Pwc.in
India Pharma Inc.
through alliances and
04 Executive summary
06 Growing through alliances and partnerships
14 Bringing cost efficiencies
24 Newer growth trends
Foreword
The social, demographic and economic context in which the global pharmaceutical
industry operates is rapidly changing. Globally, pharma companies are facing pressure from
governments and taxpayers alike for reducing prices of drugs and initiating outcome-based
pricing. Simultaneously, there is a vast decline in R&D productivity, diminished pipeline for
new drugs, increased drug discovery costs as well as increased regulatory measures that
companies need to contend with. The Indian pharma industry is showing signs of robust growth. The domestic pharma market
is expected to grow at a CAGR of 15% to 20% to reach a value anywhere between US$ 50
billion and US$74 billion by 2020.1 Foreign multinational companies along with Indian pharma companies are partnering
together to tap opportunities in the fast growing emerging economies(BRIC nations) and
the larger established markets in the West and Far East (Japan). Acquisitions, alliances and
partnerships are some of the tools used to penetrate and capture a larger share of the potential
opportunity in these markets. We are also seeing companies collaborating outside the realm of manufacturing and R&D
with players in health insurance, medical technology, Information Technology and mobile
technology to deliver superior sustainable healthcare services. These developments bode well
for the pharma industry and society as a whole who stand to benefit from such alliances and
partnerships through reduced costs and streamlined supply chains. Some Indian pharma companies are looking to increase the value of services they provide by
moving early on in along the value chain into biotechnology, drug discovery & development,
which have primarily been the domain of large innovator companies. In this report, we look
at the different types of alliances and partnerships that have taken place in the Indian market,
the synergies and benefits to the parties involved as well as the key success factors which need
to be kept in mind to achieve productive and cohesive long term collaboration.
Chairman - CII Pharma Summit 2011 and
Vice Chairman & Managing Director - Hikal Ltd.
Executive Director - India Pharmaceuticals and Life Sciences Leader - PwC
The social, demographic and
economic context in which the
global pharmaceutical industry
operates is changing. Developed
economies with spiralling
healthcare costs are looking to rein
in healthcare expenditure. Payers
are demanding a reimbursement
model based on healthcare
outcomes. The impending patent
cliff and declining R&D productivity
threaten the sustainability of the
pharma industry's current business
model. Emerging markets in
general and India in particular offer
a ray of hope for the global pharma
industry. India's large domestic
market, product development
skills and scientific talent are being
increasingly sought by pharma
MNCs to tackle the challenges of
growth and innovation. Indian
pharma companies are also looking
to move up the value chain and
change the perception of India as a
cheap manufacture base to that of a
genuine intellectual contributor.
One of the main ways MNCs enter
the Indian market is through
acquisitions. However, given the
scarcity of assets, valuations in
the sector have increased over the
last 12 to 18 months. Companies
are now exploring other ways of
collaboration through alliances and
partnerships. Such collaboration
began with product sourcing and
has now blossomed into other areas
such as drug discovery, clinical
development and marketing and
sales. Collaboration between big
pharma companies and Indian drug
4
firms has proved beneficial not just
In addition, they will have to
to the two parties but to the Indian
devise strategies for inclusive and
patient society as a whole.
sustainable growth.
A PwC survey of opinion leaders
The pharmaceutical industry in
in the Indian pharma industry
India is poised for a period of robust
revealed that quality as a key
growth driven by alliances and
determinant of the success of
partnerships. Success in the market
alliances and partnerships. Other
will be dependent not only on the
issues impacting success include
pharma companies but also on
management control, valuations,
other stakeholders like healthcare
corporate governance, cultural
providers, health insurance
differences and awareness of local
companies, medical technology
companies, government, patient
The key point of note for these
groups as well as society at large,
companies looking to do deals
acting in concert. How well they
is to choose an alliance partner
do will determine the future of the
after conducting a thorough due
diligence. While financial diligence
is a standard and integral part of
all deals and alliances, the pharma
industry needs a more thorough
operational due diligence prior
to partner selection. No one size
will fit all and companies will
have to choose and implement the
collaboration initiatives that best
meet their strategic objectives. With increasing pressure on
healthcare costs all over the
world, pharma players will have
to pay attention to cost reduction
efforts. Efficient management
of operations, supply chain and
transfer pricing are thus issues of
paramount importance. Pharma companies will also have
to strengthen collaboration with
key players outside the industry
such as health insurance, medical
technology and information and
communication technologies.
5
Growing through
alliances and
Why partnerships
The global context
As population grows and ages, new
areas of medical need emerge. The
diseases in the developing countries
are growing increasingly similar to
those of the developed world.
Demand for new anti-infectives
is mounting, especially for
diseases like multi-drug resistant
tuberculosis. Global warming can
bring diseases such as malaria,
cholera, diphtheria and dengue
fever to more developed regions.
These changes will generate
opportunities for the global pharma
industry over the next decade. Despite robust demand for its
products, the industry is facing
unprecedented challenges. The
impending patent cliff which could
see big companies lose over US$
118 billion worth of patented drug
sales by 20152 is a cause of great
concern. Compounding this is
the increased cost for developing
new drugs and requirements of
regulators for enhanced safety and
efficacy monitoring. The governments of developed
economies with huge fiscal
deficits are also under pressure
to reduce spiralling healthcare
costs. At the same time, healthcare
payers and providers everywhere
have recognised that current
6
According to PwC's pharma 2020
Trends shaping the
report, Challenging business
Lilly is currently transforming itself
global industry
models, global pharma companies
from a traditional fully integrated
pharmaceutical company into a
will have to fundamentally change
• Emphasis will be on
fully integrated pharmaceutical
their operating model to capitalise
network, so that it can draw on a
on future growth opportunities.
range of resources beyond its own
• Compliance monitoring
Most large companies have
walls. Lilly hopes teaming up with
will become a win-win
traditionally done everything
other organisations to create virtual
for patients, payers and
R&D programmes will enable it to
from R&D to commercialisation
get better access innovation, reduce
themselves. By 2020, however
• Focus will shift from
costs, manage risks more effectively
treatment to prevention.
and enhance productivity. For
example, the Chorus Project is
• New technologies will drive
Bristol Myers Squibb (BMS ) uses
a virtual organisation to take
a slew of alliances, partnerships
molecules quickly to proof of
• The current linear phase R&D
and acquisitions to complement
concept. Lilly also uses external
process will give way to in-
its internal capabilities in drug
networks comprising third parties
life testing and live licensing.
discovery and development.
such as Piramal Life Sciences,
• There will be greater
Hutchison MediPharma, Suven
BMS calls its string of pearls
international regulatory
Life Sciences in the development of
strategy in which each
transaction will be aligned to
the company's focus on specific
• The blockbuster sales model
disease areas.
will disappear.
40% of BMS patents and 50%
• The supply chain functions
Several pharmaceutical firms like
of revenue come from such
will generate revenue.
Lilly and BMS have already begun
• More sophisticated direct-
to use more collaborative models.
to-consumer distribution
The pressure to change to new
channels will diminish the
business models, triggered by
role of wholesalers
internal and external factors has led
this model may no longer work
to increasing mergers, acquisition,
for many organisations. If they
alliances and partnerships in the
are to prosper, they will need to
healthcare expenditure levels are
improve their R&D productivity,
also unsustainable unless they
reduce costs, tap the potential
deliver more demonstrable care
of emerging economies and
and cost benefit over the long term.
switch from selling medicines to
Payers are demanding evidence of
managing outcomes. Alliances and
outcomes from pharma companies
partnerships with firms within and
before including the medicines in
outside the pharma industry is a
pharma benefit plans.
key requirement of the pharma
operating model of the future.
7
The Indian context
Indian generic pharma companies
The Indian pharma industry is
have strong product development
today, the third largest market
skills and have set up world-class
announces new norms
globally in terms of volume and
active pharma ingredients (API)
for FDI in pharma
14th largest by value. According
and formulation manufacturing
to PwC's report Capitalising
facilities to cater to the price-
As of 2011, FDI through the
on India's growth potential,
sensitive India market and global
automatic route was allowed in
the domestic pharma market is
generics market. Many of these
the pharmaceutical sector in India.
expected to grow at CAGR of 15
dominate India's domestic market
Currently, 100% FDI is permitted
via the automatic route.
to 20% annually to be a USD 49
through a large sales team, strong
billion to 74 billion market by
relations with physicians and
Given the trend of acquisitions of
medical institutions. Indian pharma
domestic pharma companies by
companies are now seeking to
global players, the government
India is an attractive market for a
move up the value chain to drug
has expressed concerns about the
variety of reasons:
discovery and development by
accessibility and affordability of
medicines in the Indian market.
• India's economy continues to
leveraging the country's scientific
show signs of robust growth.
talent. Given the strengths of
To ensure that such deals do not
The increased spending on
Indian and and global pharma
result in monopolies and an increase
healthcare needs is expected
companies, it makes sense for them
in drug prices, the government is
now mulling over placing a cap on
to drive revenue growth for
to come together to develop India's
FDI in the pharma sector.
pharma companies.
domestic market, source products
for global market and to discover &
A high-level committee has been
• The emergence of chronic
develop new drugs and therapies.
appointed by the government of
diseases like cancer, diabetes,
India to look into this.
Cardio Vascular System (CVS)
MNCs and Indian companies
Government has decided the
and Central Nervous System
are stepping up their play in the
(CNS) disorders is likely to drive
market through various kinds
demand for newer therapies.
of partnerships to achieve the
• 100 % FDI through the
automatic route would be
• With increasing pressures
allowed for Greenfield projects
on curbing healthcare costs
• Capitalise on the opportunities
• 100% FDI through the FIPB
in the US, India's low-cost
provided by the Indian market
approval route for Brownfield
manufacturing capabilities
• Make the most of India's
investments in the pharma
coupled with attention to quality
capabilities in drug discovery,
sector for a period of six months
(India has the highest number
product development and
• During these six months,
of FDA-approved manufacturing
sourcing to serve overseas
necessary enabling regulations
plants outside the US.) will be
will be put in place by the
sought by MNCs.
Competition Commission
This chapter explores the different
of India (CCI) for effective
• India has a large pool of
kind of partnerships in the Indian
threshold limits on mergers and
scientific manpower which
pharma space, the challenges
acquisitions to ensure that there
can be used in drug discovery,
faced in creating and sustaining
is a balance between public
development and clinical trials.
such partnerships and the benefits
health concerns and attracting
• India's diverse genetic pool of
of these partnerships to various
FDI in the pharma sector
treatment-naive population is
• After six months the oversight
attractive for clinical trials.
will be done by the CCI
entirely in accordance with the
competition laws of the country
8
(FIPB nod will not be required)
Serving the Indian market
Types of Alliances
Given the growth slowdown in
developed countries, pharma
companies are keen to address the
opportunities offered by the growing
Indian market.
a. Mergers and acquisitions (M&A)The Abbott acquisition of Piramal
Healthcare's domestic formulations
business in 2010 is a good example.
Other examples include Reckitt
Benckiser's acquisition of Paras
Pharmaceuticals and the acquisition
of the nutrition business of Wockhardt
by Danone in 2011. Addressing the
opportunities in the Indian market
was also one of the key drivers behind
the acquisition of Ranbaxy by Daiichi
Sankyo (though Ranbaxy did have a
global presence).
Recent M&A for addressing the
Indian player
Nature of deal
Acquisition for US$
However, given the scarcity of assets,
valuations in the sector have gone
Reckitt Benckiser
Acquisition for US$
up over the last 12 to 18 months.
Companies are now exploring other
Piramal Healthcare
methods of partnership.
b. Alliances and partnerships (A&P)
business for US$ 3.7
Germany's Bayer Healthcare
announced a 50-50 joint venture with
Zydus Cadila to create a new company,
Bayer Zydus Pharma focussed on
Acquisition for US$
the India market. Bayer Healthcare's
pharma division will contribute its
Source: Industry reports, PwC analysis
sales and marketing business in India
(*) While these deals were predominantly aimed at gaining access to the domestic market, they also provided a
to the new company while Zydus
platform for the acquirers to target global markets.
will contribute its women's health
products, diagnostic imaging and
other products.7
9
Lupin has signed a deal with
drivers have created the need for
the title of a genuine intellectual
Eli Lilly for anti-diabetic drugs.
collaboration between MNCs and
Under the deal, Lupin will market
Indian pharma companies to target
Glenmark Pharmaceuticals became
and distribute the entire range
global opportunities.
the first Indian company to out-
of Huminsulin brand of Eli Lilly
license a biological product. The
in India and Nepal. Lupin will
a. Mergers and acquisitions
company licensed its biotech drug,
deploy 300 sales representatives
Pharma MNCs have acquired
which has the potential to generate
from its formulations business to
Indian companies to maximise their revenue worth US$ 613 million,14
promote the product and will also
capabilities in serving the global
to French company Sanofi Aventis.
provide education to physicians and market. The acquisition of Matrix
Glenmark sold the marketing rights
Laboratories by Mylan in 2006
for North America, Europe, Japan,
Novartis has signed a deal with USV is one of the earliest examples of
Argentina, Chile and Uruguay, while
Ltd to market Galvus(Vildagleptin)
this trend.11 More recent examples
it retained co-marketing rights for
in the Indian metros. USV will
include the acquisition of the
Russia, Brazil, Australia and New
manage marketing activities in
injectables business of Orchid
Zealand. In India, the company
Tier II and Tier III cities in the
Chemicals by Hospira12 and
retained its exclusive rights.
next phase.9 Also entering the
Sanofi's acquisition of Shantha
Another example is of Jubilant. The
fray is Belgium's Omega Pharma,
company entered into a three-year
which formed a JV with Modi-
drug deal with US-based Endo
Mundipharma Group to create
Mergers and acquisitions to
Modi Omega Pharma India. Eight
target global opportunities
brands from Omega's product
portfolio will be manufactured in
Indian player
Nature of deal
India by the Modi-Mundipharma
Sanofi-Aventis Acquisition for US$ 781
Group. The marketing strategies
and sales team will be provided by
Acquisition for US$ 400
Modi Omega Pharma India. 10
Serving the global market
Acquisition for US$ 736
Pharma MNCs are facing challenges
Source: Industry reports & PwC analysis
of impending patents and rising
R&D expenditure. They are looking
b. Alliances and partnerships
Pharmaceuticals for developing
for opportunities to increase the
oncology drugs.15 Under the deal,
drug pipeline and reduce costs.
Previously, A&P were formed to
Jubilant will receive research
In addition, given the pressures
source out products. Today, it has
funding and milestone payment
of reducing healthcare costs and
expanded in R&D as well.
on successful completion of
the increasing use of generics,
predetermined targets. Endo will
pharma MNCs are also looking
Research and development
own the developed drugs and will
to partner with companies with
Pharma MNCs are looking for
pay royalties to Jubilant on the
superior product development
opportunities to co-develop drugs,
successful commercialisation of the
capabilities. At the same time,
buy or in-license molecules from
Indian companies are also looking
Indian companies. Such deals
to move up in the value chain by
have helped India shed the tag of a
discovering new drugs. These
cheap manufacturing base and gain
10 PwC - CII
Other deals for R&D
Similarly, Pfizer signed licensing
Manufacturing deals are
deals with Aurobindo Pharma17,
Indian company
Pharma MNCs
common in India because
Claris Life Sciences18, Biocon19
of the country's legacy in
and Strides Arcolab. The deal will
strengthen Pfizer's position in
research chemistry, efficient
production and cost advantage emerging markets and expand its
medicine portfolio in established
manufacturing. These
skills coupled with the fact
products business units (EPBU).
that India has the highest
The Indian companies will benefit
Serum Institute MSD
number of USFDA-approved
from a steady revenue flow and the
possibility of receiving significant
plants outside the US, make
manufacturing alliances an
upfront payment and royalties.
Source : Industry reports & PwC analysis
attractive proposition. There
Sun Pharmaceutical Industries and
are several examples of such
Merck and Co Inc entered into a
alliances in India.
JV agreement to develop, produce
Importance of Japan
GlaxoSmithKline (GSK)
and market innovative generics in
The Japanese pharmaceutical
expanded its market share by
emerging markets.20
market stands at US$ 96.5
striking a deal with Dr Reddy's
Japan is an upcoming market for
billion.21 This market is
Laboratories16 and gaining
collaborations given the opening-
largely innovator-based with
up of generics market by the
the generics component
access to a portfolio of more
contributing about 25% of sales
than 100 drugs. For Dr Reddy's,
Japanese government. Please see
by volume. In contrast, the
the deal will help increase its
the side bar for details.
generics component of the US
product reach in regions where,
and UK stand at 88% and 71%22
till now, it only had negligible
market presence.
The Japanese market is fast
shifting its focus towards
A&P for product sourcing
generics, driven by the
government's fiscal pressures
Indian players
Nature of deal
and an ageing population.
Supply of generic medicines for developed
and emerging markets
The government of Japan has
been aggressively promoting
Strides Arcolab Ltd
Supply of 67 generic drugs to Pfizer with
focus on oncology
generics by providing incentives
to the industry and physicians.
Supply of 18 products for various markets
Hence, we see an increasing
Range of ophthalmic products for 30
number of Japanese pharma
companies seeking partnerships
with Indian generics
Development and manufacture of generic
Pharmaceuticals drugs with market size of US$ 670 million
Cadila Healthcare
JV structure for the manufacture of patent
Contract manufacturing of formulations
PharmaceuticalsStrides
Supply of drugs for semi-regulated markets
ArcolabLimitedSource : ICRA Limited. ‘CRAMS India: Overview & Outlook'. June 2011
11
Benefits of collaboration
Benefits of collaboration
Pharma MNCs collaborating with
Indian companies bring to the table
new products, latest technology,
higher investments, quality systems
and the knowledge of regulatory
processes. On their part, Indian
companies provide local market
knowledge, cost advantage
and local scientific talent. Such
alliances have the potential to bring
significant benefits to both parties
and add value to society as a whole.
Such partnerships bring in new
drugs and therapies to the market
and increase patient's awareness
about diseases and wider treatment
choices available.
Success driversPwC's survey of opinion leaders
in the Indian pharma industry
revealed that issues related to
quality, management control,
corporate governance, valuations,
cultural issues and understanding
local regulations were crucial for
any form of collaboration.
12 PwC - CII
1. Importance of quality
bound to look at India as a low-
2. Transaction-related drivers
As a result of increasing alliances
cost manufacturing destination
In addition to quality related issues,
and the growing importance of
as well as a strategic partner
attention needs to be focussed on
Indian pharma globally, prominent
for specific operations. The key
the following determinants too.
Indian pharma companies have
consideration for such MNCs is to
These need to be discussed and
come under the scanner of the US
choose a partner after conducting
resolved to the satisfaction of both
Food and Drug Administration
a thorough investigation and with
the parties involved in the A&P:
(USFDA) for varying degree of
due diligence. While financial
• Management control
diligence is a standard and an
integral part of all deals and
• Corporate governance
In India, USFDA audits and pre-
alliances, the pharma industry
approval inspections typically focus needs a more in-depth operational
• Expectations of valuation
on the following:
approach prior to selecting a
• Cultural differences
• Management roles,
• Local regulations
responsibilities and training of
Aspects to focus on include the
personnel operating in USFDA-
M&A along with A&P have a
approved facilities
major role to play in changing
• Historical review of internal and
the dynamics of the industry and
• Filed application integrity with
external regulatory audit data
taking it to the next level of growth.
specific attention to records,
manufacturing systems and
• Extent to which audit findings
A&P are likely to be more popular,
laboratory test results
have been remediated
as they are mutually beneficial
to both stakeholders. It can
• Monitoring of impurities in APIs
• Mechanisms put in place
help Indian companies scale the
and drug products
to ensure implementation
of adequate corrective and
innovation curve, while at the same
• Stability studies and
preventive actions
time helping to increase the drug
investigation of out-of-
pipeline curve for global players.
specification (OOS) incidents
• Regulations in place to ensure
India's low-cost manufacturing
sustainability of quality system
capabilities will also help pharma
• Safety and integrity of the
MNCs meet the increasing global
• Overall review of quality systems demand of generics.
While the impact of this regulatory
To ensure successful partnerships,
crisis on alliances formed cannot
issues such as quality, valuations,
be muted, the more critical issue is
Companies often require domain
management control, corporate
its impact on future alliances and
specialists to understand the
governance and cultural
on the overall image of the Indian
true nature of the above issues. A
differences need to be identified,
pharma industry.
thorough operational diligence can
help understand the appropriate
discussed and resolved through
Given the mounting internal and
measures that can be implemented
an in-depth financial, tax and
external pressures on pricing and
to mitigate any risks associated
operational diligence.
healthcare costs, MNCs are still
No one size will fit all and
companies will hav eto choose and
implement the path that best meet
their strategic objectives.
13
With increasing pressure on the
Elements of cost reduction
launching several improvement
global healthcare industry to cut
programmes to control these costs.
costs, pharma companies will
Like any other industry,
While the sourcing teams focus on
have to look at different avenues
pharmaceutical cost has several
getting materials at a competitive
to achieve it. Efficient operations,
direct and indirect costs:
landed cost, many leading API
management of the supply chain
and transfer pricing are key areas
where cost efficiencies can be
Operations
improvement
Pharmaceutical companies
can achieve year-on-year cost
reduction in their overall spending
by rigorously identifying and
eliminating wastes in their
manufacturing and business
processes. Today, for many companies,
manufacturing costs, as a fraction
of overall costs, is considerably
higher. Therefore, it is quite logical
to start with a cost reduction
exercise in manufacturing.
Currently, pharma companies are
players are undertaking initiatives
taking a hard look at various cost
to improve batch yields and the
elements and are coming up with
consumption of critical input
various innovative ways to reduce
Project teams use the DMAIC
Material cost: Around, 60 to
methodology to understand the
70%23 of pharma manufacturing
reasons behind yield loss and
cost is influenced by raw materials.
implement an action plan towards
Therefore, controlling material
improvement. Today, companies
costs is one of the most important
set year-on-year targets for
areas that companies need to focus
improvements in yield, which in
on. Leading pharma companies are
turn get converted to the budgeted
14 PwC - CII
yield numbers in the next financial
Most companies struggle with the
Energy: The pharma industry
year. This acts as a financial control
question as to what is the right
uses a variety of utility equipment,
for ensuring sustenance.
manning number. The industry
including boilers, air compressors,
defines manning for each function
API companies use various levers
chillers, brine units, air handling
based on certain thumbrules
and also fundamentally question
units (AHU), vacuum pumps,
(like ‘x' chemists per HPLC, ‘y'
the type and quantity of solvents
DG sets, etc. These machines use
scientists per project, etc.), that
required in the process. Companies
electricity, coal and furnace oil as
make it difficult to identify the right
have in several instances been able
sources of energy, all expensive
number. Moreover, the industry
to improve the recovery of solvents
and subject to active cost reduction
is also struggling with increased
by identifying and addressing the
requirement for casual labour. A
source of loss. Some companies
Savings in operating these units
majority of the pharma companies
have also adopted a better solvent
primarily result from ensuring
have started to think in terms of
management process and have
efficiency of these machines and
defining manning norms. From a
been able to eliminate a few
preventing wastage. Companies
shop-floor viewpoint, the more the
solvents, either by adopting an
typically look at generation,
number of people on the shop-floor,
alternate solvent or by an alternate
consumption and distribution
the greater are the chances of error
manufacturing process.Similar
and mix-ups.
efforts are initiated by formulations
Benchmarking key performance
players in terms of improving
These questions exist for all levels
parameters, such as efficiency,
their rolled throughput yields.
power consumption per unit
Companies are looking at various
generated, etc, of utility
factors including breakages,
machines can give insights into
powder losses, etc to improve
corrective actions required. Utility
yields. They are also effectively
requirements are very specific to
embracing various concepts of
the process and companies can do
lean to eliminate wastes in their
Leading companies are
well to link utility consumption
controlling cost by defining
with production planning to
Manpower cost: Like others,
manning norms. In PwC's own
optimise consumption and reduce
the pharma industry also faces
experience, a correct manning
wastage. PwC's experience
exercise involves the following:
challenges such as an average
suggests that energy costs can
15%24 growth in salaries and an
• Activity driver based work
be dramatically reduced by
approximate 20%25 attrition rate
synchronising planning and
at operative and executive level.
• Shared services and resource
averaging out peak loads through
This puts pressure on manpower
proper scheduling.
costs, as the costs of recruitment
• Span of control studies
Most organisations today carry out
• Process improvement for work
rigorous energy audits and take
Therefore, controlling manpower
several steps including replacement
cost is becoming an important
of old energy-guzzling equipment
agenda item for the top
with new state-of-the-art energy-
management. On an average, the
efficient equipment. Companies
pharma industry spends around 7
are adapting themselves to green
to 10% on manpower costs. This is
technologies to save energy costs.
slightly higher as compared to the
overall average.
15
This also contributes towards
be cost-effective, while at the same
Levers for cost reduction
time adhering to delivery dates,
Companies do implement
Packing costs: Packing costs are
enhancing equipment utilisation
manufacturing cost reduction
typically higher for formulations
and identifying optimum manning
programmes using levers such
as compared to API. Packing costs
as process improvements, shared
can be reduced by at least 10%26
Cost of manufacturing decisions:
services, standardisation, first
by reducing packing rejections and
Cost of manufacturing decisions
principle costing, efficiency
by value-engineering the packing
work primarily at the strategic
improvement, etc.
design. Companies use several
and tactical domain, where the
factors for reducing packaging cost.
Each of these levers needs to be
companies take decisions on the
These include strip dimensions,
addressed along two dimensions,
number of colours used, packing
material thickness, optimal fitment
of tablets within strips, number
• Where should the plant be located?
of ply, shipper sizes, etc. PwC's
• What are the RM and FG transportation costs?
experience suggests that while
• What is the technology and infrastructure such as reactors, layout,
material handling systems, etc. to be utilised?
primary packaging is a function
of stability, companies do well by
• What is the planned capacity utilisation of the plant?
addressing elements of dimension
• What should be the batch sizes to operate?
and wastages in primary packing.
• How much should be the inventory in process?• What is the production planning philosophy to be used?
However, packing designs generally
have a long gestation period as they
• Which are the products or intermediates to make or buy?
are subject to customer approval.
Hence, the benefits of these
Planned versus actual capacity
strategic and operational. Decisions
normally accrue over multiple years.
utilisation will have an impact
for strategic cost reduction will
Analysing costs: Quality costs (QC)
on product costing in terms of
have a long- to medium-term
in most organisations were not
apportioning fixed costs over the
impact. However, the complexity
tracked and it is only recently that
quantity produced. Planning during will be high. In operational cost
organisations have started looking
the project phase ensures minimum reduction, the impact will be for
time and cost overruns. This
the immediate or medium-term but
Today, organisations have gone
reduces the cost of setting up the
relatively less complex.
beyond the scope of production
project. The cost of these decisions
Many progressive companies use
and have tried to implement cost
is high, and so is the impact they
lean management as a concept to
containment in quality control
have in the medium to long term.
identify and eliminate wastes in
functions by reducing cost of
Companies need to evaluate
the process, thereby resulting in
analysis. Companies use factors
their make-buy decisions
additional throughput and better
such as material substitution,
more rigorously on the back of
service levels at a lower cost.
optimising quantities drawn for
contribution earned. Appropriate
Companies have realised 10 to
sample analysis, reduced testing,
technology selection, plant location 15%27 reduction in overall costs
standardising makes of chemicals
and layout and production planning and improvement in bottom-line
across sites, clubbing samples to
influence cost of production.
savings by implementing structured
cost reduction programmes.
16 PwC - CII
The Indian scenario
distribution reach in domestic
centric metrics, they are also
Riding on the back of 12 to 13%
markets. With these challenges, the focussing on delivering customer
year-on-year growth, the Indian
Indian pharma industry is seriously value at lower costs.
pharma industry is going through a
evaluating the ways and means to
The survey reveals that companies
very interesting phase. It is rapidly
reduce operation costs.
are targeting improved service
achieving a distinctive position
The recently concluded lean
levels but at competitive costs.
in the global pharma space with
implementation in the pharma
It is clear that the Indian scenario
generics, Contract Research and
industry survey conducted by the
is a peculiar one and delivering
Manufacturing Services (CRAMS)
Organisation of Pharmaceutical
service and cost competitiveness
and clinical trials. Also as foreign
Producers of India (OPPI) and PwC
need to go hand-in-hand. To
MNCs fight for a share of the
revealed some interesting evolving
achieve sustainable improvement
market, the fragmented domestic
trends. Almost all participants
programmes, companies need to
market is poised for consolidation.
cited improving service levels to
execute holistic programmes. The
In this scenario of increased
the customer as one of their prime
journey is difficult, but the rewards
competition, companies will try to
business needs, while reducing cost are fast and considerable.
differentiate on the basis of speed-
and improving profitability came a
to-market, cost competitiveness,
close second. So, while companies
quality, customer orientation and
today are focussing on customer-
17
Supply chain
The nature of distribution such
Analysis of the reasons behind
as fragmented channel, channel
the failure of the supply chain
power of stockists, limited
in meeting challenges of market
As Indian companies look forward
visibility and push-based supply
growth points to a variety of
to market growth on one side and
also acts as a tipping point for
practices within the Indian
the need to reduce costs on the
overhauling the supply chain.
pharma industry. These need to
other, an agile, customised and
Key concern areas
be addressed if efforts to create an
cost-efficient supply chain is of
agile, responsive, customised and
paramount importance. Companies Some of the key concern areas
cost-effective supply chain are to
in many industries have taken
with the supply chain include
pruning shears to their supply
• Pharma supply chains operate
chains to support profitable growth. • High logistics cost ranging
Until recently, pharmaceutical
from 4.72 to 6.22% of sales
on a pure push: Salvage net is
companies did not embrace this
as against 0.5% in the US and
the cost incurred by a pharma
trend. However, the industry can no
company due to expiry and
longer afford a laissez faire position
breakages of products in the
• Ineffective control over
on the operation of their supply
market or at other storage
channel inventory: 46 days
locations. This is created due
for a pharmaceutical company
to the multiplying effect of
as against 26 days for an
Why focus on the supply
inefficiencies in the supply chain.
Some of the key reasons behind
• Low ARPUs per stockist and
this include the following:
The contributors to growth
• Push-based supply to depots,
of the Indian pharma market
stockists and retailers
such as increasing disposable
• Porous supply chain
incomes, greater health insurance
facilitating easy entry of
• Misalignment between sales
penetration and a gradual shift
and supply chain organisation
in disease profile pose several
• Sub-optimal penetration of
on timing (start and end) of
questions on the existing supply
chain configuration:
• Inadequate access to
• Budget-driven forecast leading
• Is the existing supply chain
secondary and tertiary
to forecast bias, mismatched
capable of supporting market
sales information critical to
planning horizon on account of
creation (e.g. a supply chain that
planning processes
sales visibility and supply lead
supports reach and coverage in
the growing peri-urban markets,
• Inadequate infrastructure to
cold chain for biotech, etc)?
support compliance to CGMP
• Sub-optimisation at each stage
in the distribution chain
of supply chain impacting
• Is there a need to tailor the
inventory velocity
supply chain across markets
(Tier I, Tier II and rural) and
• Inventory imbalance across stock
disease profiles to support varied
approaches in terms of products,
• Lack of visibility on products
pricing and sales coverage?
18 PwC - CII
• Inefficient warehousing
• Homogenous supply chain
processes related to storage,
catering to varying customer
Goods and services tax
handling and retrieval
needs: A homogenous
• Batch size economics in
supply chain operating on
a standardised lead time
As seen in our previous report,
transportation, manufacturing
India Pharma Inc: Capitalising on
restrains pharma companies
India's growth potential, GST is a
PwC believes that effective
from effectively capitalising
comprehensive value-added tax
synchronisation between the
on all business opportunities.
(VAT) on the supply of goods or
supply chain function and other
The lead time required by the
services. The GST will bring with it
customer varies across product
opportunities to realise efficiencies
organisational functions like sales
and markets. The figure below
and related challenges.
and marketing, finance and IT can
lead to a reduction in salvage net.
illustrates an example of how
The pharma industry (including
lead time expectations vary
FMCG)is significantly affected by
across products and markets.
GST, since it disadvantages the
classic manner of concentrated
Pharma companies will have
manufacturing and disaggregated
to tailor their supply chain
distribution across a national level
strategy after understanding the
requirements along the cost and
At present, the biggest challenge for
a pharma distribution company is
the movement of goods across India,
Lead time in number of days
to cater to the need of each state and
thus save the CST payable otherwise
on such inter- state movement. Also, several entities set up
warehouses in attractive locations
like Daman as the CST rate at such
locations was previously lower than
the rates prevalent in other states. This logistical challenge and the
added cost of compliance will
become a focal point of attention,
post GST.
The distribution team needs to re-
ascertain the warehousing locations
from a commercial and logistic point
of view rather than from a pure
tax-saving perspective. Reduction
in such warehouses will reduce the
cost of distribution.
It is important for the pharma sector
to understand the implications and
challenges arising out of GST and to
ensure that the business model and
supply chains are re-engineered to
maximise benefits.
19
• Sourcing from a perspective
All these factors lead to significant
Mitigating fraud in the Indian
of aligning demand to supply
value erosion. To participate in
pharma supply chain
often overlooked: Production
future growth, the pharma supply
The worldwide scale of
plans at pharma companies are
chain will need to focus on the
pharmaceutical operations is
governed by the availability of
following dimensions:
creating supply chains that are
raw materials rather than being
• Channel management
extensive and globally dispersed.
aligned to customer demand.
• Supply chain planning
This introduces heavy reliance
The lack of a diversified supplier
on third parties and increases the
network constrains the pharma
• Supplier relationship
risk of fraud. In particular, India's
company from aligning demand
supply chain uses a fragmented
and supply, thereby creating
distribution network depicted in
inefficiencies in the supply chain.
• Security and compliance
Source: Overview of the Indian Pharmaceutical Market (2010) published by Datamonitor
20 PwC - CII
A typical organisation loses 5% of
the general tenets of good supply
TP environment in India
its annual revenue to fraud. When
chain management. They need to
applied to the estimated 2010 size
establish a culture that supports
Introduced in 2001, Indian TP
of the Indian pharma market, this
control efforts and whistleblowing
regulations are broadly modelled
figure translates to a potential total with clear, ethical guidelines. They in line with global practices
fraud loss of more than US$ 600
need to build loyalty within the
including TP guidelines issued by
million. Managing risks and fraud
organisation, give employees the
the Organisation for Economic
is therefore a key area of concern
confidence to do the right things
Cooperation and Development
for Indian and global pharma
and identify clear conditions for
(OECD).31 Indian revenue
those who commit fraud.
authorities have so far completed
six rounds of audit and have made
Fortune 500 pharma companies
an astronomical adjustment of
have established whistleblowing
Managing transfer
about Rs 54,999 crore.
reporting mechanisms which
pricing (TP)
allow employees to raise concerns
and seek guidance. They have
Introduction of the concept
Prominent TP
also initiated the concept of anti-
of "Transfer Pricing (‘TP')"
retaliation protection to ensure
is a measure adopted by the
challenges faced
that all employees can safely
governments to ensure the
by Indian pharma
report potential violations.
protection of the tax base of their
respective countries. TP refers to
These companies are developing
the basis adopted by a company
• Comparison of import price
robust compliance programmes
while transacting with its group
of original API with price of
based on their ‘dipstick
companies such that the same
assessment' of business conducted
reflect pricing and conditions
• Comparison of the export
by subsidiaries or affiliates in
similar to those adopted in
price of the product(s) with its
Brazil, Russia, India, China (BRIC)
transactions undertaken between
price in the domestic market
and east European countries. Such
• Benchmarking clinical trial
programmes are being rolled out
support services provider with
worldwide to ensure consistency in In current times, where pharma
clinical research organizations
compliance globally with specific
companies are espousing austerity
(CROs) and thereby expecting
focus on entities that were rated
measures on several counts
unsatisfactory in the dipstick
to remain cost-competitive,
• Expectation of higher mark-
it is important for companies
ups for contract R&D services
to understand TP issues and
To identify processes vulnerable to
prepare an upfront defence so as
fraud, companies are conducting
to mitigate future litigation. TP
• Seeking justification or
an enterprise-wide assessment of
commercial rationale for
principles will also aid phama
existing fraud risks on a pro-active
the payment of royalty or
companies to effectively plan their
management fee by the Indian
basis. This assessment considers
risks involved and the potential
schemes to circumvent existing
This chapter digs deeper into the
• Alleging creation of marketing
intangibles due to the
control activities.
overview of the current Indian TP
environment, key TP challenges for
promotional spends incurred
So, to avoid fraud and risk,
the pharma industry and planning
by the Indian taxpayer
companies need to adopt many of
opportunities using TP principles.
21
Key TP issues in the pharma
industryOwning significant intangible
property deployed across
geographies) coupled with
the multitude of cross-border
transactions, Pharmaceutical
industry has been exposed to some
of the most significant TP litigation
over the years. From an Indian
TP perspective, following are the
prominent challenges faced by the
Pharma companies: Please see the
side bar for details.
Possible solutions • API prices comparison
Globally, the comparison of
original (branded) API with
generic API is one of the most
contentious issues faced by
pharma companies. The same has
taken centre stage in the Indian
TP context with the Income-Tax
Appellate Tribunal (ITAT)32 ruling
on the issue in case of UCB33 and
Serdia.34 While in the case of UCB,
ITAT ruled that original API cannot
be compared with generic, in the
case of Serdia, ITAT upheld the
validity of such a comparison.
These rulings raise the question if
such a comparison is valid and if
not, how the arm's length nature of
the imported API (branded) should
be established. Instead of focusing
on the technical difference (such
as quality, efficacy, potency, etc.)
in the two APIs, one can establish
the appropriateness of the margins
earned by the Indian company
with regard to its functional profile
22 PwC - CII
(i.e., functions performed, assets
The objectives and practical
employed and risks assumed).
implementation of a business
restructuring are effectively
• High mark-up for support and
achieved by the application of
TP principles i.e., an entity's
A possible defence for the high
remuneration is linked to the
mark-ups anticipated by the
function it performs, risks it
tax authorities for the support
assumes and the assets it employs.
services (such as clinical trial
While business restructuring
support, procurement support
offer business advantages, such
etc.) provided by Indian taxpayer
exercise also pose significant
lies in demonstrating the level of
risks, including the potential
the activities performed by the
for significant transfer pricing
Indian taxpayer and its relative
adjustment. Therefore, it is
contribution in the value chain.
imperative that any restructuring
To develop a transfer pricing
is undertaken after duly
defence, the actual business
considering the established TP
conduct should be in sync with
the underlying characterisation
and should be supported by robust
Going by the trend, the challenge
• Business restructuring
of audit and the level of dispute
Business restructuring, involving
(from tax authorities) faced
cross border redeployment
by this industry will increase.
of functions, assets and risks
Therefore, it is in the best interest
is often undertaken by the
of pharma companies to adopt a
pharma companies to streamline
more proactive approach to set
their business operations.
and monitor their TP policies.
Commercial reasons such as
They should also maintain robust
increased competition, cost
documentation to support the
optimization, elimination of
basis for setting these policies.
duplicative functions, need for
Apart from being viewed as
centralisation, proximity to
compliance requirement, TP
market etc. compel the pharma
should be used to optimise
companies to adopt restructuring.
business operations too. Given
Business restructuring often
the nexus of TP to both tax and
results in achieving significant
business, effective coordination
tax optimisation by realigning
between an organisation's tax and
the distribution of profits across
business functions is required to
make the best use of TP principles.
TP is not about documenting the
end result, but about documenting
23
Newer growth
trends
Pharma companies will need to
issued to each family. One of the
RSBY is attracting a slew of
create meaningful partnerships
cards makes it possible for a worker entrepreneurs to set up hospitals
with organisations in other
based in a particular state to move
primarily targeted at the rural
industries like health insurance,
to another place and continue to be
population. Looking at the trend
medical technology and IT to drive
part of the scheme. The premium
of private hospitals' participation,
growth. In addition, they will have
amount of the scheme is shared by
the government wants to introduce
to devise strategies to make growth
the union and state governments in
public-private partnerships,
inclusive and sustainable.
75:25 ratio, with a nominal amount wherein the role of the government
of Rs 30 being paid annually by
will change from that of a provider
Health insurance
the beneficiary. Till date, RSBY
to that of a payer.
has been successfully extended
Less than 15% of the Indian
In a recent PwC publication
to 23 million poor families in 330
population is covered under any
Healthcare Unwired, we have listed
districts in 27 Indian states.36
form of health insurance, including
recommendations and specific
Beneficiaries are free to avail of
government-supported schemes.
solutions to improve the reach of
healthcare from any empanelled
Only around 2.2% of the population
health insurance. Some of these
government or private hospital of
is covered under private health
measures include creation of a
their choice.
insurance. The awareness of health
new business model, reducing
insurance schemes in rural areas is
Two private trusts, the IFMR Trust
premiums and collection costs,
disturbingly low. Health insurance
that provides rural finance to 1.7
switching from patient cure to
is, however, expected to grow at
lakh households and the Manipal
preventive care and simplifying
a CAGR of 15% by 2015.35 Given
Education and Medical Group
policies and regulatory reforms in
the diversity of India's population
covering 80,000 families, were
the healthcare and health insurance
and its limited purchasing power,
recently given the approval to
space. Initiating these measures
innovative insurance products at
participate in the RSBY scheme. The will result in increased penetration
multiple price points are needed to
two trusts together will add nearly
and improved coverage of health
tap the market.
2.5 lakh families, a development
insurance in India.
that promises to alter the delivery of
The union government rolled
healthcare to the poor.
out an insurance plan for the
poor, Rashtriya Swasthya Bima
The government is examining
Medical technology plays a
Yojana (RSBY) which provides
the possibility of turning its
pivotal role in improving access
medical cover for families below
two important social sector
to affordable healthcare services.
the poverty line (BPL). It includes
programmes--old age pension
It also helps early diagnosis of
hospitalisation, out-patient
scheme for the BPL and the Aam
diseases and creating personalised
treatment and surgical treatment
Aadmi Bima Yojana (AABY)
therapies for the Indian population.
in select hospitals. The medical
targeting the rural landless--into
insurance provides an annual
universal schemes covering the
The Indian medical technology
cover of Rs 30,000 per household
unorganised sector in phases. The
industry, which comprises medical
and covers five members of a
two schemes will be linked with the equipment, medical implants,
family. Plus, transport allowance
smartcards given under the RSBY
medical disposables and furniture,
of up to Rs 1,000 a year is given
scheme. If implemented well,
is expected to grow from US$ 2.75
to BPL families. The scheme is
they can help beef up the grossly
billion in 2008 to US$ 14 billion37
administered through biometric
inadequate social security cover
in 2020, at a compounded annual
smartcards with two smartcards
available to the poor in the country. growth rate of approximately 15%.
24 PwC - CII
Post independence, India adopted
• Usher further reform in the
an import substitution policy for
insurance sector to stimulate
the development of indigenous
health insurance.
industries under the umbrella of a
• Set up a venture investment fund
• Transasia Biomedicals has
strong public sector. The medical
developed in-vitro diagnostic
to address the lack of early stage
technology sector, however, was not
equipment through its R&D
venture capital.
on the list of government priorities.
Also, no pathbreaking effort was
• Ensure a level playing field for
• Sushrut Adler Group has
made to build domestic capabilities
all companies with a distinct
developed an external fixator
in R&D and manufacturing. The
regulatory pathway for medical
through its facility in Pune.
seeds of import reliance were thus
technology free of ambiguities.
• Johnson & Johnson has
sown in the early years of free India.
• Make research a rewarding
developed a knee implant
The reliance on imports continued in
suitable for the Indian market
the subsequent years in spite of high
as well as a reusable stapler
import duties and tariffs. Today, 80% • Reform the medical education
for use in surgeries, both at
system to include medical
amenable price points for the
of the medical technology market is
technology education with
Indian market.
through imports.
assistance from institutes
• Roche Diagnostics has
The last few years have seen
like National Institute of
developed a screening device
an increase in the domestic
Pharmaceutical Education and
for cardio-vascular disease
manufacture of medical equipment.
Research (NIPER).
suitable for use in rural
With impetus from the government,
settings too.
India is finally being recognised as
• Evolve medical technology
clusters with common facilities
• GE Healthcare has developed
a manufacturing destination for
for the benefit of small
a low-cost ECG machine and a
sophisticated medical technology.
low-cost ultrasound machine
International medical technology
entrepreneurs who want to
for the Indian market.
companies are also using India
set up companies focusing on
medical technology.
• Philips Healthcare is using its
as a manufacturing base by
recent acquisitions in India to
either setting up facilities of their
• Assist existing manufacturers to
develop and launch a low-cost
own or by acquiring domestic
upgrade their quality systems to
cath lab for the Indian market.
match international standards.
There is also a strong need
Medical technology is a
of innovation in the medical
nascent sector in India and the
technology market given its
opportunities for innovation-led
ground realities. Innovation in
growth are immense. Innovation
medical technology, however, faces
in medical technology requires a
challenges that need to be addressed vibrant and participative ecosystem
by the government. Some of the
comprising patients, medical
steps which the government can
centres, universities, the industry,
take include the following:
health insurance companies and
• Increase public spending in
the government. All stakeholders
healthcare from 1% of GDP to 3%. have to act in concert for the
sustained growth of the industry
and the benefit of patients.
25
Information
technology (IT)
Many pharma companies have
entered into strategic partnerships
with Indian IT companies in areas
of pharmacokinetic modelling,
data management and validation,
Clinical data and document
management, pharmacovigilance and
scientific writing
Clinical data management and clinical
submission support
Clinical data management, clinical
study set-up for electronic data
capture, medical coding, adverse event
Co-creation engagement model
to design and implement research
informatics system
Co-innovation hub to accelerate the
process of bringing ideas to fruition
Source: Industry & PwC Analysis
Mobile health
Mobile technologies are also
finding their way into areas
like disease awareness, disease
management, patient compliance
to drug schedules, etc.
Mobility solution provider
Diabetes disease management
Mobile product authentication
Source: Industry & PwC Analysis
26 PwC - CII
Sustainability
In recent years, addressing various
sustainability issues has become
increasingly important for the
pharma industry. Sustainability is
about long-term value creation not
only for businesses but also for all
stakeholders such as employees,
customers, the industry sector,
investors and the communities
where the company operates.
Key focus area
Indian companies have started
on environment
sustainability programmes on the
lines of their global counterparts.
• Adopting the use of
They are at various stages in their
sustainable packaging
journey on sustainability reporting.
An analysis of the sustainability
• Reducing the use of
reports of these firms identifies
potentially hazardous input
similar trends as those initiated by
global majors. They develop CSR
• Improving production
programmes which focus largely
processes to reduce
on improving environmental
environmental impacts
performance of their operations
• Reducing the emissions
and providing better access to
to air of Ozone Depleting
Substances (ODSs) and
Companies are also partnering
Volatile Organic Compounds
with suppliers to improve their
Increasing energy efficiency in
sustainability performance. Most
the manufacturing process
other companies have programmes
• Reducing the use of coal
focusing on social initiatives to
and oil in manufacturing
improve local infrastructure,
economic and social conditions,
• Implementing the
organising various medical camps,
requirements of the EU's
providing free consultations and
REACH legislation
treatments and raising awareness
about HIV-AIDS. Companies report extensively on
their initiatives and performance,
but do not focus on how to improve
their communication and the reach
of their sustainability programmes
27
The Indian pharma industry is on
a major growth trajectory and is
expected to reach US$ 74 billion
by 2020. In order to realise the
full potential of the market and
tap growing global opportunities,
companies operating here will
have to collaborate in a mutually
beneficial manner. As we move into the next decade,
mergers and acquisitions,
partnerships and licensing will
drive future growth. MNCs will
not be averse to acquisitions but
high valuations will make M&As
expensive in India. Alternatives
such as alliances and partnerships
will actually prove to be more
flexible and value-enhancing in the
long term. MNCs can benefit from the local
market knowledge of Indian
companies, the strength of their
sales force and significant cost
advantage across drug development
and the manufacturing process.
Global pharma companies have
the capability of bringing in newer
products, technology, capital and
quality leadership. They can help
their Indian counterparts in their
desire to ascend the innovation
curve.
However, alliances and
partnerships face significant
challenges of quality, valuation,
28 PwC - CII
management control, corporate
sector needs to reduce its import
governance as well as cultural
reliance as well as create innovative
issues. Success will depend on
products and solutions keeping
thorough due diligence of quality
in mind the realities of the Indian
aspects, appropriate valuation
market. Government and industry
and synergy derived from the
must work together to reduce the
barriers to innovation and create
Given the price-sensitive nature
a vibrant innovation ecosystem to
of the Indian consumer as well
deliver patient-centric solutions.
as cost pressures from developed
In meeting the challenges of
economies, pharma companies
growth, pharma companies will
will have to focus on improving
have to ensure that it is sustainable.
operational efficiencies. Creating
Pharma MNCs as well as large
an agile and responsive supply
Indian companies are taking
chain that is operationally efficient
an interest in sustainability by
and minimising the incidents
implementing initiatives and
of supply chain fraud will be of
reporting on their success in
significant importance.
the areas of energy and water
At the same time, companies
consumption, emissions and waste
entering cross border transactions
treatment and handling, access
should proactively set /monitor
to medicine by using differential
their TP policies and maintain
pricing and voluntary licensing.
robust documentation. This will
The pharmaceutical industry in
assist companies in optimising
India is poised for a period of
their business operations.Health
robust growth driven by alliances
insurance is a significant driver for
and partnerships. Success in the
the growth of the overall healthcare market will be dependent not only
market by improving access to
on pharma companies but also on
state-of-the-art medicines and
other stakeholders like healthcare
therapies. Medical technology
providers, health insurance
can also help improve access to
companies, medical technology
quality healthcare delivered in
companies, government, patient
a cost-effective way. Medical
groups as well as society at large
technology will also help drive
acting in concert. How well they
the trend towards personalised
do will determine the future of the
medicine. The medical technology
Indian pharma industry.
29
1. PwC Report-India Pharma Inc.:
16. GlaxoSmithKline Press release: ‘GSK
31. TP: Transfer Pricing Guidelines for
Capitalising on India's Growth potential,
announces a strategic alliance with
Multinationals and Tax Administrations
Dr. Reddy's to further accelerate sales
issued by Organisation for Economic
2. EP Vantage, ‘Patent storm gathering
growth in emerging markets', 15th June,
Cooperation and Development
strength' 28 January 2011
32. ITAT stands for Income-tax Appellate
3. Redefining the Meaning of a Successful
17. Aurobindo Pharma Press release:
Tribunal which is a second level
21st Century BioPharma Company,
‘Aurobindo Pharma Inks Marketing
appellate authority
"BioPharma and the String of Pearls"
Deal With Pfizer For Finished Dosage
33. UCB India Private Limited v. ACIT 317
Products', 3rd May 2009
4. PwC Report – Pharma 2020; Challenging
Business Models, 2009
18. Vishal Dutta: ‘Pfizer ties up with Claris
34. Serdia Pharmaceuticals (India) Private
for injectables' Economic Times, 20 May,
5. PwC Report – India Pharma Inc:
Limited - ITANos:2469/Mum/06,3032/
Capitalising on India's growth potential,
Mum/07 and 2531/Mum/08
19. Biocon Press release: ‘Biocon and Pfizer
35. NIC has 20 % share in BPL health
enter into Global Commercialization
6. PTI, ‘FDI in Pharmaceuticals to pass
insurance scheme, Hindu, Provider:
Agreement', 18th October, 2011
through filter', The Economic Times, 10
Kasturi & Sons Ltd, March 2011
20. Merck & Co. Press release: ‘Merck & Co.,
36. Private healthcare in rural areas gets
Inc., and Sun Pharma Establish Joint
7. Bayer Healthcare Press release: ‘Bayer
RSBY push, Economic Times, May 12,
Venture to Develop and Commercialize
and Zydus Cadila sign Joint Venture
Novel Formulations and Combinations
Agreement to strengthen pharmaceutical
of Medicines in Emerging Markets', April
37. NIPER Ahmedabad, Industry Analysis,
business in India' 28th Jan, 2011
8. Lupin Pharma Press release: ‘Eli Lilly
21. IMS Health Market Prognosis, March
38. PwC Report: Enhancing access to
India and Lupin announce strategic
healthcare through innovation, June
collaboration to help fight the battle
against diabetes' 29th July, 2011
22. Generics and Biosimilars initiative:
‘Hospira looks to biosimilars and
9. Nina Mehta, ‘Novartis ties up with USV
increased use of generics for growth' 16
to market Galvus in India' The Economic
Times, 27th Nov, 2008
23. PwC analysis, Moneycontrol website
10. Khomba Singh, ‘Modi Mundipharma in
JV with Belgian co', Economic Times,
24. C.H. Unnikrishnan, "Pharma salaries up
12% as India turns into top priority", 21
11. TNN, ‘US pharma major Mylan buys
Matrix Labs', The Economic Times, 29
25. C. H. Unnikrishnan, Rediff business,
"High attrition plagues Indian pharma
sector", August 2006
12. Mohit Bhalla and Khomba Singh, ‘US-
based Hospira to buy Orchid Chemicals'
injectables biz for $400 mn', The
Economic Times, 16 December, 2009
28. PwC report: India Pharma Inc.:
13. ET Bureau, ‘Sanofi-Aventis buys Shantha
Capitalising on India's Growth Potential
for Rs.3,740 cr', The Economic Times, 28
29. Eric Langer & Abhijeet Kelkar,
‘Pharmaceutical Distribution in India',
14. Glenmark Press release: ‘Sanofi-Aventis
India Today (BioPlan Associates),
and Glenmark Pharmaceuticals Sign
License Agreement', 3 May, 2011
30. Sapna Dogra, ‘Revamping the
15. Jubilant Biosys Ltd Press release:
distribution network', Express Pharma,
‘Jubilant and Endo Pharmaceuticals
announce Late Stage Discovery Milestone
in Oncology Program' 20 June, 2011
30 PwC - CII
We would like to express our gratitude for the input and help
we received from the following experts who so generously
donated their time towards the survey conducted for the report:• S Kalyanasundaram – Chief Executive Officer, Sun Pharma
Industries Ltd.
• K V Subramaniam - President & Chief Executive Officer, Reliance
• Prashant K Tewari - Managing Director - USV Ltd
• Ranjit Shahani - Country President, Novartis India Ltd.
• Satish Khanna - Chairman, Fullife Healthcare Pvt.Ltd.
• Vivek Mohan - Managing Director, Abbott India Ltd.
We also take this opportunity to thank all the following team members from
PwC for their contributions to this report:• Arun S Saripalli - Sr. Manager, Tax• Darshan Patel - Associate Director, FAS• Deeksha Vatsa - Associate Director, FAS• Krishnakumar Sankaranarayanan - Managing Consultant, Consulting• Nikhil Patil - Principal Consultant, Consulting• Nisha Vishwakarma - Manager, India Pharmaceuticals & Life Sciences • Madhur Rathaur - Director, PwC PRTM• Prahalad Chadrasekharan - Managing Consultant, Consulting• Suneel Aiyar - Associate Director, Consulting• Shubhra Jain - Manager - FAS• Vinita Vasanth - Experience Associate, PwC PRTM• Malvika Singh - Brand and Communication
The views expressed herein are personal and do not reflect the views of
the organisations represented by the individuals concerned.
31
The Confederation of Indian Industry (CII) works to create
and sustain an environment conducive to the growth of
industry in India, partnering industry and government alike
through advisory and consultative processes.
Charu Mathur
CII is a non-government, not-for-profit, industry led and
Regional Director
industry managed organisation, playing a proactive role
Confederation of Indian Industry (WR)
in India's development process. Founded over 116 years
105, Kakad Chambers
ago, it is India's premier business association, with a direct
132, Dr A B Road, Worli,
membership of over 8100 organisations from the private as
well as public sectors, including SMEs and MNCs, and an
Phone: +91 22 24931790
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400 national and regional sectoral associations.
Fax: +91 22 24945831 / 24939463
CII catalyses change by working closely with government
on policy issues, enhancing efficiency, competitiveness and
expanding business opportunities for industry through a
Dev Ranjan Mukherjee
range of specialised services and global linkages. It also
Head - CII Gujarat State and Head -
provides a platform for sectoral consensus building and
networking. Major emphasis is laid on projecting a positive
Confederation of Indian Industry
image of business, assisting industry to identify and execute
Western Region - Gujarat State Office
corporate citizenship programmes. Partnerships with over
120 NGOs across the country carry forward our initiatives
in integrated and inclusive development, which include
Gulbai Tekra Road
health, education, livelihood, diversity management, skill
development and water, to name a few.
Ahmedabad – 380 006
Tel: 079 40279900 - 10
CII has taken up the agenda of "Business for Livelihood" for
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Fax: 079 40279999
of spreading growth to disadvantaged sections of society,
building skills for meeting emerging economic compulsions,
and fostering a climate of good governance. In line with this,
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and 7 overseas offices in Australia, China, France, Singapore,
South Africa, UK, and USA, as well as institutional
partnerships with 224 counterpart organisations in 90
countries, CII serves as a reference point for Indian industry
and the international business community.
33
34 PwC - CII
PwC firms help organisations and individuals create
the value they're looking for. We're a network of firms
in 158 countries with close to 169,000 people who are
committed to delivering quality in assurance, tax and
advisory services. Tell us what matters to you and find
Sujay Shetty
out more by visiting us at www.pwc.com.
Executive Director,
In India, PwC (www.pwc.com/India) offers a
India Pharmaceutical & Life
comprehensive portfolio of Advisory and Tax &
Sciences Leader - PwC (India)
Regulatory services; each, in turn, presents a basket
of finely defined deliverables. Network firms of PwC
Phone: +91 22 6669 1305
in India also provide services in Assurance as per the
relevant rules and regulations in India.
Providing organisations with the advice they need,
Manager, India Pharmaceutical &
wherever they may be located, our highly qualified,
Life Sciences - PwC (India)
experienced professionals, who have sound knowledge
of the Indian business environment, listen to different
points of view to help organisations solve their business
issues and identify and maximise the opportunities
Phone: +91 22 6669 1100
they seek. Our industry specialisation allows us to help
co-create solutions with our clients for their sector of
interest. We are located in these cities: Ahmedabad, Bangalore,
Bhubaneshwar, Chennai, Delhi NCR, Hyderabad,
Kolkata, Mumbai and Pune.
35
This publication does not constitute professional advice. The information in this publication has been obtained or derived from sources believed by PricewaterhouseCoopers Private Limited (PwCPL) to be reliable but PwCPL does not represent that this information is accurate or complete. Any opinions or estimates contained in this publication represent the judgment of PwCPL at this time and are subject to change without notice. Readers of this publication are advised to seek their own professional advice before taking any course of action or decision, for which they are entirely responsible, based on the contents of this publication. PwCPL neither accepts or assumes any responsibility or liability to any reader of this publication in respect of the information contained within it or for any decisions readers may take or decide not to or fail to take.
2011 PricewaterhouseCoopers Private Limited. All rights reserved. In this document, "PwC" refers to PricewaterhouseCoopers Private Limited (a limited liability company in India), which is a member firm of PricewaterhouseCoopers International Limited (PwCIL), each member firm of which is a separate legal entity.
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Source: https://www.pwc.in/assets/pdfs/pharma/pwc-cii-pharma-summit-2011-v2.pdf
NORMA Oficial Mexicana NOM-030-SSA2-1999, Para la prevención, tratamiento y control de la hipertensión arterial. Al margen un sello con el Escudo Nacional, que dice: Estados Unidos Mexicanos.- Secretaría de Salud. NORMA OFICIAL MEXICANA NOM-030-SSA2-1999, PARA LA PREVENCION, TRATAMIENTO Y CONTROL DE LA HIPERTENSION ARTERIAL. ROBERTO TAPIA CONYER, Presidente del Comité Consultivo Nacional de Normalización de Prevención y Control de Enfermedades, con fundamento en los artículos 39 de la Ley Orgánica de la Administración Pública Federal; 3o., fracciones II y XVI, 13 apartado A), fracción I, 133, fracción I, 158 y demás relativos de la Ley General de Salud; 38, fracción II, 40, fracciones III y XI, 41 y 47, fracción IV de la Ley Federal sobre Metrología y Normalización; 28 y 34 del Reglamento de la Ley Federal sobre Metrología y Normalización; 7, fracciones V y XIX, y 38, fracción VI, del Reglamento Interior de la Secretaría de Salud, me permito ordenar la publicación en el Diario Oficial de la Federación la Norma Oficial Mexicana PROY-NOM-030-SSA2-1999, Para la prevención, tratamiento y control de la hipertensión arterial, y
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