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Brief history
The first Indian pharmaceutical
company, Bengal Chemicals and
Pharmaceutical Works, which still
exists today as one of 5
government-owned drug
manufacturers, appeared in
Calcutta in 1930. For the next 60
years, most of the drugs in India
were imported by multinationals
either in fully-formulated or bulk
form. The government started to
encourage the growth of drug
manufacturing by Indian companies
in the early 1960s, and with the
Patents Act in 1970, enabled the
industry to become what it its
today. This patent act removed
composition patents from food and
drugs, and though it kept process
patents, these were shortened to a
period of five to seven years. The
lack of patent protection made the
Indian market undesirable to the
multinational companies that had
dominated the market, and while
they streamed out, Indian
companies started to take their
places. They carved a niche in
both the Indian and world markets
with their expertise in
reverse-engineering new processes
for manufacturing drugs at low
costs. Although some of the larger
companies have taken baby steps
towards drug innovation, the
industry as a whole has been
following this business model
until the present.
The Indian pharmaceutical
industry (IPI) today
Statistics
Top 10
Pharmaceuticals in India, 2004
| Rank |
Company |
Revenue 2004
(Rs crore) |
Revenue 2004
(USD millions) |
| 1 |
Ranbaxy Laboratories |
4,461 |
1,026 |
| 2 |
Dr. Reddy's Laboratories |
1,933 |
444 |
| 3 |
Cipla |
1,842 |
423 |
| 4 |
Nicolas Piramal India |
1,387 |
319 |
| 5 |
Aurobindo Pharma |
1,260 |
290 |
| 6 |
GlaxoSmithKline |
1,228 |
282 |
| 7 |
Lupin Laboratories |
1,180 |
271 |
| 8 |
Sun Pharmaceutical Industries |
1,110 |
255 |
| 9 |
Cadila Healthcare |
1,091 |
251 |
| 10 |
Wockhardt |
980 |
225 |
USD 1 = Rs
43.5
Source:
Pharmaceutical Sales Busters,
India Business Insight,
31-Dec-04 |
In 2002, over 20,000 registered
drug manufacturers in India sold
$9 billion worth of formulations
and bulk drugs. 85% of these
formulations were sold in India
while over 60% of the bulk drugs
were exported, mostly to the
United States and Russia[25]. Most
of the players in the market are
small-to-medium enterprises; 250
of the largest companies control
70% of the Indian market[1].
Thanks to the 1970 Patent Act,
multinationals represent only 35%
of the market, down from 70%
thirty years ago[20].
Most pharma companies operating
in India, even the multinationals,
employ Indians almost exclusively
from the lowest ranks to high
level management. Mirroring the
social structure, firms are very
hierarchical. Homegrown
pharmaceuticals, like many other
businesses in India, are often a
mix of public and private
enterprise. Although many of these
companies are publicly owned,
leadership passes from father to
son and the founding family holds
a majority share.
In terms of the global market,
India currently holds a modest
1-2% share, but it has been
growing at approximately 10% per
year[27]. India gained its
foothold on the global scene with
its innovatively-engineered
generic drugs and active
pharmaceutical ingredients (API),
and it is now seeking to become a
major player in outsourced
clinical research as well as
contract manufacturing and
research. There are 74 U.S.
FDA-approved manufacturing
facilities in India, more than in
any other country outside the U.S,
and in 2005, almost 20% of all
Abbreviated New Drug Applications
(ANDA) to the FDA are expected to
be filed by Indian
companies[21,27]. Growth in other
fields notwithstanding, generics
are still a large part of the
picture. London research company
Global Insight estimates that
India’s share of the global
generics market will have risen
from 4% to 33% by 2007[27].
Patents
As it expands its core
business, the industry is being
forced to adapt its business model
to recent changes in the operating
environment. The first and most
significant change was the January
1, 2005 enactment of an amendment
to India’s patent law that
reinstated product patents for the
first time since 1972. The
legislation took effect on the
deadline set by the WTO’s
Trade-Related Aspects of
Intellectual Property Rights
(TRIPS) agreement, which mandated
patent protection on both products
and processes for a period of 20
years. Under this new law, India
will be forced to recognize not
only new patents but also any
patents filed after
January 1,
1995[2].
Indian companies achieved their
status in the domestic market by
breaking these product patents,
and it is estimated that within
the next few years, they will lose
$650 million of the local generics
market to rightful
patent-holders[42].
In the domestic market, this
new patent legislation has
resulted in fairly clear
segmentation. The multinationals
narrowed their focus onto high-end
patients who make up only 12% of
the market, taking advantage of
their newly-bestowed patent
protection. Meanwhile, Indian
firms have chosen to take their
existing product portfolios and
target semi-urban and rural
populations[45].
The new patent regime happens
to have taken effect at a time
when Indian companies had recently
started to aggressively pursue
global opportunities, so it is not
clear whether the flurry of
international activity surrounding
the enactment date is a result of
the change in legislation.
Mergers, acquisitions and
alliances have been taking place
on an unprecedented scale, most
notably with companies in the U.S.
and Europe. As stated in The Hindu
Business Line, “In the last 10-odd
months, the Indian pharma industry
has possibly seen the single
largest number of global
transactions in its 50-year
history.” These transactions
provide Indian companies with
access to foreign markets and
facilitate the process of seeking
regulatory approval for new
products, which can be quite
daunting for a company that only
has operations on Indian soil.[10]
Product development
Companies are also starting to
adapt their product development
processes to the new environment.
For years, firms have made their
ways into the global market by
researching generic competitors to
patented drugs and following up
with litigation to challenge the
patent. This approach remains
untouched by the new patent regime
and looks to increase in the
future. However, those that can
afford it have set their sights on
an even higher goal: new molecule
discovery. Although the initial
investment is huge, companies are
lured by the promise of hefty
profit margins and the recognition
as a legitimate competitor in the
global industry. Local firms have
slowly been investing more money
into their R&D programs or have
formed alliances to tap into these
opportunities.
Small and medium enterprises
As promising as the future is
for Indian pharma as a whole, the
outlook for small and medium
enterprises (SME) is not as
bright. The excise structure
changed so that companies now have
to pay a 16% tax on the maximum
retail price (MRP) of their
products, as opposed to on the
ex-factory price. Consequently,
larger companies are cutting back
on outsourcing and what business
is left is shifting to companies
with facilities in the four
tax-free states - Himachal
Pradesh, Jammu & Kashmir,
Uttaranchal and Jharkhand.[12]
As SMEs wrestled with the tax
structure, they were also
scrambling to meet the
July 1 deadline for compliance
with the revised Schedule M Good
Manufacturing Practices (GMP).
While this should be beneficial to
consumers and the industry at
large, SMEs have been finding it
difficult to find the funds to
upgrade their manufacturing
plants, resulting in the closure
of many facilities. Others
invested the money to bring their
facilities to compliance, but
these operations were located in
non-tax-free states, making it
difficult to compete in the wake
of the new excise tax.
Challenges
All of these changes are
ultimately good for the Indian
pharmaceutical industry, which
suffered in the past from
inadequate regulation and large
quantities of spurious drugs. They
force the industry to reach a
level necessary for global
competitiveness. However, they
have also exposed some of the
inadequacies in the industry
today. Its main weakness is an
underdeveloped new molecule
discovery program. Even after the
increased investment, market
leaders such as Ranbaxy and Dr.
Reddy’s Laboratories spent only
5-10% of their revenues on R&D,
lagging behind Western
pharmaceuticals like Pfizer, whose
research budget last year was
greater than the combined revenues
of the entire Indian
pharmaceutical industry[13, 37].
This disparity is too great to be
explained by cost diffentials, and
it comes when advances in genomics
have made research equipment more
expensive than ever. The drug
discovery process is further
hindered by a dearth of qualified
molecular biologists. Due to the
disconnect between curriculum and
industry, pharmas in India also
lack the academic collaboration
that is crucial to drug
development in the West[13].
R&D
Both the Indian central and
state governments have recognized
R&D as an important driver in the
growth of their pharma businesses
and conferred tax deductions for
expenses related to research and
development. They have granted
other concessions as well, such as
reduced interest rates for export
financing and a cut in the number
of drugs under price control.
Government support is not the only
thing in Indian pharma’s favor,
though; companies also have access
to a highly-developed IT industry
that can partner with them in new
molecule discovery.
Labor force
India’s greatest strengths lie
in its people. India also boasts a
cheap, well-educated,
English-speaking labor force that
is the base of its competitive
advantage. Although molecular
biologists are in short supply,
there are a number of talented
chemists who are equally as
important in the discovery
process. In addition, there has
been a reverse brain-drain effect
in which scientists are returning
from abroad to accept positions at
lower salaries at Indian
companies. Once there, these
foreign-trained scientists can
transfer the benefits of their
knowledge and experience to all of
those who work with them13,25.
India’s wealth of people extends
benefits to another part of the
drug commercialization process as
well. With one of the largest and
most genetically diverse
populations in any single country,
India can recruit for clinical
trials more quickly and perform
them more cheaply than countries
in the West[47]. Indian firms have
just recently started to leverage
Biotechnology
Relationship between
pharmaceuticals and biotechnology
Unlike in other countries, the
divide between biotechnology and
pharmaceuticals remains fairly
defined in India. Biotech there
still plays the role of pharma’s
little sister, but many outsiders
have high expectations for the
future. India accounted for 2% of
the $41 billion global biotech
market and in 2003 was ranked 3rd
in the Asia-Pacific region and
11th in the world in number of
biotechs.[45] In 2004-5, the
Indian biotech industry saw its
revenues grow 37% to $1.1
billion.[2,9] The Indian biotech
market is dominated by
biopharmaceuticals; 75% of 2004-5
revenues came from
biopharmaceuticals, which saw 30%
growth last year. Of the revenues
from biopharmaceuticals, vaccines
led the way, comprising 47% of
sales46. Biologics and
large-molecule drugs tend to be
more expensive than small-molecule
drugs, and India hopes to sweep
the market in biogenerics and
contract manufacturing as drugs go
off patent and Indian companies
upgrade their manufacturing
capabilities.
Biotechnology statistics
Most companies in the biotech
sector are extremely small, with
only two firms breaking $100
million in revenues. At last count
there were 265 firms registered in
India, over 75% of which were
incorporated in the last five
years.[2,47] The newness of the
companies explains the industry’s
high consolidation in both
physical and financial terms.
Almost 50% of all biotechs are in
or around Bangalore, and the top
ten companies capture 47% of the
market. The top five companies
were homegrown; Indian firms
account for 62% of the biopharma
sector and 52% of the industry as
a whole.[4,46] The Association of
Biotechnology-Led Enterprises
(ABLE) is aiming to grow the
industry to $5 billion in revenues
generated by 1 million employees
by 2009, and data from the
Confederation of Indian Industry (CII)
seem to suggest that it is
possible.[7,47]
Comparison with the U.S.
The Indian biotech sector
parallels that of the U.S. in many
ways. Both are filled with small
start-ups while the majority of
the market is controlled by a few
powerful companies. Both are
dependent upon government grants
and venture capitalists for
funding because neither will be
commercially viable for years.
Pharmaceutical companies in both
countries have recognized the
potential effect that
biotechnology could have on their
pipelines and have responded by
either investing in existing
start-ups or venturing into the
field themselves.[36] In both
India and the U.S., as well as in
much of the globe, biotech is seen
as a hot field with a lot of
growth potential.
Relationship with IT
Many analysts have observed
that the hype around the biotech
sector mirrors that of the IT
sector. Biotech colleges have been
popping up around the country
eager to service the pools of
students that want to take
advantage of a growing
industry.[7] The International
Finance Commission, the private
investment arm of the World Bank,
called India the “centerpiece of
IFC’s global biotech strategy.” Of
the $110 million invested in 14
biotech projects investment
globally, the IFC has given $43
million to 4 projects in
India.[29] According to Dr. Manju
Sharma, former director of the
Department of Biotechnology, the
biotech industry could become the
“single largest sector for
employment of skilled human
resource in the years to come.”[5]
British Prime Minister Tony Blair
was similarly impressed, citing
the success of India’s biotech
industry as the reason for his own
country’s own biotech
opportunities.[22] Malaysia is
also looking to India as an
example for growing its own
biotech industry.[41]
Government support
The Indian government has been
very supportive. It established
the Department of Biotechnology in
2001 under the Ministry of Science
and Technology.[47] Since then,
there have been a number of
dispensations offered by both the
central government and various
states to encourage the growth of
the industry. India’s science
minister launched a program that
provides tax incentives and grants
for biotech start-ups and firms
seeking to expand and establishes
the Biotechnology Parks Society of
India to support ten biotech parks
by 2010. Previously limited to
rodents, animal testing was
expanded to include large animals
as part of the minister’s
initiative.[10] States have
started to vie with one another
for biotech business, and they are
offering such goodies as exemption
from VAT and other fees, financial
assistance with patents and
subsidies on everything ranging
from investment to land to
utilities19.
Foreign investment
The government has also taken
steps to encourage foreign
investment in its biotech sector.
An initiative passed earlier this
year allowed 100% foreign direct
investment without compulsory
licensing from the government1.[6]
In April, a delegation headed by
the Kapil Sibal, the minister of
science and technology and ocean
development, visited five cities
in the U.S. to encourage
investment in India, with special
emphasis on biotech.[32] Just two
months later, Sibal returned to
the U.S. to unveil India’s biotech
growth strategy at the BIO2005
conference in Philadelphia.[9]
Challenges
The biotech sector faces some
major challenges in its quest for
growth. Chief among them is a lack
of funding, particularly for firms
that are just starting out. The
most likely sources of funds are
government grants and venture
capital, which is a relatively
young industry in India.
Government grants are difficult to
secure, and due to the expensive
and uncertain nature of biotech
research, venture capitalists are
reluctant to invest in firms that
have not yet developed a
commercially viable product.[26]
As previously mentioned, India
hopes to solve its funding problem
by attracting overseas investors
and partners. Before these
potential saviors will invest
significant sums in the industry,
however, there needs to be better
scientific and financial
accountability. India is slowly
working towards these goals, but
it will be a while before they are
up to the standards of Western
investors.
India’s biotech firms share
another problem with their
pharmaceutical cousins: a lack of
qualified employees. Biotech has
the additional disadvantage of
competing against IT for
ambitious, science-minded students
but not being able to guarantee
the same compensation. An aspiring
researcher in India needs 7-10
years of education covering a
range of specialties in order to
qualify to work in biotech. Even
if a student does choose to go on
the biotech path, the ineffectual
curriculum at many universities
makes it doubtful as to whether he
will be qualified to work in the
field once finished. One estimate
shows that 10% of upper-echelon
biotech recruits have come from
foreign countries. While this is
not a problem, per se, it drives
up cost in a country whose
competitive advantage is based off
of cheap, high-quality labor. Far
from ending with scientists, there
is also a shortage of people with
a knowledge of biotechnology in
related fields: doctors, lawyers,
programmers, marketing personnel
and others.[7,15,17]
While little has been done
about the latter half of the
employee crunch, the government
has addressed the problem of
educated but unqualified
candidates in its Draft National
Biotech Development Strategy. This
plan included a proposal to create
a National Task Force that would
work with the biotech industry to
revise the curriculum for
undergraduate and graduate study
in life sciences and
biotechnology. The government’s
strategy also stated intentions to
increase the number of PhD
Fellowships awarded by the
Department of Biotechnology to 200
per year. These human resources
will be further leveraged with a
“Bio-Edu-Grid” that will knit
together the resources of the
academic and scientific industrial
communities, much as they are in
the U.S.[5]
Major players
-
Ranbaxy Laboratories Ltd.
- Tejendra Khanna, Chairman
Ranbaxy is the leader in the
Indian pharmaceutical market,
taking in $1.174 billion in
revenues for a net profit of $160
million in 2004. It was the first
Indian pharmaceutical to have a
proprietary drug (extended-release
ciproflaxin, marketed by Bayer)
approved by the U.S. FDA, and the
U.S. market accounts for 36% of
its sales. 78% of Ranbaxy’s sales
are from overseas markets; its
offices in 44 countries manage
manufacturing in 7 countries and
distribution in over 100.
IMS Health estimated that
Ranbaxy is among the top 100
pharmaceuticals in the world and
that it is the 15th fastest
growing company. By 2012, Ranbaxy
hopes to be one of the top 5
generics producers in the world,
and it consolidated its position
with the purchase of French firm
RGP Aventis in 2003. Ranbaxy also
has higher aspirations, however,
“to build a proprietary
prescription business in the
advanced markets.” To this end, it
keeps a dedicated research
facility in Gurgaon staffed with
over 1100 scientists. They
currently have two molecules in
Phase II trials and 3-5 in
pre-clinical testing. It spent $75
million in R&D in 2004, a 43%
increase over its 2003
expenditure.
CEO Brian Tempest is the only
non-Indian on the senior
management team.38,39
-
Dr. Reddy’s Laboratories
- K. Anji Reddy, Chairman
Founded in 1984 with $160,000,
Dr. Reddy’s was the first
Asia-Pacific pharmaceutical
outside of Japan and the sixth
Indian company to be listed on the
New York Stock Exchange. It earned
$446 million in fiscal year 2005,
deriving 66% of this income from
the foreign market. In order to
strengthen its global position,
Dr. Reddy acquired UK-based BMS
Laboratories and subsidiary
Meridian Healthcare.
Although 58% of Dr. Reddy’s
revenues come from generic drugs,
the company was committed to
WTO-compliance long before the
2005 bill took effect, and most of
these products were already off
patent. Dr. Reddy has long been a
research-oriented firm, preceding
many of its peers in setting up a
New Drug Development Research
(NDDR) in 1993 and out-licensing
its first compound just four years
later. Dr. Reddy’s has since
outlicensed two more molecules and
currently has three others in
clinical trials.
Although Dr. Reddy’s is
publicly-traded, the Reddy family
(including founder/chairman K.
Anji Reddy, son-in-law/CEO GV
Prasad and son/COO Satish Reddy)
holds a hefty 26% share in the
company.11,44
-
Nicholas Piramal
- Ajay G. Piramal, Chairman
Now a company grossing $350
million per year, Nicholas Piramal
started its existence with the
1988 acquisition of Nicholas
Laboratories and grew through a
series of mergers, acquisitions
and alliances. The company has
formed a name for itself in the
field of custom manufacturing. It
cites its 1700-person global sales
force as another core strength;
with its acquisition of Rhodia’s
inhalation anaesthetics business,
Nicholas Piramal gained a sales
and marketing network spanning 90
countries34.
Nicholas Piramal is well-poised
for the challege of surviving in
the aftermath of product patent
protection. The company has
respected intellectual property
rights since its inception and
refused to “support generic
companies seeking first-to-file or
early-to-market strategies.”
Instead, it decided to make its
own intellectual property and
opened a research facility last
November in Mumbai with hopes of
launching its first drug in 2010
at a cost of $100,000.24,33
-
Cipla
- Dr. Yusuf K. Hamied,
Chairman and Managing Director
Cipla burst into the
international consciousness in
2000 with Triomune, an AIDS
treatment costing between $300 and
$800 per year that infringed upon
patents held by several companies
who were selling the cocktail for
$12,000 per year. Long before this
news, Cipla had been building a
strong global presence, and it now
distributes its 800-odd products
in over 140 countries.
Privately-held Cipla holds a
prominent spot in its home country
as well; it is the leader in
domestic sales, having just
unseated GlaxoSmithKline for the
first time in 28 years. Revenue in
2004 totaled $552 million (using
Rs 43.472 = $1) about 75% of which
was derived in India. Cipla did
not report having a research
program.8,18
-
Biocon
- Dr. Kiran Mazumdar-Shaw,
Chairman and Managing Director
Biocon is probably best known
for its founder, Kiran
Mazumdar-Shaw, who overcame
incredible gender-based
discrimination to become the
richest woman in India. Originally
an extension to an Irish chemicals
company seeking to break into the
Indian market, Biocon is now the
leading biotech in India, bringing
in Rs 646.36 crore (almost $150
million) in revenue for fiscal
year 2004. It initially made its
money by producing enzymes, but
Biocon recently decided to become
a research-oriented company with
the goal of bringing a proprietary
new drug to market.
The company went public in
March 2004, and “its shares were
oversubscribed by 33 times on
opening day.” Eight months later
it launched Insugen, a bio-insulin
that is its first branded product.
Biocon also has two wholly-owned
subsidiaries, Syngene and
Clinigene, that perform custom
research and clinical
trials.3,14,31
-
Serum Institute of India
- Dr. Cyrus Poonawalla,
Chairman
The Serum Institute of India
can make the enviable claim that 1
out of every 2 children in the
world is immunized with one of
their vaccines. It is the world’s
largest producer of measles and
DTP vaccines, and its portfolio
includes other vaccines, antisera,
plasma products and anticancer
compounds. The Serum Institute
earned Rs 565 crore ($130 million)
in revenue in fiscal year 2005,
selling mainly to UN agencies and
to the Indian government. The
Serum Institute is part of the
Poonawalla Group, whose holdings
include a horse stud farm and
manufacturers of industrial
equipment and components.1,4,40
Other important domestic
companies
-
Bharat Serums
- Mr. Bharat V. Daftary,
Chairman and Managing Director
-
Lupin Labs
- Dr. Desh Bandhu Gupta,
Chairman
-
Orchid Pharma
- Mr. R. Narayanan, Chairman
-
Panacea Biotech
- Mr. Soshil Kumar Jain,
Chairman
-
Sun Pharma
- Dilip S. Shangvi, Chairman
and Managing Director
-
Torrent Pharma
- Sudir Mehta, Chairman
-
Wockhardt, Ltd.
- Habil F. Khorakiwala,
Chairman
-
Zydus Cadila Healthcare Ltd
- Pankaj R. Patel, Chairman
and Managing Director
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2005.
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2005.
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