Technology in the Pharma Supply Chain – A Focus on Anti-Counterfeiting in India

7/28/2019 Technology in the Pharma Supply Chain A Focus on Anti-Counterfeiting in India

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A White Paper by

Frost & Sullivan

50 Years of Growth, Innovation and Leadership

Technology in the Pharma Supply Chain A Focus on Anti-Counterfeiting in India

2011 Frost & Sullivan


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TABLE OF CONTENTS

Introduction and Overview of Indian Pharma Industry ................................. 4

Growing Need of Technology for the Pharma Supply Chain ........................... 5

Technology in Supply Chain ............................................................................ 6

Pharma Supply Chain Challenges ................................................................... 14

Business Case: Technologies and Their Application for the Pharma Supply Chain

........................................................................................................................ 15

The Way Forward ........................................................................................... 17

Annexure ......................................................................................................... 18

F R O S T & S U L L I V A N


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INTRODUCTION AND OVERVIEW OF THE INDIAN PHARMA

INDUSTRY

The Indian pharmaceutical industry is 3rd largest in the world in terms of volume

accounting for 10 percent of worlds production and stands 14th in terms of value.

According to data published by the Department of Pharmaceuticals, Ministry of

Chemicals and Fertilizers, the total turnover of Indian Pharma Industry is US$21

billion. Out of this total, domestic formulations market was worth US$8.34 billion

and total APIs market was worth US$3.92 billion. Total Export market was worth

US$8.47 billion. Indian exports go to more than 200 countries around the globe

including the highly regulated markets of US, Europe, Japan and Australia. The

domestic Indian Pharmaceutical market is expected to reach US$ 55 billion in 2020

at a Compound Annual Growth Rate (CAGR) of around 15 percent.

Indian Pharma industry with more than 20,000 registered units is highly fragmented

with severe price competition and government price control. There are

approximately 250 large units and more than 8,000 small scale units, which form the

core of the Pharmaceutical industry in India.

Indian Pharma industry has shown remarkable progress in terms of infrastructure

development, technology base creation and its range of products. The industry nowproduces bulk drugs belonging to all major therapeutic groups ranging from

complex molecules to simpler manufacturing technologies. Finished Formulations of

various types (tabs, caps, injectables, etc.) of various dosage forms are being

produced in GMP compliant facilities and transported globally.

Indian pharmaceutical companies today are known for their global reach with high

quality generic formulations and world class APIs.

www.frost.com 2011 Frost & Sullivan4

F R O S T & S U L L I V A N Technology in the Pharma Supply Chain A Focus on Anti-Counterfeiting in India

Pharmaceutical Market India 2010 (in USD Billion)

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Exports Domestic Formulat ions Domestic APIs


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2011 Frost & Sullivan www.frost.com 5

GROWING NEED OF TECHNOLOGY FOR PHARMA SUPPLY CHAIN

The success of a global pharmaceutical company can to a large part be attributed

to its successful supply chain. The supply chain ensures drug availability at all

locations across continents, 100 percent product availability at optimum cost by

carrying a huge inventory, which maintains 100 percent fill rate.

The criticality of a seamless supply chain network is often underestimated in the

industry. A recent study has quoted that pharmaceutical companies are trying to cut

down product development time to save costs. For example, a drug manufacturer

who can trim development time by 19 percent can save up to US$ 100 million.

However, a delay in time to market of a drug can cost a company around US$ 1

million a day. So, pharmaceutical companies today are designing the supply chain to

be as responsive as possible to reduce entr y time to the market thereby increasing

profit margins.

The Pharma Supply Chain is highly sensitive where anything less than 100 percent

customer service level is unacceptable as it directly impacts patient health and

safety. The solution that many Pharmaceutical industries adopt is to maintain a large

inventory in the supply chain to ensure close to 100 percent fill rate. However, it is

a challenge to ensure 100 percent product availability at an optimal cost across

multiple locations, unless supply chain processes are streamlined towards customer

needs and demands. In this environment, it is no surprise that companies

throughout the industry are hungry for opportunities to improve the efficiency of

their operations, better understand their customers demands, and devise more

creative responses to the marketplaces challenges.

The challenges confronting many Pharma companies in India are:

Managing products in different stages of the lifecycle in an era of multiple new

product launches

Keeping supply chains flexible to align with changes in demand for new drugs,

promotions and disease outbreaks

Maintaining efficiency and effectiveness in growing supply, manufacturing and

subcontractor base

Reaching out to newer domestic and export markets without losing efficiencyExpanding Scope of Supply Chain

Until recently, supply chain was used to track and trace the product up to the

retailer. Product dispensation at retailer and replenishment of the stocks at retailer

levels was part of the sales and marketing function.

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Scope of Supply Chain, 1990s

With growing importance of supply chains, technology today has an integral role to

play in the system. Companies today are willing to invest in technology to ensure

seamless order to delivery.

Technology in the Supply Chain

As on date technology has been used for two main functions in Supply Chain

Management Analytics and Order to Delivery.

Analytical tools and data-based decision tools such as Enterprise Resource Planning

(ERP) have been implemented by many Pharma companies to fine tune traditional

forecasting and replenishment strategies This analytically driven nimbleness has

allowed leading manufacturers to increase their speed-to-market while improving

their management of working capital critical capabilities in a world where

product lifespans are shrinking year after year. The utility of such an approach for

pharma companies facing tougher generic competition and lengthening R&D

timeframes is obvious.

ERP systems are theoretically based on industry best practices and are intended to

be deployed "as is". ERP vendors do offer customers configuration options that

allow organizations to incorporate their own business rules but often functionality

gaps remain even after the configuration is complete.

Implementing ERP typically requires changing existing business processes. Poor

understanding of needed process changes prior to starting implementation is the

main reason for project failure. It is therefore crucial that organizations thoroughly

analyze business processes before implementation. This analysis can identify


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opportunities for process modernization. It also enables an assessment of the

alignment of current processes with those provided by the ERP system.

ERP's scope usually implies significant changes to staff work processes and

practices. Generally, three types of services are available to help implement suchchanges: consulting, customization, and support. Implementation time depends on

business size, number of modules, customization, the scope of process changes, and

the readiness of the customer to take ownership for the project. Modular ERP

systems can be implemented in stages. The typical project for a large enterprise

consumes about 14 months and requires around 150 consultants. Small projects can

require months; multinational and other large implementations can take years.

Customization can substantially increase implementation times.

Advantages

The fundamental advantage of ERP is that integrating the myriad processes by which

businesses operate saves time and expense. Decisions can be made more quickly

and with fewer errors. Data becomes visible across the organization. Tasks that

benefit from this integration include:

Sales forecasting, which allows inventory optimization

Order tracking, from acceptance through fulfilment

Matching purchase orders (what was ordered), inventory receipts (what

arrived), and costing (what the vendor invoiced)

Disadvantages

Customization is problematic.

Re-engineering business processes to f it the ERP system may damage

competitiveness and/or divert focus from other critical a ctivities

ERP can cost more than less integrated and/or less comprehensive solutions.

High switching costs of support, maintenance and upgrade expenses.

Overcoming resistance to sharing sensitive information between departments

Integration of truly independent businesses can create unnecessary

dependencies.

Extensive training requirements take resources from daily operations.

Anti-Counterfe it ing Technology in the Supply Chain

Some of the key applications of technology today have been in anti-counterfeiting

technologies and drug tracking to avoid theft and misuse and ensure timely delivery.

The growing global problem of counterfeit medication poses a crippling risk to

healthcare systems in developing nations. Though authoritative studies are few and

far between, the World Health Organization (WHO) estimates that counterfeit

drug prevalence rates fall between 10 percent and 30 percent in the developing

world, compared to 1 percent or less in industrialized nations. The U.S.-based

Center for Medicines in the Public Interest (CMPI) projects that by 2010, US$ 75



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billion worth of counterfeit drugs will be sold annually. Fake drug sales are expected

to grow at 13 percent yearly until 2010, a rate significantly higher than the

estimated 7.5 percent annual growth for genuine pharmaceutical commerce. The

Indian Government recently passed a law mandating the use of track-and-trace

barcodes on all drugs meant for export, effective July 2011, following reports thatChinese counterfeiters were selling fake medicines labelled Made in India in

several African countries.

Developing nations are technologically well behind, primarily due to the fact that

new anti-counterfeit technologies are oft beyond their means. History has shown

that by the time such technologies are affordable, resourceful counterfeiters could

have copied the technology, turning it into a great risk consumers can have a false

sense of security in "protected" counterfeit products. This trend is evidenced in

events that have led to the compromising of microprint, advanced product

packaging, security inks, tableting molds, unique blister packs and even holograms as

fool-proof product security technologies.

There are many technologies adopted by Pharmaceutical companies in India to

track and trace product movement and to check counterfeiting across the supply

chain.

1. Holograms

This category is preferred as a passive technology. The creation of a holographic

image, or hologram, requires some technical knowledge and expertise, though a

recent explosion of companies and low-cost machinery has made this technology

extremely accessible within many sectors of the consumer marketplace. A hologramtypically incorporates an image that appears as an illusory 3-dimensional object

with vivid depth characteristics.

A security hologram is a special reflective type of hologram that is custom-made

for a brand owner. A number of pharmaceutical companies have relied on hologram

application as a means to reduce counterfeiting. There are currently a large number

of hologram suppliers in the global marketplace.

Advantages

Holograms and security seals are generally low priced, easy to apply, and represent

a rapid way of providing a distinguishing feature to a branded product.

Disadvantage

The major disadvantage is this solution is easily replicable by a counterfeiter, and

indeed, there have been numerous instances where genuine security holograms

have been easily and expertly copied or simulated, leading to the contention that

holograms when used alone are less about security and more about sparkle. The

fact that fake holograms used by counterfeiters are not easily distinguishable by the

consumer because many products available in the marketplace have holograms; it is

extremely difficult for consumer to keep up with which products should contain a

particular type of hologram or seal.



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2. Taggants

This category of anti-counterfeiting solutions is referred to as the active

technologies because they all require an active process during the act of

verification. The application of the various technologies in this category begins with

the insertion or placement of a special marker or device, which is known as a

taggant, into or upon the branded product. In some instances, the taggant can be

placed on the package whereas in others, it can be incorporated directly into the

product itself. In all cases, the subsequent act of authenticating the product requires

a specialized device, reader, or scanner. Each type of taggant can only be detected

by its own specific reader.

Electromagnetic taggants (RFID)

The most commonly used and widely known of the active technologies is radio

frequency identification, or RFID. These taggants rely on radio signals, which are

emitted by an integrated chip or tag. RFID tags can contain significant amounts of

information related to the product and can be placed anywhere within a package

and in fact can be hidden because the emitted radio signals are able to penetrate

through most materials. An RFID reader, which is a specialized instrument that

detects the radio signals, can be used to capture the information emitted by the tag.

The information in turn is then transmitted to a software system that coordinatesall aspects of the RFID operation.

RFID technology, however, has not broken through in terms of its use as a pure anti-

counterfeiting tool in the pharmaceutical industry. RFID industry has undertaken

major efforts to promote this technology as a valid anti-counterfeiting solution.

Advantages

The major advantages of RFID relate to its wireless nature. The tags do not

require line-of-sight or any direct human intervention in order to capture the

digital information. As a result, RFID tags can be hidden in packages so as to


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provide a greater level of security.

RFID tags can be read from a considerable distance, usually many meters,

making it much easier to undertake roaming data capture.

The tags can also be read rapidly in bulk, which is ideal for high-throughoutsupply chain tracking.

In some cases, the reader can even write information directly to the tags,

thereby making the RFID technology bi-directional in nature.

Disadvantages

Major disadvantages to the use of RFID as an anti-counterfeiting tool are cost,

reliability, and privacy. The cost of the tags can vary depending on volume but

are generally quite high, which eliminates its use at the product level except for

truly expensive brands. RFID infrastructure development and implementation

would require huge capital investments.

The second factor inhibiting RFID use is reliability, primarily due to reading

errors. Radio waves are easily deflected or impeded by metals and liquids.

Reading error rates reported in various studies vary in the range of 2.5 percent

to 25 percent.

RFID has the potential to capture personal information and thereby represents

a larger problem for society if RFID is widely adopted. One can gather all sorts

of information from any RFID tags that the consumer have on them.

3. Barcode Applications

This category of anti-counterfeiting solutions includes those technologies, which

encode individual branded products in an overt digital manner. The digital

information can appear on a product as a human-readable code (that is,

alphanumeric script) and in terms of a barcode, such as the traditional linear format

or the new generation of 2D barcodes.

A barcode is an optical machine-readable representation of data whose

technological origins can be traced back to the 1930s but adopted in mass retailsettings only by the 1970s. Since then, virtually every purchasable item now

contains a barcode. The most commonly used barcodes are the linear or 1D (one-

dimensional) pattern of lines. The coding system that is widely used, the so-called

Universal Product Code (UPC), maps the data contained in the barcode to a

standardized system of information representation.

A new generation of barcodes has been recently developed that provide a 2-

dimensional (2D) way of representing information. The biggest advantage to the 2D

barcode technology is that much greater information can be encoded within a single

barcode. 2D barcodes can contain a mini-database themselves, and therefore

encode much greater information on the product.


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Advantages

The 2D barcode technology has now surpassed RFID as the most prominent

track and trace technology for pharmaceutical applications. The European

Federation of Pharmaceutical Industries and Associations (EFPIA) have clearly

come down on the side of 2D barcode.

The cost of 2D barcodes is very low compared to all other technologies. 2D

barcodes offer similar functionalities to RFID at only a fraction of the cost.

Consumer convenience and empowerment will soon be possible because the

emergence of mobile decoders allows consumers to directly interact with the

codes and obtain immediate validation.

Disadvantage

All barcode technologies were originally developed as an inventory and supply chain

management tool and not as anti-counterfeiting applications. As a result, a robust

system of encoding products for authentication and brand protection via a universal

standard was never put in place. The development of 2D barcodes, however, has

now paved the way for their use as an anti-counterfeiting tool. In this regard, two

new technologies have emerged that take advantage of the power of 2D barcodes

and the rapid growth and sophistication of mobile telephony.

Digital Mass Serialization (DMS)

Digital Mass Serialization is the process by which a unique number or code is

assigned to each product sold in the marketplace. It can be generated in a random,

pseudo-random, or sequential manner. Once a batch of codes is generated, it is

transferred to the pharmaceutical company so that they can be printed directly on

the packages during the production process. Alternatively, the code itself can be

pre-printed on a label and then affixed to the product in a manner similar to a

hologram or security seal.


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The technology provider generates a code; it is entered into a database that can be

used later at the verification stage. The database itself is managed and maintained

either by the technology provider or the brand owner. The code is printed in

human-readable form as well as a 2D barcode directly on the product or on a label.

The codes themselves can be numeric, alphabetical, or alphanumeric in nature. Theconsumer can visually read the printed script code whereas a barcode scanner can

capture the 2D barcode. The emergence of mobile phones with barcode scanners

now allow consumers to even use their mobile phones to directly read the 2D

barcode.

The authentication process involves matching the unique code on a product to

those stored in the database. If the code is present in the database, then it is

deemed to be authentic and so is the product. Several DMS providers have bundled

this technology with their own SMS short-code number. Thus, all the consumer has

to do to authenticate a product is to enter the code in the SMS field, send it to the

short-code number, and then wait for the verification message, which either

provides confirmation of the products authenticity or raises a flag if the code is not

found in the database. The cumbersome act of manually entering the code in an SMS

field can be bypassed by phones containing barcode readers.

Advantage

DMS technology directly empowers consumers to verify a medical product. A well-

designed DMS system, however, will itself flag any failed authentication efforts and

communicate this information to the brand owner, along with the date, time, place,

and mobile number of the consumer who had made the verification attempt.

Disadvantage

The major disadvantage to the DMS technology concerns the operational

characteristics and security of the database containing the serial codes. It is well

known that the larger a database becomes, the greater the time needed to find an

individual item within it. Thus, a database containing hundreds of millions (or even

billions) of codes for a major brand owners annual drug production requirements

becomes problematic in terms of database management and speed optimization. The

brand owner will have to adopt extremely high-end database software systems well-

suited for the purpose, which adds significant cost of the solution.

Digital Mass Encryption (DME)

Digital Mass Encryption (DME) is similar to DMS in all respects except for one

major difference the DME technology does not operate on a database system. As

such, it offers all the advantages of DMS but avoids its major drawbacks

requirement for database management, verification bottleneck at high volumes, and


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data security. DME can therefore be considered to be a more advanced and highly

secure version of DMS. The core technology used in DME solution through which

the codes are created and authenticated is fundamentally different from DMS

whereas serialized codes are generally created by random number generators,

encrypted codes are produced by a cryptographic algorithm. The DME algorithm is

also responsible for the decoding process involved in the authentication step.

The encrypted alphanumeric code is unique, unpredictable, and non-repetitive for

eternity. The code can be used not only for authentication (anti-counterfeiting)

purposes but also for hierarchical tracing in a complex supply chain operation. As

such, DME is fully compliant with all regulatory standards, including the emerging e-

pedigree requirements for pharmaceutical products in some countries. In the whole

process a database is not created or required either by technology provider or

Pharma Company.

The DME code itself can be used by anyone with a mobile phone to authenticatethe product at the point of sale, either through SMS or by way of mobile internet.

The reply message sent by the Pharma Company provides verification on the

authenticity of the product, as well as any other information that the brand owner

wishes to transmit to the consumer (for example, expiry date, MRP, usage cautions,

etc). The communication aspects of this technology can also be of significant

importance in the event of a recall since it allows highest degree of granularity, that

is, right now to the consumer level.

The code generated in a DME system is valid for only one authentication. Multiple

authentications attempts of the same code will raise an alert. Multiple failed

authentications of the same code will raise a flag and when confirmation is made

that a particular code has been replicated on duplicate products that code itself

serves as a tag by which the duplicate products can be identified. In such instances,

consumers are directly warned about the duplicate product and they should report

this case along with other per tinent information to the Pharma Company.


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Pharma Supply Chain ChallengesThese passive technologies certainly do allow a consumer to determine that a

hologram or some other visible feature is present. The challenge is to know what

to look for and to be savvy enough to interpret a hidden image or be able to turn

a product just enough to notice the changing colors in an OVI print. This

requirement becomes particularly problematic when a counterfeiter introduces a

fake version of one of these passive technologies, such as a hologram. It is vir tually

impossible for ordinary consumers to identify a true hologram from a fake one.

Thus, all of the passive technologies when used alone do not sufficiently empower

consumers in terms of product authentication. The situation changes considerably,

when it comes to the actual ability of an ordinary consumer to use the technology

for authenticating a product. These active technologies are also poor in terms of

consumer empowerment for the simple reason that customers do not carry around

the special readers that are needed for verification. As a result, none of the positive

aspects associated with consumer empowerment are made available to the brand

owner when implementing an active technology. When used as a stand-alone

feature, DMS and DME codes can be verified via SMS on mobile phones, which are

expected to have a market in excess of 850 million subscribers in India alone by

2011. The only technologies that empower consumers in an anti-counterfeiting

requirement are DMS and DME solutions (mass encoding).


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Business Case: Technologies and Their Applications for the Pharma Supply Chain

nonClonableID by Bilcare Technologies

Bilcare Technologies is a division of Bilcare Ltd., focused on creating next-generation solutions for anti-counterfeiting, security and brand protection across a

wide array of industry sectors. With breakthrough research in nanotechnology,

Bilcare has developed a unique security technology called nonClonableID. It

enables products to be authenticated as they move through the supply chain to the

end consumer, thus protecting brands and preventing misuse.

The technology comprises a nonClonableID fingerprint that can be seamlessly

integrated into any Supply Chain system, providing totally secure and irrefutable

real-time product identification and authentication. It also provides a reliable means

for effective track-n-trace and e-pedigree of products across the supply chain -

from manufacturer to consumer.

The technology innovatively exploits the intrinsic nature of nano- and micro-

structured composites together with their magnetic and optical properties to

provide a foolproof security system. It can significantly enhance security levels with

an impregnable personal access control and identity management system.

nonClonableID employs unique materials-based fingerprints t hat are prohibitively

difficult to copy. These tamper-evident fingerprints are irreproducible and cannot be

duplicated even by Bilcare.

Features of nonClonableID

Unique fingerprints generated out of randomly distributed micro and nano

particles

Machine-readable fingerprints enable an objective and reliable authentication

process

Real-time authentication through hand-held portable readers

Fingerprints can be integrated with overt systems like barcodes/ RFID tags etc.

and within any existing software/hardware infrastructure

Proprietary scanning device scans the fingerprint and instantly communicates

the encrypted information with a secure server through mobility platforms

such as GPRS, 3G

Complete authentication report on a mobile or computer using robust web

enterprise secured applications and data management at back-end

ID Secur ity

Anti-counterfeiting

Secure Track-n-trace

e-Pedi gree

Secure POS Information



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Solution Offerings

Pharmaceutica l

Bilcare offers a comprehensive brand security solution with multiple

checkpoints within the pharmaceutical supply chain to identify counterfeits. Itcan also address unauthorized activities of players within the legal

pharmaceutical supply chain. Bilcares solution ensures enhanced brand

recognition in the marketplace, brand loyalty from patients and an eco-system

that discourages counterfeiters.

Medical Compliance

Patient Compl iance

Bilcares solution ensures proper dispensation of medication and compliance

with the medication regimen. It also creates the capability to monitor

compliance on a real-time basis.

Clinicom Solution

nonClonableID enhances the positive outcome of clinical trials by verifying

the authenticity of origin and pedigree of a drug in the clinical trial phase

through its advanced Clinicom solution.

Agrochemical s

Bilcare offers a holistic solution to combat Agrochemical counterfeiting through

the implementation of its unique nonClonableID technology. Integrated as

unit-level tags, nonClonableID enables identification, authentication and

brand protection. With increased visibility across the supply chain,

consignments can be tracked down to individual Stock Keeping Units.

Sproxil Inc.s Mobile Product Authentication (MPA) technology

India ships drugs to over 150 countries and is a key supplier to emerging markets

where counterfeiting is often an issue. Brand and product pirates in Indian markets

pose a significant risk to legitimate Indian manufacturers, leading to brand

degradation, decrease in sales and consumer purchasing apprehension.

Sproxil Inc, a global brand protection company with its novel Mobile Product

Authentication (MPA) technology, would help to restrict proliferation of counterfeit

medicines in developing markets. The company has received a fund infusion of $1.8

million from Acumen to kick start the technology in India and East African countries

of Kenya, Tanzania and Uganda in East Africa.

MPA technology is the worlds only patented consumer SMS (Short Message

Service) verification service via cell phone. It enables consumers to verify the

authenticity of a pharmaceutical product by sending the unique code on the drug as

a free text. Sproxil has ensured smooth compliance of MPA with Indian pharma

companies adhering to the Indian regulatory requirements. The company has

already signed up two major pharma companies in India at Mumbai and Bangalore

who will use MPA to prevent drug counterfeiting.



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The technology, which will drive economies-of-scale, would benefit consumers,

government and the pharma companies. It will help the consumer who purchases

the drugs from the pharmacy counter to get a customized text message on his cell

response indicating that the product is not a fake and with health literacy tips for

the condition for which the medicine is prescribed.

The US-based company, set up in 2009, launched MPA in February 2010 with Merck

Serono as a pilot project for its anti diabetic product Glycophage. It has established

the first national mobile-based anti-counterfeit service in Africa and sold millions of

anti-counterfeit labels. The anti-counterfeiting strategy is now adopted by

GlaxoSmithKline for its drug Ampiclox and Johnson & Johnson Janssen for its derma

cream Cilag (Nizoral).

The Way Forward

The new generation of low-cost technologies, combined with emerging software

solutions, has the potential to deliver unprecedented value for Supply Chain

Management. Healthcare and other allied life sciences sectors are expected to

follow the trends obser ved in the pharmaceutical industry. The reason is that these

industries are driven by the need for anti-counterfeiting measures and patient

safety enhancements, and not just economics. This is good for the Healthcare

industry as it will drive scale, which in turn will drive down costs for all Healthcare

constituents. The need of an hour is affordable technology solution that helps

improve overall process efficiencies in the Healthcare Industry which in turn shall

enable a reduction in delivery costs to the end user, which in this case is the

patient.



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Technology in the Pharma Supply Chain – A Focus on Anti-Counterfeiting in India