into the chain of distribution even in the presence of a
regulated system.6 Many tragic incidents allegedly happened worldwide owing to inappropriate
drugs. For instance, in 2012, a sub-standard tuberculosis drug allegedly caused 100 deaths in a
hospital situated at Lahore, Pakistan. Likewise, officials in India discovered in 2013 that within a span
of five years, 8,000 patients lost their lives in a remote Himalayan hospital. The reason cited was that
the antibiotic used to prevent post operative infection lacked active ingredient.7 Against this
backdrop, a number of questions were found worth debating: What was the existing dynamics of
drug counterfeiting? What were India’s specific vulnerabilities to drug counterfeiting and what had
been the factors triggering the booming business of counterfeit drugs? Would it be possible for India
to thwart the challenge of drug counterfeiting? If so, how?
Drug Counterfeiting: An Upshot

The issues surrounding business of counterfeit drugs gained prominence in the 1980s with the
member states of the World Health Organization (WHO) increasingly reporting on such products.8
Though public health officials were aware of falsified drugs for decades, they could hardly
understand the degree of the devastation until early 2000 when they began to collect data. However,
many experts sensed the problem as the one turning increasingly formidable with more and more
criminals turning to pharma products owing to the ‘low risk and high reward’ associated with them.
“The penalties are relatively weak for trading in falsified pharmaceuticals compared to those for
4
“Counterfeit Medicine”,
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/
5
“A Serious Threat to Patient Safety: Counterfeit Pharmaceuticals”,
http://www.pfizer.com/files/products/CounterfeitBrochure.pdf
6
“The Business of Counterfeit Drugs in India: A Critical Evaluation”, op.cit.
7
Ossola Alexandra, “The Fake Drug Industry Is Exploding, And We Can’t Do Anything About It”,
http://www.newsweek.com/2015/09/25/fake-drug-industry-exploding-and-we-cant-do-anything-about-it-373088.html
8
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trade in narcotics and human trafficking,” said Oxford University’s Professor of tropical medicine Paul
Newton.9
Falsified medical products might contain no active ingredient, a wrong one or even a wrong amount
of some right active ingredient. They were allegedly manufactured in many countries spread in all
regions. Well, successful operations were also often reported by media in many countries against
those who made ‘substandard, spurious, falsely labelled, falsified and counterfeit’ (SSFFC) medical
products10 (Exhibit I). Because of their very nature, counterfeit drugs were considered dangerous.
They were neither known to be produced under any safe manufacturing condition, nor inspected by
any regulatory authority. Hence, consumers could hardly know what ingredients such products
would actually contain. Several factors allegedly contributed to the increase in drug counterfeiting.
These included the increasing involvement of under-regulated wholesalers as well as re-packagers in
the ‘drug supply chain’, the explosion of Internet pharmacies, technological development enabling
criminals to formulate counterfeit drugs, and rising importation of medicines from one country to the
other.11 Drug shortage was also believed to be a factor which could trigger counterfeiting. “We’ve
seen it happen regularly—if a shortage occurs, hospitals and clinics will step outside the normal
supply chain, and the [criminals] exploit the situation,” said one of the group leads for WHO’s

Department of Essential Medicines and Health Products, Michael Deats.12
Exhibit I
SSFFC Medical Products: Some Key Facts
 SSFFC medical products may cause harm to patients and fail to treat the diseases for which they
were intended.
 They lead to loss of confidence in medicines, healthcare providers and health systems.
 They affect every region of the world.
 SSFFC medical products from all main therapeutic categories have been reported to WHO
including medicines, vaccines and in vitro diagnostics.
 Anti-malarials and antibiotics are amongst the most commonly reported SSFFC medical products.
 Both Generic and Innovator medicines are falsified including very expensive products for cancer
to very inexpensive products for treatment of pain.
 They can be found in illegal street markets, via unregulated websites through to pharmacies,
clinics and hospitals.
Source: “Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products”,
http://www.who.int/mediacentre/factsheets/fs275/en/, January 2016
Counterfeiting could be associated with many types of organised crimes like drug trafficking, money
laundering and terrorism to name but a few. Because of its lucrative nature, criminals had allegedly
got increasingly involved in counterfeiting. As a matter of fact, profits from counterfeits could go
much beyond those from narcotics like heroin and cocaine. Pharma products were known to attract
criminal gangs owing to their easy transportability over and above a high per unit price. An added
advantage for traffickers was the relatively less severe criminal penalties for pharma counterfeiting
compared to the same for trafficking of narcotics. Besides, law enforcement agencies often lacked all
9
“The Fake Drug Industry Is Exploding, And We Can’t Do Anything About It”, op.cit.
10
“Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products”,
http://www.who.int/mediacentre/factsheets/fs275/en/, January 2016
11
“A Serious Threat to Patient Safety: Counterfeit Pharmaceuticals”, op.cit.
12
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the resources required to address the problem.13 The staggering cost of drugs also allegedly led
patients to think about cheaper alternatives. Though generic drugs could render a more affordable
option, there had still been a thriving market for the counterfeit medication, and their eventual
supply worldwide.14
Analyses showed tens of thousands of persons losing their lives every year owing to falsified drugs. It
also had risen over time in all likelihood, and this echoed what experts thought to be an increase in
the number of counterfeit drugs in circulation. However, in larger part, it was not possible to be sure
owing to the difficulty in ascertaining that it was indeed a fake drug that was responsible for
someone’s death. There could even be a wrong diagnosis or a delay in administering a quality drug.
The global pharma industry was known for having complex networks crisscrossing the whole world.
During the process of its manufacturing, a single medication might pass through many countries. This
would allegedly create chances for criminals to place fake medicines into the supply chain.15 Here a
vital question to brood over would be: If drug counterfeiting involved such a degree of complication,
how could one act against it successfully?
Manufacturing of counterfeit drugs happened in developing countries for the most part especially in

Asian countries owing to their supposedly poor law enforcement as well as government
regulations.16 While commenting on the dangers involving falsified drugs and their legal bottlenecks,
public health expert Jim Herrington said, “These falsifiers are in fact murderers—they are causing
death.” According to him, drug counterfeiters could easily get away with their crimes. “And you’re
more likely to get prosecuted for counterfeiting a Gucci purse than a drug,” he added.17 Of late,
counterfeit drugs were also being manufactured increasingly in various parts of Africa, Latin America
and Europe. While developed countries did have the presence of some illegal laboratories, owing to
the lower cost, peddlers often found it easier to smuggle in such drugs from developing countries.
Apart from the native ‘black market’, a common means whereby many patients were known to
acquire fake drugs was to buy them while holidaying overseas, generally in countries with poor
regulations on the sale of drugs. Online purchasing of such drugs and having the same shipped to the
native country of the buyers formed the other means which of late gained popularity. Unethical
pharmacists and petty grocery or spice stores might also sell counterfeit medicines albeit less
frequently to some clientele. However, law enforcement agencies had reportedly been instrumental
in cracking down on such outlets as they happened to be genuine traders dealing in counterfeit drugs
and were easier to trace because of a fixed address.18 Complications aside, a great deal of
international cooperation had been urged by experts to save customers from the menace of drug
counterfeiting. According to Ottawa University’s Professor Amir Attaran (Attaran), there should be an
international treaty wherein a set of laws would be agreed upon by countries. While making a
comparison to the aviation industry, Attaran said “There are dozens of treaties on civil aviation, and
every single country is following those. If not, they don’t fly.” He pointed out that a similar system
was necessary to lift the standards for pharmaceuticals on a global scale. This could penalise
countries failing to enforce medicinal quality controls.19
13
“A Serious Threat to Patient Safety: Counterfeit Pharmaceuticals”, op.cit.
14
Dr. Chris, “What are Fake Drugs? Counterfeit Medicines Dangers, Side Effects”,
http://www.healthhype.com/what-are-fake-drugs-counterfeit-medicines-dangers-side-effects.html
15
16
“What are Fake Drugs? Counterfeit Medicines Dangers, Side Effects”, op.cit.
17
18
“What are Fake Drugs? Counterfeit Medicines Dangers, Side Effects”, op.cit.
19
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Can India Tackle the Drug Counterfeiting Challenge?

India’s growing reputation in the pharma sector was claimed to be attained genuinely especially of
being a manufacturer of affordable medicines. At the same time, fake drugs in the country were also
having ripples worldwide. Agencies like the Delhi-based Narcotics Control Bureau (NCB) were
apprehensive of the likelihood of the drugs sold online from the country to the customers outside to
be spurious. As NCB Deputy Director A P Siddiqui said, “The market for cheap imported drugs in the
US is growing by the day and is now valued at around $50 billion. There are bound to be more
racketeers in India who would want to make money.” While referring to the uncertainties involving
those drugs, he added, “We still do not know if the racketeers sourced the medicines from dubious
distributors.”20 Some experts opined that India, the biggest generic drug manufacturer in the world,
had turned into a busy hub for counterfeit and substandard drugs. Stuffed in slick packaging, those
drugs were often labelled with names of credible companies before passing off to Indian consumers.
While such drugs were known to be sold in developing countries around the world, Indian officials
alleged that this underground industry had served damage to the image of the booming pharma
industry in India. In 2010, the health industry started a reward programme to combat the illegal trade
by offering $55,000 to the ones who could give information regarding fake-drug syndicates.21 Now

the question was: Would the reward programme prove rewarding enough to effectively put an end
to the business of counterfeit drugs?
In India, estimates varied on the number of counterfeit drugs made domestically.22 Still, it could be
said the market for fake medicines formed a big share of the domestic drug market in India, and it
was among the country’s highest growing markets. Moreover, the national capital region spread
around Delhi and its suburbs was the prime centre of spurious drugs. As suggestive from the
estimates, fake drugs constituted about a third of all drugs sold in this region.23 While no one could
decipher the extent of fake drug industry in India with certainty, the country was allegedly lacking
not only the enforcement resources but also the required corporate or political will to stop drug
counterfeiting. As noted in an analysis published in 2007, “India has only about 1,200 drug inspectors
to monitor drug manufacturing firms that, depending on who you ask, number anywhere between
6,000 and 15,000.” There had been allegation that the then health minister and the other officials
were reluctant to address the fake drug situations.24 Even with the apparent requirement, India’s
drug regulator, the Central Drugs Standard Control Organization had a staff of 323. With no apparent
expansion plans, this was about 2% of what the US FDA had. As concluded by a 2014 analysis,
“Unless serious steps are taken to improve the quality of the Indian drug supply, the global spread of
unsafe pharmaceuticals will persist and the country’s substandard drug trade will continue to
represent a huge public health threat that extends far beyond the subcontinent.”25
Marking a shocking revelation made by industry body ASSOCHAM in a paper named ‘Fake and
Counterfeit Drugs In India –Booming Biz’, showed that out of the total $14-17 billion domestic drugs
20
Shrivastava Bhuma and Kumar K P Narayana, “Fake drug industry operates openly”,
th
http://www.livemint.com/Companies/DKFwlkzPv02MPyiZxUGqDN/Fake-drug-industry-operates-openly.html, April 30
2007
21
Lakshmi Rama, “India's market in generic drugs also leads to counterfeiting”,
http://www.washingtonpost.com/wp-dyn/content/article/2010/09/10/AR2010091003435.html?sid=ST2010091105590,
th
September 11 2010
22
“India becomes a hub for fake medicines”, op.cit.
23
Singh Jyotsna, “Fake drugs constitute 25% of domestic medicines market in India: ASSOCHAM”,
http://www.downtoearth.org.in/news/fake-drugs-constitute-25-of-domestic-medicines-market-in-india-assocham-
st
45393, July 21 2014
24
“Fake drug industry operates openly”, op. cit.
25
“Fake Drugs from India Present a Public Health Threat”,
http://www.safemedsonline.org/2014/02/fake-drugs-india-present-public-health-threat/
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market, fake drugs amounted to $4.25 billion. The paper suggested that the existing rate of growth
of the market for fake drugs at 25% could take it beyond $10 billion mark by 2017. Absence of
adequate regulations, inadequate number of drug inspectors and absence of lab facilities for
checking purity of drugs had been held responsible for the booming trade of fake drugs. Some
analysis also said of the other key factors such as storages of spurious drugs made by chemists, flaws
in the system of drug distribution, inadequate or no awareness among consumers and absence of
law enforcement.26 Reports suggested that the most vulnerable populations were actually receiving
the brunt of drug counterfeiting in India. While citing an instance of fake drugs uncovered in a
Kashmir-based paediatric hospital, Dr. M Ishaq Geer, who was working as Senior Assistant Professor
in the department of pharmacology at the University of Kashmir said, “Some of the fake tablets were
also used by pregnant women in the post-surgical prevention of infections.”27 While speaking of the
thin line between real and fake drugs, Suresh Sati (Sati), the Head of an agency based in New Delhi
engaged in helping police to conduct raids against syndicates of counterfeit drugs across India,
commented, “They look real, but all these are fakes.” As he continued, “A regular customer cannot
make out if a drug is fake... The biggest giveaway is when someone is selling medicines very cheap. It
is almost always fake.”28
As a preventive step, holograms had been used by drug companies over the years or the company
logo was embossed on the packaging as a means to protect their brands. However, even these were
allegedly counterfeited in India. “It is very difficult to dismantle the entire operation,” said Sati, who
was further quoted while continuing “When we bust one operation, two more spring up elsewhere.
Convictions are rare.” The tricks of trading with counterfeit drugs included “sticking fraudulent labels
on expired products, filling vials with water, stuffing small amounts of real ingredients in packages of
popular licensed brands,” and so on. However, what was concerning the officials more than public
safety was that such incidents threatened to discredit the country’s image abroad. There were even
instances citing such embarrassment. One such example could be cited of a shipment of fake
antibiotics without active ingredients caught by officials at Abuja airport in Nigeria with a ‘Made in
India’ label in 2009. It was later said by the investigators from Nigeria that the drug was shipped by a
Chinese company via Frankfurt. Many Indian companies were “apprehensive of pursuing the cases
for fear of bad publicity and possible loss of confidence among consumers,” said Barun Mitra (Mitra),
Director of Liberty Institute, a New Delhi-based think tank. Co-writing a survey report on New-Delhi-
based pharmacies, Mitra noted that as much as 12% of sampled drugs were substandard. “We are
behaving like ostriches with our heads in the sand and pretending that nothing is amiss even as the
problem keeps growing and affecting Indian patients,” he commented.29
Despite alleged inadequacies, India did have certain legal instruments in place. “The Drugs and
Cosmetics Act (the law that lays down punishment for such offenders) is a social legislation where
everyone has a responsibility, from the manufacturers, suppliers, consumers to the government, that
counterfeit drugs don’t enter the market,” said the Drug Controller General M Venkateswarlu.30
Notwithstanding, analyses suggested that in circumstances characterising demand for drugs in
pharma industry going beyond supply, criminally minded people would have a tendency to derive
profit from crime that would involve manufacturing as well as distribution of counterfeit drugs. This
would actually be а substitute for authentic medicines in such situations. Besides, even consumers
using improper medicines could allegedly give rise to demand for such medicines, whose sources
might be counterfeit. A simple example could be the demand for counterfeit steroids generated by
weight supplement drugs. Such drugs were often known to be distributed through unauthorised
26
“Fake drugs constitute 25% of domestic medicines market in India: ASSOCHAM”, op. cit.
27
“Fake Drugs from India Present a Public Health Threat”, op.cit.
28
29
ibid.
30
ibid.
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channels at high prices. In such a scenario, would it be possible to work out a capable national drug
regulatory authority equipped with the necessary resources to manage the ‘manufacturing, import,
distribution and sale of medicines in the country’? 31
Countering the menace of drug counterfeiting had been a challenge to intelligence officials largely
because of resistance. “We face resistance from distributors and can only flag these cases to the
police who then have to take action. Even if we catch them red-handed, they slip out on bail,” said
retired intelligence officer P N Bhargava. According to Ranjit Sahahni, the Chairman of Novartis India,
counterfeit drugs could be dubbed as the perfect murder weapon. The evidence would disappear
after consumption of the pill, and the patient would die of the disease rather than the pill. As he said,
a single counterfeit drug maker could kill many unsuspecting children by making countless strips of
malaria drugs. If consumed, this could kill the patients within 48 hours simply because the medicine
would not work. “Now multiply this toll for as many life-threatening diseases across patients: it is like
three jumbo jets crashing every day,” he said. Kewal Handa, Managing Director of Pfizer in India,
claimed his company to be retaining samples from each batch while sending medicine to distributors.
This could enable differentiation of the original from any counterfeit product.32 But how could one be
sure that such a trick would work?

The challenge became all the more formidable because consumers and sometimes even prescribing
doctors themselves could fail to tell how a legitimate product would differ from a counterfeit one.
For instance, a patient could recover naturally after consuming a fake drug, and there would be no
plausible reason to suspect that drug. Besides, drug counterfeiters were also becoming increasingly
sophisticated by using newest technologies in their unlawful business33 in addition, for the most part,
there was alleged arrangement of shops selling fake drugs with a transporter. “In every consignment,
they carry a percentage of genuine drugs, which are backed with proper documentation such as tax
receipts and invoices, while the fake medicines would be backed by fake papers. If they are hauled
up, they would show the genuine goods and papers to ‘convince’ authorities that the goods were all
‘pucca (in order)’,” said the owner of a trucking company on conditions of anonymity.34 As concluded
by an experts’ analysis, “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 health care system.”35 There were also
reports suggesting involvement of EU customs authorities in confiscation of generic drugs made by
reputed companies in India.36
Nonetheless, some companies such as Roche, Lupin and Unichem had reportedly began to roll out
their medicine packs with a fresh packaging, which included the distinctive code printed on it. On the
other hand, companies like Sanofi, Pfizer, GlaxoSmithKline were planning to follow suit. Still, pharma
companies had been seeing a new weapon in the form of tech innovation to counter the threat of
counterfeit drugs. In this new approach, consumers should be sending the random alphanumeric
code visible on the medicine strip. The message would be sent through the mobile phone of the
consumers. Only after getting a response assuring the drug’s authenticity, it could be used. Besides,
the consumer would also receive health tips as well as drug-refill reminders. As Koushik Gupta, the
31
32
“Fake drug industry operates openly”, op.cit.
33
34
“Fake drug industry operates openly”, op.cit.
35
Shah Nehal A, et al., “Counterfeit drugs in India: significance and impact on pharmacovigilance”,
http://imsear.li.mahidol.ac.th/bitstream/123456789/166438/1/ijrms2015v3n9p2156.pdf, September 2015
36
Dutta Vishal, “Unique ID for drugs to check fake medicines”, http://articles.economictimes.indiatimes.com/2012-07-
th
14/news/32675028_1_hg-koshia-fake-drug-menace-drug-companies, July 14 2012
Page – 7
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General Manager marketing - wellness & oral health representing GlaxoSmithKline Consumer
Healthcare (GSKCH) India was quoted, “GSKCH is aware of counterfeiting issues and urges consumers
to look out for specific details like holograms and logos to identify the original product. We urge all
consumers to buy medicines from authorized chemists to ensure that the product is genuine. We
have always ensured state-of-the-art packaging to curb counterfeiting especially for our OTC
products.”37
Multinationals like Roche also made a small start by engaging Kezzler specialised in supply chain
security to provide encryption software. This could enable verification of medicines’ authenticity by
consumers.38 Likewise, a company named MSN Labs had reportedly been using a technology
enabling consumers to check medicines’ authenticity through text messaging the code written on
them. This technology was developed by PharmaSecure, an American startup.39 PharmaSecure was
also working with some leading pharma manufacturers besides having coded more than 300 million
drug packages for battling the problem of counterfeit drugs.40 PharmaSecure was the pioneer of
India’s drug authentication solutions. It offered solutions based on SMS/mobile apps for drug
authentication (Annexure I). With the growing problem of drug counterfeiting in the country, such
solution was expected to come in handy in tracing the counterfeit drugs from more than 250 million

codified packages of drugs to counter the trouble created by those drugs.41 In another endeavour to
counteract over-charging of medicines as well as sale of spurious drugs, a system of unique
identification code was set to be started in India. The Drug Controller General of India (DCGI), the
drug regulatory authority in the country released a list, which included frequently used painkillers
like Combiflam and antacid tablets that were found qualitatively substandard. The DCGI was also
contemplating to introduce a barcode system for imported as well as locally manufactured

medicines. In June 2016, while pointing out that the process had already started, DCGI G N Singh
(Singh) was quoted as saying, “Documents and the entire plan is with the ministry and they are
examining it. This will be a technology-driven system.” For the medicines exported to other
countries, a barcode system was already in place. As Singh continued, “We already have a barcode
system to check the authenticity of medicines that are exported. Through this system we can keep at
bay all types of spurious and fake medicines.” However, he also alleged of a lack of any system to
check the drugs brought to India from other countries or even the ones sold in this country.42 Thus,
while India had been reeling under the problem of drug counterfeiting along with the global
community, there had been efforts all around to thwart the challenge despite many a limitation.
However, only time would say how effectively the country would join forces with the global
community for strengthening the efforts to counter the menace.
37
Mukherjee Rupali, “Now send SMS to find if pill is genuine”,
http://timesofindia.indiatimes.com/city/mumbai/Now-send-SMS-to-find-if-pill-is-genuine/articleshow/16516353.cms,
rd
September 23 2012
38
“How Roche fought counterfeiting problems in India”,
st
http://kezzler.com/news/15/27/How-Roche-fought-counterfeiting-problems-in-India, May 31 2015
39
40
“Now send SMS to find if pill is genuine”, op.cit.
41
Sridhar Srivatsan, “PharmaSecure Android App helps to trace Fake Medicines”,
th
http://www.fonearena.com/blog/53887/pharmasecure-android-app-helps-to-trace-fake-medicines.html, August 28
2012
42
Malik Bismah, “India may introduce coding system to check sale of fake medicines”,
th
http://www.ibtimes.co.in/india-may-introduce-coding-system-check-sale-fake-medicines-684340, June 25 2016
Page – 8
th
Page – 9
Annexure I
August 28 2012
Mobile Technology to Trace Fake Medicine: The PharmaSecure Way
Source: Sridhar Srivatsan, “PharmaSecure Android App helps to trace Fake Medicines”,
http://www.fonearena.com/blog/53887/pharmasecure-android-app-helps-to-trace-fake-medicines.html,
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contemplating to introduce a barcode system for imported as well as locally manufactured

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