Pharmaceuticals in India

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The Indian pharmaceutical industry is the world's second-largest by volume and is likely to
lead the manufacturing sector of India.[1] India's bio-tech industry clocked a 17 percent growth
with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous
fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at
Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936 crore.[2] The
first pharmaceutical company are 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 is 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.

Contents
[hide]
• 1 The Indian pharmaceutical industry (IPo) today
○ 1.1 Statistics
○ 1.2 Patents
○ 1.3 Product development
○ 1.4 Small and medium enterprises
○ 1.5 Challenges
○ 1.6 R&D
○ 1.7 Labor force
 • 2 Biotechnology
○ 2.1 Relationship between pharmaceuticals and biotechnology
○ 2.2 Biotechnology statistics
○ 2.3 Comparison with the U.S.
○ 2.4 Relationship with IT
○ 2.5 Government support
○ 2.6 Foreign investment
○ 2.7 Challenges
• 3 Major players
• 4 See also
• 5 References
• 6 Reference

[edit] The Indian pharmaceutical industry (IPo) today

[edit] Statistics
Top 10 Pharmaceuticals in India, as of 2004[update]
Rank Company Revenue 2004 Revenue 2004
(Rs crore) (USD millions)
1 Ranbaxy Laboratories 4,461 1,026
2 Dr. Reddy's Laboratories 1,933 444
3 Cipla 1,842 423
4 Piramal Healthcare 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
11 Taj Pharmaceuticals 790 210
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].
[edit] 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 [3]. 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].
[edit] 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.
[edit] Small and medium enterprises
As promising as the future is for 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.
[edit] 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 differentials, 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].
[edit] 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.
[edit] Labor force
India’s greatest strengths lie in its people [see http://en.wikipedia.org/wiki/India]. India also
boasts a cheap, well-educated, English-speaking [only a percentage, see
http://en.wikipedia.org/wiki/Official_languages_of_India] 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 them[13,25]. 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.
[edit] Biotechnology
[edit] 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 sales[46]. 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.
[edit] Biotechnology statistics
Top 20 Biotechnology Companies in India, 2004
Rank Company Revenue 2004 Revenue 2004
(Rs crore) (USD millions)
1 Biocon 646 148.6
2 Serum Institute of India 565 129.9
3 Panacea Biotec 217 50.0
4 Venkateshwara Hatcheries 188 43.2
5 Mahyco Monsanto 166 38.3
6 Novo Nordisk 135 31.0
7 Rasi Seeds 87 20.0
8 Aventis Pharma 84 19.4
9 Bharat Serums 81 18.6
10 Chiron Behring Vaccines 78 17.9
11 GlaxoSmithKline 78 17.9
12 Indian Immunologicals 72 16.6
13 Shantha Biotechnics 70 16.1
14 Novozymes 69 15.9
15 Eli Lilly and Company 68 15.7
16 Wockhardt 67 15.4
17 Bharat Immunological & Biological Corp. 53 12.3
18 Bharat Biological International 41 9.4
19 Advanced Biochemicals 40 9.1
20 Biological E 36 8.3
USD 1 = Rs 43.5
Source: BioSpectrum Top 20: A threshold crossed
Most companies in the biotech sector are extremely small, with only two firms breaking 100
million dollars 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]
[edit] 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.
[edit] 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]
[edit] Government support
The Indian government has been very supportive. It established the Department of
Biotechnology in 1986 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 utilities[19].
[edit] 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]
[edit] 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 on 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]
[edit] Major players
This section is written like an advertisement. Please help rewrite this section from a
neutral point of view. (August 2010)
Ranbaxy Laboratories
Sri S T Kalairaj, 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 ciprofloxacin, 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
Asish Mishra, 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 challenge 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
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[4]
Dr. Cyrus Poonawalla, Chairman
The Serum Institute of India can make the enviable claim that 2 out of every 3 children in the
world are 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
Nectar Lifesciences[5]
Mr. Sanjiv Goyal, Chairman
Macleods Pharma[6]
Dr. Rajendra Agarwal, Managing Director
Intas Biopharmaceuticals
Dr. Urmish Chudgar, Managing Director
Bharat Serums[7]
Mr. Bharat V. Daftary, Chairman and Managing Director
Lupin Laboratories
Dr. Desh Bandhu Gupta, Chairman
Orchid Pharmaceuticals
Mr. R. Narayanan, Chairman
Panacea Biotech[8]
Mr. Soshil Kumar Jain, Chairman
Sun Pharmaceuticals
Dilip S. Sanghvi, Chairman and Managing Director
Torrent Pharmaceuticals
Sudir Mehta, Chairman
Wockhardt
Habil F. Khorakiwala, Chairman
Cadila Healthcare
Pankaj R. Patel, Chairman and Managing Director
Hetero Drugs
Dr. B. Partha Saradhi Reddy, Chairman and Managing Director
K. A. Malle Pharmaceuticals Ltd
AMN Pharmaceuticals[9]
Amndip, Chairman and Managing Director
 Ajanta Pharma[10]
Yogesh Agrawal, Managing Director
Green Apple Lifesciences Limited[11]
Mitesh Mehta, Chairman
Relaince Life Sciences Pvt Ltd[12]
Mr. K.V. V. Subramaniam, President and CEO
[edit] See also
• Medicine in China
• Pharmaceutical industry in China
• Pharmacology
• Biotechnology
• Pharmaceutical marketing
• Pharmaceutical industry
• National pharmaceuticals policy
• Opium and Alkaloid Works
[edit] References
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41 Singh, Karamjit. “Net value: Tapping biotech know-how.” The Edge Malaysia 16 May 2005.
42 Singh, Seema. “India kicks the habit; local drugmakers have built a thriving industry on
pilfering patents. The party ends in January.” Newsweek International (22 November. 2004): 56.
43 Sridharan, R. et al. “Indian pharma’s mid-life crisis.” Business Today 27 February. 2005: 50.
44 Tanzer, Andrew. “Pill factory to the world.” Forbes (internet) 10 December 2001. 29 July
2005.
45 Unnikrishnan, C H. “Patents carve up drug market.” Business Standard 29 July 2005.
46 “Vaccines push BioPharma sales.” BioSpectrum 3:6 (June 2005): 70-71.
47 Wilkie, Dana. “India wants to be your biotech source.” The Scientist 25 October 2004: 51-53.
48 Zinnov, "Pharmaceutical Outsourcing in India"
<http://www.zinnov.com/presentation/Pharmaceutical_Outsourcing_Overview.pdf>.
49 “Taj Pharmaceuticals.” India (Nov 2004):
[edit] Reference
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Retrieved from "http://en.wikipedia.org/wiki/Pharmaceuticals_in_India"
Categories: Biotechnology | Clinical research | Healthcare in India | Pharmaceuticals policy |
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