Pharmaceuticals in India - Wikipedia, the free encyclopedia http://en.wikipedia.

org/wiki/Pharmaceuticals_in_India

From Wikipedia, the free encyclopedia

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 (http://www.ircc.iitb.ac.in/IPcourse/patent.html)
, 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.

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

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Statistics

In 2002, over 20,000 registered drug

manufacturers in India sold $9 billion Top 10 Pharmaceuticals in India, as of 2009
worth of formulations and bulk drugs. Revenue 2009 Revenue 2009
Rank Company
85% of these formulations were sold (Rs crore) (USD millions)
in India while over 60% of the bulk 1 Cipla 6,700 1,423
drugs were exported, mostly to the
United States and Russia[25]. Most of 2 Ranbaxy Laboratories 4,461 1,026
the players in the market are small- 3 Dr. Reddy's Laboratories 1,933 444
to-medium enterprises; 250 of the 4 Piramal Healthcare 1,387 319
largest companies control 70% of the
Indian market [1] 5 Aurobindo Pharma 1,260 290
(http://www.pharmaceutical- 6 GlaxoSmithKline 1,228 282
drug-manufacturers.com/) . Thanks to
7 Lupin Ltd 1,180 271
the 1970 Patent Act, multinationals
represent only 35% of the market, 8 Sun Pharmaceutical Industries 1,110 255
down from 70% thirty years ago[20]. 9 Cadila Healthcare 1,091 251

Most pharma companies operating in 10 Wockhardt 980 225

India, even the multinationals, USD 1 = Rs 46.5
employ Indians almost exclusively Source: Pharmaceutical Sales Busters, India Business Insight, 31-Dec-09
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.[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 patent-
holders[42].

In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals

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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].

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 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 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].

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;

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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 [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.

Relationship between pharmaceuticals and biotechnology

Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in
India. Bio-tech 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.

Biotechnology statistics

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Most companies in the

biotech sector are Top 20 Biotechnology Companies in India, 2004
extremely small, with Revenue 2004 Revenue 2004
Rank Company
only two firms breaking (Rs crore) (USD millions)
100 million dollars in 1 Biocon 646 148.6
revenues. At last count
there were 265 firms 2 Serum Institute of India 565 129.9
registered in India, over 3 Panacea Biotec 217 50.0
75% of which were 4 Venkateshwara Hatcheries 188 43.2
incorporated in the last
five years.[2,47] The 5 Mahyco Monsanto 166 38.3
newness of the companies 6 Novo Nordisk 135 31.0
explains the industry’s
7 Rasi Seeds 87 20.0
high consolidation in both
physical and financial 8 Aventis Pharma 84 19.4
terms. Almost 50% of all 9 Bharat Serums 81 18.6
biotechs are in or around
10 Chiron Behring Vaccines 78 17.9
Bangalore, and the top
ten companies capture 11 GlaxoSmithKline 78 17.9
47% of the market. The 12 Indian Immunologicals 72 16.6
top five companies were
homegrown; Indian firms 13 Shantha Biotechnics 70 16.1
account for 62% of the 14 Novozymes 69 15.9
biopharma sector and 15 Eli Lilly and Company 68 15.7
52% of the industry as a
whole.[4,46] The 16 Wockhardt 67 15.4
Association of 17 Bharat Immunological & Biological Corp. 53 12.3
Biotechnology-Led 18 Bharat Biological International 41 9.4
Enterprises (ABLE) is
aiming to grow the 19 Advanced Biochemicals 40 9.1
industry to $5 billion in 20 Biological E 36 8.3
revenues generated by 1
USD 1 = Rs 43.5
million employees by Source: BioSpectrum Top 20: A threshold crossed
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.

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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 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].

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

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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]

Ranbaxy Laboratories
Arun Puri, 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

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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

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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 Ltd
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

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Green Apple Lifesciences Limited[11]

Mitesh Mehta, Chairman

Reliance Life Sciences Pvt Ltd[12]

Mr. K.V. V. Subramaniam, President and CEO

Medicine in China
Pharmaceutical industry in China
Pharmacology
Biotechnology
Pharmaceutical marketing
Pharmaceutical industry
National pharmaceuticals policy
Opium and Alkaloid Works

1 Serum Institute of India. 15 June 2005. Biospectrum. 1 August 2005 <http://www.biospectrumindia.com

/content/BSTOP20/10506153.asp>.

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4 “BioSpectrum 20: A Threshold Crossed.” BioSpectrum 3:6 (June 2005): 24-32.

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6 “Biotech sector to be single largest job churner: expert.” Global Newswire – Asia Africa Intelligence Wire 21
February 2005.

7 "BT has jobs but where are the takers?" Asia Africa Intelligence Wire 7 January 2005.

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July 2005.

11 Dr. Reddy Laboratories Ltd. Dr. Reddy’s Laboratories Ltd. 27 July 2005 <http://www.drreddys.com/>.

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19 "Incentives for bio-tech units." Asia Africa Intelligence Wire 2 July 2005.

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21 Indiainfoonline.com. Indian Pharmaceutical Sector: Big Pharma Opportunity. By Atul Rastogi and
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22 “India’s biotech strides prompts UK to hike funds in sector.” Nationwide International News (The Press
Trust of India) 7 March 2005.

23 “Intellectual property: protection and enforcement.” WTO: Understanding the WTO. World Trade
Organization. 1 August 2005 <http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm>

24 Jarvis, Lisa. "NPIL sets ambitious growth targets." Chemical Market Reporter 267:16 (18 April 2005): 32-33.

25 Joshi, Hemant N. “Analysis of the Indian pharmaceutical industry: with emphasis on opportunities in 2005.”
Pharmaceutical Technology 27:1 (2003): 74-84.

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research across India." Business Week 39:29 (18 April 2005): 20.

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