Open Access Research Article
COUNTERFEITING OF PHARMA PRODUCTS IN INDIA: WHY THERE IS A NEED FOR IPR?
Published Paper
Article Details
COUNTERFEITING OF PHARMA PRODUCTS IN INDIA: WHY THERE IS A
NEED FOR IPR?
AUTHORED BY - VAISHNAVI BANDHAKAVI
Abstract:
The Pharmaceutical industry is one of
the evergreen industries in today’s high paced world and a prime source of
medical innovation. In a pharmaceutical or biotech company, Intellectual
property (IP) is indeed the most valuable resource, which contributes significantly
to the company’s future success.IP is the bedrock on which the advancement of
new medications and cures take place[1]. People buy counterfeit products for a variety
of reasons, but nearly always because they cost less than the real thing. Unfortunately,
these deals are too good to be true and there is always a victim.
INTRODUCTION:
Brief overview of Pharmaceutical Industry In India :
The Indian Pharma Area set out on a
momentous excursion by presenting the Patent Demonstration in 1970. This act
permitted Indian drug organizations to create reasonable nonexclusive
adaptations of protected drugs, making medical services more open.
The industry has made significant
progress in research and development beyond the production of generic drugs.
Different examination foundations and organizations add to development in
drugs.[2]
The Indian drug industry is viewed as
one of the country's most beneficial areas, driven by expanded deals, higher
Research and development spending, and government medical services use. Benefit
relies upon different components, including organization execution, market
interest, worldwide patterns, and guidelines.[3]
The absolute greatest players in the
Indian drug industry incorporate Cipla, Deluge, and Zydus.
DEFINATION AND IMPAC OF COUNTERFEIT PHARMACEUTICAL PRODUCTS:
According to the definition given by
the World Health Organisation (WHO), fake medications are the "One which
is purposely and deceitfully mislabeled concerning personality or potentially
source, i.e., a fake medication is one which is dishonestly and eagerly
mislabeled in understanding to the true items or in straightforward words[4],[5]
The deceitful or improper
impersonation of valid and notable items that isn't authentic in nature and
offered to individuals with the fake goal of misdirecting them is known as
duplicating.
Item forging is a typical type of
purchaser misrepresentation wherein an item is sold in pretense of something it
isn't. The duplicating of the item generally occurs through altering,
replicating or adjustment in the bundling of the item.
With regards to Forging drugs India
and robbery, an enormous worldwide issue impacts basically every industry area
in the world. India is the same, with broad falsifying and robbery having
serious wellbeing and security repercussions in the country. Individual
customer's wellbeing and security are endangered when they are followed into
buying defective vehicle parts or dangerous drugs.
Quite possibly of the most weak
region and most impacted area due to duplicating is the drug business. The drug
items and their bundling are incredibly inclined to forging and are perhaps of
the most weak market. Because of their high offer in market. Assembling and
request on the lookout, falsifying is exceptionally normal.
Counterfeiting is a high-volume,
high-profit business that violates Intellectual Property Rights (IPR), medicine
laws, and other areas of the criminal law. Because they both involve making
exact copies of the original goods, counterfeiting and piracy are synonymous[6].
Supposed way of life prescriptions
are the most successive fake medications in Industrialized or created nations.
These medications are frequently purchased online or from unlicensed
pharmacies. Fake drugs are a main source of dreariness, mortality and makes
doubt in the medical services framework.
FACTORS CONTRIBUTING TO COUNTERFEITING IN INDIA
Falsifying exercises have expanded in
India by 24% beginning around 2019, causing loss of Rs. 1 lakh crore to the
Indian Economy. The areas that detailed most instances of falsifying from 2018
and 2019 included quick purchaser products ( FMCG), liquor, way of life,
clothing, and Drug.
In addition, the pandemic has
increased consumer demand and caused turmoil in the pharmaceutical industry
regarding organized supply chains.[7]
A few Notable and viable
associations, spreading over essentially every industry, surrender to copying
and falsifying genuine things; be that as it may, they are not exact duplicates
and may have differentiating and additionally faulty elements to a great
extent.
·
Challenges
in Pharmaceutical supply chain
·
-Absence
of administrative oversight
Predicting Demand and Managing Inventory
It very well may be difficult to
precisely foresee the amount of each medication will be required at some random
time. Changes in quiet interest, economic situations, and startling occasions
influence the interest.
Adjusting stock levels to forestall
deficiencies while staying away from abundance stock requires cautious guaging.
It additionally requires productive stock administration rehearses.
-Following rules and
regulations:
The greatest test is understanding and
agreeing with the mind boggling rules and guidelines. These principles and
guidelines administer the pharma inventory network.
Various nations have various
prerequisites for making, putting away, and shipping medications.
-Dealing with fake or poor
quality medicines:-
Fake and unsatisfactory meds are a
serious worry in the pharma store network. These phony or low quality drugs can
endanger patients. They likewise harm the standing of a pharma organization and
the medical services framework.[8]
Forestalling and distinguishing these
fake meds requires carrying out measures. Product serialization, authentication
technologies, and increased visibility of the supply chain are some examples.
PUBLIC HEALTH IMPLICATIONS:
Fake goods have the potential to not
only lead to an increase in morbidity and mortality but also to an increase in
drug resistance and treatment failure. Counterfeit meds place the client's
wellbeing at grave gamble; however, they likewise antagonistically hit the
whole pharma industry's standing, tasks, and funds. In addition, the World
Health Organization (WHO) estimates that counterfeit and substandard drugs cause
over a million deaths annually.
It is in the bigger general wellbeing
interest that all partners, including shoppers, need to remain careful of
unsatisfactory and fake medications. India's pharma industry ought to zero in
on making compelling correspondence pledges to foster a cautiousness outlook
among customers. [9]Concerned
government bodies ought to likewise effectively advance projects zeroing in on
persistent wellbeing and mindfulness through the essential utilization of
media.
At manufacturing facilities,
anti-counterfeiting measures are essential. Utilizing the technologies that are
currently available, it is necessary to place a greater emphasis on
strengthening supply-chain controls and production quality. Makers ought to
consider the reception of blockchain-based pharma answers for guarantee greater
control across the worth chain - merchants, wholesalers, packaging and bundling
and retailing. Pharma makers ought to hold back nothing, recognizable,
long-lasting sequential numbering process for each thing of medication.
Reception of measures, for example, track-and-follow advances, mass
serialization with QR codes, and so on can assist with confining unacceptable
or fake drugs from arriving at homegrown item retires and worldwide boundaries.
LEGAL AND
REGULATORY FRAMEWORKM GOVERNING
COUNTERFEITING
Indian guideline doesn't have a
specific game plan of guidelines focused on dealing with the duplicating of
items. Regardless, there are sure regulations that go about as the solution for
brand owners.
India has arrangements under licensed
innovation regulation ( The brand name act, 1999) and The licenses Act, 1970
and criminal regulations ( The Indian Corrective Code, 1860) and criminal
regulations ( The Indian Correctional Code, 1860 and Medications and beauty
care products Act,1940) to rebuff the medication forgers.
Basically, any brand can look for
cure against falsifying under the Brand name Act, 1999 (The brand name Act).
despite the fact that the term "counterfeit" is neither defined nor
included in the trademark Act; the equivalent can be brought under the ambit of
brand name encroachment.
As counted in segment 29 of the brand
name Act, on the off chance that any imprint on an item or administration is
confusingly comparative or considerably unclear from an imprint enlisted under
the Brand name Act, such imprint will be viewed as encroaching on the enrolled
mark under the brand name Act.
The Purchaser Security Act,2019
characterizes "misleading products" as firmly connected with past definations
of fake merchandise as "Such products which are dishonestly professed to
be geuine". The Buyer insurance Act,2019 endorses discipline for
assembling available to be purchased or putting away or selling or dispersing
or bringing in fake merchandise under segment 91.
Segment 79 of the data Innovation
Act, 2000 comes as a salvage to veritable go-betweens which expresses that a
delegate will be safeguarded and will be secured and will not be expected to
take responsibility for the outsider substance on its foundation given that the
said middle person noticed "A reasonable level of effort " as
endorsed by the focal government.
Solutions for counterfeiting:
•Brief Order: Transitory directive or
an in-between time order is a break cure which controls a specific party from
briefly doing a predefined act.
•John Doe Request: A John Doe request
is a pre-encroachment directive used to safeguard the maker's licensed
innovation (IPR). Such orders are typically given in copyright encroachment
cases.
ROLE OF PHARMACISTS AND CONSUMERS
Drug specialists as well as end
shoppers are fundamental players in the conflict against drug falsifying. They
are the people who are in constant communication with drug suppliers. It in
this manner becomes fundamental to guarantee that drug specialists and patients
know about the issue of falsifying and the ways of recognizing authentic meds
from forging medications.
The medicines must be purchased by
the patient from a reputable and trusted source.
Since the majority of counterfeit
products are sold through unreliable online pharmacies, a patient must purchase
the medications from a reliable source and avoid using shady ones. The patient
must quickly contact the drug specialist or the specialist in the event that
he/she sees any disparity in the appearance, taste or impact of the consumed
drug.
Pharmacists must ensure that they
purchase their medications from a reputable vendor that has been approved by
the relevant drug regulatory agencies. To determine, pharmacists should keep
product records.
Counterfeiting in the virtual world
The Information Technology Act, 2000 (the IT Act) looks to check unlawful encroaching
exercises led using PCs and other innovation. The IT Act has stringent
provisions and provides for both civil and criminal remedies. Online
counterfeiting by way of illegal domain can be tackled through arbitration
proceedings under in domain name dispute resolution policy (INDRP) or the
Uniform domain name dispute resolution policy (UDRP[11])
by laying out dishonesty with respect to the registrant. In situations where
the enrolled space name includes an indistinguishable or confusingly
comparative brand name, the bothered party can likewise look for a break
directive or a long-lasting evacuation r move of the area name through a common
claim by adding the area enlistment center as a co-litigant.
Factors that lead to counterfeiting and Piracy:
a)Lure of high overall revenues:
Pilfered and fake merchandise and administration are modest to create on the
grounds that
i) No
charges are paid
ii) Labor
utilized is modest
iii) Sometimes
kid work are utilized with no consistence with work guidelines.
iv) The
purchaser and end-client set aside to 20 to 60% on the cost of marked products.
v) Occasionally, consumers purchase
counterfeit goods knowingly and purposefully due to their low cost and
non-harmful nature. One would eagerly purchase a phony piece of clothing
however may not buy a phony medication.
Challenges confronted as a result of
Drug Brand name Encroachment
Drug brand name encroachment presents
importance challenges in India. First, it's hard to effectively monitor and
control infringement activities because of the market's size and the number of
small manufacturers and distributors. Second, the issue is exacerbated by
consumers' lack of awareness of the dangers posed by counterfeit medicines.
A
few significant central issues to consider are:
1
Global Nature: It is challenging to enforce trademark rights across diverse
jurisdictions with varying frameworks and regulations because pharmaceutical
products are frequently sold internationally.
2. Counterfeit products :Fake pharmaceutical products pose a
particular threat to the pharmaceutical industry because they can be harmful to
patients' health and damage legitimate pharmaceutical companies' reputations.
3
Complex supply chains: the intricacy of the drug store network makes it
hard to follow the beginning of fake items and recognize the gatherings engaged
with brand name encroachment.
4. Generic substitution: Conventional medication makers might attempt
to utilize brand names or bundling that looks like the brand items to use their
standing and piece of the pie, prompting potential brand name encroachment.
Intellectual property Rights (IPR) in pharmaceutical industry
Licensed innovation Freedoms assists
with safeguarding the organization's development. It assists with advancing
solid rivalry in the market that ends up being helpful for the economy of a
country. It is also a crucial tool for safeguarding the time, money, and effort
they have invested, thereby supporting industrial growth and economic
expansion.[12]
How does the pharmaceutical industry
get protected by intellectual property rights (IPR)? There are many ways that
intellectual property protects the pharmaceutical industry, as shown below:
• It provides fair and effective incentives for innovative
processes
• It
assists with safeguarding any organization against possible encroachment.
• It provides a strong enforcement mechanism for defending
infringement
in the case of patented drugs.
Patent regulation in the Indian
Pharmaceutical industry
The law that manages licenses in
India is given under the Patent Demonstration, 1970. India is a signatory to
both the Paris Show of 1883 and the Patent Collaboration Deal (PCT) of 1970.
The Licenses Act subtleties out the essentials of a patent which are important
to be fulfilled for it to be conceded insurance:
·
It should be new
·
It should not be obvious
·
It should be useful which can be the subject matter of a
patent.
There are some non-patentable inventions under the Act which includes[13]:
·
Methods of agriculture or horticulture
·
Processes for the medicinal,
·
Processes of surgical, curative, or prophylactic Or other
treatment of human beings, animals or plants or substances which are just due
to mere admixture which results in the aggregation of the properties of the
components
As to drugs in India, the substances
which are expected to be utilized or equipped for being utilized as food
compounds, drugs mixtures, or even meds or items which are created via
synthetic cycles and such cycles are conceded security.
What is the term of patent granted to an Indian pharmaceutical
company
Processes of Manufacturing of a drug in the Indian market
are protected for the period of seven years from the date of filing or five years from the date
of sealing the patent whichever shall be less. This is different from the other
inventions which are granted a period of 14 years from the date of filing
unless the patent is shown to be invalid. The method and processes of
manufacture of a substance shall be used as food, drug, or medicine.
Even though, the Patent Act is under the process of the
amendment as it has been recommended by the International Conventions of IPR
which India is a party to, the two criteria of terms are
·
Period of 7 years from the filing of the patent
·
Period of 5 years from the date of sealing the patent
·
Whichever shall be less.
Product patent or process patent? Which process is India following?
According to the
Demonstration, there are two sorts of Licenses that can be gained in India,
specifically, product patent and process patent[14].
The Indian governing body carried out these patent systems as a piece of the
Patent Amendment 2005.
In short, the Patents
Act of 1970 grants the inventor a statutory right for a predetermined time. The
government grants this right. When this patent assurance is procured by the
creator, he is conceded the option to prevent others from making, utilizing,
selling his protected interaction or item.
Product patent versus process patent
The Indian Licenses
Act, 1970 accommodates two sorts of licenses, they are process and product
licenses.
This kind of patent
safeguards the item. It offers the innovator higher security for his creation
by diminishing the degree of rivalry of a similar item. Then again, a process
patent safeguards the assembling system of an item yet not the product. The
product patent boosts the degree of syndication and limits the opposition. In
this way, we can reason that an item patent has the accompanying elements that
ultimately helps the creator or the patent proprietor:
1. It gives a more elevated level of
restraining infrastructure privileges to the designer of the patent proprietor.
2. Such an award keeps others from
assembling a similar item utilizing a similar interaction or an alternate
cycle.
3. Since the finished result is given
assurance, the degree of security is viewed as higher in correlation with
process licenses.
Process patent
In this kind, patent
security is conceded exclusively to a specific process utilized in assembling
an item yet not the finished result[15].
An interaction patent is frequently considered to give restricted security. The
explanation is, it doesn't ban or keep others from assembling or making a
similar item by utilizing a particular interaction. Subsequently, it is
conceivable that there are numerous cycle licenses conceded for a solitary
item. This in the long run diminishes the syndication that the designer
appreciates, accordingly expanding the degree of rivalry.
Positions of developed
and developing nations on product and process patents It has been demonstrated
that developed and developing nations hold divergent viewpoints regarding
product and process patents. In contrast to developed nations, developing
nations have not yet recognized the significance of product patents as
comprehensive protection. This division has prompted impediment in item
security on a worldwide level as both item and cycle assurance gives insurance
to licenses at various levels.
Since India is a piece
of WTO, it has consented to bound itself and to follow the Excursions Understanding
which happened in the year 1999. Through the Indian Patents Act Amendment of
2005, India adopted the product patent concept.
This Revision made in
2005 got two significant segments the Indian Licenses Act, specifically, Area 2
and 3. Indeed, even the meaning of 'Licenses' under Segment 2(j) of the
Demonstration changed to an innovation implies another item or cycle including
an imaginative step and fit for modern applications.
From Denying to
Perceiving Patent Insurance for Drug Items
During the drafting of
the Patent Law of 1984, patentable topic was a vital issue.
At that point, there
were two altogether different perspectives with respect to the patent insurance
of drug items. The contention that no patent right ought to be conceded to drug
items was for the most part founded on the way that prescriptions are connected
with individuals' actual wellbeing and ought not be hoarded by few individuals
and that giving patent assurance would upset homegrown organizations which were
falling a long ways behind their unfamiliar rivals in drug innovation.
The legislators came to
the conclusion, after many discussions, that patent holders should not have a
monopoly over pharmaceutical products for two reasons: to begin with,
restorative inventory is firmly connected with individuals' wellbeing and life.
Second, patent would have adverse impact on the homegrown drug industry, on the
grounds that a large portion of the drug innovations were made and possessed by
organizations of created nations. Footnote48 Under Thing 5 of Article 25 of the
Patent Law of 1984, no patent right will be conceded for drug items and
substances got through a synthetic interaction. As a matter of fact, all
through the regulative cycle, in each form of the draft, including the last
one, drug items were not recorded in that frame of mind of patent security.
However, on September 4, 1992, the Decision on Amending the Patent Law
was adopted by the Standing Committee of the National People's Congress. This
decision ended the Patent Law of 1984's policy of denying pharmaceutical
products patent protection. This intends that, from January 1, 1993, when the
change produced results, drug items and substances got through a compound
process could be conceded patent right, given that they have the qualities of novelty,
inventiveness, and industrial usefulness.[16]
Analysis of product vs process patents :
Clearly, a severe
uniqueness seems to exist among item and interaction licenses systems. Created
nations are leaned towards the item patent framework while the non-industrial
nation favors the process patent framework.
Since the interaction patent is conceded for a specific cycle and not for the
actual item, some other individual can deliver a similar item utilizing an
alternate process by modifying the parameters used . Multiple producers would be able
to make the same product, thanks to this. It is a hindrance for the creator in
light of the fact that the variety of makers in the market will give him less
security for his licensed right
Nonetheless, a process
patent is an advantage to the buyer of such an item on the grounds that the
client can get elective choices and can select an item that has every one of
the details accessible at a reasonable cost.[17]
The non-presence of syndication over an item even compresses the innovator to
showcase the item at a cheaper which makes it savvy to the purchaser of such
item.
On account of an
product patent, the right is given to
the first creator of the product. Once a patent of this kind is issued, no one
else can use, manufacture, or make the same product. Since there would be a syndication
over the item, the designer would remain to benefit since he can showcase the
item at the cost he wants. In any case, it would be a burden for the purchaser
since the value of such an item would be high and the customer who has no other
elective choice will presently be compelled to purchase the item at the rate
chose by the creator as his restrictive right.
Case Laws:
In Cartier International AG
vs. Gaurav Bhatia, the Delhi court granted damages
totaling 10 million rupees, for infringement of trademarks and the selling of
the counterfeit luxury brands online, which remains the highest punitive
damages awarded by the court in a case of trademark infringement in India.
Novartis V. Union of
India(Civil Appeal No. 2706-2716 of 2013)
Novartis filed a patent application for
Gleevec, one of its drugs, under Section 3 of the Patents Act of 1970, citing it
as an innovation. The Supreme Court refused their plea after a seven-year
fight, citing the following reasons: To begin with, no new drug was created;
simply discovering an existing drug would not qualify as creation. Second, the
Supreme Court affirmed that, in addition to the usual requirements of novelty,
inventive step, and application, the Indian Patent Act includes a new enhanced
therapeutic efficacy test for claims that include incremental improvements to
existing medications, which Novartis' drug did not meet. This was a landmark
ruling because the court saw through the technicalities to the fact that these
companies were attempting to "evergreen" their patents and make them
unavailable for a small fee.
Bayer Corporation and
Ors. V. Union of India and Ors. (2014 SCC Online Bom 963)
The Bayer Corporation attempted to link the infringement of
a patent with the approval of a Cipla drug for commercialization in this case.
In the United Kingdom, the concept of a drug-patent link exists. In India, the Delhi
High Court found that there is no method for linking medicinal patents, and
that only the patent controller has the authority to define patent standards.
It was also decided that a drug's approval for sale does not imply that it
infringes on a patent, and that the FDA has no jurisdiction over such problems.
CONCLUSION:
Maybe
developing countries have not yet completely shifted to product patents because
this will eventually affect their nation and consumers who aren’t financially
strong on a global level yet. Granting process patents would help such
countries to increase innovation in their economy, and would promote healthy
and effective pricing of the product. India, being a developing nation is also
in favour of granting both process and product patents and is not inclined
towards product patents. The reason is, the government at the end of the day
needs to implement laws only after analysing and understanding the plight of
the country .[18]
And
Audits should be conducted on a regular basis to check for any areas of concern
that may arise throughout the manufacturing process of pharmaceuticals. There
is one authenticity mark on the back or bottom of the product, and it should be
present in every medicine because it will be easier for the general public to
identify the authenticity of the product.
For
example, PharmEasy is an online medical supply store pharmacy that ensures the
authenticity of medicines using a barcode system that you can access from your
mobile phone. The Drug Controller General of India (DGI) is considering using a
barcode system to verify the legitimacy of both imported and domestically
manufactured drugs. Middle-income countries have been shown to be much more
likely to engage in the production and distribution of counterfeit drugs, so
authorized companies must collect all necessary data and information to aid in
the resolution of such a problem, as the problem arises from an unorganized
supply chain, particularly the functions performed by intermediaries.
REFERENCES:
https://excelonip.com/ip-and-counterfeit-regulations-in-india-seeking-profits-in-times-of-hardships/
[1] Sana Singh, Bhawna
Sharma [Pharmaceutical
Industry and Intellectual Property Rights – An Indian Perspective] 21-Jun-2021, https://singhania.in/blog/pharmaceutical-industry-and-intellectual-property-rights-an-indian-perspective
[2] An Overview of the Pharma Industry in
India, 07 July 2023, https://groww.in/blog/overview-of-pharma-industry-in-india
[5] Counterfeit medicine, European
Medicinesl Agency, https://www.ema.europa.eu/en/glossary/counterfeit-medicine#:~:text=A%20medicine%20made%20by%20someone,Counterfeit%20medicines%20infringe%20trademark%20law.
[7] Dr.
Gajendra Singh, Counterfeit Drugs: Threat to India’s reputation of Indian
Self-reliant Model, Mar 5, 2021, https://health.economictimes.indiatimes.com/news/pharma/counterfeit-drugs-threat-to-indias-reputation-of-indian-self-reliant-model/81342614
[8] Vivek Sehgal , Counterfeit drugs: A major public health threat, February 24, 2023, https://timesofindia.indiatimes.com/blogs/voices/counterfeit-drugs-a-major-public-health-threat/
[9]
Lucy Rana and Nihit Nagpal, The
Counterfeit conundrum: Civil and criminal remedies for spurious mediines in India, October 14, 2021, https://ssrana.in/articles/counterfeit-medicines-civil-criminal-remedies/
[11] SS Rana & Co, Intellectual Property and Combating Counterfeiting and
Piracy in Digital Environment, October 28 2022, https://www.lexology.com/library/detail.aspx?g=70718ff3-682c-476b-8f73-36eac8f2c40c
[12] Renu
Bala and Johny
Solomon Raj, India: Patents
And The Indian Pharmaceutical Industry, 23
January 2023, S.S. Rana & Co.
Advocates,
https://www.mondaq.com/india/patent/1273580/patents-and-the-indian-pharmaceutical-industry#:~:text=India's%20patent%20legislation%20must%20now,process%20that%20fulfils%20established%20criteria.
[13] Renu Bala and Johny Solomon Raj, India: Patents And The
Indian Pharmaceutical Industry, 23
January 2023, https://www.mondaq.com/india/patent/1273580/patents-and-the-indian-pharmaceutical-industry#:~:text=Through%20this%20amendment%2C%2020%20years,intensely%20%22knowledge%20driven%22%20sector.
[14] Aishwarya Parameshwaran, Difference between product patent and process patent, November 10, 2021, https://blog.ipleaders.in/difference-between-product-patent-and-process-patent/
[18] Aishwarya Parameshwaran, Difference between product patent and process patent
Article Information
COUNTERFEITING OF PHARMA PRODUCTS IN INDIA: WHY THERE IS A NEED FOR IPR?
Authors: VAISHNAVI BANDHAKAVI
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/04/18
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
All research articles published in International Journal for Legal Research and Analysis are open access and available to read, download and share, subject to proper citation of the original work.
Disclaimer: The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of International Journal for Legal Research and Analysis.