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Working Paper
382
THE SECTORAL SYSTEM OF
INNOVATION OF INDIAN
PHARMACEUTICAL INDUSTRY
Sunil Mani
September 2006
2
Working Papers published since August 1997 (WP 279 onwards)
can be downloaded from the Centre’s website (www.cds.edu)
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THE SECTORAL SYSTEM OF INNOVATION OF INDIAN
PHARMACEUTICAL INDUSTRY
Sunil Mani
September 2006
The research underlying this study has been funded by the Department
of Science and Technology as part of the Experts committee on Innovation
Surveys. Mr Parveen Arora of the DST has been most helpful in carrying
out this piece of research. He made available to me a number of otherwise
inaccessible studies on the industry. I have received very useful comments
from Sudip Chaudhuri and from an internal referee to the paper. I am
also grateful to Prabhu Dass and P P Nixon for rendering excellent
research assistance. The errors and other shortcomings that may still
remain in the paper are solely that of mine.
4
ABSTRACT
The paper undertakes a detailed mapping out of the sectoral system
of innovation of India's pharmaceutical industry. The industry is one of
the most innovative industries in the Indian manufacturing sector. The
innovation system of the industry has three strong pillars: very pro active
government policy regime especially with respect to intellectual property
right, strong government research institutes and private sector enterprises
which have invested in innovation. The TRIPS compliance of the
intellectual property right regime making it mandatory for pharmaceutical
products to be patented has not reduced the innovation capability of the
industry although it has not made them work on R&D projects that may
lead to the discovery of drugs for neglected diseases of the developing
world. Although the innovation system has the capability to develop
new chemical entities the two main components of the innovation system,
namely the enterprises and the Government Research Institutes does not
appear to be having all the requisite capabilities to bring a new drug to
the market. Although the state has been very proactive with respect to
this industry, this is an area where public policy support is still required.
Key words: Sectoral system of innovation, pharmaceutical industry,
TRIPS, innovation
JEL Classification: O31, O34 and O38
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Introduction
It is generally held that firms in developing countries such as those
in India does not necessarily innovate in the sense of doing R&D that
results in the release of new products and processes. At best they are
assumed to be introducing incremental innovations defined as adaptation
of known technologies to local conditions as these may be new to the
Indian firms although not new to the universe in which these firms are
located. Consequent to this line of thinking measuring innovation using
conventional indicators such as R&D expenditures, patent grants,
technology-content of exports has always been problematic. Although
this is the general rule, there are certain notable exceptions in terms of
firms creating new technologies on their own. The pharmaceutical
industry in India, despite the copycat image that is heaped on it rightly
or wrongly, has managed to be one of the most innovative among the
country's manufacturing establishments. Indian pharmaceutical
companies enjoyed two 'home-grown' advantages namely, much cheaper
manufacturing facilities and world-class medicinal chemistry skills,
honed by years of reverse engineering. The industry is currently one of
the fastest growing and is a major recipient of US patents. For such an
industry, the concept of a sectoral system of innovation makes eminent
sense. Against this perspective, the purpose of this paper is to attempt at
mapping out the sectoral system of innovation of India's pharmaceutical
6
industry. Such an exercise would allow us to identify the sources of
innovation in the industry.
The paper is structured into four sections. The first section outlines
some important features of this industry. The second section maps out the
sectoral system of innovation (SSI) of the industry and focuses on three
components of the SSI. The third section measures the performance of the
innovation system in terms of a number of, albeit, conventional indicators.
The fourth and concluding section sums up the main findings of the paper.
1. Features of India's pharmaceutical industry
The pharmaceutical Industry in India is one of India's foremost
science-based industries with wide ranging capabilities in the complex
field of drug manufacture and technology. The country produces
pharmaceutical formulations and over 400 active chemicals used in
the manufacturing of drugs (namely Active Pharmaceutical
Ingredients). A wide range of pharmaceutical machinery too is available
in the country. The value of the pharmaceutical market in India was
U.S.$ 6.0 billion in 2004 representing two per cent of global market,
and ranking fourth in terms of volume and thirteenth in value terms. .
The industry has been exhibiting an excellent growth performance
especially over the last decade. The structure of the industry is such
that that an entire range of firms according to type of ownership (foreign
and Indian) and according to scale (large, medium and small) occupy
the manufacturing landscape of this industry.
The industry has three key characteristics that are worth examining:
• The industry is dominated by formulations;
• The industry is very active in the world-wide market for
generics; and
• The country is self sufficient in most drugs as judged by a
growing positive trade balance;
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i. Domination of formulations
The Indian pharmaceutical industry is divided into two broad
categories on the basis of form/usage into bulk drugs1 and formulations.
The industry is dominated by formulations (Figure 1). Although it is the
development of the bulk drugs sector that is actually the most important
achievement of the pharmaceutical industry in India and it has led to the
transformation of the industry (Chaudhuri, 2005)
Figure 1: Structure of Indian pharmaceutical production,
1975-2004
Source: Chaudhuri (2005)
Chaudhuri divides the entire history of pharmaceutical production
in the country into three phases. The first phase is up the early 1970s, the
second phase covers the late 1970s through the 1980s and the third phase
refers to the period since the 1990s. The salient features of the three
phases are summarized in Table 1.
1 Bulk drugs are the active pharmaceutical ingredients (API), which are used to
manufacture formulations. APIs cannot be directly administered to the patients
and other substances called excipients are added to stabilize the formulations.
This end product, which includes the API and the excipient is referred to as a
formulation.
0
50000
100000
150000
200000
250000
300000
Rs
in
Mill
ion
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
Rat
io
of
for
mu
lati
on
s
to
bul
k
dru
gs
Bulk drugs 90 13 15 16 20 22 24 28 34 30 36 40 45 48 55 64 73 90 11 13 15 18 21 26 31 37 45 54 65 77
Formulation 40 56 70 90 10 11 12 14 16 17 18 19 21 23 31 34 38 48 60 69 79 91 1E 1E 1E 2E 2E 2E 2E 3E
Ratio 4.4 4.3 4.6 5.4 5.2 5.0 5.0 4.9 4.8 5.7 5.0 4.7 4.6 4.9 5.7 5.3 5.2 5.3 5.2 5.2 5.2 5.0 4.8 4.6 4.4 4.2 4.0 3.8 3.7 3.5
19
75 19
76 19
77 19
78 19
79 19
80 19
81 19
82 19
83 19
84 19
85 19
86 19
87 19
88 19
89 19
90 19
91 19
92 19
93 19
94 19
95 19
96 19
97 19
98 19
99 20
00 20
01 20
02 20
03 20
04
Rs in
Million
Ratio
of
formu-
lations
to bulk
drugs
8
Table 1: Salient features of the pharmaceutical industry over the three phases
Phase Ownership Patent regime Nature of drug prices Import dependence
I Foreign Product and process High High for essential bulk drugs
(till the early companies patents were recognised
1970s)
II Growth of a Only process patents Moderate due to the Increased production of
(the late 1970s strong indigenous were recognized under availability of cheaper bulk drug and
and the 1980s) production the new patent law alternatives from formulations has
sector domestic companies substituted imports.
Further the industry started exporting as well
III Continued For most of this, same Same as Phase II. Net exports as a percent
(since the growth and as phase II. The patent The National of exports increased from
1990s) consolidation regime made TRIPS Pharmaceutical 37.3 in 1990-91
by an indigenous compliant since Pricing Authority (NPPA) to 90.8 in 2002-03.
production January 1 2005. was established to
sector monitor prices of 74
bulk drugs and to revise
them periodically.
Source: Chaudhuri (2005)
9
ii. The country is very active in the world market for generics
A generic drug is identical, or bioequivalent to a brand name drug
in dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use. Although generic drugs
are chemically identical to their branded counterparts, they are typically
sold at substantial discounts from the branded price. Generics account for
around 14 per cent of the healthcare market worldwide (Figure 2) and
they are growing at a phenomenal rate. The recent growth in the generics
market has been largely fuelled by the patent expiry of several blockbusters,
and with around $12bn of innovative drugs coming off patent by 2008 in
Figure 2: Size of the generics market worldwide
Source: Drug Discovery and Development,
http://www.dddmag.comShowPR.aspx? PUBCODE=016&ACCT=
1600000100&ISSUE= 0511& origreltype =cvs& RELTYPE=
pr&ProdCode = 00000000&PRODLETT=G (accessed on 11/08/06)
10
France, Germany and the UK alone, this trend is expected to continue. For
generics companies, speed to market with the right molecules is a critical
success factor and that means being flexible, competitive and fast to
capitalise on new opportunities. Originator companies, meanwhile, facing
dwindling pipelines are being called on to show increasing creativity in
their handling of key product expiries. Several large pharma firms have
already begun buying into and owning generics businesses and with
traditional generics companies trying their hands at proprietary brands,
conventional lines of demarcation are blurring.
According to research by London-based researcher Global Insight,
Indian drugmakers will have a 33 per cent share of the global generics
market by 2007, compared with 4 per cent in 2005.
There are four main factors that helped Indian pharmaceutical
manufacturers to emerge as important generics manufacturers.
First, is the Indian Patents Act of 1970 This Act has been in force
since 1972 until December 31, 2004. As per this Act, the Indian
parliament granted patent rights only to manufacturing processes, rather
than to the end products themselves. Indian pharmaceutical firms were
able to take new drugs developed abroad, reverse-engineer the
manufacturing process and begin churning out generics. Consequent to
these local firms went from controlling 30 percent of the Indian drug
market in 1972 to 77 percent in late 2004. Developing-world consumers,
and even some in Western markets, enjoyed the benefits of low prices
and the quick introduction of the latest wonder drugs. At present the
country exports generic drugs to nearly 200 countries. Chaudhuri (2005)
has provided us with detailed analysis of the contribution of the pre
2005 Indian patent regime towards the building up of a generics industry
in the country.
Second, research in India costs 40 per cent less than in the U.S.
The cost of developing a drug from scratch in India could be as low as
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$100 million while it is up to $1 billion in the West. In other words the
industry has a significant and sustainable cost advantage over
international peers;
Third, is the availability of skilled work force with strong chemistry
skills;
Fourth, India has the largest number of US FDA approved
manufacturing plants outside the USA. It has the largest number of Drug
Master Filings (DMF) outside the US.2 Indian companies are also the
leading companies participating in Para IV challenges.3
(ii) The country is self sufficient in most drugs:
Until 1988, the industry was experiencing a negative trade balance
(Figure 3). The trade balance turned positive since 1989 and has started
steadily increasing from 1997 onwards. This shows that the country is
fairly self sufficient in most drugs and pharmaceuticals. This self-
sufficiency is a very good indicator of the country's growing technological
capability in this industry.
2 A master file (MF) is a voluntary submission to the Food and Drug Administration
(FDA) that may be used to provide confidential, detailed information about
facilities, processes, or articles used in the manufacturing, processing, packaging,
and storing of one or more drugs. Those on file with the Center for Drug
Evaluation and Research (CDER) are referred to as drug master files (DMF’s).
The master file is used to provide support information and data for an NADA,
ANADA, INADA, Export Application, or other master files
3 Once a patent challenge is successful, the challenger gets 180 days exclusivity
period for sales of the generic drug, something that can dramatically improve
the fortunes of Indian generic pharma companies. These legal battles, however,
are unpredictable and risky. DRL had earlier won a legal battle against Eli Lilly,
and enjoyed a six-month exclusivity for fluoxetine capsules, a generic version
of Lilly’s anti-depressant Prozac.
12
Figure 3: Trends in trade balance of pharmaceutical products,
1974-2004
Source: Chaudhuri (2005), p. 45
II. Mapping of the sectoral system of innovation
The paper adopts a sectoral system of innovation perspective
introduced by Malerba (2004). The framework involves mapping out
the boundaries of the innovation system in terms of the specific agencies
of the government dealing with telecommunications development, the
policy framework, the equipment suppliers, the service providers and
the regulatory agency and tracking the knowledge flows between these
various actors within the system. According to Malerba (2004), every
sectoral system of innovation has at least three blocks: (i) knowledge,
technological domain, and boundaries; (ii) actors, relationships and
networks; and (iii) institutions. These three blocks may be elaborated as
follows. First, knowledge plays a central role in innovation. It has to be
-500
0
500
1000
1500
2000
2500
3000
3500
US $ million
Exports 48 54 49 60 71 84 88 96 106115157 183159175223323515537614486568694699115145 146166191219246317
Imports 44 59 53 60 96 116148143153154 158181219 225270309392 337330371459486558664 730724347445541228687
Trade balanc e 4.1 -5 -4 0 -25 -32 -60 -46 -46 -39 -2 1.5 - 60 -51 -46 14 123 200284 1151092 08141488 729738 132146165 223249
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74 19
75 19
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99 20
00 20
01 20
02 20
03 20
04
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absorbed by firms through their differential abilities accumulated over
time. Knowledge differs across sectors in terms of domains. One
knowledge domain refers to the specific scientific and technological fields
at the base of innovative activities in a sector. The boundaries of sectoral
systems are affected by knowledge base and technologies. Second,
sectoral systems are composed of heterogeneous actors. Firms are the
key actors in the generation, adoption, and use of new technologies.
Actors also include users and suppliers who have different types of
relationships with the innovating, producing or selling firms. Other types
of agents in a sectoral system are non-firm organizations, government
agencies, local authorities, and so on. In various ways, they support
innovation, technological diffusion, and production by firms, but again
their role greatly differs among sectoral systems. Third, in all sectoral
systems, institutions play a major role in affecting the rate of technological
change, the organization of innovative activity and performance.
Innovation greatly differs across sectors in terms of sources, actors,
features, boundaries and organization.
The following figure (Figure 4) maps out the sectoral system of
innovation. There are essentially five components to the sectoral system.
In broad terms they are (i) Policy and strategic direction; (ii) The
Intellectual Property Right Regime; (iii) Human resource development
or the supply of scientists and engineers;4 (iv) Technology generating
sector; and (v) The manufacturing sector.
4 The areas are medicinal chemistry; combinatorial chemistry; Bioinformatics
and structure based molecular modelling, Genomics and proteomics, Clinical
pharmacology, and Regulatory toxicology.
14
Policy and Strategic Direction
Managed
by the Department Chemicals and Petrochemicals and the Departme nt of Science and
Technology (through the Pharmaceuticals Research and Development Support Fund) and the
Department of Biotechnology.
Licensing of firms for permission to manufacture : Drug Controller General.
Price Controls
by Drug Prices Control Order
-
95, admini
stered by The National Pharmaceutical
Pricing Authority.
Overall policy framework : Pharmaceutical policy 2002. A new policy is on the anvil.
Human Resource Development
Apartment from the Universities and Pharmacy
Colleges, The National Institute of Pha
rmaceutica l
Education and Research (NIPER) has been set up
by the Government of India as an institute of
“national importance” to achieve excellence in
pharmaceutical science and technologies, education
and Training. Through this institute, Government
end
eavor will be to upgrade the standards of
Pharmacy education and R & D.
Technology Generating Sector
•
Government Research Institutes
Central Drug Resear ch Institute (CDRI)
Indian Institute of Chemical Technology (IICT)
Indian Institute of Chemical Biology
(IICB)
Central Institute of Medicinal and Aromatic Plants
•
In
-
house R & D centers of leading private sector drugs companies
•
Contract Research Organizations primarily in the private sector.
The Intellectual Property
Rights Regime
The Trips compliant
India
n Patents Act 2005
Manufacturing Sector
•
Public (5 nos) and private sector enterprises (about 5000)
•
Affiliates of MNCs
Figure 4: Sectoral System of Innovation of the Indian
Pharmaceutical Industry (c 2006)
Source: Own Compilation
15
The three important components of the SSI are: (A) the public
policy support; (B) the manufacturing enterprises primarily in the private
sector; and (C) Government Research Institutes (GRIs). We deal with
each of these components in some detail below:
(A) The public policy support
The market conduct or behaviour of the pharmaceutical industry
in the country is subjected to the following policy framework. These
could be classified as:
- Overall policy framework towards the development of
pharmaceutical industry;
- Intellectual Property Right or patent regulations;
- Price regulations; and
- Product and quality regulations.
(a) Overall policy framework: The overall policy framework
governing the industry up to this time has been the Indian Pharmaceutical
Policy of 1994.This is because the new drugs policy formulated by the
government in 2002 could not be implemented due to litigation involving
it; hence the policy of 1994 still continues to be in force. The present
Policy known as the Draft National Pharmaceuticals Policy, 20065 has
been necessitated due to several developments that have taken place
during the course of last few years as well as to address some of the
major concerns as highlighted above. Price regulation of the essential
medicines is an important component of this policy. However several
other matters having a close bearing on the pharmaceuticals sector have
also been included. Since the purpose of the present paper is to analyse
the sectoral system of innovation of the Indian pharmaceutical industry,
5 Department of Chemicals and Petrochemicals, http://chemicals.nic.in/
npp_circulation_latest.pdf (accessed on 11/08/2006)
16
we will focus our attention only on those aspects of the policy that
explicitly deals with the promotion of innovation. The major policy
initiatives in this area are summarized below:
i. Promotion of pharmaceutical R&D through the provision of fiscal
incentives;
ii. Promotion of R&D intensive companies;
iii. Establishment of a pharmaceutical Research and Development
Support fund (PRDSF); and
iv. Development of orphaned drugs
In the following we discuss the details of each of these four policy
initiatives.
i. Fiscal incentives for R&D: a) The benefit of 150 per cent
weighted exemption (under section 35{2AB} of the Income Tax Act of
1961)6 is to be continued till 31st March, 2015; b) This deduction is to
be extended to depreciation on investment made in land and building for
dedicated research facilities, expenditure incurred for obtaining
regulatory approvals and filling of patents abroad and expenditure
incurred on clinical trials in India; c) Reference Standard (sample under
test) would be exempted from import duty; d) Reference books to be
imported for R&D would be exempted from import duty; and e) Presently
there are 101 specified instruments (list 28) required for R&D purposes,
which are exempt from import duty. With the ever-changing requirements
new instruments are required to be imported. These instruments based
on the certification of DSIR would also be exempt from import duty.
The fiscal incentives are at present only available up to 31st March 2007.
Since R&D activity has to be carried over long periods of time, fiscal
6 Income Tax Department, Government of India, http://www.taxmann.com/
TaxmannDit/DisplayPage/dpage1.aspx?md=2&typ=se&yr=2006&ch=(accessed
on 11/08/06)
17
incentives would be granted over a longer period of time extending up
to 10 years i.e., up to 31st March 2015.
ii. R&D Intensive Companies (Gold Standard Companies):
The Pharmaceutical Research and Development Committee headed by
Dr R A Mashelkar in its report submitted to Government in November,
1999 recommended that R&D intensive companies fulfilling certain
conditions should be given price benefits for the drugs under Drug Price
Control Order (DPCO). It specified certain norms in this regard and
termed these as the gold standards. Since six years have elapsed since
this report was submitted it has been considered proper to revise these
norms. The revised norms are as under: a) Invest at least 3 per cent of the
annual sales turnover on R&D or Rs 500 million per annum, (average of
last 3 years) whichever is higher on research facilities. b) Employment
of at least 200 scientists in India (MScs or PhDs employed at least for
one year). c) Own and operate manufacturing facilities in India which
have been approved by at least two reputed foreign regulatory agencies
(US, Europe, Japan, Canada, Australia, Israel, South Africa etc) d) Have
filed at least 10 patent applications in India based on research done in
India Companies fulfilling the above norms would be eligible for the
benefit of 200% weighted deduction under 35(2AB) till 31st March,
2015 Additional incentives under price control measures may also be
considered to such companies by Department of Chemicals and
Petrochemicals.
iii. The Pharmaceutical Research and Development Support
Fund: At present, the Pharmaceutical Research and Development
Support Fund (PRDSF) has a corpus of Rs. 1500 million (where only
interest income is available for spending) is utilized for funding R&D
projects of research institutions and industry in the country. It is not
adequate to meet the present day and the emerging requirements of this
sector and there needs to be sufficiently augmented over the next five
years. It has been decided to convert it into an annual grant of Rs. 1500
18
million, and thereafter it would be suitably increased further in a phased
manner over a period of next five years. Priority would be given for
R&D in case of diseases which are endemic to India like malaria,
tuberculosis, hepatitis-B,leishmania (kala-azar),HIV/AIDS etc.
iv. Development of orphaned drugs: The Central Drug Research
Institute (CDRI) has over time developed a number of drug technologies,
which could not be commercially produced and marketed. Efforts will
be made to identify such technologies with a view to enabling them to
reach the market.
Further, the following two initiatives implied in the new draft policy
has also further implications for promotion of innovation in the industry.
They are: (i) abolition of industrial licensing for bulk drugs, intermediates
and formulations; and (ii) automatic approval for foreign technology
agreements through RBI.
(b) The Patent regime: It is now fairly well accepted that it is the
provisions of the Indian Patents Act of 1970, and especially the fact this
Act did not recognize product patents but only process patents, that
allowed Indian pharmaceutical companies to reverse engineer and
manufacture at significantly lower costs. But with the country becoming
a member of the WTO in 1995, the patent regime has been made TRIPs
compliant. This TRIPS compliance in very specific terms have led to the
introduction of the following set of measures;
- The EMR (Exclusive Marketing Rights) provision was introduced
with retrospective effect from January 1, 1995 (self-expunging
provision which will be void on January 1, 2005)
- This transitional arrangement entailed India to provide for a
mailbox mechanism for accepting product patent applications and
for examining and granting EMRs till the time it accords
recognition to product patents;
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- Minimum patent term increased from 14 to 20 years
- Reversal of burden of proof from patent holder to alleged infringer
- The provisions relating to compulsory licensing have been
modified to suit the public health requirements and also to comply
with TRIPS.
- Introduction of product patents relating to Chemicals, Drugs,
Medicines and Food Products
- Provision for pre-grant objection to patents has been diluted; and
- Grace period in case of publication of inventions;
The potential effect of these amendments on the innovative
behaviour of the domestic industry is now hotly debated. One of the
most important consequences is about the availability and prices of many
essential drugs. Henceforth some of these drugs can only be manufactured
under an explicit licence. According to Ramani, Pradhan and Ravi (2005),
the Indian pharmaceutical firms have three choices open to them in a
post TRIPS compliant regime. These are:
i. They can focus on products that are either off patent (essentially
the generics market);
ii. They can collaborate with Western MNCs and biotech companies
(two areas that are likely to witness an increase in collaborations
are clinical trials and R&D outsourcing) and;
iii. They can focus on innovations that the MNCs will not be
interested in; that is mainly 'tropical' or developing world diseases.
Although a bit too early to clearly measure whether the three
possibilities are actually happening, there is enough evidence to show
that (i) and (ii) are indeed happening. We will discuss this in some more
detail in the subsequent sections. In the present we analyse, albeit briefly,
20
the efforts undertaken by Indian pharmaceutical companies towards R&D
in neglected but tropical diseases. This discussion is very largely based
on Chaudhuri (2005).
The Indian private sector started investing in R&D for developing
new drugs since the mid 1990s when TRIPS came into effect. According
to current estimates there about 15 domestic pharmaceutical companies
that are active in drug research and they have or are in the process of
establishing new research centres with new drug discovery research
(NDDR) as the major objective. The total R&D expenditure for the
development of new drugs by Indian companies has increased from Rs
6.73 billion in 2002-03 to Rs 10.02 billion in 2003-04 and a number of
new chemical entities (NCEs) have been developed which is at different
stages of development. Since they do not have all the skills or the financial
wherewithal required to engage in the entire process of drug development,
they have adopted a strategy to develop new molecules and license out
the molecules to the MNCs at early stages of clinical development.
Consequent to this the Indian companies are effectively not targeting
neglected diseases, but only those, which interest the MNCs. At this
point, it is necessary to mention that the government has taken some
initiatives for collaborative research to synergise the strengths of publicly
funded R&D institutions and the Indian pharmaceutical industry. The
only one area where some progress has been made is in the development
of an anti-TB molecule (Lupin's development of the NCE LL 4858 is a
case in point). However no special efforts have been made for the
development of new drugs for most of the neglected diseases (such as
malaria, HIV/AIDS, Chagas disease, Dengue fever, Leishmaniasis and
Leprosy).
(c) Price regulations: Drug prices in India are among the lowest
in the world (and imports are therefore negligible). This is because of
several reasons. The first is that only product patents and not process
21
patents (for pharmaceuticals) are so far recognized under Indian law.
Therefore Indian manufacturers can make bulk drugs and formulations
by "reverse engineering" of the overseas patented medicines, reducing
R&D expenses and also avoiding royalty payments. Further, Indian labour
costs are low compared to overseas levels. India also has a large pool of
technical and managerial personnel and does not need management skills
from overseas. Most of the plant and equipment required is made locally.
Most importantly a measure of statutory price control for bulk drugs
and formulations operates in India. Certain drugs (known as scheduled
drugs, as they are listed in the First Schedule to the Drug Price Contol
Oder (DPCO). The DPCO was introduced in 1970, but has since been
modified three times, the latest one being in 1995. Over time the number
of drugs under price control has been significantly reduced from 370 in
1979 to just about 25 in 2005. Non-scheduled drugs can be priced
freely, subject to some restrictions. The National Pharmaceutical Pricing
Authority (NPPA) administers the price control regime.7 The
Government can exempt certain products from price control if they are
new drugs discovered in India or bulk drugs produced from the basic
stage by a new process discovered in India or drugs manufactured by
small-scale industries (capital investment below a certain level) and sold
under their own brand names. The most important problem with respect
to price monitoring is the absence of an appropriate price index. The
government has been depending on IMS Health-AC Nielsen, (formerly
ORG) for tracking data on retail sales both in volume and value terms.
Therefore, having a pharmaceutical price index on the lines of the
Consumer Price Index or Wholesale Price Index is being considered.
Though details of the proposed index were not available, it is said that
7 The functions of the NPPA, inter alia, are to: (i) implement and enforce the
provisions of the Drugs (Prices Control) Order in accordance with the powers
delegated to it; (ii) monitor the availability of drugs, identify shortages, if any,
and to take remedial steps; and (iii) collect/ maintain data on production, exports
and imports, market share of individual companies, profitability of companies
etc, for bulk drugs and formulations.
22
the government could create an index by having a basket of drugs whose
prices would be benchmarked to a base year. It could then monitor any
changes in their prices in relation to the index. However, the therapeutic
segments that would form the basket would have to be decided. Also,
whether the index would monitor prices of only generic drugs or include
patented drugs as well would also have to be finalised.
(d) Product and quality regulations: The Drugs and Cosmetics
Act of 1940 and its subordinate legislation Drugs and Cosmetics Rules
(DCR), 1945 govern this aspect. The conduct of clinical trials- a growing
area of importance is actually governed by this legislation. The
government has decided to amend the DCR and has emphasised the
incorporation of Good Clinical Practices (GCP) protocols and to make
it legally binding to stress on the safety aspect of the patients and strict
accordance to ethics. Towards this direction the Department of Science
and Technology (Government of India) established national Good
Laboratory Practices (GLP) Compliance Monitoring Authority, with the
approval of the Union Cabinet on April 24, 2002. GLP-compliance
certification is voluntary in nature. The GLP in India are compliant with
OECD norms and principles. Industries/test/ facilities/laboratories
looking for approval from regulatory authorities before marketing them
may apply to the National GLP Compliance Monitoring Authority for
obtaining GLP Certification. So far there are only five Indian laboratories
that have received this certification (Table 2).
(B) The manufacturing enterprises
There has been confusion on the total number of pharmaceutical
units in the country. This has been variously estimated to be about 19,
203 licensees. Citing the arguments and data provided in the Mashelkar
Committee on drug regulatory issues, Chaudhuri (2005) argues that there
are about 5877 pharmaceutical units in the country. This is because the
number of pharmaceutical companies would be less than the number of
licensees because manufacturing licenses are given to specific units and
23
Table 2: Profile of Indian laboratories with GLP certification
Sl. Year of
No. Test facility Areas of expertise recognition
1 International Institute Physical-chemical testing 2004
of Biotechnology and Toxicity studies
Toxicology (IIBAT) Mutagenicity studies
Environmental toxicity
studies on aquatic & terrestrial
organisms
Studies on behavior inwater,
soil and air; bioaccumulation
Residue studies
Studies on effects on
mesocosms and natural
ecosystems
Analytical and clinical chemistry
testing
Studies on natural enemies
and predators
2 Dr. Reddy's Physical-chemical testing 2004
Laboratories Limited, Toxicity Studies
Discovery Research Mutagenicity Studies
Analytical and Clinical
Chemistry Testing
3 Jai Research Physical-chemicalTesting 2004
Foundation ToxicityStudies
Mutagenicity Studies
Environmental Toxicity Studies
on Aquatic and Terrestrial
Organisms
Studies on Behaviour in
Water, Soil and Air;
Bioaccumulation
Residue Studies
Studies on Effects on
Mesocosms and Natural
cont'd....
24
many companies have multiple manufacturing units. The structure of
the drugs manufacturing sector in India is presented in Table 3.
Ecosystems
Analytical and Clinical
Chemistry Testing
4 Orchid Chemicals Physical-chemical Testing 2005
and Pharmaceuticals Safety Pharmacology
Limited and Pharmacokinetic Studies
Toxicity Studies
Mutagenicity Studies
Analytical and Clinical
Chemistry Testing
5 Advinus Therapeutics Physical-chemical Testing 2005
Private Limited Toxicity studies
Residue studies
Mutagenicity Studies
Analytical and Clinical
Chemistry Testing
Environmental toxicity
studies on aquatic &
terrestrial organisms
Source: National Good Laboratory Practice Monitoring Authority, http:/
/indiaglp.gov.in/TestFacility.htm (accessed on January 25, 2006).
Table 3: Structure of India's Pharmaceutical Industry
Type of enterprise Number of enterprises
1. Bulk drugs 1333
2. Formulations 4354
3. Large Volume Parenterals 134
4. Vaccines 56
Total 5877
Source: Mashelkar Committee (2003), p. 49
25
According to Chaudhuri (2005), the bulks drug industry resembles
that of a perfectly competitive industry with no one firm accounting for
a significant share. Most of the units in this sector belong to the small-
scale sector. Large private sector companies, on the contrary, dominate
the formulations industry. See Table 4.
Table 4: Top twenty companies in the retail pharmaceutical market
in India, 2004
Rank Sector Comapny No. of Annual Market
products sale in share (%)
Rs.million 2004
1 Indian Cipla 707 11285 5.51
2 MNC Glaxo Smith Kline 205 11143 5.44
3 Indian Ranbaxy 437 9190 4.48
4 Indian Nicholas Piramal 449 8720 4.25
5 Indian Sun Pharma 350 6738 3.29
6 Indian Dr Reddy's 183 4988 2.43
7 Indian Zydus-Cadila 330 4959 2.42
8 Indian Aristo Pharma 175 4760 2.32
9 MNC Abott India 87 4735 2.31
10 Indian Alkem Labs 310 4477 2.18
11 MNC Aventis 44 4367 2.13
12 Indian Lupin 274 4165 2.03
13 Indian Micro Labs 461 3903 1.9
14 Indian Wockhardt 238 3776 1.84
15 Indian Torrent 150 3747 1.83
16 Indian Novartis India 127 3725 1.82
17 Indian Alembic 169 3432 1.67
18 Indian Unichem Labs 189 3430 1.67
19 Indian USV 86 3390 1.65
20 MNC Pfizer 29 3274 1.6
Source: Chaudhuri (2005), p. 17.
26
One of the most important features of the industry is the fact that
it is largely dominated by domestic private sector enterprises. In fact
there are only five MNCs in the top 20 and not a single public sector
enterprise figure in the list. The two public sector enterprises, Hindustan
Antibiotics established in 1954 and the Indian Drugs and Pharmaceuticals
established in 1961, played an important role in creating a domestic
private sector pharmaceutical industry (Chaudhuri, 2005, p. 34). This is
best summed up by Smith (2000, p 33)
"Before HAL opened its doors, the domestic pharmaceutical
industry was all but nonexistent. Furthermore, India's universities had
no provisions for the type of specialized training required by
pharmaceutical companies. HAL's founders took the initiative and laid
a considerable part of the foundation that supports today's local and
MNC subsidiary drug companies. HAL created a demand for inputs in
the form of skilled labor, specialized capital, and relevant services, and
provided the critical mass for local pharmaceutical production, created
jobs for tens of thousands, spurred innovation, and sparked industrial
development in up and downstream businesses. These contributions
eventually rendered India a favorable environment for pharmaceutical
production, research, and distribution".
However currently both these units are declared as "sick" or
financially distressed companies by the Board for Industrial and Financial
Reconstruction (BIFR) and are practically non-existent.
The amended patent law (1972) and the policy of positive
discrimination towards indigenous companies vis-à-vis MNCs ensured
that domestic companies currently (2004) account for nearly three
quarters of the pharmaceutical market (Figure 5).
Although the data on market shares provided in Table 4 appears to
give an indication that the market is fairly competitive, this is really not
the case. The reason being the pharmaceutical industry is not a
27
homogenous one but fragmented into different therapeutic segments such
as tranquilizers, analgesics, antibiotics, vitamins etc. Each of these
segments is a not substitute for each other. In fact the concentration
ratios are much higher within a specific therapeutic group. For instance,
Chaudhuri (2005) shows that, if one takes the various sub groups within
antibiotics, the degree of concentration is much higher.
Another important structural aspect has been the increased number
of mergers and acquisitions in the industry. In the period from January
2004-when Ranbaxy formalized its purchase of RPG (Aventis) for $80
million, making it the fifth-largest generics supplier in France-until
October 2005, Indian firms made 18 international acquisitions (KPMG,
2006). Glenmark, Jubilant Organosys, Nicholas Piramal and Ranbaxy
each acquired two overseas businesses during this time, but the biggest
Indian buy was Matrix Labs' acquisition of Belgium's Docpharma for
$263 million in June 2005. It is generally held that the pharmaceutical
Figure 5: Market shares of Foreign and Indian Companies in the
Indian pharmaceutical industry, 1952-2004
Source: Chaudhuri (2005), p. 18
28
enterprises are currently the most aggressive overseas investors of all
Indian industries. Several reasons8 could be attributed to this mergers
and acquisition spree. They are for the need to:
• Improve global competitiveness;
• Move up the value chain;
• Create and enter new markets;
• Increase their product offering;
• Acquire assets (including research and contract
manufacturing firms, in order to further boost their
outsourcing capabilities) and new products; and
• Consolidate their market shares
(C) Government Research Institutes
According to Chaudhuri (2005), of the total pharmaceutical R&D
expended in the country, nearly two thirds is contributed by the industry
and the remaining by the GRIs primarily under the management of the
Council of Scientific and Industrial Research (CSIR). Of the small number
of new drugs that were developed by Indian inventors a lion's share were
the products of research done at the Central Drug Research Institute
(CDRI). CDRI is considered to be one of the few public sector
organizations in the world, which have its own drug development
infrastructure. Over the years it has developed and licensed to other private
sector enterprises ten new drugs. Unfortunately most of the drugs
according to Chaudhuri (2005) did not survive in the market owing to
strong competition from MNCs.
Apart from the CDRI, which is directly connected with drug
research, the CSIR system has 20 other laboratories that are engaged in
some form of pharmaceutical research or other. The annexure lists these
8 See KPMG (2006), p.25
29
labs with their areas of competence. Four of these led by the CDRI have
been very active in drug research as indicated by the fact that they together
account for a quarter of both Indian and foreign patents secured by the
CSIR system (Table 5).
Table 5: Foreign and Indian patents granted to CSIR Labs engaged
in drugs research, 2003-04
India Foreign
CDRI 7 5
CIMAP 7 29
IICB 4 5
IICT 24 39
Total for the above 42 78
Total for CSIR 275 212
Source: Computed from CSIR Website
III. Performance of the innovation system:
It is already seen above that India has demonstrated strong
innovation capabilities in developing manufacturing processes, thanks
to the old patent regime. Conventional measures of measuring innovation
are unlikely to show the real innovation potential of pharmaceutical
companies, as most of these reverse engineered processes may not have
been done through a formal R&D route. Hence there is a strong case for
developing non-conventional measures to portray the innovation
capability of this sector. However before attempting at some non-
conventional measures, we start with the innovation record of the industry
using conventional measures such as R&D expenditure and patents and
we start with the R&D investments.
30
Table 6: Trends in R&D expenditure in the Indian pharmaceutical
industry (Rs in Millions)
Public Private Small Gowth
Sector sector scale Total rate(%)
1989-89 46.06 501.651 16.733 564.444
1989-90 54.158 579.674 32.272 666.104 18.01
1990-91 118.934 598.727 38.211 755.872 13.48
1991-92 168.313 756.592 52.763 977.667 29.34
1992-93 79.652 1053.509 58.653 1191.814 21.90
1993-94 71.416 1217.206 85.479 1374.101 15.29
1994-95 57.813 1600.268 153.832 1811.913 31.86
1995-96 48.432 1938.869 179.111 2166.412 19.56
1996-97 44.402 2618.954 2663.356 22.94
1997-98 46.318 2828.556 2874.874 7.94
1998-99 49.018 3725.958 3774.976 31.31
Source: Department of Science and Technology (Various issues)
The exercise is conducted at two levels. First we analyse the overall
R&D expenditure (Table 6) and this is followed by a more firm-level
analysis (Table 7).
The overall R&D expenditure has increased, on an average, by 21
per cent per annum. One of the more interesting conclusions that can be
derived from Table 5 is that it is the private sector, which accounts for
over 85 per cent of the R&D expenditures. The share of the small-scale
sector too has shown some increases and in 1995-96 (the latest year for
which such data are available) stood at around 8 per cent. The small-
scale sector is entirely in the private sector and so if one adds the small-
scale sector data to that of the private sector, latter's share is even higher.
The reduction in public sector's share is to be explained by the fact that
two leading public sector enterprises, HAL and IDPL, as mentioned
above, are financially speaking distressed.
The firm-level analysis (Table 7) further confirms that even with
in a short period of time the R&D expenditure of the firms under
31
consideration have actually trebled although the research intensity for
all the firms together have increased only slightly. However many of the
leading firms have increased their research intensities thus prompting us
to believe that the firms are responding to the challenges posed by a
TRIPS compliant innovation regime.
Table 7: R&D expenditure of leading Indian pharmaceutical firms
(Rs in Crores)
2001-02 2003-04
R&D R&D R&D R&D
Intensity Intensity
(%) (%)
1. Ranbaxy 77 3.6 276 6.1
2. Dr Reddy's Laboratory 111 7.1 226 13.0
3. Sun Pharma 34 4.4 108 10.2
4. Cadila Health Care 42 7.1 88 7.6
5. Wokhardt 30 4.4 60 6.2
6. Cipla 22 3.5 57 2.9
7. Nicolas Piramal 10 1.2 56 4.4
8. Lupin 54 5.6 46 3.7
9. Aurobindo Pharma 13 1.3 46 3.5
10. Torrent Pharma 22 5.1 40 8.9
11. Glenmark Pharma 12 4.7 37 9.8
12. Biocon India 7 4.4 23 4.4
13. USV Ltd 12 3.3 21 0.4
14. Alembic 14 2.3 20 3.2
15. IPCA Labs 8 1.8 17 2.6
16. Sushan 9 2.3 11 4.0
17. Cadila Pharma 9 2.3 10 2.4
18. Unichem 10 3.3 8 2.2
Total 496 4.0 1150 4.7
Source: Lok Sabha Unstarred Question no: 1916, http://164.100.24.208/
lsq14/quest.asp?qref=19536 (accessed on March 15 2006)
32
Despite this high growth the R&D expenditure incurred by Indian
firms is only a very small percentage of what is expended by foreign
firms (Figure 6).
Figure 6: R&D intensity of Indian and Western MNCs, 2001
Source: KPMG (2003)
Indian companies have been active patenting entities in the US as
far as pharmaceutical technologies are concerned (Table 8).
Pharmaceutical patents now (2000-2004 period) account for over 20 per
cent of all patents granted to Indian inventors. An important finding is
that the number of pharmaceutical patents granted to Indian inventors
has actually increased significantly during the latter period. This means
that the impending TRIPS compliance of India's patent regime has
actually made the Indian inventors more innovative. This fact is hardly
realised in the Indian literature on this issue.9
9 Even the rather conservative “Economist” of London in one of its most recent
stories on the Indian pharmaceutical industry had the following caption “Mere
copycats no longer, Indian firms are flaunting their research skills”. See
Economist (2006), http://www.economist.com/business/displayStory.
cfm?story_id=5476754
33
Table 8: Patenting performance of India in pharmaceutical technology classes in the US
India China South Africa Brazil All Indian Share of Indian
patents Pharma patents
in the US in all Indian
patents
2000 36 8 5 4 110 33
2001 46 20 4 0 174 26
2002 48 19 5 3 239 20
2003 72 24 7 9 329 22
2004 44 23 1 1 347 13
Total During
2000-2004 246 94 22 17 1199 21
Total During
1995-1999 56 316 18
Note *Based on US Patent Class 424, Drug, Bio-Affecting and Body Treating Compositions (includes Class 514))
Source: USPTO (2005)
34
It is also interesting note that most of the Indian patents (excluding
individually owned patents) have been granted to private sector
enterprises (Table 9), although the network of government research
institutes under the CSIR is also a strong contender.
Table 9:Distribution of Indian patenting organizations in
pharmaceutical technologies in the US, 2000-2004
Share
Council of Scientific and Industrial Research 46
Ranbaxy Laboratories 19
Dabur Research Foundation 10
Dr Reddy's Research Foundation 9
Panacea Biotec 4
Wockhardt 3
Biocon 3
Torrent 3
Aurobindop 3
Total 100
Source: USPTO (2005)
There are several instances of real innovations by Indian pharma
companies. Of the various instance, although a small number by Western
standards, two stand out. The first one is by Dr. Reddy's Laboratories
(DRL) which entered into agreements in 1997 and 1998 with global
pharmaceutical giant Novo Nordisk to license molecules for further
development. The second one is by the country's largest pharmaceutical
company, Ranbaxy, when it licensed its technology for an innovative
drug delivery system for ciprofloxacin, named Cipro-OD, to Germany's
Bayer, which owned the patent to the drug. (OD stands for once a day,
which was Ranbaxy's innovation.)10
India's strength in this area, as in information technology (IT), is
its talent pool. According to some estimates the country has 122,000
10 This information is based on Knowledge@Wharton (2005)
35
chemists and chemical engineers graduating each year and the
compensation that needs to be paid to these scientists are much lower
than that in the West. Goldman Sachs, an investment bank, estimates
that India's overall research-and-development costs are one-eighth of
Western levels.
Even so, no domestic company yet has the financial clout to become
a big drug innovator. This is because new drug development is a highly
uncertain affair with far more failures than successes. The cost of
developing a new drug to be marketed worldwide is usually put at about
$1 billion. Two of the leading Indian pharma companies, Ranbaxy and
Dr Reddys Laboratories are in the process of doing R&D with a view to
developing and marketing their own proprietary drugs in the near future.
Given its high quality talent pool and tremendous cost advantages an
area where the industry has immense potential is in R&D outsourcing or
contract research deals. This will be discussed in detail in the next section.
Given that much of the pharmaceutical production in the country
is of generic in nature, conventional indicators such as R&D investments
and patents are not really good measures to gauge the innovativeness of
this industry. Drug Master Files (DMFs) and Abbreviated New Drug
Applications (ANDA) approved by the USFDA can be taken as a good
indicator of the innovation capability of generic manufacturers.
Systematic data on county-wise number of DMF and ANDA applications
approved are not available from the Office of Generic Drugs of the
USFDA. The total number of ANDA applications approved by the
USFDA is presented in Figure 7. It is estimated that approximately a
third of these have gone towards Indian companies.11
11 According to Agres (2005) Indian companies were responsible for submitting
nearly 21% (73 of 350) of all abbreviated new drug applications (ANDAs) to
the FDA last year. This is expected to increase to about a third of the anticipated
500 ANDAs in 2005, according to a report by Credit Lyonnais Securities. Further
the Indian firms now account for 35 percent of Drug Master File applications.
The DMF filing gives details about a company’s facilities for manufacturing,
processing, and storing drugs.
36
0
50
100
150
200
250
300
350
400
450
500
Total number of ANDA
approvals
Total number of ANDA approvals in th e US 213 230 306 249 266 294 310 364 373 413 467
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Figure 7: Total number of ANDA applications approved in the US,
1995-2005
Source: Buehler (2005)
Growing contract research
There are two dimensions to this. First, is R&D outsourcing by
Western MNCs to Indian entities and second is the growth of clinical
trials.
R&D outsoucing is being done primarily to minimize the expenses,
time and risk involved in R&D. The estimations from industry sources
reflect that the cost of bringing one new molecule into the market amounts
to USD 1 billion. The European Federation of Pharmaceutical Industries
and Associations (EFPIA) estimates that, on an average out of 10,000
molecules developed in laboratories, only one or two will successfully
pass all stages of drug development and be commercialised.
Pharmaceutical companies looking for effective solutions, thus, prefer
outsourcing to low-cost, developing countries rather than persisting with
expensive R&D efforts in the West. Alliances with local companies,
contractual outsourcing arrangements and establishing local subsidiaries
37
are good options for enterprises thinking of utilising the strong intellectual
potential in India and indeed in China too. "Contract research
organisations (CROs) are a popular option and carry out medical and
scientific studies on a contractual basis for multiple clients," says Frost
& Sullivan Industry (http://pharmaceuticals.frost.com). These
outsourcing activities in developing countries amount to 20.0 to 30.0
per cent of total global clinical trials. Access to specialised skills in both
countries and work hours on a 24/7 basis underpins their competitive
advantage. In addition, better management from the start reduces
development risks.
Recent amendments to Schedule Y of Drugs and Cosmetics Rules
of India, 1945, signify a progressive attitude on the part of the Indian
Government, clarifying the environment for clinical research in the
country attain international standards in pharmaceutical research.
India, at the moment, is the most preferred destination for clinical
research because of its heterogeneous huge but treatment naïve patient
population; English-speaking western educated investigators (physicians)
and track record of sincerity in meeting regulatory and recruitment
timelines, and most importantly well accepted good quality auditable
data. While the global pharmaceutical companies are increasing their
clinical trial investments in India, many small and big regional pharma
companies are considering India in their drug development initiatives.
There is a perceptible change in the old mindset of people - from
skepticism to acceptance - of the capability, skill-sets and quality of data
in Indian trials.
Cost-effectiveness, competition and the increased confidence on
capabilities and skill sets have propelled many global pharmaceutical
players (Pfizer, Novartis, Astra Zeneca, Eli Lilly, GSK, Aventis, Novo
Nordisk to name but a few) to expand their own clinical research
investment and infrastructure in India. Evaluating the business
progression and futuristic projections of top notch services firm like
38
Ernst & Young, McKinsey, Strategic Associates etc, while global
pharmaceutical companies and Contract Research Organisations (CRO)
are opening up their branches / offices, the small biotech, pharmaceutical
and Research and Development (R&D) companies are looking for
preferred partners to conduct their research activities in India. The report
captures the striking regulatory change i.e. the amendment of Schedule
Y (2005), which is a step towards harmonizing the Indian regulatory
framework with international Good Clinical Practice (GCP) for all the
stakeholders in clinical research including the sponsors, CROs, Site
Management Organisations (SMOs), Institutional Ethics Committees
(IECs), Investigators and the subjects participating in clinical trials in
India
The country can accommodate these business expansions because
of the availability of huge talent pool of Investigators and clinical research
professionals.
India's growth in pharmaceutical and biotech manufacturing, and
contract research supported by IT skills has led to promising outsourcing
business in various other segments including Clinical trial data
management, statistical analysis.
The clinical research industry in the country is currently valued at
$100 million (• 83 million) and is almost doubling each year, reflecting
the shifting focus of the pharmaceutical outsourcing industry to Asia.
The findings are published in a recent report analyzing the clinical
research industry and 33 leading contract research organizations (CROs)
in India, put together by US pharmaceutical consulting firm, Proximare12.
A previous barrier to outsourcing to India has been that companies
are worried about probable loss of control in processes and proprietary
12 In fact there are no official sources of data on the number of contract research
oroganizations in India.
39
knowledge and delays due to regulatory hold-ups. Recent amendments
to Schedule Y of Drugs and Cosmetics Rules of India, 1945, signify a
progressive attitude on the part of the Indian Government, clarifying the
environment for clinical research in the country. Executives at large and
small pharmaceutical and biotech companies are increasingly becoming
intrigued about India and how they can leverage it to launch high quality
products in a quicker and more cost-effective manner.
IV. Conclusions
India's innovation system is dominated by the pharmaceutical
industry. The industry has achieved self-sufficiency in most drugs,
although a number of active pharmaceutical ingredients are still being
imported. It is very well understood that the old patents regime has
enabled the pharmaceutical industry to enhance its domestic
technological capability. This capability to reverse engineer known
pharmaceutical products have given some of the firms sufficient learning
to engage in the development of NCEs in a TRIPS compliant product
patent regime. However none of the firms are doing research on the
neglected diseases. In sum, the TRIPS compliant patent regime does not
appear to have dampened the innovation capability of the domestic
pharmaceutical industry, and on the contrary they have both increased
their research budgets and patenting. However none of the components
of the sectoral system of innovation has sufficient knowledge and
capability in the entire sequence of doing research, developing a molecule
and introducing a new drug in the market. In fact our study shows that
this is an area where public policy ought to be focusing upon.
40
References
Agres, Ted (2005), ‘Outsourcing spikes competition’ Drug Discovery
and Development, http://www.dddmag.com/default.aspx
(accessed on January 31 2006).
Buehler, Gary (2005), ‘Update from the Office of Generic Drugs’, Centre
for Drug Evaluation and Research, Food and Drugs
Administration, Generic Pharmaceutical Association, 2005
Annual Meeting.
Chaudhuri, Sudip (2005) The WTO and India's Pharmaceuticals Industry
Patent Protection, TRIPS, and Developing Countries, New Delhi:
Oxford University Press.
Department of Science and Technology (various issues), R&D Statistics,
New Delhi: Department of Science and Technology, Government
of India.
Knowledge at Wharton (2005), ‘How R&D is changing Indian Pharma
and Autocompanies?’, Knowledge at Wharton, November 21.
KPMG (2003), ‘The Emerging Face of India Pharma Inc-New Horizons’,
Presentation at the PHARMAEXPO 2003, Mumbai: KPMG
Consulting Private Ltd.
KPMG (2006), The Indian Pharmaceutical Industry, Collaboration for
Growth, Mumbai: KPMG Consulting Private Ltd.
Malerba, Franco (2004, ed.), Sectoral Systems of Innovation, Concepts,
Issues and Analyses of Six Major Sectors in Europe, Cambridge:
Cambridge University Press.
Mashelkar Committee (2003) Report of the expert committee on a
comprehensive examination of drug regulatory issues, including
the problem of spurious drugs. New Delhi: Central Drugs
Standard Control Organization.
Ramani, Shyama V, P. Pradhan and M.Ravi (2005), ‘Biotech in post
TRIPS India’, Nature Biotechnology, Volume 23, no.1, 18-19.
41
Smith, Sean Eric (2000), 'Opening up to the world: India's Pharmaceutical
Companies Prepare for (2005)', Stanford: Asia Pacific Research
Centre, Institute for International Studies, Stanford University.
USPTO (2005), Patenting By Geographic Region (State and Country),
Breakout by Technology Class, Patent Technology Monitoring
Division, U.S. Patent And Trademark Office.
42
Annexure : Indian GRIs engaged in drug research and their respective areas of core competence
Sl. No Name of the laboratory Areas of competence
1 Central Drug Research Institute Drug discovery to development, synthetic/natural product
(CDRI, Lucknow) chemistry, combinatorial chemical synthesis, molecular
modelling, HTS, structural biology, broad-based biological screening,
pharmacology, pharmaco-kinetics, toxicology, phase I clinical
studies, chemical and fermentation technology, quality control
and standardization, proteomics, medicinal chemistry, molecular
and cell biology, pharmacology, and phytochemicals/herbal
drugs/nutraceuticals research.
2 Indian Institute of Chemical Synthetic/natural products/medicinal chemistry, infectious
Biology (IICB, Kolkata) diseases, cellular physiology, drug designing, molecular modelling,
molecular biology, biotechnology, cell signals for oncogene
expression and metabolic diseases, immunology, human
genetics, genomics, proteomics, bioinformatics, molecular
and cell biology, pharmacology, phytochemicals/nutraceuticals.
43
3 Indian Institute of Chemical Synthetic and natural products chemistry, chemical /process engineering,
Technology (IICT, Hyderabad) combinatorial/medical chemistry, asymmetric synthesis for chiral drugs,
custom synthesis, computer-aided modelling and drug design,
glyco-therapeutics, peptides and peptido-mimetics, enzyme mimics
(drug delivery systems), pharmacology, pre-clinical toxicity
pharmacokinetics, toxicology, phytochemicals/herbal drugs/
nutraceuticals research, quality control and formulation.
4 Indian Institute of Microbial Molecular and cell biology, microbial genetics, immunology,
Technology (IMTECH, Chandigarh) structural biology, protein engineering, fermentation technology,
culture type depository, microbial gene bank, bioinformatics,
proteomics, molecular and cell biology.
5 Institute of Genomics and Integrative Genomics & Molecular Medicine, Predictive medicine,
Biology (IGIB, Delhi) Genome Informatics (in-silico biology), Bio-informatics,
Pathway modelling, Proteomics structural biology,
Comparative Genomics & Gene Expression, Immunology and
molecular genetics of respiratory disorders including allergy,
Nucleic Acids & Peptides, Bioactive molecules of medicinal
importance
Sl. No Name of the laboratory Areas of competence
44
6 Regional Research Laboratory Agrotechnology, synthetic (chiral) and natural product chemistry,
(RRL-Jammu) herbal drugs, select biological screening, bioprospecting,
microbial biodiversity for industrially useful enzymes,
genetic fingerprinting, identification/authentication of medicinal
plants, fermentation technology, quality control and standardization
of herbal drugs, establishment of medicinal plants gene
bank, bioinformatics, pharmacology phytochemicals/herbal
drugs/nutraceuticals research.
7 Central Institute of Medicinal and Agrotechnology of economically important herbs, process
Aromatic Plants (CIMAP, Lucknow) technology for phytochemicals, herbal drugs, nutraceuticals,
genetic finger printing of plants/herbs, plant bioinformatics,
genetic improvement, bioprospecting, molecular and cell biology,
quality control and formulation.
9 Centre for Cellular and Molecular Advanced molecular and cell biology, biotechnology, sperm-associated
Biology (CCMB, Hyderabad) proteins/fertility-potential of sperm, DNA-fingerprinting,
signal transduction, eye diseases, hepatitis vaccine, microbial
genetics, transgenics, anti-microbial proteins, genomics,
proteomics molecular and cell biology
Sl. No Name of the laboratory Areas of competence
45
10 National Chemical Laboratory Synthetic chemistry, tissue culture, biotechnology,
(NCL, Pune) industrial microbiology, nanoparticle technology, smart
polymer gels, chemical/process engineering,
process/enzyme/fermentation technology, combinatorial
chemistry, medicinal chemistry, quality control and formulation
11 Institute of Himalayan Bioresource Identification, collection, isolation and characterization of
Technology (IHBT, Palampur) plants and microbes chemical and molecular characterization
of bioactives, genomics, tissue culture, agro-technology of
medicinal plants, phytochemicals/herbal drugs/nutraceuticals
research, and chemical/process engineering
12 Industrial Toxicology Research In vitro test systems for bio-evaluation/identification of molecules
Centre (ITRC, Lucknow) or neurological disorders and antioxidant activity, complete
toxicity evaluation in small animals; identification and action
mode of hazardous toxicants/pollutants, diagnostics for
toxicants/pollutants; safety evaluation/preventive measures
for environmental/industrial hazards, and quality assessment of
drinking water
Sl. No Name of the laboratory Areas of competence
46
13 National Botanical Research Pharmacognosy, ethnopharmacology, herbal drugs (authentication,
Institute (NBRI, Lucknow) standardization, characterization), nutraceuticals, agro-technology
of medicinal plants, plant bioinformatics, genetic characterization
and genetic improvement of economically important plants,
proteomics, transgenics, molecular and cell biology, pharmacology
phytochemicals/herbal drugs, quality control and formulation
14 Central Salt & Marine Chemicals Bioactives from plants, cultivation of desert economic plants
Research Institute (CSMCRI, and their value addition, sea weed cultivation, phycocolloids
and marine microbes, biotechnology, synthetic chemistry
and drug intermediates desalination water treatment technology
for pure water for drinking, low sodium and plant/herbal salt
15 Regional Research Laboratory Bioactives from plants, drugs and drug intermediates, isolation
(RRL, Jorhat). and characterization of active molecules and analytical services
16 National Institute of Oceanography Collection and identification of marine flora and fauna, biological
(NIO, Goa) screening (antimicrobial, anticancer, oxytocic, anti-inflammatory,
anti-fouling cytotoxic, antimalarial, antiosteoporotic
antiviral, immunomodulatory) and marine natural product chemistry
for the identification and structure elucidation of active molecules
Sl. No Name of the laboratory Areas of competence
47
17 Regional Research Laboratory Synthesis of drugs/drug intermediates, natural product isolation,
(RRL-Thiruvananthapuram) biological screening, chemical finger printing, herbal drugs,
nutraceuticals, bioprocess/enzyme technology and phytochemicals.
18 Central Food Technological Nutraceuticals, health-promoting effects of spices/herbs/foods
Research Institute (antioxidants, digestion-stimulants, anti-inflammatory), traditional
(CFTRI, Mysore) remedies, food-safety/nutritional toxicology, nodal codex food
laboratory, animal and plant cell culture, PCR probes and biosensors,
phytochemicals/nutraceuticals research,quality control & formulation,
toxicology and bioprocess/enzyme/fermentation technology
19 Central Leather Research Institute Controlled drug delivery systems, collagen-based biomaterials,
(CLRI, Chennai) skin biology
20 Central Glass and Ceramics Research Ceramic membrane technology based water purification
Institute (CGCRI, Kolkata) technologies, Ceramic based bio-medical implants
21 National Environmental Engineering Water purification, diagnostic kits etc.
Research Institute (NEERI, Nagpur)
Source: http://www.csir.res.in/External/Utilities/Frames/achievements/main_page.asp?a=topframe.htm&b=leftcon.
htm&c=../../../Heads/achievements/major_achievements.htm (accessed on March 18 2005)
Sl. No Name of the laboratory Areas of competence
48
CENTRE FOR DEVELOPMENT STUDIES
LIST OF WORKING PAPERS
[New Series]
The Working Paper Series was initiated in 1971. A new series was started
in 1996 from WP. 270 onwards. Working papers beginning from 279
can be downloaded from the Centre's website (www.cds.edu)
W.P. 381 K. J. JOSEPH, GOVINDAN PARAYIL Trade Liberalization
and Digital Divide: An Analysis of the Information
Technology Agreement of WTO. July 2006.
W.P. 380 RUDRA NARAYAN MISHRA Dynamics of Caste-based
Deprivation in Child Under-nutrition in India. July 2006.
W.P. 379 P.L.BEENA, Limits to Universal Trade Liberalisation: The
Contemporary Scenario for Textiles & Clothing Sector in
South Asia. March 2006.
W.P. 378 K.N. NAIR, VINEETHA MENON, Lease Farming in
Kerala: Findings from Micro Level Studies. November 2005.
W.P. 377 NANDANA BARUAH, Anti Dumping Duty as a Measure of
Contingent Protection: An Analysis of Indian Experience.
October 2005.
W.P. 376 P. MOHANAN PILLAI, N. SHANTA Long Term Trends
in the Growth and Structure of the Net State Domestic Product
in Kerala. October 2005.
W.P. 375 R. MOHAN, D. SHYJAN Taxing Powers and
Developmental Role of the Indian States: A Study with
reference to Kerala. August 2005.
W.P. 374 K. C. ZACHARIAH, S. IRUDAYA RAJAN. Unemployment
in Kerala at the Turn of the Century: Insights from CDS Gulf
Migration Studies. August 2005.
W.P. 373 SUNIL MANI, The Dragon vs. The Elephant Comparative
Analysis of Innovation Capability in the Telecommunications
Equipment Industry in China and India. July 2005
W.P. 372 MOTKURI VENKATANARAYANA On The Non-Random
Distribution of Educational Deprivation of Children in India.
July 2005
W.P. 371 DIBYENDU S. MAITI Organisational Morphology of Rural
Industries in Liberalised India: A Study of West Bengal.
June 2005
49
W.P. 370 SUNIL MANI,
Keeping Pace with Globalisation Innovation
Capability in Korea’s Telecommunications Equipment Industry.
March 2005.
W.P. 36 9 V.R. PRABHAKARAN NAIR, Determinants of Fixed
Investment: A Study of Indian Private Corporate
Manufacturing Sector. March 2005.
W.P. 36 8 J. DEVIKA, Modernity with Democracy? : Gender and
Governance in the People’s Planning Campaign, Keralam.
February 2005
W.P. 36 7 VINEETHA MENON, ANTONYTO PAUL, K N NAIR
Dynamics of Irrigation Institutions: Case study of a Village
Panchayat in Kerala. February 2005
W.P. 366 VIJAYAMOHANAN PILLAI N. Causality and Error
Correction in Markov Chain: Inflation in India Revisited.
December 2004.
W.P. 365 R. MOHAN. Central Finances in India - Alternative to
Procrustean Fiscal Correction. November 2004.
W.P. 364 SUNIL MANI. Coping with Globalisation Public R&D
Projects in Telecommunications Technologies in Developing
Countries. November 2004.
W.P. 363 K C ZACHARIAH, S IRUDAYA RAJAN. Gulf Revisited
Economic Consequences of Emigration From Kerala,
Emigration and Unemployment. September 2004.
W.P. 362 M. VENKATANARAYANA. Educational Deprivation of
Children in Andhra Pradesh, Levels and Trends, Disparities
and Associative Factors. August 2004.
W.P. 361 K. P. KANNAN, VIJAYAMOHANAN PILLAI N. Development
as a Right to Freedom: An Interpretation of the Kerala Model.
August 2004.
W.P. 360 VIJAYAMOHANAN PILLAI N. CES Function, Generalised
Mean and Human Poverty Index: Exploring Some Links.
July 2004.
W.P. 359 PRAVEENA KODOTH, Shifting the Ground of Fatherhood:
Matriliny, Men and Marriage in Early Twentieth Century
Malabar. May 2004.
W.P. 358 MRIDUL EAPEN. Women and Work Mobility: Some
Disquieting Evidences from the Indian Data. May 2004.
50
W.P. 357 K. RAVI RAMAN. The Asian Development Bank Loan for
Kerala (India): The Adverse Implications and Search for
Alternatives, March 2004.
W.P. 356 VIJAYAMOHANAN PILLAI N. Liberalisation of Rural
Poverty: The Indian Experience, March 2004.
W.P. 355 P.L.BEENA Towards Understanding the Merger-Wave in the
Indian Corporate Sector: A Comparative Perspective, January
2004.
W.P. 354 K.P. KANNAN AND R. MOHAN India’s Twelfth Finance
Commission A View from Kerala, December 2003.
W.P. 353 K.N. HARILAL AND P.L. BEENA The WTO Agreement on
Rules of Origin Implications for South Asia, December 2003.
W.P. 352 K. PUSHPANGADAN Drinking Water and Well-being In
India: Data Envelopment Analysis, October 2003.
W.P. 351 INDRANI CHAKRABORTY Liberalization of Capital
Inflows and the Real Exchange Rate in India : A VAR
Analysis, September 2003.
W.P. 350 M.KABIR Beyond Philanthropy: The Rockefeller
Foundation’s Public Health Intervention in Thiruvithamkoor,
1929-1939, September 2003.
W.P. 349 JOHN KURIEN The Blessing of the Commons : Small-Scale
Fisheries, Community Property Rights, and Coastal Natural
Assets, August 2003.
W.P. 348 MRIDUL EAPEN, Rural Industrialisation in Kerala: Re-
Examining the Issue of Rural Growth Linkages, July 2003.
W.P. 347 RAKHE PB, Estimation of Tax Leakage and its Impact
on Fiscal Health in Kerala, July 2003.
W.P. 346 VIJAYAMOHANAN PILLAI N, A contribution to Peak load
pricing theory and Application. April 2003.
W.P. 345 V.K. RAMACHANDRAN, MADHURA SWAMINATHAN,
VIKAS RAWAL Barriers to Expansion of Mass Literacy and
Primary Schooling in West Bengal: Study Based on Primary Data
from Selected Villages. April 2003.
W.P. 344 PRADEEP KUMAR PANDA Rights-Based Strategies in the
Prevention of Domestic Violence, March 2003.
W.P. 343 K. PUSHPANGADAN Remittances, Consumption and
Economic growth in Kerala: 1980-2000, March 2003.
W.P. 342 D NARAYANA Why is the Credit-deposit Ratio Low in Kerala?
January 2003.
51
W.P. 341 MRIDUL EAPEN, PRAVEENA KODOTH Family Structure,
Women’s Education and Work: Re-examining the High Status
of Women in Kerala. November 2002.
W.P. 340 J. DEVIKA, Domesticating Malayalees: Family Planning,
the Nation and Home-Centered Anxieties in Mid- 20th Century
Keralam. October, 2002.
W.P. 339 M PARAMESWARAN, Economic Reforms and Technical
Efficiency: Firm Level Evidence from Selected Industries in
India. October, 2002.
W.P. 338 PRAVEENA KODOTH, Framing Custom, Directing
Practices: Authority, Property and Matriliny under Colonial
Law in Nineteenth Century Malabar, October 2002.
W.P. 337 K.NAVANEETHAM, Age Structural Transition and Economic
Growth: Evidence From South and Southeast Asia, August 2002.
W.P. 336 PULAPRE BALAKRISHNAN, K. PUSHPANGADAN,
M. SURESH BABU, Trade Liberalisation, Market Power and
Scale Efficiency in Indian Industry, August 2002.
W.P. 335 J. DEVIKA, Family Planning as ‘Liberation’: The Ambiguities
of ‘Emancipation from Biology’ in Keralam July 2002.
W.P. 334 E. ABDUL AZEEZ, Economic Reforms and Industrial
Performance an Analysis of Capacity Utilisation in Indian
Manufacturing, June 2002.
W.P. 333 K. PUSHPANGADAN Social Returns from Drinking Water,
Sanitation and Hygiene Education: A Case Study of Two Coastal
Villages in Kerala, May 2002.
W.P. 332 K. P. KANNAN, The Welfare Fund Model of Social Security
for Informal Sector Workers: The Kerala Experience.
April 2002.
W.P. 331 SURESH BABU, Economic Reforms and Entry Barriers in
Indian Manufacturing. April 2002.
W.P. 330 ACHIN CHAKRABORTY, The Rhetoric of Disagreement in
Reform Debates April 2002.
W.P. 329 J. DEVIKA, Imagining Women's Social Space in Early Modern
Keralam. April 2002.
W.P. 328 K. P. KANNAN, K. S. HARI, Kerala's Gulf Connection
Emigration, Remittances and their Macroeconomic Impact 1972-
2000. March 2002.
W.P. 327 K. RAVI RAMAN, Bondage in Freedom, Colonial Plantations
in Southern India c. 1797-1947. March 2002.
52
W.P. 326 K.C. ZACHARIAH, B.A. PRAKASH, S. IRUDAYA RAJAN,
Gulf Migration Study : Employment, Wages and Working
Conditions of Kerala Emigrants in the United Arab Emirates.
March 2002.
W.P. 325 N. VIJAYAMOHANAN PILLAI, Reliability and Rationing
cost in a Power System. March 2002.
W.P. 324 K. P. KANNAN, N. VIJAYAMOHANAN PILLAI, The
Aetiology of the Inefficiency Syndrome in the Indian Power Sector
Main Issues and Conclusions of a Study. March 2002.
W.P. 323 V. K. RAMACHANDRAN, MADHURA SWAMINATHAN,
VIKAS RAWAL, How have Hired Workers Fared? A Case Study
of Women Workers from an Indian Village, 1977 to 1999.
December 2001.
W.P. 322 K. C. ZACHARIAH, The Syrian Christians of Kerala:
Demographic and Socioeconomic Transition in the Twentieth
Century, November 2001.
W.P. 321 VEERAMANI C. Analysing Trade Flows and Industrial
Structure of India: The Question of Data Harmonisation,
November 2001.
W.P. 320 N. VIJAYAMOHANAN PILLAI, K. P. KANNAN, Time and Cost
Over-runs of the Power Projects in Kerala, November 2001.
W.P. 319 K. C. ZACHARIAH, P. R. GOPINATHAN NAIR,
S. IRUDAYARAJAN Return Emigrants in Kerala: Rehabilitation
Problems and Development Potential. October 2001
W.P. 318 JOHN KURIEN, ANTONYTO PAUL Social Security Nets
for Marine Fisheries-The growth and Changing Composition of
Social Security Programmes in the Fisheries Sector of Kerala
State, India. September 2001.
W.P. 317 K. J. JOSEPH, K. N. HARILAL India's IT Export Boom:
Challenges Ahead. July 2001.
W.P. 316 K. P. KANNAN, N. VIJAYAMOHANAN PILLAI The Political
Economy of Public Utilities: A Study of the Indian Power Sector,
June 2001.
W.P. 315 ACHIN CHAKRABORTY The Concept and Measurement of
Group Inequality, May 2001.
W.P. 314 U.S.MISHRA, MALA RAMANATHAN Delivery Compli-cations
and Determinants of Caesarean Section Rates in India - An Analysis
of National Family Health Surveys, 1992-93, March 2001.
53
W.P. 313 VEERAMANI. C India's Intra-Industry Trade Under Economic
Liberalization: Trends and Country Specific Factors, March 2001
W.P. 312 N. VIJAYAMOHANAN PILLAI Electricity Demand Analysis
and Forecasting –The Tradition is Questioned, February 2001
W.P. 311 INDRANI CHAKRABORTY Economic Reforms, Capital Inflows
and Macro Economic Impact in India, January 2001
W.P. 310 K. K. SUBRAHMANIAN. E. ABDUL AZEEZ, Industrial Growth
In Kerala: Trends And Explanations November 2000
W.P. 309 V. SANTHAKUMAR, ACHIN CHAKRABORTY, Environmental
Valuation and its Implications on the Costs and Benefits of a
Hydroelectric Project in Kerala, India, November 2000.
W.P. 308 K. P. KANNAN, N . VIJAYAMOHANAN PILLAI, Plight of the
Power Sector in India : SEBs and their Saga of Inefficiency
November 2000.
W.P. 307 K. NAVANEETHAM, A. DHARMALINGAM, Utilization of
Maternal Health Care Services in South India, October 2000.
W.P. 306 S. IRUDAYA RAJAN, Home Away From Home: A Survey of Oldage
Homes and inmates in Kerala, August 2000.
W.P. 305 K. N. HARILAL, K.J. JOSEPH, Stagnation and Revival of Kerala
Economy: An Open Economy Perspective, August 2000.
W.P. 304 K. P. KANNAN, Food Security in a Regional Perspective; A View
from 'Food Deficit' Kerala, July 2000.
W.P. 303 K. C. ZACHARIAH, E. T. MATHEW, S. IRUDAYA RAJAN ,
Socio-Economic and Demographic Consequenes of Migration in
Kerala, May 2000.
W.P. 302 K. PUSHPANGADAN, G. MURUGAN, Gender Bias in a
Marginalised Community: A Study of Fisherfolk in Coastal Kerala,
May 2000.
W.P. 301 P. L. BEENA An Analysis of Mergers in the Private Corporate
Sector in India, March, 2000.
W.P. 300 D. NARAYANA Banking Sector Reforms and the Emerging
Inequalities in Commercial Credit Deployment in India, March, 2000.
W.P. 299 JOHN KURIEN Factoring Social and Cultural Dimensions into
Food and Livelihood Security Issues of Marine Fisheries; A Case
Study of Kerala State, India, February, 2000.
W.P. 298 D. NARAYANA, K. K. HARI KURUP, Decentralisation of the
Health Care Sector in Kerala : Some Issues, January, 2000.
W.P. 297 K.C. ZACHARIAH, E. T. MATHEW, S. IRUDAYA RAJAN
Impact of Migration on Kerala's Economy and Society,
July, 1999.
54
W.P. 296 P.K. MICHAEL THARAKAN , K. NAVANEETHAM Population
Projection and Policy Implications for Education:A Discussion with
Reference to Kerala, July, 1999.
W.P. 295 N. SHANTA, J. DENNIS RAJA KUMAR Corporate Statistics:
The Missing Numbers, May, 1999.
W.P. 294 K. P. KANNAN Poverty Alleviation as Advancing Basic Human
Capabilities: Kerala's Achievements Compared, May, 1999.
W.P. 293 MRIDUL EAPEN Economic Diversification In Kerala : A Spa-
tial Analysis, April, 1999.
W.P. 292 PRADEEP KUMAR PANDA Poverty and young Women's Em-
ployment: Linkages in Kerala, February, 1999.
W.P. 291 P. K. MICHAEL THARAKAN Coffee, Tea or Pepper? Factors
Affecting Choice of Crops by Agro-Entrepreneurs in Nineteenth Cen-
tury South-West India, November 1998
W.P. 290 CHRISTOPHE Z. GUILMOTO, S. IRUDAYA RAJAN Regional
Heterogeneity and Fertility Behaviour in India,
November 1998.
W.P. 289 JOHN KURIEN Small Scale Fisheries in the Context of
Globalisation, October 1998.
W.P. 288 S. SUDHA, S. IRUDAYA RAJAN Intensifying Masculinity of Sex
Ratios in India : New Evidence 1981-1991, May 1998.
W.P. 287 K. PUSHPANGADAN, G. MURUGAN Pricing with Changing
Welfare Criterion: An Application of Ramsey- Wilson Model to Ur-
ban Water Supply, March 1998.
W.P. 286 ACHIN CHAKRABORTY The Irrelevance of Methodology and
the Art of the Possible : Reading Sen and Hirschman, February 1998.
W.P. 285 V. SANTHAKUMAR Inefficiency and Institutional Issues in the
Provision of Merit Goods, February 1998.
W.P. 284 K. P. KANNAN Political Economy of Labour and Development in
Kerala, January 1998.
W.P. 283 INDRANI CHAKRABORTY Living Standard and Economic
Growth: A fresh Look at the Relationship Through the Non- Para-
metric Approach, October 1997.
W.P. 282 S. IRUDAYA RAJAN, K. C. ZACHARIAH Long Term Implica-
tions of Low Fertility in Kerala, October 1997.
W.P. 281 SUNIL MANI Government Intervention in Industrial R & D, Some
Lessons from the International Experience for India, August 1997.
55
W.P. 280 PRADEEP KUMAR PANDA Female Headship, Poverty and Child
Welfare : A Study of Rural Orissa, India, August 1997.
W.P. 279 U.S. MISRA, MALA RAMANATHAN, S. IRUDAYA RAJAN
Induced Abortion Potential Among Indian Women,
August 1997.
W. P. 278 PRADEEP KUMAR PANDA The Effects of Safe Drinking Water
and Sanitation on Diarrhoeal Diseases Among Children in Rural
Orissa, May 1997.
W. P. 277 PRADEEP KUMAR PANDA Living Arrangements of the Elderly
in Rural Orissa, May 1997.
W. P. 276 V. SANTHAKUMAR Institutional Lock-in in Natural Resource
Management: The Case of Water Resources in Kerala, April 1997.
W.P. 275 G. OMKARNATH Capabilities and the process of Development
March 1997.
W.P. 274 K. PUSHPANGADAN, G. MURUGAN User Financing & Col-
lective action: Relevance sustainable Rural water supply in India.
March 1997.
W.P. 273 ROBERT E. EVENSON, K.J. JOSEPH Foreign Technology
Licensing in Indian Industry : An econometric analysis of the choice
of partners, terms of contract and the effect on licensees’ perform-
ance March 1997.
W.P. 272 SUNIL MANI Divestment and Public Sector Enterprise Reforms,
Indian Experience Since 1991 February 1997.
W.P. 271 SRIJIT MISHRA Production and Grain Drain in two inland
Regions of Orissa December 1996.
W.P. 270 ACHIN CHAKRABORTY On the Possibility of a Weighting
System for Functionings December 1996.
56
BOOKS PUBLISHED BY THE CDS
Biodiversity, Sustainable Development and Economic Analysis
J. Hans B. Opschoor
CDS, 2004, Rs. 100/$11
Plight of the Power Sector in India: Inefficiency, Reform and
Political Economy
K.P. Kannan and N. Vijayamohanan Pillai
CDS, 2002, Rs. 400/$40
Kerala’s Gulf Connection: CDS Studies on International Labour
Migration from Kerala State in India
K.C. Zachariah, K. P. Kannan, S. Irudaya Rajan (eds)
CDS, 2002, pp 232, Hardcover, Rs. 250/$25
Performance of Industrial Clusters: A Comparative Study of
Pump Manufacturing Cluster in Coimbatore (Tamil Nadu) &
Rubber Footwear Cluster in Kottayam (Kerala)
P. Mohanan Pillai
CDS, 2001, pp 158, Paperback, Rs. 175/$18
Poverty, Unemployment and Development Policy : A Case Study
of Selected Issues With Reference to Kerala
United Nations, 2000 (reprint), pp 235
(available for sale in India only), Rs. 275
Land Relations and Agrarian Development in India:A Comparative
Historical Study of Regional Variations
Sakti Padhi
CDS,1999. pp 335, Hardcover, Rs. 425/$48
Agrarian Transition Under Colonialism: Study of A Semi Arid
Region of Andhra, C.1860-1900
GN Rao
CDS,1999. pp 133, Paperback, Rs. 170/ $19
Property Rights, Resource Management & Governance: Crafting
An Institutional Framework for Global Marine Fisheries
John Kurien
CDS & SIFFS, 1998. pp 56, Paperback, Rs. 50/ $10
57
Health, Inequality and Welfare Economics
Amartya Sen
CDS. 1996. pp 26, Paperback, Rs. 70/ $ 10
Industrialisation in Kerala: Status of Current Research and Future
Issues
P Mohanan Pillai & N Shanta
CDS. 1997. pp 74, Paperback, Rs. 110/ $ 12
CDS M.Phil Theses (1990/91-1993/94): A Review Vol.II
T T Sreekumar
CDS. 1996. pp 99, Paperback, Rs. 120/$ 14
Trends In Agricultural Wages in Kerala 1960-1990
A A Baby
CDS. 1996. pp 83, Paperback, Rs. 105/ $ 12
CDS M.Phil Theses (1975/76-1989/90): A Review Vol.1
G N Rao
CDS. 1996. pp 162, Paperback, Rs. 155/ $ 18
Growth of Education in Andhra - A Long Run View
C Upendranath
CDS. 1994. pp 158, Paperback, Rs. 135/ $ 15
Growth of Market Towns in Andhra: A Study of the Rayalseema
Region C 1900-C.1945
Namerta
CDS. 1994. pp 186, Paperback, Rs.125/ $ 14
Floods and Flood Control Policies: an Analysis With Reference to
the Mahanadi Delta in Orissa
Sadhana Satapathy
CDS. 1993 pp 98, Paperback, Rs. 110/$ 12
Growth of Firms in Indian Manufacturing Industry
N Shanta
CDS. 1994. pp 228, Hardcover, Rs. 250/ $ 28
Demographic Transition in Kerala in the 1980s
K C Zachariah, S Irudaya Rajan, P S Sarma, K Navaneetham,
P S Gopinathan Nair & U S Mishra,
CDS. 1999 (2nd Edition) pp 305, Paperback, Rs.250/ $ 28
58
Impact of External Transfers on the Regional Economy of Kerala
P R Gopinathan Nair & P Mohanan Pillai
CDS 1994. pp 36, Paperback, Rs.30/ $ 10
Urban Process in Kerala 1900-1981
T T Sreekumar
CDS. 1993. pp 86, Paperback, Rs.100/ $ 11
Peasant Economy and The Sugar Cooperative: A Study Of The
Aska Region in Orissa
Keshabananda Das
CDS. 1993. pp 146, Paperback, Rs.140/ $ 16
Industrial Concentration and Economic Behaviour: Case Study of
Indian Tyre Industry
Sunil Mani
CDS. 1993. pp 311, Hardcover, Rs. 300/ $ 34
Limits To Kerala Model of Development: An Analysis of Fiscal
Crisis and Its Implications.
K K George
CDS. 1999 (2nd edition) pp 128, Paperback, Rs. 160/ $ 18
Indian Industrialization: Structure and Policy Issues. (No Stock)
Arun Ghosh, K K Subrahmanian, Mridul Eapen & Haseeb A Drabu
(EDs).
OUP. 1992. pp 364, Hardcover, Rs.350/ $ 40
Rural Household Savings and Investment: A Study of Some
Selected Villages
P G K Panikar, P Mohanan Pillai & T K Sundari
CDS. 1992. pp 144, Paperback, Rs. 50/ $ 10
International Environment, Multinational Corporations and Drug
Policy
P G K Panikar, P Mohanan Pillai & T K Sundari
CDS. 1992. pp 77, Paperback, Rs.40/ $ 10
Trends in Private Corporate Savings
N Shanta
CDS. 1991. pp 90, Paperback, Rs. 25/ $ 10
59
Coconut Development in Kerala: Ex-post Evaluation
D Narayana, K N Nair, P Sivanandan, N Shanta and
G N Rao
CDS. 1991. pp 139, Paperback, Rs.40/ $ 10
Caste and The Agrarian Structure
T K Sundari
Oxford & IBH. 1991. pp 175, Paperback, Rs.125/ $ 14
Livestock Economy of Kerala
P S George and K N Nair
CDS. 1990. pp 189, Hardcover, Rs. 95/ $ 10
The Pepper Economy of India (No Stock)
P S George, K N Nair and K Pushpangadan
Oxford & IBH. 1989. pp 88, Paperback, Rs. 65/ $ 10
The Motor Vehicle Industry in India
(Growth within a Regulatory Environment)
D Narayana
Oxford & IBH. 1989. pp 99, Paperback, Rs. 75/ $ 10
Ecology or Economics in Cardamom Development
(No Stock)
K N Nair, D Narayana and P Sivanandan
Oxford & IBH. 1989. pp 99, Paperback, Rs. 75/ $ 10
Land Transfers and Family Partitioning
D Rajasekhar
Oxford and IBH. 1988. pp 90, Hardcover, Rs. 66/ $ 10
Essays in Federal Financial Relations
I S Gulati and K K George
Oxford and IBH. 1988. pp 172, Hardcover, Rs. 82/ $ 10
Bovine Economy in India
A Vaidyanathan
Oxford & IBH. 1988. pp 209, Hardcover, Rs. 96/ $ 11
Health Status of Kerala
P G K Panikar and C R Soman
CDS. 1984. pp 159, Hardcover , Rs.100/ $ 11 & Paperback, Rs. 75/ $ 10
